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

ประเทศ: ไอร์แลนด์

ภาษา: อังกฤษ

แหล่งที่มา: HPRA (Health Products Regulatory Authority)

สารออกฤทธิ์:

Insulin human

มีจำหน่ายจาก:

Eli Lilly Nederland B.V.

รหัส ATC:

A10AC; A10AC01

INN (ชื่อสากล):

Insulin human

ปริมาณ:

100 international unit(s)/millilitre

แบบฟอร์มเภสัชกรรม:

Suspension for injection

ประเภทใบสั่งยา:

Product subject to prescription which may be renewed (B)

พื้นที่บำบัด:

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

สถานะการอนุญาต:

Not marketed

วันที่อนุญาต:

1996-04-30

สรุปลักษณะสินค้า

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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