FrancophonIA/ELRC3.0 huggingface dataset:
English: Studies in patients with renal impairment show lamivudine elimination is affected by renal dysfunction.
Slovenian: Raziskave pri bolnikih z oslabljenim delovanjem ledvic so pokazale, da nenormalno delovanje ledvic vpliva na izločanje lamivudina.
English: Lamivudine/Zidovudine Teva can make you dizzy and have other side effects that make you less alert.
Slovenian: Zdravilo Lamivudin/zidovudin Teva lahko povzroči omotičnost in tudi druge neželene učinke, ki vplivajo na zmanjšano pripravljenost.
English: Each film-coated tablet contains lamivudine 150 mg zidovudine 300 mg
Slovenian: Ena filmsko obložena tableta vsebuje lamivudin 150 mg zidovudin 300 mg
English: Cssmax levels were 4.45 μM (1.19 μg/ml) following a dose of 120 mg zidovudine (in solution)/m2 body surface area and 7.7 μM (2.06 μg/ml) at 180 mg/m2 body surface area.
Slovenian: Pri uporabi zidovudina (v obliki raztopine) v odmerku 120 mg/m telesne površine je bila največja koncentracija v stanju dinamičnega ravnovesja (Cssmax) 4,45 μM (1,19 μg/ml), pri uporabi zidovudina v odmerku 180 mg/m telesne površine pa 7,7
English: Zidovudine is contraindicated in patients with abnormally low neutrophil counts (<0.75 x 109/l), or abnormally low haemoglobin levels (<7.5 g/dl or 4.65 mmol/l).
Slovenian: 9/l) ali izredno nizkimi vrednostmi hemoglobina (<7,5 g/dl ali 4,65 mmol/l).
English: - The active substances are lamivudine 150 mg and zidovudine 300 mg. - The other ingredients are: Tablet core: Cellulose microcrystalline, sodium starch glycolate (Type A), sodium stearyl fumarate.
Slovenian: - Druge pomožne snovi so: Jedro tablete; mikrokristalna celuloza, natrijev karboksimetilškrob (vrsta A), natrijev staril fumarat.
English: The usual starting dose of Lamivudine/Zidovudine Teva is one half tablet (½) taken in the morning and one half tablet (½) taken in the evening.
Slovenian: Običajni začetni odmerek zdravila Lamivudin/zidovudin Teva je polovica (½) tablete zjutraj in polovica (½) tablete zvečer.
English: Zidovudine AUC ↑106% (UGT inhibition)
Slovenian: AUC zidovudina ↑106% (zavrtje UGT)
English: Uncommon: Fever, generalised pain and asthenia Rare: Chills, chest pain and influenza-like syndrome
Slovenian: Redki: mrzlica, bolečine v prsih in sindrom, podoben influenci
English: Zidovudine AUC ↓48% (UGT induction)
Slovenian: AUC zidovudina ↓48% (indukcija UGT)
English: What Lamivudine/Zidovudine Teva looks like and contents of the pack
Slovenian: Izgled zdravila Lamivudin/zidovudin Teva in vsebina pakiranja
English: People may be more likely to get this condition:
Slovenian: Verjetnost za to motnjo je večja, pri bolnikih:
English: Combination therapy for HIV can also cause: • increased levels of lactic acid in the blood, which on rare occasions can lead to lactic acidosis.
Slovenian: • povišane vrednosti mlečne kisline v krvi, kar v redkih primerih lahko povzroči laktacidozo.
English: As well as the side effects listed below for Lamivudine/Zidovudine Teva, other conditions can develop during combination therapy for HIV.
Slovenian: Poleg neželenih učinkov zdravila Lamivudin/zidovudin Teva, ki so navedeni spodaj, se lahko med kombiniranim zdravljenjenjem okužbe s HIV pojavijo še druge motnje.
English: • amphotericin or co-trimoxazole, to treat fungal and bacterial infections
Slovenian: • amfotericin ali kotrimoksazol za zdravljenje bakterijskih in glivičnih okužb;
English: Lamivudine has not shown any genotoxic activity in in vivo studies at doses that gave plasma concentrations up to 40-50 times higher than clinical plasma levels.
Slovenian: Lamivudin pri odmerkih, ki so dali 40- do 50-krat večje plazemske koncentracije od terapevtskih, in vivo ni pokazal nobenega genotoksičnega delovanja.
English: A very rare side effect that may show up in blood tests is: • a failure of the bone marrow to produce new red or white blood cells (aplastic anaemia).
Slovenian: • Pojavijo se lahko pri največ 1 od 10.000 bolnikov.nezmožnost kostnega mozga za tvorbo novih rdečih ali belih krvnih celic (aplastična anemija).
English: Tell your doctor if you are being treated with any of these.
Slovenian: Zdravniku morate povedati, če se zdravite s katerimkoli od teh zdravil.
English: Some medicines interact with Lamivudine/Zidovudine Teva
Slovenian: Nekatera zdravila medsebojno delujejo z zdravilom Lamivudin/zidovudin Teva
English: The clinical significance of these findings is unknown.
Slovenian: Klinični pomen teh ugotovitev ni znan.
English: Rare: Cough
Slovenian: Občasni: dispneja Redki: kašelj
English: Exacerbation of anaemia due to ribavirin has been reported when zidovudine is part of the regimen used to treat HIV although the exact mechanism remains to be elucidated.
Slovenian: Opisano je bilo poslabšanje anemije zaradi ribavirina, če je bil zidovudin del sheme za zdravljenje
English: Rare side effects These may affect up to 1 in 1000 people:
Slovenian: Pojavijo se lahko pri največ 1 od 1.000 bolnikov:
English: Weight and metabolic parameters: An increase in weight and in levels of blood lipids and glucose may occur during antiretroviral therapy.
Slovenian: Telesna masa in presnovni parametri: Med protiretrovirusnim zdravljenjem se lahko poveča telesna masa ter zviša koncentracija lipidov in glukoze v krvi.
English: Rare side effects that may show up in blood tests are:
Slovenian: Redki neželeni učinki, ki se lahko pokažejo v preiskavah krvi, so:
English: Rare: Insomnia, paraesthesiae, somnolence, loss of mental acuity, convulsions
Slovenian: Redki: nespečnost, parestezija, dremavost, zmanjšana sposobnost koncentracije, krči
English: • general feeling of being unwell
Slovenian: • splošno slabo počutje,
English: However, as dosage adjustments for zidovudine may be necessary, it is recommended that separate preparations of lamivudine and zidovudine be administered to patients with severe hepatic impairment.
Slovenian: Ker bo verjetno potrebno odmerek zidovudina prilagoditi, je pri bolnikih s hudo jetrno okvaro priporočljivo uporabljati lamivudin in zidovudin kot samostojni zdravili.
English: Opportunistic infections: Patients receiving Lamivudine/Zidovudine Teva or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection.
Slovenian: Oportunistične okužbe: Ker se pri bolnikih, ki se zdravijo z zdravilom Lamivudin/zidovudin Teva ali s katerim koli drugim protiretrovirusnim zdravljenjem, še vedno lahko pojavijo oportunistične okužbe in drugi zapleti vezani na okužbo z virusom HIV, morajo bolniki ostati pod skrbnim kliničnim nadzorom zdravnikov z izkušnjami pri zdravljenju okužbe z virusom HIV.
English: Lamivudine/Zidovudine Teva 150 mg/300 mg film-coated tablets
Slovenian: Lamivudin/zidovudin Teva 150 mg/300 mg filmsko obložene tablete
English: Rare: Oral mucosa pigmentation, taste perversion and dyspepsia.
Slovenian: Občasni: napenjanje Redki: pigmentacija ustne sluznice, motnje v okušanju in dispepsija,pankreatitis
English: Interactions involving binding site displacement are not anticipated with Lamivudine/Zidovudine Teva.
Slovenian: Interakcije, ki bi obsegale izpodrivanje z vezavnih mest pri zdravilu Lamivudin/zidovudin Teva, niso pričakovane.
English: Separate administration of Lamivudine/Zidovudine Teva and clarithromycin by at least 2 hours
Slovenian: Med uporabo zdravila Lamivudin/zidovudin Teva in uporabo klaritromicina morata miniti vsaj 2 uri.
English: Marketing Authorisation Holder and Manufacturer Marketing Autnorisation Holder
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec Imetnik dovoljenja za promet
English: • a low red blood cell count (anaemia) or low white blood cell count (neutropenia or leucopenia)
Slovenian: • zmanjšano število rdečih krvnih celic (anemija) ali zmanjšano število belih krvnih celic
English: An uncommon side effect that may show up in blood test is:
Slovenian: Občasni neželeni učinek, ki se lahko pokaže v preiskavah krvi, je:
English: In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Slovenian: Pri s HIV okuženih bolnikih s hudo imunsko pomanjkljivostjo lahko ob uvedbi kombiniranega protiretrovirusnega zdravljenja (CART -"combination antiretroviral therapy") nastane vnetna reakcija na asimptomatične ali rezidualne oportunistične okužbe (glejte poglavje 4.4).
English: Peripheral blood lymphocytes from AIDS patients receiving zidovudine treatment have also been observed to contain higher numbers of chromosome breakages.
Slovenian: ki se zdravijo z zidovudinom, so v limfocitih iz periferne krvi opazili večje število lomov kromosomov.
English: Blood and lymphatic system disorders Common: Anaemia, neutropenia and leucopenia Uncommon: Thrombocytopenia and pancytopenia (with marrow hypoplasia) Rare: Pure red cell aplasia
Slovenian: Pogosti: anemija, nevtropenija in levkopenija Občasni: trombocitopenija in pancitopenija (s hipoplazijo kostnega mozga)
English: Rifampicin/Lamivudine
Slovenian: rifampicin/lamivudin
English: Therapy should be switched to an alternative regimen if there is suspicion of lipoatrophy development.
Slovenian: Če obstaja sum, da se razvija lipoatrofija, je treba preiti na drugačno shemo zdravljenja.
English: Probenecid/Lamivudine
Slovenian: probenecid/lamivudin
English: Therefore the concomitant use of lamivudine with cladribine is not recommended (see section 4.4)
Slovenian: Zato sočasna uporaba lamivudina in kladribina ni priporočljiva (glejte poglavje
English: Stavudine/Zidovudine
Slovenian: stavudin/zidovudin
English: Clarithromycin/Lamivudine
Slovenian: klaritromicin/lamivudin
English: Lamivudine/zidovudine was shown to be bioequivalent to lamivudine 150 mg and zidovudine 300 mg given as separate tablets, when administered to fasting subjects.
Slovenian: Teva bioekvivalentno 150 mg odmerku lamivudina in 300 mg odmerku zidovudina danih v ločenih tabletah, če ju bolniki vzamejo na tešče.
English: A bioequivalence study compared lamivudine/zidovudine with lamivudine 150 mg and zidovudine 300 mg tablets taken together.
Slovenian: Zdravilo Lamivudin/zidovudin Teva so v raziskavi bioekvivalentnosti primerjali s 150 mg tabletami lamivudina in 300 mg tabletami zidovudina, ki so jih bolniki jemali skupaj.
English: Didanosine /Zidovudine
Slovenian: didanozin/zidovudin
English: It is recommended that separate preparations of lamivudine and zidovudine should be administered in cases where dosage adjustment is necessary (see section 4.2).
Slovenian: V primerih, ko je potrebno odmerek posamezne učinkovine prilagoditi, je priporočljivo uporabiti lamivudin in zidovudin kot samostojni zdravili (glejte poglavje 4.2).
English: Zidovudine AUC ↑74% (UGT inhibition)
Slovenian: AUC zidovudina ↑74% (zavrtje UGT)
English: Zidovudine AUC ↑80% (UGT inhibition)
Slovenian: AUC zidovudina ↑80% ( zavrtje UGT )
English: • feeling breathless
Slovenian: • občutek zadihanosti,
English: • fever (high temperature)
Slovenian: • zvišana telesna temperatura,
English: Not applicable.
Slovenian: ni podatkov.
English: Zidovudine and stavudine maintain their antiretroviral activities against lamivudine-resistant HIV-1.
Slovenian: Zidovudin in stavudin ohranita protiretrovirusno aktivnost na virus
English: Probenecid/Zidovudine (500 mg four times daily/2 mg/kg thrice daily)
Slovenian: probenecid/zidovudin (500 mg štirikrat na dan/2 mg/kg trikrat na dan)
English: Nervous system disorders
Slovenian: imenovanih nukleozidni zaviralci.
English: Haematological parameters should therefore be carefully monitored (see section 4.3) in patients receiving Lamivudine/Zidovudine Teva.
Slovenian: Hematološke parametre je torej potrebno pri bolnikih, ki prejemajo zdravilo Lamivudin/zidovudin
English: Neither zidovudine nor lamivudine have shown evidence of impairment of fertility in studies in male and female rats.
Slovenian: V študijah na podganjih samcih in samicah niso ne za zidovudin in ne za lamivudin ugotovili, da bi škodljivo vplivala na plodnost.
English: • changes in the colour of your nails, your skin or the skin inside your mouth
Slovenian: • težave z želodcem, motnje okušanja, • spremenjena barva nohtov, kože ali ustne sluznice,
English: Fluconazole/Lamivudine
Slovenian: flukonazol/lamivudin
English: • high doses of co-trimoxazole, an antibiotic.
Slovenian: • visoki odmerki antibiotika kotrimoksazola;
English: Rifampicin/Zidovudine (600 mg once daily/200 mg thrice daily)
Slovenian: rifampicin/zidovudin (600mg enkrat na dan/200 mg trikrat na dan)
English: Phenobarbital/Lamivudine
Slovenian: fenobarbital/lamivudin
English: Containers:
Slovenian: Plastenke:
English: Lamivudine/Zidovudine Teva 150 mg/300 mg film-coated tablets lamivudine/zidovudine
Slovenian: Lamivudin/zidovudin Teva 150 mg/300 mg filmsko obložene tablete lamivudin/zidovudin
English: Zidovudine showed clastogenic effects in an oral repeated dose micronucleus test in mice.
Slovenian: Zidovudin, v ponavljajočih odmerkih peroralno apliciran mišim v okviru mikronukleusnega testa, je imel klastogene učinke.
English: Phenobarbital/Zidovudine
Slovenian: fenobarbital/zidovudin
English: General disorders and administration site conditions Common: Fatigue, malaise, fever
Slovenian: Pogosti: utrujenost, splošno slabo počutje, vročica
English: How to take Lamivudine/Zidovudine Teva Always take this medicine exactly as your doctor or pharmacist has told you.
Slovenian: Pri jemanju zdravila Lamivudin/zidovudin Teva natančno upoštevajte navodila zdravnika ali farmacevta.
English: Very common side effects These may affect more than 1 in 10 people:
Slovenian: Pojavijo se lahko pri največ 1 od 10 bolnikov:
English: Fluconazole/Zidovudine (400 mg once daily/200 mg thrice daily)
Slovenian: flukonazol/zidovudin (400 mg enkrat na dan/200 mg trikrat na dan)
English: Methadone/Lamivudine
Slovenian: metadon/lamivudin
English: Viruses acquire phenotypic resistance to thymidine analogues through the combination of mutations at codons 41 and 215 or by the accumulation of at least four of the six mutations.
Slovenian: in 215 ali z akumulacijo najmanj štirih od šestih mutacij pridobijo fenotipsko odpornost na analoge timidina.
English: As dosage adjustment of Lamivudine/Zidovudine Teva is not possible separate preparations of zidovudine and lamivudine should be used.
Slovenian: Lamivudin/zidovudin Teva prilagajanje odmerka posamezne učinkovine ni možno, je potrebno uporabiti zidovudin in lamivudin kot samostojni zdravili.
English: There is limited experience of overdosage with lamivudine/zidovudine.
Slovenian: Izkušnje s prevelikim odmerjanjem zdravila Lamivudin/zidovudin Teva so omejene.
English: How to store Lamivudine/Zidovudine Teva
Slovenian: Kako jemati zdravilo Lamivudin/zidovudin Teva
English: Tablet film-coat Hypromellose 3cP Hypromellose 6cP Polysorbate 80
Slovenian: hipromeloza 3cP hipromeloza 6cP polisorbat 80 makrogol 400 titanov dioksid (E171)
English: Macrogol 400
Slovenian: CD4
English: Late-onset neurological disorders have been reported rarely (hypertonia, convulsion, abnormal behaviour).
Slovenian: (hipertonija, konvulzije, nenormalno obnašanje).
English: Didanosine/Lamivudine
Slovenian: didanozin/lamivudin
English: The clinical relevance of such findings remains, however, not well defined.
Slovenian: Vendar pa klinična relevantnost teh odkritij za zdaj še ni dodobra raziskana.
English: Valproic acid/Zidovudine (250 mg or 500 mg thrice daily/100 mg thrice daily)
Slovenian: valprojska kislina/zidovudin (250 mg ali 500 mg trikrat na dan/100 mg trikrat na dan)
English: Package leaflet: Information for the user Lamivudine/Zidovudine Teva 150 mg/300 mg film-coated tablets lamivudine/zidovudine
Slovenian: Navodilo za uporabo Lamivudin/zidovudin Teva 150 mg/300 mg filmsko obložene tablete lamivudin/zidovudin
English: MARKETING AUTHORISATION HOLDER
Slovenian: 7 IMETNIK DOVOLJENJA ZA PROMET
English: Common side effects that might show up in blood tests are:
Slovenian: Pogosti neželeni učinki, ki se lahko pokažejo v preiskavah krvi, so:
English: Take special care with Lamivudine/Zidovudine Teva
Slovenian: Bodite posebno pozorni pri jemanju zdravila Lamivudin/zidovudin Teva
English: Ranitidine/Zidovudine
Slovenian: ranitidin/zidovudin
English: Immune Reactivation Syndrome: In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Slovenian: Sindrom imunske reaktivacije: Pri s HIV okuženih bolnikih s hudo imunsko pomanjkljivostjo lahko ob uvedbi kombiniranega protiretrovirusnega zdravljenja (CART - "combination antiretroviral therapy")
English: Cimetidine/Zidovudine
Slovenian: cimetidin/zidovudin
English: Cimetidine/Lamivudine
Slovenian: cimetidin/lamivudin
English: When you are being treated for HIV, it can be hard to tell whether a symptom is a side effect of Lamivudine/Zidovudine Teva or other medicines you are taking, or an effect of the HIV disease itself.
Slovenian: Med zdravljenjem okužbe s HIV, je včasih težko reči ali je simptom neželeni učinek zdravila
English: • itching
Slovenian: • driska,
English: Treatment with Lamivudine/Zidovudine Teva should be stopped immediately if clinical signs, symptoms or laboratory abnormalities suggestive of pancreatitis occur.
Slovenian: Če klinični znaki, simptomi ali laboratorijska odstopanja kažejo na možnost pankreatitisa, je potrebno zdravljenje z zdravilom Lamivudin/zidovudin Teva nemudoma prekiniti.
English: Very rare: Aplastic anaemia
Slovenian: Redki: čista aplazija rdečih krvnih celic Zelo redki: aplastična anemija
English: • headache • feeling sick (nausea).
Slovenian: • občutek slabosti (navzea).
English: Stavudine/Lamivudine
Slovenian: stavudin/lamivudin
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.4).
Slovenian: toda opisani čas do začetka je bolj spremenljiv in ti dogodki se lahko pojavijo veliko mesecev po uvedbi zdravljenja (glejte poglavje 4.4).
English: • indigestion, taste disturbance
Slovenian: • slabost (navzea), bruhanje,
English: • muscle pain and discomfort
Slovenian: • bolečine v mišicah in neudobje, • bolečine v sklepih,
English: Nervous system disorders Common: Headache, insomnia Very rare: Peripheral neuropathy (or paraesthesiae)
Slovenian: Zelo redki: periferna nevropatija (ali parestezija) Bolezni dihal, prsnega koša in mediastinalnega prostora Pogosti: kašelj, nosni simptomi
English: Atovaquone/Lamivudine
Slovenian: atovakon/lamivudin
English: Ranitidine/Lamivudine
Slovenian: ranitidin/lamivudin
English: Dosage in the elderly: No specific data are available, however special care is advised in this age group due to age associated changes such as the decrease in renal function and alteration of haematological parameters.
Slovenian: zaradi s starostjo povezanih sprememb, kot sta zmanjšano delovanje ledvic in spremembe v hematoloških parametrih, potrebna posebna previdnost pri odmerjanju.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Slovenian: DATUM ZADNJE REVIZIJE BESEDILA MM/LLLL
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR THE CONTAINER
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA PLASTENKO
English: Children weighing from 14 kg to 21 kg: the recommended oral dose of Lamivudine/Zidovudine Teva is one-half tablet taken twice daily.
Slovenian: Otroci s telesno maso od 14 kg do 21 kg: Priporočeni peroralni odmerek zdravila
English: Lamivudine/Zidovudine Teva contains lamivudine and zidovudine, therefore any interactions identified for these individually are relevant to Lamivudine/Zidovudine Teva.
Slovenian: Zdravilo Lamivudin/zidovudin Teva vsebuje lamivudin in zidovudin, zato je katerakoli interakcija,
English: Phenytoin/Lamivudine
Slovenian: fenitoin/lamivudin
English: Phenytoin/Zidovudine
Slovenian: fenitoin/zidovudin
English: Zidovudine concentrations are increased in patients with advanced renal failure.
Slovenian: Pri bolnikih z napredovalo odpovedjo ledvic so koncentracije zidovudina povišane.
English: • stiffness in the joints
Slovenian: • mravljinčenje v koži,
English: Skin and subcutaneous tissue disorders Uncommon: Rash and pruritus Rare: Nail and skin pigmentation, urticaria and sweating
Slovenian: Pogosti: pigmentacija nohtov in kože, urtikarija in znojenje Bolezni mišično-skeletnega sistema in vezivnega tkiva
English: • drowsiness
Slovenian: • vrtoglavica,
English: (often referred to as PCP)
Slovenian: Pneumocystis Pneumocystis jirovecii (pogosto omenjena kot PCP);
English: • numbness
Slovenian: RAZNO
English: (neutropenia).
Slovenian: • bruhanje,
English: Haematological adverse reactions: Anaemia, neutropenia and leucopenia (usually secondary to neutropenia) can be expected to occur in patients receiving zidovudine.
Slovenian: Neželene hematološke reakcije: Pri bolnikih, ki prejemajo zidovudin se lahko pričakuje pojav anemije,
English: No Lamivudine/Zidovudine Teva dosage adjustment necessary, unless patient has renal impairment (See Section
Slovenian: Teva ni potrebna, razen če ima bolnik okvaro ledvic (glejte poglavje 4.2).
English: To ensure administration of the entire dose, the tablet(s) should ideally be swallowed without crushing.
Slovenian: Najbolje je, da bolnik tableto (tablete) pogoltne celo (cele) brez drobljenja, saj le v tem primeru povsem zanesljivo vzame celoten predpisani odmerek.
English: Musculoskeletal and connective tissue disorders Common: Arthralgia, muscle disorders Rare: Rhabdomyolysis
Slovenian: Pogosti: artralgija, mišične okvare
English: Based on these data lamivudine/zidovudine may be administered with or without food.
Slovenian: Bolnik lahko zdravilo Lamivudin/zidovudin Teva jemlje skupaj s hrano ali brez nje.
English: Metabolism and nutrition disorders Very Rare: Lactic acidosis
Slovenian: Zelo redki: laktacidoza Bolezni živčevja Pogosti: glavobol, nespečnost
English: Milk: 13.5 days.
Slovenian: Mleko: 13,5 dneva.
English: The MIC distribution pattern has not changed notably during recent years.
Slovenian: Vzorec porazdelitve MIK se v zadnjih letih ni občutno spremenil.
English: A Piso 2 Parque Industrial e Comercial Serra das Minas
Slovenian: Parque Industrial e Comercial Serra das Minas
English: In addition, clinical efficacy data have been presented to support the aforementioned indication.
Slovenian: Poleg tega so bili v podporo zgoraj omenjeni indikaciji predloženi tudi podatki o klinični učinkovitosti.
English: 1107 Budapest Hungary
Slovenian: 1107 Budapest
English: Therefore, the risk of resistance development among these bacteria can presently not be fully evaluated.
Slovenian: Posledično tveganja za razvoj odpornosti pri teh bakterijah trenutno ni mogoče natančno ovrednotiti.
English: 2635-432 Rio de Mouro Portugal
Slovenian: 2635-432 Rio de Mouro
English: Antimicrobial resistance
Slovenian: Protimikrobna odpornost
English: Via Vittor Pisani 16 20124 Milano Italy
Slovenian: Via Vittor Pisani 16 20124 Milano Italija
English: Ceva Saúde Animal - Produtos Farmacêuticos e Imunológicos, Lda.
Slovenian: Portugalska Ceva Saúde Animal - Produtos Farmacêuticos e Imunológicos, Lda.
English: Official, national and regional antimicrobial policies should be taken into account when the product is used.
Slovenian: Pri uporabi zdravila je treba upoštevati uradne, nacionalne in regionalne politike glede uporabe protimikrobnih zdravil.
English: If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.
Slovenian: Če to ni mogoče, mora zdravljenje temeljiti na lokalnih (regionalnih, na ravni kmetije) epidemioloških podatkih o občutljivosti ciljnih bakterij.
English: Ceva-Phylaxia Zrt.
Slovenian: Madžarska Ceva-Phylaxia Zrt.
English: A limited resistant populaton was observed above 64 µg/ml.
Slovenian: Omejeno odporno populacijo so opazili pri vrednostih nad 64 µg/ml.