VALACICLOVIR GENERICHEALTH valaciclovir hydrochloride 250mg tablet blister pack

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

valaciclovir hydrochloride monohydrate, Quantity: 305.85 mg

Dostupné s:

Generic Health Pty Ltd

INN (Mezinárodní Name):

Valaciclovir hydrochloride monohydrate

Léková forma:

Tablet, film coated

Složení:

Excipient Ingredients: magnesium stearate; povidone; microcrystalline cellulose; titanium dioxide; hypromellose; hyprolose; macrogol 400

Podání:

Oral

Jednotky v balení:

30 tablets, 20 tablets, 10 tablets, 100 tablets, 60 tablets, 40 tablets, 90 tablets, 50 tablets

Druh předpisu:

(S4) Prescription Only Medicine

Terapeutické indikace:

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 opthalmic 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 Altic, 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.

Přehled produktů:

Visual Identification: Oval, white, biconvex, 13.8 x 6.9 mm with VC1 on one side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Stav Autorizace:

Licence status A

Datum autorizace:

2011-05-18

Informace pro uživatele

CONSUMER MEDICINE INFORMATION
VALACICLOVIR GENERICHEALTH
TREATMENT OF ZOSTER AND HERPES LABIALIS
(VALACICLOVIR HYDROCHLORIDE MONOHYDRATE) FILM-COATED TABLET
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Valaciclovir generichealth.
It does not contain all of the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed
the risks of you taking
Valaciclovir generichealth
against the benefits they expect
it will have for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
TALK TO YOUR DOCTOR OR
PHARMACIST.
Keep this leaflet with your
medicine. You may need to read
it again.
WHAT VALACICLOVIR
GENERICHEALTH IS USED FOR
Valaciclovir generichealth is
used to treat shingles (herpes
zoster), ophthalmic zoster
(shingles affecting the eye
region) and cold sores (herpes
labialis).
Valaciclovir generichealth
belongs to a group of medicines
called antivirals.
It works by stopping the
multiplication of the virus which
causes the shingles and cold
sores. Valaciclovir generichealth
reduces the length and severity
of an outbreak and the duration
of pain associated with the
shingles and cold sores.
It is important to start treatment
within three days of the shingles
attack.
For treatment of cold sores the
tablets should be taken at the
earliest symptom of a cold sore
(eg. tingling, itching, or burning).
Valaciclovir generichealth
tablets are more effective in
patients 50 years and over.
Your doctor may have
prescribed Valaciclovir
generichealth for another
reason. Ask your doctor if you
have any questions about why
Valaciclovir generichealth has
been prescribed for you.
VALACICLOVIR GENERICHEALTH IS
NOT RECOMMENDED FOR USE IN
CHILDREN, AS THERE HAVE BEEN
NO STUDIES OF ITS EFFECTS IN
CHILDREN.
Valaciclovir generichealth is
available only with a doctor’s
prescription.
There is no evidence that
Valaciclovir generichealth is
addictive.
BEFORE YOU TAKE
VALACICLOVIR
GENERICHEALTH
_WHEN YOU MUST NOT TAKE IT _
D

Charakteristika produktu

AUSTRALIAN PRODUCT INFORMATION – VALACICLOVIR GENERICHEALTH
(VALACICLOVIR HYDROCHLORIDE MONOHYDRATE) FILM-COATED TABLET
1
NAME OF THE MEDICINE
Valaciclovir hydrochloride monohydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Valaciclovir generichealth tablets come in three strengths and contain
either 250 mg, 500 mg or 1000 mg
of valaciclovir (as hydrochloride monohydrate).
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Valaciclovir generichealth 250 mg: Oval, white, biconvex, film-coated
tablets, 13.8 x 6.9 mm with VC1
on one side.
Valaciclovir generichealth 500 mg: Oval, white, biconvex, film-coated
tablets, 17.6 x 8.8 mm with VC2
on one side.
Valaciclovir generichealth 1000 mg: Oval, white, biconvex, film-coated
tablets, 22.0 x 11.0 mm with VC3
on one side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC 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 Valaciclovir generichealth, 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.
Valaciclovir generichealth v5
Page 2 of 26
(valaciclovir hydrochloride monohydrate) film-coated tablet
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE IN ADULTS
For the treatment of herpes zoster
For treatment of herpes zoster, 1000 mg of valaciclovir three times a
day for 7 days.
For the treatment of herpes labialis (cold sores)
The recommended dosage of valaciclovir for the treatment of cold sores
is 2000 mg twice daily for 1