FrancophonIA/ELRC3.0 huggingface dataset:
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Syringe labelling
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
English: NAME OF THE VETERINARY MEDICINAL PRODUCT EQUIOXX 8.2 mg/g oral paste for horses.
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI EQUIOXX 8.2 mg/g peroralna pasta za konje
English: Concurrent administration of potentially nephrotoxic veterinary medicinal products should be avoided.
Slovenian: Ne dajajte sočasno z zdravili za uporabo v veterinarski medicini, ki so potencialno toksična za ledvice.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/08/083/002
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/08/083/002
English: EXPIRY DATE EXP {month/year} Once opened, use within 3 months
Slovenian: Odprto zdravilo uporabite znotraj 3 mesecev
English: For animal treatment only - To be supplied only on veterinary prescription.
Slovenian: Samo za živali - RpVet.
English: Lesions (erosion/ulceration) of the oral mucosa and of the skin around the mouth may occasionally be observed in treated animals when administered the recommended treatment dose.
Slovenian: Pri živalih, zdravljenih s priporočenimi odmerki zdravila, se občasno pojavijo poškodbe (erozije /ulkusi) na ustni sluznici in na koži okrog ust.
English: The VICH GL 6 states that:
Slovenian: Smernica VICH GL 6 določa:
English: Evaluation of the environmental risk assessment
Slovenian: Vrednotenje ocene okoljevarstvenega tveganja
English: Therefore, in principle, a Phase II could exceptionally be requested.
Slovenian: Zato se načeloma lahko zahteva izjema s fazo II.
English: In view of the disagreement the issue was referred to CVMP.
Slovenian: Zaradi tega nestrinjanja je bila zadeva napotena na CVMP.
English: These situations are expected to be the exception rather than the rule and some evidence in support of the concern should be available.”
Slovenian: Pričakuje se, da so te okoliščine bolj izjema kot pravilo, zato morajo biti v podporo zadržkom razpoložljivi določeni dokazi.“
English: Furthermore, the scenarios for pig and poultry manure are not necessary comparable as breeding conditions, application and agricultural practises for handling of manure are often very different.
Slovenian: Poleg tega scenarija za prašičji in perutninski gnoj nista nujno primerljiva, saj so pogoji reje, uporaba zdravila in kmetijska praksa ravnanja z gnojem pogosto zelo različni.
English: The Phase II evaluation performed by the Applicant was based on:
Slovenian: Oceno faze II je predlagatelj opravil na podlagi:
English: La Ballastière 33500 Libourne FRANCE Bristol
Slovenian: La Ballastière 33500 Libourne FRANCIJA Bristol ZDRUŽENO KRALJESTVO
English: • The rearing and production methods are similar in poultry and pigs,
Slovenian: • metode vzreje in pridelave so pri perutnini in prašičih podobne,
English: During the decentralised procedure the disagreement between the Member States was on the adequacy of the data provided for the Phase II Environmental Risk Assessment.
Slovenian: Med decentraliziranim postopkom se je med državami članicami pojavilo nestrinjanje glede zadostnosti podatkov, predloženih za oceno okoljskega tveganja faze II.
English: This response was accepted by the reference Member State but rejected by some Concerned Member States on the basis that the reference to end point values from published summary of an assessment was not sufficient to substitute environmental risk assessment data.
Slovenian: Referenčna država članica je ta odgovor sprejela, določene zadevne države članice pa so ga zavrnile z utemeljitvijo, da s sklicem na vrednosti končne točke iz objavljenega povzetka ocene ni mogoče nadomestiti podatkov ocene okoljevarstvenega tveganja.
English: The information provided does not contain details on the design, conduct, analysis and results of the study allowing a full and independent assessment therefore does not allow for a Phase II evaluation according to the legal requirements and relevant guidelines3 in force.
Slovenian: Predloženi podatki ne vsebujejo podrobnosti o zasnovi, izvedbi, analizi in rezultatih študije, ki bi omogočile popolno in neodvisno oceno, zato ne omogočajo vrednotenja faze II po veljavnih pravnih zahtevah ter zadevnih smernicah.3
English: 2.1 Assessment of Phase II data provided
Slovenian: 2.1 Ocena predloženih podatkov faze II
English: It is indicated for the prevention of clinical signs of coccidiosis in neonatal piglets on farms with a confirmed history of coccidiosis caused by Isospora sui.
Slovenian: Indicirano je za preprečevanje kliničnih znakov kokcidioze pri novoskotenih pujskih na kmetijah, kjer so bili v preteklosti potrjeni primeri kokcidioze zaradi Isospora sui.
English: 2.1 Evaluation of Phase I and considerations on the need for a Phase II assessment
Slovenian: 2.1 Vrednotenje faze I in utemeljevanje potrebe po oceni faze II
English: • argumentation for that the predicted environmental concentration (PEC) resulting from the use of the product in pigs is inferior to that, which arises from its use in poultry.
Slovenian: • argumenta, da je predvidena koncentracija v okolju (PKO), ki je posledica uporabe zdravila pri prašičih, manjša od koncentracije, do katere pride pri uporabi tega zdravila pri perutnini.
English: “Some VMPs that might otherwise stop in Phase I may require additional environmental information to address particular concerns associated with their activity and use.
Slovenian: „Za določena zdravila za uporabo v veterinarski medicini bi se sicer ocena lahko ustavila v fazi I, vendar so morda potrebni dodatni okoljski podatki za obravnavo posebnih zadržkov, ki so povezani z njihovo aktivnostjo in uporabo.
English: Having considered the overall data submitted in writing and in the oral explanation the CVMP concluded after consulting with its Environmental Risk Assessment Working Party that the objections raised during the decentralised procedure should not prevent the granting of a Marketing Authorisation.
Slovenian: CVMP je ob upoštevanju vseh podatkov, predloženih pisno in z ustnim pojasnilom, ter po posvetovanju s svojo delovno skupino za pripravo ocene okoljskega tveganja zaključil, da zadržki, ki so bili predstavljeni med decentraliziranim postopkom, ne smejo preprečiti odobritve dovoljenja za promet z zdravilom.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, APPLICANT/ MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
Slovenian: SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI, ŽIVALSKIH VRST, POTI UPORABE ZDRAVILA IN PREDLAGATELJEV/IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
English: Frequency and route of administration species
Slovenian: Pogostost in pot uporabe zdravila vrsta
English: It is acknowledged that the main metabolite is probably the same for pigs and poultry for this compound and that the calculations in Phase I of the ERA take 100% of the dose into account (total residue approach) when environmental exposure is calculated.
Slovenian: Prizna se, da je poglavitni presnovek omenjene spojine verjetno enak pri prašičih in perutnini in da se pri izračunih okoljevarstvenega tveganja faze I, ko gre za okoljsko izpostavljenost, upošteva 100 % odmerka (pristop s celotnimi ostanki).
English: Potential variation in metabolism is therefore of little practical importance in the Phase I calculation of the PEC value.
Slovenian: Možne variacije v presnovi so zato pri izračunu vrednosti PKO faze I v praksi manjšega pomena.
English: The product is a generic of Baycox 5% oral solution.
Slovenian: Zdravilo je generična različica zdravila Baycox 5 % peroralna raztopina.
English: In addition to the question whether the provided data was sufficient for a Phase II assessment (see above) the Committee revisited the Phase I submitted with the application in order to reach an opinion on whether the marketing authorisation for the product could be granted or should be refused in accordance with Article 36 of Directive 2001/82/EC.
Slovenian: Odbor je poleg vprašanja, ali predloženi podatki zadostujejo za oceno faze II (glejte zgoraj), obravnaval tudi oceno faze I, ki je bila priložena vlogi za pridobitev dovoljenja za promet z zdravilom, da bi pripravil mnenje o odobritvi ali zavrnitvi dovoljenja za promet z zdravilom v skladu s členom 36 Direktive 2001/82/ES.
English: The current evidence is therefore not sufficient to justify a prevalence of particular concern and thereby to request a Phase II evaluation.
Slovenian: Predstavljeni dokazi torej ne zadostujejo za utemeljitev prevlade posebnega zadržka in s tem zahteve po oceni faze II.
English: Some concerned Member States raised potential concerns with the persistence of the main metabolite of toltrazuril, toltrazuril sulphone, and therefore the applicant was required to submit a Phase II.
Slovenian: Nekatere zadevne države članice so izrazile morebitne zadržke glede ohranjanja glavnega presnovka toltrazurila, tj. toltrazurilsulfona, in zato so od predlagatelja zahtevale predložitev ocene faze II.
English: The CVMP concludes that the information provided by the Applicant does not allow for a Phase II evaluation according to the legal requirements and guidelines in force.
Slovenian: CVMP zaključuje, da podatki, ki jih je predložil predlagatelj, ne omogočajo ocene faze II v skladu z veljavnimi pravnimi zahtevami in smernicami.
English: Therefore the environmental risk assessment could stop at Phase I, unless there were particular concerns justifying a request for a Phase II evaluation as foreseen in the VICH GL 6.
Slovenian: Zato nadaljnja ocena okoljskega tveganja po fazi I ni potrebna, če ni posebnih zadržkov, s katerimi se utemeljuje zahteva po oceni faze II, kakor je predvideno s smernico VICH GL 6.
English: 3 CVMP/VICH GL6: Environmental impact assessment (EIAS) for veterinary medicinal products - Phase I (CVMP/VICH/592/98-FINAL), CVMP/VICH GL38: Environmental impact assessments for veterinary medicinal products (VMPs) - Phase II (CVMP/VICH/790/03-FINAL) and Environmental Impact Assessment for Veterinary Medicinal Products in support of the VICH guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005- Rev.1)
Slovenian: (CVMP/VICH/592/98-FINAL), CVMP/VICH GL38: Ocena okoljevarstvenega vpliva zdravil za uporabo v veterinarski medicini (VMP) - faza II (CVMP/VICH/790/03-FINAL) in Ocena okoljevarstvenega vpliva zdravil za uporabo v veterinarski medicini v podporo smernicam VICH GL6 in GL38 (EMEA/CVMP/ERA/418282/2005Rev.1).
English: Some evidence from the public domain indicates that the main metabolite and degradation product in soil of toltrazuril - toltrazuril sulphone - is persistent, phytotoxic and mobile with the potential to leach to groundwater.
Slovenian: Določeni javno dostopni dokazi kažejo, da je toltrazurilov glavni presnovek in produkt razgradnje v tlehtoltrazurilsulfon - perzistenten, fitotoksičen in mobilen, s potencialom spiranja v podtalnico.
English: • the conclusions from the referral procedure under Article 35 of Directive 2001/82/EC regarding veterinary medicinal products containing toltrazuril intended for use in poultry species in relation to environmental risk assessment and;
Slovenian: • zaključkov iz napotitvenega postopka po členu 35 Direktive 2001/82/ES v zvezi z oceno okoljskega tveganja za zdravila za uporabo v veterinarski medicini, ki vsebujejo toltrazuril in so namenjena uporabi pri perutnini; in
English: • The PECsoil was clearly inferior in pigs compared to poultry,
Slovenian: • vrednost PKOtla je bila jasno manjša pri prašičih kot pri perutnini,
English: The CVMP has, however, previously concluded that toltrazuril and toltrazuril sulphone do not pose an unacceptable risk at environmental concentrations exceeding the concentrations predicted as a result of normal use of Cevazuril 50mg/ml oral suspension for piglets.
Slovenian: Vendar je CVMP predhodno zaključil, da toltrazuril in toltrazurilsulfon pri okoljskih koncentracijah, ki presegajo koncentracije, predvidene pri običajni rabi zdravila Cevazuril 50 mg/ml peroralna suspenzija za pujske, ne predstavljata nesprejemljivega tveganja.
English: Therefore, the CVMP recommends the granting of the marketing authorisation for CEVAZURIL 50 mg/ml oral suspension for piglets for which the Summary of Product Characteristics, labeling and package leaflet are set out in Annex III of the CVMP Opinion.
Slovenian: CHMP zato priporoča odobritev dovoljenja za promet z zdravilom CEVAZURIL 50 mg/ml peroralna suspenzija za pujske, katerega povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so navedeni v Dodatku III mnenja CVMP.
English: The environmental risk assessment of the product in accordance to the VICH GL 6 (Environmental Impact Assessment for veterinary medicinal products- Phase I, CVMP/VICH/592/98-Final) concluded that the PECsoil for piglets was 12 µg/kg, which is well below the trigger value for a Phase II assessment of 100 µg/kg.
Slovenian: Na podlagi ocene okoljskega tveganja zdravila v skladu s smernico VICH GL 6 (Ocena okoljevarstvenega vpliva zdravil za uporabo v veterinarski medicini - faza I, CVMP/VICH/592/98-Final) je prišlo do zaključka, da je vrednost PKOtla za pujske 12 µg/kg, kar je precej pod mejno vrednostjo 100 µg/kg, pri kateri se zahteva ocena faze II.
English: In response to the questions raised in the decentralised procedure the Applicant referred to the CVMP conclusions reached during the referral procedure under Article 35 of Directive 2001/82/EC regarding veterinary medicinal products containing toltrazuril intended for use in poultry species in relation to environmental risk assessment and argued that:
Slovenian: Predlagatelj je v odgovoru na vprašanja, ki so se pojavila med decentraliziranim postopkom, navedel zaključke CVMP iz napotitvenega postopka po členu 35 Direktive 2001/82/ES v zvezi z oceno okoljskega tveganja za zdravila za uporabo v veterinarski medicini, ki vsebujejo toltrazuril in so namenjena uporabi pri perutnini, ter predstavil naslednje argumente:
English: The recommended dose is a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0.4 ml oral suspension per kg body weight, on day 3-5 of life.
Slovenian: Priporočeni odmerek je en peroralni odmerek 20 mg toltrazurila/kg telesne mase, kar ustreza 0,4 ml peroralne suspenzije na kg telesne mase 3.-5. dan življenja.
English: The CVMP considers that on the basis of the current information there is no scientific justification to request a Phase II evaluation and therefore the environmental risk assessment of the product can stop at Phase I.
Slovenian: CVMP meni, da na podlagi trenutnih podatkov ni znanstvene utemeljitve za zahtevo po oceni faze II in zato nadaljnja ocena okoljskega tveganja po fazi I ni potrebna.
English: In summary the CVMP concludes that the information submitted by the Applicant with regard to the Phase II evaluation is insufficient and therefore should a Phase II assessment be required for the evaluation of the product, a marketing authorisation should not be granted.
Slovenian: CVMP torej zaključuje, da podatki, ki jih je predlagatelj predložil v zvezi z vrednotenjem faze II, ne zadostujejo, zato se v primeru, da bi bila za vrednotenje zdravila potrebna ocena faze II, dovoljenje za promet z zdravilom ne sme odobriti.
English: The Applicant initially provided a Phase I evaluation only for the environmental risk assessment of the product concluding that the PECsoil was largely below 100 μg/kg.
Slovenian: Predlagatelj je na začetku v okviru ocene okoljskega tveganja zdravila predložil le vrednotenje faze I, pri čemer je zaključil, da je vrednost PKOtla precej pod 100 μg/kg.
English: The Committee considered the Phase I evaluation of the environmental risk assessment from the Applicant for Cevazuril 50 mg/kg for oral use in piglets in order to establish whether the environmental risk assessment of the product could stop at Phase I or whether a Phase II evaluation would be required.
Slovenian: Odbor je obravnaval predlagateljevo vrednotenje ocene okoljskega tveganja faze I za zdravilo Cevazuril 50 mg/kg za peroralno uporabo pri pujskih, da bi določil, ali je potrebna le ocena faze I ali tudi vrednotenje faze II.
English: The CVMP therefore concluded that the environmental risk assessment of the product can stop at Phase I.
Slovenian: Zato je CVMP zaključil, da nadaljnja ocena okoljskega tveganja zdravila po fazi I ni potrebna.
English: Marketing Authorisation granted
Slovenian: Dovoljenje za promet z zdravilom odobreno.
English: CEVAZURIL 50 mg/ml oral suspension for piglets is a suspension for oral administration, which contains 50 mg toltrazuril/ml as an active substance.
Slovenian: Zdravilo CEVAZURIL 50 mg/ml peroralna suspenzija za pujske je suspenzija za peroralno uporabo, ki vsebuje 50 mg zdravilne učinkovine toltrazurila/ml.
English: Strength Animal
Slovenian: Živalska
English: 12 µg/kg, which is well below the trigger value for a Phase II assessment of 100 µg/kg.
Slovenian: Z omenjeno oceno faze I je zaključil, da je vrednost PKOtla za pujske 12 μg/kg, kar je precej pod mejno vrednostjo 100 µg/kg, pri kateri se zahteva ocena faze II.
English: • The metabolism of toltrazuril was considered as qualitatively similar in poultry and in pigs Therefore the Applicant considered that the conclusions from the CVMP referral for poultry could be extrapolated to piglets.
Slovenian: • presnova toltrazurila se pri perutnini in prašičih šteje za kvalitativno podobno.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF CEVAZURIL 50mg/ml oral suspension for piglets
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA CEVAZURIL 50 mg/ml peroralna suspenzija za pujske
English: Luxembourg Ceva Santé Animale Z.I.
Slovenian: Luksemburg Ceva Santé Animale Z.I.
English: Hungary Ceva Santé Animale Z.I.
Slovenian: Madžarska Ceva Santé Animale Z.I.
English: Germany Ceva Santé Animale Z.I.
Slovenian: Portugalska Ceva Santé Animale Z.I.
English: Denmark Ceva Santé Animale Z.I.
Slovenian: Nizozemska Ceva Santé Animale Z.I.
English: CEVAZURIL 50 mg/ml, Suspensija iekšķīgai
Slovenian: CEVAZURIL 50 mg/ml, Suspensija iekšķīgai lietošanai dēļ sivēni
English: For more information see
Slovenian: Za več informacij
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 13 November 2013
Slovenian: Datum prve odobritve: 13. november 2013
English: • Any signs of inflammation or infection.
Slovenian: • Vsakršni znak vnetja ali okužbe.
English: (may affect 1 to 10 in every 100 patients treated)
Slovenian: (pojavijo se lahko pri 1 do 10 od 100 bolnikov, ki se zdravijo)
English: These symptoms may indicate that your body's improved immune system is fighting infection.
Slovenian: Ti simptomi lahko nakazujejo, da se izboljšan imunski sistem vašega telesa bori proti okužbi.
English: If you have hepatitis B infection, your doctor will carefully consider the best treatment for you.
Slovenian: Če ste okuženi s hepatitisom B, bo vaš zdravnik skrbno razmislil o najboljšem
English: The long-term effects of substantial increases in progesterone exposure are unknown.
Slovenian: Dolgoročni učinki bistvenega zvišanja izpostavljenosti progesteronu niso znani.
English: The HIV virus produces an enzyme called HIV integrase.
Slovenian: Virus HIV proizvaja encim, ki se imenuje integraza HIV.
English: Talk to your doctor if you are taking:
Slovenian: Povejte svojemu zdravniku, če jemljete:
English: • contraceptive pill, used to prevent pregnancy
Slovenian: • kontracepcijske tabletke, uporabljajo se za preprečevanje nosečnosti
English: INR should continue to be monitored during the first weeks following cessation of treatment with Vitekta.
Slovenian: INR je treba še naprej spremljati prve tedne po prenehanju zdravljenja z zdravilom Vitekta.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on
Slovenian: O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o
English: The use of Vitekta in children and adolescents has not yet been studied.
Slovenian: Uporabe zdravila Vitekta pri otrocih in mladostnikih še niso preučili.
English: The safety and efficacy of elvitegravir in children aged 0 to less than 18 years have not yet been established (see section 5.1).
Slovenian: Varnost in učinkovitost elvitegravirja pri otrocih, starih 0 do manj kot 18 let, še nista bili dokazani (glejte poglavje 5.1).
English: a The difference in proportions and its 95% CIs between randomised treatment groups is based on normal approximation.
Slovenian: a Razlika v deležih in njihovi 95-odstotni IZ med randomiziranimi skupinami zdravljenja temelji na normalnem
English: This enzyme helps the virus to multiply in the cells in your body.
Slovenian: Ta encim pomaga virusu, da se razmnožuje v celicah vašega telesa.
English: Treatment of overdose with elvitegravir consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient.
Slovenian: Zdravljenje prevelikega odmerjanja elvitegravirja je sestavljeno iz splošnih podpornih ukrepov, ki vključujejo nadziranje vitalnih znakov in opazovanje kliničnega stanja bolnika.
English: Talk to your doctor if you are taking: • rifabutin, used to treat bacterial infections including tuberculosis
Slovenian: Povejte svojemu zdravniku, če jemljete: • rifabutin, uporablja se za zdravljenje bakterijskih okužb, vključno s tuberkulozo
English: Tell your doctor or pharmacist if you are taking, plan to take, or have recently taken any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, načrtujete jemanje ali ste pred kratkim jemali katero koli drugo zdravilo.
English: Difference in percentages (95% CI)
Slovenian: Razlika v odstotkih (95-odstotni IZ)
English: No data are available for children below 18 years of age.
Slovenian: Podatkov za otroke stare do 18 let ni na voljo.
English: Elvitegravir has a relatively low genetic barrier to resistance.
Slovenian: Elvitegravir ima relativno nizko gensko pregrado za rezistenco.
English: If you are pregnant, you should not take Vitekta unless you and your doctor decide it is clearly needed.
Slovenian: Če ste noseči, ne smete jemati zdravila Vitekta, razen če ste se vi in vaš zdravnik odločili, da je to nujno potrebno.
English: Your doctor will test for these changes.
Slovenian: Zdravnik bo opravil preiskave glede teh
English: Vitekta must always be taken with certain other HIV medicines.
Slovenian: Zdravilo Vitekta je treba vedno jemati z nekaterimi drugimi zdravili proti HIV.
English: Stopping Vitekta can seriously affect your response to future treatment.
Slovenian: Prenehanje jemanja zdravila Vitekta lahko resno vpliva na vaš odziv na prihodnje zdravljenje.
English: Virologic response rate was evaluated in both treatment arms.
Slovenian: Stopnja virološkega odziva je bila ocenjena v obeh krakih zdravljenja.
English: Your doctor will discuss the potential benefits and risks of taking Vitekta to you and your child.
Slovenian: Vaš zdravnik se bo z vami pogovoril o možnih koristih in tveganjih zdravljenja z zdravilom Vitekta za vas in vašega
English: This includes medicines and herbal products obtained without a prescription.
Slovenian: To velja tudi za zdravila in zeliščne pripravke, ki ste jih dobili brez recepta.
English: • didanosine (see also section 3 of this leaflet)  Tell your doctor if you are taking any of these HIV medicines.
Slovenian: • didanozin (glejte tudi poglavje 3 tega navodila)  Povejte zdravniku, če jemljete katero od teh zdravil za zdravljenje okužbe s HIV.
English: • rifampicin, used to prevent and treat tuberculosis and other infections
Slovenian: • rifampicin, uporablja se za preprečevanje in zdravljenje tuberkuloze in drugih okužb
English: • if you are allergic to elvitegravir or any of the other ingredients of this medicine (listed in section 6 of this leaflet).
Slovenian: • Če ste alergični na elvitegravir ali katero koli sestavino tega zdravila (navedeno v poglavju 6 tega navodila).