Страна: Ізраїль
мова: англійська
Джерело: Ministry of Health
INSULIN LISPRO; INSULIN LISPRO PROTAMINE
ELI LILLY ISRAEL LTD
A10AB04
SUSPENSION FOR INJECTION
INSULIN LISPRO 50 %; INSULIN LISPRO PROTAMINE 50 %
S.C
Required
ELI LILLY & COMPANY LTD., USA
INSULIN LISPRO
INSULIN LISPRO
For the treatment of patients with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis.
2014-07-31
Page 1 of 7 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed by a physician’s prescription only HUMALOG MIX 50 SUSPENSION ACTIVE INGREDIENT AND ITS CONCENTRATION: Each cartridge contains: Insulin Lispro 100 U/ml 50% Insulin Lispro (free fast-acting) and 50% Insulin Lispro Protamine in suspension (long- acting) For the list of inactive ingredients, please see section 6. READ THIS PATIENT LEAFLET CAREFULLY IN ITS ENTIRETY 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? For the treatment of diabetes in patients who require insulin to maintain balanced blood sugar levels. THERAPEUTIC GROUP: Insulins and insulin analogs. Insulin is a hormone secreted by the pancreas, a gland located near the stomach. This hormone is essential to the body in utilizing glucose obtained from the food. Diabetes occurs when the pancreas does not provide the sufficient amount of insulin to meet the body’s needs. To balance the diabetes, the doctor has prescribed insulin injections for you. HUMALOG MIX 50 is a faster acting insulin than the regular insulin mixture, therefore it can be injected close to mealtime, before or shortly after. 2. BEFORE USING THIS MEDICINE: DO NOT USE THE PREPARATION IF: You are sensitive (allergic) to one of the medicine’s ingredients. Do not use in a state of hypoglycemia (low blood sugar). SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE: Do not inject HUMALOG MIX 50 directly into the vein! BEFORE STARTING TREATMENT WITH HUMALOG MIX 50 TELL YOUR DOCTOR IF: - You suffer from fever and vomiting or an emotional disturbance. - You suffer or have suffered in the past from impaired function of: the liver, kidney/ur Прочитайте повний документ
X HUMICT FS 06 1 of 11 HUMALOG MIX 50 1. NAME OF THE MEDICINAL PRODUCT Humalog Mix50 100 units/ml suspension for injection in cartridge 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 100 units insulin lispro* (equivalent to 3.5mg). Humalog Mix50 consists of 50% insulin lispro solution and 50% insulin lispro protamine suspension. Each cartridge contains 300 units of insulin lispro in 3 ml suspension . *produced in _E.coli_ by recombinant DNA technology. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. White suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Humalog Mix50 is indicated for the treatment of patients with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dosage should be determined by the physician, according to the requirement of the patient. Humalog Mix50 may be given shortly before meals. When necessary, Humalog Mix50 can be given soon after meals. Humalog Mix50 should only be given by subcutaneous injection. Under no circumstances should Humalog Mix50 be given intravenously. The rapid onset and early peak of activity of Humalog itself is observed following the subcutaneous administration of Humalog Mix50. This allows Humalog Mix50 to be given very close to mealtime. The duration of action of the insulin lispro protamine suspension component of Humalog Mix50 is similar to that of a basal insulin (NPH). The time course of action of any insulin may vary considerably in different individuals or at different times in the same individual. As with all insulin preparations, the duration of action of Humalog Mix50 is dependent on dose, site of injection, blood supply, temperature, and physical activity. _Special populations _ _ _ X HUMICT FS 06 2 of 11 _Renal impairment _ Insulin requirements may be reduced in the presence of renal impairment. _Hepatic impairment _ Insulin requirements may be reduced in patients with hepatic impairment due Прочитайте повний документ