OSTEOCIS 3mg kit for radiopharmaceutical preparation

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Sodium oxidronate

Предлага се от:

CIS bio International

АТС код:

V09BA; V09BA01

INN (Международно Name):

Sodium oxidronate

дозиране:

3.0 milligram(s)

Лекарствена форма:

Kit for radiopharmaceutical preparation

Вид предписание :

Product subject to Restricted Prescription (C)

Терапевтична област:

Technetium (99mTc) compounds; technetium (99mTc) oxidronic acid

Статус Оторизация:

Marketed

Дата Оторизация:

2000-05-26

Листовка

CIS bio international, member of IBA Molecular group of companies
T2010pH
06/2013
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OSTEOCIS 3 MG KIT FOR RADIOPHARMACEUTICAL PREPARATION
SODIUM OXIDRONATE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.

Keep this leaflet.You may need to read it again.

If you have any further questions, ask your nuclear medicine doctor
who will
supervise the procedure. .

If you get any side effects talk to your nuclear medicine doctor. This
includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What OSTEOCIS is and what it is used for
2.
What you need to know before OSTEOCIS is used
3.
How OSTEOCIS is used
4.
Possible side effects
5.
How OSTEOCIS is stored
6.
Contents of the pack and other information
_IBA-CISBIO_
OSTEOCIS
0007 / 1.3.1 / 9
1. WHAT OSTEOCIS IS AND WHAT IT IS USED FOR
OSTEOCIS is a radiopharmaceutical product for diagnostic use only i.e.
a radioactive
medicine used for DIAGNOSTIC PURPOSES. Osteocis contains sodium
OXIDRONATE
which is used in combination with a RADIOACTIVE SOLUTION OF TECHNETIUM
(
99M
TC) in
order to form A SOLUTION OF TECHNETIUM (
99M
TC)-OXIDRONATE.
When injected into a vein of your arm, this product temporarily
COLLECTS IN YOUR
BONES. Because of its radioactivity it can be detected outside the
body using a
special camera, and pictures, known as scans, can be taken. The scan
will show
exactly the distribution of the radioactivity within the organ and the
body. These
scans give valuable information about the STRUCTURE OF YOUR BONES.
Osteocis is used to determine if there is any BONE ABNORMALITY.
The use of OSTEOCIS does involve exposure to small amounts of
radioactivity. Your
doctor and the nuclear medicine doctor have considered that the
clinical benefit that
you will obtain from the procedure with the radiopharmaceutical
outweighs the risk
due to radiation.
2. WHAT YOU NEED TO KNOW BEFORE OSTEOCIS IS USED
OSTEOCIS MUST N

Данни за продукта

Health Products Regulatory Authority
21 May 2020
CRN009NW0
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
OSTEOCIS 3mg kit for radiopharmaceutical preparation
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 3mg of sodium oxidronate (or hydroxymethylene
diphosphonate, HMDP)
The radionuclide is not part of the kit.
Excipient with known effect:
Each vial contains 4.5 mg of sodium.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Kit for radiopharmaceutical preparation.
White pellet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
After radiolabelling with sodium pertechnetate (
99m
Tc) solution the solution of technetium (
99m
Tc) oxidronate obtained is
indicated for bone scintigraphy, where it delineates areas of altered
osteogenesis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
This medicinal product is intended for use in designated nuclear
medicine facilities only, and should only be handled by
authorised personnel.
Posology
_Adults and elderly population_
The average activity administered by single intravenous injection is
500 MBq (300 ‑ 700 MBq) for an adult weighting 70 kg.
Other activities may be justifiable. There is no special dosage
regimen for the elderly patient.
_Renal impairment_
Careful consideration of the activity to be administered is required
since an increased radiation exposure is possible in these
patients.
_Patients with high bone uptake and/or severe renal impairment_
A dose adjustment can be required.
_Paediatric population_
The use in children and adolescents has to be considered carefully,
based upon clinical needs and assessing the risk/benefit
ratio in this patient group.
The activities to be administered to children and to adolescents may
be calculated according to the recommendations of the
Paediatric Task Group of the EANM (2008). This activity can be
calculated from the formula below using a multiplying
coefficient based on the patient’s body mass (table 1).
He