QUININE - ODAN CAPSULE

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

QUININE SULFATE

Предлага се от:

ODAN LABORATORIES LTD

АТС код:

P01BC01

INN (Международно Name):

QUININE

дозиране:

200MG

Лекарствена форма:

CAPSULE

Композиция:

QUININE SULFATE 200MG

Начин на приложение:

ORAL

Броя в опаковка:

100/500

Вид предписание :

Prescription

Терапевтична област:

ANTIMALARIALS

Каталог на резюме:

Active ingredient group (AIG) number: 0106604001; AHFS:

Статус Оторизация:

APPROVED

Дата Оторизация:

2005-02-09

Данни за продукта

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PRESCRIBING INFORMATION
PR
QUININE-ODAN200 MG CAPSULES
PR
QUININE-ODAN 300 MG CAPSULES AND
PR
QUININE-ODAN 300 MG TABLETS
quinine sulfate
PART I: HEALTH CARE PRACTITIONER INFORMATION
SUMMARY PRODUCT INFORMATION
INDICATIONS AND CLINICAL USE
Quinine-ODAN (quinine sulfate) is indicated (in combination with a
second
anti-malarial drug) for the treatment of uncomplicated _Plasmodium
falciparum_ malaria.
Quinine sulfate has been shown to be effective in geographical regions
where resistance
to chloroquine has been documented.
GERIATRICS (≥ 65 YEARS OF AGE):
Reported clinical experience has not identified differences in
responses between the
elderly and younger patients.
PEDIATRICS (< 16 YEARS OF AGE):
Quinine is considered acceptable for use in children at doses
recommended for the
treatment of malaria.
CONTRAINDICATIONS
• Patients who are hypersensitive to this drug or to any ingredient
in the formulation or
component of the container. For a complete listing, see the Dosage
Forms, Composition
and Packaging section of the prescribing information.
• Hypersensitivity reactions include, but are not limited to the
following [_see _
_Warnings and Precautions_]:
• Thrombocytopenia
• Idiopathic thrombocytopenia purpura (ITP) and Thrombotic
thrombocytopenic
purpura (TTP)
• Hemolytic uremic syndrome (HUS)
• Blackwater fever (acute intravascular hemolysis, hemoglobinuria,
and
hemoglobinemia)
Quinine-ODAN is also contraindicated in patients with the following:
• Prolongation of QT interval
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency
• Myasthenia gravis
• Known hypersensitivity to quinine, mefloquine, or quinidine
• Optic neuritis
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WARNINGS AND PRECAUTIONS
GENERAL
Quinine sulphate is not approved for:
• Treatment of severe or complicated _P. falciparum_ malaria.
• Prevention of malaria.
• Treatment or prevention of nocturnal leg cramps.
_USE OF QUININE-ODAN FOR TREATMENT OR PREVENTION OF NOCTURNAL LEG
CRAMPS _
Quinine-ODAN may cause unpredictable serious and life-threatening
h