Dilantin Paediatric

Šalis: Naujoji Zelandija

kalba: anglų

Šaltinis: Medsafe (Medicines Safety Authority)

Veiklioji medžiaga:

Phenytoin 6 mg/mL

Prieinama:

Viatris Limited

INN (Tarptautinis Pavadinimas):

Phenytoin 6 mg/mL

Dozė:

30 mg/5mL

Vaisto forma:

Oral suspension

Sudėtis:

Active: Phenytoin 6 mg/mL Excipient: Aluminium magnesium silicate Carmellose sodium Carmoisine Citric acid monohydrate Ethanol Imitation banana flavour 510120E Glycerol Polysorbate 40 Purified water Sodium benzoate Sucrose Sunset yellow FCF Terpeneless orange oil Vanillin

Vienetai pakuotėje:

Bottle, 500 mL

Klasė:

Prescription

Recepto tipas:

Prescription

Pagaminta:

Pharmacia & Upjohn Company LLC

Produkto santrauka:

Package - Contents - Shelf Life: Bottle, - 500 mL - 36 months from date of manufacture stored at or below 25°C

Leidimo data:

1969-12-31

Pakuotės lapelis

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NEW ZEALAND CONSUMER MEDICINE INFORMATION
DILANTIN
®
_PHENYTOIN, PHENYTOIN SODIUM _
_CAPSULES 30 MG & 100 MG, CHEWABLE TABLETS 50 MG AND PAEDIATRIC ORAL _
_SUSPENSION 30 MG/5 ML _
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking DILANTIN
This leaflet answers some common
questions about DILANTIN.
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 taking DILANTIN
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT DILANTIN IS
USED FOR
DILANTIN is used to control

Epilepsy
Epilepsy is a condition where you
have repeated seizures (fits). There
are many different types of
seizures, ranging from mild to
severe.
DILANTIN belongs to a group of
medicines called anticonvulsants.
These drugs are thought to work by
controlling brain chemicals which
send signals to nerves so that
seizures do not happen.
DILANTIN is also used to help
prevent seizures occurring during or
after brain surgery.
DILANTIN may be used alone, or in
combination with other medicines,
to treat your condition.
Your doctor may have prescribed
this medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
This medicine is available only with
a doctor’s prescription.
There is no evidence that DILANTIN
is addictive.
BEFORE YOU TAKE
DILANTIN
_WHEN YOU MUST NOT TAKE _
_IT _
DO NOT TAKE DILANTIN IF YOU HAVE
AN ALLERGY TO:

any medicine containing
phenytoin sodium or
phenytoin, the active
ingredients in DILANTIN,

any other hydantoin
medicines

any of the ingredients listed
at the end of this leaflet

methylphenobarbitone or
any other barbiturate
medicines

other medicines used to
treat fits and convulsions.
Some of the symptoms o

Prekės savybės

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NEW ZEALAND DATA SHEET
DILANTIN
®
_ _
_ _
1. PRODUCT NAME
Dilantin 30 mg and 100 mg phenytoin sodium capsules
Dilantin Infatabs 50 mg phenytoin chewable tablets
Dilantin 30 mg/5 mL phenytoin paediatric oral suspension
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 30 mg capsule contains 30 mg phenytoin sodium.
Each 100 mg capsule contains 100 mg phenytoin sodium.
Each 50 mg chewable infatabs contains 50 mg phenytoin.
Each 5 mL of paediatric suspension contains 30 mg phenytoin.
EXCIPIENTS WITH KNOWN EFFECT
All formulations contain sucrose.
The 30 mg capsule new formulation contains lactose monohydrate.
The 100 mg capsule (both new and old formulations) contains lactose
monohydrate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Capsules 30 mg: white, marked Parke Davis, P-D 30.
Capsules 100 mg: white / orange, marked Parke Davis and P-D 100.
Infatabs 50 mg: chewable tablets, spearmint-flavoured, for children,
triangular, yellow, scored,
marked P-D 007. The scoreline is not intended to divide the tablets
into equal halves.
Paediatric suspension: reddish-pink suspension.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS _
Dilantin is indicated for the control of generalised tonic-clonic
(grand mal) and psychomotor seizures.
Dilantin 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, Dilantin frequently
improves the mental condition
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and outlook of epileptic patients and there is also increasing
evidence that Dilantin is valuable in the
prevention of seizures occurring during or after neurosurgery.
Phenytoin serum level determinations
may be necessary for optimal dosage adjustments (see section 4.2).
_4.2 _
_DOSE AND METHOD OF ADMINISTRATION _
Serum concentrations shoul