FrancophonIA/ELRC3.0 huggingface dataset:
English: Criteria to be used to verify the success of proposed risk minimisation activity: Implementation of the education program will be monitored by the MAH via auditing.
Slovenian: Merila, ki jih je treba uporabiti za preverjanje uspeha predlagane aktivnosti za zmanjšanje tveganja: Implementiranje izobraževalnega programa bo nadziral imetnik dovoljenja za promet z revizijami.
English: Your doctor will check whether your symptoms were related to a hypersensitivity reaction.
Slovenian: Zdravnik bo preveril, ali so bili simptomi povezani s preobčutljivostno reakcijo.
English: Detach this card and keep it with you at all times.
Slovenian: Kartico odtrgajte in jo imejte vedno pri sebi.
English: Methadone: CL/F ↑22%
Slovenian: metadon: CL/F ↑22%
English: Includes three non-virological failures and four unconfirmed virological failures.
Slovenian: Vključuje tri nevirusne neuspehe in štiri nepotrjene virusne neodzive.
English: These may affect up to 1 in 100 people and may show up in blood tests:
Slovenian: Pojavijo se lahko pri največ 1 od 100 bolnikov in se lahko pokažejo v preiskavah krvi:
English: • if they are also taking anti-inflammatory medicines called corticosteroids
Slovenian: • če prejemajo tudi protivnetna zdravila, imenovana kortikosteroidi;
English: Such infections may have been “silent” and not detected by the weak immune system before treatment was started.
Slovenian: Take okužbe so lahko "tihe" in jih oslabeli imunski sistem ne zazna, dokler se ne začne zdravljenje.
English: Safety Concern
Slovenian: Skrbi glede varnosti
English: Tell your doctor if you have heart problems, if you smoke, or have other illnesses that may increase your risk of heart disease such as high blood pressure, or diabetes.
Slovenian: Zdravniku morate povedati, če imate kakšne težave s srcem, če kadite, ali če imate druge bolezni, ki lahko povečajo tveganje koronarne bolezni srca (npr. visok krvni tlak ali sladkorno bolezen).
English: It cannot be excluded that abacavir may increase the risk of having a heart attack.
Slovenian: Ni mogoče izključiti, da abakavir poveča tveganje za srčni infarkt.
English: From these results, it can be concluded with 95% confidence that the true difference is no greater than 8.4% in favour of the twice daily regimen.
Slovenian: Iz teh rezultatov lahko s 95 % verjetnostjo zaključimo, da dejanska razlika, ki bi se nagibala v korist režima odmerjanja dvakrat dnevno ni večja od 8,4 %.
English: Do not take this medicine after the expiry date shown on the carton.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
English: The recommended dose of Kivexa is one tablet once daily.
Slovenian: Priporočeni odmerek zdravila Kivexa je ena tableta enkrat dnevno.
English: The symptoms of autoimmune disorders may develop many months after you start taking medicine to treat your HIV infection.
Slovenian: Simptomi avtoimunskih bolezni se lahko razvijejo veliko mesecev po tem, ko začnete jemati zdravilo za zdravljenje okužbe s HIV.
English: • if you have moderate or severe liver disease
Slovenian: • če imate zmerno ali hudo bolezen jeter;
English: (Inhibition of alcohol dehydrogenase)
Slovenian: (zavrtje alkoholne dehidrogenaze)
English: KIVEXA TABLETS ALERT CARD SIDE 1
Slovenian: OPOZORILNA KARTICA ZA TABLETE KIVEXA STRAN 1
English: While the clinical relevance of these findings is unknown, these data suggest that a carcinogenic risk to humans is outweighed by the potential clinical benefit.
Slovenian: Čeprav klinična pomembnost teh ugotovitev ni znana, ti podatki kažejo, da pri človeku potencialna klinična korist prevlada nad tveganjem zaradi karcinogenosti.
English: Key elements included in the educational material to increase understanding and awareness of ABC HSR and expand on the information already included in the currently approved EU SPC:
Slovenian: Ključni elementi, vključeni v izobraževalno gradivo za povečanje razumevanja in ozaveščenosti o preobčutljivostnih reakcijah na ABC in razširitev informacij, ki so že vključene v trenutno odobreni SPC za EU:
English: In these cases the physician should refer to the individual product information for these medicinal products.
Slovenian: V takšnih primerih mora zdravnik upoštevati informacije o vsakem posameznem zdravilu.
English: In addition, the 69 insertion complex or the Q151M mutation, usually found in combination with A62V,
Slovenian: Poleg tega sta insercijski kompleks na mestu 69 ali mutacija Q151M, običajno ugotovljena v kombinaciji z A62V,
English: ABC HSR Education Programme has been in place since the first approval of ABC as the single active preparation, ZIAGEN (USA December 1998, EU July 1999).
Slovenian: Izobraževalni program o preobčutljivostnih reakcijah na ABC je že udejanjen od prve odobritve ABC kot zdravila z eno učinkovino, ZIAGEN (ZDA, december 1998, EU julij 1999).
English: Frequencies are defined as very common (> 1/10), common (> 1/100 to < 1/10), uncommon (> 1/1000 to < 1/100), rare (> 1/10,000 to < 1/1000), very rare
Slovenian: Pogostnost je navedena kot: zelo pogosti (> 1/10), pogosti (> 1/100 do < 1/10), občasni (> 1/1.000 do < 1/100), redki (> 1/10.000 do < 1/1.000) in zelo redki (< 1/10.000).
English: These were primarily asymptomatic HIV infected patients (CDC stage A).
Slovenian: V študijo so bili vključeni pretežno z virusom HIV okuženi asimptomatski bolniki (CDC stadij A).
English: CD4 cells are a type of white blood cells that are important in helping your body to fight infection.
Slovenian: Celice CD4 so vrsta belih krvnih celic, ki so pomembne za premagovanje okužb.
English: If you have taken Kivexa during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Slovenian: Če ste zdravilo Kivexa jemali med nosečnostjo, vas lahko zdravnik naroči na redne preiskave krvi in druge diagnostične preiskave, da bo spremljal razvoj vašega otroka.
English: V75I, F77L and F116Y, cause a high level of resistance to abacavir.
Slovenian: V75I, F77L in F116Y, povzročila visoko stopnjo odpornosti proti abakavirju.
English: Possible interaction given common pathway of elimination via alcohol dehydrogenase.
Slovenian: Možna interakcija preko skupne poti izločanja preko alkoholne dehidrogenaze.
English: Drugs by Therapeutic Area Interaction Geometric mean change (%) (Possible mechanism)
Slovenian: Medsebojno delovanje Geometrijska sredina spremembe (%) (možni mehanizem)
English: Cases of pancreatitis have been reported
Slovenian: Poročali so o primerih pankreatitisa.
English: • difficulty in sleeping (insomnia)
Slovenian: • težave s spanjem (insomnija);
English: Kivexa does not completely cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level.
Slovenian: Zdravilo Kivexa okužbe s HIV ne ozdravi, ampak zmanjša količino virusa v telesu in jo vzdržuje na nizki ravni.
English: The systemic exposures were equivalent to 7 to 24 times the expected systemic exposure in humans.
Slovenian: Sistemske izpostavljenosti so bile ekvivalentne od 7- do 24-kratni sistemski izpostavljenosti, kakršna se pričakuje pri človeku.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Slovenian: • ob vskršni spremembi sistema za obvladanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnikj (farmakovigilančni ali povezan z zmanševanjem tveganja).
English: Sorbitol solution (3.2 g, 10.2 g, 13.4 g)/ Lamivudine
Slovenian: Raztopina sorbitola (3,2g , 10,2 g, 13,4 g)/lamivudin
English: Additionally, the efficacy and safety of this combination given once daily has been demonstrated in a pivotal clinical study (CNA30021- See Clinical experience).
Slovenian: Še več, učinkovitost in varnost takšne kombinacije, dane enkrat dnevno, je bila dokazana s ključno klinično študijo (CNA30021- Glejte Klinične izkušnje).
English: Very rare side effects that may show up in blood tests are: • a failure of the bone marrow to produce new red blood cells (pure red cell aplasia).
Slovenian: Zelo redek neželeni učinek, ki se lahko pokaže v preiskavah krvi, je: • nesposobnost kostnega mozga, da proizvaja nove rdeče krvne celice (čista aplazija rdečih krvnih celic).
English: If your doctor advises that you can start taking Kivexa again, you may be asked to take your first doses in a place where you will have ready access to medical care if you need it.
Slovenian: Če vam zdravnik svetuje, da lahko zdravilo Kivexa začnete jemati znova, vam bo morda naročil, da prvi odmerek vzamete na mestu, kjer bo nemudoma na voljo zdravniška pomoč, če bi jo potrebovali.
English: In such cases medicinal products containing abacavir should be permanently discontinued.
Slovenian: V takšnih primerih je potrebno zdravljenje z zdravili, ki vsebujejo abakavir, trajno opustiti.
English: Clinical diagnosis of suspected hypersensitivity to ABC remains the basis for clinical decision making.
Slovenian: Klinična diagnoza suma na preobčutljivost na ABC ostaja temelj za klinično odločanje.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Imetnik dovoljenja za promet z zdravilom mora redno posodobljena poročila o varnosti zdravila za to zdravilo predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (sezanmu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
English: Check with your doctor if you think this applies to you.
Slovenian: Posvetujte se z zdravnikom, če menite, da se to nanaša na vas.
English: Your methadone dose may need to be changed.
Slovenian: Morda bo treba spremeniti odmerek metadona.
English: The observed lamivudine half-life of elimination is 5 to 7 hours.
Slovenian: Opazovan eliminacijski razpolovni čas lamivudina znaša od 5 do 7 ur.
English: Antiviral Activity in vitro
Slovenian: Protivirusna aktivnost in vitro
English: A small amount of the ingredients in Kivexa can also pass into your breast milk.
Slovenian: Majhna količina sestavin zdravila Kivexa lahko prehaja v materino mleko.
English: Kivexa is not recommended for use during pregnancy.
Slovenian: Zdravila Kivexa ni priporočljivo uporabljati med nosečnostjo.
English: If you are taking methadone, you will be checked for any withdrawal symptoms.
Slovenian: Če jemljete metadon, vas bodo spremljali glede odtegnitvenih simptomov.
English: The list below should not be considered exhaustive but is representative of the classes studied.
Slovenian: V nadaljevanju navedene interakcije niso izčrpne, so pa reprezentativne za skupine na katerih so bile izvedene.
English: If you are hypersensitive to Kivexa, return all your unused Kivexa tablets for safe disposal.
Slovenian: Če ste preobčutljivi na zdravilo Kivexa, vrnite vse neporabljene tablete tega zdravila, da se varno uničijo.
English: Like all medicines, this medicine can cause side effects, although not everyone gets them.
Slovenian: Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: After starting treatment, the immune system becomes stronger, and may attack the infections, which can cause symptoms of infection or inflammation.
Slovenian: Po začetku zdravljenja se imunski sistem okrepi in lahko napade okužbe, to pa lahko povzroči simptome okužbe ali vnetja.
English: • lactic acidosis (excess lactic acid in the blood)
Slovenian: • laktacidoza (čezmerno kopičenje mlečne kisline v krvi).
English: Among the 104 patients who received Kivexa, including the ones who were between 40 kg and 25 kg, the viral suppression was similar
Slovenian: Med 104 bolniki, ki so prejeli zdravilo Kivexa, vključno s tistimi med 40 kg in 25 kg, je bila virusna supresija podobna.
English: Kivexa helps to control your condition.
Slovenian: Zdravilo Kivexa pomaga obvladovati vašo bolezen.
English: However, their main antiviral activity is through incorporation of the monophosphate form into the viral DNA chain, resulting in chain termination.
Slovenian: Glavni način njunega protivirusnega delovanja je vključitev monofosfatne oblike v verigo virusne DNA, kar ima za posledico prekinitev verige.
English: Pharmacotherapeutic group: Antivirals for systemic use, antivirals for treatment of HIV infections, combinations.
Slovenian: Farmakoterapevtska skupina: Zdravila za sistemsko zdravljenje virusnih infekcij, antivirusna zdravila za zdravljenje HIV, kombinacije.
English: • palpitations (rapid or irregular heartbeat) or tremor
Slovenian: • palpitacije (hitro ali neredno bitje srca) ali tremor,
English: • an increase in the level of liver enzymes
Slovenian: • povečane vrednosti jetrnih encimov;
English: It is not known whether abacavir can be removed by peritoneal dialysis or haemodialysis.
Slovenian: Ni znano, če je abakavir možno odstraniti s peritonealno dializo ali hemodializo.
English: Adults, adolescents and children weighing at least 25 kg:
Slovenian: Odrasli, mladostniki in otroci, ki tehtajo vsaj 25 kg:
English: You are more likely to develop this reaction if you have a gene called HLA-B*5701 (but you can get a reaction even if you do not have this gene).
Slovenian: Pojav te reakcije je verjetnejši, če imate gen HLA-B*5701 (vendar se vam reakcija lahko pojavi, tudi če nimate tega gena).
English: Restarting abacavir in such patients must be done in a setting where medical assistance is readily available.
Slovenian: Ponovno uvedbo abakavirja je treba pri takšnih bolnikih opraviti v okolju, kjer je takoj na voljo zdravniška pomoč.
English: Not everyone responds to treatment with Kivexa in the same way.
Slovenian: Na zdravilo Kivexa se ne odzovejo vsi bolniki enako.
English: When prescribing Kivexa, action should be taken to try to minimize all modifiable risk factors (e.g. smoking, hypertension, and hyperlipidaemia).
Slovenian: Ko predpisujete zdravilo Kivexa, poizkusite zmanjšati vse prilagodljive dejavnike tveganja (npr. kajenje, hipertenzijo in hiperlipidemijo).
English: If you know you have this gene, tell your doctor before you take Kivexa.
Slovenian: Če veste, da imate ta gen, morate to zdravniku povedati, preden vzamete zdravilo Kivexa.
English: Do not take other medicines for the infection without your doctor's advice.
Slovenian: Ne jemljite drugih zdravil proti okužbi, ne da bi se posvetovali z zdravnikom.
English: Keep in touch with your doctor, and do not stop taking Kivexa without your doctor's advice.
Slovenian: Bodite v stiku s svojim zdravnikom in ne nehajte jemati zdravila Kivexa brez zdravnikovega nasveta.
English: - The risk of virological failure with Kivexa might be higher than with other therapeutic options (see section 5.1).
Slovenian: - Tveganje za virusni neodziv bi lahko bilo pri zdravilu Kivexa večje kot pri drugih terapevtskih možnostih (glejte poglavje 5.1).
English: Glaxo Wellcome S.A., Avenida de Extremadura 3, 09400 Aranda de Duero Burgos, Spain
Slovenian: Glaxo Wellcome S.A., Avenida de Extremadura 3, 09400 Aranda de Duero Burgos, Španija
English: Kivexa and similar medicines may cause side effects in unborn babies.
Slovenian: Zdravilo Kivexa in podobna zdravila lahko povzročijo neželene učinke pri nerojenem otroku.
English: The concentration of drug necessary to effect viral replication by 50% (EC50) or 50% inhibitory concentration (IC50) varied according to virus and host cell type.
Slovenian: Koncentracija zdravila, potrebna za 50 % učinek na replikacijo virusov (EC50) ali za 50 % inhibicijsko koncentracijo (IC50), se je razlikovala glede na virus in tip gostiteljske celice.
English: The mean half-life of abacavir is about 1.5 hours.
Slovenian: Srednji razpolovni čas abakavirja znaša približno 1,5 ure.
English: Overall response
Slovenian: Celotni odziv
English: • other medicinal products containing lamivudine, used to treat HIV infection or hepatitis B
Slovenian: • druga zdravila, ki vsebujejo lamivudin, ki se uporablja za zdravljenje okužbe s HIV ali okužbe s hepatitisom B,
English: If you have stopped taking Kivexa for any reason - especially because you think you are having side effects, or because you have other illness:
Slovenian: Če ste zdravilo Kivexa prenehali jemati zaradi kakršnegakoli razloga - še zlasti če menite, da imate neželene učinke, ali ker imate druge bolezni:
English: Based on data obtained for abacavir, Kivexa is not recommended in patients with moderate or severe hepatic impairment.
Slovenian: Na podlagi podatkov pridobljenih za abakavir, se zdravilo Kivexa ne priporoča pri bolnikih, ki imajo zmerno ali hudo jetrno okvaro.
English: Zidovudine, didanosine, stavudine and tenofovir maintain their antiretroviral activities against such HIV-1 variants.
Slovenian: Zidovudin, didanozin, stavudin in tenofovir ohranijo protiretrovirusno delovanje proti takšnim variantam virusa HIV-1.
English: It is important to take Kivexa regularly, because if you take it at irregular intervals, you may be more likely to have a hypersensitivity reaction.
Slovenian: Pomembno je, da zdravilo Kivexa jemljete redno, kajti če ga jemljete v nerednih presledkih, obstaja večja verjetnost za preobčutljivostno reakcijo.
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na zdravilni učinkovini ali katerokoli pomožno snov, navedeno v poglavju 6.1.
English: Women who are HIV-positive must not breast-feed, because HIV infection can be passed on to the baby in breast milk.
Slovenian: Dojenje Ženske, ki so HIV pozitivne, ne smejo dojiti, ker se lahko okužba s HIV z mlekom prenese na otroka.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia (often referred to as PCP).
Slovenian: Ustrezni primeri so citomegalovirusni retinitis, generalizirane in/ali žariščne okužbe z mikobakterijami in s Pneumocystis jiroveci povzročena pljučnica (pogosto omenjena kot PCP).
English: • breakdown of muscle tissue.
Slovenian: • razpad mišičnega tkiva.
English: Based on more than 200 mother/child pairs treated for HIV, serum concentrations of lamivudine in breastfed infants of mothers treated for HIV are very low (< 4% of maternal serum concentrations) and progressively decrease to undetectable levels when breastfed infants reach 24 weeks of age.
Slovenian: Glede na podatke pri več kot 200 parov mater in otrok, zdravljenih zaradi okužbe HIV, je koncentracija lamivudina v serumu dojenčkov mater, zdravljenih zaradi okužbe s HIV, zelo majhna (manj kot 4 % koncentracije v materinem serumu) in se progresivno zmanjša do nezaznavne ravni, ko dojenček doseže 24 tednov starosti.
English: Abacavir: AUC ↔ Cmax ↓35%
Slovenian: abakavir: AUC ↔ Cmax ↓35%
English: Abacavir can cause a serious allergic reaction known as a hypersensitivity reaction.
Slovenian: Abakavir lahko povzroči hudo alergijsko reakcijo znano kot preobčutljivostna reakcija.
English: Subgroup analyses testing for heterogeneity of once versus twice daily demonstrated no significant effect of sex, age, or viral load at randomisation.
Slovenian: Analize podskupin za testiranje heterogenosti med enkrat in dvakrat na dan niso pokazale značilnih vplivov spola, starosti ali virusnega bremena ob randomizaciji.
English: Objective and rationale: Increased understanding and awareness of ABC HSR.
Slovenian: Cilj in utemeljitev: Povečanje razumevanja in ozaveščenosti o preobčutljivostnih reakcijah na ABC.
English: What Kivexa is and what it is used for What you need to know before you take Kivexa How to take Kivexa
Slovenian: Kaj je zdravilo Kivexa in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Kivexa Kako jemati zdravilo Kivexa
English: Two mutations conferred a 7- to 8-fold change in abacavir susceptibility and combinations of three mutations were required to confer more than an 8-fold change in susceptibility.
Slovenian: Dve mutaciji sta povzročili 7- do 8-kratno spremembo občutljivosti za abakavir, za več kot 8-kratno spremembo občutljivosti pa so bile potrebne kombinacije 3-eh mutacij.
English: Phenotypic resistance and cross-resistance
Slovenian: Fenotipska odpornost in navzkrižna odpornost
English: Abacavir + Combivir1
Slovenian: Zdravljenje Abakavir + Combivir1
English: Risk of heart attack
Slovenian: Tveganje za srčni infarkt
English: These have been identified either from clinical studies or post marketing surveillance.
Slovenian: Odkriti so bili bodisi med kliničnimi študijami ali med spremljanjem v obdobju trženja zdravila.
English: Symptoms can occur at any time during treatment with ABC, but usually occur within the first 6 weeks of therapy.
Slovenian: Simptomi se lahko pojavijo kadar koli med zdravljenjem z ABC, a se po navadi pojavijo v prvih 6 tednih zdravljenja.
English: Plasma protein binding studies in vitro indicate that abacavir binds only low to moderately (~49%) to human plasma proteins at therapeutic concentrations.
Slovenian: Študije vezave na plazemske proteine in vitro kažejo, da se abakavir pri terapevtskih koncentracijah le slabo do zmerno (~ 49 %) veže na humane plazemske proteine.
English: Data show that abacavir and lamivudine penetrate the central nervous system (CNS) and reach the cerebrospinal fluid (CSF).
Slovenian: Podatki kažejo, da abakavir in lamivudin prehajata v centralni živčni sistem (CŽS) in dosežeta cerebrospinalno tekočino (CST).
English: Number of subjects with ≥1 Thymidine Analogue Mutations (TAMs).
Slovenian: Število oseb z ≥ 1 mutacijo timidinskih analogov (TAMs; “Thymidine analogue mutations”).
English: Number of Baseline Mutations1
Slovenian: Število izhodiščnih mutacij1
English: Talk to your doctor about your ability to drive or operate machines while taking Kivexa.
Slovenian: Posvetujte se z zdravnikom o vaši sposobnosti za upravljanje vozil ali strojev, medtem ko jemljete zdravilo Kivexa.
English: IMPORTANT - ALERT CARD Kivexa (abacavir / lamivudine) tablets Carry this card with you at all times
Slovenian: POMEMBNO - OPOZORILNA KARTICA Tablete Kivexa (abakavir / lamivudin) To kartico imejte vedno pri sebi!
English: Tell your doctor or pharmacist if you are taking any other medicines, or if you have taken any recently, including herbal medicines or other medicines you bought without a prescription.
Slovenian: Druga zdravila in zdravilo Kivexa Povejte zdravniku ali farmacevtu, če jemljete katera druga zdravila, ali ste jih pred kratkim jemali, vključno z zdravili rastlinskega izvora ali drugimi zdravili, ki ste jih kupili brez recepta.
English: If you get any symptoms of infection and inflammation or if you notice any of the symptoms above: Tell your doctor immediately.
Slovenian: Če se vam pojavi kakšen simptom okužbe in vnetja, ali če opazite katerega od zgoraj opisanih simptomov: se takoj posvetujte s svojim zdravnikom.
English: • skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
Slovenian: • izpuščaj na koži, ki lahko oblikuje mehurje in daje videz majhnih tarč (temnih osrednjih točk, ki jih obdaja svetlejši predel, obdan s temnim robom) (multiformni eritem);
English: There are no additional precautions and warnings relevant to Kivexa.
Slovenian: Dodatnih previdnostnih ukrepov in opozoril, ki bi se nanašala na zdravilo Kivexa, ni.
English: K65R was absent and L74V and Y115F were uncommon (≤3%).
Slovenian: K65R ni bila prisotna, L74V in Y115F pa sta bili občasni (≤ 3 %).
English: Ask your doctor or pharmacist for advice.
Slovenian: Za nasvet prosite zdravnika ali farmacevta.