Land: Malaysia
Sprog: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Insulin human
NOVO NORDISK PHARMA (MALAYSIA) SDN. BHD.
Insulin human
3 ml x 5 Units
Novo Nordisk Production SAS
MIXTARD ® 30 100 IU/ml Suspension for injection Pre-filled pen, FlexPen ® Insulin human (rDNA) (30% dissolved insulin and 70% isophane insulin) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ 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 _ _ _ DO NOT USE MIXTARD ® ► 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 FLEXPEN ® IS DROPPED, DAMAGED OR CRUSHED. ► 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. ► ALWAYS USE A NEW needle for each injection to prevent contamination. ► NEEDLES AND MIXTARD ® 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 Læs hele dokumentet
Mixtard ® 30 FlexPen ® Professional leaflet EN-Jul-2021_site France_8-XXXX-XX-XXX-X Based on EU text: 20200603_EN_06970_MIXT_32-2 1 MIXTARD ® 30 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. 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 pre-filled pen. 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. A Læs hele dokumentet