Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - omnitrope

Document Subject

Generated Narrative: MedicinalProductDefinition mp552224bdd5379f4c4cfefcd5a85f0788

identifier: http://ema.europa.eu/identifier/EU/1/06/332/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Omnitrope 1.3 mg/ml powder and solvent for solution for injection

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-552224bdd5379f4c4cfefcd5a85f0788

identifier: http://ema.europa.eu/identifier/EU/1/06/332/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - omnitrope

Attesters

What is in this leaflet:

1. What Omnitrope is and what it is used for
2. What you need to know before you use Omnitrope
3. How to use Omnitrope
4. Possible side effects
5. How to store Omnitrope
6. Contents of the pack and other information

Omnitrope is a recombinant human growth hormone (also called somatropin). It has the same structure as natural human growth hormone which is needed for bones and muscles to grow. It also helps your fat and muscle tissues to develop in the right amounts. It is recombinant meaning it is not made from human or animal tissue. In children Omnitrope is used to treat the following growth disturbances:

If you are not growing properly and you do not have enough of your own growth hormone.

If you have Turner syndrome. Turner syndrome is a genetic disorder in girls that can affect growth your doctor will have told you if you have this.

If you have chronic renal (kidney) insufficiency. As kidneys lose their ability to function normally, this can affect growth.

If you were small or too light at birth. Growth hormone can help you grow taller if you have not been able to catch up or maintain normal growth by 4 years of age or later.

If you have Prader-Willi syndrome (a chromosomal disorder). Growth hormone will help you grow taller if you are still growing, and will also improve your body composition. Your excessive fat will decrease and your reduced muscle mass will improve. In adults Omnitrope is used to

treat persons with pronounced growth hormone deficiency. This can start during either adult life or it can continue from childhood. If you have been treated with Omnitrope for growth hormone deficiency during childhood, your growth hormone status will be retested after completion of growth. If severe growth hormone deficiency is confirmed, your doctor will propose continuation of Omnitrope treatment. You should only be given this medicine by a doctor who has experience with growth hormone treatment and who has confirmed your diagnosis.

Do not use Omnitrope

if you are allergic (hypersensitive) to somatropin or to any of the other ingredients of Omnitrope.

and tell your doctor if you have an active tumour (cancer). Tumours must be inactive and you must have finished your anti-tumour treatment before you start your treatment with Omnitrope.

and tell your doctor if Omnitrope has been prescribed to stimulate growth but you have already stopped growing (closed epiphyses).

if you are seriously ill (for example, complications following open heart surgery, abdominal surgery, accidental trauma, acute respiratory failure, or similar conditions). If you are about to have, or have had, a major operation, or go into hospital for any reason, tell your doctor and remind the other doctors you are seeing that you use growth hormone. Warnings and precautions Talk to your doctor before using Omnitrope.

If you have a replacement therapy with glucocorticoids, you should consult your doctor regularly, as you may need adjustment of your glucocorticoid dose.

If you are at risk of developing diabetes, your doctor will need to monitor your blood sugar level during therapy with somatropin.

If you have diabetes, you should closely monitor your blood sugar level during treatment with somatropin and discuss the results with your doctor to determine whether you need to change the dose of your medicines to treat diabetes.

After starting somatropin treatment some patients may need to start thyroid hormone replacement.

If you are receiving treatment with thyroid hormones it may become necessary to adjust your thyroid hormone dose.

If you have raised intracranial pressure (which causes symptoms, such as strong headache, visual disturbances or vomiting) you should inform your doctor about it.

If you walk with a limp or if you start to limp during your growth hormone treatment, you should inform your doctor.

If you are receiving somatropin for growth hormone deficiency following a previous tumour (cancer), you should be examined regularly for recurrence of the tumour or any other cancer.

If you experience worsening abdominal pain you should inform your doctor.

Experience in patients above 80 years is limited. Elderly persons may be more sensitive to the action of somatropin, and therefore may be more prone to develop side effects.

Omnitrope may cause an inflammation of the pancreas, which causes severe pain in the abdomen and back. Contact your doctor if you or your child develops stomach ache after taking Omnitrope.

An increase in sideways curvature of the spine (scoliosis) may progress in any child during rapid growth. During treatment with somatropin, your doctor will check you (or your child) for signs of scoliosis. Children with chronic renal (kidney) insufficiency

Your doctor should examine your kidney function and your growth rate before starting somatropin. Medical treatment for your kidney should be continued. Somatropin treatment should be stopped at kidney transplantation. Children with Prader-Willi syndrome

Your doctor will give you diet restrictions to follow to control your weight.

Your doctor will assess you for signs of upper airway obstruction, sleep apnoea (where your breathing is interrupted during sleep), or respiratory infection before you start treatment with somatropin.

During treatment with somatropin, tell your doctor if you show signs of upper airway obstruction (including starting to snore or worsening of snoring), your doctor will need to examine you and may interrupt treatment with somatropin.

During treatment, your doctor will check you for signs of scoliosis, a type of spinal deformity.

During treatment, if you develop a lung infection, tell your doctor so that he can treat the infection. Children born small or too light at birth

If you were too small or too light at birth and are aged between 9 and 12 years, ask your doctor for specific advice relating to puberty and treatment with this medicine.

Treatment should be continued until you have stopped growing.

Your doctor will check your blood sugar and insulin levels before the start of treatment and every year during treatment. Other medicines and Omnitrope Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. In particular, inform your doctor if you are taking or have recently taken any of the following medicines. Your doctor may need to adjust the dose of Omnitrope or of the other medicines:

medicine to treat diabetes,

thyroid hormones,

medicines to control epilepsy (anticonvulsants),

ciclosporin (a medicine that weakens the immune system after transplantation),

oestrogen taken orally or other sex hormones,

synthetic adrenal hormones (corticosteroids). Your doctor may need to adjust the dose of these medicines or the dose of somatropin. Pregnancy and breast-feeding You should not use Omnitrope if you are pregnant or trying to become pregnant. If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Important information about some of the ingredients of Omnitrope This medicine contains less than 1 mmol sodium (23 mg) per ml, i.e. essentially sodium- free .

Always use this medicine exactly as your doctor or pharmacist or nurse has told you. Check with your doctor, nurse or pharmacist if you are not sure. The dose depends on your size, the condition for which you are being treated and how well growth hormone works for you. Everyone is different. Your doctor will advise you about your individualised dose of Omnitrope in milligrams (mg) from either your body weight in kilograms (kg) or your body surface area calculated from your height and weight in square metres (m2), as well as your treatment schedule. Do not change the dosage and treatment schedule without consulting your doctor. The recommended dose is for: Children with growth hormone deficiency: 0.025 0.035 mg/kg body weight per day or 0.7 1.0 mg/m2 body surface area per day. Higher doses can be used. When growth hormone deficiency continues into adolescence, Omnitrope should be continued until completion of physical development. Children with Turner syndrome: 0.045 0.050 mg/kg body weight per day or 1.4 mg/m2 body surface area per day. Children with chronic renal (kidney) insufficiency: 0.045 0.050 mg/kg body weight per day or 1.4 mg/m2 body surface area per day. Higher doses may be necessary if the rate of growth is too low. Dosage adjustment may be necessary after 6 months of treatment. Children with Prader-Willi syndrome: 0.035 mg/kg body weight per day or 1.0 mg/m2 body surface area per day. The daily dosage should not exceed 2.7 mg. Treatment should not be used in children who have almost stopped growing after puberty. Children born smaller or lighter than expected and with growth disturbance: 0.035 mg/kg body weight per day or 1.0 mg/m2 body surface area per day. It is important to continue treatment until final height is reached. Treatment should be discontinued after the first year if you are not responding or if you have reached your final height and stopped growing. Adults with growth hormone deficiency: If you continue Omnitrope after treatment during childhood you should start with 0.2 0.5 mg per day. This dosage should be gradually increased or decreased according to blood test results as well as clinical response and side effects. If your growth hormone deficiency starts during adult life you should start with 0.15 0.3 mg per day. This dosage should be gradually increased according to blood test results as well as clinical response and side effects. The daily maintenance dose seldom exceeds 1.0 mg per day. Women may require higher doses than men. Dosage should be monitored every 6 months. Persons above 60 years should start with a dose of 0.1 0.2 mg per day which should be slowly increased according to individual requirements. The minimum effective dose should be used. The maintenance dose seldom exceeds 0.5 mg per day. Follow the instructions given to you by your doctor. Injecting Omnitrope Inject your growth hormone at about the same time every day. Bedtime is a good time because it is easy to remember. It is also natural to have a higher level of growth hormone at night. Omnitrope is intended for subcutaneous use. This means that it is injected through a short injection needle into the fatty tissue just under your skin. Most people do their injections into their thigh or their bottom. Do your injection in the place you have been shown by your doctor. Fatty tissue of the skin can shrink at the site of injection. To avoid this, use a slightly different place for your injection each time. This gives your skin and the area under your skin time to recover from one injection before it gets another one in the same place. Your doctor should have already shown you how to use Omnitrope. Always inject Omnitrope exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. How to inject Omnitrope 1.3 mg/ml The following instructions explain how to inject Omnitrope 1.3 mg/ml yourself. Please read the instructions carefully and follow them step by step. Your doctor will show you how to inject Omnitrope. Do not attempt to inject unless you are sure you understand the procedure and requirements for the injection.

After reconstitution, Omnitrope is given as an injection under the skin.

Carefully inspect the solution before injecting it and use only if clear and colourless.

Change the injection sites to minimise the risk of local lipoatrophy (local reduction of fatty tissue under the skin). Preparation Collect necessary items before you begin:

a vial with Omnitrope 1.3 mg/ml powder for solution for injection.

a vial with solvent (liquid) for Omnitrope 1.3 mg/ml.

a sterile, disposable syringe (e.g. 2 ml syringe) and needle (e.g. 0.33 mm x 12.7 mm) for withdrawing the solvent from the vial (not supplied in the pack).

a sterile, disposable syringe of appropriate size (e.g. 1 ml syringe) and injection needle (e.g. 0.25 mm x 8 mm) for subcutaneous injection (not supplied in the pack).

2 cleansing swabs (not supplied in the pack). Wash your hands before you continue with the next steps. Reconstituting Omnitrope

Remove the protective caps from the two vials in the box. With a cleansing swab, disinfect the rubber membranes of both the powder-filled and the solvent-filled vial.

Take the vial with solvent and the sterile, disposable syringe (e.g. 2 ml syringe) and needle (e.g. 0.33 mm x 12.7 mm). Push the needle fitted to the syringe through the rubber membrane.

Turn the vial with the solvent upside down and withdraw all the solvent from the vial.

Take the vial with the powder and push the needle through the rubber membrane of the vial. Inject the solvent slowly. Aim the stream of liquid against the glass wall in order to avoid foam. Remove the syringe and needle.

Gently swirl the reconstituted vial until the content is completely dissolved. Do not shake.

If the solution is cloudy (and the cloudiness does not disappear within ten minutes) or contains particles, it should not be used. The contents must be clear and colourless.

Use the solution immediately. Measuring the dose of Omnitrope to be injected

Take the sterile, disposable syringe of appropriate size (e.g. 1 ml syringe) and injection needle (e.g. 0.25 mm x 8 mm).

Push the needle through the rubber stopper of the vial with the reconstituted solution.

Turn the vial and the syringe upside down in one hand.

Be sure that the tip of the syringe is in the Omnitrope reconstituted solution. Your other hand will be free to move the plunger.

Pull back on the plunger slowly and withdraw just a bit more than the dose prescribed by your doctor into the syringe.

Hold the syringe with the needle in the vial pointing up and remove the syringe from the vial.

Check for air bubbles in the syringe. If you see any bubbles, pull the plunger slightly back; tap the syringe gently, with the needle pointing upwards, until the bubbles disappear. Push up the plunger slowly back to the correct dose.

Inspect the reconstituted solution visually prior to administration. Do not use if the solution is cloudy or contains particles. You are now ready to inject the dose. Injecting Omnitrope

Select the site of injection. The best sites for injection are tissues with a layer of fat between skin and muscle, such as the thigh or belly (except the navel or waistline).

Make sure you inject at least 1 cm from your last injection site and that you change the places where you inject, as you have been taught.

Before you make an injection, clean your skin well with an alcohol swab. Wait for the area to dry.

With one hand, pitch a fold of loose skin. With your other hand, hold the syringe as you would a pencil. Insert the needle into the pinched skin at an angle of 45 to 90 . After the needle is in, remove the hand used to pinch the skin and use it to hold the syringe barrel. Pull back the plunger very slightly with one hand. If blood comes into the syringe, the needle has entered a blood vessel. Do not inject into this site; withdraw the needle and repeat this step. Inject the solution by pushing the plunger all the way down gently.

Pull the needle straight out of the skin. After injecting

After injection, press the injection site with a small bandage or sterile gauze for several seconds. Do not massage the injection site.

The residual solution, vials, and injection materials intended for single use must be discarded. Dispose of the syringes safely in a closed container. If you use more Omnitrope than you should If you inject much more than you should, contact your doctor or pharmacist as soon as possible. Your blood sugar level could fall too low and later rise too high. You might feel shaky, sweaty, sleepy or not yourself , and you might faint. If you forget to use Omnitrope Do not use a double dose to make up for a forgotten dose. It is best to use your growth hormone regularly. If you forget to use a dose, have your next injection at the usual time the next day. Keep a note of any missed injections and tell your doctor at your next check-up. If you stop using Omnitrope Ask for advice from your doctor before you stop using Omnitrope. If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them. The very common and common side effects in adults may start within the first months of treatment and may either stop spontaneously or if your dose is reduced. Very common side effects (may affect more than 1 in 10 people) include:

Joint pain

Water retention (which shows as puffy fingers or swollen ankles, for a short time at the start of treatment)

Reddening, itchiness or pain at the injection site Common side effects (may affect up to 1 in 10 people) include:

Raised itchy bumps on the skin.

Rash

Numbness/tingling

Stiffness in the arms and legs, muscle pain In adults

Pain or burning sensation in the hands or underarms (known as Carpal Tunnel syndrome) Uncommon side effects (may affect up to 1 in 100 people) include:

Breast enlargement (gynaecomastia)

Itching Rare side effects (may affect up to 1 in 1,000 people) include: In children

Leukaemia (This has been reported in a small number of growth hormone deficiency patients, some of whom have been treated with somatropin. However, there is no evidence that leukaemia incidence is increased in growth hormone recipients without predisposing factors.)

Increased intracranial pressure (which causes symptoms, such as strong headache, visual disturbances or vomiting) Not known (frequency cannot be estimated from the available data):

Type 2 diabetes

A decrease in the levels of the hormone Cortisol in your blood

Facial swelling

Headache

Hypothyroidism In adults

Increased intracranial pressure (which causes symptoms such as strong headache, visual disturbances or vomiting) Formation of antibodies to the injected growth hormone but these do not seem to stop the growth hormone from working. The skin around the injection area can get uneven or lumpy, but this should not happen if you inject in a different place each time. There have been rare cases of sudden death in patients with Prader-Willi syndrome. However, no link has been made between these cases and treatment with Omnitrope. Slipped capital femoral epiphysis and Legg-Calv -Perthes disease may be considered by your doctor if discomfort or pain in the hip or knee is experienced whilst being treated with Omnitrope. Other possible side effects related to your treatment with growth hormone may include the following: You (or your child) may experience a high blood sugar or reduced levels of thyroid hormone. This can be tested by your doctor and if necessary your doctor will prescribe the adequate treatment. Rarely, an 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 or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.

Store and transport refrigerated (2 C 8 C).

Do not freeze.

Store in the original package in order to protect from light.

After reconstitution, from a microbiological point of view, the product should be used immediately. However, the in-use stability has been demonstrated for up to 24 hours at 2 C 8 C in the original package.

For single use only. Do not use Omnitrope if you notice that the solution is cloudy. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Omnitrope contains The active substance of Omnitrope is somatropin. One vial contains 1.3 mg (corresponding to 4 IU) of somatropin after reconstitution with 1 ml solvent. The other ingredients are: Powder: glycine disodium hydrogen phosphate heptyhydrate sodium dihydrogen phosphate dihydrate Solvent: water for injections What Omnitrope looks like and contents of the pack Powder and solvent for solution for injection (powder in a vial (1.3 mg), solvent in a vial (1 ml)). Pack size of 1. The powder is white and the solvent is a clear, colourless solution. Marketing Authorisation Holder Sandoz GmbH Biochemiestr. A-6250 Kundl Austria Manufacturer Sandoz GmbH Biochemiestr. A-6336 Langkampfen Austria Novartis Pharmaceutical Manufacturing GmbH Biochemiestr. A-6336 Langkampfen Austria This leaflet was last revised in {MM/YYYY} Detailed information on this medicine is available on the European Medicines Agency web site: