Sodium chloride 0.9% infusion 50ml Viaflex bags

Country: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Download Vara einkenni (SPC)
17-06-2018

Virkt innihaldsefni:

Sodium chloride

Fáanlegur frá:

Baxter Healthcare Ltd

ATC númer:

B05XA03

INN (Alþjóðlegt nafn):

Sodium chloride

Skammtar:

9mg/1ml

Lyfjaform:

Infusion

Stjórnsýsluleið:

Intravenous

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 09020201

Vara einkenni

                                OBJECT 1
SODIUM CHLORIDE INTRAVENOUS INFUSION BP 0.9%
W/V
Summary of Product Characteristics Updated 20-Jan-2016 | Baxter
Healthcare Ltd
1. Name of the medicinal product
Sodium Chloride Intravenous Infusion BP 0.9% w/v
2. Qualitative and quantitative composition
Each 1000 ml of solution contains:
Sodium Chloride 9.0g
For the full list of excipients, see section 6.1
3. Pharmaceutical form
A sterile non-pyrogenic intravenous infusion for administration to
human beings.
4. Clinical particulars
4.1 Therapeutic indications
Sodium Chloride Intravenous Infusion BP 0.9% w/v is of value as a
source of water and electrolytes and
is indicated for replenishing fluid and for restoring and maintaining
the concentrations of sodium and
chloride ions.
It is also of value in the treatment of poisoning, by aiding
excretion.
It may also be used as a vehicle for the reconstitution and
administration of intravenous medications.
4.2 Posology and method of administration
Posology
_Adults, older people and children:_
Doses may be expressed in terms of mEq or mmol of sodium, mass of
sodium, or mass of sodium salt (1
g NaCl = 394 mg, 17.1 mEq or 17.1 mmol of Na and Cl).
The dosage, rate and duration of administration is to be
individualised as determined by several factors
including age, weight, clinical condition, concomitant treatment and
in particular the patient's hydration
state, clinical and laboratory response to treatment. Fluid balance
and plasma electrolyte concentrations
must be monitored during treatment.
_Recommended dosage_
The recommended dosage for treatment of isotonic extracellular
dehydration and sodium depletion is:
• For adults : 500 ml to 3 litres/24h
• For babies and children: 20 to 100 ml per 24h and per kg of body
weight, depending of the age and the
total body mass.
The recommended dosage when used as a vehicle or diluent ranges from
50 to 250 ml per dose of
medicinal product to be administered.
When Sodium Chloride 0.9 % is used as a diluent for injectable
preparations of other drugs, the dosage
and the infus
                                
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