Plasma-Lyte 148 (ph 7.4) Solution for Infusion N/A

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

SODIUM CHLORIDE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE HEXAHYDRATE; SODIUM ACETATE TRIHYDRATE; SODIUM GLUCONATE

Available from:

Baxter Healthcare Limited

ATC code:

B05BB01

INN (International Name):

SODIUM CHLORIDE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE HEXAHYDRATE; SODIUM ACETATE TRIHYDRATE; SODIUM GLUCONATE

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

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

Prescription type:

POM

Therapeutic area:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Authorization status:

Authorised

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PLASMA-LYTE 148 (PH 7.4) SOLUTION FOR INFUSION
Active substances: sodium chloride, potassium chloride, magnesium
chloride hexahydrate, sodium
acetate trihydrate and sodium gluconate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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.
This medicine is called `Plasma-Lyte 148 (pH 7.4) Solution for
Infusion’, but will be referred to as
`Plasma-Lyte 148 (pH 7.4) infusion’ throughout the remainder of this
leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Plasma-Lyte
148
(pH 7.4) Infusion is and what it is used for
2.
What you need to know before you use Plasma-Lyte
148
(pH 7.4) Infusion
3.
How to use Plasma-Lyte
148
(pH 7.4) Infusion
4.
Possible side effects
5.
How to store Plasma-Lyte
148
(pH 7.4) Infusion
6.
Contents of the pack and other information
WHAT PLASMA-LYTE 148 (PH 7.4) INFUSION IS AND WHAT IT IS USED FOR
Pharmacotherapeutic group: “Electrolytes” - ATC code:
“B05BB01”
Plasma-Lyte
148
(pH 7.4) Infusion is a solution of the following substances in water:
-
sodium chloride
-
potassium chloride
-
magnesium chloride hexahydrate
-
sodium acetate trihydrate
-
sodium gluconate
Sodium, potassium, magnesium, chloride, acetate and gluconate are
chemical substances found in
the blood.
Plasma-Lyte 148 (pH 7.4) infusion is used:
-
to provide a source of fluid, for example in cases of:
-
burns
-
head injury
-
fractures
-
infection
-
peritoneal irritation (inflammations within the abdomen)
-
as a source of fluids during a surgical operation
-
for the treatment of shock due to loss of blood and for other
conditions needing rapid
replacement of blood and/or fluids
-
in metabolic acidosis (when the blood becomes too acid) that is not
life-threatening
-
lactic acidosis

Summary of Product characteristics

Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Plasma-Lyte
®
148 (pH 7.4) solution for infusion.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
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 the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for infusion.
Clear solution, free from visible particles
Osmolarity: 295 mOsm/l (approx.)
pH: approx. 7.4 (6.5 to 8.0)
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Plasma-Lyte 148 (pH 7.4) is indicated:
-
for fluid replacement (e.g. after burns, head injury, fracture,
infection, and peritoneal irritation),
-
as intraoperative fluid replacement,
-
in haemorrhagic shock and clinical conditions requiring rapid blood
transfusions (compatibility
with blood),
-
in mild to moderate metabolic acidosis, also in case of lactate
metabolism impairment.
-
Page 2 of 12
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
_ADULTS, OLDER PATIENTS AND ADOLESCENTS (AGE 12 YEARS AND OVER): _
The dosage and rate of administration depend on the age, weight,
clinical and biological conditions
of the patient and concomitant therapy.
The recommended dosage is: 500 ml to 3 litres / 24 h
_Administration rate: _
The infusion rate is usually 40 mL/kg/24h in adults, the elderly and
adolescents.
When used for intraoperative fluid replacement, normal rate can be
higher and is about 15 mL/kg/h.
_Us