What is Norditropin Simplex?

What is NORDITROPIN SIMPLEX and what is it used for?

Norditropin SimpleXx is a clear and colorless solution contained in a 1.5 ml glass cartridge, which can be injected after inserting into the appropriate NordiPen injection pen.

Norditropin SimpleXx, “growth hormone and its analogues are in the group called somatropin and somatropin agonists”, which, it contains a biosynthetic human growth hormone called somatropin, which is equivalent to naturally produced growth hormone in the body.In order to help children grow, adults also need growth hormone for their general health condition.

Norditropin SimpleXx is used in the treatment of growth retardation in children, in the following cases:

• if they do not have growth hormone production, or if they are

If you have Turner syndrome (a genetic problem that can affect growth)

• if kidney function is reduced

If they are short and are born small (SGA) according to gestational age.

Norditropin SimpleXx is used in adults to replace growth hormone: Norditropin SimpleXx, a tumor in adults that affects the gland when growth hormone production is low from childhood or producing growth hormone in adulthood, if there is no growth hormone production due to treatment of a tumor or due to an illness, it is used to replace growth hormone.

What are the Side Effects?

Like all medicines, NORDITROPIN may have side effects in people who are sensitive to substances contained in the SIMPLEXin content.

Very infrequent effects in children and adults (which can affect up to 10,000 people):

Rash; wheezing; swelling of the eyelids, face or lips; completely colaps (serious breathing difficulty-shock-like table), any of these symptoms can be a sign of an allergic reaction.

• headache, vision problems, nausea and vomiting. These may be signs of increased pressure within the brain.

Serum thyroxine levels may decrease.

If one of them is present, consult a doctor immediately. Stop using Norditropin SimpleXx until your doctor says you can continue treatment.

Antibodies to somatropin were rarely observed during Norditropin therapy.There is no evidence to suggest that somatropin is responsible, however, cases of recurrence of leukemia and brain tumors have been reported in patients treated with somatropin (The active ingredient in Norditropin SimpleXx).

If you have any of these diseases, talk to your doctor.

Other side effects in children:

Uncommon effects (which can affect up to 1 ’ in 100 children):

Headache

• redness in the area of injection, itching or pain.

Infrequent effects (which can affect up to 1000 ’) in 1000 children:

Rash

Muscle or joint pain

Swelling of the hands or feet due to fluid retention.

In rare cases, children using Norditropin SimpleXx have experienced hip and knee pain or limping. These symptoms may not be due to Norditropin SimpleXx and may be due to a disease that affects the top of the thigh bone (Legg-Calve disease) or because the bone tip has shifted from cartilage (slipping of the thigh epiphyseal head).

In clinical studies, children with Turner syndrome have been reported to have several cases where, compared to height, the growth of hands and feet increases.

A clinical study in children with Turner syndrome has shown that high doses of Norditropin iberin probably increase the risk of ear infections.

Other side effects in adults:

Very common effects (which can affect more than 10 ’ in 1):

Swelling of the hands or feet due to fluid retention.

Common effects (which can affect up to 1 ’ in 10 adults):

Headache

Tingling (formication) sensation in the skin and numbness or pain, especially in the fingers

• joint pain and stiffness; muscle pain.

Uncommon effects (which can affect up to 100 ’ in 1):

Type 2 diabetes

Carpal tunnel syndrome tingling and pain in the fingers and hands

Itching (may be severe) and pain at the injection site

• muscle hardness

How to use NORDITROPIN SIMPLEX?

Norditropin SimpleXxi always use exactly as your doctor prescribes.If you are unsure, consult your doctor or pharmacist.

The dose for children depends on body weight and body surface area. The adult dose is based on height, weight, sex and growth hormone sensitivity and will be adjusted until the correct dose is found.

Children with low growth hormone production or no growth hormone: The usual dose is 25 to 35 micrograms/kg of body weight/day or 0.7 to 1.0 mg/m of body surface area/day.

children with Turner syndrome: The usual dose is 45 to 67 micrograms/kg of body weight/day or 1.3 to 2.0 mg/m body surface area/day.

• children with kidney disease: Usual dose, 50 micrograms/kg body weight/day

2

or 1.4 mg/m body surface area/day.

Children born to the gestational age (SGA): Usual dose, final paint

2

up to 35 micrograms/kg body weight/day or 1.0 mg/m body surface area/day. (Children who were born young by their gestational age (SGA) typically used 33 and 67 micrograms/kg body weight/day doses.) in clinical trials

Low production of growth hormone or no growth hormone

adults: The usual starting dose is 0.1 to 0.3 mg/day. Until you find the right dose

your doctor will increase your dose each month. The usual maximum dose is 1.0 mg/day.

Norditropin SimpleXx is injected under the skin.

When should Norditropin SimpleXx be used?

• inject your daily dose just before bed each evening.

Use of cartridges so that you can give yourself injections

The Norditropin SimpleXx solution is available as ready-to-use cartridges in the appropriate NordiPen injection pen.

How to use the cartridges in the injection pen is described in the NordiPen user manual.

• Check before using each new Norditropin SimpleXx cartridge. Do not use broken or broken cartridges.

Do not use Norditropin SimpleXx cartridge if the solution is not clear and colorless.

• Apply it by changing the area where you have injected to avoid damaging your skin.

• do not share your Norditropin SimpleXx cartridge with others.

The time you need to continue treatment

• if you are using Norditropin SimpleXx for growth retardation caused by Turner syndrome or a kidney disease, or if you are born small for gestational age (SGA), continue using Norditropin SimpleXx until you stop growing

• If you are deficient in growth hormone, continue to use Norditropin SimpleXxi into adulthood

• Stop Norditropin SimpleXx treatment without consulting your doctor.

Use in the elderly:

experience with its use in persons over 60 years of age is limited.

Special Use Cases

If you have had a kidney transplant, you should not use somatropin. If you have a kidney disease, your kidney function should be monitored by your doctor.

Liver failure:

There is no specific use case.

If you have an impression that the Norditropin SimpleXx ⁇ effect is too strong or weak, talk to your doctor or pharmacist.

NORDITROPIN SIMPLEX

What to Do in case of Overdose?

If you have used more than you should use Norditropin SimpleXx, talk to a doctor or pharmacist.

Prolonged overdose causes abnormal growth and roughing of facial features.

What Should I Do When I Forget to Use NORDITROPIN SIMPLEX?

If you forget one dose, take the next dose as usual at normal time.

Do not take double doses to offset forgotten doses.

post Treatment For Those Using NORDITROPIN SIMPLEX

Do not discontinue Norditropin SimpleXx treatment without consulting your doctor. When the treatment is terminated, no adverse effects are expected to occur, but the expected treatment and the positive effects can be eliminated.

Things to consider before using NORDITROPIN SIMPLEX

NORDITROPIN SIMPLEX Who Shouldn't Use It?

If,

If you are allergic (hypersensitivity) to somatropine, phenolee, or other substances found in the composition of Norditropin SimpleXx ⁇ (see). Auxiliary substances)

• if you have undergone kidney transplantation

Is it Used During Pregnancy (Pregnancy) Period?

If you have cancer or a tumor in your body, or if you are being treated for a tumor

If you have a critical illness that comes on suddenly, such as open heart surgery, abdominal surgery, multiple accident injury, or sudden respiratory failure.

What Should People Using NORDITROPIN SIMPLEX Pay Attention to?

If,

• If you have diabetes, you,

If you have had cancer before or have had another type of tumor

If you have recurrent headaches, vision problems, nausea or vomiting

If your thyroid function is impaired

• if scoliosis (spine curvature) develops or

If you are over 60 years of age, or have received somatropin treatment for more than 5 years as an adult; because experience in these subjects is limited

If you have a kidney disease, your kidney function should be monitored by your doctor.

Please consult your doctor if these warnings apply to you, even at any time in the past. Norditropin SimpleXx may not be suitable.

Food and Beverage Consumption with NORDITROPIN SIMPLEX

What are the foods and drinks that are inconvenient to be consumed with the specified medication? What should we eat or not eat?

Norditropin SimpleXx is available regardless of meals.

Is it Used During Pregnancy (Pregnancy) Period?

Consult your doctor or pharmacist before using the medicine.

Norditropin SimpleXx should not be used during pregnancy.

Norditropin SimpleXx, if you become pregnant while using it, discontinue treatment and tell your doctor.

If you notice that you are pregnant during your treatment, consult your doctor or pharmacist immediately.

Can it be Used During Breastfeeding?

Consult your doctor or pharmacist before using the medicine.

Do not use Norditropin SimpleXx if you are breastfeeding. Somatropin can be passed into breast milk.

Vehicle and machinery use

Norditropin SimpleXx does not affect your ability to use vehicles and machines safely.

Important information about some of the auxiliary substances contained in Norditropin SimpleXxin

This medicinal product contains less than 1 mmol (23 mg) of sodium at each dose. No side effects of this value are observed.

Is It Used With Other Drugs?

Your doctor will want to know if you are taking the following medications:

If you use glucocorticoids or sex steroids with Norditropin SimpleXx, glucocorticoids or sex steroids at the same time, your height in adulthood may be affected.

Your insulin dose may need to be adjusted.

Thyroid hormone.

If you are currently taking any prescription or over-the-counter medications or have recently used them, please tell your doctor or pharmacist about them.

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