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

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Insulin human

Verfügbar ab:

Eli Lilly Nederland B.V.

ATC-Code:

A10AC; A10AC01

INN (Internationale Bezeichnung):

Insulin human

Dosierung:

100 international unit(s)/millilitre

Darreichungsform:

Suspension for injection

Therapiebereich:

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

Berechtigungsstatus:

Not marketed

Berechtigungsdatum:

1983-06-22

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Humulin I (Isophane) 100 IU/ml Suspension for Injection in vial.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 100 IU human insulin (produced in_ E. coli_ by
recombinant DNA technology).
One vial contains 10 ml equivalent to 1000 IU of isophane insulin.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
A suspension for injection in a vial.
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.
Humulin I (Isophane) may be administered in combination with Humulin S
(Soluble). (See Instructions for use and
handling for Mixing of Insulins).
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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