Saizen 8 mg click.easy powder and solvent for solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Somatropin, recombinant human growth hormone

Available from:

Merck Serono (Ireland) Limited

ATC code:

H01AC; H01AC01

INN (International Name):

Somatropin, recombinant human growth hormone

Dosage:

8 milligram(s)

Pharmaceutical form:

Powder and solvent for solution for injection

Prescription type:

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

Therapeutic area:

Somatropin and somatropin agonists; somatropin

Authorization status:

Not marketed

Authorization date:

1998-10-02

Patient Information leaflet

1
SUMMARY OF PRODUCT CHARACTERISTICS,
LABELLING AND PACKAGE LEAFLET
2
SUMMARY OF PRODUCT CHARACTERISTICS
3
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 contains 8 mg 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
5.83 mg/ml.
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 deficienc

Summary of Product characteristics

Health Products Regulatory Authority
19 November 2019
CRN00919S
Page 1 of 10
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 l