Nephromag 0.2 mg/2.5 ml

Country: Norway

Language: Norwegian

Source: Statens legemiddelverk

Active ingredient:

Mertiatid

Available from:

ROTOP Pharmaka GmbH

ATC code:

V09CA03

INN (International Name):

Mertiatid

Dosage:

0.2 mg/2.5 ml

Pharmaceutical form:

Preparasjonssett til radioaktive legemidler

Units in package:

5 sett

Prescription type:

C

Authorization status:

Markedsført

Authorization date:

2006-09-29

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
NephroMAG, 0.2 mg, Kit for radiopharmaceutical preparation
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The kit contains two different vials: (1) and (2).
Vial (1) contains 0.2 mg of the mercaptoacetyltriglycine (mertiatide).
Vial (2) contains 2.5 mL phosphate buffer solution.
For a full list of excipients, see section 6.1.
The radioisotope is not part of the kit. The kit contains all non
radioactive components required
for the reconsitution of technetium-(99mTc) mertiatide solution for
injection.
3.
PHARMACEUTICAL FORM
Kit for radiopharmaceutical preparation.
Properties of the product after labelling:
Clear to slightly opalescent, colourless, aqueous solution.
pH: 7.1-7.5
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
After reconstitution and labelling with sodium pertechnetate(99mTc)
solution, the
radiopharmaceutical product obtained, technetium-(99mTc) mertiatide,
is used for the
evaluation of nephrological and urological disorders in particular for
the study of function,
morphology and perfusion of the kidneys and characterisation of
urinary outflow.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS AND ELDERLY
Adults and elderly: 40 - 200 MBq,_ _depending on the pathology to be
studied and the method to
be used.
POPULATION AGED LESS THAN 18 YEARS
Although NephroMAG may be used in paediatric patients, formal studies
have not been
performed. Clinical experience indicates that, for paediatric use, the
activity should be reduced.
Because of the variable relationship between the size and body weight
of patients, it is
sometimes more satisfactory to adjust activities to body surface area.
A practical approach is to adopt the recommendations of the Paediatric
Task Group of the
European Association of Nuclear Medicine (EANM). See table below.
Reduction of the radioactivity to less than 10 % of the adult activity
would generally result in
technically unsatisfactory procedures.
2
Fraction of adul