البلد: ماليزيا
اللغة: الإنجليزية
المصدر: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Insulin human
NOVO NORDISK PHARMA (MALAYSIA) SDN. BHD.
Insulin human
1 vial Vials
Novo Nordisk Production SAS
MIXTARD ® 30 _Consumer Medication Information Leaflet (RiMUP) _ 100 IU/ml Suspension for injection in vial Insulin human (rDNA) (30% dissolved insulin and 70% isophane insulin) 1 WHAT IS IN THIS LEAFLET 1. What Mixtard ® is used for 2. How Mixtard ® works 3. Before you use Mixtard ® 4. How to use Mixtard ® 5. While you are using it 6. Side effects 7. Storage and disposal of Mixtard ® 8. Product description 9. Manufacturer 10. Product Registration Holder 11. Date of revision 1. WHAT MIXTARD ® IS USED FOR MIXTARD ® IS HUMAN INSULIN USED TO TREAT DIABETES. Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of your blood sugar. 2. HOW MIXTARD ® WORKS Mixtard ® is a mixture of fast-acting insulin and long-acting insulin. This means that it will start to lower your blood sugar about ½ hour after you take it, and the effect will last for approximately 24 hours. 3. BEFORE YOU USE MIXTARD ® _- WHEN YOU MUST NOT USE IT _ _ _ ►IN INSULIN INFUSION PUMPS. ►IF YOU ARE ALLERGIC (HYPERSENSITIVE) to human insulin or any of the other ingredients in Mixtard ® (see section 8. _ Product _ _description_). ►IF YOU SUSPECT HYPOGLYCAEMIA (low blood sugar) is starting (see section 4. _How to use Mixtard_ _®_ ). ►IF THE PROTECTIVE CAP IS LOOSE OR MISSING. Each vial has a protective, tamper-proof plastic cap. If it is not in perfect condition when you get the vial, return the vial to your pharmacy. ►IF IT HAS NOT BEEN STORED CORRECTLY or been frozen (see section 7. _Storage and Disposal of _ _Mixtard_ _®_ ). ►IF THE RESUSPENDED INSULIN DOES NOT APPEAR UNIFORMLY WHITE AND CLOUDY. _- BEFORE YOU START TO USE IT _ _ _ ►CHECK THE LABEL TO MAKE SURE it is the right type of insulin. ►REMOVE THE PROTECTIVE CAP. _- TAKING OTHER MEDICINES _ _ _ Some medicines affect the way glucose works in your body and this may influence your insulin dose. Listed below are the most common medicines which may affect your insulin treatment. Tell your doctor, nurse or pharmacist if you are اقرأ الوثيقة كاملة
Mixtard ® 30 vial 100 IU/ml Professional leaflet EN-Jul-2021_site France Based on EU text: 20200603_EN_06970_MIXT_32-2 1 100 IU/ml MIXTARD ® 30 Suspension for injection in vial. QUALITATIVE AND QUANTITATIVE COMPOSITION Insulin human, rDNA (produced by recombinant DNA technology in _Saccharomyces cerevisiae_ ). 1 ml contains 100 IU of insulin human. 1 vial contains 10 ml equivalent to 1,000 IU. One IU (International Unit) corresponds to 0.035 mg of anhydrous human insulin. Mixtard ® is a mixture of dissolved insulin and isophane (NPH) insulin. Mixtard ® 30 consists of 30% dissolved insulin and 70% isophane insulin. PHARMACEUTICAL FORM Suspension for injection in vial. Cloudy, white, aqueous suspension. THERAPEUTIC INDICATIONS Treatment of diabetes mellitus. POSOLOGY AND METHOD OF ADMINISTRATION Mixtard ® is a dual-acting insulin. It is a biphasic formulation containing both fast-acting and long-acting insulin. Premixed insulin products are usually given once or twice daily when a rapid initial effect together with a more prolonged effect is desired. DOSAGE Dosage is individual and determined in accordance with the needs of the patient. The individual insulin requirement is usually between 0.3 and 1.0 IU/kg/day. The daily insulin requirement may be higher in patients with insulin resistance (e.g. during puberty or due to obesity) and lower in patients with residual, endogenous insulin production. An injection should be followed within 30 minutes by a meal or snack containing carbohydrates. DOSAGE ADJUSTMENT Concomitant illness, especially infections and feverish conditions, usually increases the patient's insulin requirement. Concomitant diseases in the kidney, liver or affecting the adrenal, pituitary or thyroid gland can require changes in the insulin dose. Adjustment of dosage may also be necessary if patients change physical activity or their usual diet. Dosage adjustment may be necessary when transferring patients from one insulin preparation to another. ADMINISTRATION For subcutaneous use. Insulin suspen اقرأ الوثيقة كاملة