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Saizen TM

You should seek medical advice in relation to medicines and use only as directed by a healthcare professional. Always read the label. If symptoms persist see your healthcare professional.

Active ingredients: relabotulinumtoxina

Brand name

(ARTG)

: SAIZEN somatropin (rmc) 6mg/1.03mL solution for injection multidose cartridge

Download the Consumer Medicine Information Leaflet

Download consumer medicine information leaflet (pdf) from the Therapeutic Goods Administration (TGA) website

What this medicine is used for

(ARTG)

I. Growth failure in children due to human growth hormone deficiency,II. Growth failure in girls with gonadal dysgenesis (Turner Syndrome), confirmed by chromosomal analysis,III. Growth disturbance (growth retardation) in pre-pubertal children due to chronic renal insufficiency (CRI),IV. Growth disturbance (current height standard deviation score (H SDS) <-2.5 and parental adjusted H SDS <-1) in short children born small for gestational age (SGA) with a birth weight and/or length below -2 standard deviations (SD), who failed to show catch-up growth (height velocity standard deviation score (HV SDS) <0 during the last year) by four years of age or later,V. SAIZEN is indicated for replacement therapy in adults with pronounced growth hormone deficiency as diagnosed in 2 different dynamic tests for growth hormone deficiency and defined by peak GH concentrations of less than 2.5 nanogram/mL. Adults 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.

How to use this medicine

(ARTG)

This medicine contains one component only.

Component :

  • Injection, solution
  • Subcutaneous
  • practically free from visible particles

Storage conditions

(ARTG)

  • Store at 2 to 8 degrees Celsius
  • Protect from Light
  • Do not Freeze
  • Refrigerate
  • See Product information for shelf life
  • Discard 4 weeks after opening
  • Shelf lifetime is 18 Months.

Do I need a prescription ?

(ARTG)

These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.

  • 1 cartridge pack
  • 5 cartridges pack

Is this medicine subsidised ?

(PBS)

This medicine was verified as being available on the PBS (Pharmaceutical Benefits Scheme) on December, 1 2024. To learn more about this subsidy, visit the Pharmaceutical Benefits Scheme (PBS) website.

Pregnant or planning a pregnancy ?

(AHT)

For the active ingredient relabotulinumtoxina

You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.

Reporting side effects

You can help ensure medicines are safe by reporting the side effects you experience.

You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems

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