DBL Aciclovir 250mg/10mL Intravenous infusion injection vial

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

aciclovir, Quantity: 25 mg/mL

Sẵn có từ:

Pfizer Australia Pty Ltd

Dạng dược phẩm:

Injection, solution

Thành phần:

Excipient Ingredients: sodium hydroxide; water for injections

Tuyến hành chính:

Intravenous Infusion

Các đơn vị trong gói:

5 X 10mL

Loại thuốc theo toa:

(S4) Prescription Only Medicine

Chỉ dẫn điều trị:

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.

Tóm tắt sản phẩm:

Visual Identification: Clear, colourless or almost colourless solution, free from visible particulate matter.; Container Type: Vial; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Tình trạng ủy quyền:

Registered

Ngày ủy quyền:

1996-08-19

Tờ rơi thông tin

DBL™ ACICLOVIR
INTRAVENOUS INFUSION
_Aciclovir_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DBL Aciclovir
Intravenous Infusion. 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 being given aciclovir
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT DBL ACICLOVIR
INTRAVENOUS INFUSION
IS USED FOR
This medicine is used for the
management of a number of different
infections caused by viruses, such as
herpes and shingles.
This medicine belongs to a group of
medicines called antivirals.
It works by preventing the
reproduction of the virus which is
causing the condition.
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 medicine is not addictive.
This medicine is available only with
a doctor’s prescription.
BEFORE YOU ARE GIVEN
DBL ACICLOVIR
INTRAVENOUS INFUSION
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU SHOULD NOT BE GIVEN DBL
ACICLOVIR INTRAVENOUS INFUSION IF
YOU HAVE AN ALLERGY TO:
•
any medicine containing aciclovir
•
valaciclovir.
Some of the symptoms of an allergic
reaction may include shortness of
breath, wheezing or difficulty
breathing; swelling of the face, lips,
tongue or other parts of the body;
rash, itching or hives on the skin.
IF YOU ARE NOT SURE WHETHER YOU
SHOULD BE GIVEN THIS MEDICINE, TALK
TO YOUR DOCTOR.
_BEFORE YOU ARE GIVEN IT_
TELL YOUR DOCTOR IF YOU HAVE
ALLERGIES TO ANY OTHER MEDICINES,
FOODS, PRESERVATIVES OR DYES.
TELL YOUR DOCTOR IF YOU HAVE OR
HAVE HAD ANY OF THE FOLLOWING
MEDICAL CONDITIONS:
•
kidney disease
•
liver disease
•
any condition affecting your
nervous system
•
irregular electrolyte levels
•
hypoxia (inadequate o

Đặc tính sản phẩm

Version pfpaciii10321
supersedes: hhpaciii11019
Page 1 of 13
AUSTRALIAN
PRODUCT
INFORMATION
–
DBL
™ ACICLOVIR INTRAVENOUS INFUSION (ACICLOVIR)
1.
NAME OF THE MEDICINE
Aciclovir
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DBL Aciclovir Intravenous Infusion contains the equivalent of 25 mg/mL
of aciclovir in Water
for Injections BP; the aciclovir is present as aciclovir sodium.
Sodium hydroxide (4.65 mg/mL)
is included in the formulation.
The aciclovir is present as aciclovir sodium. Aciclovir sodium is a
white crystalline powder.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Solution for injection.
DBL Aciclovir Intravenous Infusion is a clear colourless or almost
colourless sterile solution.
DBL Aciclovir Intravenous Infusion has a pH of approximately 11.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DBL 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.
Version pfpaciii10321
supersedes: hhpaciii11019
Page 2 of 13
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
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 Method
of
Administration below).
Indication
Immune status
Dosage
_Herpes