Paracetamol-AFT paracetamol 1000 mg/100 mL injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

paracetamol, Quantity: 10 mg/mL

Available from:

AFT Pharmaceuticals Pty Ltd

INN (International Name):

Paracetamol

Pharmaceutical form:

Injection, intravenous infusion

Composition:

Excipient Ingredients: hydrochloric acid; cysteine hydrochloride monohydrate; dibasic sodium phosphate dihydrate; mannitol; nitrogen; water for injections; sodium hydroxide

Administration route:

Intravenous

Units in package:

10 x 100 mL vials

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

PARACETAMOL-AFT 10mg/mL, solution for infusion is indicated for the relief of mild to moderate pain and the reduction of fever where an intravenous route of administration is considered clinically necessary.

Product summary:

Visual Identification: Clear, slightly yellowish solution in a colourless type II 100 ml glass vial, closed with light gray bromobutyl rubber stopper and sealed with aluminium lever capsule with gold lever; Container Type: Vial; Container Material: Glass Type II Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2013-01-11

Patient Information leaflet

1
PARACETAMOL-AFT
(Paracetamol)
SOLUTION FOR INJECTION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about PARACETAMOL-AFT. 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 taking
PARACETAMOL-AFT against the benefits that are expected. This leaflet
does not
contain everything about PARACETAMOL-AFT. Your doctor has been
provided with full
information and can answer any questions you may have. Follow your
doctor's advice
even if it differs from what is in this leaflet.
Please read this leaflet carefully and keep it in a safe place so you
may refer to it
later.
What PARACETAMOL-AFT is used for
PARACETAMOL-AFT contains paracetamol an analgesic medicine which
relives pain
and reduces fever. PARACETAMOL-AFT is a solution of paracetamol which
is given by
intravenous infusion (IV) directly into a vein, and is used to relieve
pain or reduce fever
following surgery.
This medicine is available only with a doctor's prescription.
Before you are given PARACETAMOL-AFT
When you must not be given PARACETAMOL-AFT
You must not be given PARACETAMOL-AFT if you have an allergy to
paracetamol
or to any of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction to PARACETAMOL-AFT 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
You must not be given PARACETAMOL-AFT if you have liver failure or
severe
liver disease.
2
If you are not sure whether you should be given PARACETAMOL-AFT, talk
to your
doctor or pharmacist.
Before you are given PARACETAMOL-AFT
Tell your doctor or pharmacist if you have allergies to:
•
any other medicines
•
any other substances, such as foods, preservatives or dyes
Tell your doctor or pharmacist if you are pregnant
PARACETAMOL-AFT may be given to pregnant women, but your doctor must
be tol

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
PARACETAMOL – AFT (PARACETAMOL) SOLUTION FOR INFUSION
1
NAME OF THE MEDICINE
Paracetamol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
PARACETAMOL-AFT solution for infusion contains 10 mg/mL of paracetamol
(100 mL vial contains
1 g of paracetamol).
For the full list of excipients, see 6.1 List of excipients
3
PHARMCEUTICAL FORM
PARACETAMOL-AFT (paracetamol) solution for infusion is a clear,
colourless to slightly yellowish
solution. It contains 10 mg/mL of paracetamol.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PARACETAMOL-AFT 10 mg/mL, solution for infusion is indicated for the
relief of mild to moderate
pain and the reduction of fever where an intravenous route of
administration is considered clinically
necessary.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
DOSING IS BASED ON PATIENT WEIGHT
. Dosing recommendations are presented in the table below:
Patient weight
Paracetamol dose (10 mg/mL)
per administration
Minimum interval
between each
administration
Maximum daily dose
#
> 50 kg
1 g
(i.e. one 100 mL vial)
Up to 4 times per day
4 hours*
≤ 4 g
Must not exceed 4 g in
24 hours
> 33 kg and ≤
50 kg
15 mg/kg
(i.e. 1.5 mL solution per kg)
Up to 4 times per day
4 hours*
≤
60
mg/kg
without
exceeding 3 g
Must not exceed 3 g in
24 hours
> 10 kg and ≤
33 kg
15 mg/kg
(i.e. 1.5 mL solution per kg)
Up to 4 times per day
6 hours
≤
60
mg/kg,
without
exceeding 2 g
Must not exceed 2 g in
24 hours
≤ 10 kg**
7.5 mg/kg
(i.e. 0.75 mL solution per kg)
The volume must not exceed
7.5 mL per dose
Up to 4 times per day
6 hours
≤ 30 mg/kg
Must
not
exceed
30
mg/kg in 24 hours
2
* The minimum interval between each administration must be 4 hours in
patients without hepatic or renal
impairment. However, in patients with renal and/or hepatic impairment
the minimum interval between doses must
not be less than 6 hours.
#
The maximum daily dose takes into account all medicines containing
paracetamol or propacetamol.
** No safety and efficacy data are available for premature neonates.
There i