DEXTROSE INJECTION 10%

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

GLUCOSE AS MONOHYDRATE

Commercializzato da:

TEVA MEDICAL MARKETING LTD.

Codice ATC:

B05CX01

Forma farmaceutica:

SOLUTION FOR INJECTION

Composizione:

GLUCOSE AS MONOHYDRATE 10 %

Via di somministrazione:

I.V

Tipo di ricetta:

Required

Prodotto da:

TEVA MEDICAL LTD, ISRAEL

Gruppo terapeutico:

GLUCOSE

Area terapeutica:

GLUCOSE

Indicazioni terapeutiche:

As intravenous injection: Dextrose 10 % injection is indicated as a source of water and calories. As parenteral nutrient: Dextrose 10 % injection is indicated as a caloric component in parenteral nutrition regimen. It is used with an appropriate protein (nitrogen) source in the prevention of nitrogen loss or in the treatment of negative nitrogen balance in patients where: 1) The alimentary tract cannot should not be used. 2) Gastrointestinal absorption of protein is impaired, or 3) metabolic requirements for protein are substantially increased, as extensive burns.

Data dell'autorizzazione:

2011-01-31

Scheda tecnica

TEVA MEDICAL/DEXTROSE 10% IV INJECTION-TPN, 11. 4. 2001
10% DEXTROSE INJECTION
(DEXTROSE IN WATER) IN PLASTIC BAGS.
INTRAVENOUS INJECTION / PARENTERAL NUTRIENT
DESCRIPTION
10% Dextrose Injection is a solution of Dextrose 10% in Water. It can
be used
either:
(a)
As Intravenous solution for fluid replenishment and caloric supply in
single
dose container for intravenous administration, or
(b)
As parenteral nutrient.
10% Dextrose Injection is a sterile, nonpyrogenic, hypertonic
solution. It contains no
antimicrobial or buffering agents.
Composition, osmolarity, pH value and caloric content are as follows:
COMPOSITION
Dextrose monohydrate 100g/L
OSMOLARITY
505 mOsm/L
APPROXIMATE PH VALUE
4.0
CALORIC CONTENT
340 Kcal/L
The plastic bag is fabricated from a specially formulated polyvinyl
chloride. Water
can permeate from inside the bag into the overwrap in amounts
insufficient to affect
the solution significantly. Solutions in contact with the plastic bag
can leach out certain
of its chemical components in very small amounts, however, testing was
supportive of
the safety of the plastic container materials.
CLINICAL PHARMACOLOGY
10% Dextrose injection has a value as a source of water and calories.
it is capable
of inducing diuresis depending on the clinical condition of the
patient.
For caloric value see second table above.
INDICATIONS
_AS INTRAVENOUS INJECTION _
10% Dextrose Injection is indicated as a source of water and calories.
_ _
_AS PARENTERAL NUTRIENT _
10% Dextrose Injection is indicated as a caloric component in a
parenteral nutrition
regimen. It is used with an appropriate protein (nitrogen) source in
the prevention of
nitrogen loss or in the treatment of negative nitrogen balance in
patients where:
(1)
the alimentary tract cannot or should not be used
(2)
gastrointestinal absorption of protein is impaired, or
(3)
metabolic requirements for protein are substantially increased, as
with
extensive burns.
TEVA MEDICAL/DEXTROSE 10% IV INJECTION-TPN , 11. 4. 2001
2
USE IN PREGNANCY
Animal reproduction studies have n