APO-FAMCICLOVIR famciclovir 250mg tablet bottle

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Wirkstoff:

famciclovir, Quantity: 250 mg

Verfügbar ab:

Arrotex Pharmaceuticals Pty Ltd

INN (Internationale Bezeichnung):

Famciclovir

Darreichungsform:

Tablet

Zusammensetzung:

Excipient Ingredients: macrogol 8000; hypromellose; poloxamer; titanium dioxide; stearic acid

Verabreichungsweg:

Oral

Einheiten im Paket:

21, 56, 20, 40, 28, 14

Verschreibungstyp:

(S4) Prescription Only Medicine

Anwendungsgebiete:

Famciclovir is indicated for:. - the treatment of herpes zoster infection in adult patients who commence therapy within 72 hours of the onset of rash. Greatest benefit occurs if the drug is started within 48 hours. Efficacy has not been demonstrated in patients less than 50 years of age, although the occasional younger patient with severe herpes zoster may benefit from therapy with famciclovir. Herpes zoster infection is generally a milder condition in younger patients.. - the treatment of recurrent episodes of genital herpes in adults and adolescents 12 years of age and older.. - suppression of recurrent genital herpes.. - the treatment of recurrent herpes labialis (cold sores) in immunocompetent adult patients.. Famciclovir is indicated in immunocompromised patients for:. - treatment of uncomplicated herpes zoster;. - treatment of recurrent herpes simplex;. - suppression of recurrent herpes simplex.

Produktbesonderheiten:

Visual Identification: White, round, biconvex film-coated tablets, engraved "APO" on one side and "FAM" over "250" on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Berechtigungsstatus:

Licence status A

Berechtigungsdatum:

2010-05-12

Fachinformation

1
AUSTRALIAN PRODUCT INFORMATION
APO- FAMCICLOVIR (FAMCICLOVIR) TABLETS
1
NAME OF THE MEDICINE
Famciclovir.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 125mg, 250mg or 500mg famciclovir as the active
ingredient.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
125 MG TABLETS:
White, round, biconvex, film-coated and engraved “_FAM_” over
“_125_” on one side and “_APO_”
on the other side.
250 MG TABLETS:
White, round, biconvex, film-coated and engraved _“FAM”_ over
_“250”_ on one side and _“APO”_
on the other side.
500 MG TABLETS:
White, oval, biconvex, film-coated and engraved “_FAM500_” on one
side and “_APO_” on the other
side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Famciclovir is indicated for:
•
treatment of herpes zoster infection in adult patients who commence
therapy within 72
hours of the onset of rash. Greatest benefit occurs if the drug is
started within 48 hours.
Efficacy has not been demonstrated in patients less than 50 years of
age, although the
occasional younger patient with severe herpes zoster may benefit from
therapy with
famciclovir. Herpes zoster infection is generally a milder condition
in younger patients.
•
treatment of recurrent episodes of genital herpes in adults and
adolescents 12 years of
age and older.
•
suppression of recurrent genital herpes.
•
treatment of recurrent herpes labialis (cold sores) in immunocompetent
adult patients.
Famciclovir is also indicated in immunocompromised patients for:
•
treatment of uncomplicated herpes zoster
•
treatment of recurrent herpes simplex
•
suppression of recurrent herpes simplex.
2
4.2
DOSE AND METHOD OF ADMINISTRATION
METHOD OF ADMINISTRATION
APO- Famciclovir is intended for oral administration.
Famciclovir can be taken without regard to meals (see section 5
PHARMACOLOGICAL PROPERTIES
- 5.2 PHARMACOKINETIC PROPERTIES, EFFECT OF FOOD).
DOSAGE
IMMUNOCOMPETENT
Herpes zoster
The recommended dosage of famciclovir is 250 mg three time