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PLASMA-LYTE 148 & GLUCOSE 5% W/V SOLUTION FOR INFUSION

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

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SA-30-02-107
1a

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Errors: Yes / No PR2:
Errors: Yes / No PR1:

Comments:

N/A

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Signature

Plasma-Lyte & Glucose Infusion is a solution of the
following substances in water:
• sugar (glucose)
• sodium chloride
• potassium chloride
• magnesium chloride hexahydrate

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Pharmacotherapeutic group: “Electrolytes with
Carbohydrates” - ATC code: “B05BB02”

Name

1. What Plasma-Lyte & Glucose
Infusion is and what it is used
for

N/A

Plasma-Lyte & Glucose 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.

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

What is in this leaflet:
1. What Plasma-Lyte & Glucose Infusion is and
what it is used for
2. What you need to know before you are given
Plasma-Lyte & Glucose Infusion
3. How you will be given Plasma-Lyte & Glucose
Infusion
4. Possible side effects
5. How to store Plasma-Lyte & Glucose Infusion
6. Contents of the pack and other information

EMEA ARTWORK DESIGN CENTRE

Plasma-Lyte & Glucose infusion is used:
• to provide a source of fluid and carbohydrate (sugar)
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
• 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.

PLANT APPROVAL
HALLE ONLY

sodium acetate trihydrate
sodium gluconate

Glucose is one of the body’s sources of energy. This
solution for infusion provides 220 kilocalories per litre.
Sodium, potassium, magnesium, chloride, acetate and
gluconate are chemical substances found in the blood.

This medicine is called ‘Plasma-Lyte 148 & Glucose
5% w/v Solution for Infusion’, but will be referred to as
‘Plasma-Lyte & Glucose Infusion’ throughout the
remainder of this leaflet.

Date: 14MAR2016




DATE

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. See section 4.

Version: 00

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

Artworker: Leroi C.

Package leaflet: Information for the user
Plasma-Lyte 148 & Glucose 5% w/v Solution for Infusion

ARTWORK DESIGN CENTRE

Draft: 1st

b

Warnings and precautions

2. What you need to know before
you are given Plasma-Lyte &
Glucose Infusion












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higher levels of chloride in the blood than normal
(hyperchloraemia)
higher levels of sodium in the blood than normal
(hypernatraemia)
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)
lower levels of calcium in the blood than normal
(hypocalcaemia)
a deficiency of acid secretion in the stomach
(hypochlorhydria)
if you are taking potassium-sparing diuretics (water
tablets that cause an accumulation of potassium in
the body). Examples are:
– amiloride
– potassium canrenoate
– spironolactone
– triamterene
(These medicines may be included in combination
medicinal products)
diabetes that is not adequately treated, allowing
your blood sugar levels to rise above normal
(uncompensated diabetes)
states of glucose intolerance, for example:
– metabolic stress (when the body’s metabolism
does not function correctly, e.g. due to severe
illness)
– hyperosmolar coma (unconsciousness). This
is a type of coma that can occur if you have
diabetes and do not receive enough medicine.
– a higher amount of sugar in the blood than
normal (hyperglycaemia)
– a higher amount of lactate in the blood than
normal (hyperlactataemia)
– hypersensitivity to the active substances or to
any of the ingredients listed in section 6.

Date:



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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
(pre-eclampsia 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”).
• diabetes (your blood sugar levels will be monitored
closely and your insulin treatment may need to be
modified)
• 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
• head injury within the past 24 hours
• a high pressure within the skull (intracranial
hypertension)
• a stroke due to a clot in a blood vessel in the brain
(ischaemic stroke)

Do NOT receive Plasma-Lyte & Glucose
Infusion if you are suffering from any of the
following conditions

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Plasma-Lyte & Glucose Infusion is a hypertonic
(concentrated) solution. Your doctor will take this into
account when calculating how much solution to give you.

As Plasma-Lyte & Glucose Infusion contains sugar
(glucose), it can cause hyperglycaemia (a high level of
sugar in the blood). If this occurs, your doctor may:
• adjust the speed of infusion
• give you insulin to reduce the amount of sugar in
your blood

Other medicines that can affect or be affected by
Plasma-Lyte & Glucose 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)

This is particularly important if you are diabetic.
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.

Children
Plasma-Lyte & Glucose Infusion should be given with
special care in children.
Newborns, especially those born premature and with low
birth weight, are at increased risk of developing low or
high levels of sugar in the blood (hypo or hyperglycemia),
which may lead to complications.

Other medicines and Plasma-Lyte & Glucose
Infusion
Tell your doctor or nurse if you are taking or have
recently taken or might take any other medicines.

Plasma-Lyte & Glucose Infusion with food
and drink

The following medicines must not be used while you are
receiving an infusion of Plasma-Lyte & Glucose Infusion:
• potassium-sparing diuretics (certain water

You should ask your doctor about what you can eat or
drink.
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These medicines can increase the concentration of
potassium in your blood. This can be life-threatening. A
rise in your blood potassium levels is more likely to occur
if you have kidney disease.

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Plasma-Lyte & Glucose Infusion contains substances
that can cause metabolic alkalosis (making the blood too
alkaline).

Date:

Plasma-Lyte & Glucose 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.

Sign:

Although Plasma-Lyte & Glucose Infusion contains
potassium, it does not contain enough to treat severe
potassium deficiency (very low blood plasma levels).

Version: 00

tablets, e.g. amiloride, spironolactone, triamterene,
potassium canrenoate)

(these medicines may be included in combination
medicinal products. See also “You must NOT receive
Plasma-Lyte & Glucose Infusion if you are suffering
from any of the following conditions” at the start of
this section).
The use of the following medicines is not recommended
while you are receiving an infusion of Plasma-Lyte &
Glucose Infusion:
• 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)

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)
• the amount of sugar in your blood
• your acid-base balance (the acidity of the blood and
urine)

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

3. How you will be given PlasmaLyte & Glucose Infusion
You will be given Plasma-Lyte & Glucose 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 & Glucose
Infusion if there are particles floating in the solution or
if the pack is damaged in any way.
Plasma-Lyte & Glucose 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 & Glucose
Infusion from a bag that has been partly used.

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 you receive more Plasma-Lyte & Glucose
Infusion than you should

If a medicine has been added to your Plasma-Lyte
& Glucose 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.

If you are given too much Plasma-Lyte & Glucose 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 (paresthesia)

SA-30-02-107
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Date:

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

Sign:

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.
You may receive Plasma-Lyte & Glucose 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.

Date:

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
• hyperosmolarity (the blood becomes too
concentrated)
• a loss of water from the body (dehydration)
• a high blood sugar level (hyperglycaemia)
• sugar in the urine (hyperglycosuria)
• an increase in the amount of urine you produce
(osmotic diuresis)

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Pregnancy, breast-feeding and fertility

4. Possible side effects

Date:

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

Sign:

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

Date:

• shortness of breath (dyspnea)
• wheezing
• flushing
• hyperaemia
• feeling of weakness (asthenia)
• cold sweat
• fever (pyrexia)
• Chills

Sign:

Stopping your Plasma-Lyte & Glucose
Infusion

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)

Other side effects noted with similar products
• Other manifestations of hypersensitivity/infusion
reactions: a fast heartbeat (tachycardia), palpitations,
chest pain, respiratory rate increased, feeling
abnormal, piloerection, oedema peripheral

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 will be given treatment depending on the symptoms
The other side effects are:
• 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.
– an excess of fluid in the body (hypervolaemia)
– high levels of blood potassium which can cause
abnormal heart rhythm (hyperkalaemia)
– hyperglycaemia
• fits (seizures)
• hives (urticaria)
• serious allergic reaction which causes difficulty in
breathing or dizziness (anaphylactoid reaction)
• low blood pressure (hypotension)
• chest discomfort

You can also report side effects directly via (see details
below). By reporting side effects, you can help provide
more information on the safety of this medicine.
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.
UK
Yellow Card Scheme
Tel: Freephone 0808 100 3352
www.mhra.gov.uk/yellowcard

5. How to store Plasma-Lyte &
Glucose Infusion
Keep this medicine out of the sight and reach of children.
Do not store above 30ºC.
You should not be given this medicine after the expiry
date which is stated on the bag after EXP. The expiry date
refers to the last day of that month.
You should not be given this medicine if you notice
particles floating in the solution or if the unit is damaged
in any way.
SA-30-02-107
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Version: 00

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.

Like all medicines, this medicine can cause side effects,
although not everybody gets them.

Date:
Sign:

The active substances are:
• glucose (sugar): 55.00 g per litre
• 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

Date:

Bieffe Medital Sabiñanigo
Ctra de Biescas, Senegüé
22666 Sabiñanigo (Huesca)
Spain

What Plasma-Lyte & Glucose Infusion
contains

Sign:

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

6. Contents of the pack and other
information

For information about Plasma-Lyte
& Glucose or to request this leaflet
in formats such as audio or large
print please contact the Marketing
Authorisation Holder: Tel: 01635 206345.

The other ingredients are:
• water for injections
• concentrated hydrochloric acid

What Plasma-Lyte & Glucose Infusion looks
like and contents of the pack
Plasma-Lyte & Glucose 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:
• 250 ml
• 500 ml
• 1000 ml
The bags are supplied in cartons. Each carton contains
one of the following quantities:
• 30 bags of 250 ml
• 20 bags of 500 ml
• 10 bags of 1000 ml
Not all pack sizes may be marketed.

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

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

F

Manufacturers:
Baxter SA
Boulevard René Branquart, 80
7860 Lessines
Belgium
SA-30-02-107
6a

Version: 00

This leaflet was last revised in February
2016

Handling and Preparation
The 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.
In order to avoid potentially fatal over infusion of
intravenous fluids to the neonate, special attention
needs to be paid to the method of administration.
When using a syringe pump to administer
intravenous fluids or medicines to neonates, a bag
of fluid should not be left connected to the syringe.
When using an infusion pump all clamps on the
intravenous administration set must be closed
before removing the administration set from the
pump, or switching the pump off. This is required
regardless of whether the administration set has
an anti-free flow device. The intravenous infusion
device and administration equipment must be
frequently monitored.

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

2. Preparation for administration
The solution should NOT be administered through a
peripheral vein.

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

Use sterile material for preparation and
administration.
– Suspend container from eyelet support.
– 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.
– Use an aseptic method to set up the
SA-30-02-107
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Date:

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.

Version: 00

plastic containers.

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The following information
is intended for healthcare
professionals only:

Date:

Plasma-Lyte 148 & Glucose 5% w/v Solution for Infusion

Sign:

b

When introducing additives to Plasma-Lyte &
Glucose Infusion, aseptic technique must be used.
Mix the solution thoroughly when additives have
been introduced. Do not store solutions containing
additives.

To add medication before administration
– Disinfect medication port.
– Using syringe with 19 gauge
(1.10 mm) to 22 gauge (0.70 mm) needle,
puncture re-sealable medication port and
inject.
– Mix solution and medication thoroughly.
For high-density medication such as
potassium chloride, tap the ports gently
while ports are upright and mix.

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.
Before adding a substance or medication, verify
it is soluble and/or stable in water and that the
pH range of Plasma-Lyte & Glucose Infusion is
appropriate (pH 4.0 – 6.0). After addition, check for
a possible colour change and/or the appearance of
precipitates, insoluble complexes or crystals.

Caution: Do not store bags containing added
medications.
To add medication during administration
– Close clamp on the set.
– Disinfect medication port.
– Using syringe with 19 gauge
(1.10 mm) to 22 gauge (0.70 mm) needle,
puncture re-sealable medication port and
inject.
– Remove container from IV pole and/or turn
to an upright position.
– Evacuate both ports by tapping gently
while the container is in an upright
position.
– Mix solution and medication thoroughly.
– Return container to in use position,
re-open the clamp and continue
administration.

Glucose 5% solutions are not compatible with
blood or red blood cells, as haemolysis and
clumping have been described.
Those additives known to be incompatible should
not be used.

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

F
SA-30-02-107

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Date:

5. Incompatibilities of additive
medications

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).

Date:

3. Techniques for injection of additive
medications

Version: 00

Chemical and physical stability of any additive at
the pH of Plasma-Lyte & Glucose Infusion 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. In-use shelf-life: Additives

– Attach administration set. Refer to
complete directions accompanying set
for connection, priming of the set and
administration of the solution.

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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