DBL ACETYLCYSTEINE injection concentrate acetylcysteine 2 g/ 10 mL injection ampoule

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

acetylcysteine, Quantity: 2 g

Sẵn có từ:

Pfizer Australia Pty Ltd

INN (Tên quốc tế):

acetylcysteine

Dạng dược phẩm:

Injection, concentrated

Thành phần:

Excipient Ingredients: water for injections; disodium edetate; sodium hydroxide

Tuyến hành chính:

Intravenous

Các đơn vị trong gói:

10 ampoule pack

Loại thuốc theo toa:

(S4) Prescription Only Medicine

Chỉ dẫn điều trị:

As an antidote for paracetamol poisoning: Acetylcysteine Injection Concentrate is indicated in the treatment of paracetamol overdose to protect against hepatotoxicity.

Tóm tắt sản phẩm:

Visual Identification: Clear colourless solution free of foreign matter.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 15 Months; Container Temperature: Store below 25 degrees Celsius

Tình trạng ủy quyền:

Registered

Ngày ủy quyền:

2006-07-17

Tờ rơi thông tin

DBL™ ACETYLCYSTEINE
INJECTION CONCENTRATE
_Acetylcysteine_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DBL Acetylcysteine
Injection Concentrate. 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 DBL
Acetylcysteine Injection Concentrate
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 WITH THE MEDICINE.
You may need to read it again.
WHAT DBL
ACETYLCYSTEINE
INJECTION CONCENTRATE
IS USED FOR
This medicine is used to treat
paracetamol poisoning.
It works by reacting with a toxic
metabolite of paracetamol to prevent
it damaging the liver.
This medicine is most effective when
started within 10 hours of exposure
to paracetamol.
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.
It is available only with a doctor's
prescription.
BEFORE YOU ARE GIVEN
DBL ACETYLCYSTEINE
INJECTION CONCENTRATE
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU SHOULD NOT BE GIVEN DBL
ACETYLCYSTEINE INJECTION
CONCENTRATE IF YOU HAVE AN ALLERGY
TO:
•
Any medicine containing
acetylcysteine
•
any of the ingredients listed at the
end of this leaflet.
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:
•
asthma or difficulty breathing
•
stomach

Đặc tính sản phẩm

Version: pfpaceti10321
Supersedes: pfpacet10519
Page 1 of 14
AUSTRALIAN
PRODUCT
INFORMATION
–
DBL™
ACETYLCYSTEINE
INJECTION
CONCENTRATE (ACETYLCYSTEINE)
1.
NAME OF THE MEDICINE
Acetylcysteine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule contains 200 milligrams/mL of acetylcysteine as well as
sodium hydroxide,
disodium edetate and water for injections.
DBL Acetylcysteine Injection Concentrate is a clear, colourless,
sterile, pyrogen free aqueous
solution of acetylcysteine (N-acetyl-mercapto-alanine) with a pH of
approximately 7.0. It is
soluble in water and alcohol and practically insoluble in chloroform,
dichloromethane and
ether.
For the full list of excipients, see Section 6.1 List of Excipients.
3.
PHARMACEUTICAL FORM
DBL Acetylcysteine is a concentrated injection for intravenous use.
Acetylcysteine is a white, crystalline powder with a slight acetic
odour.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
As an antidote for paracetamol poisoning: DBL Acetylcysteine Injection
Concentrate is
indicated in the treatment of paracetamol overdose to protect against
hepatotoxicity.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
DBL Acetylcysteine Injection Concentrate is infused in two intravenous
infusions containing
different doses.
_ADULTS (AGE ≥14 YEARS) _
INITIAL INFUSION: An initial dose of 200 milligrams/kg (maximum 22 g)
of acetylcysteine
diluted in 500 mL of 5% glucose or 0.9% sodium chloride and infused
intravenously over 4
hours.
SECOND INFUSION*: The initial infusion is followed by a continuous
intravenous infusion
of 100 milligrams/kg (maximum 11 g) of acetylcysteine in 1000 mL of 5%
glucose or 0.9%
sodium chloride over 16 hours.
Version: pfpaceti10321
Supersedes: pfpacet10519
Page 2 of 14
•
*If the initial serum paracetamol concentration was more than double
the nomogram line
(refer to Figure 1) following an acute ingestion of paracetamol,
increase acetylcysteine
dose to 200 milligrams/kg (maximum 22 g) diluted in 1000 mL of 5%
glucose or 0.9%
sodium chloride intravenously, over 16 h