SODIUM IODIDE (I-131) CAPSULE T

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

IODINE SODIUM

Tilgængelig fra:

ISORAD LTD, ISRAEL

ATC-kode:

V09FX03

Lægemiddelform:

CAPSULES

Sammensætning:

IODINE SODIUM 37 MBQ

Indgivelsesvej:

PER OS

Recept type:

Required

Fremstillet af:

MALLINCKRODT MEDICAL B.V., NETHERLANDS

Terapeutisk gruppe:

SODIUM IODIDE (131I)

Terapeutisk område:

SODIUM IODIDE (131I)

Terapeutiske indikationer:

Treatment of graves disease, toxic multinodular goite or autonomous nodules.Treatment of papillary and follicular thyroid carcinoma including metastatic disease. Sodium Iodide (I-131) Therapy is often combined with surgical intervention and with antithyroid medications.

Autorisation dato:

2015-11-30

Indlægsseddel

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור
ךיראת
26/03/2014
םש
רישכת
תילגנאב
SODIUM IODIDE (I-131) CAPSULE T
רפסמ
םושיר
144-91-31759-00
םש
לעב
םושירה
SOREQ NUCLEAR RESEARCH CENTRE
םיטרפ
לע
םי/יונישה
םי/שקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
4.4 SPECIAL WARNINGS
AND PRECAUTIONS FOR USE
תפסות
השדח
ףיעסל
הז
Renal impairment
The therapeutic
administration of 131I
capsules in patients with
significant renal impairment,
in which an activity
adjustment is necessary,
requires special attention.
4.8 UNDESIRABLE EFFECTS
-
-
NEOPLASMS BENIGN,
MALIGNANT AND UNSPECIFIED
(INCL CYSTS AND POLYPS):
Bladder cancer, colon cancer
gastric cancer
Secondary malignancies
After higher activities,
typically those used in the
treatment of thyroid
malignancies, an increased
incidence of leukaemia has
been observed. Regarding the
development of gastric
cancer, bladder or colon
cancer as well as other
SKIN AND SUBCUTANEOUS
DISORDERS: Iodo acne.
FREQUENCY: Not known
GENERAL DISORDERS AND
ADMINISTRATION SITE
CONDITIONS: Local swelling.
FREQUENCY: Not known
NEOPLASMS BENIGN,
MALIGNANT AND UNSPECIFIED
(INCL CYSTS AND POLYPS): Solid
cancers
Secondary malignancies
After higher activities,
typically those used in the
treatment of thyroid
malignancies, an increased
incidence of leukaemia has
been observed. There is also
evidence for an increased
incidence of secondary solid
cancers at high activities
secondary malignancies after
treatment of malignant
disease, the results in the
literature are still
contradictory.
(more than 7.4 GBq).
4.9 OVERDOSE
OVERDOSE
In case of overdose, the risk
of high radiation exposure
may exist. As the medicinal
product is excreted through
the kidneys, the overdose of
radiation exposure can be
reduced by forced diuresis
and frequent bladder voiding.
Additionally, the blockade of
the thyroid gland should be
recommended (

Produktets egenskaber

_ _
1
SUMMARY OF PRODUCT CHARACTERISTICS
FOR
SODIUM IODIDE (I131) CAPSULES T, HARD CAPSULES
1.
NAME OF THE MEDICINAL PRODUCT
Sodium Iodide (I131) Capsules T
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One capsule contains I-131 as sodium iodide: 37-7400 MBq at activity
reference time.
Iodine-131 has a half-life of 8.02 days. It decays by emission of
gamma radiations of 365 keV
(81%), 637 keV (7.3%) and 284 keV (6.0%) and beta radiations of
maximal energy of 606 keV to
stable Xenon-131.
_Excipients with known effect: _Sucrose 23 mg, sodium: 63.5 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard.
Transparent hard gelatine capsules containing a white to light brown
powder.
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.
•
In the management of thyroid carcinoma, sodium iodide is used to
identify thyroid remnant
and metastases (after ablation).
Sodium iodide I-131 therapy is often combined with surgical
intervention and with antithyroid me-
dicinal products.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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 depends on the diagnosis, the size of the
gland, thyroid uptake, and io-
dine clearance. The following target organ doses may be used:
unifocal autonomy
300 – 400 Gy target organ dose
multifocal and disseminated autonomy
150 – 200 Gy target organ dose
Graves’ disease
200 Gy target organ dose
_ _
_ _
2
_ _
In Graves’ disease, multifocal or disseminated autonomy, the above
mentioned target organ doses
are related to the overall weight of the thyroid gland, however in the
unifocal autonomy, the target
organ dose is only related to the weight of the adenoma.
The ac