Plasma-Lyte 148 & Glucose 5% w/v solution for infusion

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Glucose monohydrate; Sodium chloride; Potassium chloride; Magnesium chloride hexahydrate; Sodium acetate trihydrate; Sodium gluconate

Disponible desde:

Baxter Healthcare Limited

Código ATC:

B05BB; B05BB02

Designación común internacional (DCI):

Glucose monohydrate; Sodium chloride; Potassium chloride; Magnesium chloride hexahydrate; Sodium acetate trihydrate; Sodium gluconate

Dosis:

5 percent weight/volume

formulario farmacéutico:

Solution for infusion

tipo de receta:

Product subject to prescription which may not be renewed (A)

Área terapéutica:

Solutions affecting the electrolyte balance; electrolytes with carbohydrates

Estado de Autorización:

Marketed

Fecha de autorización:

2007-06-01

Información para el usuario

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PLASMA-LYTE 148 & GLUCOSE 5% W/V SOLUTION FOR INFUSION
Active substances: glucose, sodium chloride, potassium chloride,
magnesium chloride hexahydrate, sodium
acetate trihydrate and sodium gluconate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
This medicine is called `Plasma-Lyte 148 & Glucose 5% w/v Solution for
Infusion’, but will be referred to as
`Plasma-Lyte & Glucose Infusion’ throughout the remainder of this
leaflet.
WHAT IS IN THIS LEAFLET
:
1.
What Plasma-Lyte & Glucose Infusion
is and what it is used for
2.
What you need to know before you are given Plasma-Lyte & Glucose
Infusion
3.
How you will be given Plasma-Lyte & Glucose Infusion
4.
Possible side effects
5.
How to store Plasma-Lyte & Glucose Infusion
6.
Contents of the pack and other information
1. WHAT PLASMA-LYTE &
GLUCOSE INFUSION IS AND WHAT IT IS USED FOR
Pharmacotherapeutic group: “Electrolytes with Carbohydrates” - ATC
code: “B05BB02”
Plasma-Lyte & Glucose Infusion is a solution of the following
substances in water:
-
sugar (glucose)
-
sodium chloride
-
potassium chloride
-
magnesium chloride hexahydrate
-
sodium acetate trihydrate
-
sodium gluconate
Glucose is one of the body’s sources of energy. This solution for
infusion provides 220 kilocalories per litre.
Sodium, potassium, magnesium, chloride, acetate and gluconate are
chemical substances found in the blood.
Plasma-Lyte & Glucose infusion is used:
-
to provide a source of fluid and carbohydrate (sugar) for example, in
cases of:
-
burns
-
head injury
-
fractures
-
infection
-
peritoneal irritation (inflammation within the abdomen)
-
as a source of fluids during a surgical operation
-
in metabolic acid

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Plasma-Lyte 148 & Glucose 5% w/v solution for infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Glucose monohydrate
55.00 g/l
Sodium Chloride:
5.26 g/l
Potassium Chloride:
0.37 g/l
Magnesium Chloride hexahydrate:
0.30 g/l
Sodium Acetate trihydrate:
3.68 g/l
Sodium Gluconate:
5.02 g/l
Na
+
K
+
Mg
++
Cl
-
CH
3
COO
-
C
6
H
11
O
7
-
(Acetate)
(Gluconate)
mmol/l
140
5.0
1.5
98
27
23
mEq/l
140
5.0
3.0
98
27
23
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
Clear solution, free from visible particles
Osmolarity: 572 mOsm/l (approx.)
pH: 4.0 to 6.0
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Plasma-Lyte 148 & Glucose 5% w/v is indicated:
-
for fluid replacement with carbohydrate supply (e.g. after burns, head
injury, fracture, infection, and peritoneal
irritation),
-
as intraoperative fluid replacement,
-
in mild to moderate metabolic acidosis, also in case of lactate
metabolism impairment.
H
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4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults, the Elderly, Adolescents and Children:
The dosage and rate of administration depend on the age, weight,
clinical and biological conditions of the patient and
concomitant therapy.
Fluid balance, blood glucose, and serum electrolytes should be
monitor