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COMPOUND SODIUM LACTATE INTRAVENOUS INFUSION BP

Active substance(s): CALCIUM CHLORIDE / POTASSIUM CHLORIDE / SODIUM CHLORIDE / SODIUM LACTATE

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Date 07 OCT 2010

PR1
DATE
-Oct 10
PR2

Yes/No

DATE
-Oct 10

Regulations

Compliance with National

per RA SOP CE-RAPV-009

Product Information proofread as

Storage Conditions and Shelf-Life

cited in the product information

Consistency check with all figures

(API & excipients)

Product name,strength,composition

RA Proofreading Checklist

Barcodes, Symbols and Re-

imbursement Information

DATE

EUROPEAN LABELLING CENTRE

RA
PROOFREAD + APPROVED

ARTWORK APPROVAL

2nd DRAFT

Country

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Wendy Martin

-Oct 10

Artworker:

-Oct 10

2nd Draft

-Oct 10

-Oct 10

1

Date

You must NOT receive Compound Sodium Lactate
Infusion if you are suffering from any of the
following conditions:
• if you’re a newborn (less than 1 month old)
receiving ceftriaxone (an antibiotic)
• if you are allergic to sodium lactate or any of
the other substances in Compound Sodium
Lactate Infusion
• when there is too much fluid in the spaces
around the cells of the body (extracellular
hyperhydration)
• when there is a larger volume of blood in
the blood vessels than there should be
(hypervolaemia)
• severe kidney failure (when your kidneys do not
work well and you require dialysis)
• uncompensated heart failure. This is heart
failure that is not adequately treated and
causes symptoms such as:
– shortness of breath
– swelling of the ankles
• higher levels of potassium in the blood than
normal (hyperkalaemia)
• higher levels of calcium in the blood than
normal (hypercalcaemia)

Compound Sodium Lactate Infusion is a solution of
the following substances in water:
• sodium chloride
• potassium chloride
• calcium chloride dihydrate
• sodium lactate.

Errors Found:

-Oct 10

2. Before you are given Compound Sodium
Lactate Infusion

1. What Compound Sodium Lactate Infusion is
and what it is used for

02

Text

-Oct 10

-Oct 10

Compound Sodium Lactate Infusion is used:
• to treat a loss of body water and chemicals
(e.g. by heavy sweating, kidney disorders)
• to treat you, if the volume of blood in your blood
vessels is low (hypovolaemia) or if you have
low blood pressure (hypotension).
• in metabolic acidosis (when the blood becomes
too acidic).

In this leaflet:
1. What Compound Sodium Lactate Infusion is
and what it is used for
2. Before you are given Compound Sodium
Lactate Infusion
3. How you will be given Compound Sodium
Lactate Infusion
4. Possible side effects
5. How Compound Sodium Lactate Infusion is
stored
6. Further information

Version:

Format

-Oct 10

-Oct 10

Sodium, potassium, calcium, chloride and lactate
are chemical substances found in the blood.

Throughout this leaflet Compound Sodium Lactate
Intravenous Infusion BP will be called Compound
Sodium Lactate Infusion

PROOFREADING

Barcode(s)

-Oct 10

Size

Edge Code

Y
Y

Active substances: sodium chloride, potassium chloride, calcium chloride dihydrate
and sodium lactate
Read all of this leaflet carefully before you start
using this medicine.
• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your
doctor or pharmacist
• This medicine has been prescribed for you. Do
not pass it on to others. It may harm them, even
if their symptoms are the same as yours
• If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

BGS
Trademark

Comments

PACKAGE LEAFLET: INFORMATION FOR THE USER
Compound Sodium Lactate Intravenous Infusion BP

Date 07 OCT 2010

PR1
DATE
-Oct 10

EUROPEAN LABELLING CENTRE

Wendy Martin

-Oct 10

Artworker:

-Oct 10

2nd Draft

-Oct 10

-Oct 10

PR2

Yes/No

DATE
-Oct 10

Regulations

Compliance with National

per RA SOP CE-RAPV-009

Product Information proofread as

Storage Conditions and Shelf-Life

cited in the product information

Consistency check with all figures

(API & excipients)

Product name,strength,composition

RA Proofreading Checklist

Barcodes, Symbols and Re-

imbursement Information

DATE

EUROPEAN LABELLING CENTRE

RA
PROOFREAD + APPROVED

ARTWORK APPROVAL

2nd DRAFT

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Signature

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Errors Found:

-Oct 10

2

Date

Compound Sodium Lactate 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.

02

Text

-Oct 10

-Oct 10

Calcium chloride can be harmful if injected into
the body tissues. Therefore, the Compound Sodium
Lactate Infusion must not be given by injecting it
into a muscle (intramuscular injection). Also, your
doctor will make every effort to avoid the escape
of the solution into the tissues surrounding the
vein.

Version:

Format

-Oct 10

-Oct 10

When you are given this infusion, your doctor will
take blood and urine samples to monitor:
• the amount of chemicals such as sodium
and potassium in your blood (your plasma
electrolytes)
• the acidity of your blood and urine
(your acid-base balance).
Although Compound Sodium Lactate Infusion
contains potassium, it does not contain enough to
treat very low blood plasma levels of potassium
(severe potassium deficiency).

PROOFREADING

Barcode(s)

-Oct 10

Size

Edge Code

Please tell your doctor if you have or have had any
of the following medical conditions:
• if you’re receiving ceftriaxone (an antibiotic).
(See also “Taking other medicines”)
• heart failure
• respiratory failure (lung disease) (special
monitoring may be required in the above
conditions)
• poor kidney function
• higher levels of chloride in the blood than
normal (hyperchloraemia)
• your blood is too acidic which is
life-threatening (severe metabolic acidosis)
• high blood pressure (hypertension)
• build up of fluid under the skin, affecting all
parts of the body (general oedema)
• 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)
• a disease that causes high levels of a hormone
called aldosterone (aldosteronism)
• higher levels of sodium in the blood than
normal (hypernatraemia) or any other condition
associated with sodium retention (when
the body retains too much sodium), such
as treatment with steroids (See also below,
“Taking other medicines”)
• heart disease of any type

Y
Y

Your doctor will take special care when giving
you Compound Sodium Lactate Infusion

BGS
Trademark

• any condition that means that 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)
Close monitoring of your blood potassium levels
is required.
• diseases associated with high levels of vitamin
D (e.g. sarcoidosis, a disease affecting the skin
and internal organs)
• kidney stones
• poor liver function
• diabetes
• you’re taking cardiac glycosides (cardiotonics)
used to treat heart failure, such as digitalis or
digoxin (See also “Taking other medicines”).

Comments

• a disorder in which the blood becomes too
alkaline (metabolic alkalosis)
• a particular type of metabolic acidosis (lactic
acidosis)
• severe liver disease (when the liver does not
function properly and requires very intensive
treatment)
• poor lactate metabolism (this occurs in severe
liver disease, as lactate is removed by the liver)
• liver disease that causes fluid to build up within
the abdomen (ascitic cirrhosis).

Wendy Martin
Date 07 OCT 2010

PR1
DATE
-Oct 10

EUROPEAN LABELLING CENTRE

Artworker:

-Oct 10

2nd Draft

-Oct 10

Errors Found:

-Oct 10

-Oct 10

02

-Oct 10

Version:

Text

-Oct 10

PROOFREADING

Format

Size

Barcode(s)

PR2

Yes/No

DATE
-Oct 10

Regulations

Compliance with National

per RA SOP CE-RAPV-009

Product Information proofread as

Storage Conditions and Shelf-Life

cited in the product information

Consistency check with all figures

(API & excipients)

Product name,strength,composition

RA Proofreading Checklist

Barcodes, Symbols and Re-

imbursement Information

These medicines can cause the body to
accumulate sodium and water, leading to:
• tissue swelling due to fluid collection under the
skin (oedema)
• high blood pressure (hypertension).

-Oct 10

It is particularly important that you inform your
doctor if you are taking:
• Ceftriaxone (an antibiotic), this should not be
given through the same infusion line, unless
thoroughly flushed
• cardiac glycosides (cardiotonics) such as
digitalis or digoxin used to treat heart failure.
The effects of these drugs can be increased
by calcium. This can lead to life threatening
changes to the heart rhythm
• corticosteroids (anti-inflammatory medicines)
• carbenoxolone (an anti-inflammatory medicine
used to treat stomach ulcers).

-Oct 10

Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained without a
prescription.

-Oct 10

Taking other medicines

-Oct 10

Other medicines that can affect or be affected by
Compound Sodium Lactate Infusion include:
• thiazide diuretics such as hydrochlorothiazide
or chlortalidone
• vitamin D
• bisphosphonates (to treat bone diseases such
as osteoporosis)
• fluoride (for the teeth and bones)
• fluoroquinolones (a type of antibiotic, including
ciprofloxacin, norfloxacin, ofloxacin)
• tetracyclines (a type of antibiotic, including
tetracycline)
• acidic medicines, including:
– salicylates used to treat inflammation
(e.g. aspirin)
– barbiturates (sleeping tablets)
– lithium (used to treat psychiatric illness)
• 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 you are given Compound Sodium Lactate
Infusion for a long time, you will be given an extra
source of nutrients.

Edge Code

Your doctor will take into account if you are
receiving parenteral nutrition (nutrition given by
infusion into a vein).

Y
Y

Compound Sodium Lactate Infusion should be
given with special care to babies less than
6 months of age.

BGS
Trademark

• 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).

Comments

As Compound Sodium Lactate Infusion contains
lactate (a substance found in the body), it can
make your blood too alkaline (metabolic alkalosis).

Using Compound Sodium Lactate Infusion with
food and drink

DATE

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Calcium can reach your unborn baby through the
placenta and, after birth, through the breast milk.

RA
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Compound Sodium Lactate Infusion can be used
safely during pregnancy or breast-feeding.

Country

Tell your doctor if you are pregnant or
breast-feeding.

Name

Ask your doctor or pharmacist for advice before
taking any medicine.

Signature

Pregnancy and breast-feeding

The following medicines can increase the
concentration of potassium in the blood. This
effect can be life-threatening. A rise in the blood
potassium levels is more likely to occur if you have
kidney disease.
• potassium-sparing diuretics (certain water
tablets, e.g. amiloride, spironolactone,
triamterene)
(Note that these medicines may be included in
combination medicinal products)

Date

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

Artworker:

02

Wendy Martin

Errors Found:

2nd Draft

Date 07 OCT 2010

PR1
DATE
-Oct 10

EUROPEAN LABELLING CENTRE

Version:

-Oct 10

PROOFREADING

-Oct 10

Size

Text

PR2

Yes/No

DATE
-Oct 10

Regulations

Compliance with National

per RA SOP CE-RAPV-009

Product Information proofread as

Storage Conditions and Shelf-Life

cited in the product information

Consistency check with all figures

(API & excipients)

Product name,strength,composition

RA Proofreading Checklist

Barcodes, Symbols and Re-

imbursement Information

DATE

EUROPEAN LABELLING CENTRE

RA
PROOFREAD + APPROVED

ARTWORK APPROVAL

2nd DRAFT

Country

Name

Signature

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-Oct 10

4

-Oct 10

If a medicine has been added to your Compound
Sodium Lactate 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.

-Oct 10

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 given too much Compound Sodium
Lactate 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
– hyperkalemia (higher levels of potassium in
the blood than normal) especially in patients
with kidney failure, causing symptoms such
as: pins and needles in the arms and legs
(paresthesia)

Date

If you receive more Compound Sodium Lactate
Infusion than you should

-Oct 10

Any unused solution should be thrown away. You
should NOT be given an infusion of Compound
Sodium Lactate Infusion from a bag that has been
partly used.

Format

Compound Sodium Lactate 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.

Barcode(s)

You should NOT be given Compound Sodium
Lactate Infusion if there are particles in the
solution or if the pack is damaged in any way.

-Oct 10

You will be given Compound Sodium Lactate
Infusion by a doctor or nurse. Your doctor will
decide on how much you need and when it is to
be given. 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.

-Oct 10

3. How you will be given Compound Sodium
Lactate Infusion

-Oct 10

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

-Oct 10

Driving and using machines

Edge Code

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.

Y
Y

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
• hypercalcemia (higher levels of calcium in the
blood than normal) causing symptoms such as:
– a decreased appetite (anorexia)
– feeling sick (nausea)
– vomiting
– constipation
– abdominal pain
– mental disturbances such as irritability or
depression
– drinking lots of water (polydipsia)
– producing more urine than normal (polyuria)
– kidney disease due to build up of calcium in
the kidneys (nephrocalcinosis)
– kidney stones
– coma (unconsciousness)
– chalky taste
– redness (hot flushes)
– dilatation of the blood vessels in the skin
(peripheral vasodilatation).
• Hypokalemia (lower levels of potassium in the
blood than normal) and metabolic alkalosis
(when the blood becomes too basic), especially
in patients with kidney failure, causing
symptoms such as:
– mood changes
– tiredness
– shortness of breath
– stiffness of the muscles
– twitching of the muscles
– contraction of muscles.

BGS
Trademark







Comments

Your doctor will monitor the levels of chemicals in
your blood and the amount of fluid in your body.

Wendy Martin

2nd Draft

Date 07 OCT 2010

PR1
DATE
-Oct 10
PR2

Yes/No

DATE
-Oct 10

Regulations

Compliance with National

per RA SOP CE-RAPV-009

Product Information proofread as

Storage Conditions and Shelf-Life

cited in the product information

Consistency check with all figures

(API & excipients)

Product name,strength,composition

DATE

EUROPEAN LABELLING CENTRE

RA
PROOFREAD + APPROVED

ARTWORK APPROVAL

2nd DRAFT

Country

Name

MARKETING
APPROVED

TH-30-01-540

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Barcodes, Symbols and Re-

imbursement Information

Signature

Date

5

EUROPEAN LABELLING CENTRE

Artworker:

Errors Found:

-Oct 10

02

-Oct 10

Other reactions due to the administration
technique:
• infection at the site of infusion
• escape of the infusion solution into the tissues
around the vein (extravasation). This can
damage the tissues and cause scarring
• numbness at the site of infusion.

Please tell your doctor or nurse if you notice any
listed or unlisted side effects. If any side effects
occur, the infusion must be stopped.

Version:

-Oct 10

-Oct 10

a blocked nose (nasal congestion)
a slow heartbeat (bradycardia)
sneezing
swelling in the throat making it difficult
to breathe (laryngeal oedema also called
Quincke’s oedema)
skin swelling (angioedema)
electrolyte disturbances
hypervolemia
panic attack.

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.

PROOFREADING

-Oct 10

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Text

-Oct 10






Format






Barcode(s)

These may be signs of a very severe or even fatal
hypersensitivity (allergic) reaction called anaphylactic
shock:

-Oct 10

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 hypersensitivity (allergic) reaction called
anaphylactic shock:
• hives (urticaria) which may be localised to a
part of the body or widespread
• skin rash
• redness of the skin (erythema)
• itching (pruritus)
• skin swelling (angioedema)
• coughing
• narrowing of the airways causing difficulty
breathing (bronchospasm)
• a fast heartbeat (tachycardia)
• a slow heartbeat (bradycardia)
• decreased blood pressure
• chest discomfort or pain
• anxiety
• tightness of the chest (making it difficult to
breathe)
• shortness of breath (dyspnea)
• flushing
• throat irritation
• pins and needles (paresthesias)
• reduced sense in the mouth (hypoesthesia oral)
• altered taste (dysgeusia)
• fever (pyrexia)
• nausea
• headache

-Oct 10

Other side effects noted with similar products
(same active ingredients) include:

-Oct 10

Like all medicines, Compound Sodium Lactate
Infusion can cause side effects, although not
everybody gets them.

-Oct 10

4. Possible Side Effects

Edge Code

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

Y
Y

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

BGS
Trademark

• changes in the concentrations of the chemicals
in the blood (hyperkalemia)
• reactions due to the administration technique:
– 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.
– rash or itching (pruritus) of the infusion site

Comments

Stopping your Compound Sodium Lactate
Infusion

Wendy Martin
Date 07 OCT 2010

PR1
DATE
-Oct 10
PR2

Yes/No

DATE
-Oct 10

Regulations

Compliance with National

per RA SOP CE-RAPV-009

Product Information proofread as

Storage Conditions and Shelf-Life

cited in the product information

Consistency check with all figures

(API & excipients)

Product name,strength,composition

DATE

EUROPEAN LABELLING CENTRE

RA
PROOFREAD + APPROVED
MARKETING
APPROVED

TH-30-01-540

ARTWORK APPROVAL

2nd DRAFT

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Barcodes, Symbols and Re-

imbursement Information

Signature

Not all pack sizes may be marketed.

EUROPEAN LABELLING CENTRE

Artworker:

-Oct 10

2nd Draft

-Oct 10

Errors Found:

-Oct 10

-Oct 10

Date

Baxter and Viaflex are trademarks of
Baxter International Inc.

Compound Sodium Lactate Infusion is a clear
solution, free from visible particles. It is supplied
in a plastic (VIAFLEX) infusion bag made from PVC.
The bag contains either 500 ml or 1000 ml and is
sealed in a protective plastic overpouch.

02

-Oct 10

request this leaflet in formats
such as audio or large print
please contact the Marketing
Authorisation Holder: Tel: 01635
206345.

What Compound Sodium Lactate Infusion looks
like and contents of the pack

Version:

Text

-Oct 10

-Oct 10

Send all enquiries to this address.
You should not be given Compound Sodium Lactate Compound Sodium Lactate Infusion can be made
Infusion, if there are particles in the solution or if
at any of these addresses:
the unit is damaged in any way.
Baxter Healthcare Ltd.
Caxton Way
6. Further Information
Thetford
Norfolk
This leaflet does not contain all the information
IP24 3SE
about this medicine. If you have any questions or
United Kingdom
are not sure about anything, ask your healthcare
Baxter Healthcare S.A.
professional.
Moneen Road
What Compound Sodium Lactate Infusion
Castlebar
contains
County Mayo
The active substances are:
Ireland
• sodium chloride (6.0 g per litre)
This leaflet was last approved in (mm/yyy).
• potassium chloride (400 mg per litre)
For information about Compound
• calcium chloride dihydrate 270 mg per litre
Sodium Lactate Infusion or to
• sodium lactate 3.22 g per litre.
The other ingredients are:
• sodium hydroxide (for pH adjustment)
• lactic acid (for pH adjustment)
• water for injections.

PROOFREADING

Format

-Oct 10

-Oct 10

Size

Barcode(s)

-Oct 10

Compound Sodium Lactate Infusion should NOT
be given to you after the expiry date shown on the
bag. The expiry date refers to the last day of that
month.

Edge Code

Y
Y

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

VIAFLEX containers should be stored within their
overpouch at a temperature not above 25°C.

BGS
Trademark

Marketing Authorisation Holder:

Keep out of the reach and sight of children.

Comments

Marketing Authorisation Holder and
Manufacturers

5. How Compound Sodium Lactate Infusion is
stored

Date 07 OCT 2010

PR1
DATE
-Oct 10

EUROPEAN LABELLING CENTRE

Wendy Martin

-Oct 10

Artworker:

-Oct 10

2nd Draft

-Oct 10

-Oct 10

Errors Found:

-Oct 10

02

Text

-Oct 10

-Oct 10

Version:

Format

-Oct 10

-Oct 10

PROOFREADING

Barcode(s)

-Oct 10

Size

Edge Code

PR2

Yes/No

DATE
-Oct 10

Regulations

Compliance with National

per RA SOP CE-RAPV-009

Product Information proofread as

Storage Conditions and Shelf-Life

cited in the product information

Consistency check with all figures

(API & excipients)

Product name,strength,composition

RA Proofreading Checklist

Barcodes, Symbols and Re-

imbursement Information

2. Preparation for administration
Use sterile material for preparation and
administration.
a. Suspend container from base eyelet support.
b. Use an aseptic technique to prepare the
administration set.
c. Remove blue protector from outlet port and
insert set connector well into port.
d. Prime set and regulate administration as required.
e. If administration set becomes blocked do not
pump contents back into container but replace
equipment.
f. Discard any unused portion and equipment
after use. Do not store or reconnect partly used
containers.
3. Techniques for injection of additive
medications
The VIAFLEX container has a second port with a
self-sealing rubber medication port designed for
the addition of medication using a syringe. This is
the only port for adding medication.
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

Y
Y

The following information is intended for medical
or healthcare professionals only:
Handling and Preparation
The solution for infusion should be visually
inspected prior to use.
Use only if the solution is clear, without visible
particles and if the container is undamaged.
Administer immediately following the insertion of
infusion set.
Do not remove unit from overwrap until ready for use.
The inner bag maintains the sterility of the product.
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.
The solution should be administered with sterile
equipment using an 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. 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.
Discard after single use.
Discard any unused portion.
Do not reconnect partially used bags.
Preparation for Administration
The VIAFLEX container has an outlet port designed
for an administration set with a short single
connector. If an administration set with a combined
air inlet/fluid path connector has to be used,
ensure the air inlet tube is always clamped off.
1. Opening
a. Remove the protective overpouch by tearing
down from notch and remove container.
b. Carefully straighten hanger and ports, if
necessary.
c. Squeeze container and inspect for minute leaks
and examine solution for visible particles or
cloudiness by viewing along seam.
d. Discard unit if leaks, particles or cloudiness are
evident.

BGS
Trademark

Comments

Compound Sodium Lactate Intravenous Infusion BP

additives should be used immediately and not stored.
(see Paragraph 5 “Incompatibilities of additive
medications” below).

DATE

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APPROVED

7

To add medication before administration
a. Swab the medication port with the appropriate
anti-bacterial fluid in line with current
recommended practice and procedure.
b. Using a syringe with a 20 – 22 gauge needle,
puncture re-sealable medication port and
inject. Do not leave the syringe and needle in
the port once the medication has been injected.
c. Shake and squeeze the VIAFLEX container so
that the solution and medication are thoroughly
mixed. For high density medications such
as potassium chloride, squeeze both ports
while upright and invert the container several
times while shaking and squeezing to ensure
thorough mixing.
TH-30-01-540

Wendy Martin
Date 07 OCT 2010

PR1
DATE
-Oct 10

EUROPEAN LABELLING CENTRE

Artworker:

-Oct 10

2nd Draft

-Oct 10

Errors Found:

-Oct 10

-Oct 10

02

-Oct 10

Version:

Text

-Oct 10

-Oct 10

PROOFREADING

Format

-Oct 10

-Oct 10

Size

Barcode(s)

-Oct 10

Y
Y

Edge Code

BGS
Trademark

PR2

Yes/No

DATE
-Oct 10

Regulations

Compliance with National

per RA SOP CE-RAPV-009

Product Information proofread as

Storage Conditions and Shelf-Life

cited in the product information

Consistency check with all figures

(API & excipients)

Product name,strength,composition

RA Proofreading Checklist

Barcodes, Symbols and Re-

imbursement Information

Before adding a drug, verify it is soluble and stable
in water at the pH of Compound Sodium Lactate
Solution (pH 5.0 to 7.0).
When making additions to Compound Sodium
Lactate solution, aseptic technique must be used.
Mix the solution thoroughly when additives have
been introduced. Do not store solutions containing
additives. As a guidance the following medications
are incompatible with the Compound Sodium
Lactate Solution (non-exhaustive listing):
• Medications incompatible with Compound
Sodium Lactate Solution
– Aminocaproic acid
– Amphotericin B
– Metaraminol tartrate
– Cefamandole
– Ceftriaxone
– Cortisone acetate
– Diethylstilbestrol
– Etamivan
– Ethyl alcohol
– Phosphate and carbonate solutions
– Oxytetracycline
– Thiopental sodium
– Versenate disodium
• Medications with partial incompatibility with
Compound Sodium Lactate Solution:
– Tetracycline stable for 12 hours
– Ampicillin sodium
concentration of 2% – 3% stable for 4 hours
concentration >3% must be given within
1 hour
– Minocycline stable for 12 hours
– Doxycycline stable for 6 hours

Comments

Those additives known to be incompatible should
not be used.

DATE
MARKETING
APPROVED

TH-30-01-540

EUROPEAN LABELLING CENTRE

RA
PROOFREAD + APPROVED

8

ARTWORK APPROVAL

2nd DRAFT

Country

Name

Signature

Baxter and Viaflex are trademarks of
Baxter International Inc.

Date

To add medication during administration
a. Close clamp on the set.
b. Disinfect medication port.
c. Using a syringe with a 20 – 22 gauge 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.
Cautions
a. Do not vent.
b. Do not administer unless the solution is clear
and container undamaged.
c. Do not use in series connections as this could
result in air embolism due to residual air being
drawn from the primary container before
administration of fluid from the secondary
container is completed.
d. Discontinue infusion if adverse reaction occurs.
e. Rapid infusion may be harmful.
f. It is recommended that the intravenous
administration set be replaced at least once
every 24 hours. Details of the use of the set can
be recorded – record labels are available from
Baxter Healthcare Ltd.
4. In-use shelf-life: Additives
The chemical and physical stability of any additive at
the pH of Compound Sodium Lactate Solution in the
VIAFLEX container should be established prior to use.
From a microbiological point of view, the diluted
product must be used immediately unless dilution
has taken place in controlled and validated aseptic
conditions. If not used immediately, in-use storage
times and conditions are the responsibility of the user.
5. Incompatibilities of additive medications
Ceftriaxone must not be mixed with
calcium-containing solutions including Ringer
Lactate solution.
As with all parenteral solutions additives may be
incompatible. Compatibility of the additives with
the Compound Sodium Lactate solution must be
assessed before addition. After addition of the
additive, incompatibility may become visible by a
possible colour change and/or the appearance of
precipitates, insoluble complexes or crystals.
The Instructions for Use of the medication to be added
and other relevant literature must be consulted.

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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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