DIFENE AMPOULES 75 MG/3 ML
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
27-04-2024
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
DICLOFENAC SODIUM
Available from:
Astellas Pharma Co. Ltd
Dosage:
25
Pharmaceutical form:
Solution for Injection
Authorization date:
2006-06-13
Summary of Product characteristics
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA1241/012/006
Case No: 2071627
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
ASTELLAS PHARMA CO. LTD
25 THE COURTYARD, KILCARBERY BUSINESS PARK, CLONDALKIN, DUBLIN 22, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
DIFENE AMPOULES 75 MG/3 ML
The particulars of which are set out in Part I and Part II of the attached Schedule. The authorisation is also subject to the general conditions as
may be specified in the said Regulations as listed on the reverse of this document.
This authorisation, unless previously revoked, shall continue in force from 16/02/2010 until 27/08/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 17/02/2010_
_CRN 2071627_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Difene ampoules 75 mg/3 ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains Diclofenac sodium 75mg/3ml.
Each ampoule contains 25mg/ml of diclofenac sodium.
For list of excipients, see section 6.1.
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 tr
Read the complete document
