0.9 mg\u00a0powder for solution for\u00a0injection.
Thyrotropin alfa<\/p>\n\n\n\n
Thyrogen contains the active substance thyrotropin alfa. Thyrogen is a human thyroid-stimulating (thyroid-stimulating) hormone ( TSH ) manufactured using biotechnology processes.<\/p>\n\n\n\n
Thyrogen is used to detect certain types of thyroid cancer<\/a> in patients who have had their thyroid removed and are taking thyroid hormones.\u00a0One of the effects is that it stimulates any remaining thyroid tissue to take up iodine, which is important for\u00a0radioiodine scintigraphy.\u00a0It also stimulates the production of thyroglobulin and thyroid hormones if there is any thyroid tissue left.\u00a0These\u00a0hormones\u00a0can be measured in the blood.<\/p>\n\n\n\n Thyrogen is also used together with radioiodine treatment to remove (ablate) the thyroid tissue that is left behind (residue) after the thyroid gland has been surgically removed in patients who do not have secondary tumor growth ( metastases ) and who are taking thyroid hormone. Talk to your doctor or pharmacist before using Thyrogen<\/p>\n\n\n\n if you have:<\/p>\n\n\n\n Effect on tumor growth Due to elevated\u00a0TSH\u00a0levels after Thyrogen, patients with secondary cancer tumors (\u00a0metastases\u00a0) may experience local swelling or bleeding where these\u00a0metastases\u00a0are located.\u00a0Metastases\u00a0can also grow.\u00a0If the\u00a0metastases\u00a0are in tight places, e.g.\u00a0intracerebrally (in the brain) or in the spinal cord, patients may have symptoms that may occur\u00a0acutely, e.g.\u00a0in the form of\u00a0partial\u00a0paralysis affecting one side of the body (hemiparesis), breathing problems or vision loss.<\/p>\n\n\n\n Your doctor will decide whether you belong to the special group of patients for whom pretreatment with corticosteroids may be considered (for example, if you have secondary cancerous tumors in the brain or spinal cord). Please discuss this with your doctor if you have any questions.<\/p>\n\n\n\n Children<\/strong><\/p>\n\n\n\n Since there is no data on the use of Thyrogen in children, Thyrogen should only be given to children in exceptional cases.<\/p>\n\n\n\n Older<\/strong><\/p>\n\n\n\n No special precautions are needed for the elderly. If your thyroid gland has not been completely removed and you also have heart disease, your doctor will help you decide whether you should receive Thyrogen.<\/a><\/p>\n\n\n\n Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines.<\/p>\n\n\n\n There are no known drug interactions with Thyrogen and the thyroid hormones you may be taking.<\/p>\n\n\n\n Your doctor will assess the exact activity of radioiodine to be used for radioiodine scintigraphy taking into account that you continue to take thyroid hormones.<\/a><\/p>\n\n\n\n Do not take Thyrogen if you are pregnant.\u00a0If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.<\/p>\n\n\n\n Thyrogen must not be given to breastfeeding women. Breastfeeding should only be resumed after you have spoken to your doctor.<\/a><\/p>\n\n\n\n Some patients may experience dizziness or headache after administration of Thyrogen which may affect the ability to drive and use machines.<\/a><\/p>\n\n\n\n This medicine contains less than 1 mmol\u00a0sodium\u00a0(23 mg) per\u00a0vial, i.e. it is almost “sodium-free”. Your medicine will be injected by a doctor or nurse.<\/p>\n\n\n\n Your treatment should be supervised by doctors with extensive experience in thyroid cancer.\u00a0Thyrogen powder must be dissolved in water intended for\u00a0injection.\u00a0Only one\u00a0vial\u00a0of Thyrogen is needed per\u00a0injection.\u00a0Thyrogen may only be injected into the buttock.\u00a0The solution must never be injected into a vein.\u00a0Thyrogen must not be mixed with other medicines in the same\u00a0injection.<\/p>\n\n\n\n The recommended dose of Thyrogen is two doses given 24 hours apart. The doctor or nurse injects 1.0 ml of the Thyrogen solution.<\/p>\n\n\n\n When you are going to undergo\u00a0radioiodine scintigraphy\u00a0or removal (ablation), the doctor will give you radioiodine 24 hours after your last Thyrogen\u00a0injection.<\/p>\n\n\n\n Diagnostic scintigraphy should be performed 48 to 72 hours after receiving radioiodine (72 to 96 hours after the last injection of Thyrogen).<\/p>\n\n\n\n Scintigraphy after the treatment can be postponed for a few days so that the background radioactivity is reduced.<\/p>\n\n\n\n For thyroglobulin (Tg) testing, the doctor or nurse takes a serum sample 72 hours after the last injection of Thyrogen.<\/p>\n\n\n\n Use in children<\/strong> Patients who have accidentally taken too much Thyrogen have reported nausea, weakness, dizziness, headache, vomiting, and hot flashes.<\/p>\n\n\n\n A suggestion for treatment in case of overdose could be to restore the fluid balance. Administration of antiemetics may also be considered.<\/p>\n\n\n\n If you have any further questions about this medicine, ask your doctor.<\/a><\/p>\n\n\n\n Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n The following side effects have been reported in connection with Thyrogen:<\/p>\n\n\n\n Very common<\/strong> (may affect more than 1 in 10 users):<\/p>\n\n\n\n Common<\/strong> (may affect up to 1 in 10 users):<\/p>\n\n\n\n Uncommon<\/strong> (may affect up to 1 in 100 users):<\/p>\n\n\n\n Has been reported<\/strong> (occurring in an unknown number of users) <\/p>\n\n\n\n Very rare cases of hyperthyroidism<\/strong> (increased activity of the thyroid gland) or atrial fibrillation<\/strong> have been reported when Thyrogen has been administered to patients who have not had a total or partial thyroidectomy.<\/p>\n\n\n\n Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n Use before the expiry date stated on the label after EXP. The expiration date is the last day of the specified month.<\/p>\n\n\n\n Store in a refrigerator (2 \u00b0C – 8 \u00b0C).<\/p>\n\n\n\n Store the vial in the outer carton. Light sensitive.<\/p>\n\n\n\n The hydrogen solution should be injected within three hours of\u00a0preparation.<\/p>\n\n\n\n The prepared solution can be stored for up to 24 hours in a refrigerator (2 \u00b0C\u20138 \u00b0C), provided it is protected from light and microbial contamination is avoided.<\/p>\n\n\n\n Do not use this medicine if the solution contains foreign particles, is cloudy, or discolored.<\/p>\n\n\n\n Medicines must not be thrown into the drain or among the household waste.\u00a0Ask the pharmacist how to dispose of medicines that are no longer used.\u00a0These measures will help to protect the environment.<\/p>\n\n\n\n Thyrogen contains\u00a0sodium, see section 2.<\/p>\n\n\n\n Powder for solution for\u00a0injection.\u00a0White to off-white freeze-dried powder.<\/p>\n\n\n\n
<\/a><\/p>\n\n\n\nWhat you need to know before using Thyrogen<\/h2>\n\n\n\n
Do not use Thyrogen<\/h2>\n\n\n\n
Warnings and precautions<\/h2>\n\n\n\n
In patients with thyroid cancer, tumor growth has been reported during\u00a0the withdrawal\u00a0of thyroid hormones for diagnostic procedures.\u00a0This was thought to be related to the elevated levels of thyroid-stimulating hormone\u00a0(\u00a0TSH\u00a0) over a longer period.\u00a0It is possible that Thyrogen can also cause tumor growth.\u00a0This has not been seen in\u00a0clinical trials.<\/p>\n\n\n\nOther medicines and Thyrogen<\/h2>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
Driving ability and use of machinery<\/h2>\n\n\n\n
Thyrogen contains sodium<\/h2>\n\n\n\n
<\/p>\n\n\n\nHow to use Thyrogen<\/h2>\n\n\n\n
Your child’s doctor will help you decide if Thyrogen should be given to your child.<\/a><\/p>\n\n\n\nIf you have received too much Thyrogen<\/h2>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n
How Thyrogen should be stored<\/h2>\n\n\n\n
Contents of the packaging and other information<\/h2>\n\n\n\n
Contents declaration<\/h2>\n\n\n\n
Appearance and package sizes of the medicine<\/h2>\n\n\n\n