STERILE WATER FOR IRRIGATION, USP Liquide

Pays: Canada

Langue: français

Source: Health Canada

Ingrédients actifs:

Eau

Disponible depuis:

BAXTER CORPORATION

Code ATC:

V07AB

DCI (Dénomination commune internationale):

SOLVENTS AND DILUTING AGENTS, INCL IRRIGAT SOLUT

Dosage:

100%

forme pharmaceutique:

Liquide

Composition:

Eau 100%

Mode d'administration:

Irrigation

Unités en paquet:

15G/50G

Type d'ordonnance:

Spécialité médicale

Domaine thérapeutique:

IRRIGATING SOLUTIONS

Descriptif du produit:

Numéro de groupe d'ingrédients actifs (GIA) :0105143002; AHFS:

Statut de autorisation:

APPROUVÉ

Date de l'autorisation:

2019-06-12

Résumé des caractéristiques du produit

88-70-18-165
Page 1 of 10
PRESCRIBING INFORMATION
STERILE WATER FOR IRRIGATION, USP
SUMMARY PRODUCT INFORMATION
Sterile Water for Irrigation, USP is a sterile, nonpyrogenic solution
and contains no bacteriostatic or antimicrobial agents
or other substance.
Sterile Water for Irrigation, USP is not isotonic and is hemolytic.
The composition, osmolarity and approx. pH of Sterile Water for
Irrigation, USP is shown in Table 1.
Table 1
Size (mL)
DIN
Container Type
Composition
Osmolarity (mOsmol/L)
pH
Water for
Injection,
USP
Sterile Water
for Irrigation,
USP
1000
00799998
Uromatic
PVC
Container
100%
0
Approx. 5.5
(5.0 to 7.0)
3000
Sterile Water
for Irrigation,
USP
500
00799998
Plastic
Pour Bottle
100%
0
Approx. 6.0
(5.0 to 7.0)
1000
UROMATIC PLASTIC CONTAINER
The Uromatic plastic container is fabricated from a specially
formulated polyvinyl chloride.
The amount of water that can permeate from inside the container into
the overwrap is insufficient to affect the fluid
significantly. Water in contact with the plastic container may leach
out certain chemical components from the plastic in
very small amounts; however, biological testing was supportive of the
safety of the plastic container materials.
PLASTIC POUR BOTTLE
The plastic pour bottle container is fabricated from specially
formulated polyolefin.
INDICATIONS AND CLINICAL USE
Sterile Water for Irrigation, USP is intended for use as an irrigant
only.
CONTRAINDICATIONS
Not for Injection.
88-70-18-165
Page 2 of 10
WARNINGS AND PRECAUTIONS
WARNINGS
FOR IRRIGATION ONLY. NOT FOR INJECTION OR INFUSION BY USUAL PARENTERAL
ROUTES.
Sterile Water for Irrigation, USP is hypotonic with an osmolarity of
zero mOsmol/L. If used for continuous irrigation or
allowed to dwell inside body cavities, absorption into the blood
stream may occur resulting in hemolysis, therefore use
under such conditions is not recommended.
Absorption of water for irrigation (e.g., through perforations, open
wounds or body cavities) has resulted in fatal
complications or permanent morbidity and use under the