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Saizen 24IU (8mg)

$60.00

Saizen 24IU (8mg) 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

Description

Saizen 24IU (8mg) 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.https://bodaxvet.com/

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 therapy instituted, before replacement therapy using growth hormone may begin.

4.2 Posology and method of administration

Saizen 8 mg click.easy is intended for multiple dose use.

Saizen dosage should be individualised for each patient based on body surface area or on body weight.

Posology

It is recommended that Saizen be administered at bedtime according to the following dosage:

Children and adolescents:

– Growth failure due to inadequate endogenous growth hormone secretion:

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