PHENYTOIN JUNO (phenytoin sodium) 100mg/ 2mL injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

phenytoin sodium, Quantity: 100 mg

Available from:

Juno Pharmaceuticals Pty Ltd

INN (International Name):

Phenytoin sodium

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: propylene glycol; sodium hydroxide; ethanol; water for injections

Administration route:

Intravenous

Units in package:

5 x 2mL, 1 x 2mL, 10 x 2mL

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Control of status epilepticus, tonic-clonic (grand mal), psychomotor seizures and the prevention of seizures occuring during or following neurosurgery. Phenytoin will prevent or effectively decrease the incidence and severity of convulvsive 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 convential antiarrhythmic agents or to cardioversion. Phenytoin serum level determinations may be necessary for optimal dosage adjustments (see dosage and administation).

Product summary:

Visual Identification: Clear , colourless solution; Container Type: Ampoule; Container Material: Glass; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2006-12-22

Patient Information leaflet

Phenytoin Sandoz®
1
PHENYTOIN SANDOZ
®
INJECTION
_Phenytoin sodium Injection _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Phenytoin Sandoz.
It does not contain all the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you using
this medicine against the
benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS
ABOUT USING THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT PHENYTOIN SANDOZ
IS USED FOR
Phenytoin Sandoz is used to
control epilepsy. Epilepsy is a
condition where you have
repeated seizures (fits). There
are many types of seizures,
ranging from mild to severe.
Phenytoin Sandoz contains the
active ingredient, phenytoin.
Phenytoin belongs to a group of
medicines known as
anticonvulsants. These drugs
are thought to work by
controlling brain chemicals which
send signals to nerves so that
seizures do not happen.
Phenytoin Sandoz is also used
to help prevent seizures during
or after brain surgery. It may also
be used to treat a rapid or
irregular heartbeat.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have
prescribed it for another reason.
There is no evidence that
Phenytoin Sandoz is addictive.
This medicine is available only
with a doctor’s prescription.
BEFORE YOU ARE GIVEN
PHENYTOIN SANDOZ
_WHEN YOU MUST NOT BE GIVEN _
_IT _
YOU MUST NOT BE GIVEN THIS
MEDICINE IF YOU HAVE AN
ALLERGY TO:

Phenytoin sodium or
phenytoin, the active
ingredients, or any other
ingredients listed at the end
of this leaflet under Product
Description

a group of medicines called
hydantoins or other similar
medicines such as
methylphenobarbitone or
any other barbiturate
medicines, succinimides,
oxazolidinediones and other
related compounds

other medicines used to
treat fits and convulsions.
Symptoms of

Summary of Product characteristics

Australian Product Information
Product Information v3.0
Page | 1
AUSTRALIAN PRODUCT INFORMATION
_PHENYTOIN JUNO (PHENYTOIN SODIUM) _
1 NAME OF THE MEDICINE
Phenytoin sodium.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Phenytoin Juno 100mg/2mL and 250mg/5mL - Ready mixed ampoules. Each mL
of solution
contains 50 mg of phenytoin sodium as an active ingredient.
EXCIPIENTS WITH KNOWN EFFECT:
Contains alcohol (ethanol) 10% v/v
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
Solution for injection.
Clear colourless solution, free from visible particulates.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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 DOSE AND METHOD OF ADMINISTRATION).
4.2 DOSE AND METHOD OF ADMINISTRATION
Phenytoin Juno must be administered slowly. Intravenous administration
should not exceed
50mg/minute in adults. In neonates and children, the drug should be
administered at a rate
not exceeding 1 to 3mg/kg/minute, maximum of 50mg/minute.
Dilution of Phenytoin Juno into intravenous infusion is not
recommended due to lack of
solubility and resultant precipitation.
The solution is suitable for use as long as it remains free of
haziness and precipitate. A
precipitate might form if the product has been kept in a refrigerator
or freezer. This
prec