DEXTROSE 5% AND 0.45% SODIUM CHLORIDE INJECTION

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

GLUCOSE AS MONOHYDRATE; SODIUM CHLORIDE

Tilgjengelig fra:

TEVA MEDICAL MARKETING LTD.

ATC-kode:

B05BB01

Legemiddelform:

SOLUTION FOR INJECTION

Sammensetning:

SODIUM CHLORIDE 4.5 MG/ML; GLUCOSE AS MONOHYDRATE 50 MG/ML

Administreringsrute:

I.V

Resept typen:

Required

Produsert av:

TEVA MEDICAL LTD, ISRAEL

Terapeutisk gruppe:

ELECTROLYTES

Terapeutisk område:

ELECTROLYTES

Indikasjoner:

Provides electrolytes and calories and is a source of water for hydration.

Autorisasjon dato:

2013-10-31

Informasjon til brukeren

לע העדוה לע העדוה לע העדוה
( הרמחה
( הרמחה
( הרמחה עדימ עדימ עדימ
ל ןולעב )תוחיטב
ל ןולעב )תוחיטב
ל ןולעב )תוחיטב
אפור
אפור
אפור :ךיראת
411.410.41
תילגנאב רישכת םש :
Dextrose 5% and Sodium Chloride 0.45% Injection
ושיר רפסמ
ם :
038 88 22826 00
םושירה לעב םש :
Teva Medical LTD
ה טורפל דעוימ הז ספוט
דבלב תורמחה
!
תושקובמה תורמחהה
ןולעב קרפ
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יחכונ
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CONTRAINDICATIONS
Solutions containing dextrose may be contraindicated in
patients with known allergy to corn or corn products
PRECAUTIONS
Pressurizing intravenous solutions contained in flexible plastic
containers to increase flow rates can result in air embolism if
the residual air in the container is not fully evacuated prior to
administration.
Use of a vented intravenous administration set with the vent in
the open position could result in air embolism. Vented
intravenous administration sets with the vent in the open
position should not be used with flexible plastic containers.
DRUG INTERACTIONS
Studies have not been conducted to evaluate additional
drug/drug or drug/food interactions with Dextrose and Sodium
Chloride Injection.
CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY
Studies with Dextrose and Sodium Chloride Injection, USP
have not been performed to evaluate carcinogenic potential,
mutagenic potential, or effects on fertility.
PREGNANCY: TERATOGENIC EFFECTS
Pregnancy Category C. Animal reproduction studies have not
been conducted with Dextrose and Sodium Chloride Injection,
USP. It is also not known whether Dextrose and Sodium
Chloride Injection, USP can cause fetal harm when
administered to a pregnant woman or can affect reproduction
capacity. Dextrose and Sodium Chloride Injection, USP
should be given to a pregnant woman only if clearly needed.
LABOR AND DELIVERY
Studies have not been conducted to evaluate the effects of
Dextrose and Sodium Ch

Preparatomtale

ונכותו תואירבה דרשמ י"ע עבקנ הז ןולע
טמרופ 26.1.2017 -ב ודי לע רשואו קדבנ
DEXTROSE 5% IN 0.45%
SODIUM CHLORIDE INJECTION
SOLUTION FOR INFUSION IN NON PVC BAGS
DESCRIPTION
Dextrose 5% in 0.45% Sodium Chloride Injection is a
sterile, nonpyrogenic solution for fluid and electrolyte
replenishment and caloric supply in single dose
containers for intravenous administration. It contains
no antimicrobial agents. Composition, osmolarity, pH,
ionic concentration and caloric content are shown
in Table 1.
TABLE 1
Size (mL)
Composition
(g/L)
*Osmolarity
(mOsmol/L) (calc.)
pH nominal (range)
Ionic
Concentration
(mEq/L)
Caloric Content
(kcal/L)
Dextrose
Monohydrate
Sodium
Chloride,
(NaCl)
Sodium
Chloride
5%
Dextrose
and
0.45%
Sodium
Chloride
Injection
500
1000
50
4.5
406
4.0
77
77
170
* NORMAL PHYSIOLOGIC OSMOLARITY RANGE IS
APPROXIMATELY 280 TO 310 MOSMOL/L.
The flexible container is a closed system, and air is
prefilled in the container to facilitate drainage. The
container does not require entry of external air during
administration.
The container has two ports: one is the administration
outlet port for attachment of an intravenous
administration set and the other port has a medication
site for addition of supplemental medication (see
DIRECTIONS FOR USE). The primary function of the
overwrap is to protect the container from the physical
environment.
DESCRIPTION OF THE PRIMARY BAGS:
Type and size: Non PVC plastic bag + overpouch;
size: 500 ml and 1000 ml.
Material composition:
- Non PVC plastic film, based on polyethylene,
polyamide, and polypropylene.
- Overpouch
based
on
co-extruded
blend:
polypropylene/polyamide/polypropylene film.
CLINICAL PHARMACOLOGY
Dextrose 5% in 0.45% Sodium Chloride Injection has
value as a source of water, electrolytes, and calories.
It is capable of inducing diuresis depending on the
clinical condition of the patient.
INDICATIONS AND USAGE
Dextrose 5% in 0.45% Sodium Chloride Injection is
indicated to provide electrolytes and calories and as a
sourc