ACETADOTE acetylcysteine 6g in 30mL concentrated injection vial

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

acetylcysteine, Quantity: 6 g

Dostupno od:

Phebra Pty Ltd

INN (International ime):

acetylcysteine

Farmaceutski oblik:

Injection

Sastav:

Excipient Ingredients: sodium hydroxide; water for injections

Administracija rute:

Intravenous

Jedinice u paketu:

4 vials per carton

Tip recepta:

(S4) Prescription Only Medicine

Terapijske indikacije:

As an antidote for paracetamol poisoning: Acetadote Injection is indicated in the treatment of paracetamol overdose to protect against hepatoxicity.

Proizvod sažetak:

Visual Identification: Clear, colourless or purplish solution, faint odour of hydrogen sulphide; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status autorizacije:

Registered

Datum autorizacije:

2011-09-23

Uputa o lijeku

Acetadote®
Page 1 of 3
_Version 03 _
ACETADOTE
®
_ _
ACETYLCYSTEINE 6G IN 30ML CONCENTRATED INJECTION
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Acetadote.
It does not contain all the available
information. It does not take the place
of talking to your doctor.
All medicines have risks and benefits
.
Your doctor has weighed the risks of
you being given Acetadote against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR.
KEEP THIS LEAFLET IN A SAFE PLACE.
You may need to read it again.
WHAT ACETADOTE IS USED
FOR
Acetadote is used to treat an overdose
of paracetamol.
This medicine belongs to a group of
medicines called antidotes.
This medicine works by reacting with
the toxic by-products of paracetamol to
prevent damage to the liver.
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.
There is no evidence that Acetadote is
addictive.
This medicine is only available with a
doctor’s prescription.
BEFORE YOU ARE GIVEN
ACETADOTE
_WHEN YOU MUST NOT BE GIVEN _
_IT_
_ _
YOU SHOULD NOT BE GIVEN ACETADOTE 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
•
redness of the skin
•
dizziness, lightheadedness
•
fast heart beat.
YOU SHOULD NOT BE GIVEN ACETADOTE IF
THE SOLUTION IS DISCOLOURED, CLOUDY,
TURBID, OR A PRECIPITATE IS PRESENT.
The solution is normally a clear
colourless solution but may turn
slightly pink or purple once in use.
This colour change does not affect the
quality of the medicine.
YOU SHOULD NOT BE GIVEN THIS
MEDICINE IF, WHEN DILUTED WITH
ANOTHER SOLUTION, IT CAUSES THE
SOLU

Svojstava lijeka

PRODUCT INFORMATION
Product Information - Acetadote
®
Concentrated Injection
Page 1 of 11
Version 04
ACETADOTE
® CONCENTRATED INJECTION
(ACETYLCYSTEINE)
1
NAME OF THE MEDICINE
Acetylcysteine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Acetylcysteine 200 mg per ml (as acetylcysteine). Each 30 mL vial
contains 6 g acetylcysteine.
While the concentration of acetylcysteine in Acetadote Concentrated
Injection is exactly the same as in other
acetylcysteine injectable products, each vial does contain three times
the quantity of the active ingredient; that is,
6 g in 30 mL for Acetadote, as compared to 2 g in 10 mL for other
acetylcysteine injectable products.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Acetadote Concentrated Injection is a clear, colourless or purplish
solution with a faint odour of hydrogen sulfide,
sterile, pyrogen free aqueous solution of acetylcysteine
(N-acetyl-mercapto-alanine) with a pH of approximately
6.5 to 7.5.
Acetadote Concentrated Injection is intended for intravenous
administration, following dilution in 5% glucose
solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
As an antidote for paracetamol poisoning: Acetadote Concentrated
Injection is indicated in the treatment of
paracetamol overdose to protect against hepatotoxicity.
4.2
D
OSE AND METHOD OF ADMINISTRATION
To be most effective in protecting against liver damage, therapy with
Acetadote should be started within 10 hours
of paracetamol ingestion. Although the role of Acetadote therapy in
patients presenting later than 15 hours after
paracetamol ingestion is not established, it may be considered as a
clinical option in high risk patients.
MANAGEMENT OF PARACETAMOL OVERDOSAGE
It should be noted that, after an ingestion of a potentially fatal
dose of paracetamol, the patient may appear
relatively well initially and may even continue normal activities for
a day or two before the onset of hepatic failure.
Hepatic damage is more likely to occur with a lower dosage of
paracetamol in