SAIZEN 3.33MG INJECTION

Land: Malaysia

Sprog: engelsk

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

Aktiv bestanddel:

SOMATOTROPIN,RECOMBINANT HUMAN

Tilgængelig fra:

MERCK SDN. BHD.

INN (International Name):

SOMATOTROPIN,RECOMBINANT HUMAN

Enheder i pakken:

5ml1Units mL; 5ml5Units mL

Fremstillet af:

Merck Serono S.A. (Aubonne)

Indlægsseddel

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
SAIZEN
® INJECTION
Somatropin (3.33mg)
WHAT IS IN THIS LEAFLET
1.
What Saizen is used for
2.
How Saizen works
3.
Before you use Saizen
4.
How to use 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:
•
Treatment of children with short
stature who have failed to grow
because their body produces no
growth hormone or insufficient
levels of growth hormone.
•
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.
•
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:
•
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 use it _
•
If you or your child are allergic
(hypersensitive) to somatropin or
any of the other ingredients of
Saizen.
•
If you or your child’s bones have
stopped growing and therefore
reached the 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, suffering
complications following open heart
surgery, abdominal surg

Produktets egenskaber

1
1. NA ME OF THE MEDICINA L PRODU CT
Saizen® 3.33 mg powder and solvent for solution for injecti on
2. QU ALITATIVE AN D QU ANTITATIVE COM POSI TION
Each vial of Saizen 3.33 mg contains somatropin* (recombinant human growth hormone).
*produced by recombinant DNA technology in mammalian cells
After reconstitution with the enclosed solvent, each vial shall contain ≥ 0.67 mg of Saizen/ml.
For the full list of excipients, see section List o f excipients .
3. PHARMACEUTICAL FORM
Powder and solvent for solution for injection
Appearance of the powder: white lyophilised powder.
Appearance of the solvent: clear colourless solution.
The pH of the reconstituted solution is 7.4 –8.5.
4. CLINICAL PARTICULARS
4.1 Therapeu tic indi cations
Saizen® is indicated in t he treatme nt of:
• growth fail ure in children caused by decreased or absent secretion of endogenous growth
hormone.
• growth fail ure in girls with gonadal dysgenesis (Turner Syndrome ), confirmed by chromosomal
analysis.
• growth disturbance (current height SDS < -2.5 and parental adjusted height SDS < -1) in short
children born small for gestati onal age (SGA) with a birth weight and/ or length below – 2 SD,
who failed to show catch -up growth (HV SDS < 0 during the last year) by 4 years of age or la ter.
• replaceme nt therapy in adults with pronounced growth hormone deficiency as diagnosed by a
single dynamic test for growth hormone deficiency. Patients must also fulfill the following
crit eria:
Formatted: Font: (Default) Calibri, (Asian) Calibri, Bold
Formatted: List Paragraph, Outline numbered + Level: 1 + Numbering Style: 1, 2, 3, … + Start at: 1 + Alignment: Left + Aligned at: 0.2 cm + Indent at: 0.84 cm
Formatted: Font: (Default) Calibri, (Asian) Calibri
Formatted: Font: (Default) Calibri, (Asian) Calibri, Bold
Formatted: List Paragraph, Outline numbered + Level: 1 + Numbering Style: 1, 2, 3, … + Start at: 1 + Alignment: Left + Aligned at: 0.2 cm + Indent at: 0.84 cm
Formatted ...
Formatted: Font: (Default) Calibri, (Asian) Calibri, Bo