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RINGERS SOLUTION

Active substance(s): CALCIUM CHLORIDE DIHYDRATE / POTASSIUM CHLORIDE / SODIUM CHLORIDE / CALCIUM CHLORIDE DIHYDRATE / POTASSIUM CHLORIDE / SODIUM CHLORIDE / CALCIUM CHLORIDE DIHYDRATE / POTASSIUM CHLORIDE / SODIUM CHLORIDE

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Signature

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PLANT APPROVAL
HALLE ONLY

Comments:

Date:
Date:

SA-30-01-989
1a

Sign:

Ringer’s Solution for Infusion is used to treat a loss
of body water (dehydration) and chemicals (e.g. by
heavy sweating, kidney disorders)

Sign:

Ringer’s Solution for Infusion is a solution of the
following substances in water:
• sodium chloride
• potassium chloride
• calcium chloride dihydrate

Errors: Yes / No PR2:

1. What Ringer’s Solution for
Infusion is and what it is used for

Errors: Yes / No PR1:

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

Date: 29 MAR 2016

• 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 breath
– swelling of the ankles
• when there is too much fluid in the body caused
by too many salts in the blood (hypertonic
dehydration)
• higher levels of potassium in the blood than
normal (hyperkalaemia)

ARTWORK APPROVAL
1st DRAFT
RA TO APPROVE
LAYOUT AND
FORMAT
Country

Do NOT receive Ringer’s Solution for
Infusion if you are suffering from any
of the following conditions

Draft: 1st

2. What you need to know before
you are given Ringer’s Solution
for Infusion

Version: 00

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.

ARTWORK DESIGN CENTRE

Active substances: sodium chloride, potassium chloride and calcium chloride
dihydrate

EMEA ARTWORK DESIGN CENTRE

PACKAGE LEAFLET: INFORMATION FOR THE USER
Ringer’s Solution for Infusion

• build up of fluid in the lungs (pulmonary
oedema)
• high blood pressure during pregnancy (preeclampsia)
• a disease that causes high levels of a hormone
called aldosterone (aldosteronism)
• any other condition associated with sodium
retention (when the body retains too much
sodium), such as treatment with steroids (see
also below “Other medicines and Ringer’s
Solution for Infusion”).
• adrenocortical insufficiency (this disease of the
adrenal gland affects hormones that control the
concentration of chemicals in the body).
• a loss of water from the body (acute
dehydration, e.g. from vomiting or diarrhoea)
• extensive tissue damage (as can occur in
severe burns)
• diseases associated with high levels of vitamin
D (e.g. sarcoidosis, a disease affecting the skin
and internal organs)

• higher levels of sodium in the blood than
normal (hypernatraemia)
• higher levels of calcium in the blood than
normal (hypercalcaemia)
• higher levels of chloride in the blood than
normal (hyperchloraemia)
• severe high blood pressure (hypertension)
• build up of fluid under the skin, affecting all
parts of the body (general oedema)
• liver disease that causes fluid to build up within
the abdomen (ascitic cirrhosis)
• if you are taking cardiac glycosides
(cardiotonics) used to treat heart failure,
such as digitalis or digoxin. (see also “Other
Medicines and Ringer’s Solution for Infusion”)

Warnings and precautions
Talk to your doctor or nurse if you have or have
had any of the following medical conditions:
• In patients of any age a certain antibiotic
named ceftriaxone must not be mixed or given
at the same time with any calcium containing
solutions given to you by a drip into your vein.
Your doctor knows this and will not give you
them together even via different infusion lines
or different infusion sites.
• However, in patients older than 28 days your
doctor may give calcium and ceftriaxone
sequentially one after the other if infusion lines
at different sites are used or if the infusion
lines are replaced or were thoroughly flushed
with physiological salt solution between the
infusions to avoid precipitation. If you or your
child suffer from low blood volume your doctor
will avoid giving you or your child calcium and
ceftriaxone sequentially heart failure
• respiratory failure (lung disease) (special
monitoring may be required in the above
conditions)
• any type of heart disease or impaired heart
function
• impaired kidney function
• high blood pressure (hypertension)
• build up of fluid under the skin, particularly
around the ankles (peripheral oedema)

Date:

Date:

SA-30-01-989
2a

Sign:

Once your dehydration has been treated using
Ringer’s Solution for Infusion, your doctor will give
you a different infusion to provide you with enough
potassium and calcium. Your doctor will take into
account if you are receiving parenteral nutrition
(nutrition given by infusion into a vein). If you are
given Ringer’s Solution for Infusion for a long time,
you will be given an extra source of nutrients.

Version: 00

Although Ringer’s Solution for Infusion contains
potassium and calcium, it does not contain enough
to:
• maintain levels of these chemicals
• treat very low blood plasma levels of potassium
(severe potassium deficiency) or calcium
(severe calcium deficiency).

Sign:

When you are given this infusion, your doctor will
take blood and urine samples and monitor:
• the amount of fluid in your body
• your vital signs
• the amount of chemicals such as sodium,
potassium, calcium and chlorides in your blood
(your plasma electrolytes)

Calcium chloride can be harmful if injected into
the body tissues. Therefore, the Ringer’s Solution
for Infusion must not be given by injecting it into a
muscle (intramuscular injection). Also, your doctor
will make every effort to avoid the escape of the
solution into the tissues surrounding the vein.





Ringer’s Solution for Infusion must not be given
through the same needle as a blood transfusion.
This can damage the red blood cells or cause them
to clump together.



(Note that these medicines may be included in
combination medicinal products)
angiotensin converting enzyme (ACE) inhibitors
(used to treat high blood pressure)
angiotensin II receptor antagonists (used to
treat high blood pressure)
tacrolimus (used to prevent rejection of a
transplant and to treat some skin diseases)
cyclosporin (used to prevent rejection of a
transplant)

Other medicines that can affect or be affected by
Ringer’s Solution for Infusion include:
• thiazide diuretics such as hydrochlorothiazide
or chlortalidone
• vitamin D

Other medicines and Ringer’s
Solution for Infusion
Tell your doctor or nurse if you are taking or have
recently taken any other medicines.
It is particularly important that you inform your
doctor if you are taking:

Ringer’s Solution for Infusion with
food and drink

• ceftriaxone (an antibiotic), when given
intravenously (see Warnings and precautions)

You should ask your doctor about what you can eat
or drink.

• cardiac glycosides (cardiotonics) such as
digitalis or digoxin, used to treat heart failure
as they must not be used with Ringer’s
Solution for Infusion (see also section “Do not
receive Ringer’s Solution for Infusion if you are
suffering from…”). The effects of these drugs
can be increased by calcium. This can lead to
life threatening changes to the heart rhythm

Pregnancy, breast-feeding and
fertility
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or nurse for advice before taking
this medicine.

The following medicines can increase the
concentration of potassium in the blood. This
effect can be life-threatening. A rise in the blood
potassium levels is more likely to occur if you have
kidney disease.
• potassium-sparing diuretics (certain water
tablets, e.g. amiloride, spironolactone,
triamterene)

Driving and using machines
Ringer’s Solution for Infusion does not affect your
ability to drive or use machines.
SA-30-01-989
3a

Version: 00

However, if another medicine is to be added to
your solution for infusion during pregnancy or
breast-feeding you should:
• consult your doctor
• read the Package Leaflet of the medicine that
is to be added.

Date:

These medicines can cause the body to
accumulate sodium and water, leading to:
• tissue swelling due to fluid collection under the
skin (oedema)
• high blood pressure (hypertension).

Date:

Calcium can reach your unborn baby through the
placenta and, after birth, through the breast milk.
Your doctor will monitor the levels of chemicals in
your blood and the amount of fluid in your body.

Sign:

• carbenoxolone (an anti-inflammatory medicine
used to treat stomach ulcers)

Sign:

Ringer’s Solution for Infusion can be used safely
during pregnancy or breast-feeding.

• corticosteroids (anti-inflammatory medicines)

• heart block (a very slow heartbeat)
• cardiac arrest (the heart stops beating; a lifethreatening situation)
• confusion
• a decreased appetite (anorexia)
• feeling sick (nausea)
• vomiting
• constipation
• abdominal pain
• mental disturbances such as irritability or
depression
• drinking lots of water (polydipsia)
• producing more urine than normal (polyuria)
• kidney disease due to build up of calcium in the
kidneys (nephrocalcinosis)
• kidney stones
• coma (unconsciousness)
• chalky taste
• redness (hot flushes)
• dilatation of the blood vessels in the skin
(peripheral vasodilatation)
• acidification of the blood (acidosis) leading to
tiredness, confusion, lethargy and increased
breathing rate

3. How to use Ringer’s Solution for
Infusion
Ringer’s Solution for Infusion will be given to you
by a doctor or nurse. Your doctor will decide on
how much you need and when it is to be given.
This will depend on your age, weight, and condition
and the reason for treatment. The amount you are
given may also be affected by other treatments
you are receiving.
You should NOT be given Ringer’s Solution for
Infusion if there are particles floating in the
solution or if the pack is damaged in any way.
Ringer’s Solution for Infusion will usually be given
to you through a plastic tube attached to a needle
in a vein. Usually a vein in your arm is used to give
you the infusion. However, your doctor may use
another method to give you the medicine.
When you are given Ringer’s Solution for Infusion,
your doctor will perform blood tests to monitor
your:
• blood levels of sodium, potassium, calcium and
chloride
• your fluid levels

If you are given too much Ringer’s Solution for
Infusion (over-infusion), or you are given your
infusion too quickly, this may lead to the following
symptoms:
• water and/or sodium (salt) overload with build
up of liquid in the tissues (oedema) causing
swelling
• pins and needles in the arms and legs
(paresthesia)
• muscle weakness
• an inability to move (paralysis)
• an irregular heartbeat (cardiac arrhythmias)

Stop receiving your Ringer’s Solution
for Infusion

Date:

If you receive more Ringer’s Solution
for Infusion than you should

Date:

If a medicine has been added to your Ringer’s
Solution for Infusion before over-infusion occurs,
that medicine may also cause symptoms. You
should read the Package Leaflet of the added
medicine for a list of possible symptoms.

Sign:

Any unused solution should be thrown away.
You should NOT be given an infusion of Ringer’s
Solution for Infusion from a bag that has been
partly used.

Sign:

If you develop any of these symptoms you must
inform your doctor immediately. Your infusion
will be stopped and you will be given treatment
depending on the symptoms.

Your doctor will decide when to stop giving you
this infusion.

SA-30-01-989
4a

Version: 00

If you have any further questions on the use of this
medicine, ask your doctor or nurse.

Reporting of side effects

4. Possible side effects

If you get any side effects, talk to your doctor or
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can
also report side effects directly via the national
reporting system listed below. By reporting side
effects you can help provide more information on
the safety of this medicine.

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
The side effects are listed according to their
frequencies.
Very common (occurring in more than 1 of every
10 patients)
• changes in the concentrations of the chemicals
in the blood (electrolyte disturbances)
If you suffer from heart disease or fluid in the
lungs (pulmonary oedema):
• too much fluid in the body (hyperhydration)
• heart failure

United Kingdom:
Via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard

Ireland:
HPRA Pharmacovigilance,
Earlsfort Terrace,
IRL - Dublin 2;
Tel: +353 1 6764971;
Fax: +353 1 6762517.
Website: www.hpra.ie;
E-mail: medsafety@hpra.ie.

Other





reactions due to the administration technique:
fever (febrile response)
infection at the site of infusion
local pain or reaction (redness or swelling at
the site of infusion)
• irritation and inflammation of the vein into
which the solution is infused (phlebitis).
This can cause redness, pain or burning and
swelling along the path of the vein into which
the solution is infused.
• the formation of a blood clot (venous
thrombosis) at the site of infusion, which
causes pain, swelling or redness in the area of
the clot
• escape of the infusion solution into the tissues
around the vein (extravasation). This can
damage the tissues and cause scarring.

Malta:
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D’Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt

Date:

Date:
Sign:

Keep this medicine out of the sight and reach of
children.

If a medicine has been added to the solution for
infusion, the added medicine may also cause side
effects. These side effects will depend on the
medicine that has been added. You should read the
Package Leaflet of the added medicine for a list of
possible symptoms.

Sign:

5. How to store Ringer’s Solution
for Infusion

This medicinal product does not require any
special temperature storage conditions

If you get any side effects, talk to your doctor or
nurse. This includes any possible side effects not
listed in this leaflet.

Do not use this medicine if you notice particles
floating in the solution or if the unit is damaged in
any way.
SA-30-01-989
5a

Version: 00

Do not use this medicine after the expiry date
which is stated on the bag. The expiry date refers
to the last day of that month.

Baxter Healthcare Ltd.
Caxton Way,
Thetford Norfolk IP24 3SE
United Kingdom

6. Contents of the pack and other
information
What Ringer’s Solution for Infusion
contains

Bieffe Medital S.A.
Ctra de Biescas, Senegüé
22666 Sabiñánigo (Huesca)
Spain

The active substances are:
• sodium chloride: 8.60 g per litre
• potassium chloride: 0.30 g per litre
• calcium chloride dihydrate: 0.33 g per litre
The other ingredients are:
• water for injections
• sodium hydroxide

This leaflet was last revised in March 2016

For information about Ringer’s
Solution for Infusion or to request
this leaflet in formats such as audio
or large print please contact the
Marketing Authorisation Holder:
Tel: +44 (0)1635 206345

What Ringer’s Solution for Infusion
looks like and contents of the pack
Ringer’s Solution for Infusion is a clear solution,
free from visible particles.
It is supplied in a polyolefin/polyamide plastic
bags (Viaflo). Each bag is wrapped in a sealed,
protective, outer plastic overpouch.
The bag sizes are:
• 500 ml
• 1000 ml
The bags are supplied in cartons. Each carton
contains one of the following quantities:
• 20 bags of 500 ml
• 10 bags of 1000 ml
Not all pack sizes may be marketed

Date:

Manufacturers:

Date:

Baxter Healthcare Ltd.
Caxton Way,
Thetford Norfolk IP24 3SE
United Kingdom

Sign:

Marketing Authorisation Holder:

Sign:

Marketing Authorisation Holder and
Manufacturers

SA-30-01-989
6a

Version: 00

Baxter and Viaflo are trademarks of
Baxter International lnc.

Baxter SA
Boulevard René Branquart, 80
7860 Lessines
Belgium

Ringer’s Solution for Infusion
The following information
is intended for healthcare
professionals only:
Handling and Preparation

administration technique might cause the
appearance of fever reactions due to the possible
introduction of pyrogens. In case of adverse
reaction, infusion must be stopped immediately.
Discard after single use.
Discard any unused portion.
Do not reconnect partially used bags.

Use only if the solution is clear, without visible
particles and if the container is undamaged.
Administer immediately following the insertion of
infusion set.
Do not remove unit from overwrap until ready for
use.
The inner bag maintains the sterility of the product.
Do not use plastic containers in series
connections. Such use could result in air embolism
due to residual air being drawn from the primary
container before the administration of the fluid
from the secondary container is completed.
Pressurizing intravenous solutions contained
in flexible plastic containers to increase flow
rates can result in air embolism if the residual
air in the container is not fully evacuated prior
to administration. Use of a vented intravenous
administration set with the vent in the open
position could result in air embolism. Vented
intravenous administration sets with the vent in
the open position should not be used with flexible
plastic containers.
The solution should be administered with sterile
equipment using an aseptic technique. The
equipment should be primed with the solution in
order to prevent air entering the system.
Additives may be introduced before infusion or
during infusion through the re-sealable medication
port.
When additive is used, verify isotonicity prior to
parenteral administration. Thorough and careful
aseptic mixing of any additive is mandatory.
Solutions containing additives should be used
immediately and not stored.
Adding medication or using an incorrect

1. Opening
a. Remove the Viaflo container from the
overpouch just before use.
b. Check for minute leaks by squeezing inner bag
firmly. If leaks are found, discard solution, as
sterility may be impaired.
c. Check the solution for limpidity and absence
of foreign matters. If solution is not clear or
contains foreign matters, discard the solution.

Date:

SA-30-01-989

1b

Date:

Warning: Additives may be incompatible (see
paragraph 5 “Incompatibilities of additive
medications” below).

Sign:

3. Techniques for injection of
additive medications

Version: 00

Use sterile material for preparation and
administration.
a. Suspend container from eyelet support.
b. Remove plastic protector from outlet port at
bottom of container:
– grip the small wing on the neck of the port
with one hand,
– grip the large wing on the cap with the other
hand and twist,
– the cap will pop off.
c. Use an aseptic method to set up the infusion.
d. Attach administration set. Refer to complete
directions accompanying set for connection,
priming of the set and administration of the
solution.

Sign:

2. Preparation for administration

for eventual colour change and/or eventual
appearance of precipitate, insoluble complexes or
crystals. The Instructions for Use of the medicinal
product to be added must be consulted.
Before adding a drug, verify it is soluble and stable
in water at the pH of Ringer’s Solution for Infusion
(pH: 5.0 to 7.5).
Calcium salts have been reported to be
incompatible with a wide range of drugs.
Complexes may form resulting in the formation of
a precipitate.
• Concomitant treatment with ceftriaxone and
Ringer’s Solution for Infusion is contraindicated
in preterm newborn infants and term newborn
infants (≤28 days of age), even if separate
infusion lines are used.
• In patients of any age ceftriaxone must not be
mixed or administered simultaneously with
any calcium-containing IV solutions even via
different infusion lines or infusion sites.
• If the same infusion line is used for sequential
administration, the line must be thoroughly
flushed between infusions with a compatible
fluid.
• Sequential infusions of ceftriaxone and
calcium-containing products must be avoided
in case of hypovolaemia

To add medication before administration
a. Disinfect medication port.
b. Using syringe with 19 gauge (1.10 mm) to 22
gauge (0.70 mm) needle, puncture re-sealable
medication port and inject.
c. Mix solution and medication thoroughly. For
high-density medication such as potassium
chloride, tap the ports gently while ports are
upright and mix.
Caution: Do not store bags containing added
medications.
To add medication during administration
a. Close clamp on the set
b. Disinfect medication port.
c. Using syringe with 19 gauge (1.10 mm) to 22
gauge (0.70 mm) needle, puncture re-sealable
medication port and inject.
d. Remove container from IV pole and/or turn to
an upright position.
e. Evacuate both ports by tapping gently while the
container is in an upright position.
f. Mix solution and medication thoroughly.
g. Return container to in use position, re-open the
clamp and continue administration

4. In-use shelf life (Additives)
The chemical and physical stability of any additive
at the pH of the Ringer’s solution in the Viaflo
container should be established prior to use.
From a microbiological point of view, the
product should be used immediately. If not used
immediately, in-use storage times and conditions
prior to use are the responsibility of the user and
would normally not be longer than 24 hours at 2
to 8°C, unless reconstitution has taken place in
controlled and validated aseptic conditions.

As a guidance, the following medications are
incompatible with the Ringer’s Solution (nonexhaustive listing):
• Amphotericin B

Date:

Date:

• Etamivan

Sign:

• Erythromycin lactobionate

Sign:

• Cortisone

• Ethyl alcohol

5. Incompatibilities of additive
medications

• Thiopental sodium

As with all parenteral solutions, before adding
medications, compatibility of these additives with
the solution in Viaflo container must be assessed.
It is the responsibility of the physician to judge
the incompatibility of an additive medication with
the Ringer’s Solution for Infusion by checking

Those additives known to be incompatible should
not be used.

Baxter and Viaflo are trademarks of
Baxter International lnc.
SA-30-01-989
2b

Version: 00

• Disodium edetate

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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