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Norditropin Flexpro 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: vorasidenib

Brand name

(ARTG)

: NORDITROPIN FLEXPRO somatropin (rbe) 15mg (10mg/mL) injection-solution 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)

Children:Treatment of growth failure in children due to pituitary growth hormone deficiency. Treatment of growth failure in girls due to gonadal dysgenesis (Turner's Syndrome). Treatment of growth failure in children due to chronic renal insufficiency whose height is on or less than the twenty-fifth percentile and whose growth velocity is on or less than the twenty-fifth percentile for bone age. Chronic renal insufficiency is defined as glomerular filtration rate of less than 30 mL/min/1.73 m2. Treatment of severe growth failure due to intrauterine growth retardation (i.e., children born small for gestational age (birth weight and/or length < -2 SD) without spontaneous catch up growth by 2 years of age). Adults: Treatment of adults with severe growth hormone deficiency as diagnosed in the insulin tolerance test for growth hormone deficiency and defined by peak growth hormone concentrations of less than 2.5 nanogram/mL. In order to establish Childhood Onset [CO] growth hormone insufficiency, reconfirmation by one provocative test is recommended. In order to establish isolated growth hormone deficiency two provocative tests are recommended. In adults, the insulin tolerance test is the provocative test of choice. When the insulin tolerance test is contraindicated, alternative provocative tests must be used. The combined arginine or the glucagon test may also be considered; however these tests have less established diagnostic value than the insulin tolerance test.

How to use this medicine

(ARTG)

This medicine contains one component only.

Component :

  • Injection, solution
  • Subcutaneous
  • Colourless solution for injection in Type I glass cartridge with bromobutyl plunger, aluminium cap, and bromobutyl / polyisoprene rubber cap, pre-sealed into disposable plastic syringes with dial-a-dose metering.

Storage conditions

(ARTG)

  • Store at 2 to 8 degrees Celsius
  • See Product information for shelf life
  • Shelf lifetime is 2 Years.

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 x 1.5mL cartridge pack

Pregnant or planning a pregnancy ?

(AHT)

For the active ingredient vorasidenib

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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