THYROGEN (THYROTROPIN ALFA)

Țară: Malaezia

Limbă: engleză

Sursă: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingredient activ:

THYROTROPIN ALFA

Disponibil de la:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (nume internaţional):

THYROTROPIN ALFA

Unități în pachet:

2Units Units

Produs de:

GENZYME CORPORATION

Caracteristicilor produsului

MY/THY/0521/CCDSv1
INDICATIONS AND USAGE
ADJUNCTIVE DIAGNOSTIC TOOL FOR SERUM THYROGLOBULIN TESTING IN WELL
DIFFERENTIATED THYROID
CANCER
THYROGEN is indicated for use as an adjunctive diagnostic tool for
serum thyroglobulin (Tg)
testing with or without radioiodine imaging in the follow-up of
patients with well-differentiated
thyroid cancer who have previously undergone thyroidectomy.
Limitations of Use:
• THYROGEN-stimulated Tg levels are generally lower than, and do not
correlate with, Tg levels
after thyroid hormone withdrawal [see
_ Clinical Studies_
].
• Even when THYROGEN-stimulated Tg testing is performed in
combination with radioiodine
imaging, there remains a risk of missing a diagnosis of thyroid cancer
or of underestimating the
extent of disease.
• Anti-Tg antibodies may confound the Tg assay and render Tg levels
uninterpretable [see
_Clinical _
_Studies_
]. Therefore, in such cases, even with a negative or low-stage
THYROGEN radioiodine
scan, consideration should be given to further evaluating patients.
ADJUNCT TO TREATMENT FOR ABLATION IN WELL DIFFERENTIATED THYROID
CANCER
THYROGEN is indicated for use as an adjunctive treatment for
radioiodine 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.
DOSAGE AND METHOD OF ADMINISTRATION
RECOMMENDED DOSAGE
THYROGEN should be used by physicians knowledgeable in the management
of patients with
thyroid cancer.
THYROGEN is indicated as a two-injection regimen. The recommended
dosage of THYROGEN
is a 0.9 mg intramuscular injection to the buttock followed by a
second 0.9 mg intramuscular
injection to the buttock 24 hours later.
THYROGEN
should
be
administered
intramuscularly
only.
THYROGEN
should
not
be
administered intravenously.
Pretreatment with glucocorticoids should be considered for patients in
whom tumor expansion
may compromise vital anatomic structures [see
_Warnings and Precautions_
].
Routin