Genotropin GoQuick – 16IU

WHAT IS GENOTROPIN GO QUICK USED FOR?

Genotropin is a recombinant human growth hormone (also called somatropin). It has the same structure as the natural human growth hormone, which is required for bone and muscle growth. It also plays a role in the balanced development of fat and muscle tissue. Recombinant means that it is not made from human or animal tissue. In children, Genotropin Go Quick is used to treat the following growth disorders:

• growth retardation as a result of insufficient production of your own growth hormone.
• growth retardation in Turner syndrome. This chromosomal condition, which only affects girls, can cause stunted growth. If you / your child has this condition, you have already heard about it from your doctor.
• Growth retardation due to chronic kidney disease. If the kidneys are not working normally, growth can be slowed.
• Prader-Willi syndrome, a chromosomal disorder. Children with this syndrome who are still growing will eventually grow taller due to the use of growth hormone. Body proportions are also improved. The excess fat decreases and the muscle mass, which is often reduced, increases.
• Children who were too small or underweight at birth and who have not yet made up for this growth retardation at the age of 4 years or older.

In adults, Genotropin is used to treat a severe deficiency of your own growth hormone. Treatment can start in adulthood or be a follow-up to childhood treatment. If you were treated with Genotropin in your youth for a growth hormone deficiency, your growth hormone production will be retested when growth has stopped. If you are found to be seriously deficient in growth hormone, your doctor will advise you to continue treatment. Only a doctor who has experience in growth hormone treatment and who has confirmed your diagnosis should prescribe this medicine for you.

2. What you need to know before you use Ciprofloxacin

WHEN SHOULD YOU NOT USE THIS MEDICINE?

• If you are allergic (hypersensitive) to somatropin or any of the other ingredients of Genotropin.
• If you have an active tumor (cancer). You should not start treatment with Genotropin until your tumor is no longer active and your anti-cancer treatment has finished.
• If you are seriously ill (for example with complications after open-heart surgery, abdominal surgery, acute breathlessness, trauma or a similar condition). If you are going to have or have recently had major surgery, or if you need to be hospitalized for any reason, tell your own doctor and other treating doctors that you are taking growth hormone.
• If your doctor has prescribed Genotropin to stimulate your growth while you are stopping growth (when your epiphyseal discs are closed).

WHEN SHOULD YOU BE EXTRA CAREFUL WITH THIS MEDICINE?

• If you have an increased risk of diabetes. Your doctor will monitor your blood sugar regularly during treatment with Genotropin.
• If you already have diabetes: check your blood sugar regularly during treatment with Genotropin and discuss the results with your doctor to determine if the dose of your diabetes medicines needs to be changed.
• After initiation of Genotropin treatment, it is necessary for some patients to initiate thyroid hormone replacement therapy.
• If you are being treated with thyroid hormone: your thyroid hormone dose may need to be adjusted.
• If you are taking growth hormones to stimulate growth and you are limping, or if you become limp during treatment due to pain in your hip, please contact your doctor.
• If you develop symptoms of increased brain pressure (with symptoms such as severe headache, vision problems or vomiting): Contact your doctor immediately.
• If your doctor has determined that you have inflammation of the muscles near the injection site caused by the preservative metacresol: change to another Genotropin product that does not contain metacresol.
• If you are taking Genotropin because you have too little growth hormone after cancer treatment: see your doctor for regular check-ups to make sure the cancer doesn’t come back.
• There is little experience in treating patients over 80 years of age. Elderly people may be more sensitive to the effect of Genotropin and will therefore suffer more from side effects.

FOR CHILDREN WITH CHRONICLY IMPAIRED KIDNEY FUNCTION:

• The doctor will check your kidney function and growth rate before you can start on Genotropin. Treatment for your kidney disease should be continued. If you are having a kidney transplant, Genotropin treatment should be stopped.

FOR CHILDREN WITH PRADER-WILLI SYNDROME:

• Your doctor will give you dietary advice to prevent you from gaining weight.
• Before you can start taking Genotropin, your doctor will examine your upper airways to look for narrowing, sleep apnea (breathing is interrupted during sleep) or respiratory infections.
• If you experience narrowing of the upper airways during treatment (for example, you start to snore or you snore harder), the doctor may decide to stop treatment with Genotropin after examining your airways.
• During the treatment your back will be checked for scoliosis, an abnormality of the spine.
• If you develop a lung infection during treatment, contact the doctor so that the infection can be treated.

FOR CHILDREN WHO ARE TOO LIGHT OR TOO SMALL AT BIRTH:

• If you were underweight or underweight at birth and are now between 9 and 12 years old, it is good to talk to your doctor about puberty and growth hormone treatment.
• Before the start of treatment, and every year thereafter, the doctor will check your blood sugar and insulin levels in your blood.
• You should continue the treatment until you have stopped growing.

Tell your doctor if any of the above applies to you or has applied to you in the past. Using other medicines Tell the doctor or pharmacist if you are taking or have recently taken any other medicines. This also applies to medicines that are available without a prescription. Tell the doctor if you are taking any of the following medicines:

• medicines to treat diabetes,
• thyroid hormone,
• synthetic adrenal hormones (corticosteroids),
• sex hormones (e.g. estrogens),
• cyclosporine (a medicine that inhibits the immune system after a transplant),
• medicines to treat epilepsy (anticonvulsants).

The dose of these medicines or Genotropin may need to be changed.

PREGNANCY AND BREAST FEEDING

You should not use Genotropin if you are pregnant or trying to become pregnant. Ask your doctor for advice before starting Genotropin while you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine.

DRIVING SKILLS AND USE OF MACHINES

No effects on the ability to drive or use machines have been observed.

SUBSTANCES IN THIS SUBSTANCE THAT YOU SHOULD TAKE INTO ACCOUNT

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.

3 How to use this medicine?

Always take this medicine exactly as your doctor or pharmacist has told you. Are you unsure about the correct use? Then contact your doctor or pharmacist.

RECOMMENDED DOSAGE

The dose depends on your height, the condition you are being treated for and also your sensitivity to growth hormone. Everybody is different. The dose of Genotropin (in milligrams) and the dosing schedule are determined by body weight in kilograms (kg) or body surface area (calculated from height and weight and expressed in square meters (m2)). Do not change the dose or dosing schedule without the doctor’s advice. Children with too little growth hormone: 0.025-0.035 mg / kg body weight per day or 0.7-1.0 mg / m2 body surface area per day. Sometimes higher doses are also used. If growth hormone deficiency persists in adolescence, Genotropin treatment should be continued until physical development is complete.Children with Turner syndrome: 0.045-0.050 mg per kg body weight per day or 1.4 mg per m2 body surface area per day. Children with chronic renal impairment: 0.045-0.050 mg per kg body weight per day or 1.4 mg per m2 body surface area per day. If the growth rate is too slow, the dosage can be increased. Dosage adjustment may be necessary after 6 months of treatment. Children with Prader-Willi syndrome: 0.035 mg per kg body weight per day or 1.0 mg per m2 body surface area per day. The daily dose should not exceed 2.7 mg. The treatment should not be used in children with a growth rate of less than 1 cm per year and when the epiphyseal discs (growth areas of cartilage) are almost closed.Children who were too small or too light at birth and who later have a growth disturbance: 0.035 mg per kg body weight per day or 1.0 mg per m2 body surface area per day. It is important to continue treatment until final height is reached. In patients who do not respond adequately to Genotropin, treatment should be discontinued after one year. Treatment should also be discontinued in patients who have stopped growing and have reached final height. Adults with growth hormone deficiency:If you continue on Genotropin after childhood treatment, you will start with 0.2-0.5 mg per day. This dose can be gradually increased or decreased according to blood test results, clinical response and side effects. If your growth hormone deficiency did not develop until adulthood, start with 0.15-0.3 mg per day. This dose can be gradually increased or decreased according to blood test results, clinical response and side effects. The daily maintenance dose rarely exceeds 1.0 mg per day. Women sometimes need more Genotropin than men. The dosage should be checked every 6 months. Patients over 60 years of age start with a dose of 0.1-0.2 mg per day. The dosage can be increased slowly until individual patient needs are met. Always use the lowest effective dose. The daily maintenance dose rarely exceeds 0.5 mg per day. Always follow your doctor’s instructions carefully when using Genotropin.

INJECTING GENOTROPIN

Genotropin is for subcutaneous use. This means that it must be injected into the fatty tissue just under the skin with a short injection needle. Your doctor or nurse has probably already shown you how to inject Genotropin. Always follow the advice of your doctor exactly when injecting Genotropin. If in doubt, consult your doctor or pharmacist.

THE INSTRUCTIONS FOR USE OF THE GENOTROPIN GO QUICK PRE-FILLED PEN ARE INCLUDED IN THE BOX OF THE PRE-FILLED PEN.

THE INSTRUCTIONS FOR USE FOR USING THE TWO-CHAMBER WITH THE GENOTROPIN GO QUICK PEN IS SUPPLIED WITH THE INJECTION PEN.

READ THE INSTRUCTIONS FOR USE BEFORE USING THE MEDICINAL PRODUCT.

The needle must be attached to the Genotropin pen (injection pen or pre-filled GoQuick pen) before you start mixing the powder and solvent. A new needle must be used for each injection. Used needles should not be reused.

• Preparing the injection:

Take Genotropin out of the refrigerator half an hour before the injection. If the liquid is a little warmer, the injection will be less painful. The GoQuick pre-filled pen contains the dual chamber cartridge containing the growth hormone and the solvent. The growth hormone and the solvent are mixed by rotating the ampoule holder (detailed description can be found in the instructions for use). A separate aid is not required for this. Genotropin in a two-chamber ampoule contains the growth hormone and the solvent and is specially designed for use in the Genotropin injection pen. The growth hormone and the solvent in the ampoule can be mixed by twisting the Genotropin injection pen together. Dissolve the powder by gently swirling the Genotropin pen back and forth 5 to 10 times, until the powder is dissolved (this applies to the injection pen and GoQuick pre-filled pen). DO NOT SHAKE while mixing Genotropin, but mix gently. Shaking creates foam; this can affect the effectiveness of the growth hormone. Do not use the solution if it is unclear or contains particles.

• Injecting Genotropin:

Always wash your hands first and cleanse the skin. Inject the growth hormone at about the same time every day, for example before going to bed. That is easy to remember. It is also very natural to have more growth hormone in the blood at night. Most people inject growth hormone into the thigh or buttock. Inject growth hormone into the site recommended by your doctor. The fatty tissue of the skin at the injection site may shrink. Therefore, choose a slightly different injection site each time. This gives your skin and subcutaneous tissue time to recover from the injection before using that same site again for an injection. Remember to put Genotropin back in the refrigerator immediately after the injection.

Have you used too much of this medicine?

If you have used too much Genotropin, contact your doctor or pharmacist immediately. Too much growth hormone can cause a sharp drop and later a sharp rise in blood sugar. In addition, you feel shaky, sweaty, sleepy or just not well and you may pass out.

HAVE YOU FORGOTTEN TO USE THIS MEDICINE

Do not use a double dose to make up for a forgotten dose. Try to inject the growth hormone at the same time as much as possible. If you miss a dose, inject the next dose at the normal time the next day. Write down if you have forgotten a dose and tell the doctor at the next check-up.

IF YOU STOP USING THIS MEDICINE

Get advice from your doctor before you stop using Genotropin. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4 Possible side effects

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

OFTEN (FOR LESS THAN 1 IN 10 PATIENTS):

Formation of antibodies to the injected growth hormone. This is unlikely to lead to reduced growth hormone efficacy.

IN CHILDREN:

• Temporary redness, itching, or pain at the injection site.

IN ADULTS:

• Numbness or tingling in the skin,
• Stiffness of the arms and legs, joint pain, muscle pain,
• Retention of body water (accompanied by swollen fingers or

ankles). This usually only occurs for a short period of time at the start of treatment and disappears on its own or when the dose is reduced. These common side effects in adults start in the first months of treatment and disappear spontaneously or when the dose is reduced.

SOMETIMES (IN LESS THAN 1 IN 100 PATIENTS): IN CHILDREN:

• Numbness or tingling in the skin,
• Stiffness of arms and legs, joint pain, muscle pain

• Retention of body water (accompanied by swollen fingers or ankles, for a short period at the start of treatment).

IN ADULTS:

• Pain or burning in the hands or forearms (carpal tunnel syndrome).

RARE (IN LESS THAN 1 IN 1,000 PATIENTS):

• Type 2 diabetes mellitus,
• Increased brain pressure (with symptoms such as severe headache, visual problems and vomiting).

VERY RARE (IN LESS THAN 1 IN 10,000 PATIENTS):

• Leukemia.

Bumps may form in the skin around the injection site; This can be prevented by choosing a different site for each injection. A very rare side effect is inflammation of the muscles near the injection site. This is caused by the preservative metacresol. If the doctor has determined that this is the case for you, you should use a Genotropin product without metacresol. Rare cases of sudden death in patients with Prader-Willi syndrome have been reported. However, it is not clear whether this was caused by Genotropin. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5 How to store this medicine?

Keep out of the sight and reach of children. Do not use this medicine after the expiry date. It can be found at the Dr. Fisher Farma label after “Exp.”. There is a month and a year. The last day of that month is the expiry date. Before mixing: Store in the refrigerator (2 ° C – 8 ° C). Keep the dual chamber ampoule in the original package in order to protect from light. Before opening, the product may be stored outside the refrigerator at or below 25 ° C for a maximum of 1 month without being returned. After this time it must be discarded. After mixing: Store in the refrigerator (2 ° C – 8 ° C) for up to 4 weeks. Do not store in the freezer. Keep the GoQuick pre-filled pen or the dual chamber cartridge in the original package in order to protect from light.