Examples of using Zutectra in English and their translations into German
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Colloquial
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Official
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Ecclesiastic
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Medicine
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Financial
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Ecclesiastic
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Political
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Computer
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Programming
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Official/political
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Political
What is Zutectra?
Zutectra treatment starts at least one week after the liver transplant.
Other information about Zutectra.
Zutectra treatment was started at least three months after the liver transplant.
The following instructions are intended to explain how to inject Zutectra.
Zutectra contains 150 mg/ml of human plasma protein of which at least 96% is immunoglobulin G IgG.
Please tell your doctor about your treatment with Zutectra prior to any vaccination.
You should inject Zutectra into the fatty layer between the skin and muscle about 8 to 12 mm under the skin.
In a local tolerance trial in rabbits,there was no evidence of irritation attributable to Zutectra.
Zutectra is presented as a solution for injection provided in pre-filled syringes 500 IU/ml- pack size of 5 in a blister.
For the full list of all side effects reported with Zutectra, see the package leaflet.
The use of standard antiviral medicines to prevent hepatitis Bre-infection should be considered together with Zutectra.
In another study in 49 patients, Zutectra was given at least one week(approximately 8-11 days) after the liver transplant.
One non-serious adverse event was reported to be related to Zutectra injection site haematoma.
Zutectra can reduce the effectiveness of some vaccines(measles, rubella, mumps, chicken pox) for a period of up to 3 months.
In total, 42/61 patients(68.9%)used antiviral medication and 19 patients received monotherapy with Zutectra during this study.
If you are HBsantigen positive you will not receive Zutectra since there is no benefit in administering this medicine to you.
Zutectra is used in adults who have had a liver transplant because of liver failure that was caused by hepatitis B infection.
The Committee for Medicinal Products for Human Use(CHMP) of the European Medicines Agency(EMEA) has adopteda positive opinion for approval of Biotest's hepatitis B immunoglobulin Zutectra.
Zutectra has been shown to be effective at maintaining antibody levels required to protect against hepatitis B re-infection.
The following adverse reactions have beenreported in the context of 4,810 subcutaneous applications of Zutectra during four completed clinical trials and 1,006 applications during a non-interventional post marketing safety study PASS.
Zutectra must not be used in people who are hypersensitive(allergic) to the active substance, to any of the other ingredients or to human immunoglobulins.
PRESS RELEASEBiotest proves effective protection from Hepatitis B virus reinfection after liver transplantation in"ZEUS" study with subcutaneous hepatitis B immunoglobulin Zutectra- The Zutectra-Early-Use-Study(ZEUS) demonstrates safe and effective switch from high dose intravenous hepatitis B immunoglobulin(HBIG) to subcutaneous HBIG, Zutectra(R), at the earliest one week after liver.
Before starting Zutectra, the patient will need to receive medicines that contain the same active substance as in Zutectra, but given into a vein.
Zutectra is used to prevent re-infection of hepatitis B in adults who have had a liver transplant at least 1 week ago because they had liver failure caused by hepatitis B.
It is strongly recommended that every time Zutectra is used(both at hospital or in a home treatment), the name and batch number of the medicine are recorded in order to maintain a record of the batches used.
Zutectra is used to prevent re-infection with the hepatitis B virus in patients without active infection i.e. those who test negative for the presence of the hepatitis B protein(HBsAg) and for hepatitis B DNA HBV-DNA.
Patients received subcutaneous injections of Zutectra of 500 IU(1 mL) or 1,000 IU(2 mL)(dose adaptation in exceptional cases up to 1,500 IU) per week or fortnightly according to serum anti-HBs trough levels.
Do not attempt to inject Zutectra until you are sure that you understand how to prepare the injection solution and give the injection.
Prior to the initiation of subcutaneous treatment with Zutectra adequate anti-HBs serum levels should be stabilised with an intravenous hepatitis B immunoglobulin to levels at or above 300-500 IU/l in order to ensure adequate anti-HBs coverage during the transition from intravenous to subcutaneous dosing.
