Land: Malaysia
Språk: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Insulin human
NOVO NORDISK PHARMA (MALAYSIA) SDN. BHD.
Insulin human
3ml x 5 Units; 3ml x 5 Units
NOVO NORDISK A/S
INSULATARD ® _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 100 IU/ml Suspension for injection in cartridge, Penfill ® 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 CARTRIDGE OR THE DEVICE CONTAINING THE CARTRIDGE IS DROPPED, DAMAGED OR CRUSHED. ►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. ►ALWAYS CHECK the cartridge, including the rubber stopper. Do not use it if any damage is seen or if there is a gap between the rubber stopper and the white label band. Take it back to your pharmacy. See your delivery system manual for further instructions. ►ALWAYS USE A NEW NEEDLE for each injection to pre Les hele dokumentet
Insulatard ® FlexPen ® Professional leaflet EN-Jun-2021_site Denmark Based on EU text: 20200603_EN_06969_INS_32-2 1 INSULATARD ® FlexPen ® 100 IU/ml Suspension for injection in pre-filled pen. QUALITATIVE AND QUANTITATIVE COMPOSITION Insulin human, rDNA (produced by recombinant DNA technology in _Saccharomyces cerevisiae_ ). 1 ml contains 100 IU of insulin human. 1 pre-filled pen contains 3 ml equivalent to 300 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 pre-filled pen. 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 Les hele dokumentet