MAXIGESIC IV paracetamol 1000 mg and ibuprofen (as sodium dihydrate) 300 mg in 100 mL solution for infusion vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

paracetamol, Quantity: 1000 mg; ibuprofen sodium dihydrate, Quantity: 385 mg (Equivalent: ibuprofen, Qty 300 mg)

Available from:

AFT Pharmaceuticals Pty Ltd

Pharmaceutical form:

Injection, intravenous infusion

Composition:

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

Administration route:

Intravenous Infusion

Units in package:

10 x 100 mL vials

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Maxigesic IV is indicated in adults 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, colourless solution in glass vial, practically free from visible particles; Container Type: Vial; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2019-07-22

Patient Information leaflet

1
MAXIGESIC
® IV
_Paracetamol 1000 mg/ibuprofen (as sodium dihydrate) 300 mg in 100 mL
_
_Solution for infusion _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet
carefully before you start using
Maxigesic
®
IV.
This leaflet answers some
common questions about
Maxigesic
®
IV. 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 using
Maxigesic
®
IV against the
benefits they expect it will
have for you.
IF YOU HAVE ANY CONCERNS
ABOUT USING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
Keep this leaflet with the
medicine. You may need to
read it again.
WHAT MAXIGESIC
® IV IS
USED FOR
Maxigesic
®
IV contains
paracetamol, an analgesic
medicine which relieves pain
and reduces fever. Maxigesic
®
IV also contains ibuprofen,
which belongs to a group of
medicines called non-steroidal
anti-inflammatory drugs
(NSAIDs). Ibuprofen relieves
pain, inflammation and fever.
Maxigesic
®
IV is a solution
which is given by intravenous
(IV) infusion directly into a
vein, and is used to relieve
pain or reduce fever. Your
doctor may have prescribed
Maxigesic
®
IV for another
reason.
Ask your doctor if you have
any questions about why
Maxigesic
®
IV has been
prescribed for you.
This medicine is available only
with a doctor's prescription.
BEFORE YOU ARE GIVEN
MAXIGESIC
® IV_ _
_WHEN YOU MUST NOT BE _
_GIVEN MAXIGESIC_
_®_
_ IV _
You must not be given
Maxigesic
®
IV if:
1. YOU HAVE AN ALLERGY TO:

paracetamol,

ibuprofen,

any of the ingredients listed
at the end of this leaflet,

aspirin or any other
NSAIDs.
Symptoms of an allergic
reaction may include:

asthma, wheezing or
coughing,

shortness of breath,
difficulty breathing,

swelling of the face, lips,
tongue which may cause
difficulty in swallowing or
breathing,

hives, itching or skin rash,

stomach ache, fever, chills,
nausea and vomiting,

fainting.
2. YOU REGULARLY

Summary of Product characteristics

Page 1 of 24
AUSTRALIAN PRODUCT INFORMATION
MAXIGESIC
® IV
PARACETAMOL / IBUPROFEN (AS SODIUM DIHYDRATE)
SOLUTION FOR INFUSION
1.
NAME OF THE MEDICINE
Paracetamol 1000 mg/ibuprofen (as sodium dihydrate) 300 mg in 100 mL
solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100 mL vial contains paracetamol 1000 mg and ibuprofen (as sodium
dihydrate) 300 mg.
Excipients with known effect:
Sodium 35.06 mg per 100 mL (0.35 mg/mL).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
Clear, colourless solution, free from visible particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Maxigesic
®
IV is indicated in adults 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
Dose
Administer one vial (100 mL) Maxigesic
®
IV as a 15-minute infusion every 6 hours, as necessary. Do
not exceed a total daily dose of 4000 mg (4 g) paracetamol.
_SPECIAL POPULATIONS _
_Paediatric population _
The safety and efficacy of Maxigesic
®
IV in children aged under 18 years have not been established._ _
_ _
_Elderly _
Clinical studies of Maxigesic
®
IV did not include sufficient numbers of subjects 65 years of age and
Page 2 of 24
over to determine whether they respond differently to younger
subjects. Dose selection for an elderly
patient should be cautious, usually starting at the low end of the
dosing range, reflecting the greater
frequency of decreased hepatic, renal, or cardiac function, and of
concomitant disease or other drug
therapy. Elderly patients are at increased risk for serious GI adverse
events (see section 4.4,
Gastrointestinal effects)_. _
_ _
_Renal impairment _
Caution is also recommended in patients with pre-existing renal
disease. No information is available
from controlled clinical studies regarding the use of Maxigesic
®
IV in patients with advanced renal
disease. If Maxigesic
®
IV therapy must be initiated in p