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

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

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

可用日期:

Baxter Holding B.V.

ATC代码:

B05BB; B05BB02

INN（国际名称）:

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

剂量:

5 percent weight/volume

药物剂型:

Solution for infusion

治疗领域:

Solutions affecting the electrolyte balance; electrolytes with carbohydrates

授权状态:

Marketed

授权日期:

2007-06-01

资料单张

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

产品特点

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/�