Land: Nýja-Sjáland
Tungumál: enska
Heimild: Medsafe (Medicines Safety Authority)
Insulin, human, recombinant DNA origin 100 [iU] (as 70% isophane insulin and 30% regular insulin)
Eli Lilly and Company (NZ) Limited
Insulin, human, recombinant DNA origin 100 IU (as 70% isophane insulin and 30% regular insulin)
100 IU/mL
Suspension for injection
Active: Insulin, human, recombinant DNA origin 100 [iU] (as 70% isophane insulin and 30% regular insulin) Excipient: Dibasic sodium phosphate heptahydrate Glycerol Hydrochloric acid as 10% solution for pH adjustment Metacresol Phenol Protamine sulfate Sodium hydroxide as 10% solution for pH adjustment Water for injection Zinc oxide
Cartridge, glass, 5 x 1.5mL (not marketed), 7.5 mL
Prescription
Prescription
Eli Lilly and Co Inc
HUMULIN is indicated for the treatment of insulin-requiring diabetes mellitus
Package - Contents - Shelf Life: Cartridge, glass, 5 x 1.5mL - 7.5 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 21 days opened stored at or below 25°C - Cartridge, glass, 5 x 3mL - 15 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 28 days opened stored at or below 30°C - Vial, glass, - 10 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 28 days opened stored at or below 30°C
1995-05-17
HUMULIN® VIALS 1 HUMULIN ® _VIALS _ _Biosynthetic Human Insulin (rbe) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about HUMULIN. It does not contain all the available information. It does not take the place of talking with your doctor or pharmacist. The information in this leaflet was last updated on the date shown on the final page. More recent information on this medicine may be available. Make sure you speak to your pharmacist, nurse or doctor to obtain the most up to date information on this medicine. You can also download the most up to date leaflet from www.lilly.com.au. The updated leaflet may contain important information about HUMULIN and its use that you should be aware of. All medicines have risks and benefits. Your doctor has weighed the risks of you taking HUMULIN against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THIS MEDICINE. You may need to read it again. WHAT HUMULIN IS USED FOR HUMULIN is used to reduce high blood sugar (glucose) levels in patients with diabetes mellitus. Diabetes mellitus is a condition in which your pancreas does not produce enough insulin to control your blood sugar level. Extra insulin is therefore needed. There are two types of diabetes mellitus: Type 1 diabetes - also called juvenile onset diabetes. Type 2 diabetes - also called maturity onset diabetes. Patients with type 1 diabetes always require insulin to control their blood sugar levels. Some patients with type 2 diabetes may also require insulin after initial treatment with diet, exercise and tablets. HUMULIN is identical to the insulin produced by the pancreas. There are 3 different types of HUMULIN vials: HUMULIN R HUMULIN NPH HUMULIN 30/70. Your doctor will tell you the type of HUMULIN that is best suited to you. The duration of action of the insulin you inject will vary according to the type being used, the dose, injection site, blood fl Lestu allt skjalið
vA8.0_Oct20 SUPERSEDES: vA7.0_Jan20 Page 1 of 10 NEW ZEALAND DATASHEET 1. PRODUCT NAME HUMULIN ® R (Regular), 100 IU/mL, solution for injection HUMULIN ® NPH, 100IU/mL, suspension for injection HUMULIN ® 30/70, 100 IU/mL, suspension for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Insulin human (rbe) recombinant DNA origin solution/suspension for injection containing 100 IU/mL. For the full list of excipients, see 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM HUMULIN R (REGULAR) (also called soluble insulin injection) is a sterile, clear colourless aqueous solution of human insulin (rbe) adjusted to a pH range of 7.0 to 7.8. HUMULIN R is a short-acting insulin preparation. HUMULIN NPH (also called isophane insulin injection) is a sterile suspension of a white, crystalline precipitate of isophane human insulin (rbe) in an isotonic phosphate buffer adjusted to a pH range of 6.9 to 7.5. HUMULIN N is an intermediate-acting insulin preparation. HUMULIN 30/70 (also called biphasic isophane insulin injection) is a mixture of human insulin (70% isophane human insulin (rbe), 30% soluble human insulin (rbe)) adjusted to a pH range of 6.9 to 7.5. HUMULIN Mixture 70/30 is an intermediate acting insulin preparation. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS HUMULIN is indicated for the treatment of insulin-requiring diabetes mellitus._ _ 4.2 DOSE AND METHOD OF ADMINISTRATION The dosage should be determined by the physician, according to the requirement of the patient. During changes to a patient’s insulin regimen, increase the frequency of glucose monitoring. HUMULIN R should be given by subcutaneous injection. It may also be administered intravenously. vA8.0_Oct20 SUPERSEDES: vA7.0_Jan20 Page 2 of 10 HUMULIN NPH and HUMULIN 30/70should be given by subcutaneous injection. These formulations should not be administered intravenously. Subcutaneous administration should be in the upper arms, thighs, buttocks or abdomen. Use of injection sites should be rotated so that the same site is not used more than a Lestu allt skjalið