Land: Israël
Taal: Engels
Bron: Ministry of Health
PEGFILGRASTIM
UNIPHARM TRADING LTD, ISRAEL
L03AA13
SOLUTION FOR INJECTION
PEGFILGRASTIM 10 MG/ML
S.C
Required
BIOCON BIOLOGICS INDIA LTD., INDIA
PEGFILGRASTIM
Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy, given at intervals of 14 days or more, for malignancy. (with the exception of chronic myeloid leukemia and myelodysplastic syndromes).
2020-09-29
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS )PREPARATIONS( – 1986 The medicine is dispensed with a doctor’s prescription only PEGIL SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 6 MG/0.6 ML For subcutaneous administration COMPOSITION: Each pre-filled syringe contains: Pegfilgrastim 6 mg/0.6 ml Inactive and allergenic ingredients in the preparation – see section 6 – ”Further Information“ and section 2 – “Important information about some of the ingredients of the medicine“. • READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor, pharmacist or nurse. • Keep this leaflet. You may need to read it again. • This medicine has been prescribed for the treatment of your ailment. Do not pass it on to others. It may harm them, even if it seems to you that their ailment is similar. • If any side effects occur, consult a doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4 – ”Side Effects“. IMPORTANT INFORMATION FOR YOUR ATTENTION • If you have been told that you are sensitive to certain types of sugars, consult the doctor before using PEGIL. • PEGIL can be self-injected in your home after receiving instruction from a healthcare professional. Please carefully read the instructions for self- injection appearing in the Instructions for Use Leaflet attached to the package. • Carefully following the doctor’s instructions (dosage, times of injection and duration of treatment) increases the chances for treatment success. In any case, do not discontinue the treatment without consulting the attending doctor. Please read sections 2 and 4 for extensive safety information. • Keep PEGIL in the refrigerator (see section 5 – “How Should The Medicine Be Stored?“(. • The medicine, PEGIL pre-filled syringe, is intended for single use! Note that it is important that you verify, each t Lees het volledige document
1 PEGIL (PEGFILGRASTIM) SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 6 MG/0.6 ML (10 MG/1 ML) 1. NAME OF THE MEDICINAL PRODUCT PEGIL 6 mg solution for injection in pre-filled syringe. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 6 mg of pegfilgrastim* in 0.6 mL solution for injection. The concentration is 10 mg/mL based on protein only**. *Produced in _Escherichia coli_ cells by recombinant DNA technology followed by conjugation with polyethylene glycol (PEG). **The concentration is 20 mg/mL if the PEG moiety is included. The potency of this product should not be compared to the potency of another pegylated or non-pegylated protein of the same therapeutic class. For more information, see section 5.1. Excipients with known effect: Each pre-filled syringe contains 30 mg sorbitol (see section 4.4). Each pre-filled syringe contains less than 1 mmol sodium (23 mg) (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear, colorless solution for injection. Pegil is a biosimilar medicinal product that has been demonstrated to be similar in quality, safety and efficacy to the reference medicinal product Neulastim®. Please be aware of any differences in the indications between the biosimilar medicinal product and the reference medicinal product. The biosimilar is not to be switched with the reference medicinal product unless specifically stated otherwise. More detailed information regarding biosimilar medicinal products is available on the website of the Ministry of Health: https://www.health.gov.il/UnitsOffice/HD/MTI/Drugs/Registration/Pages/Biosimilars.aspx 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy, given at intervals of 14 days or more, for malignancy (with the exception of chronic myeloid leukemia and myelodysplastic syndromes). 2 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Pegfilgrastim Lees het volledige document