Cinacalcet (Tablets) Instructions for Use
ATC Code
H05BX01 (Cinacalcet)
Active Substance
Cinacalcet (Rec.INN registered by WHO)
Clinical-Pharmacological Group
Antiparathyroid drug
Pharmacotherapeutic Group
Drugs regulating calcium metabolism; antiparathyroid drugs, other antiparathyroid drugs
Pharmacological Action
Antiparathyroid agent. Calcium-sensing receptors located on the surface of the chief cells of the parathyroid glands are the main regulators of parathyroid hormone (PTH) secretion. Cinacalcet has a calcimimetic action, directly reducing PTH levels by increasing the sensitivity of this receptor to extracellular calcium. The reduction in PTH is accompanied by a decrease in serum calcium levels.
The reduction in PTH levels correlates with the concentration of cinacalcet. Soon after taking cinacalcet, PTH levels begin to decrease, with the maximum reduction occurring approximately 2-6 hours after a single dose, which corresponds to the Cmax of cinacalcet. After this, the concentration of cinacalcet begins to decrease, and the PTH concentration increases over the 12 hours following the dose, and then PTH suppression remains at approximately the same level until the end of the 24-hour interval with a once-daily dosing regimen.
After reaching steady state, the serum calcium concentration remains at a constant level throughout the interval between cinacalcet doses.
In patients with secondary hyperparathyroidism taking Cinacalcet, a significant reduction in intact PTH (iPTH) levels, Ca × P (calcium-phosphorus product), and serum calcium and phosphorus levels was observed. The reduction in iPTH and Ca × P concentrations was maintained over 12 months of therapy. Cinacalcet reduced iPTH, Ca × P, calcium, and phosphorus levels regardless of baseline iPTH or Ca × P levels, dialysis modality (peritoneal dialysis compared to hemodialysis), duration of dialysis, and whether or not vitamin D was used.
The reduction in PTH levels was associated with a non-significant decrease in bone metabolism markers (bone-specific alkaline phosphatase, N-telopeptides, bone turnover, and bone fibrosis).
In clinical studies of patients with parathyroid carcinoma and primary hyperparathyroidism, Cinacalcet at doses from 30 mg twice daily to 90 mg four times daily caused a reduction in serum calcium concentration of ≥1 mg/dL (≥ 0.25 mmol/L).
Pharmacokinetics
After oral administration, the Cmax of cinacalcet in plasma is reached approximately 2-6 hours later. The absolute bioavailability when taken on an empty stomach, established based on a comparison of results from various studies, was approximately 20-25%.
An increase in the AUC and Cmax of cinacalcet occurs almost linearly in the dose range of 30-180 mg once daily. At doses above 200 mg, absorption saturation is observed, likely due to poor solubility. The pharmacokinetic parameters of cinacalcet do not change over time.
Steady-state concentration (Css) of cinacalcet is achieved within 7 days with minimal accumulation. There is a large volume of distribution (Vd) of approximately 1000 L, indicating extensive distribution. Plasma protein binding is about 97%, with minimal distribution in red blood cells.
Cinacalcet is metabolized primarily by the CYP3A4 and CYP1A2 isoenzymes (the role of CYP1A2 has not been confirmed by clinical methods). The main metabolites found in the blood are inactive. According to in vitro studies, Cinacalcet is a potent inhibitor of CYP2D6. However, at concentrations achieved under clinical conditions, Cinacalcet does not suppress the activity of other isoenzymes (including CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP3A4) and is also not an inducer of CYP1A2, CYP2C19, or CYP3A4. After administration of a 75 mg dose labeled with a radioisotope to healthy volunteers, Cinacalcet underwent rapid and extensive oxidative metabolism followed by conjugation.
The decrease in cinacalcet concentration occurs in 2 phases: the initial half-life (T1/2) is approximately 6 hours, and the terminal T1/2 is 30-40 hours.
Metabolites are primarily excreted by the kidneys: approximately 80% of the dose was detected in urine and 15% in feces.
Compared to the group with normal liver function, the mean AUC values of cinacalcet were approximately 2 times higher in the group with moderate hepatic impairment, and approximately 4 times higher in severe hepatic failure. The mean T1/2 of cinacalcet in patients with moderate and severe hepatic failure increases by 33% and 70%, respectively.
The clearance of cinacalcet may be lower in women than in men.
The clearance of cinacalcet is higher in smokers than in non-smokers. This is apparently due to induction of CYP1A2-mediated metabolism. If a patient stops or starts smoking during therapy, the plasma concentration of cinacalcet may change and a dose adjustment may be required.
Indications
Secondary hyperparathyroidism in patients with end-stage renal disease on dialysis; hypercalcemia in patients (for the purpose of reducing severity) caused by the following conditions: parathyroid carcinoma and primary hyperparathyroidism, if, despite serum calcium concentrations, parathyroidectomy is clinically unacceptable or contraindicated.
ICD codes
| ICD-10 code | Indication |
| C75.0 | Malignant neoplasm of parathyroid gland |
| E21.0 | Primary hyperparathyroidism |
| N25.8 | Other disorders resulting from impaired renal tubular function (renal tubular acidosis, secondary hyperparathyroidism of renal origin) |
| ICD-11 code | Indication |
| 2D12.Z | Malignant neoplasms of other endocrine glands or related structures, unspecified |
| 5A51.0 | Primary hyperparathyroidism |
| GB90.44 | Renal tubular acidosis |
| GB90.46 | Tubular transport disorders of sodium or potassium |
| GB90.49 | Renal hypocalciuria |
| GB90.4Z | Disorders of renal tubules, unspecified |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Take tablets orally, always with food or shortly after a meal to enhance bioavailability.
Swallow tablets whole; do not split, crush, or chew them.
For secondary hyperparathyroidism in dialysis patients, initiate therapy at 30 mg once daily.
For parathyroid carcinoma or primary hyperparathyroidism, the recommended starting dose is also 30 mg twice daily.
Titrate the dose no more frequently than every 2 to 4 weeks based on biochemical response and tolerability.
Monitor serum calcium and intact PTH (iPTH) levels closely, especially after initiation or any dose adjustment.
For secondary hyperparathyroidism, increase the dose sequentially through 60 mg, 90 mg, 120 mg, and 180 mg once daily to achieve a target iPTH level of ≤ 300 pg/mL.
The maximum recommended dose for secondary hyperparathyroidism is 180 mg once daily.
For parathyroid carcinoma and primary hyperparathyroidism, titrate the dose sequentially through 60 mg twice daily, 90 mg twice daily, and 90 mg three or four times daily to normalize serum calcium.
The maximum recommended dose for these conditions is 90 mg four times daily.
If serum calcium falls below the normal range, initiate appropriate management with calcium supplements, calcium-containing phosphate binders, and/or vitamin D sterols.
For persistent or symptomatic hypocalcemia, reduce the dose or discontinue therapy immediately.
In patients with moderate to severe hepatic impairment, initiate therapy at the lowest possible dose and titrate cautiously with close monitoring.
Adjust the dose if a patient starts or stops smoking or begins/concludes therapy with a potent CYP3A4 inhibitor or inducer.
Adverse Reactions
From the digestive system: very often – nausea, vomiting; often – anorexia; sometimes – dyspepsia, diarrhea.
From the nervous system: often – dizziness, paresthesia; sometimes – seizures.
From the musculoskeletal system: often – myalgia.
From the endocrine system: often – decreased testosterone levels.
Dermatological reactions: often – rash.
Allergic reactions: sometimes – hypersensitivity reactions.
From the cardiovascular system: in patients with heart failure, isolated idiosyncratic cases of decreased blood pressure and/or worsening of heart failure have been reported.
Other: often – asthenia, hypocalcemia.
Contraindications
Childhood and adolescence under 18 years of age; hypersensitivity to cinacalcet.
Use in Pregnancy and Lactation
There are no clinical data on the use of cinacalcet during pregnancy. Use during pregnancy is only possible if the expected benefit to the mother outweighs the potential risk to the fetus.
The possibility of cinacalcet excretion in human breast milk has not been studied to date. If it is necessary to use the drug during lactation, the issue of discontinuing breastfeeding should be considered.
In experimental studies during preclinical studies of cinacalcet in rabbits, it was shown that Cinacalcet crosses the placental barrier. No direct negative effects on the course of pregnancy, childbirth, or postnatal development were identified. No embryotoxic or teratogenic effects were identified in experiments on pregnant rats and rabbits, except for a reduction in fetal body weight in rats at doses that caused toxicity in pregnant females. Cinacalcet is excreted in the breast milk of lactating rats, with a high milk/plasma concentration ratio noted.
Special Precautions
Cinacalcet should not be used when the serum calcium concentration (adjusted for albumin) is below the lower limit of the normal range. Since Cinacalcet lowers serum calcium concentration, careful monitoring of patients for the development of hypocalcemia is necessary.
In case of hypocalcemia, to increase serum calcium levels, calcium-containing phosphate binders, vitamin D, and/or adjustment of the calcium concentration in the dialysis solution can be used. In cases of persistent hypocalcemia, the dose of cinacalcet should be reduced or its use discontinued. Potential signs of developing hypocalcemia may include paresthesia, myalgia, seizures, tetany.
Cinacalcet is not indicated for patients with chronic kidney disease not on dialysis due to an increased risk of developing hypocalcemia (serum calcium concentration <8.4 mg/dL or <2.1 mmol/L) compared to patients on dialysis, which may be due to lower baseline calcium levels and/or the presence of residual renal function.
Cinacalcet should be used with caution and under careful monitoring of liver function in patients with moderate and severe hepatic impairment (according to the Child-Pugh score), as in such cases the plasma concentration of cinacalcet may be 2-4 times higher.
Chronic suppression of PTH concentration below a level of approximately 1.5% of the upper limit of normal (ULN) according to the iPTH assay may lead to the development of adynamic bone disease. If the PTH concentration falls below the recommended range, the dose of cinacalcet and/or vitamin D should be reduced, or therapy should be discontinued.
Effect on ability to drive vehicles and operate machinery
Some adverse reactions of cinacalcet may affect the ability to drive vehicles or operate machinery.
Drug Interactions
Cinacalcet is partially metabolized by the CYP3A4 isoenzyme. Concomitant administration of ketoconazole (a strong CYP3A4 inhibitor) at a dose of 200 mg twice daily led to an approximately 2-fold increase in the plasma concentration of cinacalcet. If concomitant use with potent inhibitors (e.g., ketoconazole, itraconazole, telithromycin, voriconazole, ritonavir) or inducers of CYP3A4 (e.g., rifampicin) is necessary, dose adjustment of cinacalcet may be required.
In vitro experimental studies have shown that Cinacalcet is partially metabolized by the CYP1A2 isoenzyme. Smoking stimulates CYP1A2 activity. The clearance of cinacalcet is 36-38% higher in smokers than in non-smokers. The effect of CYP1A2 inhibitors (fluvoxamine, ciprofloxacin) on the plasma concentration of cinacalcet has not been studied. Dose adjustment may be required if during therapy the patient starts/stops smoking or starts/stops concomitant use of potent CYP1A2 inhibitors.
Cinacalcet is a potent inhibitor of CYP2D6. Concomitant use of cinacalcet and drugs with a narrow therapeutic range and/or variable pharmacokinetics that are metabolized by the CYP2D6 isoenzyme (e.g., flecainide, propafenone, metoprolol, desipramine, nortriptyline, clomipramine) may require dose adjustment of these drugs.
Concomitant administration of cinacalcet at a dose of 90 mg once daily with desipramine (a tricyclic antidepressant metabolized by CYP2D6) at a dose of 50 mg increased the exposure level of desipramine by 3.6 times in patients with active CYP2D6 metabolism.
Storage Conditions
Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.
Dispensing Status
Rx Only
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Film-coated tablets 30 mg: 10, 14, 20, 28, 30, 60, or 140 pcs.
Film-coated tablets 60 mg: 10, 14, 20, 28, 30, 60, or 140 pcs.
Film-coated tablets 90 mg: 10, 14, 20, 28, 30, 60, or 140 pcs.
Marketing Authorization Holder
Hetero Labs, Limited (India)
Manufactured By
Makiz-Pharma, LLC (Russia)
Or
Hetero Labs, Limited (India)
Dosage Forms
 |
Cinacalcet | Film-coated tablets 30 mg: 10, 14, 20, 28, 30, 60, or 140 pcs. |
| Film-coated tablets 60 mg: 10, 14, 20, 28, 30, 60, or 140 pcs. | ||
| Film-coated tablets 90 mg: 10, 14, 20, 28, 30, 60, or 140 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets light green in color, oval, biconvex, with an engraving “H” on one side and “C6” on the other.
| 1 tab. | |
| Cinacalcet hydrochloride | 33.064 mg, |
| Equivalent to cinacalcet content | 30 mg |
Excipients: microcrystalline cellulose type 102 – 86.156 mg, pregelatinized starch – 46.747 mg, crospovidone – 11.333 mg, magnesium stearate – 1.8 mg, talc – 0.9 mg.
Coating composition Opadry II green 32K510043 (hypromellose – 39%, lactose monohydrate – 28%, titanium dioxide – 20.7%, triacetin – 8%, dye “indigo carmine aluminum lake” – 2.2%, iron oxide yellow dye – 2.1%) – 5.4 mg; Aquarius BP 19008 ICE white (hypromellose – 85%, macrogol – 15%) – 1.854 mg.
10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
14 pcs. – blister packs (1) – cardboard packs.
14 pcs. – blister packs (2) – cardboard packs.
14 pcs. – blister packs (10) – cardboard packs.
30 pcs. – jars – cardboard packs.
60 pcs. – jars – cardboard packs.
Film-coated tablets light green in color, oval, biconvex, with an engraving “H” on one side and “C7” on the other.
| 1 tab. | |
| Cinacalcet hydrochloride | 66.127 mg, |
| Equivalent to cinacalcet content | 60 mg |
Excipients: microcrystalline cellulose type 102 – 172.313 mg, pregelatinized starch – 93.493 mg, crospovidone – 22.667 mg, magnesium stearate – 3.6 mg, talc – 1.8 mg.
Coating composition Opadry II green 32K510043 (hypromellose – 39%, lactose monohydrate – 28%, titanium dioxide – 20.7%, triacetin – 8%, dye “indigo carmine aluminum lake” – 2.2%, iron oxide yellow dye – 2.1%) – 10.8 mg; Aquarius BP 19008 ICE white (hypromellose – 85%, macrogol – 15%) – 3.708 mg.
10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
14 pcs. – blister packs (1) – cardboard packs.
14 pcs. – blister packs (2) – cardboard packs.
14 pcs. – blister packs (10) – cardboard packs.
30 pcs. – jars – cardboard packs.
60 pcs. – jars – cardboard packs.
Film-coated tablets light green in color, oval, biconvex, with an engraving “H” on one side and “C8” on the other.
| 1 tab. | |
| Cinacalcet hydrochloride | 99.191 mg, |
| Equivalent to cinacalcet content | 90 mg |
Excipients: microcrystalline cellulose type 102 – 258.469 mg, pregelatinized starch – 140.24 mg, crospovidone – 34 mg, magnesium stearate – 5.4 mg, talc – 2.7 mg.
Coating composition Opadry II green 32K510043 (hypromellose – 39%, lactose monohydrate – 28%, titanium dioxide – 20.7%, triacetin – 8%, dye “indigo carmine aluminum lake” – 2.2%, iron oxide yellow dye – 2.1%) – 16.2 mg; Aquarius BP 19008 ICE white (hypromellose – 85%, macrogol – 15%) – 5.562 mg.
10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
14 pcs. – blister packs (1) – cardboard packs.
14 pcs. – blister packs (2) – cardboard packs.
14 pcs. – blister packs (10) – cardboard packs.
30 pcs. – jars – cardboard packs.
60 pcs. – jars – cardboard packs.
Film-coated tablets, 30 mg: 10, 14, 20, 28, 60, or 84 pcs.
Film-coated tablets, 60 mg: 10, 14, 20, 28, 60, or 84 pcs.
Film-coated tablets, 90 mg: 10, 14, 20, 28, 60, or 84 pcs.
Marketing Authorization Holder
Jivdhara Pharma, Private Limited (India)
Manufactured By
NPC Scan Biotek, LLC (Russia)
Dosage Forms
|
Cinacalcet | Film-coated tablets, 30 mg: 10, 14, 20, 28, 60, or 84 pcs. |
| Film-coated tablets, 60 mg: 10, 14, 20, 28, 60, or 84 pcs. | ||
| Film-coated tablets, 90 mg: 10, 14, 20, 28, 60, or 84 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets light green in color, oval, biconvex, with an embossed engraving “30” on one side and smooth on the other side.
| 1 tab. | |
| Cinacalcet hydrochloride | 33.06 mg, |
| Equivalent to cinacalcet content | 30 mg |
Excipients: microcrystalline cellulose 102 – 123.54 mg, sodium starch glycolate – 10.8 mg, hypromellose – 2.7 mg, anhydrous calcium hydrogen phosphate – 9 mg, magnesium stearate – 0.9 mg.
Shell composition film coating Opadry II green (85F21865) or Vinkout green (WT-85003P) – 5.4 mg (polyvinyl alcohol – 2.16 mg, titanium dioxide (E171) – 1.09 mg, macrogol – 1.09 mg, talc – 0.8 mg, dye indigo carmine (E132) – 0.09 mg, dye iron (III) oxide yellow (E172) – 0.09 mg, dye brilliant blue (E133) – 0.07 mg).
10 pcs. – blisters (1) – carton packs.
10 pcs. – blisters (2) – carton packs.
10 pcs. – blisters (6) – carton packs.
14 pcs. – blisters (1) – carton packs.
14 pcs. – blisters (2) – carton packs.
14 pcs. – blisters (6) – carton packs.
Film-coated tablets light green, oval, biconvex, with an embossed engraving “60” on one side and smooth on the other side.
| 1 tab. | |
| Cinacalcet hydrochloride | 66.12 mg, |
| Equivalent to cinacalcet content | 60 mg |
Excipients: microcrystalline cellulose 102 – 247.08 mg, sodium carboxymethyl starch – 21.6 mg, hypromellose – 5.4 mg, anhydrous calcium hydrogen phosphate – 18 mg, magnesium stearate – 1.8 mg.
Shell composition opadry II green (85F21865): (polyvinyl alcohol – 4.32 mg, titanium dioxide – 2.187 mg, macrogol – 2.1816 mg, talc – 1.5984 mg, dye indigo carmine – 0.1901 mg, dye iron oxide yellow – 0.1804 mg, dye brilliant blue – 0.1426 mg.) – 10.8 mg.
10 pcs. – blisters (1) – carton packs.
10 pcs. – blisters (2) – carton packs.
10 pcs. – blisters (6) – carton packs.
14 pcs. – blisters (1) – carton packs.
14 pcs. – blisters (2) – carton packs.
14 pcs. – blisters (6) – carton packs.
Film-coated tablets light green, oval, biconvex, with an embossed engraving “90” on one side and smooth on the other side.
| 1 tab. | |
| Cinacalcet hydrochloride | 99.18 mg, |
| Equivalent to cinacalcet content | 90 mg |
Excipients: microcrystalline cellulose 102 – 370.62 mg, sodium carboxymethyl starch – 32.4 mg, hypromellose – 8.1 mg, anhydrous calcium hydrogen phosphate – 27 mg, magnesium stearate – 2.7 mg.
Shell composition opadry II green (85F21865): (polyvinyl alcohol – 6.48 mg, titanium dioxide – 3.2805 mg, macrogol – 3.2724 mg, talc – 2.3976 mg, dye indigo carmine – 0.2851 mg, dye iron oxide yellow – 0.2705 mg, dye brilliant blue – 0.2138 mg.) – 16.2 mg.
10 pcs. – blisters (1) – carton packs.
10 pcs. – blisters (2) – carton packs.
10 pcs. – blisters (6) – carton packs.
14 pcs. – blisters (1) – carton packs.
14 pcs. – blisters (2) – carton packs.
14 pcs. – blisters (6) – carton packs.
Film-coated tablets, 30 mg: 7, 14, or 28 pcs.
Film-coated tablets, 60 mg: 7, 14, or 28 pcs.
Film-coated tablets, 90 mg: 7, 14, or 28 pcs.
Marketing Authorization Holder
Alvils, LLC (Russia)
Manufactured By
Pharmland SP, LLC (Republic of Belarus)
Dosage Forms
|
Cinacalcet | Film-coated tablets, 30 mg: 7, 14, or 28 pcs. |
| Film-coated tablets, 60 mg: 7, 14, or 28 pcs. | ||
| Film-coated tablets, 90 mg: 7, 14, or 28 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets yellowish-pink, round, biconvex, with a score on one side; white or almost white on the cross-section, slight surface roughness is allowed.
| 1 tab. | |
| Cinacalcet hydrochloride | 33.06 mg, |
| Equivalent to cinacalcet content | 30 mg |
Excipients: microcrystalline cellulose type 102 – 61.74 mg, microcrystalline cellulose type 101 – 60.08 mg, partially pregelatinized corn starch – 12.02 mg, crospovidone – 7.62 mg, povidone K30 – 3.68 mg, colloidal silicon dioxide – 0.9 mg, magnesium stearate – 0.9 mg.
Shell composition opadry II LightBeige85F17498 – 9.6 mg (polyvinyl alcohol – 3.84 mg; titanium dioxide – 2.318 mg; macrogol-3350 – 1.939 mg; talc – 1.421 mg; dye iron oxide yellow – 0.073 mg; dye iron oxide red – 0.009 mg).
7 pcs. – contour cell blisters (1) – carton packs.
7 pcs. – contour cell blisters (2) – carton packs.
7 pcs. – contour cell blisters (4) – carton packs.
14 pcs. – jars (1) – carton packs.
28 pcs. – jars (1) – carton packs.
Film-coated tablets yellowish-pink, round, biconvex, with a score on one side; white or almost white on the cross-section, slight surface roughness is allowed.
| 1 tab. | |
| Cinacalcet hydrochloride | 66.12 mg, |
| Equivalent to cinacalcet content | 60 mg |
Excipients: microcrystalline cellulose type 102 – 123.48 mg, microcrystalline cellulose type 101 – 120.16 mg, partially pregelatinized corn starch – 24.04 mg, crospovidone – 15.24 mg, povidone K30 – 7.36 mg, colloidal silicon dioxide – 1.8 mg, magnesium stearate – 1.8 mg.
Shell composition opadry II LightBeige85F17498 – 19.2 mg (polyvinyl alcohol – 7.68 mg; titanium dioxide – 4.635 mg; macrogol-3350 – 3.878 mg; talc – 2.842 mg; dye iron oxide yellow – 0.147 mg; dye iron oxide red – 0.018 mg).
7 pcs. – contour cell blisters (1) – carton packs.
7 pcs. – contour cell blisters (2) – carton packs.
7 pcs. – contour cell blisters (4) – carton packs.
14 pcs. – jars (1) – carton packs.
28 pcs. – jars (1) – carton packs.
Film-coated tablets yellowish-pink, round, biconvex, without a score; white or almost white on the cross-section, slight surface roughness is allowed.
| 1 tab. | |
| Cinacalcet hydrochloride | 99.18 mg, |
| Equivalent to cinacalcet content | 90 mg |
Excipients: microcrystalline cellulose type 102 – 185.22 mg, microcrystalline cellulose type 101 – 180.24 mg, partially pregelatinized corn starch – 36.06 mg, crospovidone – 22.86 mg, povidone K30 – 11.04 mg, colloidal silicon dioxide – 2.7 mg, magnesium stearate – 2.7 mg.
Shell composition opadry II LightBeige85F17498 – 28.8 mg (polyvinyl alcohol – 11.52 mg; titanium dioxide – 6.953 mg; macrogol-3350 – 5.818 mg; talc – 4.262 mg; dye iron oxide yellow – 0.22 mg; dye iron oxide red – 0.027 mg).
7 pcs. – contour cell blisters (1) – carton packs.
7 pcs. – contour cell blisters (2) – carton packs.
7 pcs. – contour cell blisters (4) – carton packs.
14 pcs. – jars (1) – carton packs.
28 pcs. – jars (1) – carton packs.
Film-coated tablets, 30 mg: 14 or 28 pcs.
Film-coated tablets, 60 mg: 14 or 28 pcs.
Film-coated tablets, 90 mg: 14 or 28 pcs.
Marketing Authorization Holder
Amedart LLC (Russia)
Manufactured By
Advanced Pharma, LLC (Russia)
Dosage Forms
|
Cinacalcet | Film-coated tablets, 30 mg: 14 or 28 pcs. |
| Film-coated tablets, 60 mg: 14 or 28 pcs. | ||
| Film-coated tablets, 90 mg: 14 or 28 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white, round, biconvex.
| 1 tab. | |
| Cinacalcet hydrochloride | 33.06 mg, |
| Equivalent to cinacalcet content | 30 mg |
Excipients: low-substituted hypromellose – 34.48 mg, colloidal silicon dioxide – 0.73 mg, magnesium stearate – 0.73 mg.
Shell composition Opadry® AMB II white 88A180040 – 2 mg: polyvinyl alcohol (E1203) – 37%, talc (E553b) – 31%, titanium dioxide (E171) – 25%, glycerol monocaprylocaprate (type 1) – 4%, sodium lauryl sulfate – 3%.
14 pcs. – jars (1) – carton packs.
28 pcs. – jars (1) – carton packs.
Film-coated tablets white, round, biconvex.
| 1 tab. | |
| Cinacalcet hydrochloride | 66.12 mg, |
| Equivalent to cinacalcet content | 60 mg |
Excipients: low-substituted hypromellose – 76.96 mg, colloidal silicon dioxide – 1.46 mg, magnesium stearate – 1.46 mg.
Shell composition Opadry® AMB II white 88A180040 – 4 mg: polyvinyl alcohol (E1203) – 37%, talc (E553b) – 31%, titanium dioxide (E171) – 25%, glycerol monocaprylocaprate (type 1) – 4%, sodium lauryl sulfate – 3%.
14 pcs. – jars (1) – carton packs.
28 pcs. – jars (1) – carton packs.
14 pcs. – jar (1) – carton pack.
28 pcs. – jar (1) – carton pack.
Film-coated tablets white, round, biconvex.
| 1 tab. | |
| Cinacalcet hydrochloride | 99.18 mg, |
| Equivalent to cinacalcet content | 90 mg |
Excipients: low-substituted hypromellose – 115.44 mg, colloidal silicon dioxide – 2.19 mg, magnesium stearate – 2.19 mg.
Shell composition Opadry® AMB II white 88A180040 – 6 mg: polyvinyl alcohol (E1203) – 37%, talc (E553b) – 31%, titanium dioxide (E171) – 25%, glycerol monocaprylocaprate (type 1) – 4%, sodium lauryl sulfate – 3%.
14 pcs. – jars (1) – carton packs.
28 pcs. – jars (1) – carton packs.
14 pcs. – jar (1) – carton pack.
28 pcs. – jar (1) – carton pack.
Film-coated tablets, 30 mg: from 5 to 300 pcs.
Film-coated tablets 60 mg
Film-coated tablets, 60 mg: from 5 to 300 pcs.
Film-coated tablets, 90 mg
Film-coated tablets, 90 mg: from 5 to 300 pcs.
Marketing Authorization Holder
Atoll LLC (Russia)
Manufactured By
Ozon, LLC (Russia)
Dosage Forms
|
Cinacalcet | Film-coated tablets, 30 mg: from 5 to 300 pcs. |
| Film-coated tablets 60 mg | ||
| Film-coated tablets, 60 mg: from 5 to 300 pcs. | ||
| Film-coated tablets, 90 mg | ||
| Film-coated tablets, 90 mg: from 5 to 300 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or almost white, round, biconvex; on the cross-section the tablet core is almost white.
| 1 tab. | |
| Cinacalcet hydrochloride | 33.06 mg, |
| Equivalent to cinacalcet content | 30 mg |
Excipients: microcrystalline cellulose (MCC-102) – 118.64 mg, pregelatinized starch – 12.02 mg, croscarmellose sodium – 10.8 mg, povidone K-25 – 3.68 mg, colloidal silicon dioxide – 0.9 mg, magnesium stearate – 0.9 mg.
Shell composition: polyvinyl alcohol – 2.88 mg, macrogol 4000 – 1.44 mg, titanium dioxide – 1.08 mg.
5 pcs. – contour cell blisters (from 1 to 10 pcs.) – carton packs.
10 pcs. – contour cell blisters (from 1 to 10 pcs.) – carton packs.
14 pcs. – contour cell blisters (from 1 to 10 pcs.) – carton packs.
25 pcs. – contour cell blisters (from 1 to 10 pcs.) – carton packs.
30 pcs. – contour cell blisters (from 1 to 10 pcs.) – carton packs.
Film-coated tablets
| 1 tab. | |
| Cinacalcet | 60 mg |
10 pcs. – contour cell blisters – carton packs (10 pcs.) – Prescription only
10 pcs. – contour cell blisters (10 pcs.) – carton packs (100 pcs.) – Prescription only
10 pcs. – contour cell blisters (2 pcs.) – carton packs (20 pcs.) – Prescription only
10 pcs. – contour cell blisters (3 pcs.) – carton packs (30 pcs.) – Prescription only
10 pcs. – contour cell blisters (4 pcs.) – carton packs (40 pcs.) – Prescription only
10 pcs. – contour cell blisters (6 pcs.) – carton packs (60 pcs.) – Prescription only
14 pcs. – contour cell blisters – carton packs (14 pcs.) – Prescription only
14 pcs. – contour cell blisters (10 pcs.) – carton packs (140 pcs.) – Prescription only
14 pcs. – contour cell blisters (2 pcs.) – carton packs (28 pcs.) – Prescription only
14 pcs. – contour cell blisters (3 pcs.) – carton packs (42 pcs.) – Prescription only
14 pcs. – contour cell blisters (4 pcs.) – carton packs (56 pcs.) – Prescription only
14 pcs. – contour cell blisters (6 pcs.) – carton packs (84 pcs.) – Prescription only
25 pcs. – contour cell blisters – carton packs (25 pcs.) – Prescription only
25 pcs. – contour cell blisters (10 pcs.) – carton packs (250 pcs.) – Prescription only
25 pcs. – contour cell blisters (2 pcs.) – carton packs (50 pcs.) – Prescription only
25 pcs. – contour cell blisters (3 pcs.) – carton packs (75 pcs.) – Prescription only
25 pcs. – contour cell blisters (4 pcs.) – carton packs (100 pcs.) – Prescription only
25 pcs. – contour cell blisters (6 pcs.) – carton packs (150 pcs.) – Prescription only
30 pcs. – contour cell blisters – carton packs (30 pcs.) – Prescription only
30 pcs. – contour cell blisters (10 pcs.) – carton packs (300 pcs.) – Prescription only
30 pcs. – contour cell blisters (2 pcs.) – carton packs (60 pcs.) – Prescription only
30 pcs. – contour cell blisters (3 pcs.) – carton packs (90 pcs.) – Prescription only
30 pcs. – contour cell blisters (4 pcs.) – carton packs (120 pcs.) – Prescription only
30 pcs. – contour cell blisters (6 pcs.) – carton packs (180 pcs.) – Prescription only
5 pcs. – contour cell blisters – carton packs (5 pcs.) – Prescription only
5 pcs. – contour cell blisters (10 pcs.) – carton packs (50 pcs.) – Prescription only
5 pcs. – contour cell blisters (2 pcs.) – carton packs (10 pcs.) – Prescription only
5 pcs. – contour cell blisters (3 pcs.) – carton packs (15 pcs.) – Prescription only
5 pcs. – contour cell blisters (4 pcs.) – carton packs (20 pcs.) – Prescription only
5 pcs. – contour cell blisters (6 pcs.) – carton packs (30 pcs.) – Prescription only
Film-coated tablets white or almost white, round, biconvex; on the cross-section the tablet core is almost white.
| 1 tab. | |
| Cinacalcet hydrochloride | 66.12 mg, |
| Equivalent to cinacalcet content | 60 mg |
Excipients: microcrystalline cellulose (MCC-102) – 237.28 mg, pregelatinized starch – 24.04 mg, croscarmellose sodium – 21.6 mg, povidone K-25 – 7.36 mg, colloidal silicon dioxide – 1.8 mg, magnesium stearate – 1.8 mg.
Shell composition: polyvinyl alcohol – 5.76 mg, macrogol 4000 – 2.88 mg, titanium dioxide – 2.16 mg.
5 pcs. – contour cell blisters (from 1 to 10 pcs.) – carton packs.
10 pcs. – contour cell blisters (from 1 to 10 pcs.) – carton packs.
14 pcs. – contour cell blisters (from 1 to 10 pcs.) – carton packs.
25 pcs. – contour cell blisters (from 1 to 10 pcs.) – carton packs.
30 pcs. – contour cell blisters (from 1 to 10 pcs.) – carton packs.
Film-coated tablets
| 1 tab. | |
| Cinacalcet | 90 mg |
10 pcs. – contour cell blisters – carton packs (10 pcs.) – Prescription only
10 pcs. – contour cell blisters (10 pcs.) – carton packs (100 pcs.) – Prescription only
10 pcs. – contour cell blisters (2 pcs.) – carton packs (20 pcs.) – Prescription only
10 pcs. – contour cell blisters (3 pcs.) – carton packs (30 pcs.) – Prescription only
10 pcs. – contour cell blisters (4 pcs.) – carton packs (40 pcs.) – Prescription only
10 pcs. – contour cell blisters (6 pcs.) – carton packs (60 pcs.) – Prescription only
14 pcs. – contour cell blisters – carton packs (14 pcs.) – Prescription only
14 pcs. – contour cell blisters (10 pcs.) – carton packs (140 pcs.) – Prescription only
14 pcs. – contour cell blisters (2 pcs.) – carton packs (28 pcs.) – Prescription only
14 pcs. – contour cell blisters (3 pcs.) – carton packs (42 pcs.) – Prescription only
14 pcs. – contour cell blisters (4 pcs.) – carton packs (56 pcs.) – Prescription only
14 pcs. – contour cell blisters (6 pcs.) – carton packs (84 pcs.) – Prescription only
25 pcs. – contour cell blisters – carton packs (25 pcs.) – Prescription only
25 pcs. – contour cell blisters (10 pcs.) – carton packs (250 pcs.) – Prescription only
25 pcs. – contour cell blisters (2 pcs.) – carton packs (50 pcs.) – Prescription only
25 pcs. – contour cell blisters (3 pcs.) – carton packs (75 pcs.) – Prescription only
25 pcs. – contour cell blisters (4 pcs.) – carton packs (100 pcs.) – Prescription only
25 pcs. – contour cell blisters (6 pcs.) – carton packs (150 pcs.) – Prescription only
30 pcs. – contour cell blisters – carton packs (30 pcs.) – Prescription only
30 pcs. – contour cell blisters (10 pcs.) – carton packs (300 pcs.) – Prescription only
30 pcs. – contour cell blisters (2 pcs.) – carton packs (60 pcs.) – Prescription only
30 pcs. – contour cell blisters (3 pcs.) – carton packs (90 pcs.) – Prescription only
30 pcs. – contour cell blisters (4 pcs.) – carton packs (120 pcs.) – Prescription only
30 pcs. – contour cell blisters (6 pcs.) – carton packs (180 pcs.) – Prescription only
5 pcs. – contour cell blisters – carton packs (5 pcs.) – Prescription only
5 pcs. – contour cell blisters (10 pcs.) – carton packs (50 pcs.) – Prescription only
5 pcs. – contour cell blisters (2 pcs.) – carton packs (10 pcs.) – Prescription only
5 pcs. – contour cell blisters (3 pcs.) – carton packs (15 pcs.) – Prescription only
5 pcs. – contour cell blisters (4 pcs.) – carton packs (20 pcs.) – Prescription only
5 pcs. – contour cell blisters (6 pcs.) – carton packs (30 pcs.) – Prescription only
Film-coated tablets white or almost white, round, biconvex; the core of the tablet on the cross-section is almost white.
| 1 tab. | |
| Cinacalcet hydrochloride | 99.18 mg, |
| Equivalent to cinacalcet content | 90 mg |
Excipients: microcrystalline cellulose (MCC-102) – 355.92 mg, pregelatinized starch – 36.06 mg, croscarmellose sodium – 32.4 mg, povidone K-25 – 11.04 mg, colloidal silicon dioxide – 2.7 mg, magnesium stearate – 2.7 mg.
Shell composition: polyvinyl alcohol – 8.64 mg, macrogol 4000 – 4.32 mg, titanium dioxide – 3.24 mg.
5 pcs. – contour cell blisters (from 1 to 10 pcs.) – cardboard packs.
10 pcs. – contour cell blisters (from 1 to 10 pcs.) – cardboard packs.
14 pcs. – contour cell blisters (from 1 to 10 pcs.) – cardboard packs.
25 pcs. – contour cell blisters (from 1 to 10 pcs.) – cardboard packs.
30 pcs. – contour cell blisters (from 1 to 10 pcs.) – cardboard packs.
Film-coated tablets, 30 mg: 14, 28, or 84 pcs.
Film-coated tablets, 60 mg: 14, 28, or 84 pcs.
Film-coated tablets, 90 mg: 14, 28, or 84 pcs.
Marketing Authorization Holder
Biserno, LLC (Russia)
Manufactured By
Oncotarget, LLC (Russia)
Dosage Forms
|
Cinacalcet | Film-coated tablets, 30 mg: 14, 28, or 84 pcs. |
| Film-coated tablets, 60 mg: 14, 28, or 84 pcs. | ||
| Film-coated tablets, 90 mg: 14, 28, or 84 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets yellow, round, biconvex, the core on the break is white or almost white.
| 1 tab. | |
| Cinacalcet hydrochloride | 33.06 mg, |
| Equivalent to cinacalcet content | 30 mg |
Excipients: microcrystalline cellulose type 101 – 121.82 mg, corn pregelatinized starch – 12.02 mg, crospovidone XL – 7.62 mg, povidone K-30 – 3.68 mg, colloidal silicon dioxide – 0.9 mg, magnesium stearate – 0.9 mg.
Shell composition Opadry II yellow 85F32771 (polyvinyl alcohol – 40%; titanium dioxide (E171) – 23.7%; macrogol/PEG – 20.2%; talc – 14.8%; iron oxide yellow dye – 1.3%) – 10 mg.
14 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
28 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
84 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
14 pcs. – contour cell blisters (1) – cardboard packs.
14 pcs. – contour cell blisters (2) – cardboard packs.
14 pcs. – contour cell blisters (6) – cardboard packs.
Film-coated tablets yellow, round, biconvex, the core on the break is white or almost white.
| 1 tab. | |
| Cinacalcet hydrochloride | 66.12 mg, |
| Equivalent to cinacalcet content | 60 mg |
Excipients: microcrystalline cellulose type 101 – 243.64 mg, corn pregelatinized starch – 24.04 mg, crospovidone XL – 15.24 mg, povidone K-30 – 7.36 mg, colloidal silicon dioxide – 1.8 mg, magnesium stearate – 1.8 mg.
Shell composition Opadry II yellow 85F32771 (polyvinyl alcohol – 40%; titanium dioxide (E171) – 23.7%; macrogol/PEG – 20.2%; talc – 14.8%; iron oxide yellow dye – 1.3%) – 20 mg.
14 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
28 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
84 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
14 pcs. – contour cell blisters (1) – cardboard packs.
14 pcs. – contour cell blisters (2) – cardboard packs.
14 pcs. – contour cell blisters (6) – cardboard packs.
Film-coated tablets yellow, round, biconvex, the core on the break is white or almost white.
| 1 tab. | |
| Cinacalcet hydrochloride | 99.18 mg, |
| Equivalent to cinacalcet content | 90 mg |
Excipients: microcrystalline cellulose type 101 – 365.46 mg, corn pregelatinized starch – 36.06 mg, crospovidone XL – 22.86 mg, povidone K-30 – 11.04 mg, colloidal silicon dioxide – 2.7 mg, magnesium stearate – 2.7 mg.
Shell composition Opadry II yellow 85F32771 (polyvinyl alcohol – 40%; titanium dioxide (E171) – 23.7%; macrogol/PEG – 20.2%; talc – 14.8%; iron oxide yellow dye – 1.3%) – 30 mg.
14 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
28 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
84 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
14 pcs. – contour cell blisters (1) – cardboard packs.
14 pcs. – contour cell blisters (2) – cardboard packs.
14 pcs. – contour cell blisters (6) – cardboard packs.
Film-coated tablets, 30 mg: 14, 28, or 84 pcs.
Film-coated tablets, 60 mg: 14, 28, or 84 pcs.
Film-coated tablets, 90 mg: 14, 28, or 84 pcs.
Marketing Authorization Holder
Chemical Diversity Research Institute LLC (Russia)
Dosage Forms
|
Cinacalcet | Film-coated tablets, 30 mg: 14, 28, or 84 pcs. |
| Film-coated tablets, 60 mg: 14, 28, or 84 pcs. | ||
| Film-coated tablets, 90 mg: 14, 28, or 84 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets green, round, biconvex; the core of the tablet on the cross-section is white or almost white.
| 1 tab. | |
| Cinacalcet hydrochloride | 33.06 mg, |
| Equivalent to cinacalcet content | 30 mg |
Excipients: microcrystalline cellulose 102, sodium carboxymethyl starch, calcium hydrogen phosphate, hypromellose, magnesium stearate.
Film shell composition Opadry II 85F21865 green [polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, indigo carmine (E132), iron oxide yellow dye (E172), brilliant blue dye (E133)].
14 pcs. – contour cell blisters (1) – cardboard packs.
14 pcs. – contour cell blisters (2) – cardboard packs.
14 pcs. – contour cell blisters (6) – cardboard packs.
14 pcs. – polyethylene bottles (1) – cardboard packs.
28 pcs. – polyethylene bottles (1) – cardboard packs.
84 pcs. – polyethylene bottles (1) – cardboard packs.
Film-coated tablets orange with a brownish tint, round, biconvex; the core of the tablet on the cross-section is white or almost white.
| 1 tab. | |
| Cinacalcet hydrochloride | 66.12 mg, |
| Equivalent to cinacalcet content | 60 mg |
Excipients: microcrystalline cellulose 102, sodium carboxymethyl starch, calcium hydrogen phosphate, hypromellose, magnesium stearate.
Film shell composition Opadry II 85F38183 yellow [polyvinyl alcohol, macrogol, iron oxide yellow dye (E172), talc, titanium dioxide (E171)].
14 pcs. – contour cell blisters (1) – cardboard packs.
14 pcs. – contour cell blisters (2) – cardboard packs.
14 pcs. – contour cell blisters (6) – cardboard packs.
14 pcs. – polyethylene bottles (1) – cardboard packs.
28 pcs. – polyethylene bottles (1) – cardboard packs.
84 pcs. – polyethylene bottles (1) – cardboard packs.
Film-coated tablets white, round, biconvex; the core of the tablet on the cross-section is white or almost white.
| 1 tab. | |
| Cinacalcet hydrochloride | 99.18 mg, |
| Equivalent to cinacalcet content | 90 mg |
Excipients: microcrystalline cellulose 102, sodium carboxymethyl starch, calcium hydrogen phosphate, hypromellose, magnesium stearate.
Film shell composition Opadry II 85F48105 white [polyvinyl alcohol, macrogol, talc, titanium dioxide (E171)].
14 pcs. – contour cell blisters (1) – cardboard packs.
14 pcs. – contour cell blisters (2) – cardboard packs.
14 pcs. – contour cell blisters (6) – cardboard packs.
14 pcs. – polyethylene bottles (1) – cardboard packs.
28 pcs. – polyethylene bottles (1) – cardboard packs.
84 pcs. – polyethylene bottles (1) – cardboard packs.
Film-coated tablets 30 mg: 14, 28, or 60 pcs.
Film-coated tablets 60 mg: 14, 28, or 60 pcs.
Film-coated tablets 90 mg: 14, 28, or 60 pcs.
Marketing Authorization Holder
Pharmconcept, LLC (Russia)
Manufactured By
Hetero Drugs Limited (India)
Or
Pharmconcept, LLC (Russia)
Dosage Forms
|
Cinacalcet | Film-coated tablets 30 mg: 14, 28, or 60 pcs. |
| Film-coated tablets 60 mg: 14, 28, or 60 pcs. | ||
| Film-coated tablets 90 mg: 14, 28, or 60 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets round, biconvex, pink in color. The cross-section is white or white with a yellowish tint.
| 1 tab. | |
| Cinacalcet | 30 mg |
| (in terms of cinacalcet hydrochloride) | 33.06 mg |
Excipients: microcrystalline cellulose – 121.82 mg, corn starch – 12.02 mg, povidone K30 – 3.68 mg, crospovidone – 7.62 mg, colloidal silicon dioxide – 0.9 mg, magnesium stearate – 0.9 mg.
Composition of the finished film coating (wincoat WT-AQ-1694 Pink) hypromellose – 23.5 mg, titanium dioxide – 7.1 mg, macrogol – 6.6 mg, allura red AC aluminum lake dye – 0.35 mg, carmine red dye – 0.35 mg.
7 pcs. – contour cell blisters (2) – cardboard packs.
7 pcs. – contour cell blisters (4) – cardboard packs.
14 pcs. – jars (1) – cardboard packs (for hospitals).
28 pcs. – jars (1) – cardboard packs (for hospitals).
60 pcs. – jars (1) – cardboard packs (for hospitals).
Film-coated tablets round, biconvex, pale yellowish-pink in color. The cross-section is white or white with a yellowish tint.
| 1 tab. | |
| Cinacalcet | 60 mg |
| (in terms of cinacalcet hydrochloride) | 66.12 mg |
Excipients: microcrystalline cellulose – 243.64 mg, corn starch – 24.04 mg, povidone K30 – 7.36 mg, crospovidone – 15.24 mg, colloidal silicon dioxide – 1.8 mg, magnesium stearate – 1.8 mg.
Composition of the finished film coating (wincoat WT-AQ-1933 Brown) hypromellose – 7.014 mg, titanium dioxide – 1.45 mg, talc – 0.52 mg, iron oxide yellow dye – 0.008 mg, iron oxide red dye – 0.008 mg.
7 pcs. – contour cell blisters (2) – cardboard packs.
7 pcs. – contour cell blisters (4) – cardboard packs.
14 pcs. – jars (1) – cardboard packs (for hospitals).
28 pcs. – jars (1) – cardboard packs (for hospitals).
60 pcs. – jars (1) – cardboard packs (for hospitals).
Film-coated tablets round, biconvex, light yellow in color. The cross-section is white or white with a yellowish tint.
| 1 tab. | |
| Cinacalcet | 90 mg |
| (in terms of cinacalcet hydrochloride) | 99.18 mg |
Excipients: microcrystalline cellulose – 365.46 mg, corn starch – 36.06 mg, povidone K-30 – 11.04 mg, crospovidone – 22.86 mg, colloidal silicon dioxide – 2.7 mg, magnesium stearate – 2.7 mg.
Composition of the finished film coating (VIVACOAT® PA-2P-000) hypromellose – 3.12 mg, titanium dioxide – 2 mg, polydextrose – 1.2 mg, talc – 0.8 mg, macrogol – 0.48 mg, iron oxide yellow dye – 0.4 mg.
7 pcs. – contour cell blisters (2) – cardboard packs.
7 pcs. – contour cell blisters (4) – cardboard packs.
14 pcs. – jars (1) – cardboard packs (for hospitals).
28 pcs. – jars (1) – cardboard packs (for hospitals).
60 pcs. – jars (1) – cardboard packs (for hospitals).
Film-coated tablets, 30 mg: 10, 14, 28, 30, 60, 84, or 90 pcs.
Marketing Authorization Holder
Canonpharma Production, CJS (Russia)
Dosage Form
|
Cinacalcet Canon | Film-coated tablets, 30 mg: 10, 14, 28, 30, 60, 84, or 90 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets green, round, biconvex; on the cross-section – almost white.
| 1 tab. | |
| Cinacalcet hydrochloride | 33.06 mg, |
| Equivalent to cinacalcet content | 30 mg |
Excipients: corn pregelatinized starch – 12 mg, colloidal silicon dioxide – 0.9 mg, crospovidone – 7.62 mg, magnesium stearate – 0.9 mg, povidone K-30 – 3.7 mg, microcrystalline cellulose (type 101) – 121.82 mg.
Shell composition Opadry 03 F190003 transparent – 2.7 mg (including hypromellose (hydroxypropyl methylcellulose) – 2.16 mg, macrogol (polyethylene glycol) – 0.54 mg); Vivacoat PM-7P-182 green – 7.3 mg (including hypromellose (hydroxypropyl methylcellulose) – 3.65 mg, hyprolose (hydroxypropyl cellulose) – 0.365 mg, macrogol (polyethylene glycol) – 0.365 mg, talc – 0.5475 mg, titanium dioxide – 2.171 mg, quinoline yellow dye – 0.1752 mg, iron oxide yellow dye – 0.0241 mg, brilliant blue dye – 0.0022 mg.
7 pcs. – contour cell blisters (2) – cardboard packs.
7 pcs. – contour cell blisters (4) – cardboard packs.
10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (9) – cardboard packs.
14 pcs. – contour cell blisters (1) – cardboard packs.
14 pcs. – contour cell blisters (2) – cardboard packs.
14 pcs. – contour cell blisters (6) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.
90 pcs. – jars (1) – cardboard packs.
Film-coated tablets, 30 mg: 14, 28, or 84 pcs.
Film-coated tablets, 60 mg: 14, 28, or 84 pcs.
Film-coated tablets, 90 mg: 14, 28, or 84 pcs.
Marketing Authorization Holder
PSK Pharma, LLC (Russia)
Dosage Forms
|
Cinacalcet PSK | Film-coated tablets, 30 mg: 14, 28, or 84 pcs. |
| Film-coated tablets, 60 mg: 14, 28, or 84 pcs. | ||
| Film-coated tablets, 90 mg: 14, 28, or 84 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets from light green to green, round, biconvex; the core is white or almost white.
| 1 tab. | |
| Cinacalcet hydrochloride | 33.064 mg, |
| Equivalent to cinacalcet content | 30 mg |
Excipients: pregelatinized starch – 12.02 mg, microcrystalline cellulose type 101 – 121.5 mg, crospovidone – 7.94 mg, povidone K30 – 3.68 mg, colloidal silicon dioxide – 0.9 mg, magnesium stearate – 0.9 mg.
Film coating of tablet 1 Novomix GEN II-45006 – 7.2 mg, incl. hypromellose – 4.2 mg, lactose monohydrate – 1 mg, triacetin – 0.5 mg, titanium dioxide – 1 mg, iron oxide yellow dye – 0.334 mg, FD&C blue No. 1 lake dye – 0.166 mg.
Film coating of tablet 2 Novomix 100031 TR – 2.8 mg, incl.: hypromellose – 2.52 mg, macrogol (polyethylene glycol) – 0.28 mg.
14 pcs. – blisters (1) – cardboard packs.
14 pcs. – blisters (2) – cardboard packs.
14 pcs. – blisters (6) – cardboard packs.
14 pcs. – jars – cardboard packs.
28 pcs. – jars – cardboard packs.
84 pcs. – jars – cardboard packs.
Film-coated tablets from light green to green, round, biconvex; the core is white or almost white.
| 1 tab. | |
| Cinacalcet hydrochloride | 66.12 mg, |
| Equivalent to cinacalcet content | 60 mg |
Excipients: pregelatinized starch – 24.04 mg, microcrystalline cellulose type 101 – 243 mg, crospovidone – 15.88 mg, povidone K30 – 7.36 mg, colloidal silicon dioxide – 1.8 mg, magnesium stearate – 1.8 mg.
Film coating of tablet 1 Novomix GEN II-45006 – 14.4 mg, incl. hypromellose – 8.4 mg, lactose monohydrate – 2 mg, triacetin – 1 mg, titanium dioxide – 2 mg, iron oxide yellow dye – 0.668 mg, FD&C blue No. 1 lake dye – 0.332 mg.
Film coating of tablet 2 Novomix 100031 TR – 5.6 mg, incl.: hypromellose – 5.04 mg, macrogol (polyethylene glycol) – 0.56 mg.
14 pcs. – blisters (1) – cardboard packs.
14 pcs. – blisters (2) – cardboard packs.
14 pcs. – blisters (6) – cardboard packs.
14 pcs. – jars – cardboard packs.
28 pcs. – jars – cardboard packs.
84 pcs. – jars – cardboard packs.
Film-coated tablets from light green to green in color, round, biconvex; the core is white or almost white.
| 1 tab. | |
| Cinacalcet hydrochloride | 99.18 mg, |
| Equivalent to cinacalcet content | 90 mg |
Excipients: pregelatinized starch – 36.06 mg, microcrystalline cellulose type 101 – 364.5 mg, crospovidone – 23.82 mg, povidone K30 – 11.04 mg, colloidal silicon dioxide – 2.7 mg, magnesium stearate – 2.7 mg.
Film coating of tablet 1 Novomix GEN II-45006 – 21.6 mg, incl. hypromellose – 12.6 mg, lactose monohydrate – 3 mg, triacetin – 1.5 mg, titanium dioxide – 3 mg, iron oxide yellow dye – 1.002 mg, FD&C blue No. 1 lake dye – 0.498 mg.
Film coating of tablet 2 Novomix 100031 TR – 8.4 mg, incl.: hypromellose – 7.56 mg, macrogol (polyethylene glycol) – 0.84 mg.
14 pcs. – blisters (1) – cardboard packs.
14 pcs. – blisters (2) – cardboard packs.
14 pcs. – blisters (6) – cardboard packs.
14 pcs. – jars – cardboard packs.
28 pcs. – jars – cardboard packs.
84 pcs. – jars – cardboard packs.
Film-coated tablets, 30 mg: 14, 28, or 84 pcs.
Marketing Authorization Holder
Technology Lekarstv LLC (Russia)
Manufactured By
R-Pharm JSC (Russia)
Packaging and Quality Control Release
R-PHARM, JSC (Russia)
Or
SPUTNIK TECHNOPOLIS, LLC (Russia)
Dosage Form
|
Cinacalcet-TL | Film-coated tablets, 30 mg: 14, 28, or 84 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or almost white, round, biconvex; on the cross-section, the tablet core is from white to light yellow.
| 1 tab. | |
| Cinacalcet (as cinacalcet hydrochloride) | 30 mg |
Excipients: microcrystalline cellulose type 200, crospovidone, magnesium stearate, colloidal silicon dioxide.
Film coating composition: Opadry II 85F48105 white (polyvinyl alcohol, macrogol 4000, talc, titanium dioxide).
7 pcs. – contour cell packs (2) – cardboard packs.
7 pcs. – contour cell packs (4) – cardboard packs.
14 pcs. – polymer jars (1) – cardboard packs.
28 pcs. – polymer jars (1) – cardboard packs.
84 pcs. – polymer jars (1) – cardboard packs.
![Cinacalcet [Tablets] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Cinacalcet [Tablets] 2")