Land: Nieuw-Zeeland
Taal: Engels
Bron: Medsafe (Medicines Safety Authority)
Isophane insulin, human, pyr 70 IU/mL; ; Neutral insulin, human, pyr 30 IU/mL;
Novo Nordisk Pharmaceuticals Ltd
Isophane insulin, human, pyr 70 IU/mL
Suspension for injection
Active: Isophane insulin, human, pyr 70 IU/mL Neutral insulin, human, pyr 30 IU/mL Excipient: Dibasic sodium phosphate dihydrate Glycerol Hydrochloric acid Metacresol Phenol Protamine sulfate Sodium hydroxide Water for injection Zinc as chloride, approx
Cartridge, 3.0mL, 5 dose units
Prescription
Prescription
Novo Nordisk A/S
Treatment of diabetes mellitus.
Package - Contents - Shelf Life: Cartridge, 3.0mL - 5 dose units - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 6 weeks opened stored at or below 25°C
1988-08-05
Ins Susp Penf PIL 6.docx 1 of 6 NEW ZEALAND CONSUMER MEDICINE INFORMATION PENMIX ® 30 100 IU/ML SUSPENSION FOR INJECTION IN CARTRIDGE PENMIX ® 40 100 IU/ML SUSPENSION FOR INJECTION IN CARTRIDGE PENMIX ® 50 100 IU/ML SUSPENSION FOR INJECTION IN CARTRIDGE PROTAPHANE ® PENFILL ® 100 IU/ML SUSPENSION FOR INJECTION IN CARTRIDGE Insulin human (rDNA) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING YOUR INSULIN – Keep this leaflet. You may need to read it again. – If you have any further questions, ask your doctor, nurse or your pharmacist. – This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. – If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or your pharmacist. 1. WHAT PENMIX ® AND PROTAPHANE ® ARE AND WHAT THEY ARE USED FOR PENMIX ® AND PROTAPHANE ® ARE HUMAN INSULINS 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. PenMix ® 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. Protaphane ® 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. Protaphane ® is often given in combination with fast-acting insulin products. 2. BEFORE YOU USE PENMIX ® OR PROTAPHANE ® DO NOT USE PENMIX ® OR PROTAPHANE ® : ► IN INSULIN INFUSION PUMPS. ► IF YOU ARE ALLERGIC (HYPERSENSITIVE) to human insulin or any of the other ingredients in PenMix ® or Protaphane ® (see 7. FURTHER INFORMATION) ► IF YOU SUSPECT HYPOGLYCAMIA (low blood sugar) is starting (see 4. WHAT TO DO IN AN EMERGENCY). ► IF THE CARTRIDGE OR THE DEVICE CONTAINING THE CARTRIDGE IS DROPPED, DAMAGED OR CRUSHED . Lees het volledige document
1 NEW ZEALAND DATASHEET 1 PRODUCT NAME PENMIX ® 30 100 IU/ml PENMIX ® 40 100 IU/ml PENMIX ® 50 100 IU/ml MIXTARD ® 30 100 IU/ml PROTAPHANE ® 100 IU/ml 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Insulin human, rDNA (produced by recombinant DNA technology in _Saccharomyces _ _cerevisiae_). The PENMIX and Mixtard products contain Biphasic isophane insulin injection 100 IU/ml. The PROTAPHANE products contain Isophane (NPH) insulin suspension injection 100 IU/ml. 3 PHARMACEUTICAL FORM PENMIX 30 is a cloudy, white, aqueous suspension containing 30% dissolved insulin and 70% isophane human insulin in 3 ml Penfill ® cartridges made of glass, with a plunger (bromobutyl) and a stopper (bromobutyl/polyisoprene) in a carton. PENMIX 40 is a cloudy, white, aqueous suspension containing 40% dissolved insulin and 60% isophane human insulin in 3 ml Penfill ® cartridges made of glass, with a plunger (bromobutyl) and a stopper (bromobutyl/polyisoprene) in a carton. PENMIX 50 is a cloudy, white, aqueous suspension containing 50% dissolved insulin and 50% isophane human insulin in 3 ml Penfill ® cartridges made of glass, with a plunger (bromobutyl) and a stopper (bromobutyl/polyisoprene) in a carton. MIXTARD 30 is a cloudy, white, aqueous suspension containing 30% dissolved insulin and 70% isophane human insulin in 10 ml glass vials closed with a disc (bromobutyl/polyisoprene rubber) and a protective tamper-proof plastic cap in a carton. PROTAPHANE is a cloudy, white, aqueous suspension containing isophane insulin suspension in 3 ml penfill ® cartridges made of glass, with a plunger (bromobutyl) and a stopper (bromobutyl/polyisoprene) in a carton or in 10 ml glass vials closed with a disc (bromobutyl/polyisoprene rubber) and a protective tamper-proof plastic cap in a carton. One IU (International Unit) corresponds to 0.035 mg of anhydrous human insulin. The penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Treatment of diabetes mellitus. Lees het volledige document