Ionolyte (500ml polyolefine bag / LDPE bottle) Solution for Infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

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

Available from:

Fresenius Kabi Italia S.r.l Via Camagre 41, 37063 Isola della Scala (Vr) , Italy

ATC code:

B05BB01

INN (International Name):

SODIUM ACETATE TRIHYDRATE 2.32 g SODIUM CHLORIDE 3.01 g POTASSIUM CHLORIDE 0.15 g MAGNESIUM CHLORIDE HEXAHYDRATE 0.15 g

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

SODIUM ACETATE TRIHYDRATE 2.32 g SODIUM CHLORIDE 3.01 g POTASSIUM CHLORIDE 0.15 g MAGNESIUM CHLORIDE HEXAHYDRATE 0.15 g

Prescription type:

POM

Therapeutic area:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Authorization status:

Authorised

Authorization date:

2015-12-04

Patient Information leaflet

Page
1
of
7
PACKAGE LEAFLET: INFORMATION FOR THE USER
IONOLYTE SOLUTION FOR INFUSION
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 pharmacist.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ionolyte is and what it is used for
2.
What you need to know before you are given Ionolyte
3.
How you are given Ionolyte
4.
Possible side effects
5.
How to store Ionolyte
6.
Contents of the pack and other information
1.
WHAT IONOLYTE IS AND WHAT IT IS USED FOR
Ionolyte is a solution for infusion.
Ionolyte is used
_ _
for the treatment of:
•
extracellular dehydration (water loss)
•
hypovolaemia (sudden drop in volume of circulating blood)
•
mild metabolic acidosis (increased acid in the blood caused by a
metabolic disorder).
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN IONOLYTE
DO NOT USE IONOLYTE
•
if
you
are
allergic
to
Sodium
acetate
trihydrate,
Sodium
chloride,
Potassium
chloride,
Magnesium chloride hexahydrate or any of the other ingredients of this
medicine (listed in
section 6).
YOU SHOULD NOT RECEIVE IONOLYTE IF YOU HAVE
•
hyperhydration (too much fluid in the body), especially in cases of
pulmonary oedema (fluid
accumulation in the lungs) and congestive cardiac failure (your heart
cannot pump enough
blood througout the body)
•
severely impaired kidney function
•
metabolic alkalosis (decreased acidity of the blood caused by a
metabolic disorder)
•
hyperkalaemia (too high blood levels of potassium)
Your doctor will check these.
Page
2
of
7
SPECIAL CARE WILL BE TAKEN WITH IONOLYTE IF
•
you have heart
_ _
failure
•
you have severe heart rate disorders
•
you have impaired kidney function
•
you have severe electrolyte abnormalities (e.g. too high blood levels
of potassium, sodium,

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ionolyte Solution for infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The solution for infusion contains:
500 ml 1000 ml
Sodium acetate trihydrate
2.32 g 4.63 g
Sodium chloride
3.01 g 6.02 g
Potassium chloride
0.15 g 0.30 g
Magnesium chloride hexahydrate
0.15 g 0.30 g
Electrolytes:
Na+
137.0 mmol/l
K+
4.0 mmol/l
Mg++
1.5 mmol/l
Cl-
110.0 mmol/l
CH3COO-
34.0 mmol/l
Theoretical osmolarity:
286.5 mOsm/l
Titrable acidity:
< 2.5 mmol NaOH/l
pH:
6.9 – 7.9
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Solution for infusion
A clear and colourless solution
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ionolyte is indicated for:
- Predominantly extracellular dehydration, regardless of cause
(vomiting, diarrhea, fistulas,
etc.)
- Hypovolemia regardless of cause (hemorrhagic shock, burns,
peri-operative water and
electrolyte loss)
- Mild metabolic acidosis
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and paediatric patients
The dose and rate of administration depends on age, body weight,
clinical and biological
conditions of the patient (including acid-base balance) and the
concomitant therapy.
Recommended dosage:
The maximum daily dose corresponds to the fluid and electrolyte needs
of the patient. To
temporary restore blood volume 3 to 5 times the volume of the lost
blood is required.
Typical recommended dosages are:
For adults, the elderly and adolescents (age 12 years and above): 500
ml to 3 litres/24 hours.
For infants, toddlers and children (from 28 days to 11 years of age):
20 ml/kg to 100
ml/kg/24 hours.
Administration rate:
In continuous treatment outside acute fluid losses the infusion rate
is usually 40 ml/kg/24
hours in adults.
In paediatric patients the infusion rate is 5 ml/kg/hour in average
but the value varies with
the age: 6-8 ml/kg/hour for infants, 4-6 ml/kg/hour for toddlers, and
2-4 ml/kg/hour for
school children.
Method of administration
For intravenous use.
4.3
CONTRAINDICATIONS
Hypersens