Examples of using Zerit in English and their translations into German
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Medicine
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Colloquial
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Official
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Ecclesiastic
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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
BEFORE YOU TAKE Zerit.
Take Zerit exactly as it was prescribed for you.
Talk to your doctor before taking Zerit.
The decision to stop using Zerit should be discussed with your doctor.
Zerit 15 mg hard capsules are red and yellow and marked with“BMS 1964” on one side and“15” on the other side.
Motor weakness has been reported rarely in patients receiving combination antiretroviral therapy including Zerit.
Patients receiving Zerit should be frequently examined and questioned for signs of lipoatrophy.
These side effects areserious, usually appear with long-term use and are more commonly seen with Zerit than with other NRTI medicines.
Do not take Zerit if you are allergic to stavudine or to any of the ingredients of the medication, are pregnant or breastfeeding.
Neutropenia(< 750 cells/ mm3) was reported in 5%, thrombocytopenia(platelets< 50,000/ mm3) in 2%, and low haemoglobin(< 8 g/ dl) in<1% of patients receiving Zerit.
Peripheral neuropathy: up to 20% of patients treated with Zerit will develop peripheral neuropathy, often starting after some months of treatment.
Zerit must not be used in people who are taking another HIV medicine called didanosine, which can also have toxic effects on mitochondria.
The European Commission granted amarketing authorisation valid throughout the European Union for Zerit to BRISTOL-MYERS SQUIBB PHARMA EEIG on 8 May 1996.
Zerit is an antiviral medication which is used to treat HIV, which causes the AIDS by helping stop HIV from infecting uninfected cells in the body.
Neutropenia(< 750 cells/mm3) was reported in 5%, thrombocytopenia(platelets< 50,000/mm3) in 2%, and low haemoglobin(< 8 g/dl) in<1% of patients receiving Zerit.
Patients continuing treatment with Zerit should be assessed frequently and switched to an alternative appropriate therapy whenever possible see section 4.4.
Laboratory abnormalities reported in these two trials and an ongoing follow-up study included elevations of ALT(> 5 x ULN) in 3%, of AST(> 5 x ULN) in 3%, of lipase(≥ 2.1 ULN)in 3% of the patients in the Zerit group.
Macrocytosis was not evaluated in these trials, but was found to be associated with Zerit in an earlier trial MCV> 112 fl occurred in 30% of patients treated with Zerit.
Zerit is indicated in combination with other antiretroviral medicinal products for the treatment of HIV infected adult patients and paediatric patients(from birth) only when other antiretrovirals can not be used.
The Committee for Medicinal products for Human Use(CHMP)noted that there was good evidence for Zerit' s effectiveness when taken with other antiviral medicines for the treatment of HIV infection in adults.
Zerit is indicated in combination with other antiretroviral medicinal products for the treatment of HIV infected adult patients and paediatric patients(over the age of 3 months) only when other antiretrovirals can not be used.
When treating HIV infection, it is not alwayspossible to differentiate between unwanted effects caused by Zerit, or those caused by any other medicines you may be taking at the same time, or by the complications of the infection.
Percent of patients who have HIV RNA< 400 c/ ml or< 50 c/ ml and do not meet any criteria for treatment failure including the occurrence of anew AIDS-defining diagnosis. b These studies were designed to compare two formulations of Zerit.
Two further studies assessed the effectiveness of Zerit, taken in combination with lamivudine and efavirenz(other antiviral medicines) in 467 treatment-naïve patients who had not taken treatment for HIV infection before.
Laboratory abnormalities: laboratory abnormalities reported in these two trials and an ongoing follow-up study included elevations of ALT(> 5 x ULN) in 3%, of AST(> 5 x ULN) in 3%, of lipase(≥ 2.1 ULN)in 3% of the patients in the Zerit group.
Although there are insufficientdata to recommend a specific dosage adjustment of Zerit in this patient population, a reduction in the dose and/or an increase in the interval between doses proportional to the reduction for adults should be considered.
As with all other NRTIs, Zerit may also cause lactic acidosis(a build-up of lactic acid in the body) and, in the babies of mothers taking Zerit during pregnancy, mitochondrial dysfunction damage to the energy-producing components within cells that can cause problems in the blood.
Undesirable effects(moderate to severe) were reported from 467 patients treated with Zerit in combination with lamivudine and efavirenz in two randomised clinical trials and an ongoing long-term follow-up study total follow-up: median 56 weeks ranging up to 119 weeks.
These studies include ACTG 240, where 105 paediatric patients ages 3 months to 6 years received Zerit 2 mg/kg/day for a median of 6.4 months; a controlled clinical trial where 185 newborns received Zerit 2 mg/kg/day either alone or in combination with didanosine from birth through 6 weeks of age; and a clinical trial where 8 newborns received Zerit 2 mg/kg/day in combination with didanosine and nelfinavir from birth through 4 weeks of age.
Since its authorisation, post-marketing reports and published literature regarding the side effects of Zerit have led the CHMP to update the prescribing information for Zerit, recommending that it should be used for as short a time as possible and only when other antiviral medicines cannot be used.