Ringer’s Solution for Infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CALCIUM CHLORIDE DIHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Available from:

Baxter Healthcare Limited

ATC code:

B05BB01

INN (International Name):

CALCIUM CHLORIDE DIHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

CALCIUM CHLORIDE DIHYDRATE 0.33 g/l; POTASSIUM CHLORIDE 0.3 g/l; SODIUM CHLORIDE 8.6 g/l

Prescription type:

POM

Therapeutic area:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Authorization status:

Authorised

Authorization date:

2011-11-22

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
RINGER’S SOLUTION FOR INFUSION
Active substances: sodium chloride, potassium chloride and calcium
chloride dihydrate
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.
WHAT IS IN THIS LEAFLET:
1.
What Ringer’s Solution for Infusion is and what it is used for
2.
What you need to know before you are given Ringer’s Solution for
Infusion
3.
How you will be given Ringer’s Solution for Infusion
4.
Possible side effects
5.
How to store Ringer’s Solution for Infusion
6.
Contents of the pack and other information
1.
WHAT RINGER’S SOLUTION FOR INFUSION IS AND WHAT IT IS USED FOR
Ringer’s Solution for Infusion is a solution of the following
substances in water:
-
sodium chloride
-
potassium chloride
-
calcium chloride dihydrate
-
Ringer’s Solution for Infusion is used to treat a loss of body water
(dehydration) and chemicals (e.g. by
heavy sweating, kidney disorders)
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN RINGER’S SOLUTION FOR
INFUSION
DO NOT RECEIVE RINGER’S SOLUTION FOR INFUSION IF YOU ARE SUFFERING
FROM ANY OF THE FOLLOWING
CONDITIONS
-
Preterm newborn infants and term newborn infants (≤28 days of age):
Your child must not receive a
certain antibiotic called ceftriaxone as a drip into a vein at the
same time with this medicine
-
when there is too much fluid in the spaces around the cells of the
body (extracellular hyperhydration)
-
when there is a larger volume of blood in the blood vessels than there
should be (hypervolaemia)
-
severe kidney failure (when your kidneys do not work well and you
require dialysis)
-
uncompensated heart failure. This is heart failure that is not
adequately treated and causes symptoms
such as:
-
shortness of brea

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Ringer’s Solution for Infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium chloride:
8.60 g/l
Potassium chloride:
0.30 g/l
Calcium chloride dihydrate:
0.33 g/l
mmol/l:
Na
+
:
147
K
+
:
4
Ca
++
:
2.25
Cl
-
:155.5
mEq/l:
Na
+
:
147
K
+
:
4
Ca
++
:
4.5
Cl
-
:155.5
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
_ _
Solution for infusion.
Clear solution, free from visible particles.
Osmolarity 309 mOsm/l (approx)
pH: 5.0 to 7.5
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ringer’s Solution for Infusion is indicated to:
_ _
_-_
_ _
Replace extracellular fluid losses,
_-_
_ _
Restore the sodium, potassium, calcium and chloride balances, for
treatment of isotonic dehydration
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults, the Elderly, Adolescents and Children_:
The dosage depends on the age, weight, clinical and biological
conditions of the patient and concomitant
therapy.
_Recommended dosage:_
The recommended dosage is:
-
for adults, the elderly and adolescents : 500 ml to 3 _litres_ /24h
-
for babies and children : 20 ml to 100 ml / kg / 24 h_._
_Administration rate:_
The infusion rate is usually 40 ml/kg/24h in adults, the elderly and
adolescents.
In paediatric patients the infusion rate is 5 ml/kg/h on average but
the value varies with age: 6-8 ml/kg/h for
infants, 4-6 ml/kg/h for toddlers, and 2-4 ml/kg/h for schoolchildren.
In children with burns, the dose is on
average 3.4 ml/kg/per cent burn at 24 h post-burn and 6.3 ml/kg/per
cent burn at 48 h.
In severely head-injured children the dose is on average 2850 ml/m².
Infusion rate and total volume can be higher in surgery or in case of
need.
_Note: _
_infants and toddlers: aged from 28 days to 23 months (a toddler is an
infant who can walk) _
2
-
_children and schoolchildren: aged from 2 years to 11 years._
_Method of administration:_
The administration is performed by intravenous route.
The solution for infusion should be visually inspected prior to use.
Use only if the solutio