Gensulin N 100 IU/ml suspension 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:

A10AC01

INN (Tên quốc tế):

INSULIN HUMAN (RDNA) 100 IU/ml

Dạng dược phẩm:

SUSPENSION 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 N 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 N is and what it is used for
2.
What you need to know before you use Gensulin N
3.
How to use Gensulin N
4.
Possible side effects
5.
How to store Gensulin N
6.
Contents of the pack and other information
1. WHAT GENSULIN N IS AND WHAT IT IS USED FOR
Gensulin N 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 N is used to control glucose in the long term. 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 N as well as a
fast-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 N
GENSULIN N IN CARTRIDGES IS ONLY SUITABLE FOR SUBCUTANEOUS INJECTIONS
FROM A REUSABLE PEN.
Gensulin N in cartridges must not be administered intravenously or
intramuscularly. If administration
by syringe is needed, a vial should be used. Gensulin N in

Đặc tính sản phẩm

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 _
recombinant DNA technology process.
Each cartridge for pen contains 3 ml of suspension, corresponding to
300 IU of isophane insulin.
Gensulin N 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 N: suspension for injection in a cartridge.
Gensulin N is a sterile suspension of white crystalline isophane human
insulin precipitate in an
isotonic phosphate buffer, adjusted to the pH range of 7.0-7.6.
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 N IN CARTRIDGES IS ONLY SUITABLE FOR SUBCUTANEOUS INJECTIONS
FROM A REUSABLE PEN.
GENSULIN N IN CARTRIDGES MUST NOT BE ADMINISTERED INTRAVENOUSLY OR
INTRAMUSCULARLY.
If
administration by syringe is needed, a vial should be used. Gensulin N
in vials is available on the
market.
.
2
Gensulin N can be used in intensive insulin therapy to mimic basic
insulin secretion. Gensulin N can
be used when initiating insulin therapy in type 2 diabetes. The most
popular regimen is a once daily
injection in the evening time.
_ _
Subcutaneous administration should be in the upper arms, thighs,
buttocks or abdomen. Use of
injection sites should be rotated so that t