PARACETAMOL IV PFIZER

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

paracetamol, Quantity: 1 g

Available from:

Pfizer Australia Pty Ltd

INN (International Name):

Paracetamol

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: glucose monohydrate; sodium citrate dihydrate; water for injections; glacial acetic acid; hydrochloric acid; sodium acetate trihydrate; sodium hydroxide

Administration route:

Intravenous Infusion

Units in package:

12 bags

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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: PARACETAMOL IV PFIZER (paracetamol) solutin for infusion is a clear and colourless solution; Container Type: Bag; Container Material: PVC; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2013-01-15

Patient Information leaflet

PARACETAMOL IV PFIZER
®
_Paracetamol_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Paracetamol IV
Pfizer.
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 giving you Paracetamol
IV Pfizer against the benefits it is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT PARACETAMOL
IV PFIZER IS USED FOR
_WHAT PARACETAMOL IV_
_PFIZER DOES_
Paracetamol IV Pfizer is used to
relieve pain or reduce fever
following surgery.
This medicine belongs to a group of
medicines called analgesics.
ASK YOUR DOCTOR IF YOU HAVE ANY
CONCERNS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor's prescription.
BEFORE YOU ARE GIVEN
PARACETAMOL IV
PFIZER
_WHEN YOU MUST NOT BE GIVEN_
_PARACETAMOL IV PFIZER_
YOU MUST NOT BE GIVEN
PARACETAMOL IV PFIZER 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 IV Pfizer 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 IV PFIZER IF YOU HAVE
OR HAVE HAD THE FOLLOWING MEDICAL
CONDITIONS:
•
liver failure
•
severe liver disease.
IF YOU ARE NOT SURE WHETHER YOU
SHOULD BE GIVEN PARACETAMOL IV
PFIZER, TALK TO YOUR DOCTOR.
_BEFORE YOU ARE GIVEN_
_PARACETAMOL IV PFIZER_
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:
•
liver disease (including Gilbert's
syndrome)
•
kidney disease
•
alcoholism
•
dehydrati

Summary of Product characteristics

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Page 1 of 23
AUSTRALIAN
PRODUCT
INFORMATION
–
PARACETAMOL IV PFIZER
® (PARACETAMOL)
1.
NAME OF THE MEDICINE
Paracetamol
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of PARACETAMOL IV PFIZER contains
paracetamol 10 mg.
Paracetamol is a white crystalline solid or powder. It is soluble in
water (1 in 70), soluble in
alcohol (1 in 7), acetone (1 in 13), glycerol (1 in 40), propylene
glycol (1 in 9) and also soluble
in solutions of the alkali hydroxides.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Solution for infusion.
PARACETAMOL IV PFIZER is a colourless or faintly straw-brown coloured
solution.
PARACETAMOL IV PFIZER contains 10 mg/mL of paracetamol (50 mL bag
contains
500 mg of paracetamol; 100 mL bag contains 1 g of paracetamol).
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
PARACETAMOL IV PFIZER 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:
Version: pfpparai10220
Supersedes: pfpparai10419
Page 2 of 23
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 a day.
4 hours
*
≤ 4g
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.
*
The minimum interval between