Gensulin R 100 IU/ml solution for injection

Quốc gia: Malta

Ngôn ngữ: Tiếng Anh

Nguồn: Medicines Authority

Sẵn có từ:

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

Mã ATC:

A10AB01

INN (Tên quốc tế):

INSULIN HUMAN (RDNA) 100 IU/ml

Dạng dược phẩm:

SOLUTION FOR INJECTION

Thành phần:

INSULIN HUMAN (RDNA) 100 IU/ml

Loại thuốc theo toa:

POM

Khu trị liệu:

DRUGS USED IN DIABETES

Tình trạng ủy quyền:

Authorised

Ngày ủy quyền:

2024-02-22

Tờ rơi thông tin

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
GENSULIN R 100 IU/ML SOLUTION 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 R is and what it is used for
2.
What you need to know before you use Gensulin R
3.
How to use Gensulin R
4.
Possible side effects
5.
How to store Gensulin R
6.
Contents of the pack and other information
1.
WHAT GENSULIN R IS AND WHAT IT IS USED FOR
Gensulin R 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 R is used to control glucose in the long term.
Gensulin R is a fast-acting insulin
preparation.
Your doctor may recommend you to use Gensulin R 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 R
GENSULIN R IN CARTRIDGES IS ONLY SUITABLE FOR SUBCUTANEOUS INJECTIONS
FROM A REUSABLE PEN.
GENSULIN R IN CARTRIDGES MUST NOT BE ADMINISTERED INTRAVENOUSLY OR
INTRAMUSCULARLY.
In case
administration by syringe or intravenous injection or infusion pump is
needed, a vial should be used.
GENSULIN R IN VIA

Đặc tính sản phẩm

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 _
recombinant
_ _
DNA technology process.
Each cartridge for pen contains 3 ml of solution, corresponding to 300
IU of soluble insulin.
Gensulin R 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 R: solution for injection in a cartridge.
Gensulin R is a sterile, clear, colourless aqueous solution of human
insulin, adjusted to the pH range of
7.0-7.6.
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 R IN CARTRIDGES IS ONLY SUITABLE FOR SUBCUTANEOUS INJECTIONS
FROM A REUSABLE PEN.
GENSULIN R IN CARTRIDGES MUST NOT BE ADMINISTERED INTRAVENOUSLY OR
INTRAMUSCULARLY.
In case
administration by syringe or intravenous injection or infusion pump is
needed, a vial should be used.
Gensulin R in vials is available on the market.
Gensulin R can be used in intensive insulin therapy regimen as
mealtime, prandial insulin.
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
2
month in order to reduce the risk of lipodystrophy and cutaneous
amyloidosis (see section 4.4 and
4