Information for the patient
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have further questions, ask your doctor or your pharmacist.
• This medicine has been prescribed for you only. Do not pass it onto others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Mecasermin Rinfabate Injection and what it is used for
2. What you need to know before you take Mecasermin Rinfabate Injection
3.How to take Mecasermin Rinfabate Injection
4. Possible side effects
5. How to store Mecasermin Rinfabate Injection
6. Other information
WHAT MECASERMIN RINFABATE INJECTIONIS AND WHAT IT IS USED FOR
– Mecasermin Rinfabate Injection is a liquid that contains mecasermin which is a man-made insulin-like growth factor-1 (IGF-1), which is similar to the IGF-1 made by your body.
– Mecasermin Rinfabate Injection is used to treat children and adolescents from 2 to 18 years old who are very short for their age because their bodies do not make enough IGF-1. This condition is called primary IGF-1 deficiency.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MECASERMIN RINFABATE INJECTION
Do not use Mecasermin Rinfabate Injection
– if you are allergic to mecasermin or any of the other ingredients of this medicine (listed in section 6).
– if you have cancer.
– in premature babies or neonates because it contains benzyl alcohol.
Warnings and precautions
Talk to your doctor or pharmacist before using Mecasermin Rinfabate Injection
– if you have a curved spine (scoliosis). You should be monitored for progression of scoliosis.
– if you develop a limp or hip or knee pain
– if you have enlarged tonsils (tonsillar hypertrophy). You should have examinations periodically.
– if you have symptoms of increased pressure in the brain (intracranial hypertension), such as visual changes, headache, nausea and/or vomiting, contact the doctor for advice.
-if you have a localised reaction at the injection site or generalised allergic reaction with Mecasermin Rinfabate Injection. Call the doctor as soon as possible if you get a localised rash. Get medical help immediately
-if you have a generalised allergic reaction (hives, trouble breathing, faintness or collapse and feeling generally unwell).
– if you have finished growing (the bone growth plates are closed). In this case Mecasermin Rinfabate Injection cannot help you grow and should not be used.
Children under 2 years old
The use of this medicine has not been studied in children under 2 years of age and is therefore not recommended.
Other medicines and Mecasermin Rinfabate Injection
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Especially tell the doctor if you take insulin or other anti-diabetes medicines. A dose adjustment may be needed for these medicines.
Pregnancy, breast-feeding and fertility
A negative pregnancy test is recommended for all women of child bearing potential prior to treatment with Mecasermin Rinfabate Injection.
It is also recommended that all women of childbearing potential use adequate contraception during treatment.
Mecasermin Rinfabate Injection therapy should be discontinued if pregnancy occurs.
Mecasermin Rinfabate Injection should not be administered to a breast-feeding mother.
Driving and using machines
Mecasermin Rinfabate Injection may cause hypoglycaemia (very common side effect) that may impair your ability to drive and use machines because your ability to concentrate or react may be reduced.
You should avoid engaging in any high-risk activities (e.g., driving, etc.) within 2-3 hours after dosing, particularly at the start of Mecasermin Rinfabate Injection treatment, until a dose of Mecasermin Rinfabate Injection has been found which does not cause side effects that make these activities risky.
Mecasermin Rinfabate Injection contains benzyl alcohol
Mecasermin Rinfabate Injection contains 9 mg per ml of benzyl alcohol as a preservative.
Benzyl alcohol may cause toxic reactions and allergic reactions in infants and children up to 3 years old. This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium-free’.
HOW TO TAKE MECASERMIN RINFABATE INJECTION
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The typical dose is 0.04 to 0.12 mg/kg of patient weight administered twice a day. See the ‘Instructions for Use’ at the end of this leaflet.
Inject Mecasermin Rinfabate Injection just under your skin shortly before or after a meal or snack because it may have insulinlike hypoglycaemic effects and so it may decrease blood sugar levels (see hypoglycaemia in section 4).
Do not inject your dose of Mecasermin Rinfabate Injection if you cannot eat for any reason. Do not make up the missed dose by giving two doses the next time. The next dose should be taken as usual, with a meal or snack.
Inject Mecasermin Rinfabate Injection just below the skin in your upper arm, upper leg (thigh), stomach area (abdomen), or buttocks. Never inject it into a vein or muscle. Change the injection site for each injection.
Only use Mecasermin Rinfabate Injection that is clear and colourless.
Treatment with Mecasermin Rinfabate Injection is a long-term therapy. For further information ask the doctor.
If you use more Mecasermin Rinfabate Injection than you should Mecasermin Rinfabate Injection, like insulin, may lower blood sugar levels (see hypoglycaemia in section 4).
If more Mecasermin Rinfabate Injection than recommended was injected, contact your doctor immediately.
Acute overdose could lead to hypoglycaemia (low blood sugar). Long-term overdose may result in enlargement of certain body parts (e.g., hands, feet, parts of the face) or excessive growth of the whole body.
Treatment of acute overdose of Mecasermin Rinfabate Injection should be directed at reversing hypoglycaemia. Sugarcontaining fluids or food should be consumed. If the patient is not awake or alert enough to drink sugarcontaining fluids, an injection of glucagon into the muscle may be necessary to reverse the low blood sugar. Your doctor or nurse will instruct you how to give the injection of glucagon.
If you forget to use Mecasermin Rinfabate Injection
Do not use a double dose to make up for a forgotten dose. If a dose is skipped, the next dose should not be made larger to compensate. The next dose should be taken as usual, with a meal or snack.
If you stop using Mecasermin Rinfabate Injection
A disruption or early ending of treatment with Mecasermin Rinfabate Injection may impair the success of the growth therapy. Please ask the doctor for advice before stopping the treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
The most frequently occurring side effects with Mecasermin Rinfabate Injection are: low blood sugar (hypoglycemia), vomiting, injection site reactions, headache and middle ear infections. Serious allergic reactions have also been reported with Mecasermin Rinfabate Injection. If you develop any of these events, please follow the advice given for each event in the sections below.
Frequency not known (frequency cannot be estimated from the available data)
Serious allergic reactions (anaphylaxis) Generalised hives, difficulty in breathing, dizziness, swelling of the face and/or throat have been reported following Mecasermin Rinfabate Injection use. Stop Mecasermin Rinfabate Injection immediately and seek urgent medical advice if you develop a serious allergic reaction. Local allergic reactions at the injection site (itching, hives) have also been reported.
Hair loss (alopecia)
Hair loss has also been reported following Mecasermin Rinfabate Injection use.
Very common (may affect more than 1 in 10 people)
Low blood sugar (hypoglycaemia)
Mecasermin Rinfabate Injection may lower blood sugar levels. Signs of low blood sugar are: dizziness, tiredness, restlessness, hunger, irritability, trouble concentrating, sweating, nausea and fast or irregular heartbeats.
Severe hypoglycaemia may cause unconsciousness, seizures/fits or death. Stop Mecasermin Rinfabate Injection immediately and seek urgent medical advice if you develop seizures/fits or become unconscious.
If you take Mecasermin Rinfabate Injection, you should avoid participating in high risk activities (such as vigorous physical activity) within 2 to 3 hours after Mecasermin Rinfabate Injection, especially at the beginning of Mecasermin Rinfabate Injection treatment.
Before beginning treatment with Mecasermin Rinfabate Injection the doctor or nurse will explain to you how to treat hypoglycaemia. You should always have a source of sugar such as orange juice, glucose gel, sweets, or milk available in case symptoms of hypoglycaemia occur. For severe hypoglycaemia, if you are not responsive and cannot drink sugar-containing fluids, you should give an injection of glucagon. The doctor or nurse will instruct you how to give the injection. Glucagon raises the blood sugar when it is injected. It is important that you have a well-balanced diet including protein and fat such as meat and cheese in addition to sugarcontaining foods.
Injection site hypertrophy (tissue at injection site increases in size) and bruising
These can be avoided by changing the injection site at each injection (injection site rotation).
Vomiting and pain in the upper belly have occurred with Mecasermin Rinfabate Injection treatment.
Infections of the middle ear have been observed in children with Mecasermin Rinfabate Injection treatment.
Joint pains and pains in the limbs have occurred with Mecasermin Rinfabate Injection treatment.
Headache has occurred with Mecasermin Rinfabate Injection treatment.
Common (may affect up to 1 in 10 people)
Seizures (fits) have been observed with Mecasermin Rinfabate Injection treatment. Dizziness and tremor have also been reported with Mecasermin Rinfabate Injection treatment.
A fast heart rate and abnormal heart sounds have been reported with Mecasermin Rinfabate Injection treatment.
Increased blood sugar (hyperglycaemia)
Increased blood sugar has also been observed with Mecasermin Rinfabate Injection treatment.
Mecasermin Rinfabate Injection may enlarge your tonsils/adenoids. Some signs of enlarged tonsils/adenoids include: snoring, difficulty breathing or swallowing, sleep apnoea (a condition where breathing stops briefly during sleep), or fluid in the middle ear, as well as infections of the ear. Sleep apnoea can cause excessive daytime sleepiness. Call the doctor should these symptoms bother you. The doctor should regularly examine your tonsils/adenoids.
An enlarged thymus (a specialised organ of the immune system) has been observed with Mecasermin Rinfabate Injection treatment.
A swelling at the back of the eye (due to increased pressure within the brain) may be observed by a doctor or optician during Mecasermin Rinfabate Injection treatment.
Hypoacusis (hearing loss)
Hypoacusis (hearing loss), ear pain and fluid in the middle ear have been observed with Mecasermin Rinfabate Injection treatment. Tell the doctor if you develop hearing problems.
Worsened scoliosis (caused by rapid growth)
If you have scoliosis, you will need to be checked often for an increase in the curve of the spine. Pain in muscles has also been seen with Mecasermin Rinfabate Injection treatment. Reproductive system
Breast enlargement has been observed with Mecasermin Rinfabate Injection treatment.
Pain in the belly has occurred with Mecasermin Rinfabate Injection treatment.
Skin and hair changes
Skin thickening, moles and abnormal hair texture have been seen with Mecasermin Rinfabate Injection treatment.
Reactions at the injection site
Reactions including pain, irritation, bleeding, bruising, redness, and hardening have been reported with Mecasermin Rinfabate Injection treatment. Injection site reactions can be avoided by changing the injection site at each injection (injection site rotation).
Uncommon (may affect up to 1 in 100 people)
Increased pressure in the brain (intracranial hypertension) Mecasermin Rinfabate Injection can sometimes cause a temporary increase in pressure within the brain. The symptoms of intracranial hypertension can include visual changes, headache, nausea and/or vomiting. Tell the doctor immediately if you have any of these symptoms. Your doctor can check to see if intracranial hypertension is present. If it is present, your doctor may decide to temporarily reduce or discontinue Mecasermin Rinfabate Injection therapy. Mecasermin Rinfabate Injection may be started again after the episode is over.
In some patients treated with Mecasermin Rinfabate Injection, an ultrasound examination of the heart (echocardiogram) showed an increased size of the heart muscle and abnormalities of heart valve function. Your doctor may perform an echocardiogram before, during and after Mecasermin Rinfabate Injection treatment.
Reactions at the injection site
Reactions including rash, swelling and fatty lumps have been reported with Mecasermin Rinfabate Injection treatment. Injection site reactions can be avoided by changing the injection site at each injection (injection site rotation).
Weight increase has been observed with Mecasermin Rinfabate Injection treatment.
Other uncommon side effects seen with Mecasermin Rinfabate Injection treatment include depression, nervousness.
Reporting of side effects
If you get any side effects, talk to your doctor, 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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
For Ireland: You can also report side effects directly via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; e-mail: email@example.com.
For UK: You can also report side effects directly via the Yellow Card Scheme at:www.mhra.gov.uk/yellowcard
HOW TO STORE MECASERMIN RINFABATE INJECTION
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of the month.
Store in a refrigerator ( 2°C – 8°C). Do not freeze.
Keep the vial in the outer carton in order to protect from light. After first use, the vial may be stored for up to 30 days at 2 to 8ºC.
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 Mecasermin Rinfabate Injection contains
The active substance is mecasermin. One ml contains 10 mg of mecasermin. Each vial contains 40 mg of mecasermin.
– The other ingredients are: benzyl alcohol, sodium chloride, polysorbate 20, glacial acetic acid, sodium acetate, and water for injections.
What Mecasermin Rinfabate Injection looks like and contents of the pack
Mecasermin Rinfabate Injection is a clear and colourless solution for injection (injection) supplied in a glass vial closed with a stopper and a seal. The vial contains 4 ml of liquid.
Pack size of 1 vial.
Taj Pharmaceuticals Limited
220, Mahagujarat Ind. Estate, Moraiya, Tal. Sanand, Dist. Ahmedabad, Gujarat, INDIA
Marketing Authorization Holder:
Regal sun co., Ltd.Myanmar