PRIMACIN primaquine (as phosphate) 7.5mg tablet bottle

Valsts: Austrālija

Valoda: angļu

Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)

Aktīvā sastāvdaļa:

primaquine phosphate, Quantity: 13.2 mg (Equivalent: primaquine, Qty 7.5 mg)

Pieejams no:

Boucher & Muir Pty Ltd

SNN (starptautisko nepatentēto nosaukumu):

Primaquine phosphate

Zāļu forma:

Tablet, uncoated

Kompozīcija:

Excipient Ingredients: wheat starch; povidone; purified water; lactose monohydrate; purified talc; Gelatin; magnesium stearate; glycerol

Ievadīšanas:

Oral

Vienības iepakojumā:

28 tablets, 56 tablets

Receptes veids:

(S4) Prescription Only Medicine

Ārstēšanas norādes:

Prevention of relapses (radical cure) of malaria caused by P.vivax and P. ovale. Adjunctive therapy in the treatment of gametocytemia due to P.falciparum in patients resident in areas receptive to malaria.

Produktu pārskats:

Visual Identification: Orange tablets, 6mm diameter, flat without breakline or logo; Container Type: Bottle; Container Material: HDPE; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Autorizācija statuss:

Licence status A

Autorizācija datums:

2014-11-10

Lietošanas instrukcija

PRIMACIN
_TABLETS 7.5 MG_
_Primaquine phosphate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking Primacin.
This leaflet answers some common
questions about Primacin. It does not
contain all the available information.
The most up-to-date Consumer
Medicine Information can be
downloaded from
www.ebs.tga.gov.au.
Reading this leaflet does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Primacin
against the benefits this medicine is
expected to 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 want to read it again.
WHAT PRIMACIN IS USED
FOR
Primacin contains primaquine
phosphate. It works by killing the
malarial parasite at different stages of
its life cycle, both in the blood and in
the liver.
Primacin is used to treat the vivax
and ovale forms of malaria following
an attack. It is also used to aid in the
treatment of falciparum malaria.
Your doctor may have prescribed this
medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
Primacin is only available with a
doctor's prescription.
Primacin is not addictive.
BEFORE YOU TAKE
PRIMACIN
Primacin is not suitable for everyone.
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE PRIMACIN IF YOU:
•
have severe glucose-6-phosphate
(G6PD) deficiency
•
You may not know if you have
this deficiency but your doctor
can do a quick blood test to
check.
•
are pregnant
•
have rheumatoid arthritis or lupus
erythematosus
•
are taking quinacrine
hydrochloride to treat malaria
•
are taking other medicines that
affect your red blood cells or
bone marrow.
DO NOT TAKE PRIMACIN IF YOU ARE
ALLERGIC TO ANY MEDICINE CONTAINING
PRIMAQUINE OR OTHER 8-
AMINOQUINOLINES OR ANY OF THE
INGREDIENTS LISTED AT THE END OF THIS
LEAFLET.
DO NOT TAKE IT AFTER THE EXPIRY DATE
('EXPIRY') PRINTED ON T

Produkta apraksts

PRIMACIN
®
1
AUSTRALIAN PRODUCT INFORMATION
PRIMACIN
®
PRIMAQUINE PHOSPHATE
TABLETS
1
NAME OF THE MEDICINE
Primaquine phosphate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Primacin tablet contains 7.5 mg primaquine base as 13.2 mg
primaquine phosphate.
Excipients with known effect: Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Primacin tablets are orange tablets, 6mm diameter, flat without
breakline or logo.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
▪
Prevention of relapses (radical cure) of malaria caused by
_P. vivax_
and
_P. ovale._
▪
Adjunctive therapy in the treatment of gametocytemia due to
_P. falciparum_
in patients
resident in areas receptive to malaria.
4.2 DOSE AND METHOD OF ADMINISTRATION
Primaquine should be taken with food.
Radical treatment
(a)
15 mg daily for 14 days.
(b)
Up to 30 mg daily for 14 days in areas where resistant malaria strains
occur or where
treatment has failed with lower doses.
(c)
The WHO advises that the treatment period of 21 days should be
employed to achieve
radical cure in most of South East Asia and the Pacific regions. Other
antimalarial
agents may be used concomitantly.
(d)
For patients with G6PD deficiency: up to 45 mg once weekly for 8 weeks
with
monitoring for the development of haemolysis.
PRIMACIN
®
2
(e)
Paediatric dose: 0.3 mg/kg/day.
(f)
For the reduction of gametocytes of P. falciparum: 45 mg as a single
dose for adults
and 0.7 to 1.0 mg/kg for children.
4.3 CONTRAINDICATIONS
▪
Hypersensitivity to primaquine or other 8-aminoquinolines
▪
Hypersensitivity to other ingredients in Primacin tablets
▪
Severe glucose-6-phosphate dehydrogenase (G6PD) deficiency
▪
Pregnant women
▪
Acutely ill patients with any serious systemic diseases characterised
by a tendency to
granulocytopenia, such as rheumatoid arthritis or lupus erythematosus
▪
Patients receiving concurrently other potentially haemolytic medicines
or depressants
of myeloid elements of the bone marrow
4.4 SPECIAL WARN