Gensulin M30 (30/70) 100 IU/ml suspension for injection

Valsts: Malta

Valoda: angļu

Klimata pārmaiņas: Medicines Authority

Pieejams no:

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

ATĶ kods:

A10AD01

SNN (starptautisko nepatentēto nosaukumu):

INSULIN HUMAN (RDNA) 100 IU/ml

Zāļu forma:

SUSPENSION FOR INJECTION

Kompozīcija:

INSULIN HUMAN (RDNA) 100 IU/ml

Receptes veids:

POM

Ārstniecības joma:

DRUGS USED IN DIABETES

Autorizācija statuss:

Authorised

Autorizācija datums:

2024-02-22

Lietošanas instrukcija

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
GENSULIN M30 (30/70) 100 IU/ML SUSPENSION FOR INJECTION
_ Human insulin _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Gensulin M30 is and what it is used for
2.
What you need to know before you use Gensulin M30
3.
How to use Gensulin M30
4.
Possible side effects
5.
How to store Gensulin M30
6.
Contents of the pack and other information
1.
WHAT GENSULIN M30 IS AND WHAT IT IS USED FOR
Gensulin M30 contains the active substance human insulin, which is
used to treat diabetes. You get
diabetes if your pancreas does not make enough insulin to control the
level of glucose in your blood
(blood sugar). Gensulin M30 is used to control glucose in the long
term. It is a mixture of fast acting
and intermediate -acting insulin. The duration of action of this
insulin was extended by the use of
protamine sulfate in the suspension.
Your doctor may recommend you to use Gensulin M30 as well as a
longer-acting insulin. Each kind of
insulin comes with its own patient information leaflet to tell you
about it. Do not change your insulin
unless your doctor tells you to. Be very careful if you do change
insulin. Each type of insulin has a
different colour and symbol on the pack and the vial or the cartridge
so that you can easily tell the
difference.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE GENSULIN M30
GENSULIN M30 IN 3 ML CARTRIDGES IS INTENDED ONLY FOR SUBCUTANEOUS
INJECTION USING A REUSABLE
PEN.
Gensulin M30 in a 10 ml vial is indicated for subcutaneous

Produkta apraksts

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Gensulin M30 (30/70) 100 IU/ml suspension for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of Gensulin M30 (30/70) suspension contains 100 IU of biphasic
human insulin
_(Insulinum _
_humanum) _
obtained by
_E. coli _
recombinant DNA technology process.
Each cartridge for pen contains 3 ml of suspension, corresponding to
300 IU of biphasic insulin,
consisting of 30% soluble and 70% isophane insulin.
Gensulin M30 contains human insulin only. The product is 100%
consistent with the amino acid
composition of the insulin produced by humans – unlike animal
insulins or other insulin analogues
obtained by genetic recombination whose compositions differ from human
insulin to various extents.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Gensulin M30 (30/70): suspension for injection in a cartridge.
Gensulin M30 (30/70) is a sterile suspension of human insulin adjusted
to the pH range of 7.0-7.6,
containing 30% of soluble and 70% of isophane insulin.
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
Posology
Dosage is determined by the doctor according to patient’s insulin
requirement.
_Paediatric population _
No data are available.
Method of administration
subcutaneous use
GENSULIN M30 IN CARTRIDGES IS ONLY SUITABLE FOR SUBCUTANEOUS
INJECTIONS FROM A REUSABLE PEN.
GENSULIN M30 IN CARTRIDGES MUST NOT BE ADMINISTERED INTRAVENOUSLY OR
INTRAMUSCULARLY.
If
administration by syringe is needed, a vial should be used. Gensulin
M30 in vials is available on the
market.
2
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 in order to reduce the risk of lipodystrophy and cutaneous
amyloidosis.
_ _
(see section 4.4 an