SAIZEN 8 Mg/Ml Solution for Injection

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

SOMATROPIN

Disponibil de la:

Merck Serono Limited

Codul ATC:

H01AC01

INN (nume internaţional):

SOMATROPIN

Dozare:

8 Mg/Ml

Forma farmaceutică:

Solution for Injection

Tip de prescriptie medicala:

Product subject to prescription which may not be renewed (A)

Zonă Terapeutică:

Somatropin and somatropin agonists

Statutul autorizaţiei:

Authorised

Data de autorizare:

2011-02-25

Prospect

PAGE 1
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PACKAGE LEAFLET: INFORMATION FOR THE USER 5.83 MG/ML
SOLUTION FOR INJECTION
SOMATROPIN
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor
or pharmacist.
•
This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
•
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See Section 4.
WHAT IS IN THIS LEAFLET:
1.
What Saizen is and what it is used for
2.
What you need to know before you use Saizen
3.
How to use Saizen
4.
Possible side effects
5.
How to store Saizen
6.
Contents of the pack and other information
1.
WHAT SAIZEN IS AND WHAT IT IS USED FOR
Saizen is a growth hormone. 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).
SAIZEN IS USED:
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 pre-pubertal children who
have failed to grow due to chronic renal failure, a
condition in which kidneys are damaged
•
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 th

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Saizen 8 mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each cartridge contains 1.50 ml solution (12 mg somatroprin*) or 2.50
ml solution (20 mg somatropin*).
* recombinant human growth hormone, produced by recombinant DNA
technology in mammalian cells
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear to slightly opalescent
solution with pH of 5.6-6.6 and osmolality 250-450 mOsm/kg
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Saizen is indicated in the treatment of:
Children and adolescents:
Growth failure in children caused by decreased or absent secretion of
endogenous growth hormone.
Growth failure in girls with gonadal dysgenesis (Turner syndrome),
confirmed by chromosomal analysis.
Growth failure in prepubertal children due to chronic renal failure
(CRF).
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 SDS <0 during the last year) by 4 years of age or later.
Adults:
Replacement therapy in adults with pronounced growth hormone
deficiency as diagnosed by a single
dynamic test for growth hormone deficiency. Patients 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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Saizen 8 mg/ml is intended for multiple dose use in an individual
patient.
Posology
It is recommended that Saizen