DBL™ Phenytoin Injection

País: Nova Zelândia

Língua: inglês

Origem: Medsafe (Medicines Safety Authority)

Ingredientes ativos:

Phenytoin sodium 50 mg/mL

Disponível em:

Pfizer New Zealand Limited

DCI (Denominação Comum Internacional):

Phenytoin sodium 50 mg/mL

Dosagem:

50 mg/mL

Forma farmacêutica:

Solution for injection

Composição:

Active: Phenytoin sodium 50 mg/mL Excipient: Ethanol Hydrochloric acid Propylene glycol Sodium hydroxide Water for injection

Unidades em pacote:

Ampoule, glass, 5x2mL, 10 mL

Classe:

Prescription

Tipo de prescrição:

Prescription

Fabricado por:

Katwijk Chemie BV

Indicações terapêuticas:

Latest Regulatory Activity

Resumo do produto:

Package - Contents - Shelf Life: Ampoule, glass, 5x2mL - 10 mL - 18 months from date of manufacture stored at or below 25°C protect from light - Ampoule, glass, 5x5mL - 25 mL - 18 months from date of manufacture stored at or below 25°C protect from light

Data de autorização:

1993-02-26

Características técnicas

Version: pfdpheni10123
Supersedes: pfdpheni11022
Page 1 of 24
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
DBL
™
Phenytoin Injection 50 mg/mL Solution for Injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
DBL Phenytoin Injection is a ready mixed solution of phenytoin sodium.
Each mL of solution contains phenytoin sodium 50 mg (100 mg/2 mL, 250
mg/5 mL) propylene
glycol 0.4 mL and ethanol 0.1 mL in Water for Injection adjusted to pH
12 with either sodium
hydroxide or hydrochloric acid.
Excipient(s) with known effect
•
Alcohol
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection
DBL Phenytoin Injection is a clear, colourless solution, free from
visible particulates.
Phenytoin sodium is the sodium salt of phenytoin. It is soluble in
water and alcohol. It is a
white, odourless, slightly hygroscopic crystalline powder.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the control of status epilepticus, tonic-clonic (grand mal),
psychomotor seizures and the
prevention of seizures occurring during or following neurosurgery.
Phenytoin will prevent or
effectively decrease the incidence and severity of convulsive seizures
in a high percentage of
cases, with patients exhibiting little tendency to become resistant to
its action. Besides its
effectiveness in controlling seizures, phenytoin frequently improves
the mental condition and
outlook of epileptic patients.
It has also been used in the treatment of certain cardiac arrhythmias,
particularly in those
patients who do not respond to conventional antiarrhythmic agents or
to cardioversion.
Phenytoin serum level determinations may be necessary for optimal
dosage adjustments (see
section 4.2).
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
_STATUS EPILEPTICUS:_
For the control of status epilepticus in adults, a loading dose of 10
to 15
mg/kg should be administered slowly intravenously, at a rate not
exceeding 50 mg/min. This
Version: pfdpheni10123
Supersedes: pfdpheni11022
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will require approximately 20 minutes in a 70