GENOTROPIN® 5.3MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Страна: Малайзія

мова: англійська

Джерело: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Активний інгредієнт:

somatropin

Доступна з:

PFIZER (MALAYSIA) SDN. BHD.

ІПН (Міжнародна Ім'я):

somatropin

Одиниць в упаковці:

5 Units; 1 Units

Виробник:

Pfizer Manufacturing Belgium NV

інформаційний буклет

Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
GENOTROPIN
_®_
Somatropin (5.3 mg, 12 mg)
1
WHAT IS IN THIS LEAFLET
1.
What GENOTROPIN is used for
2.
How GENOTROPIN works
3.
Before you use GENOTROPIN
4.
How to use GENOTROPIN
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
GENOTROPIN
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT GENOTROPIN IS USED FOR
In children, GENOTROPIN is used to
treat growth disturbances:
-
If you do not have enough of your
own growth hormone.
-
If you have Turner syndrome
(chromosomal error in girls that
can affect growth).
-
If you have chronic renal (kidney)
insufficiency. As kidneys lose their
ability to function normally, this
can affect growth.
-
If you have Prader-Willi syndrome
(a chromosomal disorder). Growth
hormone will help you grow taller
if you are still growing, and will
also improve your body
composition.
-
If you were small or too light at
birth or if you have not been able to
catch up or maintain normal growth
by four years of age or later.
In adults, GENOTROPIN is used to
treat persons with pronounced growth
hormone deficiency. This can start
during adult life, or it can continue
from childhood. If you have been
treated with GENOTROPIN for
growth hormone deficiency during
childhood, your growth hormone
status will be retested after
completion of growth.
HOW GENOTROPIN WORKS
GENOTROPIN is a recombinant
human growth hormone (also called
somatropin). It has the same structure
as natural human growth hormone,
which is needed for bones and
muscles to grow. It also helps your fat
and muscle tissues to develop in the
right amounts. It is a recombinant
DNA-derived protein, meaning it is
not made from human or animal
tissue.
BEFORE YOU USE GENOTROPIN
-
_When you must not use it_
Do not take GENOTROPIN if
-
You are allergic (hypersensitive)
to somatropin or any of the other
ingredients of GENOTROPIN
(listed under Product
Description).
-
You have an active tumour
(cancer)

Характеристики продукта

1.
NAME OF THE MEDICINAL PRODUCT
GENOTROPIN 5.3 mg, or 12 mg, powder and solvent for solution for
injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Somatropin (INN) recombinant DNA-derived human growth hormone produced
in _E. coli_.
GENOTROPIN 5.3 mg powder and solvent for solution for injection, with
preservative. One
cartridge contains 5.3 mg somatropin*. After reconstitution the
concentration of somatropin is
5.3 mg/ml.
GENOTROPIN 12 mg powder and solvent for solution for injection, with
preservative. One
cartridge contains 12 mg somatropin*. After reconstitution the
concentration of somatropin is
12 mg/ml.
* Produced in _Escherichia coli _cells by recombinant DNA technology.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Two-chamber cartridge: Powder and solvent for solution for injection.
In the two-chamber
cartridge there is a white powder in the front compartment and a clear
solution in the rear
compartment.
The two-chamber cartridge is supplied for use in a sealed disposable
multidose pre-filled pen
(GoQuick).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CHILDREN
Growth disturbance due to insufficient secretion of growth hormone
(growth hormone
deficiency, GHD) and growth disturbance associated with Turner
syndrome or chronic renal
insufficiency.
Growth disturbance [current height standard deviation score (SDS) < -
2.5 and parental
adjusted height SDS < - 1] in short children born small for
gestational age (SGA), with a birth
weight and/or length below - 2 SD, who failed to show catch-up growth
[height velocity (HV)
SDS <0 during the last year] by 4 years of age or later.
Prader-Willi syndrome (PWS), for improvement of growth and body
composition. The
diagnosis of PWS should be confirmed by appropriate genetic testing.
ADULTS
Replacement therapy in adults with pronounced growth hormone
deficiency.
_Adult Onset: _Patients who have severe growth hormone deficiency
associated with multiple
hormone deficiencies as a result of known hypothalamic or pituitary
pathology, and w