GENOTROPIN MINIQUICK somatropin (rbe) 0.2mg/0.25mL powder for injection & diluent in prefilled syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Somatropin, Quantity: 0.8 mg/mL

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Injection, powder for

Composition:

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

Administration route:

Subcutaneous

Units in package:

7 syringes/pack

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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.

Product summary:

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: Syringe; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2000-11-03

Summary of Product characteristics

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