Eurartesim
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
30-08-2023
Produktets egenskaber
(SPC)
30-08-2023
Offentlige vurderingsrapport
(PAR)
26-09-2016
Aktiv bestanddel:
piperaquine tetraphosphate, Artenimol
Tilgængelig fra:
Alfasigma S.p.A.
ATC-kode:
P01BF05
INN (International Name):
piperaquine tetraphosphate, artenimol
Terapeutisk gruppe:
Antiprotozoals
Terapeutisk område:
Malaria
Terapeutiske indikationer:
Eurartesim is indicated for the treatment of uncomplicated Plasmodium falciparum malaria in adults, children and infants 6 months and over and weighing 5 kg or more.Consideration should be given to official guidance on the appropriate use of antimalarial agents.
Produkt oversigt:
Revision: 13
Autorisation status:
Authorised
Autorisation dato:
2011-10-27
Indlægsseddel
43
B. PACKAGE LEAFLET
44
PACKAGE LEAFLET: INFORMATION FOR THE USER
EURARTESIM 160 MG/20 MG FILM-COATED TABLETS
Piperaquine tetraphosphate/artenimol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
−
Keep this leaflet. 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 pass it on to
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 Eurartesim is and what it is used for
2.
What you need to know before you or your child takes Eurartesim
3.
How to take Eurartesim
4.
Possible side effects
5.
How to store Eurartesim
6.
Contents of the pack and other information
1.
WHAT EURARTESIM IS AND WHAT IT IS USED FOR
Eurartesim contains the active substances piperaquine tetraphosphate
and artenimol. It is used to treat
uncomplicated malaria when use of a medicine given by mouth is
appropriate.
Malaria is caused by infection with a parasite called
_Plasmodium_
, spread by the bite of an infected
mosquito.There are different types of
_Plasmodium_
parasite. Eurartesim kills the
_Plasmodium _
_falciparum_
parasite.
The medicine can be taken by adults, adolescents, children and infants
over 6 months old who weigh 5
kilograms or more.
2. WHAT YOU NEED TO KNOW BEFORE YOU OR YOUR CHILD TAKES EURARTESIM
DO NOT TAKE EURARTESIM IF YOU OR YOUR CHILD:
•
is allergic to the active substances, piperaquine tetraphosphate or
artenimol, or to any of the
other ingredients of this medicine (listed in section 6);
•
has a severe type of malaria infection which has affected parts of the
body such as the brain,
lungs or kidneys;
•
has a heart condition, such as changes to the rhythm or rate of heart
beat, or heart disease;
•
knows that any member of your
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Eurartesim 160 mg/20 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 160 mg piperaquine tetraphosphate (as
the tetrahydrate; PQP) and
20 mg artenimol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
White oblong biconvex film-coated tablet (dimension 11.5x5.5mm /
thickness 4.4mm) with a
break-line and marked on one side with the letters “S” and
“T”.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Eurartesim is indicated for the treatment of uncomplicated
_Plasmodium falciparum _
malaria in adults,
adolescents, children and infants 6 months and over and weighing 5 kg
or more.
Consideration should be given to official guidance on the appropriate
use of antimalarial medicinal
products, including information on the prevalence of resistance to
artenimol/piperaquine
in the
geographical region where the infection was acquired (see section
4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Eurartesim should be administered over three consecutive days for a
total of three doses taken at the
same time each day.
3
Dosing should be based on body weight as shown in the table below.
BODY WEIGHT
(KG)
DAILY DOSE (MG)
TABLET STRENGTH AND NUMBER OF TABLETS PER DOSE
PQP
Artenimol
5 to <7
80
10
½ x 160 mg / 20 mg tablet
7 to <13
160
20
1 x 160 mg / 20 mg tablet
13 to <24
320
40
1 x 320 mg / 40 mg tablet
24 to <36
640
80
2 x 320 mg / 40 mg tablets
36 to <75
960
120
3 x 320 mg / 40 mg tablets
> 75*
1,280
160
4 x 320 mg / 40 mg tablets
* see section 5.1
If a patient vomits within 30 minutes of taking Eurartesim, the whole
dose should be re-administered;
if a patient vomits within 30-60 minutes, half the dose should be
re-administered. Re-dosing with
Eurartesim should not be attempted more than once. If the second dose
is vomited, alternative
antimalarial therapy should be instituted.
If a d
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