מדינה: מלזיה
שפה: אנגלית
מקור: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
INSULIN (HUMAN MONOCOMPONENT), ISOPHANE
NOVO NORDISK PHARMA (MALAYSIA) SDN. BHD.
INSULIN (HUMAN MONOCOMPONENT), ISOPHANE
10ml1Units mL
NOVO NORDISK A/S
INSULATARD ® _Consumer Medication Information Leaflet (RiMUP) _ 100 IU/ml Suspension for injection in vial Insulin human (rDNA) (isophane insulin) ________________________________________________________________________________________________ 1 WHAT IS IN THIS LEAFLET 1. What Insulatard ® is used for 2. How Insulatard ® works 3. Before you use Insulatard ® 4. How to use Insulatard ® 5. While you are using it 6. Side effects 7. Storage and disposal of Insulatard ® 8. Product description 9. Manufacturer 10. Product Registration Holder 11. Date of revision 1. WHAT INSULATARD ® IS USED FOR INSULATARD ® 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 INSULATARD ® WORKS Insulatard ® is a long-acting insulin. This means that it will start to lower your blood sugar about 1½ hours after you take it, and the effect will last for approximately 24 hours. Insulatard ® is often given alone or in combination with fast-acting insulin products. 3. BEFORE YOU USE INSULATARD ® _- 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 Insulatard ® (see section 8._ Product _ _description_). ►IF YOU SUSPECT HYPOGLYCAEMIA (low blood sugar) is starting (see section 4. _How to use Insulatard_ _®_ ). ►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 _ _Insulatard_ _®_ ). ►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 t קרא את המסמך השלם
Insulatard ® vial 100 IU/ml Professional leaflet EN-Jun-2021_site Denmark Based on EU text: 20200603_EN_06969_INS_32-2 1 100 IU/ml INSULATARD ® 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. Insulatard ® is a suspension of isophane (NPH) insulin. PHARMACEUTICAL FORM Suspension for injection in vial. Cloudy, white, aqueous suspension. THERAPEUTIC INDICATIONS Treatment of diabetes mellitus. POSOLOGY AND METHOD OF ADMINISTRATION Insulatard® is a long-acting insulin and may be used alone or in combination with fast or rapid-acting insulin products. 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. 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 suspensions are never to be administered intravenously. Insulatard ® is administered subcutaneously by injection in the thigh. If convenient, the abdominal wall, the gluteal region or the deltoid region may also be used. Injection sites should always be rotated within the same region in order to reduce the risk of lipodystrop קרא את המסמך השלם