OZVIR Aciclovir 200mg tablet blister pack

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Активна съставка:

aciclovir, Quantity: 200 mg

Предлага се от:

Sun Pharma ANZ Pty Ltd

INN (Международно Name):

Aciclovir

Лекарствена форма:

Tablet, uncoated

Композиция:

Excipient Ingredients: microcrystalline cellulose; sodium starch glycollate; pregelatinised maize starch; magnesium stearate; colloidal anhydrous silica

Начин на приложение:

Oral

Броя в опаковка:

25 tablets, 90 tablets

Вид предписание :

(S4) Prescription Only Medicine

Терапевтични показания:

Aciclovir tablets are indicated for use in adult patients for: (1) the treatment of first episode (primary or non-primary) genital herpes and the management of recurrent episodes of genital herpes in certain patients. (2) the treatment of acute attacks of herpes zoster (shingles) when the duration of rash is less than 72 hours. (3) the management of patients with advanced symptomatic HIV disease (CD4 + counts < 150 x 10(6)/L). In accordance with details specified in the "Indications" and the "Dosage and Adminsitration" sections of the approved product information provided as Attachment 1.

Каталог на резюме:

Visual Identification: Capsule shaped biconvex uncoated white to off-white tablets with 200 debossed on one side and ACV 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 Оторизация:

Licence status A

Дата Оторизация:

2005-09-26

Листовка

OZVIR CMI V3 Mar 2011
OZVIR
ACICLOVIR 200 MG TABLETS
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about
OZVIR
(aciclovir).
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 it is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
Keep this leaflet with this medicine. You may need to read it again.
WHAT OZVIR IS USED FOR
OZVIR
contains aciclovir, a compound that belongs to a group of medicines
called antivirals.
OZVIR
is used for the treatment of shingles (herpes zoster), impaired
immunity and genital herpes.
In the case of shingles,
OZVIR
works by stopping the multiplication of the virus which causes
shingles. It can reduce the length and severity of an outbreak of
shingles but it will not get rid of the
virus from your body.
Aciclovir at high strength is used as part of the management program
in people who have human
immunodeficiency virus disease (HIV). It acts by preventing further
damage to the immune system.
In these people,
OZVIR
also guards against the herpes virus disease.
Aciclovir does not get rid of the virus from your body.
Your doctor may have prescribed
OZVIR
for another purpose.
OZVIR
is not recommended for use in children as there have been no studies
of its effects in
children
.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY OZVIR HAS BEEN
PRESCRIBED FOR YOU.
This medicine is only available with a doctor's prescription.
OZVIR CMI V3 Mar 2011
2
BEFORE YOU TAKE OZVIR
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE OZVIR IF:

you have ever had an allergic reaction to
OZVIR
or to any of the ingredients listed at the
end of this
leaflet.
Some of the symptoms of an allergic reaction may include a skin rash
similar to hives,
itchiness, shortness of breath, swelling of the face, lips or tongue.
IF YOU ARE NO

Данни за продукта

_OZVIR (CLEAN) PI_V3_Aug 2011 _
1
PRODUCT INFORMATION
NAME OF THE DRUG
OZVIR TABLETS
COMPOSITION
- Active: aciclovir
CHEMICAL STRUCTURE:
DESCRIPTION
Synthetic acyclic purine nucleoside analogue. Chemical name:
9-((2-hydroxyethoxy) methyl)
guanine. It is a white crystalline powder, slightly soluble in water,
freely soluble in dimethyl
sulphoxide, very slightly soluble in alcohol. It dissolves in dilute
solutions of mineral acids and
alkali hydroxides. CAS No.: 59277-89-3
_Excipients_
–
magnesium
stearate,
microcrystalline
cellulose,
sodium
starch
glycollate,
pregelatinised maize starch, colloidal anhydrous silica.
PHARMACOLOGY
ACTIONS
– Antiviral agent.
MICROBIOLOGY
Aciclovir is an antiviral agent which is active in vitro against
_Herpes simples_
virus (HSV) types I
and II and
_Varicella zoster_
virus (VZV), the latter being considerably less sensitive. The
relationship between the level of in vitro sensitivity of herpes
viruses to aciclovir and clinical
response to therapy has not been adequately established. Development
of resistance by HSV to
aciclovir has been documented. Aciclovir needs to be phosphorylated to
the active compound,
aciclovir triphosphate, in order to become active against the virus.
Such conversion is very
limited in normal cells and, in addition, cellular DNA polymerase is
not very sensitive to the
active compound. However in infected cells, HSV or VZV coded thymidine
kinase facilitates
the conversion of aciclovir to aciclovir monophosphate, which is then
converted to aciclovir
_OZVIR (CLEAN) PI_V3_Aug 2011 _
2
triphosphate by cellular enzymes. Aciclovir triphosphate acts as an
inhibitor of and substrate
for the herpes specified DNA polymerase, preventing further viral DNA
synthesis.
PHARMACOKINETICS_ _
Aciclovir is only partially and variably absorbed from the gut.
Estimated bioavailability
following a dose of 200mg is about 20% and decreases to about half of
this with an 800mg dose.
Mean steady state peak and trough concentrations during dosage of
200mg administered every
four hours wer