THYROGEN Powder for solution for injection (2021)
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Περιεχόμενα
Name of the medicinal product
Thyrogen 0.9 mg powder for solution for injection.
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, ...
Pharmaceutical form
Powder for solution for injection. White to off-white lyophilised powder.
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 ...
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 ...
Contraindications
Hypersensitivity to bovine or human thyroid stimulating hormone or to any of the excipients listed in section 6.1. Pregnancy (see section 4.6).
Special warnings and precautions for use
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Thyrogen should <u>not</u> be administered ...
Interaction with other medicinal products and other forms of interaction
Formal interaction studies between Thyrogen and other medicinal products have not been performed. In clinical trials, no interactions were observed between Thyrogen and the thyroid hormones triiodothyronine ...
Fertility, pregnancy and lactation
Pregnancy Animal reproduction studies have not been conducted with Thyrogen. It is not known whether Thyrogen can cause foetal harm when administered to a pregnant woman or whether Thyrogen can affect ...
Effects on ability to drive and use machines
Thyrogen may reduce the ability to drive or use machines, since dizziness and headaches have been reported.
Undesirable effects
Summary of the safety profile The most commonly reported adverse reactions are nausea and headache, occurring in approximately 11%, and 6% of patients, respectively. Tabulated list of adverse reactions ...
Overdose
Data on exposure above the recommended dose is limited to clinical studies and a special treatment program. Three patients in clinical trials and one patient in the special treatment program experienced ...
Pharmacodynamic properties
Pharmacotherapeutic group: Pituitary and Hypothalamic Hormones and Analogues, Anterior Pituitary Lobe Hormones and Analogues ATC code for thyrotropin alfa: H01AB01 Mechanism of action Thyrotropin alfa ...
Pharmacokinetic properties
The pharmacokinetics of Thyrogen were studied in patients with well-differentiated thyroid cancer following a single 0.9 mg intramuscular injection. After injection, the mean peak (C<sub>max</sub>) level ...
Preclinical safety data
Non-clinical data are limited, but reveal no special hazard for humans from use of Thyrogen.
List of excipients
Mannitol Sodium phosphate monobasic, monohydrate Sodium phosphate dibasic, heptahydrate Sodium chloride
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be administered as a mixture with other medicinal products in the same injection.
Shelf life
<u>Unopened vials:</u> 3 years. <u>Shelf-life after reconstitution:</u> It is recommended that the Thyrogen solution be injected within three hours. The reconstituted solution can be stored for up to 24 ...
Special precautions for storage
Store in a refrigerator (2°C-8°C). Keep the vial in the outer carton in order to protect from light. For storage conditions after reconstitution of the medicinal product, see section 6.3.
Nature and contents of container
Clear Type I glass 5 ml vials. The closure consists of a siliconised butyl stopper with a tamper proof flip-off cap. Each vial contains 1.1 mg thyrotropin alfa. After reconstitution with 1.2 ml water for ...
Special precautions for disposal and other handling
The powder for solution for injection has to be reconstituted with water for injection. Only one vial of Thyrogen is required per injection. Each vial of Thyrogen is for single use only. <u>Use aseptic ...
Marketing authorization holder
Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands
Marketing authorization number(s)
EU/1/99/122/001 EU/1/99/122/002
Date of first authorization / renewal of the authorization
Date of first authorisation: 9 March 2000 Date of last renewal: 9 March 2010
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