Combogesic 10 mg/ml Paracetamol + 3 mg/ml Ibuprofen solution for infusion

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Paracetamol; Ibuprofen sodium dihydrate

Disponible desde:

JED Pharma Ltd

Código ATC:

N02BE51

Designación común internacional (DCI):

Paracetamol; Ibuprofen sodium dihydrate

Dosis:

10/3 milligram(s)/millilitre

formulario farmacéutico:

Solution for infusion

Área terapéutica:

paracetamol, combinations excl. psycholeptics

Estado de Autorización:

Marketed

Fecha de autorización:

2021-10-08

Información para el usuario

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
COMBOGESIC 10 MG/ML PARACETAMOL + 3 MG/ML IBUPROFEN SOLUTION FOR
INFUSION
paracetamol/ibuprofen
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
-
You should not use this medicine for longer than 2 days.
WHAT IS IN THIS LEAFLET
1.
What Combogesic is and what it is used for
2.
What you need to know before you are given Combogesic
3.
How you are given Combogesic
4.
Possible side effects
5.
How to store Combogesic
6.
Contents of the pack and other information
1.
WHAT COMBOGESIC IS AND WHAT IT IS USED FOR
Combogesic
contains the active substances paracetamol and ibuprofen. Ibuprofen
belongs to a group
of medicines called non-steroidal anti-inflammatory drugs (or NSAIDs).
Paracetamol works in a
different way to ibuprofen, but both substances work together to
reduce pain.
Combogesic is used in adults for the short-term symptomatic treatment
of acute moderate pain, where
an intravenous route of administration is necessary and/or when other
routes of administration are not
possible.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN COMBOGESIC
YOU SHOULD NOT BE GIVEN COMBOGESIC:
•
if you are allergic to the active substances, other NSAIDs, or any of
the other ingredients of this
medicine (listed in section 6);
•
if you have severe heart failure, liver failure or kidney failure;
•
if you regularly drink large quantities of alcohol;
•
if you have asthma, urticaria or allergic-type reactions after taking
acetylsalicylic acid or other
NSAIDs;
•
if you have a history with gastrointestinal bl

Ficha técnica

Health Products Regulatory Authority
20 January 2023
CRN00D7LV
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Combogesic 10 mg/ml Paracetamol + 3 mg/ml Ibuprofen solution for
infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains 10 mg paracetamol and ibuprofen sodium dihydrate
corresponding to 3 mg ibuprofen.
One 100 mL vial contains 1000 mg paracetamol and ibuprofen sodium
dihydrate corresponding to 300 mg ibuprofen.
Excipientwith known effect:
Sodium 35 mg per 100 ml (0.35 mg/ml).
Sodium 1.52 mmol per 100 ml (0.0152 mmol/ml).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
Clear, colourless solution, free from visible particles, with a pH of
6.3-7.3 and an osmolality of 285-320 mOsmol/kg.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Combogesic is indicated in adults for the short-term symptomatic
treatment of acute moderate pain, where an intravenous
route of administration is considered clinically necessary and/or when
other routes of administration are not possible.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
For intravenous administration and short-term use only for a maximum
of two days. Undesirable effects may be minimised by
using the lowest effective dose for the shortest duration necessary to
control symptoms (see section 4.4).
ADULTS (WEIGHING >50 KG)
Administer one vial (100 ml) Combogesic as a 15-minute infusion every
6 hours, as necessary. Do not exceed a total daily dose
of four vials (400 ml), which equates to 4000 mg (4 g) paracetamol and
1200 mg ibuprofen.
ADULTS (WEIGHING ≤50 KG)
Adults weighing 50 kg or under should be dosed according to their
weight, at a dosage of 1.5 ml/kg (15 mg/kg paracetamol +
4.5 mg/kg ibuprofen), as a 15-minute infusion every 6 hours, as
necessary. This equates to a maximum single dose of 75 ml
(discard remaining medicine in vial), and a total daily dose of 3000
mg (3 g) paracetamol and 900 mg ibuprofen.
PAEDIATRIC POPULATION
Combogesic is contraindicated in pat