APO-ACICLOVIR aciclovir 800mg tablet blister pack

Држава: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

aciclovir, Quantity: 800 mg

Доступно од:

Arrotex Pharmaceuticals Pty Ltd

INN (Међународно име):

Aciclovir

Фармацеутски облик:

Tablet

Састав:

Excipient Ingredients: magnesium stearate; croscarmellose sodium; indigo carmine; microcrystalline cellulose; colloidal anhydrous silica; brilliant blue FCF

Пут администрације:

Oral

Јединице у пакету:

35 tablets

Тип рецептора:

(S4) Prescription Only Medicine

Терапеутске индикације:

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 10exp6/L). For use in accordance with details specified in the "Indications" and the "Dosage and Adminsitration" sections of the approved product information document. A copy is provided as Attachment 1.

Резиме производа:

Visual Identification: Oval, blue, biconvex tablet. Engraved APO partial bisect 800 on one side, plain on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Статус ауторизације:

Registered

Датум одобрења:

2009-08-26

Информативни летак

APO-ACICLOVIR
_Aciclovir_
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 this medicine. It does
not contain all the available
information. It does not take the
place of talking to your doctor.
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
The name of your medicine is APO-
Aciclovir. It contains the active
ingredient aciclovir.
The 200mg strength is used to:
•
treat genital herpes. It makes an
outbreak of genital herpes shorter
and less severe
•
prevent or reduce the number of
outbreaks and/or severity of
genital herpes in people who
experience them often.
The 800mg strength is used:
•
to treat shingles, also known as
herpes zoster. Shingles is caused
by the same virus which causes
chicken pox. It usually involves
nerve pain and a blistery rash,
limited to one area of the body. If
taken within 72 hours of first
getting the rash, aciclovir makes
an outbreak of shingles shorter
and less severe
•
as part of the management
program for certain infections in
people who have the human
immunodeficiency virus (HIV).
HIV is the virus that causes
acquired immune deficiency
syndrome (AIDS). Aciclovir does
not cure AIDS or get rid of the
HIV virus from your body, but it
may prevent further damage to
the immune system by stopping
production of the herpes viruses.
It belongs to a group of medicines
called anti-virals.
This medicine works by stopping the
production of the virus that causes
herpes and shingles.
Aciclovir does not get rid of the virus
from your body.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicin

Карактеристике производа

1
AUSTRALIAN PRODUCT INFORMATION – APO-
ACICLOVIR (ACICLOVIR)
1
NAME OF THE MEDICINE
Aciclovir
2
AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND
PHARMACEUTICAL FORM
Aciclovir is a synthetic acyclic purine nucleoside analogue. It is a
white crystalline powder
slightly soluble in water and practically insoluble in most organic
solvents.
Each tablet contains 200mg or 800mg of acyclovir as the active
ingredient.
In addition, each tablet contains the following inactive ingredients:
lactose
monohydrate(200mg tablet only), magnesium stearate, colloidal
anhydrous silica,
croscarmellose sodium, –microcrystalline cellulose , brilliant blue
FCF (800mg tablet only)
and indigo carmine.
Aciclovir 200mg tablets contains sugars as lactose.
Aciclovir tablets are gluten free.
200mg tablets are round, blue flat faced, bevel-edged tablets,
engraved “APO” over “200” on
one side and the other side plain.
800mg tablets are oval, blue, biconvex tablets, scored. Engraved APO
partial bisect 800 on
one side, plain in the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Aciclovir tablets are indicated for use in adult patients for:
o
the
treatment of first episode (primary or non-primary) genital herpes and
the
management of recurrent episodes of genital herpes in certain patients
;
o
the treatment of acute attacks of herpes zoster (shingles), when the
duration of rash
is less than 72 hours;
o
the management of patients with advanced symptomatic HIV disease (CD4+
counts
< 150 x 10
6
/L).

Genital Herpes
Initial Episodes
The duration of viral shedding is reduced very significantly; the
duration of pain and time
to healing are also reduced. The promptness of initiation of therapy
and/or the patient's
prior exposure to Herpes simplex virus may influence the degree of
benefit from therapy.
Intravenous aciclovir should be considered in patients in whom
prostration, central
nervous system involvement or inability to take oral medication
requires hospitalisation
and initiation of more aggressive management.
Aciclovi