Humulin I (Isophane) 100 IU/ml Suspension for Injection in cartridge

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Insulin human

可用日期:

Eli Lilly Nederland B.V.

ATC代码:

A10AC; A10AC01

INN（国际名称）:

Insulin human

剂量:

100 international unit(s)/millilitre

药物剂型:

Suspension for injection

处方类型:

Product subject to prescription which may be renewed (B)

治疗领域:

Insulins and analogues for injection, intermediate-acting; insulin (human)

授权状态:

Not marketed

授权日期:

1996-04-30

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Humulin I (Isophane) 100 IU/ml Suspension for Injection in cartridge.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 100 IU human insulin (produced in_ E. coli_ by
recombinant DNA technology).
One cartridge contains 3 ml equivalent to 300 IU of isophane insulin.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
A suspension for injection in a cartridge.
Humulin I is a sterile suspension of a white, crystalline precipitate
of isophane human insulin in an isotonic phosphate
buffer.
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
The dosage should be determined by the physician, according to the
requirement of the patient.
Humulin I
should be given by subcutaneous
injection but
may although not
recommended,
also be given by
intramuscular injection. This formulation 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 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
Hypoglycaemia.
Hypersensitivity to Humulin or to the formulation excipients, unless
used as part of a desensitisation programme.
Under no circumstances should any Humulin formulation other than
Humulin S (Soluble) be given intravenously.
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