Plasma-Lyte® 148 (pH 7.4) solution for infusion
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
09-08-2017
Summary of Product characteristics
(SPC)
02-08-2018
Active ingredient:
Sodium chloride; Magnesium chloride hexahydrate; Potassium chloride; Sodium gluconate; Sodium acetate trihydrate
Available from:
Baxter Healthcare Limited
ATC code:
B05BB; B05BB01
INN (International Name):
Sodium chloride; Magnesium chloride hexahydrate; Potassium chloride; Sodium gluconate; Sodium acetate trihydrate
Dosage:
Unknown
Pharmaceutical form:
Solution for infusion
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Solutions affecting the electrolyte balance; electrolytes
Authorization status:
Authorised
Authorization date:
2017-07-07
Patient Information leaflet
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
1. 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 (a type of metabolic acidosis
caused by the accumulation of lactic acid in
the body). Lactic acid is produced mainly by
the muscles and is removed by the liver.
Plasma-Lyte 148 (pH 7.4) i
Read the complete document
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):_
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.
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