131I-sodium-iodide ThyroTop 38-7400 MBq hard capsules capsules hard

Țară: Armenia

Limbă: engleză

Sursă: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredient activ:

131I sodium iodide

Disponibil de la:

Institute of Isotopes Co. Ltd.

Codul ATC:

V10XA01

INN (nume internaţional):

131I sodium iodide

Dozare:

38-7400MBq

Forma farmaceutică:

capsules hard

Unități în pachet:

(1) in container

Tip de prescriptie medicala:

Prescription

Statutul autorizaţiei:

Registered

Data de autorizare:

2019-10-21

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
131
I-SODIUM-IODIDE THYROTOP 38-7400 MBQ HARD CAPSULES
Sodium (
131
I) iodide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE THIS MEDICINE IS USED FOR
YOUR EXAMINATION.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor.
-
IN THIS LEAFLET:
1.
What ThyroTop is and what it is used for
2.
Before you use ThyroTop
3.
How to use ThyroTop
4.
Possible side effects
5.
How to store ThyroTop
6.
Further information
1.
WHAT THYROTOP IS AND WHAT IT IS USED FOR
131
I-sodium iodide ThyroTop 38-7400 MBq hard capsule is a radioactive
medicine, which can be used
for , treatment of hyperfunction in case of hyperthyroidism, reducing
the size of thyroid, therapy of
thyroid carcinoma. This medicine can be use only in nuclear medicine
departments.
The capsule itself is colourless and contains white powder. After oral
administration of the capsule,
131
I-
sodium iodide gets into the blood stream and reaches the thyroid, the
salivary glands, placenta, gastric
mucosa and plexus chorioideus (and breast milk in case of lactaion).
2.
BEFORE YOU USE THYROTOP
DO NOT TAKE THYROTOP
-
if you are allergic (hypersensitive) to sodium (
131
I) iodide or any of the other ingredients of
ThyroTop
-
if you are pregnant, or breastfeeding
-
if you are under 18 years of age
-
if you do not consent to the nuclear medicine examination
TAKING OTHER MEDICINES
Please tell your doctor if you are taking or have recently taken any
other medicines, including medicines
obtained without a prescription.
Hindered radioiodine uptake of thyroid is a problem in case of thyroid
scintigraphy as well as in case of
radionuclide therapy of thyroid. That is why administration of
inactive iodines should be avoided:
Treatment with Methothyrin, triiodthyronine and thyroxine should be
witheld 4-7 days, 2 weeks, and 1
month, respectively prior to radioiodine admini

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
131
I-SODIUM-IODIDE THYROTOP 38-7400 MBQ HARD CAPSULES
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
38-7400 MBq sodium iodide (
131
I) per hard capsule
Excipients: disodium hydrogen phosphate dihydrate, sodium
thiosulphate, sodium hydroxide, sodium
carbonate, sodium hydrogen carbonate, water for injection
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Colourless hard capsule
Radioactive pharmaceutical containing
131
I-labelled sodium iodide active substance, for oral
administration
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
INDICATIONS FIELD: RADIONUCLID THERAPY
Treatment of hyperthyreosis

Graves disease

Hyperfunctioning adenoma

Non immunogenic diffuse goiter
Treatment of thyroid carcinoma

Ablation of residual thyroid tissues following thyroid cancer surgery

Treatment of recidivations and metastases
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Use of
131
I-sodium-iodide ThyroTop capsule is contraindicated for children under
18 years of age
except if the necessity and importance of treatment outweights the
risk associated with the radiation
exposure.
POSOLOGY
a) Therapy of hyperthyroidism
Administered radioactivity of
131
I in MBq/mL tissue in:
•
Graves’ disease and disseminated autonomy: 15 MBq/mL
•
UFA, unifocal autonomy: 40 MBq/mL
•
MFA, multifocal autonomy: 20 MBq/mL,
according to the empric fixed – however individual, volume
dependent, personalized - amount of
radioactivity of
131
I without measurement of uptake in the thyroid gland.
b.) Treatment of thyroid carcinoma administration of capsules with
following activities are
recommended:
Ablation following thyroid carcinoma surgery: 1.8 – 3.7 GBq/patient
Before treatment of local recidivations and metastases 370 MBq
131
I is administered. 48-72 hours after
whole body image is taken. For treatment use 3.7-7.4 GBq
131
I activity depending on the number and
size of metastases.
METHOD OF ADMINISTRATION
Required amount of activity is admi