Plasma-Lyte® 148 (pH 7.4) solution for infusion

Main information

  • Trade name:
  • Plasma-Lyte® 148 (pH 7.4) solution for infusion
  • Dosage:
  • Unknown
  • Pharmaceutical form:
  • Solution for infusion
  • Prescription type:
  • Product subject to prescription which may not be renewed (A)
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Plasma-Lyte® 148 (pH 7.4) solution for infusion
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • Solutions affecting the electrolyte balance; electrolytes

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization status:
  • Authorised
  • Authorization number:
  • PA0167/144/001
  • Authorization date:
  • 07-07-2017
  • Last update:
  • 21-02-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

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.

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:

What Plasma-Lyte 148 (pH 7.4) Infusion is

and what it is used for

What you need to know before you use

Plasma-Lyte 148 (pH 7.4) Infusion

How to use Plasma-Lyte 148 (pH 7.4)

Infusion

Possible side effects

How to store Plasma-Lyte 148 (pH 7.4)

Infusion

Contents of the pack and other information

1. What Plasma-Lyte 148 (pH 7.4)

Infusion is and what it is used

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.

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.

SA-30-02-174

Package leaflet: Information for the user

Active substances: sodium chloride, potassium chloride, magnesium chloride

hexahydrate, sodium acetate trihydrate and sodium gluconate

Plasma-Lyte 148 (pH 7.4) Solution for Infusion

ARTWORK DESIGN CENTRE

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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 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.

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 (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”).

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

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.

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 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)

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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 life-

threatening. A rise in your blood potassium levels

is more likely to occur if you have kidney disease.

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)

Plasma-Lyte 148 (pH 7.4) Infusion with

food and drink

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.

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.

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 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

(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)

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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

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:

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

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)

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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: low blood pressure

(hypotension), Wheezing, Cold sweat, Chills,

Hyperkalaemia

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

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.

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

What Plasma-Lyte 148 (pH 7.4) Infusion

contains

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

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

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

Marketing Authorisation Holder:

Baxter Healthcare Ltd.

Caxton Way,

Thetford Norfolk IP24 3SE

United Kingdom

Manufacturers:

Baxter SA

Boulevard René Branquart, 80

7860 Lessines

Belgium

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Poland:

Plasmalyte roztwór do

infuzji

Portugal:

Plasma-Lyte (ph 7,4) 148

Viaflo

Slovenia:

Plaslyte raztopina za

infundiranje

Slovakia:

Plasmalyte infúzny roztok

Sweden:

Plasmalyte infusionsvätska,

lösning

United Kingdom:

Plasma-Lyte 148(pH 7.4)

Solution for Infusion

This leaflet was last revised in 04/2017

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.

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

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

Baxter, Plasma-Lyte and Viaflo are trademarks of

Baxter International lnc.

SA-30-02-174

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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.

Preparation for administration

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 infusion.

Attach administration set. Refer to complete

directions accompanying set for connection,

priming of the set and administration of the

solution.

Techniques for injection 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

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).

Plasma-Lyte 148 (pH 7.4) Solution for Infusion

The following information

is intended for healthcare

professionals only:

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.

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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.

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.

4. Shelf life after first opening: The

product should be used immediately

after opening.

In-use shelf-life after reconstitution

with 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.

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.

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.

Baxter, Plasma-Lyte and Viaflo are trademarks of

Baxter International lnc.

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