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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

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Package leaflet: Information for the user
Plasma-Lyte 148 (pH 7.4) Solution for Infusion
Active substances: sodium chloride, potassium chloride, magnesium chloride
hexahydrate, sodium acetate trihydrate and sodium gluconate
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.

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

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.
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

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

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Warnings and precautions

• 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.

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”).
• 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.

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.

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
• 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)
• hypersensitivity to the active substances or to
any of the ingredients listed in section 6.

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
SA-30-01-775
blood and urine).
2a

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).

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.

Plasma-Lyte 148 (pH 7.4) Infusion contains
substances that can cause metabolic alkalosis
(making the blood too alkaline).

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).

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.

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.
The following medicines must not be used 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)
(these medicines may be included in
combination medicinal products. See also “You
must NOT receive Plasma-Lyte 148
(pH 7.4) Infusion if you are suffering from any
of the following conditions” at the start of this
section).

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

The use of the following medicines is not
recommended while you are receiving an infusion
of Plasma-Lyte 148 (pH 7.4) 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).

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

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor 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.
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• 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.

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.

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.

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.

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 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.

If you receive more Plasma-Lyte 148
(pH 7.4) Infusion than you should
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
(paresthesia)
• muscle weakness
• an inability to move (paralysis)

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.
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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).

chest discomfort
shortness of breath (dyspnea)
respiratory rate increased
flushing
hyperaemia
feeling of weakness (asthenia)
feeling abnormal
piloerection
oedema peripheral
fever (pyrexia).

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.

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
– 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

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.

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 it 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.

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5a

Manufacturers:

6. Contents of the pack and other
information

Baxter SA
Boulevard René Branquart, 80
7860 Lessines
Belgium

What Plasma-Lyte 148 (pH 7.4) Infusion
contains

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

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.

Bieffe Medital S.A.
Ctra de Biescas, Senegüé
22666 Sabiñánigo (Huesca)
Spain
Baxter Healthcare S.A.
Moneen Road
Castlebar
County Mayo
Ireland

The other ingredients are:
• water for injections
• sodium hydroxide.

What Plasma-Lyte 148 (pH 7.4) Solution
for Infusion looks like and contents of
the pack

Baxter Manufacturing Sp. z o.o.
42 B Wojciechowska Str.
20-704 Lublin
Poland

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.

This leaflet was last revised in 01/2013
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: 01635 206345.

The bag sizes are:
• 500 ml
• 1000 ml
The bags are supplied in cartons. Each carton
contains one of the following quantities:
• 20 bags of 500 ml
• 10 bags of 1000 ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder and
Manufacturers
Baxter, Plasma-Lyte and Viaflo are trademarks of
Baxter International lnc.

Marketing Authorisation Holder:

F

Send all enquiries to this address
Baxter Healthcare Ltd.
Caxton Way
Thetford Norfolk IP24 3SE
United Kingdom

SA-30-01-775
6a

b

Plasma-Lyte 148 (pH 7.4) Solution for Infusion

The following information
is intended for healthcare
professionals only:

Discard after single use.
Discard any unused portion.
Do not reconnect partially used bags.

1. Opening

Handling and Preparation

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.

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.

2. Preparation for administration

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.

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.

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.

SA-30-01-775
1b

3. Techniques for injection of additive
medications

4. In-use shelf-life: Additives
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.

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).
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.

5. Incompatibilities of additive
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.

Caution: Do not store bags containing added
medications.

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.

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

F

SA-30-01-775
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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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