Thyrogen 900microgram powder for solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Thyrotropin alfa

Available from:

Genzyme Therapeutics Ltd

ATC code:

H01AB01

INN (International Name):

Thyrotropin alfa

Dosage:

900microgram

Pharmaceutical form:

Powder for solution for injection

Administration route:

Intramuscular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06050100; GTIN: 5030045000142

Summary of Product characteristics

OBJECT 1
THYROGEN 0.9 MG POWDER FOR SOLUTION FOR
INJECTION
Summary of Product Characteristics Updated 30-Jun-2016 | Genzyme
Therapeutics
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.
_Elderly _
Results from controlled trials indicate no difference in the safety
and efficacy of Thyrogen between adult
patients less tha