FrancophonIA/ELRC3.0 huggingface dataset:
English: Common (may affect up to 1 in 10 people): Dizziness, sleepiness; palpitations (awareness of your heart beat); flushing, ankle swelling (oedema); abdominal pain, feeling sick (nausea).
Slovenian: Pogosti (pojavijo se pri do 1 od 10 ljudi): omotica, zaspanost; palpitacije (zavedanje bitja vašega srca); vročinski oblivi, otekanje gležnjev (edem); bolečine v trebuhu, slabost s siljenjem na bruhanje (navzea).
English: No dosage adjustment is required for patients with mild to moderate renal impairment.
Slovenian: DafiroBolnikom z blago do zmerno okvaro ledvic odmerka ni treba prilagoditi.
English: In an embryo-foetal development study in the rat, increased incidences of dilated ureters, malformed sternebrae, and unossified forepaw phalanges were noticed at exposures of about 12 (valsartan) and 10 (amlodipine) times the clinical doses of 160 mg valsartan and 10 mg amlodipine.
Slovenian: V študiji embriofetalnega razvoja pri podganah so pri izpostavljenosti, ki je bila za valsartan okrog 12-krat in za amlodipin okrog 10-krat večja kot ob kliničnih odmerkih 160 mg valsartana in 10 mg amlodipina, ugotovili večjo incidenco razširjenih ureterjev, malformirane sternebre in nezakostenele falange sprednjih tac.
English: The addition of amlodipine 10 mg and 5 mg produced an additional reduction in systolic/diastolic blood pressure of 6.0/4.8 mmHg and 3.9/2.9 mmHg, respectively, compared to patients who remained on valsartan 160 mg only.
Slovenian: V primerjavi z bolniki, ki so ostali samo na 160 mg valsartana, je dodatek 10 mg amlodipina dodatno znižal sistolični krvni tlak za 6,0 mm Hg in diastoličnega za 4,8 mm Hg, 5 mg amlodipina pa sistolični krvni tlak za 3,9 mm Hg in diastoličnega za 2,9 mm Hg.
English: A multicentre, randomised, double-blind, active-controlled, parallel-group trial showed normalisation of blood pressure (trough sitting diastolic blood pressure <90 mmHg at the end of the trial) in patients not adequately controlled on amlodipine 10 mg in 78% of patients treated with amlodipine/valsartan 10 mg/160 mg, compared to 67% of patients remaining on amlodipine 10 mg.
Slovenian: Pokazalo je, da se je krvni tlak normaliziral (najnižji diastolični krvni tlak sede <90 mm Hg na koncu preskušanja) pri 78 % bolnikov, ki so dobivali amlodipin/valsartan 10 mg/160 mg, in pri 67 % bolnikov, ki so ostali na 10 mg amlodipina.
English: No information is available regarding the use of Dafiro during breast-feeding, therefore Dafiro is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Slovenian: Za uporabo med dojenjem je bolje izbrati drugo zdravilo z dokazanim varnostnim profilom, še posebno če gre za dojenje novorojenčka ali nedonošenčka.
English: Active-controlled trials in patients who were non-responders to monotherapy A multicentre, randomised, double-blind, active-controlled, parallel-group trial showed normalisation of blood pressure (trough sitting diastolic blood pressure <90 mmHg at the end of the trial) in patients not adequately controlled on valsartan 160 mg in 75% of patients treated with amlodipine/valsartan 10 mg/160 mg and 62% of patients treated with amlodipine/valsartan 5 mg/160 mg, compared to 53% of patients remaining on valsartan 160 mg.
Slovenian: Pokazalo se je, da se je krvni tlak normaliziral (najnižji diastolični krvni tlak sede <90 mm Hg na koncu preskušanja) pri 75 % bolnikov, ki so dobivali amlodipin/valsartan 10 mg/160 mg, pri 62 % bolnikov, ki so dobivali amlodipin/valsartan 5 mg/160 mg in pri 53 % bolnikov, ki so ostali na 160 mg valsartana.
English: Uncommon (may affect up to 1 in 100 people): Dizziness; nausea and abdominal pain; dry mouth; drowsiness, tingling or numbness of the hands or feet; vertigo; fast heart beat including palpitations; dizziness on standing up; cough; diarrhoea; constipation; skin rash, redness of the skin; joint swelling, back pain; pain in joints.
Slovenian: Občasni (pojavijo se pri do 1 od 100 ljudi): omotica; slabost v želodcu in bolečine v trebuhu; suhost ust; zaspanost, mravljinčenje ali omrtvelost dlani in stopal; vrtoglavica; hitro bitje srca, vključno s palpitacijami; omotičnost stoje; kašelj; driska; zaprtje; osip, pordelost kože; oteklost sklepov, bolečine v hrbtu; bolečine v sklepih.
English: Dafiro 5 mg/80 mg film-coated tablets
Slovenian: Dafiro 5 mg/80 mg filmsko obložene tablete
English: A vasoconstrictor may be helpful in restoring vascular tone and blood pressure,
Slovenian: Za obnovitev žilnega tonusa in krvnega tlaka lahko koristi vazokonstriktor, če za njegovo uporabo ni kontraindikacij.
English: Dafiro 5 mg/80 mg film-coated tablets Dafiro 5 mg/160 mg film-coated tablets Dafiro 10 mg/160 mg film-coated tablets amlodipine/valsartan
Slovenian: Dafiro 5 mg/80 mg filmsko obložene tablete Dafiro 5 mg/160 mg filmsko obložene tablete Dafiro 10 mg/160 mg filmsko obložene tablete amlodipin/valsartan
English: if you have experienced swelling, particularly of the face and throat, while taking other medicines (including angiotensin converting enzyme inhibitors).
Slovenian: če je v času jemanja drugih zdravil (kar vključuje tudi zaviralce angiotenzinske konvertaze) pri vas prišlo do otekanja, zlasti v obraz in grlo oziroma žrelo.
English: Monitoring of potassium levels and creatinine is advised in moderate renal impairment.
Slovenian: Pri bolnikih z zmerno okvaro ledvic je priporočljivo kontrolirati koncentracije kalija in kreatinina.
English: Dafiro 10 mg/160 mg film-coated tablets
Slovenian: Dafiro 10 mg/160 mg filmsko obložene tablete
English: Amlodipine dosage recommendations have not been established in patients with mild to moderate hepatic impairment.
Slovenian: Pri bolnikih z blago do zmerno okvaro jeter priporočljivega odmerjanja amlodipina niso ugotavljali.
English: Each tablet contains 5 mg amlodipine and 80 mg valsartan.
Slovenian: Ena tableta vsebuje 5 mg amlodipina in 80 mg valsartana.
English: Light yellow, oval film-coated tablet, imprinted with “NVR” on one side and “UIC” on the other side.
Slovenian: Svetlorumene, ovalne filmsko obložene tablete, ki imajo na eni strani oznako “NVR” in na drugi “UIC”.
English: EU/1/06/371/035 280 film-coated tablets (4x70) EU/1/06/371/038 280 film-coated tablets (20x14)
Slovenian: EU/1/06/371/035 280 filmsko obloženih tablet (4x70) EU/1/06/371/038 280 filmsko obloženih tablet (20x14)
English: How to store Dafiro
Slovenian: Shranjevanje zdravila Dafiro
English: An increased incidence and severity of renal tubular basophilia/hyalinisation, dilation and casts, as well as interstitial lymphocyte inflammation and arteriolar medial hypertrophy were found at an exposure of 8-13 (valsartan) and 7-8 (amlodipine) times the clinical doses of 160 mg valsartan and 10 mg amlodipine.
Slovenian: Pri izpostavljenosti, ki je bila za valsartan od 8- do 13-krat večja in za amlodipin od 7- do 8-krat večja kot ob kliničnih odmerkih 160 mg valsartana in 10 mg amlodipina, so ugotovili večjo pojavnostjo in izrazitost bazofilije/hialinizacije, dilatacije in cilindrov ledvičnih tubulov ter intersticijskega limfocitnega vnetja in hipertrofije arteriolarne medije.
English: EU/1/06/371/036 280 film-coated tablets (4x70) EU/1/06/371/039 280 film-coated tablets (20x14)
Slovenian: EU/1/06/371/036 280 filmsko obloženih tablet (4x70) EU/1/06/371/039 280 filmsko obloženih tablet (20x14)
English: EU/1/06/371/017 EU/1/06/371/018 EU/1/06/371/019 EU/1/06/371/020 EU/1/06/371/021 EU/1/06/371/022 EU/1/06/371/023 EU/1/06/371/024 EU/1/06/371/031 EU/1/06/371/032 EU/1/06/371/033 EU/1/06/371/036 EU/1/06/371/039
Slovenian: EU/1/06/371/017 EU/1/06/371/018 EU/1/06/371/019 EU/1/06/371/020 EU/1/06/371/021 EU/1/06/371/022 EU/1/06/371/023 EU/1/06/371/024
English: Dafiro 10 mg/160 mg film-coated tablets amlodipine/valsartan
Slovenian: Dafiro 10 mg/160 mg filmsko obložene tablete amlodipin/valsartan
English: EU/1/06/371/034 280 film-coated tablets (4x70) EU/1/06/371/037 280 film-coated tablets (20x14)
Slovenian: EU/1/06/371/034 280 filmsko obloženih tablet (4x70) EU/1/06/371/037 280 filmsko obloženih tablet (20x14)
English: Dafiro 5 mg/160 mg film-coated tablets
Slovenian: Dafiro 5 mg/160 mg filmsko obložene tablete
English: Uncommon Insomnia, mood changes (including anxiety), depression, tremor, dysgeusia, syncope, hypoesthesia, visual disturbance (including diplopia), tinnitus, hypotension, dyspnoea, rhinitis, vomiting, dyspepsia, alopecia, purpura, skin discolouration, hyperhidrosis, pruritus, exanthema, myalgia, muscle cramps, pain, micturition disorder, increased urinary frequency, impotence, gynaecomastia, chest pain, malaise, weight increase, weight decrease.
Slovenian: Amlodipin pogosti somnolenca, omotica, palpitacije, bolečine v trebuhu, navzea, otekanje gležnjev nespečnost, spremembe razpoloženja (vključno z anksioznostjo), depresija, tremor, motnje v zaznavanju okusa, sinkopa, hipestezija, motnje vida (vključno z diplopijo), tinitus, hipotenzija, dispneja, rinitis, bruhanje, dispepsija, alopecija, purpura, obarvanje kože, hiperhidroza, srbenje, eksantem, mialgija, mišični krči, bolečine, motnje uriniranja, zvečana pogostnost uriniranja, impotenca, ginekomastija, bolečine v prsih, slabo počutje, zvečanje ali zmanjšanje telesne mase redki zmedenost zelo redki levkopenija, trombocitopenija, alergijske reakcije, hiperglikemija, hipertonija, periferna nevropatija, miokardni infarkt, aritmija (vključno z bradikardijo, ventrikularno tahikardijo in atrijsko fibrilacijo), vaskulitis, pankreatitis, gastritis, hiperplazija dlesni, hepatitis, zlatenica, zvišanje ravni jetrnih encimov*, angioedem, multiformni eritem, urtikarija, eksfoliativni dermatitis, Stevens-Johnsonov sindrom, Quinckejev edem, fotosenzitivnost pogostnost neznana toksična epidermalna nekroliza * o tem so najpogosteje poročali v povezavi s holestazo Izjemoma so poročali o primerih ekstrapiramidnega sindroma.
English: Each tablet contains 10 mg amlodipine and 160 mg valsartan.
Slovenian: Ena tableta vsebuje 10 mg amlodipina in 160 mg valsartana.
English: Hypromellose, substitution type 2910 (3 mPa.s) Titanium dioxide (E171) Iron oxide, yellow (E172) Iron oxide, red (E172)
Slovenian: Obloga hipromeloza, substitucijski tip 2910 (3 mPa.s) titanov dioksid (E171) rumeni železov oksid (E172) rdeči železov oksid (E172) makrogol 4000 smukec
English: What Dafiro looks like and contents of the pack Dafiro 5 mg/80 mg tablets are round and dark yellow with “NVR” on one side and “NV” on the other side.
Slovenian: Tablete zdravila Dafiro 5 mg/80 mg so okrogle in temnorumene; na eni strani imajo oznako “NVR” in na drugi “NV”.
English: Dark yellow, round film-coated tablet with bevelled edges, imprinted with “NVR” on one side and “NV” on the other side.
Slovenian: Temnorumene, okrogle filmsko obložene tablete s poševnimi robovi, ki imajo na eni strani oznako “NVR” in na drugi “NV”.
English: The addition of valsartan 160 mg produced an additional reduction in systolic/diastolic blood pressure of 2.9/2.1 mmHg compared to patients who remained on amlodipine 10 mg only.
Slovenian: V primerjavi z bolniki, ki so ostali samo na 10 mg amlodipina, je dodatek 160 mg valsartana dodatno znižal sistolični krvni tlak za 2,9 mm Hg in diastoličnega za 2,1 mm Hg.
English: Each tablet contains 5 mg amlodipine and 160 mg valsartan.
Slovenian: Ena tableta vsebuje 5 mg amlodipina in 160 mg valsartana.
English: ACE inhibitors and ARBs should not be used concomitantly in patients with diabetic nephropathy.
Slovenian: Pri bolnikih z diabetično nefropatijo se zaviralcev ACE in antagonistov angiotenzinskih receptorjev ne sme uporabljati sočasno.
English: Dafiro 5 mg/80 mg film-coated tablets amlodipine/valsartan
Slovenian: Dafiro 5 mg/80 mg filmsko obložene tablete amlodipin/valsartan
English: Apontis Pharma GmbH & Co. KG Tel: +49 2173 48 4949
Slovenian: KG Tel: +49 2173 48 4949
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors or angiotensin II receptor antagonists, including valsartan..
Slovenian: Med sočasno uporabo litija in zaviralcev angiotenzinske konvertaze ali antagonistov angiotenzinskih receptorjev tipa II, vključno z valsartanom, so poročali o reverzibilnem povečanju koncentracije litija v serumu in povečanju njegovih toksičnih učinkov.
English: EU/1/06/371/009 EU/1/06/371/010 EU/1/06/371/011 EU/1/06/371/012 EU/1/06/371/013 EU/1/06/371/014 EU/1/06/371/015 EU/1/06/371/016 EU/1/06/371/028 EU/1/06/371/029 EU/1/06/371/030 EU/1/06/371/035 EU/1/06/371/038
Slovenian: EU/1/06/371/009 EU/1/06/371/010 EU/1/06/371/011 EU/1/06/371/012 EU/1/06/371/013 EU/1/06/371/014 EU/1/06/371/015 EU/1/06/371/016
English: Dark yellow, oval film-coated tablet, imprinted with “NVR” on one side and “ECE” on the other side.
Slovenian: Temnorumene, ovalne filmsko obložene tablete, ki imajo na eni strani oznako “NVR” in na drugi “ECE”.
English: Dafiro 5 mg/160 mg film-coated tablets amlodipine/valsartan
Slovenian: Dafiro 5 mg/160 mg filmsko obložene tablete amlodipin/valsartan
English: Uncommon Very rare Uncommon
Slovenian: Bolezni imunskega sistema preobčutljivost redki zelo redki pogostnost neznana
English: EU/1/06/371/017 7 film-coated tablets EU/1/06/371/018 14 film-coated tablets EU/1/06/371/019 28 film-coated tablets EU/1/06/371/020 30 film-coated tablets EU/1/06/371/021 56 film-coated tablets EU/1/06/371/022 90 film-coated tablets EU/1/06/371/023 98 film-coated tablets EU/1/06/371/024 280 film-coated tablets EU/1/06/371/031 56x1 film-coated tablet (unit dose) EU/1/06/371/032 98x1 film-coated tablet (unit dose) EU/1/06/371/033 280x1 film-coated tablet (unit dose)
Slovenian: EU/1/06/371/017 7 filmsko obloženih tablet EU/1/06/371/018 14 filmsko obloženih tablet EU/1/06/371/019 28 filmsko obloženih tablet EU/1/06/371/020 30 filmsko obloženih tablet EU/1/06/371/021 56 filmsko obloženih tablet EU/1/06/371/022 90 filmsko obloženih tablet EU/1/06/371/023 98 filmsko obloženih tablet EU/1/06/371/024 280 filmsko obloženih tablet EU/1/06/371/031 56x1 filmsko obložena tableta (za enkratni odmerek) EU/1/06/371/032 98x1 filmsko obložena tableta (za enkratni odmerek) EU/1/06/371/033 280x1 filmsko obložena tableta (za enkratni odmerek)
English: EU/1/06/371/009 7 film-coated tablets EU/1/06/371/010 14 film-coated tablets EU/1/06/371/011 28 film-coated tablets EU/1/06/371/012 30 film-coated tablets EU/1/06/371/013 56 film-coated tablets EU/1/06/371/014 90 film-coated tablets EU/1/06/371/015 98 film-coated tablets EU/1/06/371/016 280 film-coated tablets EU/1/06/371/028 56x1 film-coated tablet (unit dose) EU/1/06/371/029 98x1 film-coated tablet (unit dose) EU/1/06/371/030 280x1 film-coated tablet (unit dose)
Slovenian: EU/1/06/371/009 7 filmsko obloženih tablet EU/1/06/371/010 14 filmsko obloženih tablet EU/1/06/371/011 28 filmsko obloženih tablet EU/1/06/371/012 30 filmsko obloženih tablet EU/1/06/371/013 56 filmsko obloženih tablet EU/1/06/371/014 90 filmsko obloženih tablet EU/1/06/371/015 98 filmsko obloženih tablet EU/1/06/371/016 280 filmsko obloženih tablet EU/1/06/371/028 56x1 filmsko obložena tableta (za enkratni odmerek) EU/1/06/371/029 98x1 filmsko obložena tableta (za enkratni odmerek) EU/1/06/371/030 280x1 filmsko obložena tableta (za enkratni odmerek)
English: EU/1/06/371/001 7 film-coated tablets EU/1/06/371/002 14 film-coated tablets EU/1/06/371/003 28 film-coated tablets EU/1/06/371/004 30 film-coated tablets EU/1/06/371/005 56 film-coated tablets EU/1/06/371/006 90 film-coated tablets EU/1/06/371/007 98 film-coated tablets EU/1/06/371/008 280 film-coated tablets EU/1/06/371/025 56x1 film-coated tablet (unit dose) EU/1/06/371/026 98x1 film-coated tablet (unit dose) EU/1/06/371/027 280x1 film-coated tablet (unit dose)
Slovenian: EU/1/06/371/001 7 filmsko obloženih tablet EU/1/06/371/002 14 filmsko obloženih tablet EU/1/06/371/003 28 filmsko obloženih tablet EU/1/06/371/004 30 filmsko obloženih tablet EU/1/06/371/005 56 filmsko obloženih tablet EU/1/06/371/006 90 filmsko obloženih tablet EU/1/06/371/007 98 filmsko obloženih tablet EU/1/06/371/008 280 filmsko obloženih tablet EU/1/06/371/025 56x1 filmsko obložena tableta (za enkratni odmerek) EU/1/06/371/026 98x1 filmsko obložena tableta (za enkratni odmerek) EU/1/06/371/027 280x1 filmsko obložena tableta (za enkratni odmerek)
English: Given their similar pharmacodynamic properties, these results are also relevant for other ACE inhibitors and ARBs.
Slovenian: Ti izsledki so pomembni tudi za druge zaviralce ACE in antagoniste angiotenzinskih receptorjev, ker so njihove farmakodinamične lastnosti podobne.
English: Each tablet contains 10 mg amlodipine (as amlodipine besylate) and 160 mg valsartan.
Slovenian: Ena tableta vsebuje 10 mg amlodipina (v obliki amlodipinijevega besilata) in 160 mg valsartana.
English: Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besylate) and 80 mg of valsartan.
Slovenian: Ena filmsko obložena tableta vsebuje 5 mg amlodipina (v obliki amlodipinijevega besilata) in 80 mg valsartana.
English: Each tablet contains 5 mg amlodipine (as amlodipine besylate) and 80 mg valsartan.
Slovenian: Ena tableta vsebuje 5 mg amlodipina (v obliki amlodipinijevega besilata) in 80 mg valsartana.
English: Visual impairment
Slovenian: Okvara jeter
English: Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besylate) and 160 mg of valsartan.
Slovenian: Ena filmsko obložena tableta vsebuje 10 mg amlodipina (v obliki amlodipinijevega besilata) in 160 mg valsartana.
English: Each tablet contains 5 mg amlodipine (as amlodipine besylate) and 160 mg valsartan.
Slovenian: Ena tableta vsebuje 5 mg amlodipina (v obliki amlodipinijevega besilata) in 160 mg valsartana.
English: Pollakiuria
Slovenian: Odmerjanje
English: Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels
Slovenian: Diuretiki, ki varčujejo s kalijem, kalijevi dodatki, nadomestki soli, ki vsebujejo kalij in druge učinkovine, ki lahko zvišajo koncentracijo kalija Če je treba v kombinaciji z valsartanom predpisati zdravilo, ki vpliva na koncentracijo kalija, je priporočljivo kontrolirati koncentracijo kalija v plazmi.
English: Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besylate) and 160 mg of valsartan.
Slovenian: Ena filmsko obložena tableta vsebuje 5 mg amlodipina (v obliki amlodipinijevega besilata) in 160 mg valsartana.
English: Amlodipine and valsartan exhibit linear pharmacokinetics.
Slovenian: Farmakokinetiki amlodipina in valsartana sta linearni.
English: Pharyngolaryngeal pain Uncommon Rhinitis
Slovenian: Quinckerjev edem zelo redki toksična epidermalna nekroliza pogostnost neznana
English: Orthostatic hypotension Uncommon Vasculitis
Slovenian: Žilne bolezni navali rdečice pogosti hipotenzija redki ortostatska hipotenzija vaskulitis zelo redki pogostnost neznana
English: 100 x 1 tablets
Slovenian: 100 x 1 tableta
English: Strength Pharmaceutical Form Route of Administration Packaging
Slovenian: Farmacevtska oblika pot uporabe ovojnina
English: Pharmaceutical Form
Slovenian: Številka EU Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina vsebina (koncentracija)
English: What measures are being taken to ensure the safe and effective use of this medicine?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe tega zdravila?
English: What are the benefits and risks of this medicine?
Slovenian: Kakšne so koristi in tveganja, povezani s tem zdravilom?
English: As for every medicine, the company provided studies on its quality.
Slovenian: Kot to velja za vsako zdravilo, je družba zagotovila študije o njegovi kakovosti.
English: Why is the medicine approved?
Slovenian: Zakaj je bilo zdravilo odobreno?
English: If patients need to stop taking one of the active substances in the medicine, or need to take different doses, they will need to change to separate individual medicines.
Slovenian: Če morajo bolniki prenehati jemati eno od zdravilnih učinkovin v zdravilu ali morajo jemati drugačne odmerke, bodo morali začeti jemati posamezna, ločena zdravila.
English: It is not intended to provide practical advice on how to use the medicine.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: It does not cure HIV infection or AIDS, but it may hold off the damage to the immune system and the development of infections and diseases associated with AIDS.
Slovenian: Ne ozdravi okužbe z virusom HIV ali aidsa, lahko pa upočasni slabšanje imunskega sistema ter prepreči razvoj okužb in bolezni, povezanih z aidsom.
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.
Slovenian: Dve zdravili sta biološko enakovredni, kadar dosegata enake ravni zdravilne učinkovine v telesu in imata zato po pričakovanjih enak učinek.
English: The educational pack also contains recommendations for monitoring kidney function in patients taking the medicine.
Slovenian: Izobraževalno gradivo vsebuje tudi priporočila za spremljanje delovanja ledvic pri bolnikih, ki jemljejo zdravilo.
English: It is only used in patients whose levels of HIV in the blood (viral load) have been below 50 copies/ml for more than 3 months on their current HIV treatment combination.
Slovenian: Uporablja se samo pri bolnikih, pri katerih je raven virusa HIV v krvi (virusno breme) ob dosedanjem kombiniranem zdravljenju virusa HIV že več kot tri mesece nižje od 50 kopij/ml.
English: The company that markets the medicine will ensure that all doctors expected to prescribe the medicine are provided with an educational pack that includes information on the increased risk of kidney disease with medicines containing tenofovir disoproxil such as this one.
Slovenian: Družba, ki trži zdravilo, bo zagotovila, da bodo vsi zdravniki, ki naj bi predpisovali zdravilo, prejeli izobraževalno gradivo, ki bo vsebovalo informacije o povečanem tveganju za ledvično bolezen pri zdravilih, ki vsebujejo dizoproksiltenofovirat, kot ga tudi to zdravilo.
English: Also, it must not be started in patients who have ever been infected with HIV that is resistant to any of the three active substances in the medicine.
Slovenian: Prav tako se ne sme uvesti pri bolnikih, ki so se kadar koli okužili z virusom HIV, odpornim proti kateri koli od treh zdravilnih učinkovin v zdravilu.
English: It must not be used in patients in whom any previous HIV treatment combinations have not worked or have stopped working.
Slovenian: Ne sme se uporabljati pri bolnikih, pri katerih predhodna kombinirana zdravljenja virusa HIV niso bila ali so prenehala biti učinkovita.
English: The Agency recommended that it be approved for use in the EU.
Slovenian: Priporočila je, da se zdravilo odobri za uporabo v EU.
English: Treatment should be started by a doctor who has experience in the management of HIV infection.
Slovenian: Zdravljenje lahko uvede le zdravnik, ki ima izkušnje z zdravljenjem okužbe z virusom HIV.
English: Patients should take the medicine regularly and not miss any doses.
Slovenian: Bolniki morajo zdravilo jemati redno in odmerkov ne smejo izpuščati.
English: Recommendations and precautions to be followed by healthcare professionals and patients for its safe and effective use have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo tega zdravila upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: This means that it contains the same active substances and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Atripla.
Slovenian: To pomeni, da vsebuje enake zdravilne učinkovine in ima enak način delovanja kot referenčno zdravilo Atripla, ki je že odobreno v Evropski uniji (EU).
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555