Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Sterile Concentrate for Cardioplegia Infusion
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Potassium chloride, Magnesium chloride hexahydrate, Procaine hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for Before Sterile Concentrate for Cardioplegia Infusion is 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
Frequently asked questions about Sterile Concentrate for Cardioplegia Infusion
How do I take Sterile Concentrate for Cardioplegia Infusion?
Sterile Concentrate for Cardioplegia Infusion comes as infusion. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Sterile Concentrate for Cardioplegia Infusion?
The active substance in Sterile Concentrate for Cardioplegia Infusion is potassium chloride, magnesium chloride hexahydrate, procaine hydrochloride.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Sterile Concentrate for Cardioplegia Infusion, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Sterile Concentrate for Cardioplegia Infusion without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: potassium chloride, magnesium chloride hexahydrate, procaine hydrochloride
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Sterile Concentrate for Cardioplegia Infusion is used during heart surgery to induce cardioplegia.Solution for infusion into the coronary arteries during cardiopulmonary bypass to induce cardioplegia.
4.2. 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.
4.3. Contraindications
Hypersensitivity to procaine
4.4. 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.
4.5. Interaction with other medicinal products and other forms of interaction
None stated.
4.6. Pregnancy and lactation
None stated
4.7. Effects on ability to drive and use machines
None stated.
4.8. Undesirable effects
None stated.
4.9. Overdose
Appropriate supportive measures should be taken. Apnoea: It may be necessary to apply artificial respirationFor circulatory depression: Give a vasopressor and intravenous fluids.For seizures: Give oxygen and intravenous diazepam. For methaemoglobinaemia: Give oxygen and methylene blue
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Not the same combination. This medicine contains Potassium chloride, Magnesium chloride hexahydrate, Procaine hydrochloride. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
- GEROVITAL H³ 100 mg/5 ml prescription partial — not the same combinationPROCAINI HYDROCHLORIDUM · injection / infusion
- MAGNESII SULFURICI POLPHARMA 200 mg/ml prescription partial — not the same combinationMAGNESII SULFAS · injection / infusion
- MAGNESIUM SULFATE KALCEKS 200 mg/ml prescription partial — not the same combinationMAGNESII SULFAS · injection / infusion
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Not the same combination. This medicine contains Potassium chloride, Magnesium chloride hexahydrate, Procaine hydrochloride. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
- Inj. Magnesii Sulfurici 20% Polpharma partial — not the same combinationMagnesii sulfas · injection / infusion
- Veto-Mag partial — not the same combinationMagnesium sulfuricum · injection / infusion
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Sterile Concentrate for Cardioplegia Infusion. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.