COMPOUND SODIUM LACTATE SOLUTION FOR INFUSION BP

Active substance: SODIUM LACTATE

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

Compound Sodium Lactate Solution for Infusion B.P.
Active substances: sodium chloride, potassium chloride, calcium chloride dihydrate and
sodium lactate



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.

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

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

2. What you need to know before you
are given Compound Sodium Lactate
Infusion
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 28 days old)
receiving ceftriaxone (an antibiotic).
• if you’re allergic to sodium lactate or any of the
other substances in Compound Sodium Lactate
• 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)

This medicine is called “Compound Sodium Lactate
Solution for Infusion BP”, but will be referred to as
“Compound Sodium Lactate Infusion” throughout the
document.

1. What Compound Sodium Lactate
Infusion is and what it is used for
Compound Sodium Lactate Infusion is a solution of
the following substances in water:
• sodium chloride
• potassium chloride
• calcium chloride dihydrate
• sodium lactate

1

TH-30-01-530









disorder in which the blood becomes too
alkaline (metabolic alkalosis)
liver disease that causes fluid to build up within
the abdomen (ascetic cirrhosis)
your blood is too acidic which is life-threatening
(severe metabolic acidosis)
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)
if you are taking cardiac glycosides (cardiotonics)
used to treat heart failure, such as digitalis or
digoxin. (see also “Taking other medicines”)







Warning and precautions
Talk to your doctor or nurse before receiving
Compound Sodium Lactate Infusion if you have or
have had any of the following medical conditions:
• if you’re receiving ceftriaxone (an antibiotic).
(See also “Other medicines and Compound
Sodium Lactate Infusion”)
• 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)
• 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
• 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

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).
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.
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.
As Compound Sodium Lactate Infusion contains lactate
(a substance found in the body), it can make your blood
too alkaline (metabolic alkalosis).
Compound Sodium Lactate Infusion should be given
with special care to babies less than 6 months of age.

2

TH-30-01-530

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
Other medicines and Compound Sodium
osteoporosis)
Lactate Infusion
• fluoride (for the teeth and bones)
Please tell your doctor or nurse if you are taking,
• fluoroquinolones (a type of antibiotic, including
have recently taken, or might have taken any other
ciprofloxacin, norfloxacin, ofloxacin)
medicines.
• tetracyclines (a type of antibiotic, including
It is particularly important that you inform your doctor
tetracycline)
if you are taking:
• acidic medicines, including:
• ceftriaxone (an antibiotic), this should not be
– salicylates used to treat inflammation (aspririn)
given through the same infusion line, unless
– barbiturates (sleeping tablets)
thoroughly flushed.
– lithium (used to treat psychiatric illness)
• cardiac glycosides (cardiotonics) such as digitalis
• alkaline (basic) medicines including:
or digoxin used to treat heart failure, must
– sympathomimetics (stimulant medicines
not be used with Compound Sodium Lactate
such as ephedrine and pseudoephedrine,
Infusion (see also section “You must NOT receive
used in cough and cold preparations)
Compound Sodium Lactate Infusion if you are
suffering from…”). The effects of these drugs can
– other stimulants (e.g. dexamphetamine,
be increased by calcium.
phenfluramine).
This can lead to life threatening changes to the heart
Compound Sodium Lactate Infusion with
rhythm
food and drink
• corticosteroids (anti-inflammatory medicines)
You should ask your doctor about what you can eat
These medicines can cause the body to accumulate
or drink.
sodium and water, leading to:
• tissue swelling due to fluid collection under the
Pregnancy and breast-feeding
skin (oedema)
If you are pregnant or breast feeding, think you may
• high blood pressure (hypertension).
be pregnant or are planning to have a baby, ask your
doctor will take into account if you are receiving
parenteral nutrition (nutrition given by infusion into
a vein). If you are given Compound Sodium Lactate
Infusion for a long time, you will be given an extra
source of nutrients.

doctor or nurse for advice before taking this medicine.

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)
• 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).

Compound Sodium Lactate Infusion can be used
safely during pregnancy or breast-feeding. Your
doctor will monitor the levels of chemicals in your
blood and the amount of fluid in your body.
Calcium can reach your unborn baby through the
placenta and, after birth, through the breast milk.
However, if another medicine is to be added to your
solution for infusion during pregnancy or breastfeeding 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

TH-30-01-530

– 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).
• Hypokalaemia (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.

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

If you receive more Compound Sodium
Lactate Infusion than you should
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
– hyperkalaemia (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)
– 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
• hypercalcaemia (higher levels of calcium in the
blood than normal) causing symptoms such as:
– a decreased appetite (anorexia)
– feeling sick (nausea)
– vomiting
– constipation
– abdominal pain

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 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.

Stopping your Compound Sodium Lactate
Infusion
Your doctor will decide when to stop giving you this
infusion.
If you have any further questions on the use of this
product, 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.
4

TH-30-01-530

may 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
Higher levels of potassium on the blood than normal
(hyperkalemia)

• Changes in the concentrations of the chemicals in
the blood (electrolyte disturbances)
• A larger volume of blood in the blood vessels than
there should be (hypervolemia)
• panic attack
• 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.
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.
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 Compound Sodium
Lactate Infusion
Keep this medicine out of the sight and reach of children.
Compound Sodium Lactate Infusion does not require
special storage conditions.
Compound Sodium Lactate Infusion should NOT be
given to you after the expiry date which figures on the
bag (eg EXP: MM/YYYY). The expiry date refers to the
last day of that month.

Reactions due to the administration technique
manifested by one or more of the following symptoms:
• 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.

You should not be given Compound Sodium Lactate
Infusion, if there are particles floating in the solution
or if the unit is damaged in any way.

Other side effects noted with similar products
(other sodium-lactate containing solutions) include:
• Other manifestations of hypersensitivity/infusion
reactions: a blocked nose (nasal congestion),
sneezing, swelling in the throat making it
difficult to breathe (laryngeal oedema also called
Quincke’s oedema), skin swelling (angioedema)

The active substances are:
• sodium chloride: 6.00 g per litre
• potassium chloride: 0.40 g per litre
• calcium chloride dihydrate: 0.27 g per litre
• sodium lactate: 3.20 g per litre.
The only other ingredient is water for injections.

6. Contents of the pack and other
information
What Compound Sodium Lactate Infusion
contains

What Compound Sodium Lactate Infusion
looks like and contents of the pack
Compound Sodium Lactate Infusion is a clear solution,
free from visible particles. It is supplied in polyolefin/
polyamide plastic bags (Viaflo). Each bag is wrapped
in a sealed, protective, outer plastic overpouch.
The bag sizes are:
• 250 ml
• 500 ml
• 1000 ml

For Information about Compound
Sodium Lactate 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.

Pack sizes:
30 bags of 250 ml per carton.
1 bag of 250 ml
20 bags of 500 ml per carton.
1 bag of 500 ml
10 bags of 1000 ml per carton.
1 bag of 1000 ml
Not all pack sizes may be marketed

Marketing Authorisation Holder and
Manufacturers
Marketing Authorisation Holder:
Send all enquiries to this address
Baxter Healthcare Ltd.
Caxton Way,
Thetford, Norfolk, IP24 3SE
United Kingdom
Manufacturers:
Baxter SA
Boulevard René Branquart, 80
7860 Lessines
Belgium
Baxter Healthcare Ltd.
Caxton Way
Thetford, Norfolk, IP24 3SE
United Kingdom
Bieffe Medital S.A.
Ctra de Biescas, Senegüé
22666 Sabiñánigo (Huesca)
Spain

This leaflet was last revised in
February 2013

and Viaflo are trademarks of
Baxter International lnc.

Compound Sodium Lactate Solution for Infusion B.P.
The following information is intended 1. Opening
a. Remove the Viaflo container from the
for healthcare professionals only:

overpouch just before use.
b. Check for minute leaks by squeezing inner
bag firmly. If leaks are found, discard
solution, as sterility may be impaired.
c. Check the solution for clarity and absence
of foreign matters. If solution is not clear
or contains foreign matters, discard the
solution.

Handling and Preparation
Parenteral drug products should be inspected
visually for particulate matter and discoloration 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
a 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 injection site.
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.
Adding other medication or using an incorrect
administration technique might cause the appearance
of fever reactions due to the possible introduction of
pyrogens. In case of adverse reaction, infusion must
be stopped immediately.
Discard after single use.
Discard any unused portion.
Do not reconnect partially used bags.

2. Preparation for administration
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.

3. 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.
(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.
7

TH-30-01-530

The Instructions for Use of the medication to be added
and other relevant literature must be consulted.

c. Mix solution and medication thoroughly. For
high-density medication such as potassium
chloride, tap the ports gently while ports are
upright and mix.

Before adding a substance or medication, verify it
is soluble and/or stable in water at the pH range of
Compound Sodium Lactate Infusion (pH 5.0 to 7.0).

Caution: Do not store bags containing added
medications.

When making additions to Compound Sodium
Lactate Infusion aseptic technique must be used.
Mix the solution thoroughly when additives have
been introduced. Do not store solutions containing
additives. As guidance the following medications are
incompatible with the Compound Sodium Lactate
Infusion (non-exhaustive listing):
• Medications incompatible with Compound
Sodium Lactate Infusion
− 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.

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.

4. In-use shelf-life: Additives
The chemical and physical stability of any additive at
the pH of Compound Sodium Lactate Infusion in the
Viaflo 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 Compound Sodium Lactate
Infusion.
As with all parenteral solutions additives may be
incompatible. Compatibility of the additives with the
Compound Sodium Lactate Infusion 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.

Those additives known to be incompatible should not
be used.

Baxter and Viaflo are trademarks of
Baxter International lnc.

F

8

TH-30-01-530

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web2)