Description

NORDITROPIN SIMPLEXX 45IU 15MG CARTRIDGE

NORDITROPIN SIMPLEXX 45IU*15 mg in a 1.5 ml of solution in a cartridge (Type I glass) closed at the bottom with a rubber stopper (Type I rubber closures) shaped as a plunger and at the top with a laminated rubber stopper (Type I rubber closures) shaped as a disc and sealed with an aluminium cap. The aluminium cap is sealed with a coloured cap (green). Pack sizes of 1, 3 and 5. The cartridges are blister packed in a box.

The pen contains a sealed cartridge of 1.5 ml solution for injection, or a quantity of somatropin per pen of:
5 mg (15 IU) for NORDITROPINE NORDIFLEX 5 mg / 1.5 ml. The system delivers a maximum of 1.5 mg somatropin per dose in 0.025 mg somatropin increments;
10 mg (30 IU) for NORDITROPINE NORDIFLEX 10 mg / 1.5 ml. The system delivers a maximum of 3 mg of somatropin per dose at a level of 0.050 mg somatropin;
15 mg (45 IU) for NORDITROPINE NORDIFLEX 15 mg / 1.5 ml. The system delivers a maximum of 4.5 mg of somatropin per dose at a level of 0.075 mg somatropin.

As with other presentations of NORDITROPINE (NORDIFLEX and SIMPLEXX), NORDITROPINE NORDIFLEX 5 mg / 1.5 ml and 10 mg / 1.5 ml should be stored in a refrigerator (2 °C – 8 °C) in the package. outside, away from light.

After first opening and then in use, the product may be stored for up to 28 days in the refrigerator (2 °C – 8 °C), or up to 21 days at a temperature not exceeding 25 °C.
It is necessary :

Norditropin is a polypeptide hormone of recombinant DNA origin. The hormone is synthesized by a special strain of E. coli bacteria that has been modified by the addition of a plasmid which carries the gene for human growth hormone. Norditropin contains the identical sequence of 191 amino acids constituting the naturally occurring pituitary human growth hormone with a molecular weight of about 22,000 Daltons.

Therapy with Norditropin should be supervised by a physician who is experienced in the diagnosis and management of pediatric patients with short stature associated with GHD, Noonan syndrome, Turner syndrome or SGA, and adult patients with either childhood onset or adult onset GHD.

Dosage :

Growth hormone insufficiency

0.025-0.035 mg/kg/day or 0.7-1.0 mg/m2/day

When GHD persists after growth completion, growth hormone treatment should be continued to achieve full somatic adult development including lean body mass and bone mineral accrual (for guidance on dosing, see Replacement therapy in adults).

Turner syndrome

0.045-0.067 mg/kg/day or 1.3-2.0 mg/m2/day

Chronic renal disease

0.050 mg/kg/day or 1.4 mg/m2/day (see section 4.4)

Small for Gestational Age

0.035 mg/kg/day or 1.0 mg/m2/day

A dose of 0.035 mg/kg/day is usually recommended until final height is reached (see section 5.1).

Treatment should be discontinued after the first year of treatment, if the height velocity SDS is below +1.

Treatment should be discontinued if height velocity is < 2 cm/year and, if confirmation is required, bone age is > 14 years (girls) or > 16 years (boys), corresponding to closure of the epiphyseal growth plates.

Adult population:

Replacement therapy in adults

The dosage must be adjusted to the need of the individual patient.

In patients with childhood onset GHD, the recommended dose to restart is 0.2-0.5 mg/day with subsequent dose adjustment on the basis of IGF-I concentration determination.

In patients with adult onset GHD, it is recommended to start treatment with a low dose: 0.1-0.3 mg/day. It is recommended to increase the dosage gradually at monthly intervals based on the clinical response and the patient’s experience of adverse events. Serum IGF-I can be used as guidance for the dose titration. Women may require higher doses than men, with men showing an increasing IGF-I sensitivity over time. This means that there is a risk that women, especially those on oral oestrogen replacement are under-treated while men are over-treated.

Dose requirements decline with age. Maintenance dosages vary considerably from person to person, but seldom exceed 1.0 mg/day.

Side effects :

In children, side-effects are usually uncommon or rare.

In adults, oedema of the extremities is very common (1 in 10). Less common side effects include headaches, joint pain or stiffness, muscle pain or tenderness and paraesthesia. In addition, carpal tunnel syndrome, diabetes, pain at the injection sites, itching or muscle stiffness is uncommon. On rare occasions skin rash may occur, sometimes in children.

Other symptoms (with unknown frequencies) include:

– abnormal laboratory test results
– bone problems
– ear problems especially in people with Turner’s syndrome
– hypersensitivity reactions
– increase in the size of hands and feet
– increased blood glucose
– intracranial hypertension
– Leukaemia
– metabolic problems
– production of anti-Norditropin SimpleXx antibodies
– reduced glucose tolerance
– thyroid problems.

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