Hemangiol

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

propranolol hydrochloride

Διαθέσιμο από:

Pierre Fabre Medicament

Φαρμακολογική κατηγορία (ATC):

C07AA05

INN (Διεθνής Όνομα):

propranolol

Θεραπευτική ομάδα:

Beta blocking agents

Θεραπευτική περιοχή:

Hemangioma

Θεραπευτικές ενδείξεις:

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.,

Περίληψη προϊόντος:

Revision: 6

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2014-04-23

Φύλλο οδηγιών χρήσης

21
B. PACKAGE LEAFLET
22
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
1.
What HEMANGIOL is and what it is used for
2.
What you need to know before your child receives HEMANGIOL
3.
How to give HEMANGIOL to your child
4.
Possible side effects
5.
How to store HEMANGIOL
6.
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 p

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1
NAME OF THE MEDICINAL PRODUCT
HEMANGIOL 3.75 mg/mL oral solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains 4.28 mg of propranolol hydrochloride
equivalent to 3.75 mg of propranolol
base.
Excipients with known effect:
1 ml of solution contains
Propylene
glycol………………………………………………….2.60
mg.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Oral solution.
Clear, colourless to slightly yellow oral solution, with a fruity
odour.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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 (see section
4.2).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Treatment with HEMANGIOL should be initiated by physicians who have
expertise in the diagnosis,
treatment and management of infantile haemangioma, in a controlled
clinical setting where adequate
facilities for handling of adverse reactions, including those
requiring urgent measures, are available.
_ _
Posology
The posology is expressed in propranolol base.
The recommended starting dose is 1 mg/kg/day which is divided into two
separate doses of 0.5 mg/kg.
It is recommended to increase the dose up to the therapeutic dose
under medical supervision as
follows: 1 mg/kg/day for 1 week, then 2 mg/kg/day for 1 week and then
3 mg/kg/day as a maintenance
dose.
The therapeutic dose is 3 mg/kg/day, which is to be administered into
2 separate doses of 1.5 mg/kg,
one in the morning and one in late afternoon, with a time interval of
at least 9 hours between two
intakes. HEMANGIOL is to be given during or right after a feed to
avoid the risk of hypoglycaemia.
If the child is not eating enough or is vomi