SHILOVA valaciclovir (as hydrochloride) 1000mg tablet blister pack

Држава: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

valaciclovir hydrochloride, Quantity: 1112 mg

Доступно од:

Strides Pharma Science Pty Ltd

INN (Међународно име):

valaciclovir hydrochloride

Фармацеутски облик:

Tablet, film coated

Састав:

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

Пут администрације:

Oral

Јединице у пакету:

30, 10

Тип рецептора:

(S4) Prescription Only Medicine

Терапеутске индикације:

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, it is recommended that patients use safer sex practices. ,Prophylaxis of cytomegalovirus (CMV) infection and disease following solid organ transplantation in patients at risk of CMV disease.

Резиме производа:

Visual Identification: Blue, film coated, capsule shaped tablets with partial scorebar on both sides containing 'F' on one side and '8' and '3' 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

Статус ауторизације:

Registered

Датум одобрења:

2011-10-25

Информативни летак

SHILOVA
CONSUMER MEDICINE INFORMATION
Ver 1.0
Page 1 of 5
SHILOVA 500 & 1000 TABLETS
_FOR HERPES SIMPLEX, HERPES ZOSTER AND HERPES LABIALIS _
_valaciclovir_
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about SHILOVA tablets.
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 risks and
benefits. Your doctor has weighed
the risks of you taking SHILOVA
tablets against the benefits this
medicine is expected to 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
SHILOVA TABLETS ARE USED
FOR
HOW SHILOVA TABLETS WORK
SHILOVA tablets belong to a group
of medicines called antivirals.
SHILOVA
tablets are used for the
treatment of genital herpes
infection, shingles (infection zoster),
ophthalmic zosters (shingles
affecting the eye region), cold sores
(herpes labialis) and for the
prevention of Cytomegalovirus
(CMV) infection in people
following an organ transplant.
SHILOVA tablets work by stopping
the multiplication of the virus which
causes herpes, shingles and cold
sores. They can reduce the length
and severity of an outbreak of
herpes, shingles and cold sores and
the duration of pain and shorten the
time to healing of crusts associated
with herpes.
GENITAL HERPES
SHILOVA tablets do not eliminate
the herpes virus from the body. The
herpes virus is also known as the
Herpes Simplex Virus, or HSV.
SHILOVA tablets help the blisters
to heal more quickly. If you start
taking them as soon as you feel an
outbreak starting, you may actually
prevent the blisters from
developing.
SHILOVA tablets can also be taken
long term to help prevent the HSV
infection coming back.
SHILOVA tablets can also reduce
the risk of transmitting the virus that
causes genital herpes in patients
who are taking it continuously to
prevent or reduce recurrent
outbreaks. It does not cure genital
her

Карактеристике производа

Page 1 of 23
PRODUCT INFORMATION
SHILOVA™ 500 & 1000
FILM-COATED TABLETS
NAME OF THE MEDICINE
Active ingredient:
Valaciclovir (as hydrochloride)
Chemical name:
2-[(2-Amino-6-oxo-1, 6-dihydro-9_H_-purin-9-yl) methoxy]ethyl-L-
valinate hydrochloride
CAS number:
124832-27-5 (anhydrous)
Molecular weight:
360.8 (anhydrous)
Molecular formula:
C
13
H
21
ClN
6
O
4
,_x_H
2
O
Chemical structure:
DESCRIPTION
Valaciclovir is the L-valine ester of aciclovir. Aciclovir is a purine
nucleoside analogue.
Valaciclovir hydrochloride is a white or almost white powder,
hygroscopic. It is freely
soluble in water, very slightly soluble in anhydrous ethanol,
practically insoluble in
acetonitrile.
INACTIVE: Microcrystalline cellulose, crospovidone, povidone,
magnesium stearate and
opadry blue 13B50578.
PHARMACOLOGY
MODE OF ACTION
Valaciclovir is rapidly and almost completely converted in man to
aciclovir probably by the
enzyme valaciclovir hydrolase. Aciclovir is a specific inhibitor of
the herpes viruses with _in _
_vitro _activity against herpes simplex viruses (HSV) type 1 and type
2 (IC
50
0.1 – 3.0μM),
varicella-zoster virus (VZV) (IC
50
1.6 – 5.1μM) and human cytomegalovirus (HCMV) (IC
50
10->200μM).
Aciclovir
inhibits
herpes
virus
DNA
synthesis
once
it
has
been
phosphorylated
to
the
active
triphosphate
form.
The
first
stage
of
phosphorylation
requires the activity of a virus-specific enzyme: thymidine kinase in
HSV and VZV
infected cells or protein kinase in HCMV infected cells. This
requirement for activation of
aciclovir
by
a
virus
specific
enzyme
largely
explains
its
unique
selectivity.
The
phosphorylation process is completed (conversion from mono- to
triphosphate) by cellular
Page 2 of 23
kinases. Aciclovir triphosphate competitively inhibits the virus DNA
polymerase and
incorporation of this nucleoside analogue results in obligate chain
termination, halting
virus DNA synthesis and thus blocking virus replication.
PHARMACODYNAMIC EFFECTS
_PHARMACODYNAMICS/RESISTANCE DEVELOPMENT _
Resistance to aciclovir is normally d