PFIZER (Australia) ACICLOVIR INTRAVENOUS INFUSION aciclovir 250mg/10mL injection ampoule

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

aciclovir

제공처:

Pfizer Australia Pty Ltd

승인 상태:

Registered

환자 정보 전단

ACICLOVIR INTRAVENOUS
INFUSION
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Aciclovir
Intravenous Infusion. It does not
contain all the available information.
It does not take the place of talking to
your doctor or nurse.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Aciclovir
Intravenous Infusion against the
benefits this medicine is expected to
have for you.
This medicine is likely to be used
while you are in hospital. If possible,
please read this leaflet carefully
before this medicine is given to you.
In some cases this leaflet may be
given to you after the medicine has
been used.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR NURSE.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT ACICLOVIR
INTRAVENOUS INFUSION
IS USED FOR
Aciclovir Intravenous Infusion
belongs to a group of medicines
known as antivirals. It works by
stopping the viruses multiplying in
the body.
Aciclovir Intravenous Infusion is
used for the management of a
number of different conditions
caused by certain viruses. Your
doctor will be able to tell you about
the specific condition for which you
have been prescribed Aciclovir
Intravenous Infusion.
This medicine is available only with
a doctor's prescription.
BEFORE YOU ARE GIVEN
ACICLOVIR INTRAVENOUS
INFUSION
_WHEN YOU MUST NOT BE GIVEN_
_IT_
DO NOT USE ACICLOVIR INTRAVENOUS
INFUSION IF:
•
you have an allergy to aciclovir
or valaciclovir
If you are not sure whether this
applies to you, check with your
doctor.
_BEFORE YOU ARE GIVEN IT_
TELL YOUR DOCTOR IF:
1.
YOU HAVE ANY ALLERGIES TO:
•
any other medicine
•
any other substances, such as
foods, preservatives or dyes
2.
YOU ARE PREGNANT OR INTEND TO
BECOME PREGNANT
Aciclovir is not known to be
harmful in pregnancy. However,
if you are pregnant you should
discuss with your doctor the risks
and benefits involved before
using Aciclovir.
3.
YOU ARE BREAST-FEEDING OR PLAN
TO BREAST FEED
Ask your doctor's advice if you

제품 특성 요약

Version: pfpacici10919
Supersedes: pfpacici10411
Page 1 of 10
AUSTRALIAN
PRODUCT
INFORMATION
–
ACICLOVIR
INTRAVENOUS
INFUSION
(ACICLOVIR)
1.
NAME OF THE MEDICINE
Aciclovir
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Aciclovir Intravenous Infusion contains aciclovir. The solutions are
available as either 250 mg
in 10 mL or 500 mg in 20 mL.
It does not contain preservatives.
3.
PHARMACEUTICAL FORM
Solution for injection.
Aciclovir Intravenous Infusion is an isotonic, sterile, clear,
colourless to pale yellow solution
in a ready-to use, single dose presentation.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Aciclovir Intravenous Infusion is indicated for the purpose of:
•
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
immunocompetent patients.
•
Treatment
of
acute
manifestations
of
_Varicella _
_zoster_
virus
infection
in
immunocompromised patients.
•
Treatment of
_Herpes zoster_
(shingles) in immunocompetent 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 immunocompetent patients with
shingles.
•
Treatment of
_Herpes simplex_
encephalitis.
Version: pfpacici10919
Supersedes: pfpacici10411
Page 2 of 10
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
Indications
Immune status
Dosage
_Herpes simplex_
infection
Normal or
immunocompromised
5mg/kg every 8
hours
Very severe
_Herpes zoster _
infection
(shingles)
Normal
5mg/kg every 8
hours
_Varicella zoster_
infection
_ _
Immunocompromised
_ _
10mg/kg every 8
hours
_ _
_Herpes simplex_
encephalitis
Normal or
immunocompromised
10mg/kg every 8
hours
Each dose should be administered by slow intravenous infusion
OVER A ONE HOUR PERIOD
.
DOSAGE ADJUSTMENT
IMPAIRED RENAL FUNCTION:
Aciclovir Intravenous Infusi