CALDOLOR ibuprofen 800mg/8mL concentrated solution for injection vial

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

ibuprofen, Quantity: 100 mg/mL

Dostupné z:

Phebra Pty Ltd

INN (Medzinárodný Name):

Ibuprofen

Forma lieku:

Injection, concentrated

Zloženie:

Excipient Ingredients: hydrochloric acid; water for injections; arginine

Spôsob podávania:

Intravenous

Počet v balení:

10 x 8 mL vials per carton

Typ predpisu:

(S4) Prescription Only Medicine

Terapeutické indikácie:

Caldolor injection is indicated in adults for the management of acute mild to moderate post-operative pain and moderate to severe post-operative pain with adjunctive reduced morphine dosage, where an intravenous route of administration is considered clinically necessary.,Caldolor is indicated for the reduction of fever in adults where an intravenous route of administration is considered clinically necessary.

Prehľad produktov:

Visual Identification: A clear, colourless to slightly yellow solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 72 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Stav Autorizácia:

Registered

Dátum Autorizácia:

2012-12-12

Príbalový leták

Caldolor

1 of 4
CALDOLOR

kal-do-lor
_ _
_ _
_IBUPROFEN_
_(eye-bue-pro-fen)_
_ _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Caldolor
®
.
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
Caldolor
®
against the benefits they
expect it will have for you. Your
doctor has been provided with full
information and can answer any
questions you may have.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR.
PLEASE READ THIS LEAFLET CAREFULLY
AND KEEP IT IN A SAFE PLACE.
You may need to read it again.
WHAT CALDOLOR
® IS
USED FOR
Caldolor
®
contains ibuprofen, a
medicine that relieves pain,
inflammation (swelling, redness,
heat) and fever (high temperature).
Caldolor
®
is a solution of ibuprofen
which is given by infusion into a vein
after it has been diluted. Caldolor
®
must only be given to you by a
doctor or nurse.
Caldolor
®
is used:
•
to relieve pain following
surgery, sometimes in addition
to other medication
_ _
•
to reduce fever (high
temperature).
_ _
Although Caldolor
®
can relieve the
symptoms of pain and fever it will
not cure your condition.
This medicine belongs to a group of
medicines called non-steroidal anti-
inflammatory drugs (or NSAIDs).
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.
Caldolor
®
is only available with a
doctor’s prescription.
There is not enough information to
recommend the use of this medicine
for children under the age of 18
years.
BEFORE YOU ARE GIVEN
CALDOLOR
®
_WHEN YOU MUST NOT BE GIVEN _
_CALDOLOR_
_®_
_ _
YOU MUST NOT BE GIVEN CALDOLOR
®
IF:
1. YOU HAVE AN ALLERGY TO:
•
any medicine containing
ibuprofen or aspirin
•
any of the ingredients listed at the
end of this leaflet
•
any other NSAIDs.
Many medicines used to trea

Súhrn charakteristických

PRODUCT INFORMATION
Caldolor
®
Page 1 of 28
AUSTRALIAN PRODUCT INFORMATION – CALDOLOR
®
(IBUPROFEN) CONCENTRATED SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Ibuprofen
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Caldolor
®
concentrated injection for infusion contains the active ingredient
ibuprofen.
Each 1 mL of Caldolor
®
concentrated injection for infusion contains 100 mg of ibuprofen in
Water for Injections, USP. For the full list of excipients, see
Section 6.1: LIST OF
EXCIPIENTS.
3
PHARMACEUTICAL FORM
Caldolor
®
is sterile and is intended for intravenous (IV) administration by
infusion following
dilution only. Caldolor
®
is a clear, colourless to slightly yellow solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Caldolor
®
is indicated in adults for the management of acute mild to moderate
post-operative
pain and moderate to severe post-operative pain with adjunctive
reduced morphine dosage,
where an intravenous route of administration is considered clinically
necessary.
Caldolor
®
is indicated for the reduction of fever in adults where an intravenous
route of
administration is considered clinically necessary.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE:
Use the lowest effective dose for the shortest duration consistent
with individual patient
treatment goals. After observing the response to initial therapy with
Caldolor
®
, the dose and
PRODUCT INFORMATION
Caldolor
®
Page 2 of 28
frequency should be adjusted to suit an individual patient's needs. Do
not exceed a total daily
dose of 3200 mg ibuprofen. Use of the recommended maximum dose of
Caldolor
®
800 mg
every 6 hours has only been studied for a period of up to 2 days.
To reduce the risk of renal adverse reactions, patients must be well
hydrated prior to
administration of Caldolor
®
.
_Analgesia (Pain) _
Administer 400 mg to 800 mg of Caldolor
®
by IV infusion every 6 hours as necessary.
Caldolor
®
is a concentrated injection for infusion that must be diluted prior to
administration.
_Antipyretic (Fever) _
Administer 400 mg of C