Gensulin R Cartridge Solution for Injection 100IU/ml

Negara: Malta

Bahasa: Inggris

Sumber: Malta Medicines Authority

Bahan aktif:

INSULIN HUMAN, RDNA

Tersedia dari:

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

Kode ATC:

A10AB01

INN (Nama Internasional):

INSULIN HUMAN (RDNA) 100 IU/ml

Bentuk farmasi:

SOLUTION FOR INJECTION

Komposisi:

INSULIN HUMAN (RDNA) 100 IU/ml

Jenis Resep:

POM

Area terapi:

DRUGS USED IN DIABETES

Ringkasan produk:

Licence number in the source country: Poland - 8521

Status otorisasi:

Expired

Tanggal Otorisasi:

2018-09-04

Karakteristik produk

Version 6.2
1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Gensulin R, 100 IU/ml, solution for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of Gensulin R solution contains 100 IU of soluble human insulin
_(Insulinum humanum) _
obtained
by
_E. coli _
DNA recombination.
The pen cartridge contains 3 ml of solution, corresponding to 300 IU
of soluble insulin.
Gensulin R 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 R: solution for injection in a cartridge.
Gensulin R is a sterile, transparent, colourless aqueous solution of
human insulin, 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 R in cartridges is indicated only for subcutaneous injections
with a multiple use pen injector.
Gensulin
R
in
cartridges
must
not
be
administered
intravenously
or
intramuscularly.
In
case
administration with a syringe or by intravenous injection or by
infusion pump is needed, a vial must be
used. Gensulin R in vials is available on the market.
Version 6.2
2
Gensulin R can be used in intensive insulin therapy as nutritional or
prandial insulin.
While making an injection, caution should be used to prevent needle
insertion into a blood vessel. Do
not massage the injection site after insulin administration. Inform
your patients how to make the
injection correctly.
Gensulin R should be administered within 15 minutes before a meal.
Gensul