MITOMYCIN-C KYOWA 2 MG, POWDER FOR SOLUTION FOR IN 2 Milligram Pdr for Soln for Injection
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
16-05-2024
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Active ingredient:
MITOMYCIN
Available from:
Kyowa Hakko Kirin UK Ltd
INN (International Name):
MITOMYCIN
Dosage:
2 Milligram
Pharmaceutical form:
Pdr for Soln for Injection
Authorization status:
Withdrawn
Authorization date:
2008-07-01
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998
(S.I. NO.142 OF 1998)
PA0892/001/001
Case No: 2036657
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
KYOWA HAKKO UK LIMITED
258 BATH ROAD, SLOUGH, BERKSHIRE, SL1 4DX, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
MITOMYCIN-C KYOWA 2 MG, POWDER FOR SOLUTION FOR INJECTION
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 24/05/2007 until 12/12/2008.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 22/08/2007_
_CRN 2036657_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mitomycin-C Kyowa 2 mg, powder for solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 2 mg of Mitomycin-C. When reconstituted as directed this equates to 400 micrograms per ml.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection
Blue/purple crystalline powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Mitomycin C must be used under supervision of an Oncologist.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For parenteral use.
Intravenously, the dose should be given with great care in order to avoid extravasation.
The usual dose
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