CARDIOLITE Kit for radiopharmaceutical preparation
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
27-04-2024
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Active ingredient:
STANNOUS CHLORIDE DIHYDRATE TETRAKIS (2-METHOXY ISOBUTYL ISONITRILE) COPPER (I) TETRAFLUOROLBORATE CYSTEINE HYDROCHLORIDE MONOHYDRATE
Available from:
Bristol-Myers Squibb Pharma
Pharmaceutical form:
Kit for radiopharmaceutical preparation
Authorization date:
2001-08-26
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)
PA1052/001/001
Case No: 2041882
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
BRISTOL-MYERS SQUIBB PHARMA
CHAUSSEE DE LA HULPE 185, B-1170 BRUSSELS, BELGIUM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
CARDIOLITE KIT FOR RADIOPHARMACEUTICAL PREPARATION
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 22/10/2007.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 23/10/2007_
_CRN 2041882_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cardiolite kit for radiopharmaceutical preparation
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Kit for radiopharmaceutical preparation of Technetium Tc-99m Sestamibi.
Powder for solution for injection.
Sterile non-pyrogenic lyophilized white powder for reconstitution with oxidant-free Sodium Pertechnetate Tc-99m
Injection Ph. Eur.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For intravenous injection after reconstitution with Sodium pertechnetate [
99m
Tc] solution and may be used for:
Adjunct for diagnosis of ischaemic heart disease.
Adjunct for diagnosis and localisation of myocardia
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