Thyrogen
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
31-01-2024
Valmisteyhteenveto
(SPC)
31-01-2024
Julkisesta arviointikertomuksesta
(PAR)
12-01-2013
Aktiivinen ainesosa:
thyrotropin alfa
Saatavilla:
Sanofi B.V.
ATC-koodi:
H01AB01
INN (Kansainvälinen yleisnimi):
thyrotropin alfa
Terapeuttinen ryhmä:
Anterior pituitary lobe hormones and analogues, Pituitary and hypothalamic hormones and analogues
Terapeuttinen alue:
Thyroid Neoplasms
Käyttöaiheet:
Thyrogen is indicated for use with serum thyroglobulin (Tg) testing with or without radioiodine imaging for the detection of thyroid remnants and well-differentiated thyroid cancer in post thyroidectomy patients maintained on hormone suppression therapy (THST).Low risk patients with well-differentiated thyroid carcinoma who have undetectable serum Tg levels on THST and no rh (recombinant human) TSH-stimulated increase of Tg levels may be followed-up by assaying rh TSH-stimulated Tg levels.Thyrogen is indicated for pre-therapeutic stimulation in combination with a range of 30 mCi (1.1 GBq) to 100 mCi (3.7 GBq) radioiodine for ablation of thyroid tissue remnants in patients who have undergone a near-total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of distant metastatic thyroid cancer (see section 4.4).
Tuoteyhteenveto:
Revision: 29
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2000-03-09
Pakkausseloste
21
B. PACKAGE LEAFLET
22
PACKAGE LEAFLET: INFORMATION FOR THE USER
THYROGEN 0.9 MG POWDER FOR SOLUTION FOR INJECTION
Thyrotropin alfa
_ _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist
.
-
If you experience any side effects, talk to your doctor or pharmacist.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Thyrogen is and what it is used for
2. What you need to know before you use Thyrogen
3. How to use Thyrogen
4. Possible side effects
5. How to store Thyrogen
6. Contents of the pack and other information
1.
WHAT THYROGEN IS AND WHAT IT IS USED FOR
Thyrogen contains the active substance thyrotropin alfa. Thyrogen is a
human thyroid stimulating hormone
(TSH) manufactured using biotechnology processes.
Thyrogen is used to detect certain types of thyroid cancer in patients
who have had their thyroid gland removed
and who are taking thyroid hormones. One of the effects is that it
stimulates any remaining thyroid tissue to take
up iodine which is important for radioiodine imaging. It also
stimulates the production of thyroglobulin and
thyroid hormones if there is any thyroid tissue left. These hormones
can be measured in your blood.
Thyrogen is also used with radioiodine treatment to eliminate (ablate)
the thyroid tissue left over after surgical
removal of the thyroid gland (remnant) in patients who do not have
secondary cancer growths (metastases) and
who are taking thyroid hormone.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE THYROGEN
DO NOT USE THYROGEN:
•
if you are allergic to bovine or human thyroid stimulating hormone
(TSH) or any of the other
ingredients of this medicine (listed in section 6).
•
if you are pregnant.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Thyrogen
•
if you have kidney disease that requires dialysis and
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Valmisteyhteenveto
1
ANNEX 1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Thyrogen 0.9 mg powder for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of Thyrogen contains a nominal value of 0.9 mg thyrotropin
alfa. Following reconstitution, each
vial of Thyrogen contains 0.9 mg of thyrotropin alfa in 1.0 ml.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection.
White to off-white lyophilised powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Thyrogen is indicated for use with serum thyroglobulin (Tg) testing
with or without radioiodine imaging
for the detection of thyroid remnants and well-differentiated thyroid
cancer in post-thyroidectomy patients
maintained on hormone suppression therapy (THST).
Low risk patients with well-differentiated thyroid carcinoma who have
undetectable serum Tg levels on
THST and no rh (recombinant human) TSH-stimulated increase of Tg
levels may be followed-up by
assaying rhTSH-stimulated Tg levels.
Thyrogen is indicated for pre-therapeutic stimulation in combination
with a range of 30 mCi (1.1 GBq) to
100 mCi (3.7 GBq) radioiodine for ablation of thyroid tissue remnants
in patients who have undergone a
near-total or total thyroidectomy for well-differentiated thyroid
cancer and who do not have evidence of
distant metastatic thyroid cancer (see section 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be supervised by physicians with expertise in thyroid
cancer.
Posology
The recommended dose regimen is two doses of 0.9 mg thyrotropin alfa
administered at a 24-hour interval
by intramuscular injection only.
_Paediatric population _
Due to a lack of data on the use of Thyrogen in children, Thyrogen
should be given to children only in
exceptional circumstances.
3
_Elderly _
Results from controlled trials indicate no difference in the safety
and efficacy of Thyrogen between adult
patients less than 65 years and those greater than 65 years of age,
when Thyrogen is used for diagnostic
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