PARACETAMOL IV PFIZER

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Активна съставка:

paracetamol, Quantity: 500 mg

Предлага се от:

Pfizer Australia Pty Ltd

INN (Международно Name):

Paracetamol

Лекарствена форма:

Injection, solution

Композиция:

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

Начин на приложение:

Intravenous Infusion

Броя в опаковка:

12 bags

Вид предписание :

(S4) Prescription Only Medicine

Терапевтични показания:

for the relief of mild to moderate pain and the reduction of fever where an intravenous route of administration is considered clinically necessary.

Каталог на резюме:

Visual Identification: PARACETAMOL IV PFIZER (paracetamol) solutin for infusion is a clear and colourless solution; Container Type: Bag; Container Material: PVC; Container Life Time: 12 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Статус Оторизация:

Registered

Дата Оторизация:

2013-01-15

Листовка

PARACETAMOL IV PFIZER
®
1
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 di

Данни за продукта

Version: pfpparai10220
Supersedes: pfpparai10419
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