Tissue or organ absorbed dose (DT):

Absorbed dose per unit activity administered (mGy/ MBq) Adult male Adult female

the absorbed dose, in tissue or organ T weighted for the type and quality of radiation R. It is given by:

The absorbed dose to the uterus following administration of Yttrium (90Y)-labelled medicinal products is dependent on the specific medicinal product being radiolabelled and is to be specified in the Summary of Product Characteristics/ package leaflet of the medicinal product to be radiolabelled.

Overall average absorbed dose

The overall average absorbed dose shall be calculated in accordance with Annex III.

From the dose distribution determined in this manner an average can be calculated which is the overall average absorbed dose.

the overall average absorbed radiation dose does not exceed the limit values recommended by the Scientific Committee for Food;

(b) the overall average absorbed radiation dose does not exceed the limit values recommended by the Scientific Committee for Food;

foodstuffs exposed to ionising radiation generated by measuring or inspection devices, provided that the dose absorbed is not greater than 0,01 Gy for inspection devices which utilise neutrons and 0,5 Gy in other cases, at a maximum radiation energy level of 10 MeV in the case of X-rays, 14 MeV in the case of neutrons and 5 MeV in other cases;

(a) foodstuffs exposed to ionising radiation generated by measuring or inspection devices, provided that the dose absorbed is not greater than 0,01 Gy for inspection devices which utilise neutrons and 0,5 Gy in other cases, at a maximum radiation energy level of 10 MeV in the case of X-rays, 14 MeV in the case of neutrons and 5 MeV in other cases;

the data for control of the irradiation process as provided for in Annex III, the dosimetric checks carried out and the results obtained, with details in particular of the limits, lower and upper, of the dose absorbed and the type of ionising radiation;

(g) the data for control of the irradiation process as provided for in Annex III, the dosimetric checks carried out and the results obtained, with details in particular of the limits, lower and upper, of the dose absorbed and the type of ionising radiation;

The overall average absorbed dose can be determined directly for homogenous products or for bulk goods of homogenous apparent density by distributing an adequate number of dosimeters strategically and at random throughout the volume of the goods.

Absorbed dose per unit activity administered (mGy/ MBq)

In this Directive absorbed dose denotes the dose averaged over a tissue or an organ.

DT,R is the absorbed dose averaged over tissue or organ T, due to radiation R,

where D(L)dL is the absorbed dose at 10 mm between linear energy transfer L and L + dL;

The unit for absorbed dose is the gray.

the special name of the unit of absorbed dose.

6 Estimated absorbed radiation dose

In the unlikely event of the administration of a radiation overdose with LeukoScan, the absorbed dose to the patient may be reduced by increased oral or intravenous intake of fluids to promote excretion of the radiolabel.

In the unlikely event of a radiation overdose being administered with LeukoScan [ 99mTc ], the absorbed dose to the patient may be reduced by increased oral or intravenous intake of fluids to promote excretion of the radiolabel.

RADIATION ABSORBED DOSES Organ Adrenals Brain Chest Gallbladder Ascending colon wall Descending colon wall Small intestine Myocardial wall Kidneys Liver Lungs Muscle Ovaries Pancreas Red marrow Bone surfaces Skin Spleen Stomach Testes Thymus Thyroid Urinary bladder wall Uterus Effective dose (mSv/ MBq)

Estimated Radiation Absorbed Doses From [ 90Y]-Zevalin

a dimensionless factor used to weight the tissue or organ absorbed dose.

The estimated radiation-absorbed doses to normal organs were substantially below recognised upper safety limits.

Administration of 750 MBq LeukoScan will give an estimated absorbed dose of 4.1 mGy to an embryo or fetus at an early stage.

average value of the quality factor at a point in tissue where the absorbed dose is delivered by particles with different L values.

a function of linear energy transfer (L) used to weight absorbed doses at a point in such a way as to take into account the quality of a radiation.

The estimated absorbed radiation doses to an average adult patient from an intravenous injection of QUADRAMET are shown in Table 2.

When the radiation field is composed of types and energies with different values of wR, the absorbed dose must be subdivided into blocks, each with its own value of wR and added to give the total equivalent dose.

To minimise the dose of radiation absorbed by the bladder, the intake of fluids should be increased during the first few hours after injection to permit frequent voiding.

Based on human data, the absorbed radiation doses by individual organs of an average human adult (70 kg) from an intravenous injection of the agent are listed below.

The estimated absorbed radiation doses to an average adult patient (70 kg) from an intravenous administration of LeukoScan labeled with 750 MBq of technetium-99m are provided in Table 1.

To minimise the dose of radiation absorbed by the bladder, adequate hydration should be encouraged to permit frequent voiding during the first few hours after injection.

Alternatively, it may be expressed as a continuous distribution in energy where each element of absorbed dose from the energy element between E and E + dE is multiplied by the value of wR from the relevant entry in the Table below.

Analyses of estimated radiation absorbed dose were carried out using quantitative imaging with the gamma-emitter [ 111In]-radiolabelled Zevalin, blood sampling, and the MIRDOSE3 software program.

13 Based upon dosimetry studies with [ 111In]-radiolabelled Zevalin, the estimated radiation dosimetry for individual organs following administration of [ 90Y]-radiolabelled Zevalin at activities of 15 MBq/ kg and 11 MBq/ kg was calculated according to Medical Internal Radiation Dosimetry (MIRD) (Table 2).