What Thyrogen contains
The active substance in Thyrogen is thyrotropin alfa.
Each vial contains 0.9 mg/ml of thyrotropin alfa when reconstituted with 1.2 ml water for injection. Only 1 ml should be withdrawn equal to 0.9 mg of thyrotropin alfa.
The other ingredients are:
- mannitol
- sodium phosphate monobasic, monohydrate
- sodium phosphate dibasic, heptahydrate
- sodium chloride
(see at the endof Section 2 ?Important information about some of the ingredients of Thyrogen?)
What Thyrogen looks like and contents of the pack
Powder for solution for injection. White to off-white lyophilised powder.
Pack sizes: one or two vials of Thyrogen per carton.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder:
Genzyme Europe B.V.,
Gooimeer 10,
1411 DD Naarden,
The Netherlands.
Manufacturing authorisation holder:
Genzyme Ltd.,
37 Hollands Road,
Haverhill, Suffolk CB9 8PU,
United Kingdom
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For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Ísland Genzyme AS, Tel 354 535 7000 BelgiëBelgiqueBelgien LuxemburgLuxembourg Genzyme Belgium N.V., TelTél 32 2 714 17 11
Magyarország Genzyme Genzyme Europe B.V. Képviselet CEE GmbH Tel 36 1 310 7440 . 359 2 971 1001
Nederland Genzyme Europe B.V., Tel 31 35 6991200 eská RepublikaSlovenská Republika Slovenija Genzyme Czech s.r.o., Tel 420 227 133 655
DanmarkNorgeSverigeSuomiFinland Genzyme AS, DanmarkTanska TlfPuh. 45 32712600 Österreich Genzyme Austria GmbH Tel 43 1 774 65 38
Deutschland Genzyme GmbH Tel 49 610236740 PolskaEestiLatvijaLietuva Genzyme Polska Sp. z o.o. PoolaPolijaLenkija, Tel 48 22 246 0900
Genzyme Hellas Ltd , 30 210 99 49 270 Portugal Genzyme Portugal S.A., Tel 351 21 422 0100
España Genzyme, S.L., Tel 34 91 6591670 România Genzyme CEE GmbH- Reprezentana pentru România Tel 40 21 243 4228
France Genzyme S.A.S., Tél 33 0 825 825 863 United KingdomIreland Genzyme Therapeutics United Kingdom Tel 44 1865 405200
Italia/Malta
Genzyme Srl (Italia/Italja),
Tel: +39 059 349811
This leaflet was last approved in
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The following information is intended for medicinal or healthcare professionals only:
The recommended dose regimen of Thyrogen is two intramuscular injections of 0.9 mg thyrotropin alfa administered at a 24-hour interval.
Use aseptic technique
Add 1.2 ml water for injection to the Thyrogen powder in the vial. Swirl the contents of the vial gently until all material is dissolved. Do not shake the solution. When the powder is dissolved the total volume in the vial is 1.2 ml. The pH of the Thyrogen solution is approximately 7.0.
Visually inspect the Thyrogen solution in the vial for foreign particles and discoloration. The Thyrogen solution should be a clear, colourless solution. Do not use vials exhibiting foreign particles, cloudiness or discoloration.
Withdraw 1.0 ml of the Thyrogen solution from the product vial. This equals 0.9 mg thyrotropin alfa to be injected.
Thyrogen does not contain preservatives. Dispose of any unused solution immediately.
After reconstitution, the solution should be injected within three hours, however the Thyrogen solution will stay chemically stable for up to 24 hours, when stored between 2°C and 8°C protected from light. It is important to note that the microbiological safety depends on the aseptic conditions during the preparation of the solution.
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