DIFENE AMPOULES 75/3 Mg/Ml Solution injection or concentrate for solution infusion

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

DICLOFENAC SODIUM

Disponible desde:

Astellas Pharma Co. Ltd

Designación común internacional (DCI):

DICLOFENAC SODIUM

Dosis:

75/3 Mg/Ml

formulario farmacéutico:

Solution injection or concentrate for solution infusion

tipo de receta:

Product subject to prescription which may not be renewed (A)

Estado de Autorización:

Withdrawn

Fecha de autorización:

2014-01-01

Información para el usuario

PACKAGE LEAFLET: INFORMATION FOR THE USER  
DIFENE AMPOULES 75 MG / 3 ML 
SOLUTION FOR INJECTION OR CONCENTRATION FOR SOLUTION FOR INFUSION 
(DICLOFENAC SODIUM) 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. 
• 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. Do not pass it on to
others. It may harm them,   
   even if their symptoms are the same as yours. 
• If any of the side effects get serious, or if you notice any
side effects not listed in this leaflet,    
   please tell your doctor or pharmacist. 

IN THIS LEAFLET: 
1 What Difene is and what it is used for 
2 What you need to know before you use Difene 
3 How to receive Difene 
4 Possible side effects 
5 How to store Difene 
6 Contents of the pack and other information  
_ _
_ _
_1._ WHAT DIFENE IS AND WHAT IT IS USED FORDifene ampoules contain
diclofenac sodium as the 
active ingredient, which is a non-steroidal anti-inflammatory drug
(NSAID). This means that 
it is a “painkilling” medicine which reduces inflammation and
swelling, but it does not 
contain any steroid medicine. Difene ampoules are for intramuscular
injection (IM) or 
preparation of intravenous infusion (IV). 

INTRAMUSCULAR USE (IM): 
Difene can be used in the management of aggravated rheumatoid
arthritis and osteoarthritis, 
in acute back pain, acute gout, post-operative pain, relief of pain in
acute traumatic musculo-
skeletal disorders and fractures and for abdominal pain commonly
caused by kidney stones. 

INTRAVENOUS INFUSION (IV): 
For treatment or prevention of post-operative pain in the hospital
setting. 
_ _
_2. _WHAT YOU NEED TO KNOW BEFORE YOU USE DIFENE DO NOT TAKE
DIFENE: 
• if you are allergic (hypersensitive) to diclofenac or any of the
other ingredients of Difene   
  ampoules. Please refer to section 6 of this leaflet for full list
of ingredi

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Difene ampoules 75 mg/3 ml Solution for Injection or Concentrate for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Diclofenac sodium 75mg/3ml
Each millilitre of solution for injection contains 25mg of diclofenac sodium
Excipients with known effect: benzyl alcohol [105mg/3ml per ampoule (35mg/ml)]
For list of excipients, see section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Solution for intramuscular injection or concentrate for solution for infusion.
A clear colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Intramuscular use:
Difene can be used in the symptomatic management of acute exacerbation of rheumatoid arthritis and osteoarthritis, in
acute back pain, acute gout, post operative pain, relief of pain in acute traumatic musculo-skeletal disorders and
fractures and renal colic.
Intravenous infusion:
For the treatment or prevention of post-operative pain in the hospital setting.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For intravenous infusion or intramuscular use only.
For Instruction on dilution of the product before IV administration, see section 6.6.
Renal colic: One 75 mg ampoule intramuscularly. A further ampoule may be administered after 30 minutes if
necessary.
As with oral Difene the total daily dose should not exceed 150 mg. Difene ampoules should not be given for more than
2 days; if necessary, treatment can be continued with capsules or suppositories.
Elderly: NSAIDs should be used with particular caution in elderly patients who are more prone to adverse events. The
lowest dose compatible with adequate safe clinical control should be employed. See also _section 4.4, Special warnings_
_and precautions for use._
Undesirable effects may be minimised by using t