DEXTROSE 5 % AND SODIUM CHLORIDE 0.45 % INJECTION

Country: Իսրայել

language: անգլերեն

source: Ministry of Health

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SPC SPC (SPC)
17-08-2016

active_ingredient:

GLUCOSE ANHYDROUS; SODIUM CHLORIDE

MAH:

NEOPHARM (ISRAEL) 1996 LTD

ATC_code:

B05BB01

pharmaceutical_form:

SOLUTION FOR INJECTION

composition:

GLUCOSE ANHYDROUS 5 G / 100 ML; SODIUM CHLORIDE 0.45 G / 100 ML

administration_route:

I.V

prescription_type:

Required

manufactured_by:

NEOPHARM (ISRAEL) LTD - CURE MEDICAL MANUFACTURING PLANT

therapeutic_group:

ELECTROLYTES

therapeutic_area:

ELECTROLYTES

therapeutic_indication:

Supply of water for administration of electrolytes or calories. Vehicle for therapeutic regimen.

authorization_date:

2011-01-31

SPC

                                NEOPHARM (ISRAEL) LTD. -
INTRAVENOUS INJECTIONS IN PLASTIC CONTAINERS
1. SINGLE ELECTROLYTE SOLUTIONS
1. 0.45% Sodium Chloride Injection.
2. SINGLE ELECTROLYTE SOLUTIONS WITH DEXTROSE
1. 3.3% Dextrose and 0.3% Sodium Chloride Injection.
2. 4.3% Dextrose and 0.18% Sodium Chloride Injection.
3. 5% Dextrose and 0.33% Sodium Chloride Injection.
4. 5% Dextrose and 0.45% Sodium Chloride Injection.
5.
5% Dextrose and 0.9% Sodium Chloride Injection.
3. MULTIPLE ELECTROLYTE SOLUTIONS WITH DEXTROSE
1. 5% Dextrose and 0.3% Sodium Chloride and 0.15% Potassium Chloride
Injection.
DESCRIPTION
Intravenous solutions are sterile, nonpyrogenic and contain no
bacteriostatic or antimicrobial agents or added buffers.
The composition, osmolarity and approx. pH values of the individual
solutions are shown in
Table 1.
ACTIONS
Intravenous solutions provide electrolytes and/or calories, and are a
source of water for hydration. All are capable of
inducing diuresis depending on the clinical condition of the patient.
Solutions containing dextrose provide calories. See
Table 2 for calories per liter of the various solutions.
Solutions which are di-electrolytic or polyelectrolytic have value in
maintaining or replenishing electrolytes. See Table 2
for ionic concentrations.
INDICATIONS

Supply of water, for administration of electrolytes or calories.

Vehicle for therapeutic regimen.
CONTRAINDICATIONS
Excess body water volume.
Diabetic coma with excessively high blood sugar (solutions containing
glucose).
Hypovolaemia.
Cardiac insufficiency.
Edema, ascites ( cirrhosis related syndrome).
WARNINGS
Dispensing without a doctor's prescription is prohibited.
The administration of Intravenous Injections can cause fluid and/or
solute overloading resulting in dilution of serum
electrolyte concentrations, overhydration, congestive conditions, or
pulmonary edema. The risk of serum dilution is
inversely proportional to the electrolyte concentrations of the
injections.
The risk of solute overload causing congestion with peripheral and
pulmonary edema 
                                
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