البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
INSULIN (HUMAN)
ELI LILLY ISRAEL LTD, ISRAEL
A10AB01
SUSPENSION FOR INJECTION
INSULIN (HUMAN) 100 IU/ML
S.C
Required
ELI LILLY & COMPANY LTD., USA
INSULIN (HUMAN)
INSULIN (HUMAN)
For the treatment of patients with diabetes mellitus who require insulin for the maintenance of glucose homeostasis
2021-07-31
I HUMUCTVL AF 09 Page 1 of 8 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is to be supplied by a physician’s prescription only HUMULIN R - Regular HUMULIN N - NPH Solution 10 ml vial ACTIVE INGREDIENT AND ITS QUANTITY: Each vial contains: Human insulin (rDNA origin) 100 units/ml Suspension 10 ml vial ACTIVE INGREDIENT AND ITS QUANTITY: Each vial contains: Isophane human insulin (rDNA origin) 100 units/ml HUMULIN R - Regular HUMULIN N - NPH HUMULIN 70/30 Solution 5 X 3 ml cartridge ACTIVE INGREDIENT AND ITS QUANTITY: Each cartridge contains: Human insulin (rDNA origin) 100 units/ml Suspension 5 X 3 ml cartridge ACTIVE INGREDIENT AND ITS QUANTITY: Each cartridge contains: Isophane human insulin (rDNA origin) 100 units/ml Suspension 5 X 3 ml cartridge ACTIVE INGREDIENT AND ITS QUANTITY: Each cartridge contains: 70% Isophane human insulin and 30% human insulin (rDNA origin) 100 units/ml INACTIVE INGREDIENTS AND ALLERGENS: see section 2 “important information about some of the ingredients of this medicine” and section 6 “Additional information”. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, please contact your doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar. 1. WHAT IS THIS MEDICINE INTENDED FOR? To treat patients who suffer from diabetes and need insulin in order to maintain balanced blood sugar levels. THERAPEUTIC GROUP: Insulins and analogue for injection. Humulin preparations contain insulin of human origin, which is used to treat diabetes. You get diabetes if your pancreas does not make enough insulin to control the level of glucose in your blood. Contact your doctor so s/he can explain to you the operating mechanism of the different types of insulin and their range of action. Do not change your in اقرأ الوثيقة كاملة
X HUMUCTVL AF 09 Page 1 of 10 1. NAME OF THE MEDICINAL PRODUCT Humulin R (Soluble Insulin Injection) Solution for Injection (100 IU/ml, 10 ml vials; 100 IU/ml 3.0 ml cartridges for use in a reusable pen Humulin N (Isophane Insulin Injection) Suspension for Injection (100 IU/ml 10 ml vials; 100 IU/ml, 3.0 ml cartridges for use in a reusable pen). Humulin 70/30 (Biphasic Isophane Insulin Injection) (30% soluble insulin/70% isophane insulin) Suspension for Injection (100 IU/ml, 3.0 ml cartridges for use in a reusable pen) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 100 IU human Insulin (produced in _E. coli_ by recombinant DNA technology). One vial contains 10 ml equivalent to 1000 IU. or One cartridge contains 3 ml equivalent to 300 IU. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM HUMULIN R: A solution for injection in a vial or in a cartridge. Humulin R (Soluble) is a sterile, clear, colorless, aqueous solution of human insulin. HUMULIN N: A suspension for injection in a vial or in a cartridge. Humulin N (Isophane) is a sterile suspension of a white, crystalline precipitate of isophane human insulin in an isotonic phosphate buffer. Humulin 70/30: A suspension for injection in a cartridge. Humulin 70/30 (Mixture) is a sterile suspension of human insulin in the proportion of 30% soluble insulin to 70% isophane insulin. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of patients with diabetes mellitus who require insulin for the maintenance of glucose homeostasis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION X HUMUCTVL AF 09 Page 2 of 10 Posology The dosage should be determined by the physician, according to the requirement of the patient. _Pediatric population _ _ _ No data are available Method of administration Cartridges: Humulin Soluble in cartridges is only suitable for subcutaneous injections from a reusable pen. If administration by syringe or intravenous injection is necessary, a vial should be used. Humulin Isophane in cartridges is only suitable for اقرأ الوثيقة كاملة