GENOTROPIN 5.0 mg (somatropin) powder for injection with preserved diluent in a two compartment cartridge

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

Somatropin, Quantity: 5 mg/mL

Disponibil de la:

Pfizer Australia Pty Ltd

INN (nume internaţional):

Somatropin

Forma farmaceutică:

Diluent, not applicable

Compoziție:

Excipient Ingredients: metacresol; water for injections

Calea de administrare:

Subcutaneous

Unități în pachet:

5's, 1's

Tip de prescriptie medicala:

(S4) Prescription Only Medicine

Indicații terapeutice:

Short stature due to decreased or failed secretion of pituitary growth hormone. INDICATIONS AS AT 20 MARCH 2001: Short stature due to decreased or failed secretion of pituitary hormone. Growth distrubances associated with gonadal dysgenesis (Turner's Syndrome). Improvement of body composition and treatment of short stature associated with Prader-Willi syndrome (PWS) in paediatric patients. INDICATIONS AS AT 26 NOVEMBER 2001: Short stature due to decreased or failed secretion of pituitary growth hormone. Treatment of adults with severe growth hormone deficiency as diagnosed in the insulin tolerance test for growth hormone deficiency and defined by peak growth hormone concentrations of less than 2.5 nanograms/mL. Growth disturbances associated with gonadal dysgenesis (Turner's syndrome). Improvement of body composition and treatment of short stature associated with Prader-Willi syndrome (PWS) in paediatric patients. INDICATIONS AS AT 13 JUNE 2003: Short stature due to decreased or failed secretion of pituitary growth hormone. Treatment of adults with severe growth hormone deficiency as diagnosed in the insulin tolerance test for growth hormone deficiency and defined by peak growth hormone concentrations of less than 2.5 nanogram/mL. Growth disturbances associated with gonadal dysgenesis (Turner's syndrome). Improvement of body composition and treatment of short stature associated with Prader-Willi syndrome (PWS) in paediatric patients. For treatment of growth disturbance in children with chronic renal insufficiency whose height is on or less than twenty-fifth percentile and whose growth velocity is on or less than twenty-fifth percentile for bone age. Chronic renal insufficiency is defined as glomerular filtration rate of less than 50 mL/min/1.73m2.

Rezumat produs:

Visual Identification: Clear, colourless solution; Container Type: Cartridge; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Statutul autorizaţiei:

Licence status A

Data de autorizare:

2001-07-02

Prospect

GENOTROPIN
®
_somatropin (rbe), recombinant human growth hormone_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions that you may
have about GENOTROPIN.
It does not contain all the available
information.
It does not take the place of talking
with your doctor, nurse or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using
GENOTROPIN against the expected
benefits it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR, NURSE
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 is used to treat:
•
Short stature caused by the lack
of growth hormone.
GENOTROPIN promotes the
growth of the long bones (for
example, upper legs) in children
with reduced height due to lower
than normal levels of growth
hormone.
•
Reduced growth in girls with
Turner syndrome.
Turner syndrome is a genetic
disorder found in females. The
condition may cause short stature
and ovaries to not fully develop.
•
Children with Prader-Willi
syndrome.
Prader-Willi syndrome is a
genetic disorder that may cause
short stature, low muscle tone and
a constant feeling of hunger.
GENOTROPIN helps to improve
growth and body composition. It
also helps to reduce excessive fat
and improve muscle mass.
Diet restrictions may still be
necessary during treatment with
GENOTROPIN.
•
Children with kidney disease, to
help them grow at a normal rate.
•
Adults who do not produce
enough natural growth hormone.
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 canc

Caracteristicilor produsului

Version: pfpgenov10220
Supersedes: pfpgenov10619
Page 1 of 17
AUSTRALIAN PRODUCT INFORMATION
GENOTROPIN
 AND GENOTROPIN _ GOQUICK_
 POWDER FOR INJECTION
WITH DILUENT (WITH PRESERVATIVE)
GENOTROPIN MINIQUICK
 POWDER FOR INJECTION WITH DILUENT (SINGLE
DOSE SYRINGES)
1. NAME OF THE MEDICINE
Somatropin (rbe).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, GENOTROPIN and GENOTROPIN GoQuick 5 mg with
preservative, two-
compartment cartridge contains somatropin (rbe) 5 mg/mL.
After reconstitution, GENOTROPIN and GENOTROPIN GoQuick 5.3 mg with
preservative, two-
compartment cartridge contains somatropin (rbe) 5.3 mg/mL.
After reconstitution, GENOTROPIN and GENOTROPIN GoQuick 12 mg with
preservative, two-
compartment cartridge contains somatropin (rbe) 12 mg/mL.
After reconstitution, GENOTROPIN MiniQuick, two-compartment cartridge
contains somatropin
(rbe) 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1.0 mg, 1.2 mg, 1.4 mg, 1.6 mg,
1.8 mg or 2.0 mg in 0.25 mL.
Reconstituted solution has an osmolality of approximately 300 mOsm/kg
and pH approximately 6.7.
EXCIPIENT(S) WITH KNOWN EFFECT
•
Mannitol
For the full list of excipients, see Section 6.1 - List of excipients.
3.
PHARMACEUTICAL FORM
Powder for injection.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Short stature due to decreased or failed secretion of pituitary growth
hormone.
Treatment of adults with severe growth hormone deficiency as diagnosed
in the insulin tolerance test
for growth hormone deficiency and defined by peak growth hormone
concentrations of less than
2.5 nanogram/mL.
Growth disturbances associated with gonadal dysgenesis (Turner
syndrome).
Version: pfpgenov10220
Supersedes: pfpgenov10619
Page 2 of 17
Improvement of body composition and treatment of short stature
associated with Prader-Willi
syndrome (PWS) in paediatric patients.
For treatment of growth disturbance in children with chronic renal
insufficiency whose height is on or
less than twenty-fifth percentile and whose growth velocity is on or
less than twenty-fifth percen