ACETYLCYSTEINE-LINK INJECTION acetylcysteine 2g/10mL concentrated injection ampoule

Country: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

acetylcysteine, Quantity: 2 g

Disponibbli minn:

Link Medical Products Pty Ltd T/A Link Pharmaceuticals

INN (Isem Internazzjonali):

acetylcysteine

Għamla farmaċewtika:

Injection, concentrated

Kompożizzjoni:

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

Rotta amministrattiva:

Intravenous Infusion

Unitajiet fil-pakkett:

10 x 10 mL ampoules

Tip ta 'preskrizzjoni:

(S4) Prescription Only Medicine

Indikazzjonijiet terapewtiċi:

Antidote for paracetamol poisoning. ,Acetylcysteine is indicated in the treatment of paracetamol overdose to protect against hepatotoxity.

Sommarju tal-prodott:

Visual Identification: Clear colourless solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

L-istatus ta 'awtorizzazzjoni:

Registered

Data ta 'l-awtorizzazzjoni:

2012-01-31

Fuljett ta 'informazzjoni

Acetylcysteine-Link CMI
1
ACETYLCYSTEINE-LINK
_Acetylcysteine_
(AS-it-ile-SIS-teen)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Acetylcysteine-
Link. 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
Acetylcysteine-Link 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 WITH MEDICINE.
You may need to read it again.
WHAT ACETYLCYSTEINE-
LINK 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
ACETYLCYSTEINE-LINK
_WHEN YOU MUST NOT BE _
_GIVEN IT _
_ _
DO NOT USE ACETYLCYSTEINE-LINK 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 ulcers
•
Kidney problems
•
Liver problems
TELL YOUR DOCTOR IF YOU WEIGH LESS
THAN 40 KILOGRAMS.
Your doctor may ha

Karatteristiċi tal-prodott

_Page 1 of 10_
AUSTRALIAN PRODUCT INFORMATION - ACETYLCYSTEINE-LINK
(ACETYLCYSTEINE)
1
NAME OF THE MEDICINE
Acetylcysteine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Acetylcysteine 2 g in 10 mL
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Concentrated injection.
Acetylcysteine-Link is a clear, colourless, sterile, pyrogen free,
aqueous solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
Antidote for paracetamol poisoning. Acetylcysteine is indicated in the
treatment of paracetamol
overdose to protect against hepatotoxity.
4.2
DOSE
AND
METHOD
OF
ADMINSTRATION
To be most effective in protecting against liver damage, therapy with
acetylcysteine should be
started within ten hours of paracetamol ingestion. Although the role
of acetylcysteine 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 patients who have a history of chronic
alcohol or enzyme
inducing drug ingestion (e.g. isoniazid, rifampicin, anticonvulsants
including carbamazepine,
phenytoin, phenobarbitone, primidone, sodium valproate).
Patients are notoriously unreliable as to the amount ingested and the
time of ingestion.
Hepatic necrosis is preventable if treatment can be instituted within
10 to 12 hours of
ingestion.
NOTE:
Liver damage may not be biochemically apparent for 24 to 48 hours
after ingestion.
Hepatic necrosis has been seen with 6 g of paracetamol, and death with
15 g.
PATIENTS PRESENTING WITHIN 15 HOURS OF INGESTION
Give activated charcoal (1 to 2 g/kg) if it is within one hour of
paracetamol ingestion,
and the patient's conscious state is