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PLASMA-LYTE 148 (PH 7.4) SOLUTION FOR INFUSION

Active substance(s): MAGNESIUM CHLORIDE HEXAHYDRATE / POTASSIUM CHLORIDE / SODIUM ACETATE TRIHYDRATE / SODIUM CHLORIDE / SODIUM GLUCONATE / MAGNESIUM CHLORIDE HEXAHYDRATE / POTASSIUM CHLORIDE / SODIUM ACETATE TRIHYDRATE / SODIUM CHLORIDE / SODIUM GLUCONATE

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(and pages ___ to ___ for TIL)
Applicable for pages ___ to ___

DRAFT
Comments:

Date:

Date

Signature

Name

Country

ARTWORK APPROVAL
2nd DRAFT
LAYOUT AND FORMAT
PLANT APPROVAL
APPROVAL
HALLE ONLY

Date:

SA-30-02-174
1a

Sign:

Pharmacotherapeutic group: “Electrolytes” - ATC
code: “B05BB01”
Plasma-Lyte 148 (pH 7.4) Infusion is a solution of
the following substances in water:
• sodium chloride
• potassium chloride

Sign:

1. What Plasma-Lyte 148 (pH 7.4)
Infusion is and what it is used
for

Errors: Yes / No PR2:

Plasma-Lyte 148 (pH 7.4) infusion can be used
• in adults, elderly and adolescents
• in infants and toddlers from 28 days to 23
months and children from 2 to 11 years.

Errors: Yes / No PR1:

What is in this leaflet:
1. What Plasma-Lyte 148 (pH 7.4) Infusion is
and what it is used for
2. What you need to know before you use
Plasma-Lyte 148 (pH 7.4) Infusion
3. How to use Plasma-Lyte 148 (pH 7.4)
Infusion
4. Possible side effects
5. How to store Plasma-Lyte 148 (pH 7.4)
Infusion
6. Contents of the pack and other information

EMEA ARTWORK DESIGN CENTRE

This medicine is called `Plasma-Lyte 148 (pH 7.4)
Solution for Infusion’, but will be referred to as
`Plasma-Lyte 148 (pH 7.4) infusion’ throughout the
remainder of this leaflet.

Draft: 2nd

Plasma-Lyte 148 (pH 7.4) infusion is used:
• to provide a source of fluid, for example in
cases of:
– burns
– head injury
– fractures
– infection
– peritoneal irritation (inflammations within
the abdomen)
• as a source of fluids during a surgical
operation
• for the treatment of shock due to loss of
blood and for other conditions needing rapid
replacement of blood and/or fluids
• in metabolic acidosis (when the blood
becomes too acid) that is not life-threatening
• lactic acidosis (a type of metabolic acidosis
caused by the accumulation of lactic acid in
the body). Lactic acid is produced mainly by
the muscles and is removed by the liver.

Date: 19 apr 2017

• magnesium chloride hexahydrate
• sodium acetate trihydrate
• sodium gluconate
Sodium, potassium, magnesium, chloride, acetate
and gluconate are chemical substances found in
the blood.

Version: 03

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

Artworker: B. Chantry

Active substances: sodium chloride, potassium chloride, magnesium chloride
hexahydrate, sodium acetate trihydrate and sodium gluconate

ARTWORK DESIGN CENTRE

Package leaflet: Information for the user
Plasma-Lyte 148 (pH 7.4) Solution for Infusion



2. What you need to know before
you use Plasma-Lyte 148 (pH
7.4) Infusion
You must NOT receive Plasma-Lyte 148
(pH 7.4) Infusion if you are suffering
from any of the following conditions

When you are given this infusion, your doctor will
take blood and urine samples to monitor:
• the amount of fluid in your body
• the amount of chemicals such as sodium
and potassium in your blood and urine (your
plasma and urine electrolytes)
• your acid-base balance (the acidity of the
blood and urine)

Warnings and precautions
Please tell your doctor if you have or have had any
of the following medical conditions.
• heart failure
• respiratory failure (lung disease)
• kidney failure
(special monitoring may be required in the
above conditions).
• high blood pressure (hypertension)
• build up of fluid under the skin, particularly
around the ankles (peripheral oedema)
• build up of fluid in the lungs (pulmonary
oedema)
• high blood pressure during pregnancy (preeclampsia or eclampsia)
• aldosteronism (a disease that causes high
levels of a hormone called aldosterone)
• any other condition associated with sodium
retention (when the body retains too much
sodium), such as treatment with steroids (See
also below, “Other medicines”).
• higher levels of chloride in the blood than
normal (hyperchloraemia)
• higher levels of sodium in the blood than
normal (hypernatraemia)
• lower levels of calcium in the blood than
normal (hypocalcaemia)
• any condition that means you are more
likely to have high blood levels of potassium
(hyperkalaemia), such as:
– kidney failure

Although Plasma-Lyte 148 (pH 7.4) Infusion
contains potassium, it does not contain enough to
treat severe potassium deficiency (very low blood
plasma levels).
Plasma-Lyte 148 (pH 7.4) Infusion contains
substances that can cause metabolic alkalosis
(making the blood too alkaline).
If repeated treatment is required, your doctor will
also give you other types of infusions. These will
cover the needs of your body for other chemicals
and nutrients (food).

Other medicines and Plasma-Lyte 148
(pH 7.4) Infusion

Date:

If your blood is tested for the presence of a
fungus called Aspergillus, the test may detect the
presence of Aspergillus even if it is not present.

Sign:





Date:





Sign:





higher levels of potassium in the blood than
normal (hyperkalaemia)
kidney failure
heart block (a very slow heart beat)
disorders in which the blood becomes too
alkaline (metabolic or respiratory alkalosis)
a deficiency of acid secretion in the stomach
(hypochlorhydria)
hypersensitivity to the active substances or to
any of the ingredients listed in section 6.

Tell your doctor or pharmacist if you are taking or
have recently taken any other medicines.
The use of the following medicines is not
recommended while you are receiving an infusion
of Plasma-Lyte 148 (pH 7.4) Infusion:
• potassium-sparing diuretics (certain water
tablets, e.g. amiloride, spironolactone,
triamterene, potassium canrenoate)
• angiotensin converting enzyme (ACE) inhibitors
(used to treat high blood pressure)
SA-30-02-174
2a

Version: 03



adrenocortical insufficiency (this disease
of the adrenal gland affects hormones that
control the concentration of chemicals in
the body)
– acute dehydration (a loss of water from
the body, e.g. due to vomiting or diarrhoea)
– extensive tissue damage (as can occur in
severe burns)
(In such cases, close monitoring of your blood
potassium level is required)
myasthenia gravis (a disease that causes
progressive muscle weakness)
recovery after an operation

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 Patient Information Leaflet of the
medicine that is to be added



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)
These medicines can increase the concentration
of potassium in your blood. This can be lifethreatening. A rise in your blood potassium levels
is more likely to occur if you have kidney disease.

Driving and using machines
Ask your doctor or pharmacist for advice before
driving or using machines.

Other medicines that can affect or be affected by
Plasma-Lyte 148 (pH 7.4) Infusion:
• corticosteroids (anti-inflammatory medicines)
• carbenoxolone (an anti-inflammatory medicine
used to treat stomach ulcers)
• neuromuscular blocking agents (e.g.
tubocurarine, suxamethonium and
vecuronium). These are medicines used in
surgical operations and are controlled by your
anaesthetist.
• acetylcholine
• aminoglycosides (a type of antibiotic)
• nifedipine (used to treat high blood pressure
and chest pain)
• acidic medicines including:
– salicylates used to treat inflammation
(aspirin)
– sleeping tablets (barbiturates)
– lithium (used to treat psychiatric illnesses)
• alkaline (basic) medicines including:
– sympathomimetics (stimulant medicines
such as ephedrine and pseudoephedrine,
used in cough and cold preparations)
– other stimulants (e.g. dexamphetamine,
phenfluramine)

3. How to use Plasma-Lyte 148 (pH
7.4) Infusion
You will be given Plasma-Lyte 148 (pH 7.4) Infusion
by a doctor or nurse. Your doctor will decide how
much you need and when it is to be administered.
This will depend on your age, weight, 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 Plasma-Lyte 148 (pH
7.4) Infusion if there are particles floating in the
solution or if the pack is damaged in any way.
Plasma-Lyte 148 (pH 7.4) 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.
Any unused solution should be thrown away. You
should NOT be given an infusion of Plasma-Lyte
148 (pH 7.4) Infusion from a bag that has been
partly used.

If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor for advice before taking this
medicine.
You may receive Plasma-Lyte 148 (pH 7.4) Infusion
if you are pregnant or breast-feeding. Your doctor
will monitor the levels of chemicals in your blood
and the amount of fluid in your body.

SA-30-02-174

3a

Date:

Pregnancy, breast-feeding and fertility

Sign:

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

Date:

If you are given too much Plasma-Lyte 148 (pH 7.4)
Infusion (over-infusion) or it is given too fast, 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
(paraesthesia)
• muscle weakness
• an inability to move (paralysis)
• an irregular heartbeat (cardiac arrhythmias)
• heart block (a very slow heartbeat)
• cardiac arrest (the heart stops beating; a life
threatening situation)

Sign:

Plasma-Lyte 148 (pH 7.4) Infusion with
food and drink

Version: 03

If you receive more Plasma-Lyte 148 (pH
7.4) Infusion than you should

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.
If a medicine has been added to your Plasma-Lyte
148 (pH 7.4) Infusion before over-infusion occurs,
that medicine may also cause symptoms. You
should read the Patient Information Leaflet of the
added medicine for a list of possible symptoms.

Stopping your Plasma-Lyte 148 (pH 7.4)
Infusion
Your doctor will decide when to stop giving you
this infusion.
If you have any further questions on the use of this
medicine, ask your doctor or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
If you have any of the following symptoms you
should tell your doctor or nurse immediately. These
may be signs of a very severe or even fatal allergic
(hypersensitivity) reaction:

SA-30-02-174
4a

Date:

The other side effects are:
• reactions due to the administration technique:
– fever (febrile response)
– infection at the site of infusion
– burning sensation
– 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.
• an excess of fluid in the body (hypervolaemia).
• fits (seizures)
• hives (urticaria)
• serious allergic reaction which causes
difficulty in breathing or dizzines
(anaphylactoid reaction)
• a fast heartbeat (tachycardia)
• palpitations
• chest pain
• chest discomfort
• shortness of breath (dyspnea)
• respiratory rate increased
• flushing
• hyperaemia
• feeling of weakness (asthenia)
• feeling abnormal
• piloerection
• oedema peripheral
• fever (pyrexia)

Sign:

You will be given treatment depending on the
symptoms

Date:












swelling of the skin of the face, lips and
swelling of the throat
difficulty breathing
skin rash
redness of the skin (erythema)

Sign:





confusion
loss of the tendon reflexes
reduced breathing (respiratory depression)
feeling sick (nausea)
vomiting
flushing (redness) of the skin
thirst
low blood pressure (hypotension)
drowsiness
a slow heartbeat (bradycardia)
coma (unconsciousness)
acidification of the blood (acidosis), leading to
tiredness, confusion, lethargy and increased
breathing rate.
Hypokalaemia (lower levels of potassium in
the blood than normal) and metabolic alkalosis
(when the blood becomes too alkaline)
especially in patients with kidney failure
mood change
tiredness
shortness of breath
stiffness of muscles
twitching of the muscles
contractions of muscles

Version: 03














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
Patient Information Leaflet of the added medicine
for a list of possible symptoms.

6. Contents of the pack and other
information
What Plasma-Lyte 148 (pH 7.4) Infusion
contains

Other side effects noted with similar products
• Other manifestations of hypersensitivity/
infusion reactions: low blood pressure
(hypotension), Wheezing, Cold sweat, Chills,
• Hyperkalaemia

The active substances are:
• sodium chloride: 5.26 g per litre
• potassium chloride: 0.37 g per litre
• magnesium chloride hexahydrate: 0.30 g per
litre
• sodium acetate trihydrate: 3.68 g per litre
• sodium gluconate: 5.02 g per litre
The other ingredients are:
• water for injections
• sodium hydroxide

Reporting of side effects
If you get any side effects, talk to your doctor
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.
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.
Malta
Website: www.medicinesauthority.gov.mt/adrportal

What Plasma-Lyte 148 (pH 7.4) Infusion
looks like and contents of the pack
Plasma-Lyte 148 (pH 7.4) Solution for Infusion
is a clear solution, free from visible particles.
It is supplied in polyolefin/polyamide plastic
bags (Viaflo). Each bag is wrapped in a sealed,
protective, outer plastic overpouch.
The bag sizes are:
• 500 ml
• 1000 ml

This medicinal product does not require any
special temperature storage conditions.

Baxter SA
Boulevard René Branquart, 80
7860 Lessines
Belgium

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.
Do not use this medicine if you notice particles
floating in the solution or if the unit is damaged in
any way.

SA-30-02-174
5a

Date:

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

Version: 03

Marketing Authorisation Holder:
Baxter Healthcare Ltd.
Caxton Way,
Thetford Norfolk IP24 3SE
United Kingdom
Manufacturers:

Sign:

5. How to store Plasma-Lyte 148
(pH 7.4) Infusion

Date:

Marketing Authorisation Holder and
Manufacturers

Sign:

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.

Baxter Healthcare Ltd.
Caxton Way,
Thetford Norfolk IP24 3SE
United Kingdom
Bieffe Medital S.A.
Ctra de Biescas, Senegüé
22666 Sabiñánigo (Huesca)
Spain
Baxter Manufacturing Sp. z o.o.
42 B Wojciechowska Str.
20-704 Lublin
Poland

Poland:
Portugal:
Slovenia:
Slovakia:
Sweden:
United Kingdom:

This medicinal product is authorised in the
Member States of the EEA under the following
names:
Austria:
Plasmalyt – Infusionslösung
Belgium, Luxemburg: Plasmalyte A Viaflo, solution
pour perfusion
Croatia:
Plasma-Lyte 148 (pH 7,4)
Viaflo, otopina za infuziju
Czech Republic:
Plasmalyte roztok
Cyprus:
Plasma-Lyte 148 (pH 7,4)
Solution for infusion
Spain:
Viaflo Plasmalyte 148
(pH 7,4), solución para
perfusion
Denmark:
Plasmalyte, infusionsvæske,
opløsning
Finland:
Plasmalyte infuusioneste,
liuos
France:
Plasmalyte Viaflo, solution
pour perfusion
Greece:
Plasma-Lyte 148 (pH 7,4)
Solution for infusion
Iceland:
Plasmalyte innrennslislyf,
lausn
Ireland:
Plasma-Lyte 148 (pH 7.4)
Solution for infusion
Italy:
CrystalSol Solution for
infusion
Lithuania:
Plasmalyte infuzinis tirpalas
Malta:
Plasma-Lyte 148 (pH 7.4)
Solution for infusion
Netherlands:
Plasma-Lyte 148, oplossing
voor infusie
Norway:
Plasmalyte infusjonsvæske,
oppløsning

Plasmalyte roztwór do
infuzji
Plasma-Lyte (ph 7,4) 148
Viaflo
Plaslyte raztopina za
infundiranje
Plasmalyte infúzny roztok
Plasmalyte infusionsvätska,
lösning
Plasma-Lyte 148(pH 7.4)
Solution for Infusion

This leaflet was last revised in 04/2017

Date:

Date:

Sign:

Sign:

For information about Plasma-Lyte 148
(pH 7.4) 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.

SA-30-02-174
6a

Version: 03

Baxter, Plasma-Lyte and Viaflo are trademarks of
Baxter International lnc.

Plasma-Lyte 148 (pH 7.4) Solution for Infusion
The following information
is intended for healthcare
professionals only:

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 broken.
c. Check the solution for clarity and absence
of foreign matters. If solution is not clear
or contains foreign matters, discard the
solution.

Handling and Preparation
This solution should be inspected visually for
particulate matter and discolouration prior to
administration whenever solution and container
permit. Do not administer unless the solution is
clear and the seal is intact.Do not remove unit from
overwrap until ready for use.
The inner bag maintains the sterility of the product.
Administer immediately following the insertion of
infusion set.
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 is for intravenous administration
through sterile administration set using 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.
Adding other medications or using an incorrect
administration technique might cause the
appearance of fever reactions due to the possible
introduction of pyrogens. In case of an adverse
reaction, infusion must be stopped immediately.
Discard after single use.
Discard any unused portion.
Do not reconnect partially used bags.

2. Preparation for administration
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.

Date:

Date:
Sign:

SA-30-02-174
1b

Sign:

Warning: Additives may be incompatible Check
additive compatibility with both the solution and
container prior to use.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. (see Paragraph 5 “Incompatibilities of
additive medications” below).

Version: 03

3. Techniques for injection of additive
medications

5. Incompatibilities of additive
medications

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.

When introducing additives to Plasma-Lyte 148
(pH 7.4), aseptic technique must be used. Mix the
solution thoroughly when additives have been
introduced. Do not store solutions containing
additives.
Incompatibility of the medicinal product to be
added with the solution in Viaflo container must be
assessed before addition.
The Instructions for Use of the medicinal product
to be added must be consulted.

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.

Before adding a substance or medication, verify
it is soluble and/or stable in water and that
the pH range of Plasma-Lyte 148 (pH 7.4) is
appropriate (pH 6.5 - 8.0). After addition, check for
a possible colour change and/or the appearance of
precipitates, insoluble complexes or crystals.
Those additives known to be incompatible should
not be used.

Date:
Sign:

SA-30-02-174
2b

Date:
Baxter, Plasma-Lyte and Viaflo are trademarks of
Baxter International lnc.

Version: 03

Chemical and physical stability of any additive at
the pH of Plasmalyte 148 (pH 7.4) solution in the
Viaflo container should be established prior to use.
From a microbiological point of view, the diluted
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.

Sign:

4. Shelf life after first opening: The
product should be used immediately
after opening.
In-use shelf-life after reconstitution
with additives:

(and pages ___ to ___ for TIL)
Applicable for pages ___ to ___

DRAFT
Date:
Date:

Comments:

Sign:
Sign:

Date

Signature

Name

Country

EMEA ARTWORK DESIGN CENTRE

Errors: Yes / No PR2:

TH-30-01-842
1

Errors: Yes / No PR1:

What is in this leaflet:
1. What Plasma-Lyte 148 (pH 7.4) Infusion is
and what it is used for
2. What you need to know before you use
Plasma-Lyte 148 (pH 7.4) Infusion
3. How to use Plasma-Lyte 148 (pH 7.4)
Infusion
4. Possible side effects
5. How to store Plasma-Lyte 148 (pH 7.4)
Infusion
6. Contents of the pack and other information

Draft: 2nd

This medicine is called `Plasma-Lyte 148 (pH 7.4)
Solution for Infusion’, but will be referred to as
`Plasma-Lyte 148 (pH 7.4) infusion’ throughout the
remainder of this leaflet.

Date: 14 apr 2017

Pharmacotherapeutic group: “Electrolytes” - ATC
code: “B05BB01”
Plasma-Lyte 148 (pH 7.4) Infusion is a solution of
the following substances in water:
• sodium chloride
• potassium chloride
• magnesium chloride hexahydrate
• sodium acetate trihydrate
• sodium gluconate
Sodium, potassium, magnesium, chloride, acetate
and gluconate are chemical substances found in
the blood.
Plasma-Lyte 148 (pH 7.4) infusion is used:
• to provide a source of fluid, for example in
cases of:
– burns
– head injury
– fractures
– infection
– peritoneal irritation (inflammations within
the abdomen)
• as a source of fluids during a surgical
operation
• for the treatment of shock due to loss of
blood and for other conditions needing rapid
replacement of blood and/or fluids
• in metabolic acidosis (when the blood
becomes too acid) that is not life-threatening
• lactic acidosis (a type of metabolic acidosis
caused by the accumulation of lactic acid in
the body). Lactic acid is produced mainly by
the muscles and is removed by the liver.

Version: 02

1. What Plasma-Lyte 148 (pH
7.4) Infusion is and what it is
used for

Artworker: E. Mahieu

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 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, magnesium chloride
hexahydrate, sodium acetate trihydrate and sodium gluconate

ARTWORK APPROVAL
2nd DRAFT
LAYOUT AND FORMAT
PLANT APPROVAL
APPROVAL
HALLE ONLY

Package leaflet: Information for the user
Plasma-Lyte 148 (pH 7.4) Solution for Infusion

Plasma-Lyte 148 (pH 7.4) infusion can be used
• in adults, elderly and adolescents
• in infants and toddlers from 28 days to 23
months and children from 2 to 11 years.

normal (hypernatraemia)
lower levels of calcium in the blood than
normal (hypocalcaemia)
• any condition that means you are more
likely to have high blood levels of potassium
(hyperkalaemia), such as:
– kidney failure
– adrenocortical insufficiency (this disease
of the adrenal gland affects hormones that
control the concentration of chemicals in
the body)
– acute dehydration (a loss of water from
the body, e.g. due to vomiting or diarrhoea)
– extensive tissue damage (as can occur in
severe burns)
(In such cases, close monitoring of your blood
potassium level is required)
• myasthenia gravis (a disease that causes
progressive muscle weakness)
• recovery after an operation
When you are given this infusion, your doctor will
take blood and urine samples to monitor:
• the amount of fluid in your body
• the amount of chemicals such as sodium
and potassium in your blood and urine (your
plasma and urine electrolytes)
• your acid-base balance (the acidity of the
blood and urine)
Although Plasma-Lyte 148 (pH 7.4) Infusion
contains potassium, it does not contain enough to
treat severe potassium deficiency (very low blood
plasma levels).
Plasma-Lyte 148 (pH 7.4) Infusion contains
substances that can cause metabolic alkalosis
(making the blood too alkaline).
If repeated treatment is required, your doctor will
also give you other types of infusions. These will
cover the needs of your body for other chemicals
and nutrients (food).
If your blood is tested for the presence of a
fungus called Aspergillus, the test may detect the
presence of Aspergillus even if it is not present.




Warnings and precautions
Please tell your doctor if you have or have had any
of the following medical conditions.
• heart failure
• respiratory failure (lung disease)
• kidney failure
(special monitoring may be required in the
above conditions).
• high blood pressure (hypertension)
• build up of fluid under the skin, particularly
around the ankles (peripheral oedema)
• build up of fluid in the lungs (pulmonary
oedema)
• high blood pressure during pregnancy (preeclampsia or eclampsia)
• aldosteronism (a disease that causes high
levels of a hormone called aldosterone)
• any other condition associated with sodium
retention (when the body retains too much
sodium), such as treatment with steroids (See
also below, “Other medicines”).
• higher levels of chloride in the blood than
normal (hyperchloraemia)
• higher levels of sodium in the blood than

Other medicines and Plasma-Lyte 148
(pH 7.4) Infusion
Tell your doctor or pharmacist if you are taking or
have recently taken any other medicines.
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Date:





higher levels of potassium in the blood than
normal (hyperkalaemia)
kidney failure
heart block (a very slow heart beat)
disorders in which the blood becomes too
alkaline (metabolic or respiratory alkalosis)
a deficiency of acid secretion in the stomach
(hypochlorhydria)
hypersensitivity to the active substances or to
any of the ingredients listed in section 6.

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Date:

You must NOT receive Plasma-Lyte 148
(pH 7.4) Infusion if you are suffering
from any of the following conditions

Sign:

2. What you need to know
before you use Plasma-Lyte
148 (pH 7.4) Infusion

Version: 02



Pregnancy, breast-feeding and fertility

The use of the following medicines is not
recommended while you are receiving an infusion
of Plasma-Lyte 148 (pH 7.4) Infusion:
• potassium-sparing diuretics (certain water
tablets, e.g. amiloride, spironolactone,
triamterene, potassium canrenoate)
• 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)
These medicines can increase the concentration
of potassium in your blood. This can be lifethreatening. A rise in your blood potassium levels
is more likely to occur if you have kidney disease.

If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor for advice before taking this
medicine.
You may receive Plasma-Lyte 148 (pH 7.4) Infusion
if you are pregnant or breast-feeding. Your doctor
will monitor the levels of chemicals in your blood
and the amount of fluid in your body.
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 Patient Information Leaflet of the
medicine that is to be added

Driving and using machines
Ask your doctor or pharmacist for advice before
driving or using machines.

Other medicines that can affect or be affected by
Plasma-Lyte 148 (pH 7.4) Infusion:
• corticosteroids (anti-inflammatory medicines)
• carbenoxolone (an anti-inflammatory medicine
used to treat stomach ulcers)
• neuromuscular blocking agents (e.g.
tubocurarine, suxamethonium and
vecuronium). These are medicines used in
surgical operations and are controlled by your
anaesthetist.
• acetylcholine
• aminoglycosides (a type of antibiotic)
• nifedipine (used to treat high blood pressure
and chest pain)
• acidic medicines including:
– salicylates used to treat inflammation
(aspirin)
– sleeping tablets (barbiturates)
– lithium (used to treat psychiatric illnesses)
• alkaline (basic) medicines including:
– sympathomimetics (stimulant medicines
such as ephedrine and pseudoephedrine,
used in cough and cold preparations)
– other stimulants (e.g. dexamphetamine,
phenfluramine)

3. How to use Plasma-Lyte 148
(pH 7.4) Infusion
You will be given Plasma-Lyte 148 (pH 7.4) Infusion
by a doctor or nurse. Your doctor will decide how
much you need and when it is to be administered.
This will depend on your age, weight, condition
and the reason for treatment. The amount you are
given may also be affected by other treatments
you are receiving.

Date:

Date:
Sign:

Plasma-Lyte 148 (pH 7.4) 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.

Sign:

You should NOT be given Plasma-Lyte 148 (pH
7.4) Infusion if there are particles floating in the
solution or if the pack is damaged in any way.

If you receive more Plasma-Lyte 148
(pH 7.4) Infusion than you should

Plasma-Lyte 148 (pH 7.4) Infusion with
food and drink

If you are given too much Plasma-Lyte 148 (pH 7.4)

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

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Version: 02

Any unused solution should be thrown away. You
should NOT be given an infusion of Plasma-Lyte
148 (pH 7.4) Infusion from a bag that has been
partly used.

Stopping your Plasma-Lyte 148 (pH 7.4)
Infusion

Infusion (over-infusion) or it is given too fast, 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
(paraesthesia)
• muscle weakness
• an inability to move (paralysis)
• an irregular heartbeat (cardiac arrhythmias)
• heart block (a very slow heartbeat)
• cardiac arrest (the heart stops beating; a life
threatening situation)
• confusion
• loss of the tendon reflexes
• reduced breathing (respiratory depression)
• feeling sick (nausea)
• vomiting
• flushing (redness) of the skin
• thirst
• low blood pressure (hypotension)
• drowsiness
• a slow heartbeat (bradycardia)
• coma (unconsciousness)
• acidification of the blood (acidosis), leading to
tiredness, confusion, lethargy and increased
breathing rate.
• Hypokalaemia (lower levels of potassium in
the blood than normal) and metabolic alkalosis
(when the blood becomes too alkaline)
especially in patients with kidney failure
• mood change
• tiredness
• shortness of breath
• stiffness of muscles
• twitching of the muscles
• contractions of muscles

Your doctor will decide when to stop giving you
this infusion.
If you have any further questions on the use of this
medicine, ask your doctor or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
If you have any of the following symptoms you
should tell your doctor or nurse immediately. These
may be signs of a very severe or even fatal allergic
(hypersensitivity) reaction:
• swelling of the skin of the face, lips and
swelling of the throat
• difficulty breathing
• skin rash
• redness of the skin (erythema)

Date:

TH-30-01-842
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Sign:

If a medicine has been added to your Plasma-Lyte
148 (pH 7.4) Infusion before over-infusion occurs,
that medicine may also cause symptoms. You
should read the Patient Information Leaflet of the
added medicine for a list of possible symptoms.

Date:

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.

Sign:

The other side effects are:
• reactions due to the administration technique:
– fever (febrile response)
– infection at the site of infusion
– burning sensation
– 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.
• an excess of fluid in the body (hypervolaemia).
• fits (seizures)
• hives (urticaria)

Version: 02

You will be given treatment depending on the
symptoms

Website: www.hpra.ie;
E-mail: medsafety@hpra.ie.
Malta
Website: www.medicinesauthority.gov.mt/adrportal

5. How to store Plasma-Lyte 148
(pH 7.4) Infusion
Keep this medicine out of the sight and reach of
children.
This medicinal product does not require any
special temperature storage conditions.
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.

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
Patient Information Leaflet of the added medicine
for a list of possible symptoms.

Do not use this medicine if you notice particles
floating in the solution or if the unit is damaged in
any way.

6. Contents of the pack and
other information

Other side effects noted with similar products
• Other manifestations of hypersensitivity/
infusion reactions: low blood pressure
(hypotension), Wheezing, Cold sweat, Chills,
• Hyperkalaemia

If you get any side effects, talk to your doctor
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.
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.

Date:

Reporting of side effects

Sign:

The active substances are:
• sodium chloride: 5.26 g per litre
• potassium chloride: 0.37 g per litre
• magnesium chloride hexahydrate: 0.30 g per
litre
• sodium acetate trihydrate: 3.68 g per litre
• sodium gluconate: 5.02 g per litre
The other ingredients are:
• water for injections
• sodium hydroxide

Date:

What Plasma-Lyte 148 (pH 7.4) Infusion
contains

Sign:















serious allergic reaction which causes
difficulty in breathing or dizzines
(anaphylactoid reaction)
a fast heartbeat (tachycardia)
palpitations
chest pain
chest discomfort
shortness of breath (dyspnea)
respiratory rate increased
flushing
hyperaemia
feeling of weakness (asthenia)
feeling abnormal
piloerection
oedema peripheral
fever (pyrexia)

What Plasma-Lyte 148 (pH 7.4) Infusion
looks like and contents of the pack
Plasma-Lyte 148 (pH 7.4) Solution for Infusion
is a clear solution, free from visible particles.
It is supplied in polyolefin/polyamide plastic
bags (Viaflo). Each bag is wrapped in a sealed,
protective, outer plastic overpouch.
The bag sizes are:
• 500 ml
5

TH-30-01-842

Version: 02



1000 ml

Finland:

The bags are supplied in cartons. Each carton
contains one of the following quantities:
• 20 bags of 500 ml
• 10 bags of 1000 ml

France:
Greece:

Not all pack sizes may be marketed.

Iceland:

Marketing Authorisation Holder and
Manufacturers

Ireland:

Marketing Authorisation Holder:
Baxter Healthcare Ltd.
Caxton Way,
Thetford Norfolk IP24 3SE
United Kingdom
Manufacturers:
Baxter SA
Boulevard René Branquart, 80
7860 Lessines
Belgium
Baxter Healthcare Ltd.
Caxton Way,
Thetford Norfolk IP24 3SE
United Kingdom
Bieffe Medital S.A.
Ctra de Biescas, Senegüé
22666 Sabiñánigo (Huesca)
Spain
Baxter Manufacturing Sp. z o.o.
42 B Wojciechowska Str.
20-704 Lublin
Poland
This medicinal product is authorised in the
Member States of the EEA under the following
names:
Austria:
Plasmalyt – Infusionslösung
Belgium, Luxemburg: Plasmalyte A Viaflo, solution
pour perfusion
Croatia:
Plasma-Lyte 148 (pH 7,4)
Viaflo, otopina za infuziju
Czech Republic:
Plasmalyte roztok
Cyprus:
Plasma-Lyte 148 (pH 7,4)
Solution for infusion
Spain:
Viaflo Plasmalyte 148
(pH 7,4), solución para
perfusion
Denmark:
Plasmalyte, infusionsvæske,
opløsning

Italy:
Lithuania:
Malta:
Netherlands:
Norway:
Poland:
Portugal:
Slovenia:
Slovakia:
Sweden:
United Kingdom:

Plasmalyte infuusioneste,
liuos
Plasmalyte Viaflo, solution
pour perfusion
Plasma-Lyte 148 (pH 7,4)
Solution for infusion
Plasmalyte innrennslislyf,
lausn
Plasma-Lyte 148 (pH 7.4)
Solution for infusion
CrystalSol Solution for
infusion
Plasmalyte infuzinis tirpalas
Plasma-Lyte 148 (pH 7.4)
Solution for infusion
Plasma-Lyte 148, oplossing
voor infusie
Plasmalyte infusjonsvæske,
oppløsning
Plasmalyte roztwór do
infuzji
Plasma-Lyte (ph 7,4) 148
Viaflo
Plaslyte raztopina za
infundiranje
Plasmalyte infúzny roztok
Plasmalyte infusionsvätska,
lösning
Plasma-Lyte 148(pH 7.4)
Solution for Infusion

Date:

TH-30-01-842
6

Sign:

Baxter, Plasma-Lyte and Viaflo are trademarks of
Baxter International lnc.

Date:

For information about Plasma-Lyte 148
(pH 7.4) 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.

Sign:

This leaflet was last revised in 04/2017

Version: 02



Plasma-Lyte 148 (pH 7.4) Solution for Infusion
The following information
is intended for healthcare
professionals only:

Do not reconnect partially used bags.

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 broken.
c. Check the solution for clarity and absence
of foreign matters. If solution is not clear
or contains foreign matters, discard the
solution.

Handling and Preparation
This solution should be inspected visually for
particulate matter and discolouration prior to
administration whenever solution and container
permit. Do not administer unless the solution is
clear and the seal is intact.Do not remove unit from
overwrap until ready for use.
The inner bag maintains the sterility of the product.
Administer immediately following the insertion of
infusion set.
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 is for intravenous administration
through sterile administration set using 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.
Adding other medications or using an incorrect
administration technique might cause the
appearance of fever reactions due to the possible
introduction of pyrogens. In case of an adverse
reaction, infusion must be stopped immediately.
Discard after single use.
Discard any unused portion.

2. Preparation for administration

Date:

TH-30-01-842

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To add medication before administration
a. Disinfect medication port.

Date:

Warning: Additives may be incompatible Check
additive compatibility with both the solution and
container prior to use.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. (see Paragraph 5 “Incompatibilities of
additive medications” below).

Version: 02

3. Techniques for injection of additive
medications

Sign:

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.

5. Incompatibilities of additive
medications

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.

When introducing additives to Plasma-Lyte 148
(pH 7.4), aseptic technique must be used. Mix the
solution thoroughly when additives have been
introduced. Do not store solutions containing
additives.

Caution: Do not store bags containing added
medications.

Incompatibility of the medicinal product to be
added with the solution in Viaflo container must be
assessed before addition.

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.

The Instructions for Use of the medicinal product
to be added must be consulted.
Before adding a substance or medication, verify
it is soluble and/or stable in water and that
the pH range of Plasma-Lyte 148 (pH 7.4) is
appropriate (pH 6.5 - 8.0). After addition, check for
a possible colour change and/or the appearance of
precipitates, insoluble complexes or crystals.
Those additives known to be incompatible should
not be used.

Date:
Sign:

TH-30-01-842
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Date:
Baxter, Plasma-Lyte and Viaflo are trademarks of
Baxter International lnc.

Version: 02

Chemical and physical stability of any additive at
the pH of Plasmalyte 148 (pH 7.4) solution in the
Viaflo container should be established prior to use.
From a microbiological point of view, the diluted
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.

Sign:

4. Shelf life after first opening: The
product should be used immediately
after opening.
In-use shelf-life after reconstitution
with additives:

Expand view ⇕

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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