5 mg and 12 mg of powder and solvent for injection, solution
somatropin

1. What Genotropin is and what it is used for

Genotropin is a recombinant human growth hormone (also called somatropin). It has the same composition as a natural human growth hormone that is necessary for the growth of bone tissue and muscle. It also contributes to the normal development of adipose tissue and muscle. Recombinant means that it does not come from human or animal tissue.

Genotropin is used in children with the following growth disorders:

  • Growth disorder due to insufficient production of the body’s own growth hormone .
  • Turner syndrome , which is a chromosomal disorder in girls that can affect the plant. Your doctor has informed you if you have this disease.
  • Chronic renal failure . Impaired kidney function may affect growth.
  • In Prader-Willi syndrome (a chromosomal disorder ) to improve growth during growth and for better body composition. Excess adipose tissue will decrease and muscle mass will increase.
  • For children who are very short or underweight at birth. Growth hormone improves growth if the baby has not reached normal height at the age of four or later.

Genotropin is used in adults with significant growth hormone deficiency. This can occur in adulthood or be a continuation of growth hormone deficiency during childhood.

If you have been treated with Genotropin for growth hormone deficiency during childhood, your ability to produce growth hormone will be tested again when you have fully grown. If significant growth hormone deficiency is found, your doctor will suggest continued treatment with Genotropin.

Genotropin treatment should be performed by a physician experienced in growth hormone therapy.

2. What you need to know before you use Genotropin

Do not use Genotropin and tell your doctor

  • If you are allergic (hypersensitive) to somatropin or any of the other ingredients of Genotropin.
  • In active tumor (cancer). Tumors must be inactive and cancer treatment must be stopped before starting treatment with Genotropin.
  • In case of serious illness (eg in complications of open heart surgery, stomach surgery, acute lung failure, accidents or similar situations). Before a major operation, or after a recent one, or during a hospital visit for another reason, the doctors concerned must be informed about the treatment with growth hormone .
  • If Genotropin has been prescribed to stimulate growth in children who have already stopped growing (closed epiphyses / growth plates).

Take special care with Genotropin and tell your doctor if any of the following apply:

  • If there is a risk of developing diabetes (diabetes), your doctor will need to check your blood sugar level regularly while you are being treated with Genotropin.
  • In diabetes , blood sugar levels should be closely monitored during treatment with Genotropin. Discuss the results of the measurements with your doctor, the dose of one of your diabetes medicines may need to be adjusted.
  • After starting treatment with Genotropin, some patients may need to start treatment with thyroid hormone.
  • During treatment with thyroid hormone, the dose of one of the thyroid hormones may need to be adjusted.
  • If you are receiving Genotropin to stimulate growth and you limp or start limping due to pain in the hip, your doctor should be informed.
  • In case of severe headache, visual disturbance, or vomiting, which may be a sign of increased intracranial pressure , a doctor should be consulted.
  • If a doctor determines that an inflammation has developed in muscles near the injection site due to the preservative metacresol, you should switch to Genotropin without preservatives .
  • If growth hormone deficiency is due to a previous tumor and is being treated with Genotropin, regular check-ups should be performed for recurrence of tumor disease or other cancers.
  • In case of worsening abdominal pain, a doctor should be contacted.
  • Experience from treating patients over the age of 80 is limited. Elderly patients may be more sensitive to Genotropin, and may therefore have more side effects .

Children with chronic renal failure

  • Renal function and growth rate should be checked before starting treatment with Genotropin. The medication for kidney disease should continue. Genotropin treatment should be discontinued during kidney transplantation.

Children with Prader-Willi syndrome

  • The doctor will give instructions on diet to be followed so that the baby’s weight can be controlled.
  • Your doctor will check for signs of breathing problems, sleep apnea (short pauses in breathing during sleep) or respiratory infection before starting treatment with Genotropin.
  • The doctor should examine the child if, while the treatment is taking place, it shows signs of difficulty breathing, e.g. starts snoring or snores more than before. Genotropin treatment may then need to be discontinued.
  • The doctor will check for signs of scoliosis, a type of deformity of the spine.
  • Contact your doctor for pneumonia so that the child receives treatment for it.

Children born very short or underweight

  • Discuss growth hormone therapy during puberty with your doctor if the baby, who was very short or underweight at birth, is between nine and twelve years old.
  • Your doctor will check your blood sugar and insulin levels before starting treatment and every year during treatment.
  • The treatment should continue until the child has stopped growing.

Use of other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Warnings and cautions

Talk to your doctor or pharmacist before using Genotropin.

If you have a replacement therapy with glucocorticoids, you should contact your doctor regularly, as you may need to adjust your glucocorticoid dose.

Tell your doctor if you are using:

  • Diabetes drugs
  • Thyroid hormones
  • Synthetic adrenal hormones ( corticosteroids )
  • Estrogen taken by mouth or other sex hormones
  • Ciclosporin (a medicine that weakens the immune system after a transplant)
  • Antiepileptic drugs ( antiepileptics )

Your doctor may need to adjust your dose for these medicines or Genotropin.

Pregnancy, breastfeeding and fertility

You should not use Genotropin if you are pregnant, think you may be pregnant, or are trying to become pregnant.

Talk to your doctor before using Genotropin during breastfeeding.

Consult a physician, nurse, or pharmacist before taking any medicine.

Driving and using machines

Genotropin has no effect on the ability to drive and use machines.

Important information about some of the ingredients of Genotropin

This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free.

3. How to use Genotropin

Recommended dosage

Dose one is affected by the child’s weight and height, the condition being treated for, and how well the patient responds to the growth hormone. The doctor determines the dose of a Genotropin in milligrams (mg), which is individually adjusted for each patient, either by weight in kilograms (kg) or by body surface area in square meters (m 2 ) calculated by height and weight and according to the treatment program. Do not change the dosage or treatment program without consulting your doctor.

Children with insufficient production of the body’s own growth hormone:

0.025-0.035 mg / kg body weight and day or 0.7-1.0 mg / m 2 body surface area and day. There are also higher doses. If growth hormone deficiency persists into adolescence and early adulthood, treatment with Genotropin should be continued until physical development has stopped.

Children with Turner syndrome:

0.045-0.050 mg/kg body weight and a day or 1.4 mg / m 2 body surface area and day.

Children with chronic renal failure:

0.045-0.050 mg/kg body weight and a day or 1.4 mg / m 2 body surface area and day. Even higher doses may be needed if the growth rate is too slow. A dose adjustment may be required after 6 months of treatment.

Children with Prader-Willi syndrome:

0.035 mg/kg body weight and a day or 1.0 mg / m 2 body surface area and day. The daily dose should not exceed 2.7 mg. Children who have almost stopped growing after puberty should not be treated.

Children born very short or underweight:

0.035 mg/kg body weight and a day or 1.0 mg / m 2 body surface area and day. It is important that the treatment continues until the final body length is reached. The treatment should be stopped after one year if it has not given the desired result or if the final length has been reached and the growth has stopped.

Adults with growth hormone deficiency:

The recommended starting dose for patients who continue growth hormone therapy after being treated for growth hormone deficiency during childhood is 0.2-0.5 mg per day. The dose should be increased or decreased gradually depending on the result of the blood test, the result of the treatment, and the side effects.

For patients starting treatment as adults, treatment should start with

0.15–0.3 mg per day. The dose should be increased gradually depending on the results of the blood test, the results of the treatment, and the side effects. The daily dose rarely exceeds 1.0 mg per day. Women may need a higher dose of you than men. Dose one should be checked every 6 months. People over the age of 60 should start with a dose of 0.1–0.2 mg per day, which is then slowly increased depending on individual needs. The minimum effective dose should be used. The daily dose is rarely more than 0.5 mg per day.

Follow your doctor’s instructions.

Injecting Genotropin

Genotropin should be injected under the skin ( subcutaneously ). This means that it is injected through a short injection needle into the adipose tissue just under the skin. Your doctor or nurse should have given you instructions on how to use Genotropin. Always follow the instructions of a doctor or nurse carefully. Contact a doctor, nurse, or pharmacist if anything is unclear.

Instructions for using the GoQuick pre-filled pen are in its box. Instructions for use of the Genotropin two-chamber ampoule with Genotropin Pen are included with the injection aid Genotropin Pen. Read the instructions for use before you start using this medicine.

When using the GoQuick pre-filled pen and the Genotropin Pen, the needle must be screwed on before mixing the solution. A new needle must be used for each injection, the needle must not be reused.

Prepare the injection:

Genotropin can be removed from the refrigerator half an hour before injection. The drug then heats up slightly and it becomes more comfortable to take an injection.

The pre-filled GoQuick pen contains a two-chamber ampoule containing both growth hormone and solution for injection. The powder ( growth hormone ) and liquid for solution for injection are mixed when screwing on the ampoule holder (see detailed instructions in the instructions for use). No additional aids are needed.

Genotropin is a two-chamber ampoule contains both growth hormone and liquid for injection and should be used with the injection aid, Genotropin Pen. The powder ( growth hormone ) and liquid for solution for injection are mixed automatically when the Genotropin Pen is screwed together after insertion of the two-chamber ampoule.

For both the GoQuick pre-filled pen and the two-chamber ampoule, dissolve the powder by gently inverting it 5-10 times until the powder has dissolved.

DO NOT SHAKE the solution during preparation. Mix gently. Shaking can cause the growth hormone to foam and be destroyed. Check the solution and do not inject a solution that is still very cloudy after the powder has dissolved or if there are particles in it.

Inject Genotropin:

Remember to wash your hands first and clean your skin.

Inject growth hormone at about the same time each day. Bedtime is a good time that is easy to remember and it is natural to have a higher level of growth hormone during the night.

Most people inject into the thigh or buttocks. Inject at the place you have been instructed by your doctor. The skin’s oily layer can be thinned at the injection site. To avoid this, the injection site should be varied. Then the skin can recover before injecting in the same place again.

Remember to put Genotropin back in the refrigerator after injection one.

If you use more Genotropin than you should 

If the injection has become much larger than it should be, a doctor or pharmacist should be contacted as soon as possible. The blood sugar level may become too low and then rise too high. You may feel unsteady, sweat, feel sleepy, or “not yourself”, and you may faint.

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center immediately for assessment of the risk and advice.

If you forget to use Genotropin

Do not take a double dose to make up for a forgotten dose .

It is preferable to use growth hormone regularly. If you forget to take a dose, take the next dose at the usual time the next day. Note the missed dose and inform the doctor at the next check-up.

If you stop using Genotropin

Do not stop taking Genotropin without consulting your doctor.

If you have any further questions on the use of this product, ask your doctor, nurse or pharmacist or nurse.

4. Possible side effects

Like all medicines, Genotropin can cause side effects , although not everybody gets them.

Adverse reactions within the categories very common and common may occur in adults within the first months of treatment and may cease spontaneously or if the dose is reduced.

Very common ( may affect more than 1 user in 10):

In adults:

  • Joint pain
  • Edema (manifesting as swollen fingers or ankles).

Common ( may affect up to 1 in 10 people ):

In children:

  • Temporary redness , itching or pain at the injection site.
  • Joint pain
  • Rash
  • Raised itchy lumps on the skin

In adults:

  • Numbness / tingling
  • Stiffness in arms and legs, muscle aches
  • Pain or burning sensation in the hands or forearms (called carpal tunnel syndrome ).

Uncommon (may affect up to 1 in 100 people):

In children:

  • Edema (manifesting as swollen fingers or ankles for a short time after starting treatment)
  • Itching

Rare (may affect up to 1 in 1,000 people):

In children:

  • Numbness / tingling
  • Leukemia (this has been reported in a small number of growth hormone deficient patients , some of whom had been treated with somatropin. However, there is no evidence that the incidence of leukemia increases in patients receiving growth hormone without any predisposing factors).
  • Elevated intracranial pressure (causing symptoms such as severe headache, visual disturbances or vomiting)
  • Muscle aches

Has been reported (occurs in an unknown number of users):

  • Type 2 diabetes
  • Decreased level of hormone a cortisol in the blood
  • Swelling of the face

In children:

  • Stiffness in arms and legs

In adults:

  • Elevated intracranial pressure (causing symptoms such as severe headache, visual disturbances or vomiting).
  • Redness , itching or pain at the injection site
  • Rash
  • Itching
  • Raised itchy lumps on the skin

The formation of antibodies against the injected growth hormone , but these do not seem to affect the activity of the growth hormone.

The skin at the injection site may become bumpy, but this should not happen if injection is given in different places each time.

A very rare side effect is inflammation in the muscle at the injection site due to the preservative metacresol. If your doctor finds that this has happened, you should switch to a Genotropin product that does not contain metacresol.

Isolated cases of sudden death in patients with Prader-Willi syndrome have been reported.

However, no association with Genotropin treatment has been demonstrated.

If you experience discomfort or pain in the hip or knee while being treated with Genotropin, your doctor may consider the diagnoses displacement of the upper femoral epiphysis and Legg – Calvé – Perthes disease.

Other possible side effects as a result of growth hormone treatment may include the following: you (or your child) may experience high blood sugar or lowered thyroid hormone levels. The doctor can determine this with the help of samples and, if necessary, prescribe appropriate treatment. In rare cases, inflammation of the pancreas has been reported in patients treated with growth hormone .

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Genotropin

Genotropin is kept out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the carton as month / year. The expiration date is the last day of the specified month.

Before preparation:

Store in a refrigerator (2 ° C-8 ° C). Store the biconvex cartridge in the outer carton. Sensitive to light.

Before opening the package, the product can be removed from the refrigerator and stored at a maximum of 25 ° C for a maximum of one month. During this period, the product must not be put back in the refrigerator and unused product must be discarded after this month.

After preparation:

Store in a refrigerator (2 ° C-8 ° C) for up to 4 weeks. Do not freeze. Keep the GoQuick pre-filled pen in the outer carton and biconvex cartridge in the Genotropin Pen case. Sensitive to light.

Do not use this medicine if you see particles or if the solution is not clear.

Genotropin must not be frozen or exposed to frost. Do not use frozen Genotropin.

Never dispose of needles or partially used or empty ampoules among household waste. Used needles should be carefully destroyed so that no one can use them or sting on them.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is recombinant somatropin *.
  • One ampoule contains 5 or 12 mg of somatropin *.
  • After reconstitution , the concentration is 5 or 12 mg somatropin * per ml.
  • The other ingredients in the powder are glycine (E640), mannitol (E421), anhydrous monosodium phosphate (E339), anhydrous disodium phosphate (E339).
  • The solution for injection contains water for injections, mannitol (E421) and metacresol.

* Produced in Escherichia coli cells by recombinant DNA technology.

What the medicine looks like and contents of the pack

Genotropin (powder and solvent for solution for injection ) is a two-chamber ampoule containing powder in one part and liquid in the other (5 mg / ml or 12 mg / ml). Ampoule one can be included in a pre-filled pen. The pack sizes are 1 pre-filled pen or 5 pre-filled pens, or 1 ampoule , 5 or 20 ampoules .

Not all strengths and pack sizes may be marketed.

The powder is white and the liquid is clear.

Genotropin in a two-chamber ampoule is used with an injection device, Genotropin Pen.

The ampoules have color codes and should be used with Genotropin Pen with the corresponding color code. Genotropin 5.0 mg (green) should be used with Genotropin Pen 5 (green). Genotropin 12 mg (purple) should be used with Genotropin Pen 12 (purple).

Instructions for use are included in the Genotropin Pen package. If you have not yet received one, ask your doctor or nurse for a Genotropin Pen.

Marketing Authorization Holder and Manufacturer

Pfizer AB

191 90 Sollentuna

Tel .: 08-550 520 00

Email: eumedinfo@pfizer.com

Manufacturer

Pfizer Manufacturing Belgium NV

Rijksweg 12

2870 Puurs

Belgium

Muhammad Nadeem

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