Genotropin

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Somatropin 5.3mg (18.4IU [6.1mg] with overage.)

Available from:

Pfizer New Zealand Limited

INN (International Name):

Somatropin 5.3 mg (18.4IU [6.1mg] with overage.)

Dosage:

5.3 mg

Pharmaceutical form:

Powder for injection

Composition:

Active: Somatropin 5.3mg (18.4IU [6.1mg] with overage.) Excipient: Dibasic sodium phosphate Glycine Mannitol Monobasic sodium phosphate Mannitol Metacresol Water for injection

Units in package:

Cartridge, 1 x GoQuick multidose pen (not marketed),

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Pfizer Health AB

Therapeutic indications:

Adults Replacement therapy in adults with pronounced growth hormone deficiency as diagnosed in two different dynamic tests for growth hormone deficiency. Patients must also fulfill the following criteria. Childhood onset: Patients, who were diagnosed as growth hormone deficient during childhood, must be retested and their growth hormone deficiency confirmed before replacement therapy with GENOTROPIN MINIQUICK is started. Adult onset: Patients must have growth hormone deficiency as a result of hypothalamic or pituitary disease and at least one other hormone deficiency diagnosed (except for prolactin) and adequate replacement therapy instituted, before replacement therapy using growth hormone may begin. Prader-Willi syndrome, for improvement of body composition.

Product summary:

Package - Contents - Shelf Life: Cartridge, 1 x GoQuick multidose pen -   - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 28 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) 1 months unopened stored at or below 25°C - Cartridge, Prefilled dual - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 28 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) 1 months unopened stored at or below 25°C - Cartridge, Prefilled dual compartment - 5 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 4 weeks reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) 1 months unopened stored at or below 25°C

Authorization date:

1989-02-03

Patient Information leaflet

Page 1 of 4
GENOTROPIN

5.3 MG AND 12 MG CARTRIDGES
RECOMBINANT HUMAN SOMATROPIN (RHGH)
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
GENOTROPIN.
It does not contain all the
available information.
It does not take the place of
talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you using
GENOTROPIN against the
benefits it is expected to have
for you.
IF YOU HAVE ANY CONCERNS
ABOUT USING THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read
it again.
WHAT
GENOTROPIN IS
USED FOR
GENOTROPIN is a growth
hormone.
GENOTROPIN promotes the
growth of long bones (for
example: upper legs) in children
with reduced height due to lower
than normal levels of growth
hormone. It is also used to treat
reduced growth in girls with
Turner’s syndrome and in
children prior to the onset of
puberty who have long-term
kidney problems causing growth
disturbance.
GENOTROPIN is also used in
adults who have low levels of
growth hormone due to a disease
in the pituitary gland or
hypothalamus in the brain.
GENOTROPIN is used for
children and adults who have a
genetic disorder called Prader-
Willi syndrome (symptoms
include intellectual impairment,
uncontrollable urge to eat).
However, your doctor may
prescribe GENOTROPIN for
another purpose. Ask your
doctor if you have any questions
about why GENOTROPIN has
been prescribed for you.
BEFORE YOU USE
GENOTROPIN
WHEN YOU MUST NOT USE
GENOTROPIN (DISCUSS
WITH YOUR DOCTOR)
YOUR DOCTOR WILL NOT PRESCRIBE
GENOTROPIN IF YOU:
•
are a child and have closed
epiphyses (this means that
your bones have finished
growing)
•
have an active tumour or
evidence of cancer growth
•
are currently being treated
for cancer
•
have a serious injury or
illness, or surgical
procedures requiring
intensive therapy
•
have Prader-Willi syndrome
and are severely overweight
or have breathing difficulties
•
are allergic to any of the
ingredients of
GENOTROPIN.
DO NOT USE GENOTR

Summary of Product characteristics

Version: pfdgentv10821
Supersedes: pfdgentv11119
Page 1 of 12
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
GENOTROPIN
®
5 mg powder for injection with solvent.
GENOTROPIN
_®_
5.3 mg powder for injection with solvent.
GENOTROPIN
_®_
12 mg powder for injection with solvent.
GENOTROPIN _GoQuick_
_®_
5 mg powder for injection with solvent.
GENOTROPIN _GoQuick_
_®_
5.3 mg powder for injection with solvent.
GENOTROPIN _GoQuick_
_®_
12 mg powder for injection with solvent.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
GENOTROPIN / GENOTROPIN _ GoQuick_ 5 mg powder for injection with
solvent. One
cartridge contains 5 mg somatropin*. After reconstitution the
concentration of somatropin is 5
mg/mL.
GENOTROPIN / GENOTROPIN _ GoQuick_ 5.3 mg powder for injection with
solvent. One
cartridge contains 5.3 mg somatropin*. After reconstitution the
concentration of somatropin is
5.3 mg/mL.
GENOTROPIN / GENOTROPIN _ GoQuick_ 12 mg powder for injection with
solvent. 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
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
(GH)
and growth
disturbance associated with Turner syndrome or chronic renal
insufficiency. Prader-Willi
syndrome, for improvement of growth and body composition.
Version: pfdgentv10821
Supersedes: pfdgentv11119
Page 2 of 12
ADULTS
Replacement therapy in adults with pronounced growth hormone
deficiency as diagnosed in
two different dynamic tests for GH deficiency. Patients must also
fulfil the following criteria.
_Childhood onset:_ Patients who were diagnosed as growth hormone
deficient during childhood
must be retested and their growth