Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Insulin human
NOVO NORDISK PHARMA (MALAYSIA) SDN. BHD.
Insulin human
3ml x 5 Units
Novo Nordisk Production SAS
ACTRAPID ® 100 IU/ml Solution for injection Pre-filled pen, FlexPen ® Insulin human (rDNA) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ WHAT IS IN THIS LEAFLET 1. What Actrapid ® is used for 2. How Actrapid ® works 3. Before you use Actrapid ® 4. How to use Actrapid ® 5. While you are using it 6. Side effects 7. Storage and disposal of Actrapid ® 8. Product description 9. Manufacturer 10. Product Registration Holder 11. Date of revision 1. WHAT ACTRAPID ® IS USED FOR ACTRAPID ® 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 ACTRAPID ® WORKS Actrapid ® is a fast-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 8 hours. Actrapid ® is often given in combination with longer-acting insulin products. 3. BEFORE YOU USE ACTRAPID ® _- 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 Actrapid ® (see section 8. _Product _ _description_ ). ►IF YOU SUSPECT HYPOGLYCAEMIA (low blood sugar) is starting (see section 4. _How to use Actrapid_ _®_ ). ► IF THE FLEXPEN ® IS DROPPED, DAMAGED OR CRUSHED. ► IF IT HAS NOT BEEN STORED CORRECTLY or been frozen (see section 7. _Storage and Disposal of Actrapid_ _®_ ). ► IF THE INSULIN DOES NOT APPEAR CLEAR AND COLOURLESS. _- BEFORE YOU START TO USE IT _ ► CHECK THE LABEL TO MAKE SURE it is the right type of insulin. ► ALWAYS USE A NEW NEEDLE for each injection to prevent contamination. ►NEEDLES AND ACTRAPID ® FLEXPEN ® MUST NOT BE SHARED. _- 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 taking or have recently taken any oth Baca dokumen lengkap
Actrapid ® FlexPen ® Professional leaflet_EN-May-2021_site France_8-XXXX-XX-XXX-X Based on EU text: 20200603_EN_06946_APID_30-2 1 ACTRAPID ® FlexPen ® 100 IU/ml Solution 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. PHARMACEUTICAL FORM Solution for injection in pre-filled pen. Clear, colourless, aqueous solution. THERAPEUTIC INDICATIONS Treatment of diabetes mellitus. POSOLOGY AND METHOD OF ADMINISTRATION Actrapid ® is a fast-acting insulin and may be used in combination with long-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. 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 or intravenous use. Actrapid ® is administered subcutaneously by injection in the abdominal wall. If convenient, the thigh, 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 Baca dokumen lengkap