Dicobalt edetate 300mg/20ml solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Dicobalt edetate

Available from:

Alliance Pharmaceuticals Ltd

ATC code:

n/a

INN (International Name):

Dicobalt edetate

Dosage:

15mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 19020700; GTIN: 5024403000219

Patient Information leaflet

D
ICOBALT
E
DETATE
INJECTION 300 mg
(Dicobalt edetate)
READ ALL OF THIS LEAFLET CAREFULLY
- This leaflet contains information about Dicobalt Edetate Injection,
which will have already been given to
you by injection into one of your veins.
- Although you will not be taking this medicine yourself, this leaflet
contains important information to help
you understand how Dicobalt Edetate Injection is used.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or nurse
- If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell
your doctor or nurse.
IN THIS LEAFLET:
1.
What Dicobalt Edetate Injection is and what it is used for
2.
Before you are given Dicobalt Edetate Injection
3.
How Dicobalt Edetate Injection is given
4.
Possible side effects
5.
How to store Dicobalt Edetate Injection
6.
Further information
1. WHAT DICOBALT EDETATE INJECTION IS AND WHAT IT IS USED FOR
Dicobalt Edetate Injection 300 mg is an antidote for cyanide poisoning
which must be treated as quickly
as possible. It is usually only given when the patient is, or
becoming, unconscious.
Dicobalt Edetate is a life-saving injection and will not be given as a
precautionary measure.
2. BEFORE YOU ARE GIVEN DICOBALT EDETATE INJECTION
THIS SOLUTION MUST NOT BE GIVEN IF:
•
the poisoning is so mild that the patient is fully conscious._ _
•
the patient’s condition is not due to cyanide poisoning - the
injection on its own is toxic._ _
TAKING OTHER MEDICINES
There is no information available about the interaction of this
injection with other medicines.
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines,
including medicines obtained without a prescription.
PREGNANCY AND BREAST-FEEDING
There is no information available about the use of this injection in
pregnant or breast-feeding women.
IMPORTANT
INFORMATION
ABOUT
SOME
OF
THE
INGREDIENTS
IN
DICOBALT
EDETATE
INJECTION
DEXTROSE is an ingredient in the soluti

Summary of Product characteristics

OBJECT 1
DICOBALT EDETATE INJECTION 300MG
Summary of Product Characteristics Updated 20-Feb-2012 | Alliance
Pharmaceuticals
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 may be 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 Contraind