MALARONE TABLETS FOR ADULTS

País: Israel

Língua: inglês

Origem: Ministry of Health

Ingredientes ativos:

ATOVAQUONE; PROGUANIL HYDROCHLORIDE

Disponível em:

GLAXO SMITH KLINE (ISRAEL) LTD

Código ATC:

P01BB51

Forma farmacêutica:

FILM COATED TABLETS

Composição:

ATOVAQUONE 250 MG; PROGUANIL HYDROCHLORIDE 100 MG

Via de administração:

PER OS

Tipo de prescrição:

Required

Fabricado por:

GLAXO WELLCOME SA, SPAIN

Grupo terapêutico:

PROGUANIL, COMBINATIONS

Área terapêutica:

PROGUANIL, COMBINATIONS

Indicações terapêuticas:

Prevention of malaria: For the prophylaxis of P.falciparum malaria, including in areas where chloroquine resistance has been reported. Treatment of malaria: For the treatment of acute, uncomplicated P.flaciparum malaria. Malarone has been shown to be effective in regions where the drugs chloroquine, halofantrine, mefloquine, and amodiaquine may have unacceptable failure rates, presumably due to drug resistance.

Data de autorização:

2023-05-31

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Características técnicas

1
1.
NAME OF THE MEDICINAL PRODUCT
MALARONE TABLETS FOR ADULTS
MALARONE PAEDIATRIC TABLETS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Malarone tablet for adults contains 250 mg atovaquone and 100 mg
proguanil hydrochloride.
Each Malarone
_ _
paediatric tablets contains 62.5 mg atovaquone and 25 mg proguanil
hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film coated tablet.
Malarone tablets for adults – Round, biconvex, pink tablets engraved
‘GX CM3’ on one side.
Malarone
_ _
paediatric tablets – Round, biconvex, pink tablets engraved ‘GX
CG7’ on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PREVENTION OF MALARIA
Malarone is indicated for the prophylaxis of
_Plasmodium falciparum_
malaria, including in areas where
chloroquine resistance has been reported.
TREATMENT OF MALARIA
Malarone is indicated for the treatment of acute, uncomplicated
_P. falciparum_
malaria. Malarone has
been shown to be effective in regions where the drugs chloroquine,
halofantrine, mefloquine, and
amodiaquine may have unacceptable failure rates, presumably due to
drug resistance.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The daily dose should be taken at the same time each day with food or
a milky drink. In the event of
vomiting within 1 hour after dosing, a repeat dose should be taken.
Malarone Paediatric Tablets:
Malarone may be crushed and mixed with condensed milk just prior to
administration to patients who
may have difficulty swallowing tablets.
Malarone Tablets for adults:
There is no data regarding crush/divide/chew
PREVENTION OF MALARIA
2
Start prophylactic treatment with Malarone 1 or 2 days before entering
a malaria-endemic area and
continue daily during the stay and for 7 days after return.
Adults:
One
tablet
of
Malarone
Tablets
For
Adults
(
250 mg
atovaquone/100 mg
proguanil
hydrochloride) per day.
Paediatric Patients: The dosage for prevention of malaria in
paediatric patients is based upon body
weight (Table 1).
TABLE 1. DOSAGE FOR PREVENTION OF MALARI