Gensulin N Vial Suspension for Injection 100IU/ml

国: マルタ

言語: 英語

ソース: Malta Medicines Authority

有効成分:

INSULIN HUMAN, ISOPHANE, RDNA

から入手可能:

Bioton SA ul. Staroscinska 5, 02-516, Warsaw, Poland

ATCコード:

A10AC01

INN（国際名）:

INSULIN HUMAN ISOPHANE (RDNA) 100 IU/ml

医薬品形態:

SUSPENSION FOR INJECTION

構図:

INSULIN HUMAN ISOPHANE (RDNA) 100 IU/ml

処方タイプ:

POM

治療領域:

DRUGS USED IN DIABETES

製品概要:

Licence number in the source country: Poland - 8523

認証ステータス:

Expired

承認日:

2018-09-04

製品の特徴

Version 5.0
1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Gensulin N, 100 IU/ml, suspension for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of Gensulin N suspension contains 100 IU of isophane human
insulin
_(Insulinum humanum) _
obtained by
_E.coli _
DNA recombination.
The vial contains 10 ml of suspension, corresponding to 1000 IU of
isophane insulin.
Gensulin N contains human insulin only. The products are 100%
consistent with the amino acid
composition of the insulin produced by humans – unlike animal
insulin or other insulin analogues
obtained by genetic recombination whose compositions differ from human
insulin to various extents.
Full list of excipients, see: 6.1.
3. PHARMACEUTICAL FORM
Gensulin N: suspension for injection in a vial.
Gensulin N is a sterile suspension of white crystalline isophane human
insulin precipitate in an
isotonic phosphate buffer, adjusted to the pH range of 7-7.6.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Diabetes of patients requiring insulin administration in order to
maintain proper glucose metabolism.
Gestational diabetes.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Dosage is determined by the doctor on the basis of patient’s insulin
requirement. In type 2 diabetes the
average initial dose is 0.2 IU/kg body weight.
Gensulin N should be administered by subcutaneous injection. It is not
recommended, however,
possible
to
be
administered
intramuscularly.
These
forms
of
insulin
must not
be administered
intravenously. Gensulin N can be used in intensive insulin therapy to
ensure basic insulin secretion.
Gensulin N can be used at initiation of insulin therapy in type 2
diabetes. The most popular scheme is
a once daily injection in the evening time. Subcutaneous injections
should be made in the abdominal
area, buttocks, thigh or upper arm. The injection site should be
changed to prevent skin thickening.
Version 5.0
2
Injections should be made at different sites in the same anatomic
area, the same site should not be used
mor