Pemetrexed (Solution, Lyophilisate) Instructions for Use
ATC Code
L01BA04 (Pemetrexed)
Active Substance
Pemetrexed (Rec.INN registered by WHO)
Clinical-Pharmacological Group
Antimetabolite. Folic acid analogue
Pharmacotherapeutic Group
Antineoplastic agents; antimetabolites; folic acid analogues
Pharmacological Action
Antineoplastic agent, antimetabolite. It is an antifolate, inhibits thymidylate synthase (TS), dihydrofolate reductase (DHFR), glycinamide ribonucleotide formyltransferase (GARFT) – key folate-dependent enzymes in the biosynthesis of thymidine and purine nucleotides. Pemetrexed enters cells via the reduced folate carrier and folate-binding protein transport systems. Upon entering the cell, Pemetrexed is rapidly and efficiently converted to polyglutamate forms by the enzyme folylpolyglutamate synthase. Polyglutamate forms are retained in cells and are more potent inhibitors of TS and GARFT. Polyglutamation is a time- and concentration-dependent process that occurs in tumor cells and, to a lesser extent, in normal tissues. The polyglutamated metabolites have an increased T1/2, thereby increasing the duration of the drug’s action on tumor cells.
In studies in vitro, a synergistic antitumor effect was observed with the combined use of pemetrexed and cisplatin.
Pharmacokinetics
At steady state, the Vd of pemetrexed is 16.1 L. Binding to plasma proteins is approximately 81%.
Pemetrexed undergoes limited metabolism in the liver.
Within the first 24 hours after administration, 70-90% is excreted by the kidneys unchanged. The total plasma clearance of pemetrexed is 92 ml/min, the T1/2 from plasma is 3.5 hours in patients with normal renal function.
In severe renal impairment, binding to plasma proteins does not change.
Indications
Locally advanced or metastatic non-squamous, non-small cell lung cancer – in combination with cisplatin as first-line therapy.
Locally advanced or metastatic non-squamous, non-small cell lung cancer without disease progression after four cycles of first-line platinum-based chemotherapy – for maintenance therapy.
Locally advanced or metastatic, non-squamous, non-small cell lung cancer – as monotherapy for second-line therapy.
Treatment of malignant pleural mesothelioma in patients who have not received prior chemotherapy, with inoperable tumor or in the presence of contraindications to surgery.
ICD codes
| ICD-10 code | Indication |
| C34 | Malignant neoplasm of bronchus and lung |
| C45.0 | Mesothelioma of pleura |
| ICD-11 code | Indication |
| 2C25.Z | Malignant neoplasms of bronchus or lung, unspecified |
| 2C26.0 | Mesothelioma of pleura |
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. |
Administer pemetrexed as an intravenous infusion over 10 minutes. Calculate the dose using body surface area (BSA). The standard dose is 500 mg/m².
Administer pemetrexed prior to cisplatin when used in combination. Infuse cisplatin after a 30-minute hydration protocol following the end of the pemetrexed infusion.
Repeat the administration cycle every 21 days. Administer on day 1 of each cycle.
Perform dose adjustments based on hematologic and non-hematologic toxicity observed in the previous cycle. Do not re-administer until the absolute neutrophil count (ANC) recovers to ≥1500 cells/µL and platelets recover to ≥100,000 cells/µL.
For nadir ANC <500 cells/µL and nadir platelets ≥50,000 cells/µL, reduce the subsequent dose to 75% of the previous dose. For nadir platelets <50,000 cells/µL without bleeding, regardless of nadir ANC, reduce the subsequent dose to 50% of the previous dose.
For any grade 3 or 4 non-hematologic toxicity (excluding nausea/vomiting), reduce the dose to 75% of the previous dose. For grade 3 or 4 diarrhea or any diarrhea requiring hospitalization, withhold therapy until resolution, then reduce the dose to 75%.
Initiate supplementation with folic acid (350-1000 mcg orally daily) or a multivitamin with folic acid at least 5 days before the first dose. Continue daily throughout therapy and for 21 days after the last dose.
Administer vitamin B12 (1000 mcg intramuscularly) within the 10 weeks before the first dose and every 3 cycles thereafter. Subsequent vitamin B12 injections may be given on the same day as pemetrexed administration.
Administer dexamethasone (4 mg orally twice daily) the day before, the day of, and the day after pemetrexed administration to reduce the risk and severity of cutaneous reactions.
For patients with moderate renal impairment (CrCl 45-79 mL/min), reduce the dose according to the calculated creatinine clearance. Do not administer to patients with CrCl <45 mL/min.
Adverse Reactions
From the hematopoietic system: very common – leukopenia, neutropenia, anemia; common – thrombocytopenia.
From the digestive system: very common – nausea, vomiting, anorexia, stomatitis/pharyngitis, diarrhea, increased ALT and AST levels; common – constipation, abdominal pain.
Dermatological reactions: very common – rash/desquamation; common – skin itching, alopecia; rare – erythema multiforme.
From the peripheral nervous system: common – sensory or motor neuropathy.
From the urinary system: common – increased creatinine levels.
From the cardiovascular system: rare – supraventricular tachycardia.
Other: very common – increased fatigue; common – fever, febrile neutropenia, allergic reactions, and secondary infections without neutropenia.
Contraindications
Pregnancy, lactation, hypersensitivity to pemetrexed.
Pemetrexed is not intended for the treatment of patients with squamous non-small cell lung cancer.
Use in Pregnancy and Lactation
Use during pregnancy and the period of lactation (breastfeeding) is contraindicated.
Use in Hepatic Impairment
To assess liver function, periodic biochemical blood tests are necessary.
Use in Renal Impairment
To assess renal function, periodic biochemical blood tests are necessary.
Pediatric Use
Pemetrexed is not recommended for use in pediatrics, as safety and efficacy in children have not been established.
Special Precautions
A complete blood count with differential leukocyte count and platelet count should be performed before each administration of pemetrexed.
To assess renal and liver function, periodic biochemical blood tests are necessary.
Before starting use, the absolute neutrophil count should be ≥1500/µL, platelets ≥100,000/µL.
Prescription of folic acid and vitamin B12 reduces the toxicity of pemetrexed and the need for dose reduction in case of grade 3-4 hematological and non-hematological toxicity, including neutropenia, febrile neutropenia, and infection with grade 3-4 neutropenia.
Patients with clinical manifestations of ascites and pleurisy require drainage of the effusion before starting pemetrexed, as the influence of these conditions on the effect of pemetrexed is unknown.
Pemetrexed is not recommended for use in pediatrics, as safety and efficacy in children have not been established.
Drug Interactions
Concomitant use with nephrotoxic drugs and/or substances excreted by the kidneys may reduce the clearance of pemetrexed.
Results of in vitro studies indicate that Pemetrexed minimally interacts with drugs metabolized by CYP3A, CYP2D6, CYP2C9, CYP1A2.
The pharmacokinetics of pemetrexed do not change with oral folic acid, intramuscular vitamin B12, or combined use with cisplatin. The total clearance of platinum is not impaired with the use of pemetrexed.
Pemetrexed can be used concomitantly with ibuprofen (400 mg four times/day) in patients with normal renal function (CrCl≥80 ml/min). Caution should be exercised when prescribing ibuprofen together with pemetrexed in patients with mild or moderate renal impairment (CrCl 45-79 ml/min).
In patients with mild and moderate renal impairment, the use of NSAIDs with a short T1/2 is not recommended for 2 days before pemetrexed administration, on the day of administration, and for 2 days after administration.
Due to the lack of data on possible interaction between pemetrexed and NSAIDs with a long T1/2, all patients taking NSAIDs should discontinue them at least 5 days before pemetrexed administration, on the day of administration, and for 2 days after administration. If concomitant administration of NSAIDs is required, patients require strict monitoring for toxicity, especially myelosuppression and gastrointestinal toxicity.
Pemetrexed is incompatible with Ringer’s lactate solution and Ringer’s solution.
Concomitant use of pemetrexed with other drugs and solutions has not been studied and is therefore not recommended.
Storage Conditions
Store at 15°C (59°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
Lyophilisate for the preparation of a concentrate for the preparation of an infusion solution 100 mg: fl. 1 pc.
Lyophilisate for the preparation of a concentrate for the preparation of an infusion solution 500 mg: fl. 1 pc.
Marketing Authorization Holder
Hetero Labs, Limited (India)
Manufactured By
Hetero Labs, Limited (India)
Packaging and Quality Control Release
HETERO LABS, Limited (India)
Or
MAKIZ-PHARMA, LLC (Russia)
Dosage Forms
 |
Pemetrexed | Lyophilisate for the preparation of a concentrate for the preparation of an infusion solution 100 mg: fl. 1 pc. |
| Lyophilisate for the preparation of a concentrate for the preparation of an infusion solution 500 mg: fl. 1 pc. |
Dosage Form, Packaging, and Composition
Lyophilisate for the preparation of a concentrate for the preparation of an infusion solution
| 1 vial | |
| Pemetrexed disodium heptahydrate | 142.7 mg, |
| Equivalent to pemetrexed content | 100 mg |
Excipients :
100 mg – vials (1) – cardboard packs.
Lyophilisate for the preparation of a concentrate for the preparation of an infusion solution
| 1 vial | |
| Pemetrexed disodium heptahydrate | 713.5 mg, |
| Equivalent to pemetrexed content | 500 mg |
Excipients :
500 mg – vials (1) – cardboard packs.
Infusion solution 10 mg/1 ml: 10 ml, 50 ml, or 100 ml bottle 1 pc.
Marketing Authorization Holder
Shilpa Medicare, Ltd (India)
Dosage Form
|
Pemetrexed | Infusion solution 10 mg/1 ml: 10 ml, 50 ml, or 100 ml bottle 1 pc. |
Dosage Form, Packaging, and Composition
Infusion solution clear, colorless or from light yellow to greenish-yellow.
| 1 ml | |
| Pemetrexed (in the form of disodium hemipentahydrate) | 10 mg |
Excipients : mannitol, sodium chloride, L-cysteine hydrochloride monohydrate (calculated as anhydrous substance), sodium hydroxide solution 1N – to pH 6.5-8.0, hydrochloric acid solution 1N – to pH 6.5-8.0, water for injections – up to 1 ml.
10 ml – vials of colorless glass (1) – cardboard packs.
50 ml – vials of colorless glass (1) – cardboard packs.
100 ml – vials of colorless glass (1) – cardboard packs.
Lyophilizate for the preparation of solution for infusion 100 mg: vial 1 pc.
Lyophilizate for preparation of solution for infusion 500 mg: fl. 1 pc.
Marketing Authorization Holder
Biocad, JSC (Russia)
Dosage Forms
|
Pemetrexed | Lyophilizate for the preparation of solution for infusion 100 mg: vial 1 pc. |
| Lyophilizate for preparation of solution for infusion 500 mg: fl. 1 pc. |
Dosage Form, Packaging, and Composition
Lyophilizate for the preparation of solution for infusion as a porous mass from white to white with a yellowish tint.
| 1 vial | |
| Pemetrexed disodium (in the form of hemipentahydrate) | 121.4 mg, |
| Equivalent to pemetrexed content | 100 mg |
Excipients : mannitol – 106.4 mg, hydrochloric acid or sodium hydroxide (10% solution, to maintain pH level) – to pH 7.0.
100 mg – vials (1) – cardboard packs.
Lyophilizate for the preparation of solution for infusion as a porous mass from white to white with a yellowish tint.
| 1 vial | |
| Pemetrexed disodium (in the form of hemipentahydrate) | 607 mg, |
| Equivalent to pemetrexed content | 500 mg |
Excipients : mannitol – 500 mg, hydrochloric acid or sodium hydroxide (10% solution, to maintain pH level) – to pH 7.0.
100 mg – vials (1) – cardboard packs.
Lyophilisate for the preparation of a concentrate for the preparation of an infusion solution 100 mg: fl. 1 pc.
Lyophilisate for the preparation of a concentrate for the preparation of an infusion solution 500 mg: fl. 1 pc.
Marketing Authorization Holder
Institute Of Bioorganic Chemistry Of The National Academy Of Sciences Of Belarus, State Institution (Republic Of Belarus)
Dosage Forms
|
Pemetrexed | Lyophilisate for the preparation of a concentrate for the preparation of an infusion solution 100 mg: fl. 1 pc. |
| Lyophilisate for the preparation of a concentrate for the preparation of an infusion solution 500 mg: fl. 1 pc. |
Dosage Form, Packaging, and Composition
Lyophilisate for the preparation of a concentrate for the preparation of an infusion solution as a lyophilized powder or porous mass from white to light yellow or light yellow with a greenish tint; reconstituted solution is clear, light yellow or yellowish-greenish in color.
| 1 vial | |
| Pemetrexed disodium heptahydrate | 142.7 mg, |
| Equivalent to pemetrexed content | 100 mg |
Excipients : mannitol – 106 mg, sodium hydroxide solution 2.5M or hydrochloric acid solution 2.5% – to pH 6.8-7.6 (if necessary).
Vials of colorless glass with a capacity of 10 ml (1) – cardboard packs.
Lyophilisate for the preparation of a concentrate for the preparation of an infusion solution as a lyophilized powder or porous mass from white to light yellow or light yellow with a greenish tint; reconstituted solution is clear, light yellow or yellowish-greenish in color.
| 1 vial | |
| Pemetrexed disodium heptahydrate | 713.5 mg, |
| Equivalent to pemetrexed content | 500 mg |
Excipients : mannitol – 500 mg, sodium hydroxide solution 2.5M or hydrochloric acid solution 2.5% – to pH 6.8-7.6 (if necessary).
Vials of colorless glass with a capacity of 50 ml (1) – cardboard packs.
Lyophilizate for the preparation of solution for infusion 100 mg: vial.
Lyophilisate for the preparation of solution for infusions 500 mg: fl.
Marketing Authorization Holder
Canonpharma Production, CJS (Russia)
Manufactured By
Omutninskaya Scientific Experimental-Industrial Base, JSC (Russia)
Dosage Forms
|
Pemetrexed Canon | Lyophilizate for the preparation of solution for infusion 100 mg: vial. |
| Lyophilisate for the preparation of solution for infusions 500 mg: fl. |
Dosage Form, Packaging, and Composition
Lyophilizate for the preparation of solution for infusion as a dense mass from white to white with a yellowish tint.
| 1 vial | |
| Pemetrexed disodium heptahydrate | 139.78 mg, |
| Equivalent to pemetrexed content | 100 mg |
Excipients : mannitol – 100 mg, hydrochloric acid or sodium hydroxide (10% solution, to maintain pH level) – to pH 6.6-7.8.
Vials – cardboard pack.
Lyophilizate for the preparation of solution for infusion as a dense mass from white to white with a yellowish tint.
| 1 vial | |
| Pemetrexed disodium heptahydrate | 698.9 mg, |
| Equivalent to pemetrexed content | 500 mg |
Excipients : mannitol – 500 mg, hydrochloric acid or sodium hydroxide (10% solution, to maintain pH level) – to pH 6.6-7.8.
Vials – cardboard pack.
Lyophilizate for the preparation of solution for infusion 100 mg: vial.
Lyophilisate for the preparation of solution for infusions 500 mg: fl.
Marketing Authorization Holder
Jodas Expoim, LLC (Russia)
Manufactured By
Jodas Expoim, Pvt. Ltd. (India)
Dosage Forms
|
Pemetrexed J | Lyophilizate for the preparation of solution for infusion 100 mg: vial. |
| Lyophilisate for the preparation of solution for infusions 500 mg: fl. |
Dosage Form, Packaging, and Composition
Lyophilizate for the preparation of solution for infusion from white to light yellow or light yellow with a greenish tint; clumping is allowed.
| 1 vial | |
| Pemetrexed disodium heptahydrate | 142.7 mg, |
| Equivalent to pemetrexed content | 100 mg |
Excipients: mannitol – 100 mg, hydrochloric acid solution 1M or sodium hydroxide solution 1M – to pH 6.8-7.2.
100 mg – vials (1) – cardboard packs.
Lyophilizate for the preparation of solution for infusion from white to light yellow or light yellow with a greenish tint; clumping is allowed.
| 1 vial | |
| Pemetrexed disodium heptahydrate | 713.5 mg, |
| Equivalent to pemetrexed content | 500 mg |
Excipients: mannitol – 500 mg, hydrochloric acid solution 1M or sodium hydroxide solution 1M – to pH 6.8-7.2.
500 mg – vials (1) – cardboard packs.
Lyophilizate for solution for infusion 100 mg
Lyophilisate for preparation of solution for infusion 500 mg
Marketing Authorization Holder
Amedart LLC (Russia)
Dosage Forms
|
Pemetrexed-Amedart | Lyophilizate for solution for infusion 100 mg |
| Lyophilisate for preparation of solution for infusion 500 mg |
Dosage Form, Packaging, and Composition
Lyophilizate for the preparation of concentrate for the preparation of solution for infusion in the form of a white or almost white lyophilized powder.
| 1 vial | |
| Pemetrexed (in the form of pemetrexed disodium) | 100 mg |
Excipients: mannitol, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment).
100 mg – colorless glass vials (1) – cardboard packs.
Lyophilizate for the preparation of concentrate for the preparation of solution for infusion in the form of a white or almost white lyophilized powder.
| 1 vial | |
| Pemetrexed (in the form of pemetrexed disodium) | 500 mg |
Excipients: mannitol, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment).
500 mg – colorless glass vials (1) – cardboard packs.
Lyophilisate for preparation of solution for infusion 100 mg: vial 1 or 10 pcs.
Lyophilizate for the preparation of solution for infusion 500 mg: fl. 1 or 10 pcs.
Marketing Authorization Holder
Deko Company, LLC (Russia)
Dosage Forms
|
Pemetrexed-Deco | Lyophilisate for preparation of solution for infusion 100 mg: vial 1 or 10 pcs. |
| Lyophilizate for the preparation of solution for infusion 500 mg: fl. 1 or 10 pcs. |
Dosage Form, Packaging, and Composition
Lyophilizate for the preparation of concentrate for the preparation of solution for infusion in the form of a porous mass from white to light yellow or light yellow with a greenish tint.
| 1 vial | |
| Pemetrexed disodium heptahydrate | 139.8 mg, |
| Equivalent to pemetrexed content | 100 mg |
Excipients: mannitol – 106.4 mg, hydrochloric acid solution 1M – to pH 7.0.
100 mg – colorless glass vials (1) – cardboard packs.
100 mg – colorless glass vials (10) – cardboard packs.
Lyophilizate for the preparation of concentrate for the preparation of solution for infusion in the form of a porous mass from white to light yellow or light yellow with a greenish tint.
| 1 vial | |
| Pemetrexed disodium heptahydrate | 698.8 mg, |
| Equivalent to pemetrexed content | 500 mg |
Excipients: mannitol – 500 mg, hydrochloric acid solution 1M – to pH 7.0.
500 mg – colorless glass vials (1) – cardboard packs.
500 mg – colorless glass vials (10) – cardboard packs.
Lyophilizate for the preparation of solution for infusion 100 mg: vial 1 pc.
Lyophilizate for preparation of solution for infusion 500 mg: fl. 1 pc.
Marketing Authorization Holder
Kelun-Kazpharm, LLP (Kazakhstan)
Dosage Forms
|
Pemetrexed-Kelun-Kazpharm | Lyophilizate for the preparation of solution for infusion 100 mg: vial 1 pc. |
| Lyophilizate for preparation of solution for infusion 500 mg: fl. 1 pc. |
Dosage Form, Packaging, and Composition
Lyophilizate for the preparation of concentrate for the preparation of solution for infusion from white to light yellow or light yellow with a greenish tint.
| 1 vial | |
| Pemetrexed disodium heptahydrate | 140.46 mg |
| Equivalent to pemetrexed content | 100 mg |
Excipients: mannitol – 100 mg, hydrochloric acid solution 10% and sodium hydroxide solution 10% — q.s. to pH 6.6-7.8.
100 mg – vials (1) – cardboard packs (1).
Lyophilizate for the preparation of concentrate for the preparation of solution for infusion from white to light yellow or light yellow with a greenish tint.
| 1 vial | |
| Pemetrexed disodium heptahydrate | 702.28 mg |
| Equivalent to pemetrexed content | 500 mg |
Excipients: mannitol – 500 mg, hydrochloric acid solution 10% and sodium hydroxide solution 10% — q.s. to pH 6.6-7.8.
Lyophilisate for the preparation of solution for infusions 500 mg: fl.
Marketing Authorization Holder
Pharmstandard-Ufimsky Vitaminny Zavod OJSC (Russia)
Dosage Form
|
Pemetrexed-Nativ | Lyophilisate for the preparation of solution for infusions 500 mg: fl. |
Dosage Form, Packaging, and Composition
Lyophilizate for the preparation of solution for infusion in the form of a porous amorphous mass from white to light yellow or light yellow with a greenish tint. Clumping is allowed.
| 1 vial | |
| Pemetrexed disodium heptahydrate | 713.5 mg |
| Equivalent to pemetrexed content | 500 mg |
Excipients: mannitol – 500 mg, hydrochloric acid solution 1M or sodium hydroxide solution 1M – to pH 6.8 – 7.2.
500 mg – glass vials (1) – cardboard packs.
Lyophilizate for the preparation of solution for infusion 100 mg: vial.
Marketing Authorization Holder
Pharmstandard-Ufimsky Vitaminny Zavod OJSC (Russia)
Dosage Form
|
Pemetrexed-Nativ | Lyophilizate for the preparation of solution for infusion 100 mg: vial. |
Dosage Form, Packaging, and Composition
Lyophilizate for the preparation of solution for infusion in the form of a porous amorphous mass from white to light yellow or light yellow with a greenish tint. Clumping is allowed.
| 1 vial | |
| Pemetrexed disodium heptahydrate | 142.7 mg, |
| Equivalent to pemetrexed content | 100 mg |
Excipients: mannitol – 100 mg, hydrochloric acid solution 1M or sodium hydroxide solution 1M – to pH 6.8 – 7.2.
100 mg – glass vials (1) – cardboard packs.
Lyophilisate for preparation of solution for infusion 100 mg: vial 1 or 50 pcs.
Lyophilisate for preparation of solution for infusion 500 mg: vial 1 or 50 pcs.
Marketing Authorization Holder
Promomed Rus LLC (Russia)
Manufactured By
Biokhimik, JSC (Russia)
Dosage Forms
|
Pemetrexed-Promomed | Lyophilisate for preparation of solution for infusion 100 mg: vial 1 or 50 pcs. |
| Lyophilisate for preparation of solution for infusion 500 mg: vial 1 or 50 pcs. |
Dosage Form, Packaging, and Composition
Lyophilizate for the preparation of concentrate for the preparation of solution for infusion in the form of a mass or lyophilized powder from white to light yellow or light yellow with a greenish tint; reconstituted solution – clear or slightly opalescent colorless or from yellow to greenish-yellow.
| 1 vial | |
| Pemetrexed | 100 mg |
Excipients: mannitol, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment).
100 mg – colorless glass vials with a capacity of 10 ml (1) – cardboard packs.
100 mg – colorless glass vials with a capacity of 10 ml (50) – cardboard packs (for hospitals).
Lyophilizate for the preparation of concentrate for the preparation of solution for infusion in the form of a mass or lyophilized powder from white to light yellow or light yellow with a greenish tint; reconstituted solution – clear or slightly opalescent colorless or from yellow to greenish-yellow.
| 1 vial | |
| Pemetrexed | 500 mg |
Excipients: mannitol, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment).
500 mg – colorless glass vials with a capacity of 50 ml (1) – cardboard packs.
500 mg – colorless glass vials with a capacity of 50 ml (50) – cardboard packs (for hospitals).
Lyophilizate for the preparation of solution for infusion 100 mg: vial 1 pc.
Lyophilizate for preparation of solution for infusion 500 mg: fl. 1 pc.
Marketing Authorization Holder
Manas Med, LLC (Russia)
Manufactured By
Rus-Med Exports Private Limited (India)
Dosage Forms
|
Pemetrexed-Rus | Lyophilizate for the preparation of solution for infusion 100 mg: vial 1 pc. |
| Lyophilizate for preparation of solution for infusion 500 mg: fl. 1 pc. |
Dosage Form, Packaging, and Composition
Lyophilizate for the preparation of concentrate for the preparation of solution for infusion in the form of a mass from white to light yellow or light yellow with a greenish tint.
| 1 vial | |
| Pemetrexed disodium hemipentahydrate | 120.8 mg, |
| Equivalent to pemetrexed content | 100 mg |
Excipients: mannitol – 106 mg, hydrochloric acid or sodium hydroxide – to pH 6.6-7.6.
100 mg – colorless glass ampoules (1) – cardboard packs.
Lyophilizate for the preparation of concentrate for the preparation of solution for infusion in the form of a mass from white to light yellow or light yellow with a greenish tint.
| 1 vial | |
| Pemetrexed disodium hemipentahydrate | 698.95 mg, |
| Equivalent to pemetrexed content | 500 mg |
Excipients: mannitol – 500 mg, hydrochloric acid or sodium hydroxide – to pH 6.6-7.6.
500 mg – colorless glass vials (1) – cardboard packs.
Lyophilisate for preparation of concentrate for preparation of solution for infusion 100 mg
Lyophilisate for preparation of concentrate for preparation of solution for infusion 500 mg
Marketing Authorization Holder
Teva Pharmaceutical Industries, Ltd. (Israel)
Manufactured By
Pharmachemie, B.V. (Netherlands)
Dosage Forms
|
Pemetrexed-Teva | Lyophilisate for preparation of concentrate for preparation of solution for infusion 100 mg |
| Lyophilisate for preparation of concentrate for preparation of solution for infusion 500 mg |
Dosage Form, Packaging, and Composition
Lyophilizate for the preparation of concentrate for the preparation of solution for infusion
| 1 vial | |
| Pemetrexed (in the form of pemetrexed disodium) | 100 mg |
100 mg – vials – cardboard packs – Prescription only
Lyophilizate for the preparation of concentrate for the preparation of solution for infusion
| 1 vial | |
| Pemetrexed (in the form of pemetrexed disodium) | 500 mg |
500 mg – vials – cardboard packs – Prescription only
Lyophilizate for the preparation of solution for infusion 100 mg: vial 1 pc.
Marketing Authorization Holder
Technology Lekarstv LLC (Russia)
Manufactured By
N.N. Blokhin Russian Cancer Research Center of the Ministry of Health of Russia (Russia)
Dosage Form
|
Pemetrexed-TL | Lyophilizate for the preparation of solution for infusion 100 mg: vial 1 pc. |
Dosage Form, Packaging, and Composition
Lyophilizate for the preparation of solution for infusion white or almost white, in the form of a lyophilized mass or powder.
| 1 vial | |
| Pemetrexed disodium hemipentahydrate | 120.8 mg, |
| Equivalent to pemetrexed content | 100 mg |
Excipients: mannitol (E421), sodium hydroxide and/or hydrochloric acid solution 0.1M (added during production to set pH 7.2).
100 mg – vials (1) – cardboard packs.
Lyophilizate for preparation of solution for infusion 500 mg: fl. 1 pc.
Marketing Authorization Holder
Technology Lekarstv LLC (Russia)
Manufactured By
N.N. Blokhin Russian Cancer Research Center of the Ministry of Health of Russia (Russia)
Dosage Form
|
Pemetrexed-TL | Lyophilizate for preparation of solution for infusion 500 mg: fl. 1 pc. |
Dosage Form, Packaging, and Composition
Lyophilizate for the preparation of solution for infusion white or almost white, in the form of a lyophilized mass or powder.
| 1 vial | |
| Pemetrexed disodium hemipentahydrate | 604.1 mg, |
| Equivalent to pemetrexed content | 500 mg |
Excipients: mannitol (E421), sodium hydroxide and/or 0.1M hydrochloric acid solution (added during production to adjust pH to 7.2).
500 mg – vials (1) – carton packs.
![Pemetrexed [Solution, Lyophilisate] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Pemetrexed [Solution, Lyophilisate] 2")