Saizen

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Somatropin 8 mg/mL

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Somatropin 8 mg/mL

Dosage:

8 mg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Somatropin 8 mg/mL Excipient: Citric acid Phenol Poloxamer Sodium hydroxide Sucrose Water for injection

Units in package:

Cartridge, glass, 20 mg/2.5 mL, 1 dose unit

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Merck SL

Therapeutic indications:

SAIZEN is indicated for: 1. Growth failure in children due to human growth hormone deficiency. 2. Growth failure in girls with gonadal dysgenesis (Turner Syndrome), confirmed by chromosomal analysis. 3.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. 4. Growth disturbance (growth retardation) in pre-pubertal children due to chronic renal insufficiency (CRI).

Product summary:

Package - Contents - Shelf Life: Cartridge, glass, 20 mg/2.5 mL - 1 dose units - 18 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 28 days opened stored at 2° to 8°C (Refrigerate, do not freeze). Within the 28 days in-use shelf-life, storage can be for up to 7 days at or below 25°C. - Cartridge, glass, 12 mg/1.5 mL - 1 dose units - 18 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 28 days opened stored at 2° to 8°C (Refrigerate, do not freeze). Within the 28 days in-use shelf-life, storage can be for up to 7 days at or below 25°C. - Cartridge, glass, 20 mg/2.5 mL - 5 dose units - 18 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 28 days opened stored at 2° to 8°C (Refrigerate, do not freeze). Within the 28 days in-use shelf-life, storage can be for up to 7 days at or below 25°C. - Cartridge, glass, 12 mg/1.5 mL - 5 dose units - 18 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 28 days opened stored at 2° to 8°C (Refrigerate, do not freeze). Within the 28 days in-use shelf-life, storage can be for up to 7 days at or below 25°C.

Authorization date:

2012-07-03

Patient Information leaflet

SAIZEN
®
1
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
co

Summary of Product characteristics

A009-1019
-1-
Supersedes: A008-0618
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
SAIZEN
®
solution for injection cartridge
Somatropin (rmc*), recombinant human growth hormone
6 mg/1.03 mL (5.83 mg/mL)
12 mg/1.5 mL (8 mg/mL)
20 mg/2.5 mL (8 mg/mL)
*recombinant mouse cell
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
SAIZEN is a recombinant human growth hormone (somatropin), which is
prepared from
genetically engineered mammalian cells (recombinant mouse cells –
C127) transformed with
a bovine papilloma virus vector containing the human growth hormone
coding sequence.
According to the European Pharmacopoeia, somatropin (rmc) 3 IU equals
1 mg somatropin
(rmc) by weight. The dose in mg, set out below, is based on this
equivalence.
Each cartridge contains somatropin (rmc) 6 mg/1.03 mL (5.83 mg/mL), 12
mg/1.5 mL (8
mg/mL) or 20 mg/2.5 mL (8 mg/mL).
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
SAIZEN solution for injection is a clear solution, free from visible
particles. The solution
should not be administered if it contains particles or is not clear.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
SAIZEN is indicated for:
Children and adolescents (≤ 18 years old):
1.
Growth failure in children due to human growth hormone deficiency.
2.
Growth failure in girls with gonadal dysgenesis (Turner Syndrome),
confirmed by
chromosomal analysis.
A009-1019
-2-
Supersedes: A008-0618
3.
Growth disturbance (growth retardation) in pre-pubertal children due
to chronic renal
insufficiency (CRI).
Adults (> 18 years old):
4.
SAIZEN is indicated for replacement therapy in adults (over 18 years
old) 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 S