Quest for the right Drug
אנג'יימו ENJAYMO (SUTIMLIMAB)
תרופה במרשם
תרופה בסל
נרקוטיקה
ציטוטוקסיקה
צורת מתן:
תוך-ורידי : I.V
צורת מינון:
תמיסה לאינפוזיה : SOLUTION FOR INFUSION
עלון לרופא
מינוניםPosology התוויות
Indications תופעות לוואי
Adverse reactions התוויות נגד
Contraindications אינטראקציות
Interactions מינון יתר
Overdose הריון/הנקה
Pregnancy & Lactation אוכלוסיות מיוחדות
Special populations תכונות פרמקולוגיות
Pharmacological properties מידע רוקחי
Pharmaceutical particulars אזהרת שימוש
Special Warning עלון לרופא
Physicians Leaflet
Special Warning : אזהרת שימוש
4.4 Special warnings and precautions for use Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Infections Enjaymo targets the classical complement pathway (CP) specifically binding to complement protein component 1, s subcomponent (C1s) preventing the cleavage of complement protein C4. Although the lectin and alternate pathways remain unaffected, patients may have an increased susceptibility to serious infections, especially infections caused by encapsulated bacteria such as Neisseria meningitides, Streptococcus pneumoniae, and Haemophilus influenza. Patients should be vaccinated against encapsulated bacteria before treatment with Enjaymo is started, please see “Vaccinations” below. In clinical studies with CAD, serious infections, including sepsis, have been reported in patients receiving treatment with Enjaymo (see section 4.8). Enjaymo should not be initiated in patients with active, serious infections. Patients should be monitored for early signs and symptoms of infections and should be informed to seek immediate medical care if such symptoms should occur. Patients with viral hepatitis and HIV were excluded from the clinical studies. Before and during treatment, patients must notify their physician if they have been diagnosed with hepatitis B, hepatitis C, or HIV infection. Be cautious when treating patients with a history of hepatitis B, hepatitis C, or HIV infection. Vaccinations Vaccinate patients according to the most current local recommendations for patients with persistent complement deficiencies, including meningococcal and streptococcal vaccines. Revaccinate patients in accordance with local recommendations. Immunize patients without a history of vaccination against encapsulated bacteria at least 2 weeks prior to receiving the first dose of Enjaymo. If urgent Enjaymo therapy is indicated in an unvaccinated patient, administer vaccine(s) as soon as possible. The benefits and risks of antibiotic prophylaxis for prevention of infections in patients receiving Enjaymo have not been established. Hypersensitivity reactions As with other protein products, administration of Enjaymo may result in hypersensitivity reactions, including anaphylaxis. In clinical studies, no serious hypersensitivity reactions were observed with Enjaymo. If hypersensitivity reactions occur, discontinue Enjaymo and initiate appropriate treatment. Infusion-related reactions Administration of Enjaymo may result in infusion-related reactions during the infusion or immediately after the infusion (see section 4.8). Patients should be monitored for infusion-related reactions, infusion interrupted if a reaction occurs and appropriate treatment initiated. Systemic lupus erythematosus (SLE) Individuals with inherited classical complement deficiency are at a higher risk for developing SLE. Patients with SLE were excluded from clinical studies with Enjaymo. Patients being treated with Enjaymo should be monitored for signs and symptoms of SLE and evaluated appropriately. Use Enjaymo with caution in patients with SLE or those who develop signs and symptoms of SLE. Monitoring CAD manifestations after Enjaymo discontinuation The effects on haemolysis diminish after end of treatment. Patients should therefore be monitored for signs and symptoms of haemolysis in case of treatment discontinuation. Sodium This medicinal product contains 3.5 mg per mL or 77 mg sodium per vial, equivalent to 3.85% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Effects on Driving
4.7 Effects on ability to drive and use machines Enjaymo has no or negligible influence on the ability to drive and use machines.
שימוש לפי פנקס קופ''ח כללית 1994
לא צוין
תאריך הכללה מקורי בסל
לא צוין
הגבלות
לא צוין
מידע נוסף