SAIZEN CLICK.EASY 8 Milligram Pdr+Solv for Soln for Inj

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

SOMATROPIN, RECOMBINANT HUMAN GROWTH HORMONE

Available from:

Merck Serono Limited

ATC code:

H01AC01

INN (International Name):

SOMATROPIN, RECOMBINANT HUMAN GROWTH HORMONE

Dosage:

8 Milligram

Pharmaceutical form:

Pdr+Solv for Soln for Inj

Prescription type:

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

Therapeutic area:

Somatropin and somatropin agonists

Authorization status:

Authorised

Authorization date:

2013-03-01

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
SAIZEN 8 MG CLICK.EASY POWDER AND SOLVENT FOR 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 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
defi

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Saizen 8 mg click.easy powder and solvent for solution for injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of Saizen 8 mg click.easy powder contains somatropin*
(recombinant human growth hormone).
*produced by recombinant DNA technology in mammalian cells
Reconstitution with the contents of the bacteriostatic solvent
cartridge gives a concentration of about 5.83 mg / ml.
Excipients: 54.7 mg sucrose.
For the full list of excipients, see section 6.1.
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 6.5 – 8.5.
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