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STERILE CONCENTRATE FOR CARDIOPLEGIA INFUSION.

Active substance(s): MAGNESIUM CHLORIDE HEXAHYDRATE / POTASSIUM CHLORIDE / PROCAINE HYDROCHLORIDE

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4. Possible side effects

6. Further Information

Sterile Concentrate for Cardioplegia Infusion

Like all medicines Sterile Concentrate for Cardioplegia Infusion
can cause side effects, although not everybody gets them.

Magnesium Chloride Hexahydrate 163mg/ml
Potassium Chloride 60mg/ml
Procaine Hydrochloride 14mg/ml
2. Before Sterile Concentrate for Cardioplegia
Read this leaflet carefully before you are given Sterile
Infusion is given
Concentrate for Cardioplegia Infusion.

Tell your doctor immediately if you have difficulty in breathing or
swallowing, experience swelling to your face, lips, throat or
tongue. These allergic reactions are rare but do need urgent
medical treatment.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

What Sterile Concentrate for Cardioplegia Infusion contains
The active ingredients are magnesium chloride hexahydrate
163mg/ml, potassium chloride 60mg/ml and procaine
hydrochloride 14mg/ml. The other ingredients are disodium
edetate, sodium hydroxide and water for injections.

Package leaflet: information for the user

D02492 00000

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor
or nurse.
• If any of the side effects become serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or nurse.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Sterile Concentrate for Cardioplegia Infusion is and what
it is used for
Before Sterile Concentrate for Cardioplegia Infusion is given
How Sterile Concentrate for Cardioplegia Infusion will be
given
Possible side effects
Storing Sterile Concentrate for Cardioplegia Infusion
Further information

1. What Sterile Concentrate for Cardioplegia
infusion is and what it is used for
Sterile Concentrate for Cardioplegia Infusion is used during
heart surgery to prevent the heart from beating (i.e. to induce
cardioplegia). This medicine contains a combination of drugs;
Magnesium Chloride, Potassium Chloride and Procaine
Hydrochloride. The Magnesium Chloride and Potassium Chloride
are used to stop the heart from beating, whilst the Procaine
Hydrochloride acts as a local anaesthetic.

Do NOT use Sterile Concentrate for Cardioplegia Infusion if:
• You are allergic (hypersensitive) to Magnesium Chloride,
Potassium Chloride and Procaine Hydrochloride, or any of the
other ingredients of this medicine listed in Section 6 (Further
Information).
Taking with other medicines
Please tell your doctor if you are taking or have recently taken
any other medicines, including medicines obtained without a
prescription.
Pregnancy and breast-feeding
Ask your doctor for advice before taking any medicine.

3. How Sterile Concentrate for Cardioplegia
Infusion will be given
Sterile Concentrate for Cardioplegia Infusion will be given as an
infusion (drip) during surgery by a medically competent person
trained in open heart surgery. Before it is given to you, it will be
diluted by adding 20ml Sterile Concentrate for Cardioplegia
Infusion to 1 litre of Compound Sodium Chloride Injection
immediately before use.
If you are given too much Sterile Concentrate for
Cardioplegia Infusion
As Sterile Concentrate for Cardioplegia Infusion is given to you in
hospital under the supervision of your doctor, it is unlikely that
you will receive too much. Your doctor has information on how
to recognise and treat an overdose.

5. Storing Sterile Concentrate for Cardioplegia
Infusion
• Keep out of the sight and reach of children
• Sterile Concentrate for Cardioplegia Infusion should be kept
in the original carton in order to protect from light and stored
below 25ºC
• The doctor or nurse will check that this product is not used
after the expiry date. The expiry date refers to the last day of
that month. The doctor or nurse will also check that
the product does not show signs of visible damage or
discoloration

What Sterile Concentrate for Cardioplegia Infusion looks like
and contents of the pack
Sterile Concentrate for Cardioplegia Infusion is a clear, colourless
solution supplied in glass ampoules. Each ampoule contains
20ml of Sterile Concentrate for Cardioplegia and is available in
packs of ten ampoules. Each pack of ten ampoules comes in a
cardboard carton that contains a patient information leaflet.
Marketing Authorisation Holder and Manufacturer
Martindale Pharmaceuticals,
Bampton Road, Romford, RM3 8UG, United Kingdom.

If this leaflet is difficult to see or read, please
contact the marketing authorisation holder for
help.
Product licence number: PL 01883/0012
Date of last revision: June 2013

If you have any questions on this product, ask your doctor or nurse.
Continued overleaf

TECHNICAL PRESCRIBING INFORMATION

Sterile Concentrate for Cardioplegia Infusion
Magnesium Chloride Hexahydrate 163mg/ml
Potassium Chloride 60mg/ml
Procaine Hydrochloride 14mg/ml
Trade Name of the Medicinal Product
Sterile Concentrate for Cardioplegia Infusion
Qualitative and Quantitative Composition
Each ml of solution contains 0.163g Magnesium Chloride
Hexahydrate Ph Eur, 0.060g Potassium Chloride Ph Eur and
0.014g Procaine Hydrochloride Ph Eur.
Pharmaceutical Form
Sterile aqueous solution
Therapeutic Indications
Sterile Concentrate for Cardioplegia Infusion is used during
heart surgery to induce cardioplegia.

Special Warnings and Precautions for Use
The contents of one (20 ml) ampoule must be diluted
with 1 litre of Compound Sodium Chloride Injection BPC,
immediately before use.
Interactions with other Medicaments and other forms of
Interaction
None stated.
Pregnancy and Lactation
None stated.
Effects on Ability to Drive and Use Machines
None stated.

Solution for infusion into the coronary arteries during
cardiopulmonary bypass to induce cardioplegia.

Undesirable Effects
None stated.

Posology and Method of Administration
A sterile aqueous solution for dilution. 20 ml are diluted
with 1 litre of Compound Sodium Chloride Injection BPC,
immediately before use.

Overdose
Appropriate supportive measures should be taken.
Apnoea: It may be necessary to apply artificial respiration
For circulatory depression: Give a vasopressor and intravenous
fluids. For seizures: Give oxygen and intravenous diazepam.
For methaemoglobinaemia: Give oxygen and methylene blue

Contra-indications
Hypersensitivity to procaine

Pharmacodynamic Properties
At the concentration produced after diluting the product,
magnesium chloride increases conduction time and the
PR and QRS intervals are lengthened. Elevated potassium
levels have significant effects on electrical activity in the
heart. The T waves become increased in height, the PR
interval lengthens and the P wave disappears as potassium
concentration increases. The Procaine hydrochloride acts as a
local anaesthetic. The primary site of action for procaine is the
myocardium, resulting in a decrease in electrical excitability,
conduction rate and force of contraction.
Pharmacokinetic Properties
Procaine hydrochloride is almost completely metabolised with
only about 2% excreted unchanged in the urine. The half life is
less than one minute.
Preclinical Safety Data
Acute toxicity data for procaine hydrochloride indicates an
LD50 of 200 mg/kg following oral administration in the Rat.
There are no other additional preclinical safety data that
would be of significance to the prescriber.

Incompatibilities
None stated.
Shelf Life
3 years (36 month)
Special Precautions for Storage
Do not store above 25°C.
Protect from light
Nature and Contents of Container
Clear colourless Ph Eur type I glass ampoules containing 20 ml
of solution.
The ampoules are packed in cartons of 10.
Instruction for Use/Handling
None stated
Product licence number: PL 01883/0012

List of Excipients
Disodium Edetate BP
Sodium Hydroxide
Water for Injections BP

Continued overleaf

D0249200000

2492-C

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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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