Plasma-Lyte® 148 (pH 7.4) solution for infusion

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Baxter Holding B.V.

ATC kanuni:

B05BB; B05BB01

INN (Jina la Kimataifa):

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

Kipimo:

148 (pH 7.4)

Dawa fomu:

Solution for infusion

Eneo la matibabu:

Solutions affecting the electrolyte balance; electrolytes

Idhini hali ya:

Marketed

Idhini ya tarehe:

2017-07-07

Taarifa za kipeperushi

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

Tabia za bidhaa

Health Products Regulatory Authority
10 January 2024
CRN00DVSV
Page 1 of 10
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/l140 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 ri