Quest for the right Drug
סטימופג STIMOPEG (PEGFILGRASTIM)
תרופה במרשם
תרופה בסל
נרקוטיקה
ציטוטוקסיקה
צורת מתן:
תת-עורי : S.C
צורת מינון:
תמיסה להזרקה : SOLUTION FOR INJECTION
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
Pharmaceutical particulars : מידע רוקחי
6. PHARMACEUTICAL PARTICULARS 6.1 List of excipients Sorbitol Glacial acetic acid Sodium hydroxide Polysorbate 20 Water for injection 6.2 Incompatibilities This medicinal product must not be mixed with other medicinal products, particularly with sodium chloride solutions. 6.3 Shelf life The expiry date of the product is indicated on the packaging materials. 6.4 Special precautions for storage Store in a refrigerator (2°C–8°C). StimoPeg may be exposed to room temperature (not above 25°C ±2°C) for a maximum single period of up to 15 days. If left at room temperature for more than 15 days it should be discarded. Do not freeze. Accidental exposure to freezing temperatures for a single period of less than 24 hours does not adversely affect the stability of StimoPeg. Keep the container in the outer carton, in order to protect from light. 6.5 Nature and contents of container Pre-filled syringe (type I glass) with a permanently attached stainless steel injection needle, with a needle safety guard. The needle cap of the pre-filled syringe contains dry natural rubber (a derivative of latex) (see section 4.4). Each pre-filled syringe contains 0.6 ml of solution for injection. Pack size of one pre-filled syringe, in a blister package using paper and PVC film. Not all pack sizes may be marketed. 6.6 Special precautions for disposal and other handling Before administration, StimoPeg solution should be inspected visually for particulate matter. Only a solution that is clear and colorless should be injected. Excessive shaking may aggregate pegfilgrastim, rendering it biologically inactive. Allow the pre-filled syringe to reach room temperature before injecting. Any unused product or waste material should be disposed of in accordance with local requirements.
שימוש לפי פנקס קופ''ח כללית 1994
לא צוין
תאריך הכללה מקורי בסל
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הגבלות
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מידע נוסף