Paracetamol BNM paracetamol 1000mg/100mL solution for infusion plastic bags

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

paracetamol, Quantity: 10 mg/mL

Available from:

Boucher & Muir Pty Ltd

INN (International Name):

Paracetamol

Pharmaceutical form:

Injection, intravenous infusion

Composition:

Excipient Ingredients: water for injections; mannitol; sodium hydroxide; dibasic sodium phosphate dihydrate; povidone

Administration route:

Intravenous

Units in package:

100mL bags in packs of 12

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Paracetamol BNM 1000mg/100mL, 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: A clear and particle free solution; Container Type: Bag; Container Material: Plastic; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2013-08-09

Patient Information leaflet

1
PARACETAMOL BNM
Consumer Medicine Information
PARACETAMOL BNM
_PARACETAMOL _
_ _
1000 mg/100 mL solution for infusion
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you are given Paracetamol
BNM.
This leaflet answers some common questions about Paracetamol BNM. It
does not
contain all the available information.
Reading this leaflet 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 giving you
Paracetamol BNM against the benefits this medicine is expected to have
for you.
IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET.
You may want to read it again.
WHAT PARACETAMOL BNM IS USED FOR
Paracetamol BNM contains paracetamol, an analgesic medicine which
relieves pain and
reduces fever.
Paracetamol BNM is a sterile solution for infusion which is given by
intravenous infusion
directly into a vein, and is used to relieve pain or reduce fever
following surgery.
Your doctor may have prescribed this medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR
YOU.
Paracetamol BNM is available only with a doctor's prescription.
Paracetamol BNM is not addictive.
2
PARACETAMOL BNM
BEFORE YOU ARE GIVEN PARACETAMOL BNM
_ _
Paracetamol BNM is not suitable for everyone.
_WHEN YOU MUST NOT BE GIVEN IT _
_ _
YOU MUST NOT BE GIVEN PARACETAMOL BNM IF:
▪
you are allergic to any medicine containing paracetamol or any of the
ingredients
listed at the end of this leaflet
▪
you have liver failure or severe liver disease.
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.
PARACETAMOL BNM MUST NOT BE USED AFTER THE EXPIRY DATE PRINTED ON THE
PACK, OR IF
THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING. THE SOLUTION MUST
BE CLEAR
BEFORE USE.
IF YOU ARE NOT SURE WHETHER Y

Summary of Product characteristics

PARACETAMOL BNM
1
AUSTRALIAN PRODUCT INFORMATION
PARACETAMOL BNM
(PARACETAMOL)
SOLUTION FOR INFUSION
1
NAME OF THE MEDICINE
Paracetamol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Paracetamol
BNM
(paracetamol)
solution
for
infusion
contains
1000mg/100mL
of
paracetamol.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Paracetamol BNM solution for infusion is clear to slightly brownish
solution.
The pH of the solution is adjusted to remain between 4.5 and 6.5
during the approved
shelf life. The solution is isotonic and slightly hypobaric.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Paracetamol BNM 1000mg/100mL 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
THE PRESCRIBED DOSE MUST BE BASED ON THE PATIENT’S WEIGHT.
UNINTENTIONAL OVERDOSE CAN LEAD TO SERIOUS LIVER DAMAGE AND DEATH
(see Section 4.9
Overdose).
Healthcare providers are reminded that it is essential to follow both
the weight-
related
dose
recommendations
and
to
consider
individual
patient
risk
factors
for
hepatotoxicity
including
hepatocellular
insufficiency,
chronic
alcoholism,
chronic
malnutrition (low reserves of hepatic glutathione), and dehydration
(see Section 4.2 Dose and
method of administration, hepatic impairment)
PARACETAMOL BNM
2
It is recommended that a suitable oral analgesic treatment be
substituted for Paracetamol
BNM as soon as the patient can be treated by oral route (see Section
4.3
Contraindications).
Intravenous route
Paracetamol BNM 1000mg/100mL solution for infusion should not be mixed
with other
medicinal products.
Use of the 100 mL bag is restricted to adults, adolescents and
children weighing more than
33 kg.
Dosage
DOSING IS BASED ON PATIENT WEIGHT
. Dosing recommendations are presented in the table
below:
TABLE 1
PATIENT WEIGHT
PARACETAMOL DOSE
(10 MG/ML) PER
ADMINISTRATION
MINIMUM INTERVAL
BETWEEN EACH
ADM