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

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

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

Available from:

Baxter Holding B.V.

ATC code:

B05BB; B05BB02

INN (International Name):

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

Dosage:

5 percent weight/volume

Pharmaceutical form:

Solution for infusion

Therapeutic area:

Solutions affecting the electrolyte balance; electrolytes with carbohydrates

Authorization status:

Marketed

Authorization date:

2007-06-01

Patient Information leaflet

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 acido

Summary of Product characteristics

HealthProductsRegulatoryAuthority
22March2019
CRN008KF8
Page1of11
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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
HealthProductsRegulatoryAuthority
22March2019
CRN008KF8
Page2of11
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monitoredbeforeandduringadministration(seesections4.4,
4.5,4.6and4.8).
_Recommended dosage_:
Therecommendeddosageis:
-
foradults,theelderlyandadolescents:500mlto3litres/�