ACICLOVIR VIATRIS aciclovir (as sodium) 500 mg powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

aciclovir sodium dihydrate, Quantity: 628.8 mg (Equivalent: aciclovir, Qty 500 mg)

Available from:

Alphapharm Pty Ltd

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients:

Administration route:

Intravenous

Units in package:

5 vials

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Aciclovir Mylan (aciclovir sodium) is indicated for:,- Promoting resolution of acute clinical manifestations of mucocutaneous Herpes simplex virus infections in immunocompromised patients,- Treatment of severe first episode primary or non-primary genital herpes in immune competent patients,- Treatment of acute manifestations of Varicella zoster virus infection in immunocompromised patients,- Treatment of Herpes zoster (shingles) in immune competent patients who show very severe acute local or systemic manifestations of the disease. (Benefits can be expected in patients with rash duration shorter than 72 hours. The use of the intravenous infusion may be warranted in only a small subgroup of immune competent patients with shingles).,- Treatment of Herpes simplex encephalitis.

Product summary:

Visual Identification: White to off-white lyophilized powder or cake; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2021-05-28

Patient Information leaflet

ACICLOVIR VIATRIS
_Aciclovir sodium dihydrate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Aciclovir Viatris.
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 Aciclovir
Viatris 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 ACICLOVIR VIATRIS
IS USED FOR
Aciclovir sodium is used to treat
number of different conditions
caused by viruses, such as shingles
and herpes, especially in patients
who have reduced immunity.
Aciclovir Viatris belongs to a group
of medicines called antivirals.
Aciclovir Viatris works by
preventing the multiplication of the
virus which is causing the condition.
Your doctor may have prescribed it
for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription. It should only
be given to you under the supervision
of medical professionals.
Aciclovir Viatris is not addictive.
BEFORE YOU TAKE
ACICLOVIR VIATRIS
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE ACICLOVIR VIATRIS IF YOU
HAVE AN ALLERGY TO:
•
aciclovir
•
any of the other ingredients listed
at the end of this leaflet under the
product description
•
valciclovir
Some of the symptoms of an allergic
reaction may include
•
asthma
•
wheezing or shortness breath
•
swelling of the face, lips or
tongue which may cause
difficulty in swallowing or
breathing or fainting
•
rash, itching or hives on the skin
DO NOT GIVE ACICLOVIR VIATRIS TO A
CHILD UNDER THE AGE OF ONE YEARS.
Safety and effectiveness of Aciclovir
Viatris in children younger than one
years have not been established.
IF YOU ARE NOT SURE WHETHER YOU
SHOULD START TAKING THIS MEDICINE,
TALK TO YOUR DO

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
ACICLOVIR VIATRIS
Aciclovir (as sodium dihydrate) powder for injection
_ _
1
NAME OF THE MEDICINE
Aciclovir sodium dihydrate.
2
&
3
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
AND
PHARMACEUTICAL FORM
ACICLOVIR VIATRIS 250 MG POWDER FOR INJECTION
is a white to off-white lyophilized powder
or cake that
contains aciclovir sodium dihydrate 314.4 mg, as the active ingredient
equivalent to 250
mg aciclovir per vial.
ACICLOVIR VIATRIS 500 MG POWDER FOR INJECTION
is a white to off-white lyophilized powder or
cake that
contains aciclovir sodium dihydrate 628.8 mg, as the active ingredient
equivalent to 500 mg
aciclovir per vial.
Excipients with known effect: none
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ACICLOVIR VIATRIS (aciclovir sodium dihydrate) is indicated for:
•
Promoting resolution of acute clinical manifestations of mucocutaneous
_Herpes simplex_
virus
infections in immunocompromised patients
•
Treatment of severe first episode primary or non-primary genital
herpes in immune competent patients
•
Treatment of acute manifestations of
_Varicella zoster _
virus infection in immunocompromised patients
•
Treatment of
_Herpes zoster _
(shingles) in immune competent patients who show very severe acute
local or systemic manifestations of the disease. Benefits can be
expected in patients with rash duration
shorter than 72 hours. The use of the intravenous infusion may be
warranted in only a small subgroup
of immune competent patients with shingles.
•
Treatment of
_Herpes simplex _
encephalitis.
_ _
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
INDICATION
IMMUNE STATUS
DOSAGE
_Herpes simplex _
infection
Very severe
_Herpes zoster _
infection
(shingles)
_Varicella zoster _
infection
_Herpes simplex _
encephalitis
Normal or
Immunocompromised
Normal
Immunocompromised
Normal or
Immunocompromised
5mg/kg every 8 hours
5mg/kg every 8 hours
10mg/kg every 8 hours
10mg/kg every 8 hours
Each dose should be administered b