GENOTROPIN MINIQUICK somatropin (rbe) 0.8mg/0.25mL powder for injection & diluent in prefilled syringe

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

Somatropin, Quantity: 3.2 mg/mL

Disponibil de la:

Pfizer Australia Pty Ltd

Forma farmaceutică:

Injection, powder for

Compoziție:

Excipient Ingredients: glycine; mannitol; monobasic sodium phosphate; dibasic sodium phosphate

Calea de administrare:

Subcutaneous

Unități în pachet:

7 syringes/pack

Tip de prescriptie medicala:

(S4) Prescription Only Medicine

Indicații terapeutice:

INDICATIONS: Short stature due to decreased or failed secretion of pituitary growth hormone. 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: Before Reconstitution: Sterile, white lyophilised powder in the front compartment. After Reconstitution: The reconstituted solution is almost colourless and can be slightly opalescent.; Container Type: Multiple containers; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Statutul autorizaţiei:

Licence status A

Data de autorizare:

2000-11-03

Prospect

GENOTROPIN
MINIQUICK
®
_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
MiniQuick.
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 MiniQuick 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
MINIQUICK IS USED FOR
GENOTROPIN is a growth
hormone. GENOTROPIN MiniQuick
is a device containing a single dose
of GENOTROPIN for injection.
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 MiniQuick for
another purpose. Ask your doctor if
you have any questions about why
GENOTROPIN MiniQuick has been
prescribed for you.
BEFORE YOU USE
GENOTROPIN
MINIQUICK
_WHEN YOU MUST NOT USE_
_GENOTROPIN MINIQUICK_
_(DISCUSS WITH YOUR DOCTOR)_
YOUR DOCTOR WILL NOT P

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