TRENTAL Concentrate for Soln for Inf 300/15 Mg/Ml
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
PENTOXIFYLLINE
Available from:
Sanofi-Aventis Ireland Limited
Dosage:
300/15 Mg/Ml
Pharmaceutical form:
Concentrate for Soln for Inf
Authorization date:
2001-01-03
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998
(S.I. NO.142 OF 1998)
PA0540/080/001
Case No: 2030105
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
SANOFI-AVENTIS IRELAND LIMITED
CITYWEST BUSINESS CAMPUS, DUBLIN 24, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
TRENTAL CONCENTRATE FOR SOLUTION FOR INFUSION 300MG/15ML
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 30/11/2006 until 02/01/2011.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 02/12/2006_
_CRN 2030105_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Trental Concentrate for Solution for Infusion 300mg/15ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 15ml ampoule contains 300mg pentoxifylline (equivalent to 20mg/ml).
Each ampoule also contains 41mg (1.8 mmol) sodium, as excipient.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion
Clear, colourless, sterile aqueous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Trental is indicated in the management of peripheral vascular disease and cerebrovascular insufficiency. Trental has
been shown to increase cerebral blood flow but this may
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