ZELITREX valaciclovir 500mg (as hydrochloride) tablet bottle

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Viambatanisho vya kazi:

valaciclovir hydrochloride, Quantity: 556 mg (Equivalent: valaciclovir, Qty 500 mg)

Inapatikana kutoka:

Arrotex Pharmaceuticals Pty Ltd

INN (Jina la Kimataifa):

valaciclovir hydrochloride

Dawa fomu:

Tablet, film coated

Tungo:

Excipient Ingredients: microcrystalline cellulose; crospovidone; povidone; magnesium stearate; colloidal anhydrous silica; Carnauba Wax; Colour

Njia ya uendeshaji:

Oral

Vitengo katika mfuko:

100 tablets

Dawa ya aina:

(S4) Prescription Only Medicine

Matibabu dalili:

For the treatment of herpes zoster (shingles) in adult patients who commence therapy within 72 hours of the onset of rash. For the treatment of ophthalmic zoster. For the treatment of herpes labialis (cold sores). For the treatment of clinical episodes of genital herpes simplex infections. For the prevention of recurrent genital herpes. Reduction of transmission of genital herpes in patients suffering from recurrent genital herpes. In addition to therapy with Zelitrex, it is recommended that patients use safer sex practices. (See PRECAUTIONS). Prophylaxis of cytomegalovirus (CMV) infection and disease following solid organ transplantation in patients at risk of CMV disease.

Bidhaa muhtasari:

Visual Identification: White, film coated tablet, white to off-white core, biconvex, elongated, unscored engraved with "500" on one side and plain on the other; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Idhini hali ya:

Licence status A

Idhini ya tarehe:

2012-08-30

Tabia za bidhaa

1
AUSTRALIAN PRODUCT INFORMATION – ZELITREX (VALACICLOVIR AS
HYDROCHLORIDE) TABLETS
1
NAME OF THE MEDICINE
Valaciclovir as hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ZELITREX tablets 500mg contain 500mg of valaciclovir as hydrochloride.
3
PHARMACEUTICAL FORM
ZELITREX tablets 500mg: White, film coated tablet, white to off-white
core, biconvex, elongated,
unscored engraved with “500” on one side and plain on the other.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
For the treatment of herpes zoster (shingles) in adult patients who
commence therapy within 72 hours
of the onset of rash.
For the treatment of ophthalmic zoster.
For the treatment of recurrent herpes labialis (cold sores)
For the treatment of clinical episodes of genital herpes simplex
infections.
For the prevention of recurrent genital herpes.
Reduction of transmission of genital herpes in patients suffering from
recurrent genital herpes. In
addition to therapy with ZELITREX, it is recommended that patients use
safer sex practices. (SEE
SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).
Prophylaxis of cytomegalovirus (CMV) infection and disease following
solid organ transplantation in
patients at risk of CMV disease.
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE IN ADULTS
FOR THE TREATMENT OF HERPES ZOSTER (SHINGLES)
For treatment of herpes zoster, 1000 mg of ZELITREX three times a day
for seven days.
FOR THE TREATMENT OF HERPES LABIALIS (COLD SORES)
The recommended dosage of ZELITREX for the treatment of cold sores is
2000 mg twice daily for 1 day
with the second dose taken about 12 hours (no sooner than 6 hours)
after the first dose. Therapy
should be initiated at the earliest symptom of a cold sore (e.g.
tingling, itching, or burning)
GENITAL HERPES
_For the treatment of genital herpes _
For treatment of first clinical presentation of genital herpes, 500 mg
of ZELITREX twice a day for 5 to
10 days. For recurrent episodes of genital herpes, 500 mg twice