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(PDF/12.38 KB) Ulteriori informazioni sono disponibili nel riassunto del piano di gestione dei rischi.Il 1° settembre 2014 la Commissione europea ha rilasciato un'autorizzazione all'immissione in commercio per Triumeq, valida in tutta l'Unione europea. (PDF/603.61 KB) (PDF/8.64 KB) In August 2015, the FDA sent a bulletin regarding label updates for Tivicay and Triumeq regarding drug-drug information.Drug interactions was updated to include a statement that in vitro, dolutegravir was not a substrate of OATP1B1 or OATP1B3.Additionally, less common adverse reactions observed in clinical trials was updated to include suicidal ideation, attempt, behavior, or completion in order to be consistent with Tivicay label.In September 2015, the FDA added a boxed warning of hypersensitivity reactions, lactic acidosis, and severe hepatomegaly in abacavir-containing products regarding HLA-B*507 allele.Other medications patented by ViiV Healthcare for HIV treatment include:A year supply of abacavir/dolutegravir/lamivudine costs around In July 2015, ViiV Healthcare struck a deal with Shanghai-based Desano Pharmaceuticals for a cheaper supply of dolutegravir (Tivicay) with the goal of cutting the cost in China and other developing countries. (PDF/124.97 KB) (PDF/11.87 KB)
(PDF/112.18 KB) (PDF/59.43 KB) (PDF/58.89 KB) (PDF/580.64 KB) abacavir sulfate / dolutegravir sodium / lamivudine (PDF/78.83 KB) (PDF/593.8 KB)
The combined medicine reduces the number of tablets patients have to take, helping them to adhere to their treatment. (PDF/27.08 KB) EMA is in the process of making appropriate changes to this website. (PDF/686.43 KB) (PDF/14.1 KB) Triumeq è un medicinale antivirale indicato per il trattamento di pazienti con infezione da Triumeq può essere ottenuto soltanto con prescrizione medica e la terapia deve essere prescritta da un medico con esperienza nella gestione delle infezioni da HIV. It is used in adults and adolescents over 12 years old who weigh at least 40 kg.Triumeq can only be obtained with a prescription and treatment should be prescribed by a doctor who is experienced in managing HIV infections.
(PDF/11.02 KB) The Agency concluded that the medicine had demonstrated its effectiveness in previously-untreated patients, and that similar benefits are expected in previously-treated patients.The Agency also noted that giving the combination of dolutegravir, abacavir and lamivudine as a single tablet is an additional treatment option for patients with HIV infection and without the HLA-B (type 5701) gene.
(PDF/703.25 KB) Your risk of this allergic reaction to abacavir is much higher if you have a gene variation called HLA-B*5701.
(PDF/151.04 KB) (PDF/27.08 KB) (PDF/35.07 KB) (PDF/603.61 KB)
In base a tale piano, al riassunto delle caratteristiche del prodotto e al foglio illustrativo di Triumeq sono state aggiunte le informazioni relative alla sicurezza, ivi comprese le opportune precauzioni che gli operatori sanitari e i pazienti devono prendere. (PDF/57.57 KB) (PDF/128.54 KB) Prescription Hope works with over 180 U.S.-based pharmaceutical manufacturers and their pharmacy to access over 1,500 FDA-approved medications. (PDF/756.94 KB)
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