STERILE WATER FOR IRRIGATION, USP Liquide

מדינה: קנדה

שפה: צרפתית

מקור: Health Canada

מרכיב פעיל:

Eau

זמין מ:

BAXTER CORPORATION

קוד ATC:

V07AB

INN (שם בינלאומי):

SOLVENTS AND DILUTING AGENTS, INCL IRRIGAT SOLUT

כמות:

100%

טופס פרצבטיות:

Liquide

הרכב:

Eau 100%

מסלול נתינה (של תרופות):

Irrigation

יחידות באריזה:

15G/50G

סוג מרשם:

Spécialité médicale

איזור תרפויטי:

IRRIGATING SOLUTIONS

leaflet_short:

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

מצב אישור:

APPROUVÉ

תאריך אישור:

2019-06-12

מאפייני מוצר

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