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

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

有效成分:

valaciclovir, Quantity: 500 mg

可用日期:

Sun Pharma ANZ Pty Ltd

INN（国际名称）:

Valaciclovir

药物剂型:

Tablet, film coated

组成:

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

给药途径:

Oral

每包单位数:

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

处方类型:

(S4) Prescription Only Medicine

疗效迹象:

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.

產品總結:

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: 36 Months; Container Temperature: Store below 25 degrees Celsius

授权状态:

Licence status A

授权日期:

2009-07-09

资料单张

Valaciclovir RBX CMI V4 June 2019
Page 1 of 11
VALACICLOVIR RBX
_VALACICLOVIR TABLETS_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about VALACICLOVIR RBX
(valaciclovir).
It does not contain all the available information.
It does not take the place of talking to your doctor or
pharmacist.
This leaflet was last updated on the date at the end of this
leaflet. More recent information may be available. The latest
Consumer
Medicine
Information
is
available
from
https://www.ebs.tga.gov.au/ and may contain important information
about the medicine and its use of which you should be aware.
All medicines have risks and benefits. Your doctor has weighed
the risks of you taking VALACICLOVIR RBX
against the benefits it
is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT USING/TAKING THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
Keep this leaflet with this medicine. You may need to read it
again.
WHAT VALACICLOVIR RBX TABLET IS USED FOR
VALACICLOVIR RBX
tablets contain valaciclovir (as hydrochloride).
VALACICLOVIR RBX tablets belong to a group of medicines called
anti-virals.
VALACICLOVIR RBX
tablets are used for one or more of the
following in adults:

_TREATMENT OF HERPES ZOSTER (SHINGLES): _Valaciclovir_ _works by
stopping
the
multiplication
of
the
virus
which
causes
shingles. It can reduce the length and severity of an outbreak
of shingles and the duration of pain associated with shingles.
It is important the treatment is started within the first
three days of the shingles attack.
Valaciclovir RBX CMI V4 June 2019
Page 2 of 11

_TREATMENT OF OPHTHALMIC ZOSTER (SHINGLES AFFECTING THE EYE _
_REGION)_

_TREATMENT OF GENITAL HERPES INFECTION:_
Valaciclovir works by
stopping the multiplication of the virus which causes herpes.
It can reduce the length and severity of an outbreak of
herpes, the duration of pain and shorten the time to healing
of crusts associated with herpes. They do not eliminate the
herpes virus from the body. The herpes virus is also known a

产品特点

Valaciclovir RBX PI V5 June 2019
1
AUSTRALIAN PRODUCT INFORMATION
VALACICLOVIR RBX
VALACICLOVIR
1
NAME OF THE MEDICINE
Valaciclovir
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
VALACICLOVIR RBX film-coated tablet 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 PARTICULARS
VALACICLOVIR RBX is 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 RBX (valaciclovir),
it is recommended that
patients use safer sex practices. (see SECTION 4.4 SPECIAL WARNINGS
AND PRECAUTIONS
FOR USE).
•
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 RBX) three times
a day for seven days.
Valaciclovir RBX PI V5 June 2019
2
For treatment of first clinical presentation of genital herpes, 500 mg
of valaciclovir (1 tablet of
VALACICLOVIR RBX) twice a day for 5 to 10 days.
For recurrent episodes of genital herpes, 500 mg of valaciclovir (1
tablet of VALACICLOVIR RBX) twice
daily for 5 days.
Dosing should begin as early as possible. For recurrent episodes of
genital herpes, this should ideally
be duri