国家: 加拿大
语言: 英文
来源: Health Canada
QUININE SULFATE
PRO DOC LIMITEE
P01BC01
QUININE
300MG
CAPSULE
QUININE SULFATE 300MG
ORAL
100
Prescription
ANTIMALARIALS
Active ingredient group (AIG) number: 0106604002; AHFS:
APPROVED
2020-01-24
____________________________________________________________________________ _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 阅读完整的文件