MEDRONATE DRAXIMAGE 10 Milligrams per Ampule Kit for radiopharmaceutical preparation
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
07-05-2024
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Active ingredient:
MEDRONIC ACID
Available from:
DRAXIMAGE (UK) Limited
INN (International Name):
MEDRONIC ACID
Dosage:
10 Milligrams per Ampule
Pharmaceutical form:
Kit for radiopharmaceutical preparation
Prescription type:
Product subject to Restricted Prescription (C)
Authorization status:
Withdrawn
Authorization date:
0000-00-00
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Medronate DRAXIMAGE 10mg Kit for radiopharmaceutical preparation
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 10 mg of medronic acid.
The radioisotope is not part of the kit.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Kit for radiopharmaceutical preparation
To be reconstituted with sodium pertechnetate (
99m
Tc) solution for injection (not included in this kit).
White freeze-dried plug that may break into powder
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
After reconstitution with sodium pertechnetate (
99m
Tc) solution, the agent is used for bone scintigraphy for the
detection of areas of altered osteogenesis associated with:
Neoplasms:
The detection, staging, and evaluation of response to therapy of primary bone tumors (e.g. Ewing’s sarcoma,
osteosarcoma)
The detection and follow-up of bone metastases
Non-neoplastic lesions:
As an aid in the evaluation of:
•
Osteomyelitis
•
Avascular necrosis
•
Paget’s disease
•
Stress fractures, shin splints
•
Loose or infected joint prosthesis
•
Reflex sympathetic syndrome
•
Bone graft viability
Since areas or altered osteogenesis can be detected with high sensitivity but low specificity, additional examinations
may be necessary.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 24/11/2011_
_CRN 2098517_
_page number: 1_
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS: The optimal activity of technetium (
99m
Tc) medronate injection has not been systematically investigated.
Injected activity may vary according to patient characteristics, imaging procedures, and imaging equipment.
The average
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