ACICLOVIR ACCORD aciclovir 250 mg/10 mL injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

aciclovir, Quantity: 25 mg/mL

Available from:

Accord Healthcare Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium hydroxide; hydrochloric acid; water for injections

Administration route:

Intravenous Infusion

Units in package:

1

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Aciclovir Intravenous Infusion is indicated for the purpose of:,1. Promoting resolution of acute clinical manifestations of mucocutaneous Herpes simplex virus infections in immunocompromised patients.,2. Treatment of severe first episode primary or non-primary genital herpes in immune competent patients.,3. Treatment of acute manifestations of Varicella zoster virus infection in immunocompromised patients.,4. Treatment of shingles (Varicella zoster virus infection) 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.,5. Treatment of Herpes simplex encephalitis.

Product summary:

Visual Identification: A clear, colourless or almost colourless solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2020-06-17

Patient Information leaflet

Aciclovir Accord - version 2
1
ACICLOIR ACCORD
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING ACICLOVIR ACCORD?
Aciclovir Accord contains the active ingredient aciclovir. Aciclovir
belongs to a group of medicines called antivirals. It works by
preventing the reproduction of the virus which is causing the
condition.
Aciclovir Accord is used for the management of several different
infections caused by viruses, such as herpes and shingles.
For more information, see Section 1. Why am I using Aciclovir Accord?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ACICLOVIR ACCORD?
Do not use if you have ever had an allergic reaction to aciclovir,
valaciclovir or any of the ingredients listed at the end of the
CMI.
Talk to your doctor if you have any other medical conditions, take any
other medicines, or are pregnant or plan to become
pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use
Aciclovir Accord?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Aciclovir Accord and affect how it
works.
See Section 3. What if I am taking other medicines?
in the full CMI.
4.
HOW DO I USE ACICLOVIR ACCORD?
Aciclovir Accord is an injection and will be given to you by your
doctor or nurse.
More instructions can be found in Section 4. How do I use Aciclovir
Accord?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ACICLOVIR ACCORD?
THINGS YOU
SHOULD DO
You should drink plenty of fluids as instructed by your doctor or
nurse. If you are unable to drink, due
to your condition, your doctor will ensure that you receive plenty of
fluids.
DRIVING OR USING
MACHINES
Be careful driving or operating machinery until you know how Aciclovir
Accord affects you. This
medicine may cause dizziness, light-headedness, tiredness, or
drowsiness in some people. If you have
any of these symptoms, do not drive, operate machinery

Summary of Product characteristics

Page 1 of 9
AUSTRALIAN PRODUCT INFORMATION
ACICLOVIR ACCORD (ACICLOVIR) INJECTION
1
NAME OF THE MEDICINE
Aciclovir
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Aciclovir sodium is a synthetic acyclic purine nucleoside analogue.
Aciclovir sodium is a white
crystalline powder.
Aciclovir Accord contains the equivalent of 25 mg/mL of aciclovir; the
aciclovir is present as aciclovir
sodium.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Aciclovir Accord is a clear colourless or almost colourless sterile
solution. Aciclovir Accord has a pH of
approximately 11.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Aciclovir Accord Intravenous Infusion is indicated for the purpose of:
1.
Promoting resolution of acute clinical manifestations of mucocutaneous
_Herpes simplex _
virus
infections in immunocompromised patients.
2.
Treatment of severe first episode primary or non-primary genital
herpes in immune competent
patients.
3.
Treatment of acute manifestations of
_Varicella zoster _
virus infection in immunocompromised
patients.
4.
Treatment of shingles (
_Varicella zoster _
virus infection) 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.
5.
Treatment of
_Herpes simplex _
encephalitis.
4.2
D
OSE AND METHOD OF ADMINISTRATION
RAPID OR BOLUS INTRAVENOUS AND INTRAMUSCULAR OR SUBCUTANEOUS INJECTION
OF ACICLOVIR MUST BE
AVOIDED (
see SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
and ADMINISTRATION
below
).
Indication
Immune status
Dosage
_Herpes simplex _
infection
Normal or immunocompromised
5 mg/kg every 8 hours
Very severe
_Herpes zoster _
infection (shingles)
Normal
5 mg/kg every 8 hours
_Varicella zoster _
infection
Immunocompromised
10 mg/kg every 8 hours
_Herpes simplex _
encephalitis
Normal or immunocompromised
10 mg/