SAIZEN Liquid 6mg (5.83mgml) solution for injection

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Somatropin , recombinant DNA derived human growth hormone

Boleh didapati daripada:

MERCK SDN. BHD.

INN (Nama Antarabangsa):

Somatropin , recombinant DNA derived human growth hormone

Unit dalam pakej:

1units Units; 5units Units

Dikeluarkan oleh:

Merck Serono S.p.A.

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
1
SAIZEN LIQUID
Somatrapin (6mg, 12mg, 20mg)
WHAT IS IN THIS LEAFLET
1.
What Saizen is used for
2.
How Saizen works
3.
Before you use Saizen
4.
How to take Saizen
5.
While you are using Saizen
6.
Side Effects
7.
Storage and disposal of Saizen
8.
Product description
9.
Manufacturer and Product
registration holder
10.
Date of revision
WHAT SAIZEN IS USED FOR
Saizen is a growth hormone.
In children and adolescents:

In the treatment of children with
short stature who have failed to
grow because their body produces
no growth hormone or insufficient
levels of growth hormone.

In the treatment of girls who have
failed to grow due to gonadal
dysgenesis (also referred to as
Turner Syndrome), confirmed by a
test on the chromosomes.

In the treatment of growth problems
in children who were born small and
who have not reached normal height
by the age of 4 years or later.
In adults:

In the treatment of adults with a
marked lack of growth hormone
(growth hormone deficiency).
This therapy is given to adults who
have a serious growth hormone
deficiency that has been medically
diagnosed by a test.
HOW SAIZEN WORKS
Saizen's main action is to increase
growth in children and adolescents
and to treat adults with growth
hormone deficiency. The growth
hormone (somatropin) contained in
Saizen is almost the same as human’s
natural growth hormone except that it
is made outside the body by a process
called “recombinant DNA
technology” (genetic engineering).
BEFORE YOU USE SAIZEN
_When you must not take it _

If you or your child are allergic
(hypersensitive) to somatropin or
any of the other ingredients of
Saizen.

If you have been told that your
child’s bones have stopped growing
and that he/she has therefore
reached his/her final height.

If you have an active tumour
(cancer). Tumours must be inactive
and you must have finished your
anti- tumour treatment before you
start your treatment with Saizen.

If you or your child have an acute
critical illness, s

Ciri produk

1. NAME OF THE MEDICIN AL PRODUCT
6 mg (5.83 mg/ml),
12 mg (8 mg/ml),
20 mg (8 mg/ml)
solution for injection
2. QUALITATIV E AN D QUAN TITATIVE COMPOSITION
Saizen Liquid 6 mg solution for injection. Each cartridge contains 1.03 ml solution (6 mg somatropin*)
Saizen Liquid 12 mg & 20 mg for injection: Each cartridge contains 1.50 ml solution (12 mg somatrop rin*)
or 2.50 ml solution (20 mg somatropin*).
*recombinant human growth hormone, pro duced by recombinant DNA technology in mammalian cells
For a full list of excipients, see sectio n 6.1.
3. PHARMACEUTICAL FORM
Solutio n for injection.
Clear to slightly opalescent solution with pH of 5.6 -6.6 and osmolality 250 -450 mOsm/k g.
4. CLINICA L PARTICULARS
4.1 Therapeutic indications
Saizen® is indicated in the treatment of:
• growth failure in children caused by decreased or absent secretion of endogenous growth hormone.
• growt h failur e in girls wit h gonada l dysgenesi s (Turne r Syndrome) , confirme d by chromosomal
analysis.
• growth disturbance (current height SDS < -2.5 and parental adjusted height SDS < -1) in short
children born small for gestational age (SGA) with a birth weight and/ or length below – 2 SD, who
failed to show catch -up growth (HV SD S < 0 during the last year) by 4 years of age or later.
• replacemen t therap y in adult s with pronounce d growt h hormon e deficienc y as diagnose d by a single
dynami c test for growt h hormon e deficiency .