SAIZEN somatropin (rmc) 20mg/2.5mL solution for injection multidose cartridge

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Somatropin, Quantity: 8 mg/mL

Available from:

Merck Healthcare Pty Ltd

INN (International Name):

Somatropin

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: phenol; sucrose; citric acid; poloxamer; water for injections; sodium hydroxide

Administration route:

Subcutaneous

Units in package:

5 cartridges, 1 cartridge

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

SAIZEN is indicated for:,1. Treatment of growth failure in children due to human growth hormone deficiency.,2. Treatment of growth failure in girls with gonadal dysgenesis (Turner syndrome), confirmed by chromosomal analysis.,3. Replacement therapy in adults with pronounced growth hormone deficiency as diagnosed in 2 different dynamic tests for growth hormone deficiency and defind by peak GH concentrations of less than 2.5 nanogram/ml. Adults 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 SAIZEN 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.,4. Treatment of growth disturbance (growth retardation) in pre-pubertal children due to chronic renal insufficiency (CRI).

Product summary:

Visual Identification: practically free from visible particles; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2011-08-22

Patient Information leaflet

SAIZEN
®
_Somatropin (rmc), recombinant human growth hormone_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about SAIZEN.
It does not contain all of the available
information.
It does not take the place of talking to
your doctor, nurse or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of using SAIZEN against the
benefits it is expected to have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR, NURSE OR PHARMACIST.
KEEP THIS INFORMATION WITH THE
MEDICINE.
You may need to read it again later.
WHAT SAIZEN IS USED
FOR
SAIZEN is used to treat:
•
Growth failure in children who
have a deficiency of natural
human growth hormone.
•
Growth failure in girls who have
a genetic condition called gonadal
dysgenesis, often referred to as
Turner Syndrome, which may
cause short stature.
•
Growth hormone deficiency in
adults.
•
Growth disturbance (growth
retardation) in pre-pubertal
children with chronic renal
insufficiency (CRI).
SAIZEN contains somatropin, which
is the same as natural human growth
hormone, but is made in a laboratory.
IF YOU ARE UNSURE AS TO WHY YOU
HAVE BEEN PRESCRIBED SAIZEN, ASK
YOUR DOCTOR.
Your doctor may have prescribed it
for another reason.
SAIZEN is available only on a
doctor's prescription.
BEFORE YOU USE
SAIZEN
_WHEN YOU MUST NOT USE IT_
DO NOT USE SAIZEN IF YOU HAVE AN
ALLERGY TO:
•
somatropin
•
any of the other ingredients listed
at the end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
DO NOT USE SAIZEN IF:
•
You currently have any type of
active cancer.
All cancer treatments must be
finished before starting treatment
with SAIZEN.
•
You have an active brain lesion,
e.g. brain injury, abscess or
tumour.
•
You have diabetic retinopathy, an
eye disease caused by
complications of

Summary of Product characteristics

Version: A013-1019
Page 1 of 18
Supersedes: A012-0818
AUSTRALIAN PRODUCT INFORMATION
SAIZEN

(SOMATROPIN)
1.
NAME OF THE MEDICINE
Somatropin (rmc), recombinant human growth hormone
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
SAIZEN SOLUTION FOR INJECTION
Somatropin (rmc) 6 mg/1.03 mL (5.83 mg/mL), 12 mg/1.5 mL (8.00 mg/mL)
or 20 mg/2.5
mL (8.00 mg/mL). SAIZEN solution for injection also contains sucrose,
poloxamer, phenol
and Water for Injection. Sodium hydroxide and citric acid are used for
pH adjustment.
3.
PHARMACEUTICAL FORM
SAIZEN SOLUTION FOR INJECTION
SAIZEN solution for injection is presented as a sterile liquid
(opalescent white to off-white
solution, practically free from visible particles) in glass cartridges
for multidose use.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
I.
Growth failure in children due to human growth hormone deficiency
II.
Growth failure in girls with gonadal dysgenesis (Turner Syndrome),
confirmed by
chromosomal analysis
III.
Growth disturbance (growth retardation) in pre-pubertal children due
to chronic renal
insufficiency (CRI)
IV.
SAIZEN is indicated for replacement therapy in adults with pronounced
growth
hormone deficiency as diagnosed in 2 different dynamic tests for
growth hormone
deficiency and defined by peak GH concentrations of less than 2.5
nanogram/mL.
Adults must also fulfil 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 SAIZEN 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.
Version: A013-1019
Page 2 of 18
Supersedes: A012-0818
4.2.
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
Treatment should be discontinued when a satisfactory adult height has
been reac