Genotropin 5.3mg powder and solvent for solution for injection cartridges

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Somatropin (rbe)

Available from:

Pfizer Ltd

ATC code:

H01AC01

INN (International Name):

Somatropin (rbe)

Dosage:

5.3mg

Pharmaceutical form:

Powder and solvent for solution for injection

Administration route:

Subcutaneous

Class:

Schedule 4 (CD Anab)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06050100; GTIN: 7317961665876

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
GENOTROPIN
® 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.
-
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.
IN THIS LEAFLET
:
1.
What Genotropin is and what it is used for
2.
Before you use Genotropin
3.
How to use Genotropin
4.
Possible side effects
5
How to store Genotropin
6.
Further 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 help you
grow taller if you have
not been able to catch up or maintain normal growth by four years of
age or lat

Summary of Product characteristics

OBJECT 1
GENOTROPIN 5.3MG POWDER AND SOLVENT
Summary of Product Characteristics Updated 01-May-2018 | Pfizer
Limited
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 co