Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom Pro-Epanutin is distributed in the UK by Blackstaff Pharmaceuticals Limited.
Pro-Epanutin 75 mg/mL, Concentrate for solution for infusion/Solution for injection.
| Pharmaceutical Form |
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Concentrate for solution for infusion/Solution for injection. Pro-Epanutin is a clear, colourless to pale yellow, sterile solution buffered with trometamol adjusted to pH 8.6 to 9.0 with hydrochloric acid. |
Fosphenytoin sodium injection is a prodrug intended for parenteral administration; its active metabolite is phenytoin. 1.5 mg of fosphenytoin sodium is equivalent to 1 mg phenytoin sodium, and is referred to as 1 mg phenytoin sodium equivalents (PE). The amount and concentration of fosphenytoin is always expressed in terms of mg PE.
One mL of Pro-Epanutin contains 75 mg of fosphenytoin sodium (equivalent to 50 mg of phenytoin sodium) (see section 4.2).
Pro-Epanutin is available in 10 mL and 2 mL vials.
Each 10 mL vial contains 500 mg PE.
Each 2 mL vial contains 100 mg PE.
For the full list of excipients, see section 6.1.
| List of Excipients |
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Water for injection |
5 and 10 mL untreated Type I clear glass vials (containing 2 and 10 mL solution, respectively) with a Fluorotec coated stopper, and an aluminium seal with flip-off cap.
Boxes of 5 vials with 2 mL solution.
Boxes of 10 vials with 2 mL solution.
Boxes of 25 vials with 2 mL solution.
Boxes containing 10 boxes of 5 vials (=50 vials) with 2 mL solution.
Boxes of 5 vials with 10 mL solution.
Boxes of 10 vials with 10 mL solution.
Boxes containing 5 boxes of 5 vials (=25 vials) with 10 mL solution.
Not all pack sizes may be marketed.
Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom
Pro-Epanutin is distributed in the UK by Blackstaff Pharmaceuticals Limited.
PL 00057/0551
Date of first authorisation: 28th July 2004
Date of latest renewal: 11th September 2009
| Drug | Countries | |
|---|---|---|
| PRO-EPANUTIN | Finland, Ireland, United Kingdom |
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