Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Insulin glulisine
SANOFI-AVENTIS (MALAYSIA) SDN. BHD.
Insulin glulisine
5Units Units
Sanofi-Aventis Deutschland GmbH
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ APIDRA SOLOSTAR 100 UNITS/ML Solution for Injection in a Pre-filled Pen Insulin glulisine (100 Units/ml) 1 WHAT IS IN THIS LEAFLET: 1. What is Apidra used for 2. How Apidra works 3. Before you use Apidra 4. How to use Apidra 5. While you are using Apidra 6. Side effects 7. Storage and disposal of Apidra 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT IS APIDRA USED FOR Apidra is used in the treatment of adults, adolescents and children 6 years or older with diabetes mellitus, where treatment with insulin is required. HOW APIDRA WORKS Apidra is an antidiabetic agent, used to reduce high blood sugar in patients with diabetes mellitus. Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of blood sugar. It is made by biotechnology. It has a rapid onset within 10-20 minutes and a short duration, about 4 hours. Insulin glulisine lowers blood glucose levels by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis (breakdown of fats) in the adipocyte (cells for the storage of fat), inhibits proteolysis (breakdown of proteins) and enhances protein synthesis. BEFORE YOU USE APIDRA _-When you must not use it _ - If you are allergic (hypersensitive) to insulin glulisine or any of the other ingredients of Apidra. - If your blood sugar is too low (hypoglycaemia), follow the guidance for hypoglycaemia (see HYPERGLYCAEMIA AND HYPOGLYCAEMIA at the end of this leaflet). _-Before you start to use it _ Apidra in a pre-filled pen is only suitable for injecting just under the skin. Speak to your doctor if you need to inject your insulin by another method. Take special care with Apidra Follow closely the instructions for dose, monitoring (blood tests), diet and physical activity (physical work and exercise) as discussed with your doctor. Special patient groups If you have liver or kidney problem Baca dokumen lengkap
MY/API/1120/CCDSv12 PROPOSED CLEAN PACKAGE INSERT SANOFI LOGO 1. NAME OF THE MEDICINAL PRODUCT Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 100 Units insulin glulisine (equivalent to 3.49 mg). Each pen contains 3 ml of solution for injection, equivalent to 300 Units. Insulin glulisine is produced by recombinant DNA technology in _Escherichia coli_. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection in a pre-filled pen. Clear, colourless, aqueous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of adults, adolescents and children 6 years or older with diabetes mellitus, where treatment with insulin is required. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The potency of this preparation is stated in units. These units are exclusive to Apidra and are not the same as IU or the units used to express the potency of other insulin analogues (see section 5.1). Apidra should be used in regimens that include an intermediate or long acting insulin or basal insulin analogue and can be used with oral hypoglycaemic agents. The dosage of Apidra should be individually adjusted. Special populations _Renal impairment _ The pharmacokinetic properties of insulin glulisine are generally maintained in patients with renal impairment. However, insulin requirements may be reduced in the presence of renal impairment (see section 5.2). _ _ _Hepatic impairment _ The pharmacokinetic properties of insulin glulisine have not been investigated in patients with decreased liver function. In patients with hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism. _ _ _Elderly _ Limited pharmacokinetic data are available in elderly patients with diabetes mellitus. Deterioration of renal function may lead to a decrease in insulin requirements. _ _ _Paediatric population _ There is insufficient clinical information o Baca dokumen lengkap