6 mg / 12 mg / 24 mg powder and solvent for injection , solution
somatropin

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or pharmacist.

– This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about:
1. What Humatrope® is and what it is used for
2. Before you use Humatrope®
3. How to use Humatrope®
4. Possible side effects
5. How to store Humatrope®
6. Other information

1. WHAT HUMATROPE® IS AND WHAT IT IS USED FOR

This medicine is called Humatrope and contains growth hormone, also called somatropin. Humatrope is made using a special technology called recombinant DNA technology. It has the same structure as the growth hormone that the body normally produces.

Growth hormone regulates the growth and development of cells in the body. When cell growth in the spine and tubular bones is stimulated, it results in an increase in body length.

In the absence of growth hormone, the addition of growth hormone also results in an increased bone mineral content, increased number and size of muscle cells, and reduced body fat storage.

Humatrope is used for

  • Treatment of children and adolescents with disorders of height growth depending on
    • insufficient release of own growth hormone (growth hormone deficiency)
    • Turner syndrome (female chromosome disorder with no or few X chromosomes missing)
    • chronic kidney disease in children before puberty with delayed growth
    • SGA – small for gestational age, ie short stature in children who are born small in relation to the length of the fetal period and who have not recovered growth at 4 years of age or later
    • Lack of SHOX gene function (genetic disease)
  • Treatment of adults with confirmed growth hormone deficiency that began either in childhood or in adulthood.

Somatropin contained in Humatrope may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

2. BEFORE YOU USE HUMATROPE®

DO NOT USE Humatrope:

  • If you are allergic (hypersensitive) to somatropin or to any of the other ingredients of Humatrope (eg metacresol, glycerol in the diluent), see section 6.
  • and tell your doctor if you have an active tumor (cancer). Tumors must be inactive and you must have stopped your cancer treatment before starting treatment with Humatrope.
  • If you have already stopped growing (closed growth plate at the end of the tubular bone ) and want to grow further in length. Your doctor will examine you to determine if you still need Humatrope after your legs have stopped growing.
  • If you are very ill and need intensive care after serious heart or abdominal surgery, are treated for multiple injuries after an accident or need mechanical breathing assistance after acute lung problems.

Warnings and cautions

Talk to your doctor or pharmacist before using Humatrope.

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


If you have been treated for growth hormone deficiency during childhood. Your doctor will re-examine you for growth hormone deficiency to determine if you need further treatment with Humatrope in adulthood.


If you have previously stopped treatment for a tumor. X-rays of the brain may be required before treatment with Humatrope. You should be examined regularly to determine that the tumor has not returned or started to grow.


A higher risk of getting secondary tumors (benign and malignant) has been reported in patients who have survived their cancer and who have been treated with somatropin. Of these secondary tumors, it is especially brain tumors that were the most common.


If you have symptoms such as recurrent or severe headaches with nausea and/or visual disturbances. Talk to your doctor immediately. Your doctor should do an examination of the eyes to see if there are signs of increased pressure in the brain. Depending on the results of this study, treatment with Humatrope may need to be stopped.


If you start to limp or have hip pain. Consult your doctor. During the growth period, bone diseases can develop in the hip.


If you start treatment with Humatrope. Humatrope can affect the amount of thyroid hormone in the blood. If the thyroid hormone level is low, it may reduce the effect of Humatrope. Therefore, regular check-ups of thyroid function should be done regardless of whether you are receiving thyroid hormone treatment or not.


If you are a child. Make sure that the treatment continues until the final length is reached.


If you take a higher dose than prescribed. Somebody parts can be enlarged and roughened e.g. ears, nose, jaw, hands, and feet. Overdose can also cause increased blood sugar and sugar in the urine. Always use the dose recommended by your doctor.


If you have a growth disorder due to kidney damage. Humatrope treatment should be stopped before kidney transplantation.


If you have an acute, serious illness. Your doctor should be informed. Deaths have occurred in patients receiving somatropin in severe diseases.


If you have growth hormone deficiency and also have Prader-Willi syndrome (a congenital disease). Your doctor should check if you have any breathing problems or respiratory infections before starting Humatrope treatment. This is especially true for obese people who have previously had problems with severe breathing disorders (especially during sleep) or have had infections in their lungs or airways. If you experience breathing problems (snoring) during treatment, stop treatment and investigate the cause by your doctor.


Humatrope can affect how the sugar from food and drink is taken care of by the body by intervening in the way the body uses insulin. Therefore, if you are taking Humatrope, your doctor should check that your body is taking care of your sugar properly. If you have diabetes mellitus, your insulin dose may need to be adjusted after starting your Humatrope treatment. Your doctor will check the amount of sugar in your blood and may adjust your diabetes treatment.


If you have a growth disorder due to the length at birth was short in relation to the length of the fetal period. Blood sugar and insulin levels will be checked before starting treatment and then regularly during treatment.


Elderly patients (over 65 years). You may be more sensitive to Humatrope and more likely to experience side effects.

Humatrope can lead to inflammation of the pancreas that causes severe pain in the abdomen and back. Contact a doctor if you or your child get stomach pain after treatment with Humatrope.


Scoliosis (increased lateral curvature of the spine) can develop in all children who grow rapidly. Signs of scoliosis should be noted during treatment.

Other medicines and Humatrope

Tell your doctor or pharmacist if you have recently taken or might take any other medicines.

In particular, tell your doctor if you are taking or have recently taken any of the following medicines. Your doctor may need to adjust the dose of one of Humatrope or other medicines:

  • drugs for the treatment of diabetes mellitus . Dose one may need to be adjusted.
  • adrenal cortex hormones ( glucocorticoids are), e.g. cortisone or prednisolone . Your doctor may need to adjust dose one, as combining these medicines with Humatrope may reduce the effectiveness of both treatments.
  • estrogen taken by mouth or other sex hormones . These may affect Humatrope treatment. If the way estrogen is given changes, for example, from oral (by mouth) to transdermal (through the skin) dose one of Humatrope may need to be adjusted.
  • anticonvulsants ( antiepileptic drugs ) or cyclosporine.

Pregnancy and breastfeeding

Humatrope should not be used during pregnancy unless your doctor tells you to. If you become pregnant, tell your doctor immediately.

It is unknown whether somatropin is excreted in human milk. Therefore, talk to your doctor before using Humatrope if you are breastfeeding or planning to breastfeed.

Driving and using machines

Humatrope has no known effects on the ability to drive and use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Humatrope contains sodium

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

3. HOW TO USE HUMATROPE®

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

  • Make sure you use the ampoule strength prescribed by your doctor (one of the strengths 6 mg, 12 mg or 24 mg) and the correct CE marked Humatrope pen. Never use other ampoules of medicine in your Humatrope pen.
  • In addition to the ampoule, the Humatrope package contains a syringe containing diluent , which is to be used in the preparation of the injection solution .
  • You must not mix or inject Humatrope until you have received appropriate training from your doctor or other healthcare professional.
  • See the “ How to inject Humatrope ” section at the end of this leaflet for detailed instructions on how to prepare and inject Humatrope. You may only prepare Humatrope with the diluent contained in the package. Never mix Humatrope with anything else unless your doctor tells you to.
  • Humatrope should after preparing a injected into the fatty tissue just under the skin with a pen equipped with a short needle.
  • The injection site should be varied to avoid local hardening and reduced subcutaneous fat (lipoatrophy).
  • After preparation must Humatrope not be stored outside the refrigerator for more than 30 minutes per day.
  • Store Humatrope and the pen in the refrigerator. Do not use Humatrope that has been left in the pen for 28 days after reconstitution .

Dosage

Your doctor will prescribe the appropriate dose and how often you should take Humatrope. Do not change the dosage without first talking to your doctor.

Treatment with Humatrope usually lasts for a long time. Your doctor may need to adjust the dose over time depending on your body weight and the effect of the treatment. In general, dose one is calculated as follows and is given once a day:

Children and adolescents with:

  • Growth hormone deficiency
    0.025-0.035 mg / kg body weight daily
  • Turner syndrome
    0.045-0.050 mg / kg body weight daily
  • Chronic kidney problems
    0.045-0.050 mg / kg body weight daily
  • Short stature in children born small in relation to the length of the fetal period
    0.035 mg / kg body weight daily. The treatment should be stopped after the first year of treatment if the growth rate is insufficient.
  • Lack of SHOX gene function
    0.045-0.050 mg / kg body weight daily.

Adults with growth hormone deficiency

Treatment should be started with a low dose of 0.15-0.30 mg daily. A lower starting dose may be required in elderly and obese patients. The starting dose can be increased gradually according to the needs of the individual patient. The total daily dose does not normally exceed 1 mg.

With increasing age, a lower dose may be required. Women, especially those receiving estrogen replacement therapy, may need a higher dose than men.

If you take more Humatrope than you should

If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. If you have been given more Humatrope than you should, consult your doctor.

  • If you have injected too much Humatrope, your blood sugar may first drop and become too low ( hypoglycaemia ) and then increase and become too high ( hyperglycaemia ).
  • If you inject too much Humatrope for an extended period (years), certain parts of your body, e.g. ears, nose, jaw, hands and feet, grow too much ( acromegaly ).

If you forget to take Humatrope

Do not take a double dose to make up for a forgotten dose. Continue with the prescribed dose one. If you forget to take Humatrope and do not know what to do, contact your doctor.

If you stop taking Humatrope

Talk to your doctor before stopping Humatrope. Discontinuation or premature discontinuation of treatment may impair the treatment effect of Humatrope.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them. You may get any of the following side effects after injecting Humatrope:

The following grouping of side effects is used:

Very common side effects may affect more than 1 in 10 people.

Common side effects may affect 1 in 100 to 1 in 10 users.

Uncommon side effects may affect 1 in 1,000 to 1 in 100 people.

Rare side effects may affect 1 in 10,000 to 1 in 1,000 users.

Very rare side effects may affect less than 1 in 10,000 people and include isolated reports.

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

Children
Usual Less common Rare Very rare Has been reported
Injection site pain
Swelling ( edema )
High blood sugar ( hyperglycaemia )
Hypersensitivity to meta cresol and/or glycerol
Low thyroid hormone levels
The formation of the antibody is against the growth
Development of scoliosis (increased lateral curvature of the spine)
Weakness
Type 2 diabetes mellitus
Breast augmentation ( gynecomastia )
Severe or frequent headaches with nausea and / or visual disturbances are signs of increased pressure in the brain ( benign intracranial hypertension ). Contact your doctor immediately if this occurs.
Numbness and tingling ( paresthesias )
Local muscle pain ( myalgia )
Difficulty sleeping high blood pressure( hypertension )
Sugar in the urine (glycosuria)
Hypersensitivity to the active substance

Adults
Very common Usual Less common Rare Has been reported
HeadacheJoint pain ( arthralgia ) Injection site painSwelling ( edema )High blood sugar ( hyperglycaemia )Hypersensitivity to metacresol and/or glycerolLow thyroid hormone levelsDifficulty sleepingNumbness and tingling ( paresthesias )Numbness and tingling in fingers and palms due to pinched nerve in wrist ( carpal tunnel syndrome )Local muscle pain ( myalgia )High blood pressure ( hypertension )Shortness of breath ( dyspnoea )Temporary interruption of breathing during sleep ( sleep apnea ) WeaknessBreast augmentation ( gynecomastia ) Severe or frequent headaches with nausea and / or visual disturbances are signs of increased pressure in the brain ( benign intracranial hypertension ). Contact your doctor immediately if this occurs.Sugar in the urine (glycosuria) Type 2 diabetes mellitusHypersensitivity to the active substance

The effect of insulin may be reduced.

Leukemia has been reported in a small number of children who have been treated with growth hormone. However, there is no evidence of an increased risk of leukemia 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 HUMATROPE®

  • Keep out of sight and reach of children.
  • Do not use this medicine after the expiry date which is stated on the label (EXP) and carton (EXP or EXP). The expiration date is the last day of the specified month.
  • Do not use this medicine if the solution is cloudy or contains particles.
  • Always store Humatrope in a refrigerator (2 ° -8 ° C). Do not freeze.
  • Pre-dissolved Humatrope should be stored in a refrigerator and should not be left at room temperature for more than 30 minutes per day.
  • Humatrope can be used for up to 28 days after reconstitution if stored in a refrigerator and not left out at room temperature for more than 30 minutes per day.
  • 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. FURTHER INFORMATION

Content declaration

Powdered in ampoule one

The active substance is somatropin. One ampoule contains, depending on the strength, 6 mg, 12 mg or 24 mg. After resolution:

Humatrope 6 mg contains 2.08 mg somatropin per ml solution

Humatrope 12 mg contains 4.17 mg somatropin per ml solution

Humatrope 24 mg contains 8.33 mg somatropin per ml solution

The other ingredients are mannitol, glycine, disodium hydrogen phosphate. ( Phosphoric acid and / or sodium hydroxide may have been used in the manufacture to adjust the acidity).

The sterile diluent in the syringe

The pre-filled syringe with diluent contains: glycerol , metacresol, water for injections. ( Hydrochloric acid and / or sodium hydroxide may have been used in the manufacture to adjust the acidity).

What the medicine looks like and contents of the pack

Humatrope 6 mg: 1 ampoule of white powder for solution for injection3.17 ml clear, colorless diluent in a pre-filled syringe pack sizes 1, 5 and 10
Humatrope 12 mg: 1 ampoule of white powder for solution for injection3.15 ml clear, colorless diluent in a pre-filled syringe pack sizes 1, 5 and 10
Humatrope 24 mg: 1 ampoule of white powder for solution for injection3.15 ml clear, colorless diluent in a pre-filled syringe pack sizes 1, 5 and 10

Not all pack sizes may be available.

Marketing Authorisation Holder

Box 721

169 27 Solna

Manufacturer

Lilly France

Rue du Colonel Lilly

F-67640 Fegersheim

France

Muhammad Nadeem

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