Land: Armenia
Språk: engelsk
Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
insulin human regular (recombinant DNA)
Lilly France S.A.S.
A10AB01
insulin human regular (recombinant DNA)
100IU/ml
solution for injection
(5) cartridges 3ml
Prescription
Registered
2016-08-23
NL047FSXE00 EUSPC20JUL2016 HUMULIN TM N NPH HUMAN INSULIN (RDNA ORIGIN) ISOPHANE SUSPENSION HUMULIN TM 70/30 70% HUMAN INSULIN ISOPHANE SUSPENSION AND 30% HUMAN INSULIN INJECTION (RDNA ORIGIN) HUMULIN TM R REGULAR INSULIN HUMAN INJECTION (RDNA ORIGIN) 1. NAME OF THE MEDICINAL PRODUCT Humulin N 100 IU/ml suspension for injection in cartridge Humulin 70/30 100 IU/ml suspension for injection in cartridge Humulin R 100 IU/ml solution for injection in cartridge 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 100 IU insulin human (produced in _E. coli_ by recombinant DNA technology). HUMULIN N One cartridge contains 3 ml equivalent to 300 IU of isophane insulin. HUMULIN 70/30 One cartridge contains 3 ml equivalent to 300 IU of biphasic isophane insulin – 30 % soluble insulin / 70 % isophane insulin. HUMULIN R One cartridge contains 3 ml equivalent to 300 IU of soluble insulin. For a full list of excipients, see section 6.1. Not all formulations may be marketed. 3. PHARMACEUTICAL FORM HUMULIN N A suspension for injection in a cartridge. Humulin N is a sterile suspension of a white, crystalline precipitate of isophane human insulin in an isotonic phosphate buffer. HUMULIN 70/30 A suspension for injection in a cartridge. Humulin 70/30 is a sterile suspension of human insulin in the proportion of 30 % soluble insulin to 70 % isophane insulin. HUMULIN R A solution for injection in a cartridge. Humulin R is a sterile, clear, colourless, aqueous solution of human insulin. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of patients with diabetes mellitus who require insulin for the maintenance of glucose homeostasis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dosage should be determined by the physician, according to the requirement of the patient. _Paediatric population_ No data are available Method of administration 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 Les hele dokumentet
1 HUMULIN ™ R CARTRIDGE SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Humulin R 100 IU/ml solution for injection in cartridge 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 100 IU insulin human (produced in _E. coli_ by recombinant DNA technology). One cartridge contains 3 ml equivalent to 300 IU of soluble insulin. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM A solution for injection in a cartridge. Humulin R is a sterile, clear, colourless, aqueous solution of human insulin. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of patients with diabetes mellitus who require insulin for the maintenance of glucose homeostasis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dosage should be determined by the physician, according to the requirement of the patient. _Paediatric population _ _ _ No data are available Method of administration Humulin R should be given by subcutaneous injection but may, although not recommended, also be given by intramuscular injection. It may also 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 approximately once a month. Care should be taken when injecting any Humulin insulin preparations to ensure that a blood vessel has not been entered. After any insulin injection, the injection site should not be massaged. Patients must be educated to use proper injection techniques. Each pack contains a patient information leaflet with instructions on how to inject insulin. 4.3 CONTRAINDICATIONS 3 Hypoglycaemia. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, unless used as part of a desensitisation programme. Under no circumstances should any Humulin formulation other than Humulin R be given intravenously. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Transferring a patient to another type or brand of insulin should Les hele dokumentet