VALACICLOVIR APOTEX valaciclovir 500 mg (as valaciclovir hydrochloride) tablet blister pack

Երկիր: Ավստրալիա

Լեզու: անգլերեն

Աղբյուրը: Department of Health (Therapeutic Goods Administration)

Ակտիվ բաղադրիչ:

valaciclovir, Quantity: 500 mg

Հասանելի է:

Arrotex Pharmaceuticals Pty Ltd

INN (Միջազգային անվանումը):

Valaciclovir

Դեղագործական ձեւ:

Tablet, film coated

Կազմը:

Excipient Ingredients: magnesium stearate; povidone; crospovidone; microcrystalline cellulose; indigo carmine aluminium lake; titanium dioxide; hypromellose; polysorbate 80; macrogol 6000; macrogol 400

Կառավարման երթուղին:

Oral

Միավորները փաթեթում:

10 tablets per pack, 42 tablets per pack, 100 tablets per pack, 30 tablets per pack

Ռեկվիզորի տեսակը:

(S4) Prescription Only Medicine

Թերապեւտիկ ցուցումներ:

For the treatment of herpes zoster (shingles) in adult patients who commence therapy within 72 hours of the onset of rash. Treatment of ophthalmic zoster. Treatment of clinical episodes of genital herpes simplex infections. For the prevention of recurrent genital herpes in immunocompromised patients with creatinine clearance of > 15 ml/min. For the reduction of transmission of genital herpes in patients suffering from recurrent genital herpes. In addition to therapy with valaciclovir, it is recommended that patients use safer sex practices (see PRECAUTIONS). For prophylaxis of cytomegalovirus (CMV) infection and disease following solid organ transplantation in patients at risk of CMV disease.

Ապրանքի ամփոփագիր:

Visual Identification: Blue, capsule shaped, biconvex, film coated, tablets, debossed with 'V' AND '5' on either side of breakline on one side, notched on either side along with the breakline and plain on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Լիազորման կարգավիճակը:

Licence status A

Հաստատման ամսաթիվը:

2011-02-22

Տեղեկատվական թերթիկ

VALACICLOVIR
APOTEX
_Valaciclovir Tablets_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about valaciclovir. 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 this medicine
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 THIS MEDICINE IS
USED FOR
Valaciclovir belong to a group of
medicines called antivirals.
Valaciclovir is used for the following
conditions in adults:
•
TREATMENT OF HERPES ZOSTER
(SHINGLES):
It can reduce the duration of pain,
length and severity of a shingles
outbreak. Start the treatment
within the first three days of the
shingles attack.
•
TREATMENT OF OPHTHALMIC ZOSTER
(shingles affecting the eye region)
•
TREATMENT OF GENITAL HERPES:
Valaciclovir can reduce the
length and severity of a herpes
outbreak, and reduce the duration
of pain and time to healing of
herpes blisters and crusts. It does
not eliminate the herpes simplex
virus (HSV) from the body. If
you start taking it as soon as you
feel an outbreak starting, you may
prevent blisters from developing.
PREVENTION OF GENITAL HERPES IN
IMMUNOCOMPROMISED PATIENTS WITH
MODERATE TO NORMAL KIDNEY
FUNCTION:
Valaciclovir can be taken by
immunocompromised patients
with adequate kidney function to
help prevent the HSV infection
coming back.
•
REDUCTION OF TRANSMISSION OF
GENITAL HERPES:
Valaciclovir can reduce the risk
of transmitting the HSV virus in
patients who are taking it
continuously. It does not cure
genital herpes or eliminate the
risk of transmission. Therefore, in
addition to valaciclovir, it is
recommended to avoid
intercourse during a herpes
outbreak and always use condoms
to minimise the risk of spreading
he

Ապրանքի հատկությունները

1
AUSTRALIAN PRODUCT INFORMATION
VALACICLOVIR APOTEX
(VALACICLOVIR HYDROCHLORIDE)
1
NAME OF THE MEDICINE
Valaciclovir Hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
VALACICLOVIR APOTEX film-coated tablets contains 500 mg valaciclovir
(as hydrochloride).
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Tablet.
Blue coloured, capsule shaped, biconvex, film coated tablets, debossed
with ‘V’ and ‘5’ on either
side of the breakline on one side, notched on either side along with
the breakline and plain on the
other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
VALACICLOVIR APOTEX are indicated:
•
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 clinical episodes of genital herpes simplex
infections.
•
For
the
prevention
of
recurrent
genital
herpes
in
immunocompromised
patients
with
creatinine clearance of >15 mL/min.
•
For reduction of transmission of genital herpes in patients suffering
from recurrent genital
herpes. In addition to therapy with valaciclovir, it is recommended
that patients use safer
sex practices. (see SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR
USE
).
2
•
For prophylaxis of cytomegalovirus (CMV) infection and disease
following solid organ
transplantation in patients at risk of CMV disease.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE IN ADULTS
For treatment of herpes zoster, 1000 mg of valaciclovir (2 tablets of
VALACICLOVIR APOTEX) three
times a day for seven days.
For treatment of first clinical presentation of genital herpes, 500 mg
of valaciclovir (1 tablet of
VALACICLOVIR APOTEX) twice a day for 5 to 10 days.
For recurrent episodes of genital herpes, 500 mg of valaciclovir (1
tablet of VALACICLOVIR
APOTEX) twice daily for 5 days.
Dosing should begin as early as possible. For recurrent episodes of
genital herpes, this should
ideally be during the prodromal period or immedia