FrancophonIA/ELRC3.0 huggingface dataset:
English: b ATV/RTV with tenofovir disoproxil fumarate/emtricitabine (fixed dose 300 mg/200 mg tablets once daily).
Icelandic: b Atazanavír/rítónavír með tenófóvír tvísóproxílfúmarati/emtricitabíni (fastur skammtur 300 mg/200 mg töflur einu sinni á dag).
English: Co-administration of atazanavir/ritonavir and these glucocorticoids is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects (see section 4.4).
Icelandic: Samhliða gjöf atazanavírs/rítónavírs og þessara barkstera er ekki ráðlögð nema hugsanlegur ávinningur meðferðarinnar vegi þyngra en hætta á altækum barksteraáhrifum (sjá kafla 4.4).
English: Metabolism and nutrition disorders uncommon: weight decreased, weight gain, anorexia, appetite increased
Icelandic: sjaldgæfar: þyngdarminnkun, þyngdaraukning, lystarleysi, aukin matarlyst
English: Cap: titanium dioxide (E171), yellow ferric oxide (E172), red ferric oxide (E172), gelatine and ink (shellac, black ferric oxide (E172), potassium hydroxide
Icelandic: Lok: títan tvíoxíð (E171), gult járnoxíð (E172), rautt járnoxíð (E172), gelatín og blek (shellakk, svart járnoxíð (E172), kalíum hýdroxíð)
English: Treatment- Experienced atazanavir Capsules/ritonavir (300 mg/100 mg once daily) n=25
Icelandic: Sjúklingar sem hafa fengið meðferð með andretróveirulyfjum atazanavír hylki/ rítónavír (300 mg/100 mg einu sinni á sólarhring) n=25
English: Treatment-Naive atazanavir Capsules/ritonavir (300 mg/100 mg once daily) n=16
Icelandic: Sjúklingar sem hafa ekki fengið meðferð með andretróveirulyfjum atazanavír hylki/ rítónavír (300 mg/100 mg einu sinni á sólarhring) n=16
English: Glecaprevir 300 mg / pibrentasvir 120 mg once daily
Icelandic: Glecaprevir 300 mg / pibrentasvir 120 mg einu sinni á dag (atazanavír 300 mg / rítónavír 100 mg einu sinni á dag*)
English: Administration of atazanavir with ritonavir with either a light or a high-fat meal decreased the coefficient of variation of AUC and cmax by approximately 25% compared to the fasting state.
Icelandic: Gjöf atazanavírs með rítónavíri annaðhvort með léttri eða fituríkri máltíð minnkaði fráviksstuðull AUC og Cmax um u.þ.b.
English: (atazanavir 300 mg / ritonavir 100 mg once daily)
Icelandic: á dag (atazanavír 300 mg/ rítónavír 100 mg einu sinni á dag)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON
Icelandic: Lýsing á útliti Atazanavir Krka og pakkningastærðir
English: In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant Summary of Product Characteristics for these medicinal products (see section 4.8).
Icelandic: B eða C sem fá samsetta meðferð með andretróveirulyfjum eru í aukinni hættu á að fá alvarleg og hugsanlega lífshættuleg viðbrögð í lifur, sjá einnig Samantekt á eiginleikum þessara lyfja (sjá kafla 4.8).
English: All patients HIV RNA <400 copies/ml, %
Icelandic: HIV RNA <400 eintök/ml, % a
English: Atazanavir Krka 200 mg hard capsules Each hard capsule contains 200 mg atazanavir (as sulphate).
Icelandic: Krka 200 mg hörð hylki Hvert hylki inniheldur 200 mg atazanavíri (sem súlfat).
English: Didanosine (with food) Didanosine AUC ↓34% (↓41% ↓27%) Didanosine cmax ↓38% (↓48% ↓26%) Didanosine cmin
Icelandic: Dídanósín Cmax ↓38% (↓48% ↓26%) Dídanósín Cmin ↑25% (↓8% ↑69%)
English: Co-administration with glecaprevir/pibrentasvir fixed dose combination (see section 4.5)
Icelandic: Gjöf samhliða samsetningu með föstum glecaprevir/pibrentasvir skammti (sjá kafla 4.5).
English: c LPV/RTV with tenofovir disoproxil fumarate/emtricitabine (fixed dose 300 mg/200 mg tablets once daily).
Icelandic: c Lópinavír/rítónavír með tenófóvír tvísóproxílfúmarati/emtricitabíni (fastur skammtur 300 mg/200 mg töflur einu sinni á dag).
English: Atazanavir is expected to increase plasma levels of lurasidone due to CYP3A4 inhibition.
Icelandic: Atazanavír getur aukið plasmaþéttni lurasidons vegna CYP3A4 hömlunar.
English: Cap: titanium dioxide (E171), yellow ferric oxide (E172), red ferric oxide (E172), black ferric oxide (E172), gelatine and ink (shellac, titanium dioxide (E171), potassium hydroxide
Icelandic: Lok: títan tvíoxíð (E171), gult járnoxíð (E172), rautt járnoxíð (E172), svart járnoxíð (E172), gelatín og blek (shellakk, svart járnoxíð (E172), kalíum hýdroxíð)
English: Elbasvir 50 mg once daily (atazanavir 300 mg/ ritonavir 100 mg once daily)
Icelandic: Elbasvir 50 mg einu sinni á dag (atazanavír 300 mg/ rítónavír 100 mg einu sinni á dag)
English: Consult the dosing table for the specific formulation (see Summary of Product Characteristics for other formulations).
Icelandic: Sjá leiðbeiningar í skammtatöflu fyrir tiltekin lyfjaform (sjá Samantekt á eiginleikum lyfs fyrir önnur lyfjaform).
English: Cap: titanium dioxide (E171) yellow ferric oxide (E172) red ferric oxide (E172) gelatine ink:
Icelandic: Lok títan tvíoxíð (E171) gult járnoxíð (E172) rautt járnoxíð (E172) gelatín blek:
English: Desacetyl-diltiazem AUC ↑165% Desacetyl-diltiazem cmax ↑172% Desacetyl-diltiazem cmin ↑121%
Icelandic: Desacetyl-diltiazem Cmin ↑121% (↑102%
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 150 mg atazanavir (as sulphate).
Icelandic: VIRK(T) EFNI Hvert hylki inniheldur 150 mg af atazanavíri (sem súlfat).
English: The mechanism of interaction is decreased solubility of atazanavir as intra-gastric pH increases with H2- blockers.
Icelandic: Verkunarháttur milliverkana er sá að með auknu pH í maga af völdum H2-viðtakablokka dregur úr leysanleika atazanavírs.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 200 mg atazanavir (as sulphate).
Icelandic: VIRK(T) EFNI Hvert hylki inniheldur 200 mg af atazanavíri (sem súlfat).
English: Atazanavir AUC ↓61% (↓65%
Icelandic: Dídanósín AUC ↓34% (↓41% ↓27%)
English: Atazanavir Krka once daily dose ritonavir once daily dosea
Icelandic: Atazanavir Krka skammtur einu sinni á dag rítónavír skammtur einu sinni á daga
English: Co-administration of Atazanavir Krka with proton pump inhibitors is not recommended (see section 4.5).
Icelandic: Ekki er ráðlagt að gefa Atazanavir Krka samtímis prótónpumpuhemlum (sjá kafla 4.5).
English: Atazanavir AUC ↑43% (↑30% Atazanavir cmax ↑12% (↑1% Atazanavir cmin ↑23% (↑13% Grazoprevir AUC: ↑958% (↑678% Grazoprevir cmax: ↑524% (↑342% Grazoprevir cmin: ↑1064% (↑696%
Icelandic: Atazanavír AUC ↑43% (↑30% ↑57%) Atazanavír Cmax ↑12% (↓1% ↑24%) Atazanavír Cmin ↑23% (↑13% ↑134%)
English: Atazanavir and fluconazole concentrations were not significantly modified when atazanavir /ritonavir was coadministered with fluconazole.
Icelandic: Engin marktæk breyting varð á þéttni atazanavírs og flúkónazóls þegar atazanavír/rítónavír var gefið ásamt flúkónazól.
English: Atazanavir Krka 300 mg hard capsules Each hard capsule contains 300 mg atazanavir (as sulphate).
Icelandic: Krka 300 mg hörð hylki Hvert hylki inniheldur 300 mg atazanavíri (sem súlfat).
English: Patients co-infected with hepatitis B and/or hepatitis C virus Among 1,151 patients receiving atazanavir 400 mg once daily, 177 patients were co-infected with chronic hepatitis B or C, and among 655 patients receiving atazanavir 300 mg once daily with ritonavir 100 mg once daily, 97 patients were co-infected with chronic hepatitis B or C. Coinfected patients were more likely to have baseline hepatic transaminase elevations than those without chronic viral hepatitis.
Icelandic: 300 mg atazanavír einu sinni á dag með 100 mg rítónavíri einu sinni á dag voru 97 sjúklingar einnig með langvinna lifrarbólgu B eða C. Meiri líkur eru á transamínasahækkun hjá sjúklingum sem einnig eru með lifrarbólgu
English: common: fatigue; uncommon: chest pain, malaise, pyrexia, asthenia; rare: gait disturbance aThese adverse reactions were identified through post-marketing surveillance, however, the frequencies were estimated from a statistical calculation based on the total number of patients exposed to atazanavir in randomised controlled and other available clinical trials (n = 2321).
Icelandic: a Þessar aukaverkanir komu fram eftir markaðssetningu, hins vegar var tíðnin metin með tölfræðiútreikningum byggðum á heildarfjölda sjúklinga sem fengu atazanavír í slembuðum samanburðarrannsóknum og öðrum tiltækum klínískum rannsóknum (n = 2.321).
English: PULMONARY ARTERIAL HYPERTENSION PDE5 Inhibitors
Icelandic: PDE5 hemlar
English: Cap: titanium dioxide (E171) yellow ferric oxide (E172) red ferric oxide (E172) black ferric oxide (E172) gelatine ink:
Icelandic: Lok títan tvíoxíð (E171) gult járnoxíð (E172) rautt járnoxíð (E172) svart járnoxíð (E172) gelatín blek:
English: bSee description of selected adverse reactions for more details.
Icelandic: b Sjá frekari upplýsingar í lýsingu á völdum aukaverkunum.
English: The mechanism of this decrease is unknown (see sections 4.2 and 4.4.
Icelandic: (Sjá kafla 4.2 og 4.4).
English: For treatment-naive paediatric patients, the mean baseline CD4 cell count was 344 cells/mm3 (range: 2 to 800 cells/ mm3) and mean baseline plasma HIV-1 RNA was 4.67 log10 copies/ml (range: 3.70 to 5.00 log10 copies/ml).
Icelandic: a Meðalupphafsgildi CD4 var 214 frumur/mm3 (á bilinu 2 til 810 frumur/mm3 og meðalupphafsgildi HIV-1 RNA í plasma var 4,94 log10 eintök/ml (á bilinu 2,6 til 5,88 log10 eintök/ml) b Atazanavír/rítónavír með tenófóvír tvísóproxílfúmarati/emtricitabíni (fastur skammtur 300 mg/200 mg töflur einu sinni á dag).
English: Antiretroviral treatment experienced adult patients In antiretroviral treatment experienced patients from Studies 009, 043, and 045, 100 isolates from patients designated as virological failures on therapy that included either atazanavir, atazanavir + ritonavir, or atazanavir + saquinavir were determined to have developed resistance to atazanavir.
Icelandic: Í 100 stofnum frá sjúklingum þar sem meðferð með veirueyðandi lyfjum hafði ekki skilað viðunandi árangri með annaðhvort atazanavíri, atazanavíri+rítónavíri, eða atazanavíri+saquinavíri var ónæmi fyrir atazanavíri staðfest.
English: The capsule cap is imprinted with white mark A300.
Icelandic: Lok hylkisins er merkt með „A300“ með svörtu bleki.
English: Tenofovir disoproxil fumarate 300 mg once daily (atazanavir 300 mg once daily with ritonavir 100 mg once daily)
Icelandic: Tenófóvír tvísóproxílfúmarat 300 mg einu sinni á dag (atazanavír 300 mg einu sinni á dag ásamt rítónavíri 100 mg einu sinni á dag)
English: Phenobarbital and phenytoin should be used with caution in combination with atazanavir /ritonavir.
Icelandic: Gæta skal varúðar við notkun fenóbarbitals og fenýtóíns samhliða atazanavíri/rítónavíri.
English: Hard gelatine capsule, size no. 00.
Icelandic: Hart gelatínhylki, stærð 00.
English: the clarithromycin/atazanavir interaction is CYP3A4 inhibition.
Icelandic: Verkunarháttur milliverkunar claritrómýcins/atazanavírs er CYP3A4 hömlun.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 300 mg atazanavir (as sulphate).
Icelandic: VIRK(T) EFNI Hvert hylki inniheldur 300 mg af atazanavíri (sem súlfat).
English: No drug interaction study has been performed for the coadministration of atazanavir with benzodiazepines.
Icelandic: Engar rannsóknir á milliverkunum vegna samtímis notkunar atazanavírs og benzódíazepína hafa verið gerðar.
English: Atazanavir Krka 150 mg hard capsules
Icelandic: Krka 150 mg hörð hylki
English: The use of Atazanavir Krka with ritonavir may be considered during pregnancy only if the potential benefit justifies the potential risk.
Icelandic: Krka ásamt rítónavíri á meðgöngu aðeins ef hugsanlegir kostir vega þyngra en hugsanleg áhætta.
English: *Lack of pharmacokinetics interaction bounds 70-143% Effect on atazanavir and ritonavir exposure has not been studied.
Icelandic: *Mörk þar sem engar lyfjahvarfamilliverkanir eru 70-143%
English: Switching to capsules from other formulations is encouraged as soon as patients are able to consistently swallow capsules.
Icelandic: Hvatt er til þess að um leið og sjúklingar geta án undantekninga gleypt hylki skipti þeir frá öðrum lyfjaformum yfir í hylki.
English: The mechanism of diltiazem/atazanavir interaction is CYP3A4 inhibition.
Icelandic: Verkunarháttur milliverkana diltiazems/atazanavírs er CYP3A4 hömlun.
English: The mechanism of nevirapine/atazanavir interaction is CYP3A4 induction.
Icelandic: Verkunarháttur milliverkunar nevírapíns/atazanavírs er CYP3A4 virkjun.
English: Atazanavir cmin ↓65% (↓71%
Icelandic: Atazanavír Cmin ↓25% (↓47% ↑7%) *
English: HCV Protease Inhibitors Boceprevir 800 mg three times daily (atazanavir 300 mg/ritonavir 100 mg once daily)
Icelandic: C Boceprevír 800 mg þrisvar á dag (atazanavír 300 mg/ rítónavír 100 mg einu sinni á dag)
English: Musculoskeletal and connective tissue disorders uncommon: muscle atrophy, arthralgia, myalgia; rare: myopathy
Icelandic: sjaldgæfar: vöðvarýrnun, liðverkir, vöðvaþrautir mjög sjaldgæfar:
English: Table 1: Dose for paediatric patients (6 years to less than 18 years of age and weighing at least 15 kg) for Atazanavir Krka capsules with ritonavir Body Weight (kg)
Icelandic: Krka hylkja með rítónavíri fyrir börn (6 ára til yngri en 18 ára og sem vega að minnsta kosti 15 kg)
English: Nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) Lamivudine 150 mg twice daily + zidovudine 300 mg twice daily (atazanavir 400 mg once daily)
Icelandic: Lamivúdín 150 mg tvisvar á dag + zídóvúdín 300 mg tvisvar á dag (atazanavír 400 mg einu sinni á dag)
English: INFORMATION IN BRAILLE Atazanavir Krka 300 mg
Icelandic: MEÐ BLINDRALETRI Atazanavir Krka 300 mg
English: LIST OF EXCIPIENTS Contains also lactose monohydrate.
Icelandic: Inniheldur einnig laktósa einhýdrat.
English: uncommon: nephrolithiasis a, haematuria, proteinuria, pollakiuria, interstitial nephritis; chronic kidney diseasea rare: kidney pain
Icelandic: (DRESS heilkenni)a,b, ofnæmisbjúgura, ofsakláði, hárlos, kláði mjög sjaldgæfar:
English: The frequency of treatment emergent hepatitis or transaminase elevations in co-infected patients was comparable between atazanavir and comparator regimens (see section 4.4).
Icelandic: B eða C var sambærileg milli atazanavírs og samanburðarmeðferðarinnar (sjá kafla 4.4).
English: Atazanavir Krka with ritonavir must not be used in patients with moderate to severe hepatic impairment (see sections 4.3, 4.4 and 5.2).
Icelandic: Krka ásamt rítónavíri má ekki nota hjá sjúklingum með í meðallagi alvarlega lifrarbilun (sjá kafla 4.2, 4.4 og 5.2).
English: Co-administration of atazanavir with ritonavir and proton pump inhibitors is not recommended.
Icelandic: Samhliða gjöf atazanavírs ásamt rítónavíri og prótónpumpuhemla er ekki ráðlögð.
English: It is not known whether atazanavir with ritonavir administered to the mother during pregnancy will exacerbate physiological hyperbilirubinaemia and lead to kernicterus in neonates and infants.
Icelandic: Þegar atazanavír ásamt rítónavíri er gefið konum á meðgöngu er ekki vitað hvort það eykur bilirúbín í blóði og valdi gulufárstaugakvilla hjá nýburum og ungbörnum.
English: NAME OF THE MEDICINAL PRODUCT Atazanavir Krka 200 mg hard capsules atazanavir
Icelandic: Krka 200 mg hörð hylki Atazanavir
English: Didanosine should be taken at the fasted state 2 hours after atazanavir taken with food.
Icelandic: Dídanósín á að taka fastandi 2 klst.
English: Atazanavir, dosed 1 hr after ddI+d4T (fasted) Atazanavir AUC ↔3% (↓36% Atazanavir cmax ↑12% (↓33% Atazanavir cmin ↔3% (↓39%
Icelandic: Atazanavír AUC ↔3% (↓36% ↑67%) Atazanavír Cmax ↑12% (↓33% ↑18%) Atazanavír Cmin ↔3% (↓39% ↑73%)
English: Atazanavir Krka is contraindicated in patients with severe hepatic insufficiency (see sections 4.2, 4.4 and 5.2).
Icelandic: Krka má ekki nota hjá sjúklingum með alvarlega lifrarbilun (sjá kafla 4.2, 4.4 og 5.2).
English: Systemic corticosteroid effects including Cushing's syndrome and adrenal suppression have been reported in patients receiving ritonavir and inhaled or intranasally administered fluticasone propionate; this could also occur with other corticosteroids metabolised via the P450 3A pathway, e.g., budesonide.
Icelandic: Greint hefur verið frá altækum barksteraáhrifum m.a. Cushings heilkenni og bælandi áhrifum á nýrnahettur hjá sjúklingum sem fengu rítónavír og flútíkasón própíónat með innöndun eða í nef.
English: Ethinyloestradiol AUC ↑48% Ethinyloestradiol cmax ↑15% (↓1% Ethinyloestradiol cmin ↑91%
Icelandic: Etinýlöstradiól AUC ↑48% (↑31%; ↑68%) Etinýlöstradiól Cmax ↑15% (↓1%; ↑32%) Etinýlöstradiól Cmin ↑91% (↑57%; ↑133%)
English: Caution should be exercised when verapamil is coadministered with atazanavir.
Icelandic: Gæta skal varúðar þegar verapamíl er gefið samhliða atazanavíri.
English: Atazanavir cmin ↓84% (↓90%
Icelandic: Atazanavír Cmin ↓20% (↓31% ↓8%)
English: Co-administration of salmeterol and Atazanavir Krka is not recommended (see section 4.5).
Icelandic: Samhliða gjöf salmeteróls og Atazanavir Krka er ekki ráðlögð (sjá kafla 4.5).
English: - medicines containing St. John's wort (Hypericum perforatum, a herbal preparation) - triazolam and oral (taken by mouth) midazolam (used to help you sleep and/or to relieve anxiety) - simvastatin and lovastatin (used to lower blood cholesterol).
Icelandic: lyf sem innihalda jóhannesarjurt (Hypericum perforatum, náttúrulyf) tríazólam og mídazólam til inntöku (notað til að auðvelda fólki að sofna og/eða draga úr kvíða) - simvastatín og lóvastatín (notað til að draga úr kólesteróli í blóði) lyf sem innihalda grazoprevir, m.a. samsetningar með föstum elbasvir/grazoprevir skammti og samsetningar með föstum glecaprevir/pibrentasvir skammti (notað við langvinnri lifrarbólgu C)
English: Hard gelatine capsule (capsule), size no. 00.
Icelandic: Hart gelatínhylki (hylki), stærð 00.
English: Atazanavir Krka 150 mg hard capsules Atazanavir Krka 200 mg hard capsules Atazanavir Krka 300 mg hard capsules atazanavir
Icelandic: Atazanavir Krka 300 mg hörð hylki atazanavír
English: Sofosbuvir AUC : ↑40% (↑25% Sofosbuvir cmax :↑29% (↑9% Velpatasvir AUC: ↑93% (↑58% Velpatasvir cmax : ↑29% (↑7% Voxilaprevir AUC : ↑331% Voxilaprevir cmax : ↑342% (↑265%
Icelandic: Velpatasvír AUC: ↑93% (↑58% ↑136%) Velpatasvír Cmax : ↑29% (↑7% ↑56%)
English: The Summary of Product Characteristics for ritonavir must be consulted before initiation of therapy with Atazanavir Krka and ritonavir.
Icelandic: Áður en meðferð með Atazanavir Krka og rítínóvíri hefst þarf að athuga Samantekt á eiginleikum rítónavírs.
English: % (responder/evaluable) NA
Icelandic: Núkleósíð/núkleótíð bakritahemlar(NRTI)
English: Paediatric patients (6 years to less than 18 years of age and weighing at least 15 kg) The dose of atazanavir capsules for paediatric patients is based on body weight as shown in Table 1 and should not exceed the recommended adult dose.
Icelandic: Skammtur atazanavír hylkja fyrir börn er ákvarðaður út frá líkamsþyngd eins og fram kemur í töflu 1 og á ekki að vera stærri en ráðlagður skammtur fyrir fullorðna.
English: Alternative antiretroviral therapy to Atazanavir Krka may be considered if jaundice or scleral icterus is unacceptable to a patient.
Icelandic: Hugleiða þarf aðra meðferð en Atazanavir Krka meðferð ef gula eða gul augnhvíta reynist óbærileg fyrir sjúklinginn.
English: common: jaundice; uncommon: hepatitis, cholelithiasisa, cholestasisa; rare: hepatosplenomegaly, cholecystitis a
Icelandic: algengar: gula sjaldgæfar: lifrarbólga, gallsteinara, gallteppaa mjög sjaldgæfar: lifrar- og miltisstækkun, gallblöðrubólgaa
English: See section 4.
Icelandic: 3.-4. stigs bilirúbíndreyra.
English: Take Atazanavir Krka capsules with food (a meal or a substantial snack).
Icelandic: Atazanavir Krka hylkin á að taka með mat (máltíð eða staðgóðum bita milli mála).
English: Children receiving Atazanavir Krka may require their heart to be monitored.
Icelandic: Nauðsynlegt getur verið að fylgjast með hjartastarfsemi hjá börnum sem fá Atazanavir Krka.
English: Atorvastatin
Icelandic: Verkunarháttur
English: Co-administration of alfuzosin concentrations which can result in hypotension.
Icelandic: Þéttni alfuzosíns getur aukist og valdið lágum blóðþrýstingi.
English: During postpartum:
Icelandic: QT lenging:
English: For treatmentexperienced paediatric patients, the mean baseline CD4 cell count was 522 cells/mm3 (range: 100 to
Icelandic: Hjá sjúklingum sem höfðu fengið meðferð með andretróveirulyfjum áður var meðalupphafsgildi CD4 522 frumur/mm3 (á bilinu:100-1.157 frumur/mm3) og meðalupphafsgildi HIV-1
English: HIV RNA <100,000 copies/ml
Icelandic: <100.000 eintök/ml
English: If the co-administration of Atazanavir Krka with an NNRTI is required, an increase in the dose of both Atazanavir Krka and ritonavir to 400 mg and 200 mg, respectively, in combination with efavirenz could be considered with close clinical monitoring.
Icelandic: Atazanavir Krka í 400 mg og rítónavírs í 200 mg ásamt nánu klínísku eftirliti, þegar þau eru gefin í samsettri meðferð með efavírenzi.
English: ANTI-HCV AGENTS Grazoprevir 200 mg once daily (atazanavir 300 mg/ ritonavir 100 mg once daily)
Icelandic: LYF VIÐ LIFRARBÓLGU C Grazoprevir 200 mg einu sinni á dag (atazanavír 300 mg/ rítónavír 100 mg einu sinni á dag)
English: - Gallbladder problems uncommonly happen in people taking atazanavir.
Icelandic: - Gallblöðrusjúkdómur getur komið fram hjá þeim sem taka atazanavír en það er sjaldgæft.
English: Other side effects reported for patients treated with atazanavir are the following: Common (may affect up to 1 in 10 people): - headache - vomiting, diarrhoea, abdominal pain (stomach pain of discomfort), nausea, dyspepsia
Icelandic: Algengar (geta komið fyrir hjá allt að 1 af hverjum 10 notendum): - höfuðverkur - uppköst, niðurgangur, kviðverkir (magaverkir eða óþægindi), ógleði, meltingartruflanir (tregða) - örmögnun
English: Atazanavir AUC ↑7% (↓2% Atazanavir cmax ↑2% (↓4% ↑8%) Atazanavir cmin ↑15% (↑2% ↑29%) Elbasvir AUC: ↑376% (↑307% Elbasvir cmax: ↑315% (↑246% Elbasvir cmin: ↑545% (↑451%
Icelandic: Noretindrón AUC ↑ 110% (↑68%; ↑162%) Noretindrón Cmax ↑67% (↑42%; ↑196%) Noretindrón Cmin ↑262% (↑157%; ↑409%)
English: Co-administration of atazanavir and elbasvir/grazoprevir is contraindicated because of a significant increase in grazoprevir plasma concentrations and an associated potential increase in the risk of ALT elevations (see section
Icelandic: Ekki má gefa atazanavír samhliða elbasviri/grazopreviri vegna marktækrar aukningar á þéttni grazoprevirs í plasma ásamt hugsanlega aukinni hættu á ALAT hækkun (sjá kafla 4.3).
English: Atazanavir cmax ↔9% (↓5%
Icelandic: Atazanavír Cmin ↓19% (↓37% ↑5%) *
English: Increased monitoring for rifabutinassociated adverse reactions including neutropenia and uveitis is warranted due to an expected increase in exposure to rifabutin.
Icelandic: Hafa skal aukið eftirlit með aukaverkunum tengdum rifabútíni, þ.m.t. daufkyrningafæð og æðahjúpsbólgu þar sem búast má við aukinni útsetningu fyrir rifabútíni.
English: Atazanavir AUC ↔6% (↓10%
Icelandic: boceprevír AUC ↔5%
English: SPECIAL STORAGE CONDITIONS Do not freeze.
Icelandic: SÉRSTÖK GEYMSLUSKILYRÐI Má ekki frjósa.
English: This was observed in less than 10% of the cattle treated in clinical studies.
Icelandic: Þetta sást hjá færri en 10% nautgripa sem fengu meðferð í klínískum rannsóknum.
English: This is equivalent to 1 ml of Contacera per 25 kg body weight of horse.
Icelandic: Þetta jafngildir 1 ml af Contacera fyrir hver 25 kg líkamsþunga hestsins.
English: For example, a horse weighing 400 kg will receive 16 ml of Contacera, a horse weighing 500 kg will receive 20 ml of Contacera, and a horse weighing 600 kg will receive 24 ml of Contacera.
Icelandic: Til dæmis mun hestur sem vegur 400 kg fá 16 ml af Contacera, hestur sem vegur 500 kg mun fá 20 ml af Contacera og hestur sem vegur 600 kg mun fá 24 ml af Contacera.
English: Meloxicam Meloxicam Bovine, caprine, porcine, rabbit,
Icelandic: Meloxicam Meloxicam Nautgripum, geitum, svín, kanína,
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 06/12/2012
Icelandic: Dagsetning fyrstu útgáfu markaðsleyfis: 06/12/2012
English: Eurovet Animal Health B.V. Handelsweg 25
Icelandic: Eurovet Animal Health B.V.
English: After administration of the veterinary medicinal product, close the bottle by replacing the cap, wash the measuring syringe with warm water and let it dry.
Icelandic: Eftir að lyfið hefur verið gefið skal loka flöskunni með tappanum, þvo mælisprautuna með volgu vatni og láta hana þorna.