RINGER'S INJ LIQUID

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

SODIUM CHLORIDE; CALCIUM CHLORIDE; POTASSIUM CHLORIDE

Предлага се от:

BAXTER CORPORATION

АТС код:

B05BB01

INN (Международно Name):

ELECTROLYTES

дозиране:

860MG; 33MG; 30MG

Лекарствена форма:

LIQUID

Композиция:

SODIUM CHLORIDE 860MG; CALCIUM CHLORIDE 33MG; POTASSIUM CHLORIDE 30MG

Начин на приложение:

INTRAVENOUS

Броя в опаковка:

1000ML

Вид предписание :

Ethical

Терапевтична област:

REPLACEMENT PREPARATIONS

Каталог на резюме:

Active ingredient group (AIG) number: 0300137001; AHFS:

Статус Оторизация:

CANCELLED POST MARKET

Дата Оторизация:

2016-07-15

Данни за продукта

Page 1 of 5
PRESCRIBING INFORMATION
RINGER’S INJECTION, USP
IN VIAFLEX PLASTIC CONTAINER
Parenteral Replenisher
Baxter Corporation
Mississauga, Ontario L5N 0C2
Canada
Date of Revision:
November 17, 2014
Submission Control No: 177995
Baxter and Viaflex are Trademarks of Baxter International Inc.
Page 2 of 5
RINGER’S INJECTION, USP
IN VIAFLEX PLASTIC CONTAINER
SUMMARY PRODUCT INFORMATION
Ringer’s Injection, USP is a sterile, nonpyrogenic solution and
contains no bacteriostatic or antimicrobial agents or added buffers.
The composition, osmolarity and approx. pH of Ringer’s Injection,
USP is shown in Table 1.
Table 1
DIN
Size (mL)
Composition (g/L)
Osmolarity
(mOsmol/L)
pH
Ionic Concentration (mmol/L)
Caloric Content
(kcal/L)
Sodium
Chloride, USP
Calcium
Chloride
Dihydrate,
USP
Potassium
Chloride, USP
Sodium
Potassium
Calcium
Chloride
Ringer’s
Injection,
USP
00060925
1000
8.60
0.33
0.30
310
5.0 – 7.5
147
4
2.24
156
0
The Viaflex plastic container is fabricated from a specially
formulated polyvinyl chloride (PL 146 Plastic).
The amount of water that can permeate from inside the container into
the overwrap is insufficient to affect the solution
significantly. Solutions in contact with the plastic container can
leach out certain of its chemical components in very small
amounts within the expiration period, e.g. di-2-ethylhexyl phthalate
(DEHP), up to 5 parts per million. However, the safety of the
plastic has been confirmed in tests in animals according to USP
biological tests for plastic containers as well as by tissue culture
toxicity studies.
Normal physiologic isotonicity range is approximately 280-310
mOsmol/L. Administration of substantially hypotonic solutions
may cause hemolysis and administration of substantially hypertonic
solutions may cause vein damage.
ACTIONS
Ringer’s Injection, USP is a source of water for hydration and
provides electrolytes. It is capable of inducing diuresis depending
on the clinical conditions of the patient.
Solutions which are polyelectrolytic have value in maintaining