Examples of using Atripla in English and their translations into German
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What Atripla contains.
No drug interactionstudies have been conducted using Atripla.
The Committee recommended that Atripla be given marketing authorisation.
Atripla is not recommended if you have moderate to severe kidney disease.
As with other medicines containing NRTIs, Atripla may also cause lactic acidosis a build-up of lactic acid in the body.
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If Atripla is stopped, speak to your doctor before you restart taking Atripla tablets.
The response rate at 48 weeks was 88%(364 of 414 patients) in those given Tivicay-based treatment compared with 81%(338 of 419 patients)in those given Atripla.
Due to similarities with emtricitabine, Atripla should not be administered concomitantly with other cytidine analogues, such as lamivudine see section 4.5.
After 48 weeks, 88% of the patients given the combination found in Triumeq(364 out of 414)responded to treatment, compared with 81% of the patients who were given Atripla 338 out of 419.
Atripla must be discontinued in patients developing severe rash associated with blistering, desquamation, mucosal involvement or fever.
In 91% of the patients the HIV-1 RNA plasma concentrations remained< 50 copies/ ml and in 97%< 400 copies/ ml,after 24 weeks of Atripla treatment intention to treat analysis(ITT), missing=failure.
Also, Atripla should not be taken with any other medicines that contain efavirenz, emtricitabine, tenofovir disoproxil, lamivudine or adefovir dipivoxil.
Patients who discontinued treatment with other non-nucleoside reverse transcriptase inhibitors due to rash may be athigher risk of developing rash during treatment with Atripla.
Since Atripla is a fixed- dose combination product, the dose of efavirenz cannot be altered; therefore, voriconazole and Atripla must not be co-administered.
When treating HIV infection, it is not always possible totell whether some of the unwanted effects are caused by Atripla or by other medicines that you are taking at the same time, or by the HIV disease itself.
Patients receiving methadone and Atripla concomitantly should be monitored for signs of withdrawal and their methadone dose increased as required to alleviate withdrawal symptoms.
Patients had never experienced virological failure on a previous antiretroviral therapy,had no known HIV-1 mutations that confer resistance to any of the three components within Atripla, and had been virologically suppressed for at least three months at baseline.
Since Atripla is a fixed-dose combination product, the dose of efavirenz cannot be altered; therefore, voriconazole and Atripla must not be co-administered see section 4.3 and Table 1.
If there is evidence of worsening liver disease or persistent elevations of serum transaminases to greater than 5 times the upper limit of thenormal range, the benefit of continued therapy with Atripla needs to be weighed against the potential risks of significant liver toxicity.
The company that makes Atripla will make sure that the medicine is used safely, bearing in mind concerns over possible effects of tenofovir disoproxil on the kidneys.
The Committee for Medicinal Products for Human Use(CHMP) noted that Atripla needs to be taken on an empty stomach to prevent certain side effects, but that this could result in low tenofovir levels in the blood.
Atripla is a treatment for Human Immunodeficiency Virus(HIV) infection in adults aged 18 and over who have previously been treated with other antiretroviral medicines and have their HIV-1 infection under control for at least three months.
If your doctor decides to stop one of the components of Atripla, you may be given efavirenz, emtricitabine and/ or tenofovir disoproxil separately or with other medicines for the treatment of your HIV infection.
Since Atripla is a combination product and the dosing interval of the individual components cannot be altered, treatment with Atripla must be interrupted in patients with confirmed creatinine clearance< 50 ml/ min or decreases in serum phosphate to< 1.0 mg/ dl 0.32 mmol/ l.
The Committee noted that the demonstration of Atripla' s benefit is based mainly on 48-week data from a study in patients with stable suppression of HIV on anHIV treatment combination who then switched to Atripla.
Therefore, the Committee decided that Atripla' s benefits are greater than its risks for the treatment of HIV-1 infection in adults with virologic suppression to HIV-1 ribonucleic acid(RNA) levels of less than 50 copies/ ml on their current combination antiretroviral therapy for more than three months.
Adverse reactions associated with the individual components of Atripla The adverse reactions from clinical study and post-marketing experience with the individual components of Atripla in antiretroviral combination therapy are listed in Table 4 below by body system organ class and frequency.
Therefore, the Committee concluded that Atripla could be a convenient‘ one-tablet once-a- day'treatment when used to maintain low viral loads in patients already taking HIV treatment, but 2/ 3 there is not enough information to be certain about its effects in patients who have not been treated before.
Adverse reactions from clinical study experience with Atripla In a 48-week open-label randomised clinical study in HIV infected patients with successful virological suppression on their current antiretroviral regimen, patients either changed to Atripla(n=203) or continued on their original antiretroviral treatment regimen n=97.
Other interactions Interactions between the components of Atripla and protease inhibitors, antiretroviral agents other than protease inhibitors and other non-antiretroviral medicinal products are listed in Table 1 below increase is indicated as“↑”, decrease as“↓”, no change as“↔”, twice daily as“ b. i. d.”, once daily as“ q. d.” and once every 8 hours as“ q8h”.