SSP+ SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

SODIUM CITRATE; SODIUM ACETATE; DISODIUM PHOSPHATE; SODIUM PHOSPHATE MONOBASIC; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Tersedia dari:

MACO PHARMA

Kode ATC:

V07AC

INN (Nama Internasional):

BLOOD TRANSFUSION, AUXILIARY PRODUCTS

Dosis:

3.18G; 4.42G; 3.05G; 1.05G; 0.3G; 0.37G; 4.05G

Bentuk farmasi:

SOLUTION

Komposisi:

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

Rute administrasi :

INTRAVENOUS

Unit dalam paket:

100

Jenis Resep:

Ethical

Area terapi:

PHARMACEUTICAL AIDS

Ringkasan produk:

Active ingredient group (AIG) number: 0761850001; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2019-09-19

Karakteristik produk

_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
......................