Plasma-Lyte 148 (ph 7.4) Solution for Infusion (500ml)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

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

Available from:

Baxter Holding B.V. Kobaltweg 49, 3542CE Utrecht, Netherlands

ATC code:

B05BB01

INN (International Name):

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

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

Authorization date:

2016-11-11

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. See section 4.
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) t

Summary of Product characteristics

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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
_ADULTS, OLDER PATIENTS AND ADOLESCENTS (AGE 12 YEARS AND OVER): _
Fluid balance, serum electrolytes and acid-base balance should be
monitored before and
during administration, with particular attention to serum sodium in
patients with increased
non-osmotic vasopressin release (syndrome of inappropriate
antidiuretic hormone secretion,
SIADH) and in patients co-medicated with vasopressin agonist drugs,
due to the risk of
hospital acquir