DICOBALT EDETATE INJECTION 300 MG - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Dicobalt Edetate Injection 300mg

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ampoule contains 300mg Dicobalt Edetate INN (15mg/ml)

3 PHARMACEUTICAL FORM

Solution for Injection

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Dicobalt Edetate Injection is a specific antidote for acute cyanide poisoning. In view of the difficulty of certain diagnosis in emergency situations, it is recommended that Dicobalt Edetate Injection only be given when the patient is tending to lose or has lost consciousness. The product should not be used as a precautionary measure.

4.2 Posology and method of administration

Cyanide poisoning must be treated as quickly as possible and intensive supportive measures must be instituted: clear airways and adequate ventilation are essential. 100% oxygen should be administered concurrently with Dicobalt Edetate.

Expert advice on the treatment of poisoning is available at the local poisons centre.

Adults

One 300mg ampoule intravenously over approximately one minute. If the patient shows inadequate response, a second ampoule may be given. If there is no response after a further five minutes, a third ampoule maybe administered.

Each ampoule of Dicobalt Edetate Injection may be followed immediately by 50ml Glucose Intravenous Infusion BP 500g/l.

When the patient’s condition is less severe but in the physician’s jud­gement still warrants the use of Dicobalt Edetate Injection, the period over which the injection is given should be extended to 5 minutes.

Children

There is no clinical experience of the use of Dicobalt Edetate Injection in children. As with adults the dose required will be related to the quantity of cyanide ingested.

The elderly

There is no clinical evidence of the use of Dicobalt Edetate Injection in the elderly, but there is no reason to believe that the dosage schedule should be different from that for adults.

4.3 Contraindications

None

4.4 Special warnings and precautions for use

There is a reciprocal antidote action between cyanide and cobalt. Thus in the absence of cyanide, Dicobalt Edetate Injection itself is toxic. It is therefore essential that the product only be used in cases of cyanide poisoning. When the patient is fully conscious, it is unlikely that the extent of poisoning warrants the use of Dicobalt Edetate Injection.

4.5 Interaction with other medicinal products and other forms of interaction No information is available

4.6 Pregnancy and lactation

No information is available

4.7 Effects on ability to drive and use machines

Not applicable

4.8 Undesirable effects

The initial effects of Dicobalt Edetate Injection are vomiting, a fall in blood pressure and compensatory tachycardia. After this the patient should recover.

4.9 Overdose

Signs and symptoms – these may be due to cobalt toxicity or to an anaphylactic type reaction, which may be dramatic. Oedema (particularly of the face and neck), vomiting, chest pain, sweating, hypotension, cardiac irregularities and rashes may occur.

Treatment – intensive supportive therapy is required.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Cyanide blocks intracellular respiration by binding to cytochrome oxidase. Dicobalt Edetate Injection forms a stable complex with the cyanide thereby acting as an antidote.

5.2 Pharmacokinetic properties

Only very limited data are available. Intravenous infusion of Dicobalt Edetate Injection is likely to result in rapid distribution in the extracellular fluid compartment. Excretion is entirely via the kidneys within 24 hours and it is not metabolised.

5.3 Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Dextrose Monohydrate

Water for Injections

6.2 Incompatibilities

Not applicable

6.3 Shelf life

Three years

6.4 Special precautions for storage

Store below 25°C away from light

6.5 Nature and contents of container

Packs of six Ph.Eur Type I glass ampoules each containing 20ml of rose-violet coloured sterile pyrogen free solution

6.6 Special precautions for disposal None

7 MARKETING AUTHORISATION HOLDER

SERB, 40 avenue George V, F-75008 PARIS, FRANCE

8 MARKETING AUTHORISATION NUMBER(S)

PL 26080/0001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

31/05/1996 / 17/03/2003