Huminsulin 30/70

NAME OF THE MEDICINAL PRODUCT
Huminsulin 30/70 40 IU/mL suspension for injection in vial (Biphasic isophane insulin injection – 30% Soluble insulin and 70% Isophane Insulin). Monocomponent Human Insulin (r-DNA origin)
 
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains: 40IU Human Insulin IP (r-DNA origin) as active ingredient, 1.6 mg m-cresol Ph. Eur. as preservative, 16mg Glycerol IP as tonicity modifier, 0.65 mg Phenol IP as preservative, Protamine Sulphate IP for complexing with insulin to prolong its action q.s. to obtain 0.0756 mg of protamine base, 3.78 mg Dibasic Sodium Phosphate Ph. Eur. as buffer, Zinc Oxide IP q.s. as stabilizer, Hydrochloric Acid Solution 10% q.s. and Sodium Hdryoxide Solution 10% q.s. for pH adjustment, Water for Injection IP q.s. 1mL.

1mL contains 40IU human insulin (produced in E. coli by recombinant DNA technology).

One vial contains 10 ml equivalent to 400IU of biphasic isophane insulin-30% soluble insulin/70% isophane insulin.


PHARMACEUTICAL FORM
A suspension of injection in a 10mL vial.

Huminsulin 30/70 is a sterile suspension of human insulin in the proportion of 30% soluble insulin to 70% isophane insulin, adjusted to a pH range of 6.9 to 7.5.

Huminsulin 30/70 is an intermediate acting insulin preparation.

CLINICAL PARTICULARS

Therapeutic Indications

For the treatment of patients with diabetes mellitus who require insulin for the maintenance of glucose homeostasis.

Posology and method of administration

The dosage should be determined by the physician, according to the requirement of the patient.

Huminsulin 30/70 should be given by subcutaneous injection buy may, although not recommended, also be given by intramuscular injection. Huminsulin 30/70 should 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 Huminsulin preparations to ensure that a blood vessil has not been entered. After any insulin injection, the injection site should not be massaged. Patients must be educated to use proper injection techniques.

Huminsulin 30/70 formulation is a ready made defined mixture of regular insulin and isophane insulin designed to the need for the patient to mix insulin preparations. A patient’s treatment regimen should be based on the individual metabolic requirements.

Contraindications

Hypoglycaemia.

Hypersensitivity to Huminsulin or to the formulation excipients, unless used as a part of a desensitisation proramme.

Under no circumstances should Huminsulin 30/70 formulation be given intravenously.