PegIntron® (Lyophilisate) Instructions for Use
ATC Code
L03AB10 (Peginterferon alfa-2b)
Active Substance
Peginterferon alfa-2b
Peginterferon alfa-2b (Rec.INN registered by WHO)
Clinical-Pharmacological Group
Interferon. An immunomodulatory drug with antiviral action
Pharmacotherapeutic Group
MIBP-cytokine
Pharmacological Action
An immunomodulator and antiviral agent. It is a covalent conjugate of recombinant interferon alfa-2b and monomethoxypolyethylene glycol. The average molecular weight is about 31,300 Daltons.
Recombinant interferon alfa-2b is obtained from an E.coli clone containing a plasmid hybrid (obtained by genetic engineering) that encodes human leukocyte interferon alfa-2b. In vitro and in vivo studies indicate that the biological activity of peginterferon alfa-2b is due to interferon alfa-2b. The cellular effects of interferons are realized through binding to specific receptors on the cell surface. Studies of other interferons have demonstrated their species specificity.
Recombinant interferon alfa-2b also suppresses virus replication in vitro and in vivo. Although the exact mechanism of the antiviral action of recombinant interferon alfa-2b is unknown, it is believed to alter host cell metabolism. This leads to the suppression of virus replication; if replication does occur, the resulting virions are unable to leave the cell.
Pharmacokinetics
After subcutaneous administration, the Cmax of the active substance in the serum is reached within 15-44 hours and persists for up to 48-72 hours. The Cmax and AUC of peginterferon alfa-2b increase proportionally to the dose. The Vd averages 0.99 L/kg. Upon repeated administration, accumulation of immunoreactive interferons occurs. However, the biological activity increases only slightly.
The T1/2 of peginterferon alfa-2b averages about 30.7 hours, and the clearance is 22 mL/h/kg. The mechanisms of interferon elimination have not been definitively established. However, it is known that the renal clearance fraction accounts for about 30% of the total clearance of peginterferon alfa-2b.
After a single dose of 1 mcg/kg in patients with impaired renal function, an increase in Cmax, AUC, and T1/2 proportional to the degree of renal failure was observed. In severe renal impairment (creatinine clearance <50 mL/min), the clearance of peginterferon alfa-2b is reduced.
Indications
As monotherapy for histologically confirmed hepatitis C in adults with serum markers of hepatitis C virus replication (elevated aminotransferase activity, presence of HCV RNA or anti-HCV antibodies in the serum in the absence of liver disease decompensation) in case of ribavirin intolerance or contraindications to its use; as part of combination therapy with ribavirin in patients with chronic hepatitis C.
ICD codes
| ICD-10 code | Indication |
| B18.2 | Chronic viral hepatitis C |
| ICD-11 code | Indication |
| 1E51.1 | Chronic viral hepatitis C |
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. |
Lyophilisate
It is administered subcutaneously at a dose of 0.5 mcg/kg or 1 mcg/kg once a week for at least 6 months, or at a dose of 1.5 mcg/kg of body weight when used as part of combination therapy with ribavirin. The dose is established taking into account the expected efficacy of the drug and the possibility of developing adverse reactions. If HCV RNA is detected in the serum after 6 months, treatment is continued for another 6 months; the total duration of treatment is 1 year.
If adverse reactions occur during treatment, it is recommended to reduce the dose of peginterferon alfa-2b by half. If adverse effects persist or reappear after dose adjustment, treatment should be discontinued.
The dose is adjusted depending on the neutrophil count, platelet count, and renal function. Therapy should be discontinued if the neutrophil count decreases to less than 0.50×109/L or the platelet count decreases to less than 25×109/L.
Adverse Reactions
From the digestive system anorexia, nausea, diarrhea, abdominal pain.
From the musculoskeletal system pain, myalgia, arthralgia.
From the nervous system headache, depression, anxiety, dizziness, impaired concentration, insomnia, irritability.
Frequently itching, dry skin, malaise, sweating, pain in the right hypochondrium, neutropenia, rash, vomiting, dry mouth, emotional lability, nervousness, dyspnea, viral infections, drowsiness, thyroid dysfunction, chest pain, dyspepsia, flushing, paresthesia, cough, agitation, sinusitis, arterial hypertension, hyperesthesia, blurred vision, confusion, abdominal bloating, decreased libido, erythema, eye pain, apathy, hypoesthesia, unstable stool, conjunctivitis, nasal congestion, constipation, menorrhagia, menstrual disorders, granulocytopenia, thrombocytopenia.
Rarely suicidal thoughts and attempts, hearing impairment, retinal changes, diabetes mellitus, hepatopathy, and arrhythmias.
Local reactions inflammation, local hypersensitivity reaction.
Others asthenia, fatigue, fever, flu-like symptoms, chills, weight loss, alopecia, pharyngitis.
Contraindications
Autoimmune hepatitis or a history of autoimmune disease; severe mental illness or a history of significant mental disorders; thyroid dysfunction resistant to drug therapy; severe impairment of renal or liver function; epilepsy and/or CNS dysfunction; pregnancy; hypersensitivity to peginterferon alfa-2b and other interferons.
Use in Pregnancy and Lactation
Contraindicated for use during pregnancy.
If use during lactation is necessary, breastfeeding should be discontinued.
It can be used in women of reproductive age provided they use effective methods of contraception throughout the entire treatment period.
Use in Hepatic Impairment
The safety and efficacy of peginterferon alfa-2b in patients with severe hepatic impairment have not been studied; therefore, it should not be used in this category of patients.
Use in Renal Impairment
During treatment, patients with impaired renal function require constant monitoring.
Pediatric Use
Not recommended for use in children and adolescents under 18 years of age.
Special Precautions
Before starting and during treatment with peginterferon alfa-2b, it is recommended to perform complete blood count, biochemical blood tests, and thyroid function tests. The following baseline blood values are acceptable: platelets – ≥100,000/µL, neutrophils – ≥1,500/µL, TSH – within normal limits.
The safety and efficacy of peginterferon alfa-2b in patients with severe hepatic impairment have not been studied; therefore, it should not be used in this category of patients.
Patients with heart disease are recommended to have an ECG before starting and during treatment. Arrhythmias (mainly supraventricular) are usually amenable to conventional therapy, but discontinuation of peginterferon alfa-2b may be required. Patients with congestive heart failure (including history), myocardial infarction, and/or arrhythmia require constant medical supervision during treatment with peginterferon alfa-2b.
If immediate-type hypersensitivity reactions (including urticaria, angioedema, bronchospasm, anaphylaxis) develop during the administration of peginterferon alfa-2b, treatment should be discontinued and adequate symptomatic therapy should be immediately prescribed. Transient skin rash does not require discontinuation of treatment.
If symptoms appear that may indicate decompensation of liver disease, the use of peginterferon alfa-2b should be discontinued.
Although fever may be a manifestation of the flu-like syndrome, which is often observed during interferon treatment, it is necessary to exclude other causes of persistent fever.
During treatment with peginterferon alfa-2b, adequate hydration should be ensured, as some patients experienced arterial hypotension associated with a decrease in fluid volume. In such cases, fluid administration may be required.
Use with caution in patients with lung diseases (e.g., chronic obstructive pulmonary disease), diabetes mellitus accompanied by ketoacidosis, in patients with coagulation disorders (e.g., thrombophlebitis, pulmonary embolism) or pronounced myelosuppression.
In rare cases, patients receiving interferon alfa developed infiltrates in the lungs of unclear etiology. If fever, cough, dyspnea, and other respiratory symptoms appear, all patients should undergo chest X-ray. If infiltrates are present on lung X-rays or signs of impaired lung function, patients should be constantly monitored and, if necessary, Peginterferon alfa-2b should be discontinued.
Patients with diabetes mellitus or arterial hypertension are recommended to have an eye examination before starting treatment with peginterferon alfa-2b.
If mental disorders or CNS changes occur, including overt depression, patients are recommended to be constantly monitored, given the potential seriousness of such adverse events. If symptoms persist or worsen, Peginterferon alfa-2b should be discontinued.
If any thyroid dysfunction is detected before starting treatment with peginterferon alfa-2b, standard therapy is recommended. Peginterferon alfa-2b should not be used if such therapy does not maintain TSH activity at a normal level.
In patients with psoriasis, Peginterferon alfa-2b should be used only if the expected benefit of therapy outweighs the possible risk.
During treatment, patients with impaired renal function require constant monitoring.
Not recommended for use in children and adolescents under 18 years of age.
Effect on the ability to drive vehicles and operate machinery
If fatigue, drowsiness, or confusion occurs during therapy, it is not recommended to drive a car or operate complex machinery.
Storage Conditions
Store at 2°C (36°F) to 8°C (46°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 solution for subcutaneous administration 120 mcg: vial in set with solvent
Marketing Authorization Holder
Schering-Plough Labo N.V. (Belgium)
Manufactured By
Schering-Plough (Brinny) Co. (Ireland)
Dosage Form
 |
PegIntron® | Lyophilisate for the preparation of solution for subcutaneous administration 120 mcg: vial in set with solvent |
Dosage Form, Packaging, and Composition
Lyophilized powder for the preparation of injection solution white or almost white, free from foreign inclusions; solvent – a clear, colorless liquid, free from visible particles.
| 1 vial | 0.5 ml of prepared solution | |
| Peginterferon alfa-2b | 120 mcg | 120 mcg |
Excipients: sodium hydrogen phosphate, sodium dihydrogen phosphate, sucrose, polysorbate 80.
Solvent water for injections – 0.7 ml*.
* – the solvent is added in an excess amount to compensate for losses during the dissolution of the lyophilisate and the administration of the prepared solution.
120 mcg – Glass vials with a volume of 2 ml (1) in a set with a solvent (amp. 1 pc.) – cardboard packs.
Lyophilisate for preparation of solution for subcutaneous administration 50 mcg: two-chamber pen-injectors with solvent in a set with needle and wipes
Marketing Authorization Holder
Schering-Plough Labo N.V. (Belgium)
Manufactured By
Schering-Plough, Ltd. (Singapore)
Dosage Form
|
PegIntron® | Lyophilisate for preparation of solution for subcutaneous administration 50 mcg: two-chamber pen-injectors with solvent in a set with needle and wipes |
Dosage Form, Packaging, and Composition
Lyophilized powder for the preparation of injection solution white or almost white, free from foreign inclusions; solvent – a clear, colorless liquid, free from visible particles.
| 1 pen-injector | 0.5 ml of prepared solution | |
| Peginterferon alfa-2b | 50 mcg | 50 mcg |
Excipients: sodium hydrogen phosphate, sodium dihydrogen phosphate, sucrose, polysorbate 80.
Solvent water for injections – 0.7 ml*.
* – the solvent is added in an excess amount to compensate for losses during the dissolution of the lyophilisate and the administration of the prepared solution.
50 mcg – Two-chamber pen-injectors with solvent (1) – contour plastic packaging (1) in a set with a needle for s.c. injection and wipes (2 pcs.) – cardboard packs.
Lyophilizate for the preparation of solution for subcutaneous administration 80 mcg: two-chamber pen-injectors with solvent in a set with a needle and wipes
Marketing Authorization Holder
Schering-Plough Labo N.V. (Belgium)
Manufactured By
Schering-Plough, Ltd. (Singapore)
Dosage Form
|
PegIntron® | Lyophilizate for the preparation of solution for subcutaneous administration 80 mcg: two-chamber pen-injectors with solvent in a set with a needle and wipes |
Dosage Form, Packaging, and Composition
Lyophilized powder for the preparation of injection solution white or almost white, free from foreign inclusions; solvent – a clear, colorless liquid, free from visible particles.
| 1 pen-injector | 0.5 ml of prepared solution | |
| Peginterferon alfa-2b | 80 mcg | 80 mcg |
Excipients: sodium hydrogen phosphate, sodium dihydrogen phosphate, sucrose, polysorbate 80.
Solvent water for injections – 0.7 ml*.
* – the solvent is added in an excess amount to compensate for losses during the dissolution of the lyophilisate and the administration of the prepared solution.
80 mcg – Two-chamber pen-injectors with solvent (1) – contour plastic packaging (1) in a set with a needle for s.c. injection and wipes (2 pcs.) – cardboard packs.
Lyophilisate for the preparation of solution for subcutaneous administration 100 mcg: two-chamber pen-injectors with solvent in set with needle and wipes
Marketing Authorization Holder
Schering-Plough Labo N.V. (Belgium)
Manufactured By
Schering-Plough, Ltd. (Singapore)
Dosage Form
|
PegIntron® | Lyophilisate for the preparation of solution for subcutaneous administration 100 mcg: two-chamber pen-injectors with solvent in set with needle and wipes |
Dosage Form, Packaging, and Composition
Lyophilized powder for the preparation of injection solution white or almost white, free from foreign inclusions; solvent – a clear, colorless liquid, free from visible particles.
| 1 pen-injector | 0.5 ml of prepared solution | |
| Peginterferon alfa-2b | 100 mcg | 100 mcg |
Excipients: sodium hydrogen phosphate, sodium dihydrogen phosphate, sucrose, polysorbate 80.
Solvent water for injections – 0.7 ml*.
* – the solvent is added in an excess amount to compensate for losses during the dissolution of the lyophilisate and the administration of the prepared solution.
100 mcg – Two-chamber pen-injectors with solvent (1) – contour plastic packaging (1) in a set with a needle for s.c. injection and wipes (2 pcs.) – cardboard packs.
Lyophilisate for the preparation of solution for subcutaneous administration 120 mcg: two-chamber pen-injectors with solvent in set with needle and wipes
Marketing Authorization Holder
Schering-Plough Labo N.V. (Belgium)
Manufactured By
Schering-Plough, Ltd. (Singapore)
Dosage Form
|
PegIntron® | Lyophilisate for the preparation of solution for subcutaneous administration 120 mcg: two-chamber pen-injectors with solvent in set with needle and wipes |
Dosage Form, Packaging, and Composition
Lyophilized powder for the preparation of solution for injection white or almost white, free from foreign inclusions; solvent – a clear, colorless liquid, free from visible particles.
| 1 pen-injector | 0.5 ml of prepared solution | |
| Peginterferon alfa-2b | 120 mcg | 120 mcg |
Excipients : sodium hydrogen phosphate, sodium dihydrogen phosphate, sucrose, polysorbate 80.
Solvent water for injections – 0.7 ml*.
* – the solvent is added in an excess amount to compensate for losses during dissolution of the lyophilisate and administration of the prepared solution.
120 mcg – Two-chamber pen-injectors with solvent (1) – contour plastic packages (1) in a set with a needle for s/c injection and wipes (2 pcs.) – cardboard packs.
Lyophilisate for the preparation of solution for subcutaneous administration 150 mcg: two-chamber pen-injectors with solvent in set with needle and wipes
Marketing Authorization Holder
Schering-Plough Labo N.V. (Belgium)
Manufactured By
Schering-Plough, Ltd. (Singapore)
Dosage Form
|
PegIntron® | Lyophilisate for the preparation of solution for subcutaneous administration 150 mcg: two-chamber pen-injectors with solvent in set with needle and wipes |
Dosage Form, Packaging, and Composition
Lyophilized powder for the preparation of solution for injection white or almost white, free from foreign inclusions; solvent – a clear, colorless liquid, free from visible particles.
| 1 pen-injector | 0.5 ml of prepared solution | |
| Peginterferon alfa-2b | 150 mcg | 150 mcg |
Excipients : sodium hydrogen phosphate, sodium dihydrogen phosphate, sucrose, polysorbate 80.
Solvent water for injections – 0.7 ml*.
* – the solvent is added in an excess amount to compensate for losses during dissolution of the lyophilisate and administration of the prepared solution.
150 mcg – Two-chamber pen-injectors with solvent (1) – contour plastic packages (1) in a set with a needle for s/c injection and wipes (2 pcs.) – cardboard packs.
Lyophilisate for preparation of solution for subcutaneous administration 50 mcg: fl. in a set with solvent
Marketing Authorization Holder
Schering-Plough Labo N.V. (Belgium)
Manufactured By
Schering-Plough (Brinny) Co. (Ireland)
Dosage Form
|
PegIntron® | Lyophilisate for preparation of solution for subcutaneous administration 50 mcg: fl. in a set with solvent |
Dosage Form, Packaging, and Composition
Lyophilized powder for the preparation of solution for injection white or almost white, free from foreign inclusions; solvent – a clear, colorless liquid, free from visible particles.
| 1 vial | 0.5 ml of prepared solution | |
| Peginterferon alfa-2b | 50 mcg | 50 mcg |
Excipients : sodium hydrogen phosphate, sodium dihydrogen phosphate, sucrose, polysorbate 80.
Solvent water for injections – 0.7 ml*.
* – the solvent is added in an excess amount to compensate for losses during dissolution of the lyophilisate and administration of the prepared solution.
50 mcg – Glass vials with a volume of 2 ml (1) in a set with solvent (amp. 1 pc.) – cardboard packs.
Lyophilizate for the preparation of solution for subcutaneous administration 80 mcg: fl. in a set with solvent
Marketing Authorization Holder
Schering-Plough Labo N.V. (Belgium)
Manufactured By
Schering-Plough (Brinny) Co. (Ireland)
Dosage Form
|
PegIntron® | Lyophilizate for the preparation of solution for subcutaneous administration 80 mcg: fl. in a set with solvent |
Dosage Form, Packaging, and Composition
Lyophilized powder for the preparation of solution for injection white or almost white, free from foreign inclusions; solvent – a clear, colorless liquid, free from visible particles.
| 1 vial | 0.5 ml of prepared solution | |
| Peginterferon alfa-2b | 80 mcg | 80 mcg |
Excipients : sodium hydrogen phosphate, sodium dihydrogen phosphate, sucrose, polysorbate 80.
Solvent water for injections – 0.7 ml*.
* – the solvent is added in an excess amount to compensate for losses during dissolution of the lyophilisate and administration of the prepared solution.
80 mcg – Glass vials with a volume of 2 ml (1) in a set with solvent (amp. 1 pc.) – cardboard packs.
Lyophilisate for the preparation of solution for subcutaneous administration 100 mcg: vial in set with solvent
Marketing Authorization Holder
Schering-Plough Labo N.V. (Belgium)
Manufactured By
Schering-Plough (Brinny) Co. (Ireland)
Dosage Form
|
PegIntron® | Lyophilisate for the preparation of solution for subcutaneous administration 100 mcg: vial in set with solvent |
Dosage Form, Packaging, and Composition
Lyophilized powder for the preparation of solution for injection white or almost white, free from foreign inclusions; solvent – a clear, colorless liquid, free from visible particles.
| 1 vial | 0.5 ml of prepared solution | |
| Peginterferon alfa-2b | 100 mcg | 100 mcg |
Excipients : sodium hydrogen phosphate, sodium dihydrogen phosphate, sucrose, polysorbate 80.
Solvent water for injections – 0.7 ml*.
* – the solvent is added in an excess amount to compensate for losses during dissolution of the lyophilisate and administration of the prepared solution.
100 mcg – Glass vials with a volume of 2 ml (1) in a set with solvent (amp. 1 pc.) – cardboard packs.
Lyophilisate for the preparation of solution for subcutaneous administration 100 mcg: vial in set with solvent
Marketing Authorization Holder
Schering-Plough Labo N.V. (Belgium)
Manufactured By
Schering-Plough (Brinny) Co. (Ireland)
Labeled By
ORTAT, JSC (Russia)
Dosage Form
|
PegIntron® | Lyophilisate for the preparation of solution for subcutaneous administration 100 mcg: vial in set with solvent |
Dosage Form, Packaging, and Composition
Lyophilized powder for the preparation of solution for injection white or almost white, free from foreign inclusions; solvent – a clear, colorless liquid, free from visible particles.
| 1 vial | 0.5 ml of prepared solution | |
| Peginterferon alfa-2b | 100 mcg | 100 mcg |
Excipients : sodium hydrogen phosphate, sodium dihydrogen phosphate, sucrose, polysorbate 80.
Solvent water for injections – 0.7 ml*.
* – the solvent is added in an excess amount to compensate for losses during dissolution of the lyophilisate and administration of the prepared solution.
100 mcg – Glass vials with a volume of 2 ml (1) in a set with solvent (amp. 1 pc.) – cardboard packs.
Lyophilisate for the preparation of solution for subcutaneous administration 120 mcg: vial in set with solvent
Marketing Authorization Holder
Schering-Plough Labo N.V. (Belgium)
Manufactured By
Schering-Plough (Brinny) Co. (Ireland)
Labeled By
ORTAT, JSC (Russia)
Dosage Form
|
PegIntron® | Lyophilisate for the preparation of solution for subcutaneous administration 120 mcg: vial in set with solvent |
Dosage Form, Packaging, and Composition
Lyophilized powder for the preparation of solution for injection white or almost white, free from foreign inclusions; solvent – a clear, colorless liquid, free from visible particles.
| 1 vial | 0.5 ml of prepared solution | |
| Peginterferon alfa-2b | 120 mcg | 120 mcg |
Excipients : sodium hydrogen phosphate, sodium dihydrogen phosphate, sucrose, polysorbate 80.
Solvent water for injections – 0.7 ml*.
* – the solvent is added in an excess amount to compensate for losses during dissolution of the lyophilisate and administration of the prepared solution.
120 mcg – Glass vials with a volume of 2 ml (1) in a set with solvent (amp. 1 pc.) – cardboard packs.
Lyophilizate for the preparation of solution for subcutaneous administration 80 mcg: fl. in a set with solvent
Marketing Authorization Holder
Schering-Plough Labo N.V. (Belgium)
Manufactured By
Schering-Plough (Brinny) Co. (Ireland)
Labeled By
ORTAT, JSC (Russia)
Dosage Form
|
PegIntron® | Lyophilizate for the preparation of solution for subcutaneous administration 80 mcg: fl. in a set with solvent |
Dosage Form, Packaging, and Composition
Lyophilized powder for the preparation of solution for injection white or almost white, free from foreign inclusions; solvent – a clear, colorless liquid, free from visible particles.
| 1 vial | 0.5 ml of prepared solution | |
| Peginterferon alfa-2b | 80 mcg | 80 mcg |
Excipients : sodium hydrogen phosphate, sodium dihydrogen phosphate, sucrose, polysorbate 80.
Solvent water for injections – 0.7 ml*.
* – the solvent is added in an excess amount to compensate for losses during dissolution of the lyophilisate and administration of the prepared solution.
80 mcg – Glass vials with a volume of 2 ml (1) in a set with solvent (amp. 1 pc.) – cardboard packs.
Lyophilisate for the preparation of solution for subcutaneous administration 100 mcg: two-chamber pen-injectors with solvent in set with needle and wipes
Marketing Authorization Holder
Schering-Plough Labo N.V. (Belgium)
Manufactured By
Schering-Plough, Ltd. (Singapore)
Labeled By
ORTAT, JSC (Russia)
Dosage Form
|
PegIntron® | Lyophilisate for the preparation of solution for subcutaneous administration 100 mcg: two-chamber pen-injectors with solvent in set with needle and wipes |
Dosage Form, Packaging, and Composition
Lyophilized powder for the preparation of solution for injection white or almost white, free from foreign inclusions; solvent – a clear, colorless liquid, free from visible particles.
| 1 pen-injector | 0.5 ml of prepared solution | |
| Peginterferon alfa-2b | 100 mcg | 100 mcg |
Excipients : sodium hydrogen phosphate, sodium dihydrogen phosphate, sucrose, polysorbate 80.
Solvent water for injections – 0.7 ml*.
* – the solvent is added in an excess amount to compensate for losses during dissolution of the lyophilisate and administration of the prepared solution.
100 mcg – Two-chamber pen-injectors with solvent (1) – contour plastic packages (1) in a set with a needle for s/c injection and wipes (2 pcs.) – cardboard packs.
Lyophilisate for the preparation of solution for subcutaneous administration 120 mcg: two-chamber pen-injectors with solvent in set with needle and wipes
Marketing Authorization Holder
Schering-Plough Labo N.V. (Belgium)
Manufactured By
Schering-Plough, Ltd. (Singapore)
Labeled By
ORTAT, JSC (Russia)
Dosage Form
|
PegIntron® | Lyophilisate for the preparation of solution for subcutaneous administration 120 mcg: two-chamber pen-injectors with solvent in set with needle and wipes |
Dosage Form, Packaging, and Composition
Lyophilized powder for the preparation of solution for injection white or almost white, free from foreign inclusions; solvent – a clear, colorless liquid, free from visible particles.
| 1 pen-injector | 0.5 ml of prepared solution | |
| Peginterferon alfa-2b | 120 mcg | 120 mcg |
Excipients : sodium hydrogen phosphate, sodium dihydrogen phosphate, sucrose, polysorbate 80.
Solvent water for injections – 0.7 ml*.
* – the solvent is added in an excess amount to compensate for losses during dissolution of the lyophilisate and administration of the prepared solution.
120 mcg – Two-chamber pen-injectors with solvent (1) – contour plastic packages (1) in a set with a needle for s/c injection and wipes (2 pcs.) – cardboard packs.
Lyophilisate for the preparation of solution for subcutaneous administration 150 mcg: two-chamber pen-injectors with solvent in set with needle and wipes
Marketing Authorization Holder
Schering-Plough Labo N.V. (Belgium)
Manufactured By
Schering-Plough, Ltd. (Singapore)
Labeled By
ORTAT, JSC (Russia)
Dosage Form
|
PegIntron® | Lyophilisate for the preparation of solution for subcutaneous administration 150 mcg: two-chamber pen-injectors with solvent in set with needle and wipes |
Dosage Form, Packaging, and Composition
Lyophilized powder for the preparation of solution for injection white or almost white, free from foreign inclusions; solvent – a clear, colorless liquid, free from visible particles.
| 1 pen-injector | 0.5 ml of prepared solution | |
| Peginterferon alfa-2b | 150 mcg | 150 mcg |
Excipients : sodium hydrogen phosphate, sodium dihydrogen phosphate, sucrose, polysorbate 80.
Solvent water for injections – 0.7 ml*.
* – the solvent is added in an excess amount to compensate for losses during dissolution of the lyophilisate and administration of the prepared solution.
150 mcg – Two-chamber pen-injectors with solvent (1) – contour plastic packages (1) in a set with a needle for s/c injection and wipes (2 pcs.) – cardboard packs.
Lyophilisate for preparation of solution for subcutaneous administration 50 mcg: two-chamber pen-injectors with solvent in a set with needle and wipes
Marketing Authorization Holder
Schering-Plough Labo N.V. (Belgium)
Manufactured By
Schering-Plough, Ltd. (Singapore)
Labeled By
ORTAT, JSC (Russia)
Dosage Form
|
PegIntron® | Lyophilisate for preparation of solution for subcutaneous administration 50 mcg: two-chamber pen-injectors with solvent in a set with needle and wipes |
Dosage Form, Packaging, and Composition
Lyophilized powder for the preparation of solution for injection white or almost white, free from foreign inclusions; solvent – a transparent, colorless liquid, free from visible particles.
| 1 pen-injector | 0.5 ml of prepared solution | |
| Peginterferon alfa-2b | 50 mcg | 50 mcg |
Excipients : sodium hydrogen phosphate, sodium dihydrogen phosphate, sucrose, polysorbate 80.
Solvent water for injections – 0.7 ml*.
* – the solvent is added in an excess amount to compensate for losses during dissolution of the lyophilizate and administration of the prepared solution.
50 mcg – Two-chamber pen-injectors with solvent (1) – plastic contour packages (1) in a set with a needle for s/c injection and wipes (2 pcs.) – cardboard packs.
Lyophilizate for the preparation of solution for subcutaneous administration 80 mcg: two-chamber pen-injectors with solvent in a set with a needle and wipes
Marketing Authorization Holder
Schering-Plough Labo N.V. (Belgium)
Manufactured By
Schering-Plough, Ltd. (Singapore)
Labeled By
ORTAT, JSC (Russia)
Dosage Form
|
PegIntron® | Lyophilizate for the preparation of solution for subcutaneous administration 80 mcg: two-chamber pen-injectors with solvent in a set with a needle and wipes |
Dosage Form, Packaging, and Composition
Lyophilized powder for the preparation of solution for injection white or almost white, free from foreign inclusions; solvent – a transparent, colorless liquid, free from visible particles.
| 1 pen-injector | 0.5 ml of prepared solution | |
| Peginterferon alfa-2b | 80 mcg | 80 mcg |
Excipients : sodium hydrogen phosphate, sodium dihydrogen phosphate, sucrose, polysorbate 80.
Solvent water for injections – 0.7 ml*.
* – the solvent is added in an excess amount to compensate for losses during dissolution of the lyophilizate and administration of the prepared solution.
80 mcg – Two-chamber pen-injectors with solvent (1) – plastic contour packages (1) in a set with a needle for s/c injection and wipes (2 pcs.) – cardboard packs.
![PegIntron® [Lyophilisate] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "PegIntron® [Lyophilisate] 2")