Country: Канада
Језик: Енглески
Извор: Health Canada
SODIUM CITRATE; SODIUM ACETATE; DISODIUM PHOSPHATE; SODIUM PHOSPHATE MONOBASIC; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
MACO PHARMA
V07AC
BLOOD TRANSFUSION, AUXILIARY PRODUCTS
3.18G; 4.42G; 3.05G; 1.05G; 0.3G; 0.37G; 4.05G
SOLUTION
SODIUM CITRATE 3.18G; SODIUM ACETATE 4.42G; DISODIUM PHOSPHATE 3.05G; SODIUM PHOSPHATE MONOBASIC 1.05G; MAGNESIUM CHLORIDE 0.3G; POTASSIUM CHLORIDE 0.37G; SODIUM CHLORIDE 4.05G
INTRAVENOUS
100
Ethical
PHARMACEUTICAL AIDS
Active ingredient group (AIG) number: 0761850001; AHFS:
APPROVED
2019-09-19
_SSP+ Product Monograph _ _Draft Date: September 12, 2018 _ _Page 1 of 16_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION SSP+ Platelet Additive Solution E (PAS-E) Sodium citrate dihydrate 3.18 g/L, Sodium acetate trihydrate 4.42 g/L, Sodium dihydrogen phosphate dihydrate 1.05 g/L, Disodium phosphate anhydrous 3.05 g/L, Potassium chloride 0.37 g/L, Magnesium chloride hexahydrate 0.30 g/L, Sodium chloride 4.05 g/L Sterile solution Platelet Additive Solution MACO PHARMA Rue Lorthiois 59420 MOUVAUX FRANCE www.macopharma.com Distributor: MACOPHARMA CANADA INC. MONTREAL H3B 4G7 (QC) CANADA Date of Approval: Date of Revision:September 19, 2019 Submission Control No: 220402 _ _ _SSP+ Product Monograph _ _Draft: September 12, 2018 _ _Page 2 of 16_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .................................................... 3 1 INDICATIONS ...................................................................................................... 3 2 CONTRAINDICATIONS ....................................................................................... 3 3 DOSAGE AND ADMINISTRATION ..................................................................... 3 4 OVERDOSAGE .................................................................................................... 3 5 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............. 4 6 WARNINGS AND PRECAUTIONS ...................................................................... 5 7 ADVERSE REACTIONS ...................................................................................... 5 8 DRUG INTERACTIONS ....................................................................................... 6 9 ACTION AND CLINICAL PHARMACOLOGY ..................................................... 6 10 STORAGE, STABILITY AND DISPOSAL ........................................................... 6 11 SPECIAL HANDLING INSTRUCTIONS .............................................................. 7 PART II: SCIENTIFIC INFORMATION ...................... Прочитајте комплетан документ