PHENOBARBITAL SODIUM Solution for injection Ref.[7809] Active ingredients: Phenobarbital

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Macarthys Laboratories Ltd, T/A Martindale Pharma, Bampton Road, Harold Hill, Romford RM3 8UG

Product name and form

Phenobarbital Sodium 200mg/ml Injection.

Pharmaceutical Form

Solution for Injection.

Clear, colourless, solution practically free from particles.

pH = 10.0–11.0

Qualitative and quantitative composition

Each ml of solution contains 200mg of Phenobarbital Sodium.

Excipient with known effect: Propylene Glycol: 90.000%v/v

For the full list of excipients, see section 6.1.

Active Ingredient Description
Phenobarbital

Phenobarbital has sedative effects and has some protective action against all varieties of human partial and generalised epilepsy, with the exception of absence seizures. Phenobarbital is also effective in preventing seizures in the corresponding experimental animal models of epilepsy.

List of Excipients

Disodium edetate
Propylene glycol
Water for injection

Pack sizes and marketing

Clear type 1 Ph Eur glass ampoules each containing sufficient product to allow removal of 1ml. Sold in cardboard outers of 10 ampoules.

Marketing authorization holder

Macarthys Laboratories Ltd, T/A Martindale Pharma, Bampton Road, Harold Hill, Romford RM3 8UG

Marketing authorization dates and numbers

PL 01883/6190R

Date of first authorisation: 10 August 1982

Date of latest renewal: 20 December 2008

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