THERACAP 131

.201

THERACAP 131

, hard capsules

פאקארת

131

,

תולוספק תושק

,ה/דבכנ ת/חקור ,ה/אפור

ולעה

כדוע אפורל

ינויב

2018

.הרמחה םניאש םיפסונ םייוניש ןולעב .הרמחה םיווהמה םייונישה םיניוצמ וז העדוהב

.הצוח וקב ןמוסמ רסוהש טסקט ,יתחת וקב ןמוסמ ףסוותהש טסקט

:ליעפה רמוחה

Sodium Iodide (

ןלהל

חסונ

היוותהה

:רישכתל רשואמה

Theracap 131 is a radioiodine thyroid therapy indicated for:

Treatment of Grave's disease, toxic multinodular goitre or autonomous nodules.

Treatmernt of papilary and follicular thyroid carcinoma including metastastic disease.

ושענ אפורל ןולעב םיירקיעה םינוכדעה :םיאבה םיפיעסב

4.4 Special warnings and special precautions for use

]...[

Hyponatraemia: Serious manifestations of hyponatraemia have been reported after sodium iodide

[131I] therapy in elderly patients who have undergone total thyroidectomy. Risk factors include

older age, female sex, use of thiazide diuretics and hyponatraemia at the start of sodium iodide

[131I] therapy. Regular serum electrolytes measurements shall be considered for these patients.

]...[

תואירבה דרשמ רתאבש תופורתה רגאמל ותאלעה ךרוצל תואירבה דרשמל חלשנ אפורל ןולעה

לבקל ןתינ

ולע

הז

ספדומ

די לע

הינפ הרישי :םושירה לעבל

,מ''עב ינורטקלא דויצ ןדלא 'חר חולישה

.ד.ת

7641

הווקת חתפ ,

4917001

לט , ןופ

03-9371111

,הכרבב

ךלוו זוע

הנוממ חקור

מ''עב ינורטקלא דויצ ןדלא

GE Healthcare

PACKAGE LEAFLET:

INFORMATION FOR THE

HEALTHCARE PROFESSIONAL

THERACAP

131TM

37 MBq-5.55 GBq

capsules, hard

Sodium [

l] iodide

IBS600P

1.

NAME OF THE MEDICINAL PRODUCT

THERACAP

131 TM

37 MBq-5.55 GBq capsules, hard

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

THERACAP is presented as a single yellow capsule containing sodium [

l] iodide in the following

dosage range; 37-740 MBq in 37 MBq steps, 50 – 1000 MBq in 50 MBq steps, 0.925-5.55 GBq in 185

MBQ steps and 1000 – 5500 MBq in 100 MBq steps at the activity reference date. Each capsule

contains a maximum of 20 µg of sodium iodide. The specific activity of the sodium [

l] iodide is not

less than 222 GBq/mg.

Iodine-131 is produced by fission of uranium-235 or by neutron bombardment of stable tellurium in a

nuclear reactor. Iodine-131 has a half life of 8.02 days. It decays by emission of gamma radiations of

365 keV (81.7%), 637 keV (7.2%) and 284 keV (6.1%) and beta radiations of maximal energy of 606 keV

to stable xenon-131.

This medicinal product contains:

not more than 1.9 mmol (44

mg) of sodium per capsule.

For a full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Capsule, hard.

Yellow gelatin capsule.

4.

CLINICAL PARTICULARS

4.1 Therapeutic indications

Radioiodine thyroid therapy is indicated for:

Treatment of Graves’ disease, toxic multinodular goitre or autonomous nodules.

Treatment of papillary and follicular thyroid carcinoma including metastatic disease.

Sodium [131l]

iodide

therapy

often

combined

with

surgical

intervention

with

antithyroid

medications.

4.2 Posology and method of administration

The activity administered is a matter for clinical judgement. The therapeutic effect is only achieved

after several months.

For the treatment of hyperthyroidism

The activity administered is usually in the range of 200-800 MBq but repeated treatment may be

necessary. The dose required depends on the diagnosis, the size of the gland, thyroid uptake and

iodine clearance. Patients should be rendered euthyroid medically whenever possible before giving

radioiodine treatment for hyperthyroidism.

For thyroid ablation and treatment of metastases

The administered activities following total or sub total thyroidectomy to ablate remaining thyroid

tissue are in the range of 1850-3700 MBq. It depends on the remnant size and radioiodine uptake. In

subsequent treatment for metastases, administered activity is in the range 3700-11100 MBq.

The activity to be administered in children and adolescents should be a fraction of the adult dose

calculated from the body weight/surface area methods according to the following equation.

Paediatric dose (MBq) = Adult dose (MBq) x child weight (kg)

70 kg

Paediatric dose (MBq) = Adult dose (MBq) x child surface (m

1.73 m

Correction factors given for guidance are proposed below.

Fraction of adult dose

3Kg = 0.10

4Kg = 0.14

6Kg = 0.19

8Kg = 0.23

10Kg = 0.27

12Kg = 0.32

14Kg = 0.36

16Kg = 0.40

18Kg = 0.44

20Kg = 0.46

22Kg = 0.50

24Kg = 0.53

26Kg = 0.56

28Kg = 0.58

30Kg = 0.62

32Kg = 0.65

34Kg = 0.68

36Kg = 0.71

38Kg = 0.73

40Kg = 0.76

42Kg = 0.78

44Kg = 0.80

46Kg = 0.82

48Kg = 0.85

50Kg = 0.88

52-54Kg = 0.90

56-58Kg = 0.92

60-62Kg = 0.96

64-66Kg = 0.98

68Kg = 0.99

(Paediatric Task Group, European Association of Nuclear Medicines (EANM))

The capsule is administered orally together with a drink. It should be swallowed whole.

In patients with suspected gastrointestinal disease, great care should be taken when administering

sodium [

I] iodide capsules. The capsules should be swallowed whole with sufficient fluid to ensure

clear passage into the stomach and upper small intestine. Concomitant use of H

antagonists or proton

pump inhibitors is advised.

After high doses used e.g. for the treatment of thyroid carcinoma, patients should be encouraged to

increase oral fluids to have frequent bladder emptying to reduce bladder radiation.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients

Pregnancy.

For diagnostic purposes in children under 10 years of age.

Thyroid

scanning

except

follow-up

malignant

disease

when

iodine-123

technetium-99m is not available.

Patients with dysphagia, oesophageal stricture, active gastritis, gastric erosions and peptic

ulcer.

Patients with suspected reduced gastrointestinal motility.

4.4 Special warnings and special precautions for use

The possibility of hypersensitivity including anaphylactic / anaphylactoid reactions should always be

considered. Advanced life support facilities should be readily available.

For radioprotection reasons following therapeutic doses, it is recommended to avoid close contact

between mother and child for at least one week.

The risk of second primary malignancies in thyroid cancer survivors treated with radioactive iodine is

slightly increased compared to thyroid cancer survivors not treated with radioiodine.

This medicinal product contains not more than 1.9 mmol (44 mg) of sodium in each capsule. To be

taken into consideration by patients on a controlled sodium diet.

The administration of high dose radioiodine may result in significant environmental hazard. Suitable

precautions should be taken concerning the activity eliminated by the patients in order to avoid any

contamination.

The therapeutic administration of sodium [

I] iodide in patients with significant renal impairment

requires special attention with regards to administered activity.

There is inconclusive evidence of a beneficial effect of saliva stimulation to avoid sialadenitis.

low-iodine

diet

prior

therapy

will

enhance

uptake

into

functioning

thyroid

tissue.

Thyroid

replacement therapy should be stopped prior to radioiodine administration for thyroid carcinoma to

ensure adequate uptake.

Hyponatraemia: Serious manifestations of hyponatraemia have been reported after sodium iodide

[131I] therapy in elderly patients who have undergone total thyroidectomy. Risk factors include older

age, female sex, use of thiazide diuretics and hyponatraemia at the start of sodium iodide [131I]

therapy. Regular serum electrolytes measurements shall be considered for these patients.

Sperm banking should be considered for young men who have extensive disease and therefore may

need high radioiodine therapeutic doses.

Contraception for 6 months (for patients with benign thyroid conditions) or 12 months (for patients

with thyroid cancer) is recommended for both sexes after therapeutic administration of sodium [

iodide.

For each patient, exposure to ionising radiation must be justifiable on the basis of likely benefit. The

activity administered must be such that the resulting radiation dose is as low as reasonable achievable

bearing in mind the need to obtain the intended diagnostic or therapeutic result.

4.5 Interaction with other medicinal products and other forms of interaction

A full drug history should be taken and relevant medication including the ones mentioned below

should be withheld prior to the administration of sodium [

I] iodide.

Active substances

Withdrawal

period

prior

to

administration of sodium [

131

I] iodine.

Antithyroid

agents

(e.g.

carbimazole,

methimazole, propyluracil), perchlorate

2 – 5 days before until several days after

administration.

Salicylates, steroids, sodium nitroprusside,

sodium

sulfobromophthalein, anticoagulants,

antihistamines,

antiparasitics,

penicillins,

sulphonamides, tolbutamide, thiopental

1 week.

Phenylbutazone

1-2 weeks.

Containing iodine

expectorants and vitamins

approx. 2 weeks.

Thyroid hormone

preparations

2-6 weeks.

Amiodarone*, benzodia-

zepines, lithium

approx. 4 weeks.

Containing iodine

preparations for topical use

1–9 months.

Water-soluble

iodine-containing

contrast

media

up to 3 months .

Oral cholecystographic agents

for a period of up to 1 year.

* Due to the long half-life of amiodarone, iodine uptake in the thyroid tissue can be decreased for

several months.

4.6 Fertility, pregnancy and lactation

Pregnancy

Sodium [

I] iodide is contraindicated during established or suspected pregnancy or when pregnancy

has not been excluded. The absorbed dose to the uterus for this agent is likely to be in the range 11-

mGy,

foetal

thyroid

gland

avidly

concentrates

iodine

during

second

and third

trimesters.

When

necessary

administer

radioactive

products

women

childbearing

potential, information should always be sought about pregnancy. Any woman who has missed a

period should be assumed to be pregnant until proven otherwise.

Alternative techniques which do not involve ionising radiation should be considered. In the case of

differentiated thyroid carcinoma diagnosed in pregnancy therefore, radioiodine treatment should be

postponed until after the pregnancy has ended. Women receiving sodium [

I] iodide should be

advised not to become pregnant within 6-12 months of administration.

Breastfeeding

Breastfeeding should be discontinued after sodium [

I] iodide administration.

4.7 Effects on ability to drive and use machines

No studies on the effect on the ability to drive or use machines have been performed.

4.8 Undesirable Effects

The following undesirable effects are recognised for sodium [

I] iodide:

The frequencies of undesirable effects are defined as follows:

Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000

to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).

Blood and the lymphatic system disorders

Not known: Bone marrow depression, including serious thrombcytopenia, erythrocytopenia and/or

leukopenia

Eye disorders

Common: Sicca syndrome, endocrine ophthalmopathy

Not known: acquired dacryostenosis

Gastrointestinal disorders

Very common: Transient or persistent sialadenitis, including dry mouth, Nausea, vomiting Endocrine

disorders

Endocrine disorders

Very common: Hypothyroidism

known:

Aggravated

hyperthyroidism,

Basedow’s

(Graves’)

disease,

hypoparathyroidism,

hyperparathyroidism

Neoplasms benign, malignant and unspecified (including cysts and polyps)

Uncommon: leukaemia

Not known: Gastric cancer, bladder and breast cancer

Immune system disorders

Not known: Hypersensitivity

Injury, poisoning and procedural complications

Very common: Radiation injury, including radiation thyroiditis, radiation associated pain, tracheal

obstruction

Reproductive system and breast disorders

Not known: Impairment of fertility in man and woman

Congenital, familial and genetic disorders

Not known: Congenital thyroid disorders

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It

allows continued monitoring of the benefit/risk balance of the medicinal product.

Any suspected adverse events should be reported to the Ministry of Health according to the National

Regulation by using an online form

http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=Advers

EffectMedic@moh.gov.il

and emailed to the Registration Holder’s Patient Safety Unit at:

drugsafety@neopharmgroup.com

4.9 Overdose

High radiation exposure through overdose can be reduced by means of administration of thyroid

blocking agent, such as potassium perchlorate, the use of emetics and promoting a diuresis with

frequent voiding of urine.

5.

PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic

group:

therapeutic

radiopharmaceuticals,

sodium

iodine,

Code:

V10XA01

Iodide, in the amount used for therapeutic indications, is not known to have any pharmacological

effect. More than 90 % of the radiation effects result from beta radiation which has a mean range of

0.5 mm.

5.2 Pharmacokinetic properties

After oral administration, sodium [

I] iodide is absorbed rapidly from the upper gastrointestinal tract

(90 % in 60 minutes). The pharmacokinetics follow that of un -labelled iodide. From the extra thyroidal

compartment it is predominantly taken up by the thyroid or excreted renally. Small amounts of sodium

I] iodide are taken up by salivary glands, gastric mucosa and would also be localised in breast milk,

the placenta and choroids plexus.

The effective half-life of radioiodine in plasma is in the order of 12 hours whereas that for radioiodine

taken

thyroid

gland

about

days.

Thus,

after

administration

sodium

iodide,

approximately 40% of the activity has an effective half life of 0.4 days and the remaining 60%, 8 days.

Urinary excretion is 37-75%, faecal excretion is about 10% with almost negligible excretion in sweat.

5.3 Preclinical safety data

No acute toxicity is expected or observed.

There are no data available on the toxicity of repeated doses of sodium iodide nor on its effects on

reproduction in animals or its mutagenic or carcinogenic potential.

6.

PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium thiosulphate, pentahydrate

Disodium phosphate anhydrous

Sodium hydroxide

Silica, colloidal anhydrous

Maize starch

Water for injections

Capsule:

Gelatin

Yellow iron oxide (E172)

Titanium dioxide (E171)

Sodium laurilsulfate

Acetic acid

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal

products.

6.3 Shelf Life

The shelf life for this product is 14 days from the activity reference date stated on the label.

6.4 Special precautions for storage

Store below 25

C. Do not freeze.

Store in the original lead container or in equivalent shielding

6.5 Nature and contents of container

Each capsule is contained within a polycarbonate cup with a charcoal disc to absorb iodine-131. This

cup is enclosed within a lead shield.

Pack sizes: 37-740 MBq in 37 MBq steps, 50 – 1000 MBq in 50 MBq steps, 0.925-5.55 GBq in 185 MBq

steps and 1000 – 5500 MBq in 100 MBq steps. Each pack contains a single capsule.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

Normal

safety

precautions

handling

radioactive

materials

should

observed.

After

use,

materials associated with the preparation and administration of radiopharmaceuticals, including any

unused product and its container, should be decontaminated or treated as radioactive waste and

disposed

accordance

with

conditions

specified

local

competent

authority.

Contaminated material must be disposed of as radioactive waste via an authorised route.

7

DOSIMETRY

The ICRP model refers to intravenous administration. Since absorption of radioiodide is rapid and

complete, this model is applicable in case of oral administration also but there is a further radiation

dose to the stomach wall in addition to that due to gastric and salivary excretion. Assuming that the

mean residence time in the stomach is 0.5 hr, the absorbed dose to the stomach wall increase by

about 30 % for iodine-131.

Radiation dose to specific organs, which may not be the target organ of therapy can be influenced

significantly by pathophysiological changes induced by the disease process.

As part of the risk-benefit assessment it is advised that the effective dose equivalent (EDE) and likely

radiation doses to individual target organ(s) be calculated prior to administration. The activity might

then be adjusted according to thyroid mass, biological half-life and the “re-cycling” factor which takes

into account the physiological status of the patient (including iodine depletion) and the underlying

pathology.

The tables below show the dosimetry as calculated according to the Publication 53 of the ICRP

(International

Commission

Radiological

Protection,

Radiation

Dose

Patients

from

Radiopharmaceuticals, Pergamon Press 1987).

Iodide (

I; 8.02 days)

Thyroid blocked uptake 0%

Organ

Absorbed dose

per unit activity administered (mGy/MBq)

Adult

15 years

10 years

5 years

1 year

Adrenals

Bladder wall

Bone surfaces

Breast

GI tract

Stomach wall

Small intest

ULI wall

LLI wall

Kidneys

Liver

Lungs

Ovaries

Pancreas

Red marrow

Spleen

Testes

Thyroid

Uterus

Other tissue

3.7E-02

6.1E-01

3.2E-02

3.3E-02

3.4E-02

3.8E-02

3.7E-02

4.3E-02

6.5E-02

3.3E-02

3.1E-02

4.2E-02

3.5E-02

3.5E-02

3.4E-02

3.7E-02

2.9E-02

5.4E-02

3.2E-02

4.2E-02

7.5E-01

3.8E-02

3.3E-02

4.0E-02

4.7E-02

4.5E-02

5.2E-02

8.0E-02

4.0E-02

3.8E-02

5.4E-02

4.3E-02

4.2E-02

4.0E-02

4.5E-02

3.8E-02

6.7E-02

3.9E-02

6.7E-02

1.1E+00

6.1E-02

5.2E-02

6.4E-02

7.5E-01

7.0E-02

8.2E-02

1.2E-01

6.5E-02

6.0E-02

8.4E-02

6.9E-02

6.5E-02

6.5E-02

7.5E-02

6.3E-02

1.1E-01

6.2E-02

1.1E-01

1.8E+00

9.7E-02

8.5E-02

1.0E-01

1.2E-01

1.2E-01

1.3E-01

1.7E-01

1.0E-01

9.6E-02

1.3E-01

1.1E-01

1.0E-01

1.0E-01

1.2E-01

1.0E-01

1.7E-01

1.0E-01

2.0E-01

3.4E+00

1.9E-01

1.7E-01

1.9E-01

2.2E-01

2.1E-01

2.3E-01

3.1E-01

2.0E-01

1.9E-01

2.4E-01

2.1E-01

1.9E-01

2.0E-01

2.3E-01

2.0E-01

3.0E-01

1.9E-01

Effective

dose

equivalent

(mSv/MBq)

7.2E-02

8.8E-02

1.4E-01

2.1E-01

4.0E-01

Bladder wall contributes to 50.8% of the effective dose equivalent.

The effective dose equivalent to an adult administered 5.55GBq with 0% thyroid uptake is 399.6 mSv.

Incomplete blockage:

Effective dose equivalent (mSv/MBq) with little uptake in the thyroid.

Uptake: 0.5%

3.0E-01

4.5E-01

6.9E-01

1.5E+00

2.8E+00

Uptake: 1.0%

5.2E-01

8.1E-01

1.2E+00

2.7E+00

5.3E+00

Uptake: 2.0%

9.7E-01

1.5E+00

2.4E+00

5.3E+00

1.0E+01

Thyroid uptake 15%

Organ

Absorbed dose

per unit activity administered (mGy/MBq)

Adult

15 years

10 years

5 years

1 year

Adrenals

Bladder wall

Bone surfaces

Breast

GI tract

Stomach wall

Small intest

ULI wall

LLI wall

Kidneys

Liver

Lungs

Ovaries

Pancreas

Red marrow

Spleen

Testes

Thyroid

Uterus

Other tissue

3.6E-02

5.2E-01

4.7E-02

4.3E-02

4.6E-01

2.8E-01

5.9E-02

4.2E-02

6.0E-02

3.2E-02

5.3E-02

4.3E-02

5.2E-02

5.4E-02

4.2E-02

2.8E-02

2.1E+02

5.4E-02

6.5E-02

4.3E-02

6.4E-01

6.7E-02

4.3E-02

5.8E-01

3.5E-01

6.5E-02

5.3E-02

7.5E-02

4.1E-02

7.1E-02

5.9E-02

6.2E-02

7.4E-02

5.1E-02

3.5E-02

3.4E+02

6.8E-02

8.9E-02

7.1E-02

9.8E-01

9.4E-02

8.1E-02

8.4E-01

6.2E-01

1.0E-01

8.2E-02

1.1E-01

6.8E-02

1.2E-01

9.2E-02

1.0E-01

9.9E-02

8.1E-02

5.8E-02

5.1E+02

1.1E-01

1.4E-01

1.1E-01

1.5E+00

1.4E-01

1.3E-01

1.5E+00

1.0E+00

1.6E-01

1.3E-01

1.7E-01

1.1E-01

1.9E-01

1.4E-01

1.5E-01

1.4E-01

1.2E-01

9.4E-02

1.1E+03

1.7E-01

2.2E-01

2.2E-01

2.9E+00

2.4E-01

2.5E-01

2.9E+00

2.0E+00

2.8E-01

2.3E-01

2.9E-01

2.2E-01

3.3E-01

2.6E-01

2.7E-01

2.4E-01

2.3E-01

1.8E-01

2.0E+03

3.1E-01

4.0E-01

Effective

dose

equivalent

(mSv/MBq)

6.6E+00

1.0E+01

1.5E+01

3.4E+01

6.2E+01

The effective dose equivalent (EDE) in an adult administered 5.55 GBq with 15% thyroid uptake is

36,630

mSv.

Thyroid uptake 35%

Organ

Absorbed dose

per unit activity administered (mGy/MBq)

Adult

15 years

10 years

5 years

1 year

Adrenals

Bladder wall

Bone surfaces

Breast

GI tract

Stomach wall

Small intest

ULI wall

LLI wall

Kidneys

Liver

Lungs

Ovaries

Pancreas

Red marrow

Spleen

Testes

Thyroid

Uterus

Other tissue

4.2E-02

4.0E-01

7.6E-02

6.7E-02

4.6E-01

2.8E-01

5.8E-02

4.0E-02

5.6E-02

3.7E-02

9.0E-02

4.2E-02

5.4E-02

8.6E-02

4.6E-02

2.6E-02

5.0E+02

5.0E-02

1.1E-01

5.0E-02

5.0E-01

1.2E-01

6.6E-02

5.9E-01

3.5E-01

6.5E-02

5.1E-02

7.2E-02

4.9E-02

1.2E-01

5.7E-02

6.9E-02

1.2E-01

5.9E-02

3.2E-02

7.9E+02

6.3E-02

1.6E-01

8.7E-02

7.6E-01

1.6E-01

1.3E-01

8.5E-01

6.2E-01

1.0E-01

8.0E-02

1.1E-01

8.2E-02

2.1E-01

9.0E-02

1.1E-01

1.6E-01

9.6E-02

5.4E-02

1.2E+03

1.0E-01

2.6E-01

1.4E-01

1.2E+00

2.3E-01

2.2E-01

1.5E+00

1.0E+00

1.7E-01

1.3E-01

1.7E-01

1.4E-01

3.3E-01

1.4E-01

1.8E-01

2.2E-01

1.5E-01

8.9E-02

2.6E+03

1.6E-01

4.1E-01

2.8E-01

2.3E+00

3.5E-01

4.0E-01

3.0E+00

2.0E+00

3.0E-01

2.4E-01

2.9E-01

2.7E-01

5.6E-01

2.7E-01

3.2E-01

3.5E-01

2.8E-01

1.8E-01

4.7E+03

3.0E-01

7.1E-01

Effective

dose

equivalent

(mSv/MBq)

1.5E+01

2.4E+01

3.6E+01

7.8E+01

1.4E+02

The effective dose equivalent (EDE) in an adult administered 5.55 GBq with 35% thyroid

uptake is 83,250 mSv.

Thyroid uptake 55%

Organ

Absorbed dose

per unit activity administered (mGy/MBq)

Adult

15 years

10 years

5 years

1 year

Adrenals

Bladder wall

Bone surfaces

Breast

GI tract

Stomach wall

Small intest

ULI wall

LLI wall

Kidneys

Liver

Lungs

Ovaries

Pancreas

Red marrow

Spleen

Testes

Thyroid

Uterus

Other tissue

4.9E-02

2.9E-01

1.1E-01

9.1E-02

4.6E-01

2.8E-01

5.8E-02

3.9E-02

5.1 E-02

4.3E-02

1.3E-01

4.1E-02

5.8E-02

1.2E-01

5.1E-02

2.6E-02

7.9E+02

4.6E-02

1.6E-01

5.8E-02

3.6E-01

1.7E-01

8.9E-02

5.9E-01

3.5E-01

6.7E-02

4.9E-02

6.8E-02

5.8E-02

1.8E-01

5.6E-02

7.6E-02

1.8E-01

6.8E-02

3.1E-02

1.2E+03

6.0E-02

2.4E-01

1.1E-01

5.4E-01

2.2E-01

1.9E-01

8.6E-01

6.2E-01

1.1E-01

7.8E-02

1.0E-01

9.7E-02

3.0E-01

9.0E-02

1.3E-01

2.2E-01

1.1E-01

5.2E-02

1.9E+03

9.9E-02

3.7E-01

1.7E-01

8.5E-01

3.2E-01

3.1E-01

1.5E+00

1.0E+00

1.8E-01

1.3E-01

1.7E-01

1.7E-01

4.8E-01

1.5E-01

2.1E-01

2.9E-01

1.7E-01

8.7E-02

4.1E+03

1.6E-01

5.9E-01

3.4E-01

1.6E+00

4.8E-01

5.6E-01

3.0E+00

3.0E+00

3.2E-01

2.4E-01

2.9E-01

3.3E-01

8.0E-01

2.7E-01

3.8E-01

4.6E-01

3.3E-01

1.7E-01

7.4E+03

3.0E-01

1.0E+00

Effective

dose

equivalent

(mSv/MBq)

2.4E+01

3.7E+01

5.6E+01

1.2E+02

2.2E+02

For this product, the effective dose equivalent (EDE) to an adult with 55% thyroid

uptake resulting from the administration of a 5.55GBq capsule is 133,200mSv.

8

INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

This radiopharmaceutical may be received, used and administered only by authorised

persons, in designated clinical setting. Their receipt, storage, use, transfer and disposal

are subject to the regulations and/or appropriate licences of the local competent official

organisation. (see section 6.6).

administration

radiopharmaceuticals

creates

risks

other

persons

from

external

radiation

contamination

from

spills

urine,

vomiting,

etc.

Radiation

protection precautions in accordance with national regulations must therefore be taken.

9

MANUFACTURER

GE Healthcare Buchler GmbH & Co. KG

Gieselweg 1

D-38110 Braunschweig

Germany

10

REGISTRATION HOLDER

Eldan Electronic Instruments Co.Ltd., P.O.Box 7641, Petach Tiqva 4917001

11

LICENSE NUMBER

144-46-31928-00

Theracap is a trademark of GE Healthcare.

GE and the GE Monogram are trademarks of General Electric Company.

The content of this leaflet was approved by the Ministry of Health in 02/2017 and

updated according to the guidelines of the Ministry of Health in 06/2018.