Summary of Product Characteristics (SmPC) - Sterile concentrate for Cardioplegia infusion.
1 NAME OF THE MEDICINAL PRODUCT
Sterile Concentrate for Cardioplegia Infusion
2 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.
3 PHARMACEUTICAL FORM
Sterile aqueous solution
4 CLINICAL PARTICULARS
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. Contra-indications
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. Interactions with other Medicaments 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 respiration For circulatory depression: Give a vasopressor and intravenous fluids. For seizures: Give oxygen and intravenous diazepam. For methaemoglobinaemia: Give oxygen and methylene blue
5 PHARMACOLOGICAL PROPERTIES
5.1 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.
5.2. 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.
5.3. 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.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Disodium Edetate BP
Sodium Hydroxide
Water for Injections BP
6.2. Incompatibilities
None stated.
6.3. Shelf Life
3 years (36 month)
6.4. Special Precautions for Storage
Do not store above 25°C.
Protect from light
6.5. 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.
6.6. Instruction for Use/Handling
None stated
7 MARKETING AUTHORISATION HOLDER
Macarthy's Laboratories Ltd
T/a Martindale Pharmaceuticals
Bampton Road,
Romford
RM3 8UG
8. Marketing Authorisation Number
PL 01883/0012
9. Date of First Authorisation/Renewal of Authorisation
6 April 1982
10 DATE OF REVISION OF THE TEXT
24/06/2013