Promozio 250/100

Land: New Zealand

Sprog: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv bestanddel:

Atovaquone 250mg; Proguanil hydrochloride 100mg

Tilgængelig fra:

sanofi-aventis new zealand limited

INN (International Name):

Atovaquone 250 mg

Lægemiddelform:

Film coated tablet

Sammensætning:

Active: Atovaquone 250mg Proguanil hydrochloride 100mg Excipient: Colloidal silicon dioxide Hyprolose Magnesium stearate Microcrystalline cellulose Opadry brown 03C86943 Poloxamer Sodium starch glycolate Tolpovidone I 131

Recept type:

Prescription

Fremstillet af:

Glenmark Pharmaceuticals Limited

Terapeutiske indikationer:

Promozio (250mg atovaquone/100mg proguanil hydrochloride) is indicated for: · Prophylaxis of Plasmodium falciparum malaria in adults · Treatment of Plasmodium falciparum malaria in adults.

Produkt oversigt:

Package - Contents - Shelf Life: Blister pack, PVC-PVDC/Al - 12 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC-PVDC/Al - 24 tablets - 36 months from date of manufacture stored at or below 25°C

Autorisation dato:

2016-07-05

Indlægsseddel

PROMOZIO 250/100
1
PROMOZIO
® 250/100
_ (Atovaquone and Proguanil Hydrochloride) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you take Promozio 250/100.
This leaflet answers some common
questions about Promozio 250/100. It
does not contain all of the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the expected benefits of you taking
Promozio 250/100 against the risks
this medicine could have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again
WHAT IS PROMOZIO
250/100 USED FOR?
Promozio 250/100 belongs to a broad
group of medicines called
antimalarials.
It contains in one tablet a mixture of
two antimalarial medicines which
work well when taken together. One
medicine is atovaquone and the other
is proguanil hydrochloride.
Promozio 250/100 is used to prevent
or treat the type of malaria infection
known as Plasmodium falciparum
malaria. Plasmodium falciparum
belongs to one particular family of
malaria parasites. It affects the blood
and liver. Promozio 250/100 works
by killing this parasite.
Promozio 250/100 is not addictive.
BEFORE YOU TAKE
PROMOZIO 250/100
_DO NOT TAKE IT: _
YOU MUST NOT TAKE PROMOZIO
250/100 IF:
•
YOU HAVE EVER HAD AN ALLERGIC
REACTION TO ATOVAQUONE
(WELLVONE™) OR PROGUANIL
HYDROCHLORIDE (PALUDRINE), OR
ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET (SEE
"INGREDIENTS").
•
THE EXPIRY DATE (EXP) PRINTED
ON THE PACK HAS PASSED.
• THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING
_TELL YOUR DOCTOR IF: _
YOU MUST TELL YOUR DOCTOR IF:
•
YOU ARE ALLERGIC TO FOODS, DYES,
PRESERVATIVES OR ANY OTHER
MEDICINES.
•
IN THE PAST PROMOZIO 250/100
HAS BEEN INEFFECTIVE FOR YOU.
•
AFTER TAKING PROMOZIO 250/100,
YOUR SYMPTOMS OF MALARIA HAVE
RETURNED AFTER IMPROVING FOR A
TIME.
•
YOU HAVE DIARRHOEA (LOOSE
BOWEL MOTIONS). THIS M

Produktets egenskaber

promozio-dsv2-07apr20 PAGE 1 OF 13
NEW ZEALAND DATA SHEET
1
PROMOZIO 250/100 FILM-COATED TABLETS
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains the active ingredients atovaquone 250 mg and
proguanil hydrochloride
100 mg.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Pinkish brown to brown coloured, circular, biconvex, bevelled-edged,
film-coated tablets with
‘404’ debossed on one side and ‘G’ debossed on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Promozio 250/10 is a fixed dose combination of atovaquone and
proguanil hydrochloride which
acts as a blood schizonticide and also has activity against the
hepatic forms of
_Plasmodium _
_falciparum._
It is indicated for:
•
Prophylaxis of
_Plasmodium falciparum_
malaria in adults
•
Treatment of
_Plasmodium falciparum_
malaria in adults.
Because Promozio 250/100 is effective against drug sensitive and drug
resistant
_P. falciparum_
it is
especially recommended for prophylaxis and treatment of
_P. falciparum_
malaria in areas where
the pathogen may be resistant to other antimalarials.
Official guidelines and local information on the prevalence of
resistance to antimalarial drugs
should be taken into consideration. Official guidelines will normally
include WHO and public
health authorities guidelines.
4.2
DOSE AND METHOD OF ADMINISTRATION
The daily dose should be taken with food or a milky drink at the same
time each day.
promozio-dsv2-07apr20 PAGE 2 OF 13
In the event of vomiting, within 1 hour of dosing, a repeat dose
should be taken.
Promozio (250/100) should be swallowed whole.
PROPHYLAXIS
Prophylaxis should start 1 to 2 days before entering a malaria-endemic
area, and be continued
daily until seven days after leaving the area.
If patients are unable to tolerate food, Promozio 250/100 tablets
should be administered, but
systemic exposure of atovaquone will be reduced.
_DOSAGE IN ADULTS: _
One Promozio 250/100 tablet daily.
TREATMENT
_DOSAGE IN ADULTS: _
Four tablets (total