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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 / GLUCOSE MONOHYDRATE / MAGNESIUM CHLORIDE HEXAHYDRATE / POTASSIUM CHLORIDE / SODIUM ACETATE TRIHYDRATE / SODIUM CHLORIDE / SOD

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Plasma-Lyte 148 & Glucose 5% w/v Solution for Infusion
Active substances: glucose, sodium chloride, potassium chloride, magnesium
chloride hexahydrate, sodium acetate trihydrate and sodium gluconate
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.

• 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.
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.
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.

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.
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

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

Pharmacotherapeutic group: “Electrolytes with
Carbohydrates” - ATC code: “B05BB02”
Plasma-Lyte & Glucose Infusion is a solution of the
following substances in water:
• sugar (glucose)
• sodium chloride
• potassium chloride
• magnesium chloride hexahydrate

Do NOT receive Plasma-Lyte & Glucose
Infusion if you are suffering from any of
the following conditions
• higher levels of chloride in the blood than
normal (hyperchloraemia)
• higher levels of sodium in the blood than
normal (hypernatraemia)
1

• 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”).
• 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)

• 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.

Warnings and precautions
Plasma-Lyte & Glucose Infusion is a hyper-osmotic
(concentrated) solution. Your doctor will take this
into account when calculating how much solution
to give you.
Please tell your doctor if you have or have had any
of the following medical conditions.
• heart failure
• respiratory failure (lung disease)

2

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)

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)
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.

Although Plasma-Lyte & Glucose Infusion contains
potassium, it does not contain enough to treat
severe potassium deficiency (very low blood
plasma levels).
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.
Plasma-Lyte & Glucose Infusion contains
substances that can cause metabolic alkalosis
(making the blood too alkaline).
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
This is particularly important if you are diabetic.

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)

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.
The following medicines must not be used while
you are receiving an infusion of Plasma-Lyte &
Glucose Infusion:
• potassium-sparing diuretics (certain water
tablets, e.g. amiloride, spironolactone,
triamterene, potassium canrenoate)
(these medicines may be included in

Plasma-Lyte & Glucose Infusion with
food and drink
3

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

Pregnancy, breast-feeding and fertility

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)
• 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)
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 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.
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

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

3. How you will be given Plasma-Lyte
& 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. 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 receive more Plasma-Lyte &
Glucose Infusion than you should
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
4

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.





Stopping your Plasma-Lyte & Glucose
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:
– swelling of the skin of the face, lips and
swelling of the throat
– difficulty breathing
– skin rash
– redness of the skin (erythema)
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 (hyperkalemia)
– hyperglycaemia
fits (seizures)
hives (urticaria)
serious allergic reaction which causes difficulty
in breathing or dizziness (anaphylactoid
reaction)
low blood pressure (hypotension)
chest discomfort
shortness of breath (dyspnea)
wheezing
flushing
hyperaemia
feeling of weakness (asthenia)
cold sweat
fever (pyrexia)
Chills

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.
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 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

5

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

UK
Yellow Card Scheme
Tel: Freephone 0808 100 3352
www.mhra.gov.uk/yellowcard

5. How to store Plasma-Lyte & Glucose
Infusion

Not all pack sizes may be marketed.

Marketing Authorisation Holder and
Manufacturers

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

Marketing Authorisation Holder:

Do not store above 30ºC.

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

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.

Manufacturers:

You should not be given this medicine if you notice
particles floating in the solution or if the unit is
damaged in any way.

Baxter SA
Boulevard René Branquart, 80
7860 Lessines
Belgium

6. Contents of the pack and other
information

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

What Plasma-Lyte & Glucose Infusion
contains

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

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

This leaflet was last revised in 03/2017
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.

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

The bag sizes are:
• 250 ml
• 500 ml
• 1000 ml
6

Plasma-Lyte 148 & Glucose 5% w/v Solution for Infusion
The following information is intended
for healthcare professionals only:
Handling and Preparation

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.
The solution should be inspected visually for
Additives may be introduced before infusion or during
particulate matter and discolouration prior to
infusion through the re-sealable medication port.
administration whenever solution and container
Adding other medications or using an incorrect
permit. Do not administer unless the solution is
administration technique might cause the
clear and the seal is intact. Do not remove unit
appearance of fever reactions due to the possible
from overwrap until ready for use.
introduction of pyrogens. In case of an adverse
The inner bag maintains the sterility of the product.
reaction, infusion must be stopped immediately.
Administer immediately following the insertion of
Discard after single use.
infusion set.
Discard any unused portion.
In order to avoid potentially fatal over infusion of
Do not reconnect partially used bags.
intravenous fluids to the neonate, special attention
1. Opening
needs to be paid to the method of administration.
a. Remove the Viaflo container from the
When using a syringe pump to administer
overpouch just before use.
intravenous fluids or medicines to neonates, a bag
b. Check for minute leaks by squeezing inner
of fluid should not be left connected to the syringe.
bag firmly. If leaks are found, discard
When using an infusion pump all clamps on the
solution, as sterility may be broken.
intravenous administration set must be closed
c. Check the solution for clarity and absence
before removing the administration set from the
of foreign matters. If solution is not clear
pump, or switching the pump off. This is required
or contains foreign matters, discard the
regardless of whether the administration set has
solution.
an anti-free flow device. The intravenous infusion
2. Preparation for administration
device and administration equipment must be
The solution should NOT be administered through a
frequently monitored.
peripheral vein.
Do not use plastic containers in series
connections. Such use could result in air embolism Use sterile material for preparation and
administration.
due to residual air being drawn from the primary
a. Suspend container from eyelet support.
container before the administration of the fluid
b. Remove plastic protector from outlet port at
from the secondary container is completed.
bottom of container:
Pressurizing intravenous solutions contained
– grip the small wing on the neck of the
in flexible plastic containers to increase flow
port with one hand,
rates can result in air embolism if the residual

grip
the large wing on the cap with the
air in the container is not fully evacuated prior
other hand and twist,
to administration. Use of a vented intravenous
– the cap will pop off.
administration set with the vent in the open
c. Use an aseptic method to set up the
position could result in air embolism. Vented
infusion.
intravenous administration sets with the vent in
d. Attach administration set. Refer to complete
the open position should not be used with flexible
directions accompanying set for connection,
plastic containers.
priming of the set and administration of the
solution.
7

3. Techniques for injection of additive
medications

5. Incompatibilities of additive
medications

Warning: Additives may be incompatible. Check
additive compatibility with both the solution and
container prior to use. When additive is used,
verify osmolarity 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).

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.
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 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.

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.
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.

4. In-use shelf-life: Additives
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.

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

8

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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