THERACAP 131

Страна: Израел

Език: английски

Източник: Ministry of Health

Активна съставка:

SODIUM IODIDE (131 I)

Предлага се от:

ELDAN ELECTRONIC INSTRUMENTS CO LTD, ISRAEL

АТС код:

V09FX03

Лекарствена форма:

HARD CAPSULE

Композиция:

SODIUM IODIDE (131 I) 37 - 5550 MBQ

Начин на приложение:

PER OS

Вид предписание :

Required

Произведено от:

GE HEALTHCARE BUCHLER GmbH & Co. KG

Терапевтична група:

SODIUM IODIDE (131I)

Терапевтична област:

SODIUM IODIDE (131I)

Терапевтични показания:

Theracap 131 is a radioiodine thyroid therapy indicated for:1.Treatment of Grave's disease, toxic multinodular goitre or autonomous nodules.2.Treatmernt of papilary and follicular thyroid carcinoma including metastastic desease.

Дата Оторизация:

2015-09-30

Листовка

.201
6
0
8
THERACAP 131
, HARD CAPSULES פאקארת
131 , תולוספק
תושק
,ה/דבכנ ת/חקור ,ה/אפור

ולעה
ן
כדוע אפורל
ן
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
I)
131
Sodium Iodide (
ןלהל
חסונ
היוותהה
:רישכתל רשואמה
Theracap 131 is a radioiodine thyroid therapy indicated for:
1.
Treatment of Grave's disease, toxic multinodular goitre or autonomous
nodules.
2.
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
ן
הז
ספדומ
די לע
י
הינפ
הרישי
:םושירה לעבל
,מ''עב ינורטקלא דויצ ןדלא
'חר
חולישה
6
,
.ד.ת
7641
הווקת חתפ ,
4917001
לט ,
ןופ
:
03-9371111
.
,הכרבב
ךלוו זוע
הנוממ חקור
מ''עב ינורטקלא דויצ ןדלא

Данни за продукта

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
iodide (
131
l) 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. 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.
Excipient(s) with known effect
One hard capsule contains not more than 50 mg of sodium.
For the 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:
•
Treat
et of Graes’ disease, toi
ulti
odular goitre or autooous
odules.
•
Treatment of papillary and follicular thyroid carcinoma including
metastatic disease.
Sodium iodide
(
131
l) therapy is often combined with surgical intervention and with
antithyroid medicinal
products.
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 remain