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 Φάρμακα Α - Ζ  Συγχορήγηση  Μητρότητα

THYROGEN Powder for solution for injection (2019)

Αναφορές

Βιβλιογραφική αναφορά

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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

Thyrogen should not be administered intravenously. When used as an alternative to thyroid hormone withdrawal, the combination of the whole body scintigraphy (WBS) and Tg testing after Thyrogen administration ...

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

Shelf-life Unopened vials: 3 years. Shelf-life after reconstitution: It is recommended that the Thyrogen solution be injected within three hours. The reconstituted solution can be stored for up to 24 hours ...

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. Use aseptic technique. ...

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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