PRO-QUININE - 200 CAPSULE

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

QUININE SULFATE

Tilgængelig fra:

PRO DOC LIMITEE

ATC-kode:

P01BC01

INN (International Name):

QUININE

Dosering:

200MG

Lægemiddelform:

CAPSULE

Sammensætning:

QUININE SULFATE 200MG

Indgivelsesvej:

ORAL

Enheder i pakken:

100

Recept type:

Prescription

Terapeutisk område:

ANTIMALARIALS

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2020-01-24

Produktets egenskaber

____________________________________________________________________________
_PRO-QUININE _
_ 1 of 18 _
PRESCRIBING INFORMATION
PR
PRO-QUININE
– 200
PR
PRO-QUININE
– 300
Quinine Sulfate Capsules
200 mg and 300 mg
Manufacturer Standard
ANTIMALARIAL AGENT
PRO DOC LTÉE
2925, boul. Industriel,
Laval, Québec
H7L 3W9
Submission Control#: 235116
Date of Revision:
January 24, 2020
____________________________________________________________________________
_PRO-QUININE _
_ 2 of 18 _
PRESCRIBING INFORMATION
PR
PRO-QUININE
– 200
PR
PRO-QUININE
– 300
Quinine Sulfate Capsules
Antimalarial Agent
PART I: HEALTH PROFESSIONAL INFORMATION
SUMMARY PRODUCT INFORMATION
ROUTE OF
ADMINISTRATION
DOSAGE FORM /
STRENGTH
ALL NON-MEDICINAL INGREDIENTS
Oral
Capsule, 200 mg and
300 mg
Ammonium hydroxide, black iron oxide,
butyl alcohol, colloidal silicon dioxide,
dehydrated alcohol, gelatin, isopropyl
alcohol, lactose monohydrate,
magnesium stearate, potassium
hydroxide, pregelatinized starch,
propylene glycol, purified water, shellac,
sodium lauryl sulfate and talc.
INDICATIONS AND CLINICAL USE
PRO-QUININE (quinine sulfate) is indicated (in combination with a
second antimalarial 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.
Strains of _P. falciparum_ with decreased susceptibility to quinine
can be selected _in vivo_. _P. _
_falciparum_ malaria that is clinically resistant to quinine has been
reported in some areas of South
America, Southeast Asia, and Bangladesh.
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.
____________________________________________________________________________
_PRO-QUININE _
_ 3 of 18 _
CONTRAINDICATIONS

Patients who ar