Norditropin NordiFlex Pen 10mg/1.5 ml (30IU)

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Norditropin NordiFlex Pen is a multi-dose, pre-filled injection device containing somatropin, a recombinant human growth hormone. Somatropin has the same 191-amino-acid sequence as naturally occurring human growth hormone produced by the pituitary gland. The medicine is supplied as a clear, colourless solution intended for subcutaneous injection and should be used under the supervision of a qualified healthcare professional.

According to the Canadian product information, Norditropin is indicated in pediatric patients for growth failure caused by inadequate secretion of natural growth hormone. It is also indicated for certain children born small for gestational age who have not achieved appropriate catch-up growth, as well as short stature associated with Turner syndrome or Noonan syndrome. Treatment suitability and dosage are determined individually according to the diagnosed condition, body weight, growth response, and clinical monitoring.

Available Norditropin NordiFlex Pen Strengths

The Norditropin NordiFlex Pen is available in three pre-filled strengths:

5 mg/1.5 mL
Each 1.5 mL pen contains 5 mg of somatropin.

10 mg/1.5 mL
Each 1.5 mL pen contains 10 mg of somatropin.

15 mg/1.5 mL
Each 1.5 mL pen contains 15 mg of somatropin.

Non-medicinal ingredients include histidine, mannitol, phenol, poloxamer 188, hydrochloric acid and/or sodium hydroxide for pH adjustment, and water for injection. Each strength is supplied as an individually packaged pre-filled pen.

Pen Design and Administration

Norditropin NordiFlex is designed as a ready-to-use, multi-dose pen, removing the need to manually reconstitute growth hormone before injection. The pen is designed for use with compatible NovoFine or NovoFine Plus disposable needles up to 8 mm in length.

Norditropin is administered by subcutaneous injection. The prescribed dose and treatment schedule should be followed exactly. Injection sites should be rotated with each administration to reduce the risk of lipoatrophy, which is localized loss of fatty tissue beneath the skin.

A fresh needle should be fitted for every injection. Pens and needles must never be shared with another person, even when the needle has been changed, because sharing injection equipment can transmit infections.

Before injecting, check the solution inside the cartridge. It should appear clear and colourless. Do not use a pen containing cloudy or unclear solution, and never shake the Norditropin NordiFlex Pen vigorously. Follow the supplied manufacturer instructions for checking medication flow, selecting the prescribed dose, administering the injection, and removing the needle safely.

Storage and Handling

Before first use, store an unused Norditropin NordiFlex Pen in a refrigerator between 2°C and 8°C. Do not freeze the medicine, place it directly beside a refrigerator cooling element, or expose it to excessive heat. The pen should also be protected from direct light.

After the first injection, there are two approved storage options. The pen may remain refrigerated at 2°C to 8°C and be used within 4 weeks, or it may be stored at room temperature not exceeding 25°C and used within 3 weeks.

Any medicine remaining after the applicable storage period should be discarded. Do not use Norditropin that has been frozen or exposed to excessive temperatures. Keep pens and needles out of the sight and reach of children.

Drug Interactions

Somatropin can affect or be affected by other medicines. Particular attention may be necessary when it is used alongside:

• corticosteroids or glucocorticoids such as cortisone or prednisone;
• insulin and other medicines used to control diabetes;
• oral estrogens and other sex hormones;
• certain anticonvulsant medicines;
• cyclosporine;
• medicines metabolized through CYP450 liver enzymes.

Growth hormone treatment can affect glucose metabolism, meaning patients using insulin or other diabetes medicines may require additional monitoring. Medication changes should only be made by the treating healthcare professional.

Important Safety Information

Norditropin should not be used simply for bodybuilding, anti-aging, or athletic performance enhancement. Growth hormone therapy requires an appropriate medical diagnosis and ongoing supervision.

Treatment is contraindicated in several circumstances, including active malignancy, certain acute critical illnesses, proliferative or preproliferative diabetic retinopathy, and growth promotion after the growth plates have closed. Specific restrictions also apply to some patients with Prader-Willi syndrome.

Possible effects reported during somatropin treatment include injection-site redness or itching, headache, nausea, fluid retention, joint or muscle discomfort, and changes in glucose control. Severe allergic reactions, persistent headache with visual changes, breathing problems, or significant hip or knee pain require prompt medical assessment.

Use the Norditropin NordiFlex Pen only as prescribed. Do not increase the dose, change growth hormone products, or discontinue treatment without guidance from the healthcare professional managing the therapy.