Ringer’s Solution for Infusion, Viaflo container

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Sodium chloride; Potassium chloride; Calcium chloride dihydrate

Dostupné z:

Baxter Holding B.V.

ATC kód:

B05BB; B05BB01

INN (Medzinárodný Name):

Sodium chloride; Potassium chloride; Calcium chloride dihydrate

Dávkovanie:

0 milligram(s)/litre

Forma lieku:

Solution for infusion

Typ predpisu:

Product subject to prescription which may not be renewed (A)

Terapeutické oblasti:

Solutions affecting the electrolyte balance; electrolytes

Stav Autorizácia:

Marketed

Dátum Autorizácia:

2003-07-11

Príbalový leták

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 a

Súhrn charakteristických

Health Products Regulatory Authority
10 January 2024
CRN00DVSL
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ringer’s Solution for Infusion, Viaflo container
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
-
: 155.50
mEq/l:
Na
+
: 147
K
+
: 4
Ca
++
: 4.50
Cl
-
: 155.50
_For 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 _litres_ /24h
- for babies and children: 20 ml to 100 ml / kg / 24 h_._
_Administration rate:_
Health Products Regulatory Authority
10 January 2024
CRN00DVSL