Genotropin 5.3mg powder and solvent for solution for injection

দেশ: মাল্টা

ভাষা: ইংরেজি

সূত্র: Medicines Authority

সক্রিয় উপাদান:

SOMATROPIN

থেকে পাওয়া:

Pfizer Hellas S.A. 243 Messoghion Ave., Neo Psychiko 15451, Athens, Greece

এটিসি কোড:

H01AC01

INN (আন্তর্জাতিক নাম):

SOMATROPIN 5.3 mg/ml

ফার্মাসিউটিকাল ফর্ম:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

রচনা:

SOMATROPIN 5.3 mg/ml

প্রেসক্রিপশন টাইপ:

POM

থেরাপিউটিক এলাকা:

PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES

অনুমোদন অবস্থা:

Authorised

অনুমোদন তারিখ:

2006-10-31

তথ্য লিফলেট

PACKAGE LEAFLET: INFORMATION FOR THE USER
GENOTROPIN
® 5.0 MG, 5.3 MG AND 12 MG POWDER AND SOLVENT FOR SOLUTION FOR
INJECTION
somatropin
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 or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
WHAT IS IN THIS LEAFLET
:
1.
What Genotropin is and what it is used for
2.
What you need to know before you use Genotropin
3.
How to use Genotropin
4.
Possible side effects
5
How to store Genotropin
6.
Contents of the pack and other information
1.
WHAT GENOTROPIN IS AND WHAT IT IS USED FOR
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 recombinant meaning it is not
made from human or animal tissue.
In children, Genotropin is used to treat the following growth
disturbances:
•
If you are not growing properly and you do not have enough of your own
growth hormone.
•
If you have Turner syndrome. Turner syndrome is a chromosomal error in
girls that can affect
growth - your doctor will have told you if you have this.
•
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. Your
excessive fat will decrease and your reduced muscle mass will improve.
•
If you were small or too light at birth. Growth hormone can h

পণ্য বৈশিষ্ট্য

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
GENOTROPIN 5.3 mg, powder and solvent for solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
* produced in _Escherichia coli _cells by recombinant DNA technology
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
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.
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 who have at least one
known deficiency of a pituitary hormone not being prolactin. These
patients should undergo an
appropriate dynamic test in order to diagnose or exclude a growth
hormone deficiency.
_Childhood Onset:_ Patients who were growth hormone deficient during
childhood as a result of
congenital, genetic, acquired, or idiopathic causes. Patients with
childhood onset GH