Ringer’s Solution for Infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CALCIUM CHLORIDE, DIHYDRATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE

Available from:

Baxter Holding B.V. Kobaltweg 49, 3542CE Utrecht, Netherlands

ATC code:

B05BB01

INN (International Name):

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

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

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

Prescription type:

POM

Therapeutic area:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Authorization status:

Authorised

Authorization date:

2004-10-07

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 bre

Summary of Product characteristics

PAGE 1 OF 9
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_
:
Fluid balance, serum electrolytes and acid-base balance may need to 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 risk of hospital acquired
hyponatraemia (see sections 4.4, 4.5 and 4.8). Monitoring of serum
sodium is particularly important
for hypotonic fluids.
Ringer’s Solution tonicity: Isotonic solution
The infusion rate and volume depend on the age, weight, clinical
condition (e.g. burns, surgery, head-injury,
infections), and concomitant therapy should be determined by the
consulting physician experienced in
paediatric intravenous fluid therapy (see sections 4.4. and 4.8).
_Recommended dosage: _
The recommended dosage is:
-
for adults, the elderly and adolescents : 500 ml to 3 liters /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 in average but
the value