Hemangiol

Основна информация

  • Търговско наименование:
  • Hemangiol
  • Използвай за:
  • Хората
  • Вид на лекарството:
  • алопатични наркотици

Документи

Локализация

  • Предлага се в:
  • Hemangiol
    Европейски съюз
  • Език:
  • английски

Терапевтична информация

  • Терапевтична група:
  • Beta blocking agents
  • Терапевтична област:
  • Hemangioma
  • Терапевтични показания:
  • Hemangiol is indicated in the treatment of proliferating infantile haemangioma requiring systemic therapy:, - Life- or function-threatening haemangioma, , - Ulcerated haemangioma with pain and/ or lack of response to simple wound care measures, , - Haemangioma with a risk of permanent scars or disfigurement., It is to be initiated in infants aged 5 weeks to 5 months,
  • Каталог на резюме:
  • Revision: 4

Състояние

  • Източник:
  • EMA - European Medicines Agency
  • Статус Оторизация:
  • Authorised
  • Номер на разрешението:
  • EMEA/H/C/002621
  • Дата Оторизация:
  • 23-04-2014
  • EMEA код:
  • EMEA/H/C/002621
  • Последна актуализация:
  • 11-05-2020

Доклад обществена оценка

EMA/252150/2014

EMEA/H/C/002621

EPAR summary for the public

Hemangiol

propranolol

This is a summary of the European public assessment report (EPAR) for Hemangiol. It explains how the

Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is

not intended to provide practical advice on how to use Hemangiol.

For practical information about using Hemangiol, patients should read the package leaflet or contact

their doctor or pharmacist.

What is Hemangiol and what is it used for?

Hemangiol is a medicine that contains the active substance propranolol. It is used to treat children with

proliferating infantile haemangioma, which are benign tumours (abnormal non-cancerous growths) of

blood vessels.

Hemangiol is used in infants with serious complications, such as painful ulcers, scarring and breathing

difficulties

who require systemic therapy (treatment which can have an effect on the whole body).

Treatment with Hemangiol is started in babies aged five weeks to five months.

How is Hemangiol used?

Hemangiol can only be obtained with a prescription. Treatment should be started by a doctor who has

experience in the diagnosis, treatment and management of infantile haemangioma. Treatment should

be started in appropriate facilities in case serious side effects develop.

Hemangiol is available as a solution to be taken by mouth. The recommended starting dose of

Hemangiol is 0.5 mg per kilogram bodyweight (0.5 mg/kg), twice a day (at least 9 hours apart). The

dose is progressively increased to a maintenance dose of 1.5 mg/kg twice a day. The dose is given to

the baby during or immediately after a feed using the oral syringe provided. Treatment with Hemangiol

should last for six months and the child should be monitored once a month, in particular for dose

adjustments. For further information, see the package leaflet.

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© European Medicines Agency, 2014. Reproduction is authorised provided the source is acknowledged.

How does Hemangiol work?

The active substance in Hemangiol, propranolol, belongs to a group of medicines called beta-blockers,

which have been widely used to treat several conditions in adults, including diseases of the heart and

high blood pressure.

Although it is not exactly known how Hemangiol works in proliferative infantile haemangioma, it is

thought to do so by several mechanisms including narrowing the blood vessels and so decreasing blood

supply to the haemangioma, blocking the formation of new blood vessels in the growth, triggering cell

death of the abnormal blood vessel cells and blocking the effect of certain proteins (called VEGF and

bFGF), which are important for the growth of blood vessels.

What benefits of Hemangiol have been shown in studies?

Hemangiol was investigated in one main study involving 460 children aged from five weeks to five

months at the start of treatment and who had proliferative infantile haemangioma that required

systemic therapy. The study compared different doses of propranolol with placebo (a dummy

treatment) and the main measure of effectiveness was based on whether the haemangiomas

disappeared completely or almost completely after 6 months of treatment.

Hemangiol at a dose of 3 mg/kg per day (given as two separate doses of 1.5 mg/kg) given for 6

months was shown to be more effective than placebo. In around 60% (61 out of 101) of children

treated with the most effective dose of Hemangiol (3 mg/kg/day for 6 months), haemangiomas

disappeared completely or almost completely compared with around 4% (2 out of 55) in children who

received placebo.

What are the risks associated with Hemangiol?

The most common side effects with Hemangiol (which may affect more than 1 in 10 children) are sleep

disorders, respiratory tract infections such as bronchitis (inflammation of the airways in the lungs),

diarrhoea and vomiting. Serious side effects observed with Hemangiol include bronchospasm

(temporary narrowing of the airways) and low blood pressure. For the full list of all side effects

reported with Hemangiol, see the package leaflet.

Hemangiol must not be used in: premature babies who have not reached the corrected age of 5 weeks

(the corrected age is the age a premature baby would be if he/she had been born on the due date);

breastfed children if the mother is being treated with medicines that must not be used with

propranolol; children with asthma or with a history of bronchospasm; children with certain diseases of

the heart and blood vessels, such as low blood pressure; and children who tend to have low blood

sugar levels. For the full list of restrictions, see the package leaflet.

Why is Hemangiol approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Hemangiol’s

benefits are greater than its risks and recommended that it be approved for use in the EU. The

Committee concluded that Hemangiol was an effective treatment for haemangioma. Regarding safety,

the CHMP considered that the safety profile is acceptable; the risks identified are those already known

for propranolol and can be appropriately managed.

Hemangiol

EMA/252150/2014

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What measures are being taken to ensure the safe and effective use of

Hemangiol?

A risk management plan has been developed to ensure that Hemangiol is used as safely as possible.

Based on this plan, safety information has been included in the summary of product characteristics and

the package leaflet for Hemangiol, including the appropriate precautions to be followed by healthcare

professionals and patients.

The Company will provide caregivers who will give Hemangiol to children with an educational pack to

inform them of the need to monitor children for certain side effects and how to manage them. It will

also provide instructions on how to give the medicine correctly, in order to avoid the risk of low blood

sugar levels.

Further information can be found in the summary of the risk management plan.

Other information about Hemangiol

The European Commission granted a marketing authorisation valid throughout the European Union for

Hemangiol on 23 April 2014.

The full EPAR and risk management plan summary for Hemangiol can be found on the Agency’s

website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For

more information about treatment with Hemangiol, read the package leaflet (also part of the EPAR) or

contact your doctor or pharmacist.

This summary was last updated in 04-2014.

Hemangiol

EMA/252150/2014

Page 3/3

Листовка за пациента: състав, показания, Нежелани лекарствени реакции, дозиране, взаимодействия, бременност, кърмене

B. PACKAGE LEAFLET

Package leaflet: Information for the user

HEMANGIOL 3.75 mg/mL oral solution

propranolol

Read all of this leaflet carefully before your child starts receiving this medicine because it

contains important information.

Keep this leaflet. You may need to read it again.

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

This medicine has been prescribed for your child only. Do not pass it on to others. It may harm

them, even if their signs of illness are the same as your child’s.

If your child get any side effects, talk to your doctor or pharmacist or nurse. This includes any

possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

What HEMANGIOL is and what it is used for

What you need to know before your child receives HEMANGIOL

How to give HEMANGIOL to your child

Possible side effects

How to store HEMANGIOL

Contents of the pack and other information

1

What HEMANGIOL is and what it is used for

What HEMANGIOL is

The name of your medicine is HEMANGIOL. The active ingredient is propranolol.

Propranolol belongs to a group of medicines known as beta-blockers.

What it is used for

This medicine is used to treat a disease called haemangioma. A haemangioma is a collection of extra

blood vessels that have formed a lump in or under the skin. Haemangioma can be superficial or deep.

It is sometimes called ‘strawberry mark’ because the surface of a haemangioma looks a bit like a

strawberry.

Hemangiol is started in infants aged 5 weeks to 5 months, when:

the localisation and/or extend of the lesions are life- or function threatening (might impair

vital organs or senses such as vision or hearing);

the haemangioma is ulcerated (i.e. with sore on the skin which fails to heal) and painful,

and/or does not respond to simple wound care measures;

there is a risk of permanent scars or disfigurement.

2

What you need to know before your child receives HEMANGIOL

Do not give HEMANGIOL

If your child:

is born prematurely and he/she has not reached the corrected age of 5 weeks (the corrected age

being the age a premature baby would be if he/she had been born on their due date).

is allergic to propranolol or any of the other ingredients of this medicine (listed in section 6). An

allergic reaction can include a rash, itching or shortness of breath.

has asthma or history of breathing difficulties.

has a slow heart rate for his/her age. Please check with your doctor if you are not sure.

has a heart problem (such as disorders of the heart rhythm and heart failure.

has very low blood pressure.

has circulation problems which make the toes and fingers numb and pale.

is prone to low blood sugar level.

has a high blood pressure caused by a tumour on the adrenal gland. This is called

'phaeochromocytoma'.

If you are breastfeeding your child,

and if you are taking medicines that must not be used with

HEMANGIOL (see ‘‘If you are breastfeeding your child’’ and “Other medicines and HEMANGIOL”)

do not

give

this medicine to your child.

Warnings and precautions

Before your child receives HEMANGIOL, tell your doctor:

If your child has problems with his/her liver or kidneys. This medicine will not be recommended

in case of liver or kidneys impairment.

If your child has ever had an allergic reaction whatever its origin (e.g. medicine or alimentary

substance etc.). An allergic reaction can include a rash, itching or shortness of breath.

If your child has psoriasis (a skin condition that produces red, dry plaques of thickened skin), as

this medicine may worsen the symptoms of this condition.

If your child has diabetes: in this case, your child’s blood sugar level should be measured more

frequently.

If your child has a PHACE syndrome (a condition combining haemangioma and vascular

abnormalities including cerebral blood vessels), as this medicine may increase the risk of

cerebral stroke.

Important signs to look after administration of HEMANGIOL

Risk of hypotension and bradycardia (low heart rate)

HEMANGIOL can decrease blood pressure (hypotension) and heart rate (bradycardia). This is why

your child will be kept under close clinical and heart rate monitoring for 2 hours after the first dose or

after a dose increase. Then, your doctor will regularly examine your child during treatment.

Call your doctor right away if your child has any signs such as tiredness, coldness, pallor,

bluish-coloured skin, or fainting while taking HEMANGIOL.

Risks of hypoglycaemia

This medicine can mask the warning signs of hypoglycaemia (also known as low blood sugar level),

especially if the baby is fasting, vomiting or in case of overdose. These signs may be:

Minor: pallor, tiredness, sweating, shaking, palpitations, anxiety, hunger, difficulty waking up.

Major: excessive sleeping, difficulty responding, poor feeding, decrease in body temperature,

convulsions (fits), brief pauses in breathing, loss of consciousness.

To avoid risks of hypoglycaemia, your child must be fed regularly during treatment. If your

child is not eating, develops another illness or is vomiting, it is recommended to skip the dose.

DO NOT GIVE HEMANGIOL TO YOUR CHILD UNTIL HE IS BEING CORRECTLY FED

AGAIN.

If your child has any signs of hypoglycaemia while taking HEMANGIOL, give if possible oral

liquid containing sugar and, if symptoms persist, call your doctor right away or go directly to

hospital.

Risks of bronchospasm

Stop treatment and contact your doctor immediately if after giving HEMANGIOL to your child you

observe the following symptoms suggestive of a bronchospasm (temporary restriction of the bronchial

tubes that leads to difficulty breathing): cough, quick or difficult breathing or wheezing, associated or

not with a bluish

-

coloured skin.

Risk of hyperkaliemia

HEMANGIOL may increase potassium blood level (hyperkaliemia). In case of large ulcerated

haemangioma,, your child’s blood potassium level should be measured.

If your child should undergo a general anaesthesia

Tell the your doctor that he/she is taking HEMANGIOL. This is because your child can get low blood

pressure if given certain anaesthetics while taking this medicine (see “Other medicines and

HEMANGIOL”). HEMANGIOL might need to be discontinued at least 48h before the anaesthesia.

If you are breastfeeding your child

Tell your doctor before giving this medicine.

Do not give this medicine to your child if you are taking medicines that must not be used with

HEMANGIOL (see “Other medicines and HEMANGIOL”).

Other medicines and HEMANGIOL

Tell your doctor, pharmacist or nurse if you are giving, have recently given or might give any

other medicines to your child. This is because HEMANGIOL can change the way other

medicines work, and some medicines can have an effect on the way HEMANGIOL works.

Moreover, if you are breastfeeding your child, it is important to tell your doctor, pharmacist or

nurse which medicines you are yourself taking, as they may pass into your breast-milk and

interfere with the treatment of your child. Your doctor will advise you on whether you need to

stop breastfeeding or not.

In particular, in case you are breastfeeding, tell your doctor or pharmacist if you are or if your child is

taking:

Medicines for diabetes,

Medicines for heart and blood vessels problems such as uneven heart beats, chest pain or angina,

high blood pressure, heart failure,

Medicines to treat anxiety and depression as well as more serious mental health problems, and

epilepsy,

Medicines to treat tuberculosis,

Medicines to treat pain and inflammation,

Medicines used to lower lipids in the blood,

Medicines used for anaesthesia.

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

HEMANGIOL contains sodium and propylene glycol

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

This medicine contains 2.08 mg of propylene glycol/kg/day. If your baby is less than 4 weeks old, talk

to your doctor or pharmacist before giving them this medicine, in particular if the baby is given other

medicines that contain propylene glycol or alcohol.

3

How to give HEMANGIOL to your child

The treatment of your child has been initiated by a physician who has expertise in the diagnosis,

treatment and management of infantile haemangioma.

Always give this medicine to your child exactly as your doctor or pharmacist has told you. Check with

your doctor or pharmacist if you are not sure.

Never change the dose you are giving to your child yourself. Every increase in dose or any dose

adjustment to your baby’s weight must be done by your doctor

Dose

Dosing is based on your baby’s weight following the scheme below:

Weeks

(daily dose)

Dose by intake

Timing of intakes

First week

(1 mg/kg/day)

0.5 mg/kg

one in the morning

one in late afternoon

at least 9 hours interval

between two intakes

Second week

(2 mg/kg/day)

1mg/kg

Third and following weeks

(3 mg/kg/day)

1.5 mg/kg

If necessary, you may mix the medicine with a small quantity of baby-milk or age-adapted apple

and/or orange fruit juice and give it to your child in a baby bottle. Do not mix the medicine with a

full bottle of milk or juice.

For children weighing up to 5 kg you may mix the dose with one teaspoonful of milk

(approximately 5 mL). For children weighing more than 5 kg the dose may be mixed with a

tablespoonful of milk or fruit juice (approximately 15 mL).

Use the mixture within 2 hours of preparation.

How to give HEMANGIOL to your child

Hemangiol is for oral use.

The medicine is to be given during or straight after a feed.

The dose should always be measured using the oral syringe supplied with the bottle.

Give HEMANGIOL directly into your child's mouth using the oral syringe supplied with the

bottle.

Feed your child regularly to avoid prolonged fast.

If your child is not eating or is vomiting it is recommended to skip the dose.

If your child spits up a dose or if you are uncertain whether he/she got all of the medicine, do not

give another dose, just wait until the next scheduled dose.

HEMANGIOL and the feed must be given by the same person in order to avoid the risk of

hypoglycaemia. If different people are involved, good communication is essential in order to

ensure the safety of your child.

Instructions for use:

Step 1. Remove the items from the box

The carton contains the following items that you will need to administer the medicine:

The glass bottle containing 120 mL propranolol oral solution

The oral syringe graduated in mg provided with this medicine

Remove the bottle and oral syringe from the box and remove the syringe from the plastic bag.

Step 2. Check the dose

Check the HEMANGIOL dose in milligrams (mg) as prescribed by your doctor. Locate this number

on the oral syringe.

Step 3. Open the bottle

The bottle comes with a child-proof cap. Here is how to open it: push down the plastic cap while

turning the cap counter-clockwise (to the left).

Do not shake the bottle before use.

Step 4. Insert the syringe

Insert tip of the oral syringe into the upright bottle and push the plunger all the way down.

Do not remove the syringe adapter from the neck of the bottle.

Only use the oral syringe that is supplied with the medicine to measure and administer the dose. Do

not use a spoon or any other dispensing device.

Step 5: Remove the dose

With the oral syringe in place, turn the bottle upside down.

Pull the plunger of the syringe up to the number of mg you need.

Step 6: Check for air bubbles

If you see air bubbles in the syringe, hold the syringe upright, push the plunger upwards just far

enough to completely push out any large air bubbles and then readjust to the dose prescribed by your

doctor.

Step 7. Remove the syringe

Turn bottle upright and remove the entire syringe from the bottle. Be careful, do not push the plunger

in during this step.

Step 8. Close the bottle.

Replace the plastic cap on the bottle by turning it clock-wise (to the right).

Step 9. Give HEMANGIOL to your child

Insert the syringe into your baby’s mouth and place it against the inside of the cheek.

Now you can slowly squirt HEMANGIOL from the syringe directly into your baby’s mouth.

Do not lie the child down immediately after the administration.

Step 10: Clean the syringe.

Do not dismantle the syringe. Rinse the empty syringe after each use into a glass of clean water:

1- Take a glass of clean water

2- Pull the plunger in

3- Discard the water into your sink

Repeat this cleaning process 3 times.

Do not use any soap or alcohol based product to clean. Wipe the outside dry.

Do not put the syringe through a sterilizer or dishwasher.

Store the bottle and the syringe together in the carton until next use in a safe place where your child

can’t see or reach it. Discard the syringe once the bottle is finished.

If you give to your child more HEMANGIOL than you should

If you have given to your child more HEMANGIOL than you should, please consult your doctor

immediately.

If you forget to give HEMANGIOL to your child

Skip the missed dose, and do not give a double dose to make up for a forgotten dose. Continue the

treatment at the usual frequency: one dose in the morning and one in the late afternoon.

If you stop giving HEMANGIOL

to your child

HEMANGIOL may be stopped at once at the end of the treatment as decided by the doctor.

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

4

Possible side effects

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

Important warning signs of potential side effects such as low blood pressure, low heart rate, low blood

sugar level, and bronchospasm (breathing difficulties)

should be looked after following administration

of HEMANGIOL. Please refer to section 2 of this leaflet.

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

Bronchitis (inflammation of the bronchi),

Sleep disorders (insomnia, poor quality of sleep and difficulties to wake-up),

Diarrhoea and vomiting.

Common side effects (may affect up to 1 in 10 people)

Bronchospasm (breathing difficulties),

Bronchiolitis (inflammation of small bronchi with breathing difficulties and wheeze in the chest,

associated with cough and fever),

Decreased blood pressure.

Decreased appetite,

Agitation, nightmares, irritability,

Somnolence,

Cold extremities,

Constipation, abdominal pain,

Erythema (skin redness),

Nappy rash.

Uncommon side effects (may affect up to 1 in 100 people)

Heart conduction or rhythm disorders (slow or uneven heart beats),

Urticaria (allergic reaction of the skin), alopecia (loss of hair),

Decreased blood sugar levels,

Reduction of the number of white blood cells.

The frequency of the following side effects is not known (frequency cannot be estimated from the

available data)

Convulsions (fits) linked to hypoglycaemia (abnormally low blood sugar levels),

Bradycardia (abnormally low heart rate),

Low blood pressure,

Very low levels of white blood cells that fight infection

Circulation problems which make the toes and fingers numb and pale

Elevated level of potassium in the blood

Reporting of side effects

If your child gets any side effects, talk to your doctor or pharmacist. 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.

5

How to store HEMANGIOL

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 outer carton and bottle label. The

expiry date refers to the last day of that month.

Keep the bottle in the outer carton in order to protect from light. Store the bottle and the oral syringe in

the outer carton between each use. Do not freeze.

After first opening, the medicine should be used within 2 months.

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.

6

Contents of the pack and other information

What HEMANGIOL contains

The active substance is propranolol. Each ml contains 4.28 mg of propranolol hydrochloride

equivalent to 3.75 mg of propranolol.

The other ingredients are hydroxyethylcellulose, sodium saccharin, strawberry flavour (contains

propylene glycol), vanilla flavour (contains propylene glycol), citric acid monohydrate, purified

water. See section 2 under ‘HEMANGIOL contains sodium and propylene glycol’ for further

information.

What HEMANGIOL looks like and contents of the pack

HEMANGIOL is a clear, colourless to slightly yellow oral solution, with a fruity odour.

It is supplied in a 120-mL amber glass bottle, with a child resistant screw-cap. Box of 1 bottle.

An oral polypropylene syringe graduated in mg of propranolol, is provided with each bottle.

Marketing Authorisation Holder

PIERRE FABRE DERMATOLOGIE

45 Place Abel Gance

92100 BOULOGNE

FRANCE

Manufacturer

FARMEA

10 rue Bouché Thomas

ZAC Sud d’Orgemont

49000 ANGERS

FRANCE

PIERRE FABRE MEDICAMENT PRODUCTION

Site PROGIPHARM, Rue du Lycée

45500 GIEN

FRANCE

For any information about this medicine, please contact the Marketing Authorisation Holder.

This leaflet was last revised in.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu.