FrancophonIA/ELRC3.0 huggingface dataset:
English: If serum phosphate is < 1.5 mg/dL (0.48 mmol/L) or creatinine clearance is decreased to < 60 mL/min in any individual receiving Truvada for pre-exposure prophylaxis, renal function should be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Slovenian: Če je vrednost serumskega fosfata < 1,5 mg/dl (0,48 mmol/l) ali se očistek kreatinina zmanjša na < 60 ml/min, je pri vsakem posamezniku, ki prejema zdravilo Truvada za zaščito pred izpostavitvijo, treba ponovno ovrednotiti ledvično funkcijo v roku enega tedna, vključno z merjenjem koncentracije glukoze in kalija v krvi ter glukoze v urinu (glejte poglavje 4.8, proksimalna tubulopatija).
English: Consideration should be given to interrupting use of Truvada in individuals with creatinine clearance decreased to < 60 mL/min or decreases in serum phosphate to < 1.0 mg/dL (0.32 mmol/L).
Slovenian: Pri posameznikih z zmanjšanjem očistka kreatinina na < 60 ml/min ali z zmanjšanjem serumskega fosfata na < 1,0 mg/dl (0,32 mmol/l) je treba razmisliti o prekinitvi uporabe zdravila Truvada.
English: Consideration should be given to interrupting treatment with Truvada in patients with creatinine clearance decreased to < 50 mL/min or decreases in serum phosphate to < 1.0 mg/dL (0.32 mmol/L).
Slovenian: Pri bolnikih z zmanjšanjem očistka kreatinina na < 50 ml/min ali z zmanjšanjem serumskega fosfata na < 1,0 mg/dl (0,32 mmol/l) je treba razmisliti o prekinitvi zdravljenja z zdravilom Truvada.
English: Table 8: Study population from study CO-US-104-0380 (Partners PrEP)
Slovenian: Preglednica 8: Populacija v študiji CO-US-104-0380 (Partners PrEP) Placebo
English: Renal adverse reactions consistent with proximal renal tubulopathy have been reported in HIV-1 infected paediatric patients aged 2 to < 12 years in clinical study GS-US-104-0352 (see sections 4.8 and 5.1).
Slovenian: Pri pediatričnih bolnikih, starih od 2 do < 12 let, okuženih s HIV-1, so v klinični študiji GS-US-104-0352 poročali o neželenih učinkih na ledvice, skladnih s proksimalno renalno tubulopatijo (glejte poglavji 4.8 in 5.1).
English: Truvada [Outer packaging only]
Slovenian: PODATKI V BRAILLOVI PISAVI Truvada [samo na zunanji ovojnini]
English: If serum phosphate is < 1.5 mg/dL (0.48 mmol/L) or creatinine clearance is decreased to < 50 mL/min in any patient receiving Truvada, renal function should be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Slovenian: Če je vrednost serumskega fosfata < 1,5 mg/dl (0,48 mmol/l) ali se očistek kreatinina zmanjša na < 50 ml/min, je pri vsakem bolniku, ki prejema zdravilo Truvada, treba ponovno ovrednotiti ledvično funkcijo v roku enega tedna, vključno z merjenjem koncentracije glukoze in kalija v krvi ter glukoze v urinu (glejte poglavje 4.8, proksimalna tubulopatija).
English: ANTI-INFECTIVES Antiretrovirals
Slovenian: PERORALNI KONTRACEPTIVI
English: Emtricitabine+ tenofovir disoproxil+efavirenz
Slovenian: Emtricitabin+ dizoproksiltenofovirat+ efavirenz
English: • That if serum phosphate is confirmed to be < 3.0 mg/dL (0.96 mmol/L) in any paediatric patient receiving tenofovir disoproxil fumarate, renal function should be re-evaluated within one week.
Slovenian: • da je treba po enem tednu delovanje ledvic ponovno oceniti, če so potrjene vrednosti serumskega fosfata < 3,0 mg/dl (0,96 mmol/l) pri vsakem pediatričnem bolniku, ki dobiva dizoproksiltenofovirijev fumarat.
English: If renal abnormalities are detected or suspected then consultation with a nephrologist should be obtained to consider interruption of Truvada treatment
Slovenian: Ob odkritju nenormalnega delovanja ledvic ali sumu nanje se je treba posvetovati z nefrologom in razmisliti o prekinitvi zdravljenja;
English: AUC: ↑ 26% (↑ 20 to ↑ 32) Cmax: ↓ 5% (↓ 11 to ↑ 1)
Slovenian: AUC: ↑ 26 % (↑ 20 do ↑ 32) Cmax: ↓ 5 % (↓ 11 do ↑ 1) Cmin: n/i
English: Truvada should not be administered concomitantly with adefovir dipivoxil.
Slovenian: Zdravilo Truvada se ne sme sočasno uporabljati z dipivoksiladefoviratom.
English: AUC: ↑ 96% (↑ 74 to ↑ 121) Cmax: ↑ 68% (↑ 54 to ↑ 84) Cmin: ↑ 118% (↑ 91 to ↑ 150)
Slovenian: AUC: ↑ 96 % (↑ 74 do ↑ 121) Cmax: ↑ 68 % (↑ 54 do ↑ 84) Cmin: ↑ 118 % (↑ 91 do ↑ 150)
English: AUC: ↑ 6% (↓ 1 to ↑ 13) Cmax: ↑13% (↑ 1 to ↑ 27)
Slovenian: AUC: ↑ 6 % (↓ 1 do ↑ 13) Cmax: ↑ 13 % (↑ 1 do ↑ 27) Cmin: n/i
English: (may affect up to 1 in 1,000 people)
Slovenian: Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov)
English: Adefovir dipivoxil and Truvada should not be administered concomitantly (see section 4.4).
Slovenian: Dipivoksiladefovirat in zdravilo Truvada se ne sme uporabljati sočasno (glejte poglavje 4.4).
English: • PrEP educational brochure for the individual at risk entitled ‘Important Information About
Slovenian: • izobraževalno gradivo PrEP za ogrožene posameznike z naslovom »Pomembne informacije glede zdravila Truvada za zmanjšanje tveganja okužbe s humanim imunodeficientnim virusom (HIV)«;
English: Co-administration of Truvada and didanosine is not recommended (see section 4.4).
Slovenian: Sočasna uporaba zdravila Truvada in didanozina ni priporočljiva (glejte poglavje 4.4).
English: Truvada (n = 1251)
Slovenian: (n = 1.251)
English: In a study of 498 men, the mean changes from baseline to week 24 in BMD ranged from -0.4% to -1.0% across hip, spine, femoral neck and trochanter in men who received daily Truvada prophylaxis (n = 247) vs. placebo (n = 251).
Slovenian: Pri moških, ki so vsak dan prejemali zdravilo Truvada za zaščito (n = 247) v primerjavi s placebom (n = 251) so bile povprečne spremembe MKG od izhodišča do 24. tedna na kolkih, hrbtenici, vratu in trohantru stegnenice od - 0,4 % do - 1,0 %.
English: AUC: ↓ 4% (↓ 15 to ↑ 8) Cmax: ↑ 102% (↓ 96 to ↑ 108)
Slovenian: AUC: ↓ 4 % (↓ 15 do ↑ 8) Cmax: ↑ 102 % (↓ 96 do ↑ 108) Cmin: n/i
English: AUC: ↑ 5% (↓ 2 to ↑ 13) Cmax: ↑ 5% (↓ 3 to ↑ 14)
Slovenian: AUC: ↑ 5 % (↓ 2 do ↑ 13) Cmax: ↑ 5 % (↓ 3 do ↑ 14) Cmin: n/i
English: Use of Truvada should be avoided with concurrent or recent use of a nephrotoxic medicinal product.
Slovenian: Zdravila Truvada naj ne bi uporabljali sočasno oziroma neposredno po uporabi nefrotoksičnih zdravil.
English: Tenofovir disoproxil 245 mg (n = 1584)
Slovenian: 245 mg (n = 1.584)
English: 35 kg, and who have already been treated with other HIV medicines that are no longer effective or have caused side effects.
Slovenian: • Uporablja se tudi za zdravljenje okužbe z virusom HIV pri mladostnikih, starih 12 let do manj kot 18 let, s telesno maso vsaj 35 kg, ki so se predhodno že zdravili z drugimi zdravili za zdravljenje okužbe s HIV, ki pa več ne učinkujejo ali so povzročila neželene učinke.
English: Relative Risk Reduction (95% CI)b URAI Within 12 Weeks Prior to Screening, mITT Analysis Seroconversions / N
Slovenian: URAI v 12 tednih pred presejanjem, analiza mITT
English: HBV, there is a serious risk of liver problems when you stop taking Truvada, whether or not you also have HIV.
Slovenian: Če imate hepatitis B, obstaja resno tveganje za jetrne težave, ko prenehate jemati zdravilo Truvada, ne glede na to, ali imate HIV ali ne. Pomembno je, da zdravila Truvada ne prenehate jemati, ne da bi se posvetovali z zdravnikom: glejte poglavje 3.
English: If Truvada is co-administered with an NSAID, renal function should be monitored adequately.
Slovenian: Pri sočasnem jemanju zdravila Truvada z NSAID je potrebno spremljati ledvično funkcijo.
English: AUC: ↓ 1% (↓ 8 to ↑ 6) Cmax: ↑ 7% (↓ 6 to ↑ 22)
Slovenian: AUC: ↓ 1 % (↓ 8 do ↑ 6) Cmax: ↑ 7 % (↓ 6 do ↑ 22) Cmin: n/i
English: FTC/tenofovir disoproxil Groupa Tenofovir disoproxil Groupa
Slovenian: FTC/dizoproksiltenofovi rata
English: AUC: ↓ 7% (↓ 13 to ↓ 1) Cmax: ↓ 11% (↓ 20 to ↑ 1)
Slovenian: AUC: ↓ 7 % (↓ 13 do ↓ 1) Cmax: ↓ 11 % (↓ 20 do ↑ 1) Cmin: n/i
English: 90 (3 bottles of 30) film-coated tablets.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 30 filmsko obloženih tablet 90 (3 plastenke s 30) filmsko obloženih tablet
English: The use of Truvada is not recommended in individuals under the age of 18 years with renal impairment (see section 4.2).
Slovenian: Uporabe zdravila Truvada pri posameznikih z ledvično okvaro, starih manj kot 18 let, se ne priporoča (glejte poglavje 4.2).
English: Emtricitabine: AUC: ↔
Slovenian: efavirenz: AUC: ↔
English: AUC: ↓ 2% (↓ 5 to ↑ 0) Cmax: ↓ 1% (↓ 7 to ↑ 6)
Slovenian: AUC: ↓ 2 % (↓ 5 do ↑ 0) Cmax: ↓ 1 % (↓ 7 do ↑ 6) Cmin: n/i
English: A single 245 mg dose of tenofovir disoproxil was administered to non-HIV infected subjects with varying degrees of hepatic impairment defined according to Child-Pugh-Turcotte (CPT) classification.
Slovenian: Osebam brez okužbe s HIV, ki so imele različne stopnje jetrne okvare po klasifikaciji Child-Pugh-Turcotte (CPT), so vzeli enkratni 245-mg odmerek dizoproksiltenofovirata.
English: Placebo (n = 1248)
Slovenian: (n = 1.248)
English: The adverse reactions considered at least possibly related to treatment with the components of Truvada from clinical study and post-marketing experience in HIV-1 infected patients are listed in Table 3, below, by body system organ class and frequency.
Slovenian: Spodaj v preglednici 3 so po organskih sistemih in pogostnosti navedeni neželeni učinki, ki so vsaj možno povezani z zdravljenjem z učinkovinama zdravila Truvada pri bolnikih s HIV-1 na podlagi kliničnih študij in izkušenj po prihodu zdravila na tržišče.
English: Truvada should not be initiated in paediatric patients with renal impairment and should be discontinued in paediatric patients who develop renal impairment during Truvada use.
Slovenian: pri bolnikih, pri katerih se med zdravljenjem z zdravilom Truvada razvije ledvična okvara, pa je treba uporabo prekiniti.
English: Efavirenz/Emtricitabine/Tenofovir disoproxil (600 mg/200 mg/245 mg q.d.)
Slovenian: efavirenz/emtricitabin/dizoproksil tenofovirat (600 mg/200 mg/245 mg enkrat dnevno)
English: AUC: ↑ 39% Cmax: ↑ 48%
Slovenian: AUC: ↑ 39 % Cmax: ↑ 48 % Cmin: ↑ 47 %
English: • Truvada is used to treat Human Immunodeficiency Virus 1 (HIV-1) infection in adults • It is also used to treat HIV in adolescents aged 12 to less than 18 years who weigh at least
Slovenian: • Zdravilo Truvada se uporablja za zdravljenje okužbe z virusom HIV-1 (virus človeške imunske pomanjkljivosti 1) pri odraslih.
English: AUC: ↓ 5% (↓ 9 to ↓ 1) Cmax: ↓ 11% (↓ 17 to ↓ 5)
Slovenian: AUC: ↓ 5 % (↓ 9 do ↓ 1) Cmax: ↓ 11 % (↓ 17 do ↓ 5) Cmin: n/i tenofovir:
English: • The active substances are emtricitabine and tenofovir disoproxil.
Slovenian: • Učinkovine so emtricitabin in dizoproksiltenofovirat.
English: Placebo (n = 1584)
Slovenian: (n = 1.584)
English: • muscle weakness
Slovenian: • mišična oslabelost
English: AUC: ↑ 4% (↓ 3 to ↑ 11) Cmax: ↑ 3% (↓ 3 to ↑ 9)
Slovenian: AUC: ↑ 4 % (↓ 3 do ↑ 11) Cmax: ↑ 3 % (↓ 3 do ↑ 9) Cmin: n/i emtricitabin:
English: Protease inhibitors Atazanavir/Ritonavir/Tenofovir disoproxil (300 mg q.d./100 mg q.d./245 mg q.d.)
Slovenian: Protiretrovirusne učinkovine Zaviralci proteaz atazanavir/ritonavir/ dizoproksiltenofovirat (300 mg enkrat dnevno/100 mg enkrat dnevno/245 mg enkrat dnevno)
English: + Emtricitabine/Rilpivirine/ Tenofovir disoproxil (200 mg/25 mg/245 mg q.d.)
Slovenian: emtricitabin/rilpivirin/dizoproksil tenofovirat (200 mg/25 mg/245 mg enkrat dnevno)
English: Co-administration of tenofovir disoproxil and didanosine results in a 40-60% increase in systemic exposure to didanosine that may increase the risk for didanosine-related adverse reactions.
Slovenian: 40-60%, kar lahko poveča tveganje pojava neželenih učinkov, povezanih z didanozinom.
English: AUC: ↓ 9% (↓ 16 to ↓ 1) Cmax: ↓ 7% (↓ 22 to ↑ 11)
Slovenian: AUC: ↓ 9 % (↓ 16 do ↓ 1) Cmax: ↓ 7 % (↓ 22 do ↑ 11) Cmin: n/i emtricitabin:
English: • You must be HIV negative before you start to take Truvada to reduce the risk of getting
Slovenian: • Pred začetkom jemanja zdravila Truvada za zmanjšanje tveganja za okužbo z virusom HIV-1, morate biti HIV negativni.
English: Sofosbuvir/Velpatasvir/ Voxilaprevir (400 mg/100 mg/ 100 mg+100 mg q.d.
Slovenian: sofosbuvir/velpatasvir/ voksilaprevir (400 mg/100 mg/ 100 mg+100 mg enkrat dnevno)3 + darunavir (800 mg enkrat dnevno) + ritonavir (100 mg enkrat dnevno) + emtricitabin/dizoproksiltenofovir at (200 mg/245 mg enkrat dnevno)
English: Emtricitabine/Tenofovir disoproxil (200 mg/245 mg q.d.)
Slovenian: emtricitabin/ dizoproksiltenofovirat (200 mg/245 mg enkrat dnevno)
English: * Patients receiving emtricitabine, tenofovir disoproxil and efavirenz were given Truvada plus efavirenz from week 96 to ** The p-value based on the Cochran-Mantel-Haenszel Test stratified for baseline CD4 cell count TLOVR = Time to Loss of Virologic Response a: Van Elteren Test
Slovenian: ** Vrednost p temelji na Cochran-Mantel-Haenszlovem testu, stratificiranem za število celic CD4 ob izhodišču.
English: The safety of tenofovir disoproxil when used with sofosbuvir/velpatasvir/voxilaprevir and a pharmacokinetic enhancer (e.g. ritonavir or cobicistat) has not been established.
Slovenian: Varnost dizoproksiltenofovirata, uporabljenega s sofosbuvirjem/velpatasvirjem/voksil aprevirjem in farmakokinetičnim ojačevalcem (npr. ritonavirjem ali kobicistatom), ni bila dokazana.
English: AUC: ↓ 4% (↓ 32 to ↑ 34) Cmax: ↓ 5% (↓ 27 to ↑ 24)
Slovenian: AUC: ↓ 4 % (↓ 32 do ↑ 34) Cmax: ↓ 5 % (↓ 27 do ↑ 24) Cmin: n/i etinilestradiol:
English: Oral administration.
Slovenian: - Navodilo shranite.
English: Didanosine/Tenofovir disoproxil
Slovenian: Skupina dizoproksiltenofovirata
English: Uncommon side effects
Slovenian: Nezaznana učinkovina
English: rates of virological failure within several tested combinations for the treatment of HIV-1 infection.
Slovenian: Sočasna uporaba zmanjšanega odmerka didanozina (250 mg) in zdravljenje z dizoproksiltenofoviratom je bilo v več preizkušenih kombinacijah za zdravljenje okužbe z virusom HIV-1
English: + Efavirenz/Emtricitabine/Tenofovir disoproxil (600 mg/200 mg/245 mg q.d.)
Slovenian: (400 mg enkrat dnevno) + efavirenz/emtricitabin/ dizoproksiltenofovirat (600 mg/200 mg/245 mg enkrat dnevno)
English: AUC: ↔ Cmax: ↓ 30%
Slovenian: AUC: ↔ Cmax: ↓ 30 % Cmin: N/V
English: ORAL CONTRACEPTIVES Norgestimate/Ethinyl oestradiol/Tenofovir disoproxil
Slovenian: norgestimat/etinilestradiol/
English: Increased plasma concentrations of tenofovir resulting from co-administration of tenofovir disoproxil, ledipasvir/sofosbuvir and darunavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Slovenian: Povečane koncentracije tenofovirja v plazmi zaradi sočasnega dajanja dizoproksiltenofovirata, sofosbuvirja/velpatasvirja/voksilapr evirja in darunavirja/ritonavirja lahko povečajo neželene učinke, povezane z dizoproksiltenofoviratom, vključno z motnjami delovanja ledvic.
English: HIV.
Slovenian: izpuščaj
English: Pre-exposure prophylaxis
Slovenian: IMUNOSUPRESIVI
English: Hepatitis C virus (HCV) antiviral agents Ledipasvir/Sofosbuvir (90 mg/400 mg q.d.)
Slovenian: Protivirusna zdravila za zdravljenje hepatitisa C (HCV) ledipasvir/sofosbuvir (90 mg/400 mg enkrat dnevno) + atazanavir/ritonavir (300 mg enkrat dnevno/100 mg enkrat dnevno) + emtricitabin/ dizoproksiltenofovirat (200 mg/245 mg enkrat dnevno)1
English: • joint or muscle aches
Slovenian: • bolečine v sklepih ali mišicah
English: Regular determination of resistance is therefore recommended.
Slovenian: Zato je priporočeno redno določanje rezistence.
English: Very rare (<1/10,000), not known (cannot be estimated from the available data)
Slovenian: Zelo redki (< 1/10000), neznano (iz razpoložljivih podatkov ni mogoče oceniti)
English: Adequate hydration must be ensured.
Slovenian: zagotoviti je treba ustrezno hidracijo.
English: It is advisable never to use several medicines at the same time without consulting your doctor first.
Slovenian: Nikoli ni priporočljivo jemati več zdravil hkrati, ne da bi se prej posvetovali z zdravnikom.
English: To be used immediately after the vial is opened.
Slovenian: Uporabite takoj po odprtju viale.
English: Furthermore, you should drink a sufficient amount of liquid (about 1.5 - 2 litres daily).
Slovenian: Poleg tega morate piti dovolj tekočine (približno 1,5-2 litra na dan);
English: The percentage of resistant strains can be subject to great local variation.
Slovenian: Odstotek rezistentnih sevov je lahko odvisen od velikih lokalnih variacij.
English: Therefore the bleeding time should be monitored.
Slovenian: Zato je treba čas krvavitve spremljati;
English: Use during pregnancy is contraindicated.
Slovenian: Uporaba med nosečnostjo je kontraindicirana.
English: • Mycobacerium tuberculosis test.
Slovenian: • preizkus za Mycobacerium tuberculosis.
English: • liver impairment in the past.
Slovenian: • jetrna okvara v preteklosti.
English: The treatment should be continued for at least three days after the signs of the infection have disappeared.
Slovenian: Zdravljenje je treba nadaljevati vsaj še tri dni po tem, ko izginejo simptomi.
English: This may increase the risk of methotrexate associated toxic reactions.
Slovenian: To lahko poveča tveganje za toksične reakcije, povezane z metotreksatom.
English: Sequential therapy can also be used.
Slovenian: Lahko se uporabi tudi sekvenčno zdravljenje.
English: These reactions occur more frequently when the infusion time is 30 minutes or less.
Slovenian: Te reakcije so pogostejše, kadar je čas infundiranja 30 minut ali manj.
English: The above-mentioned substances are converted by a specific enzyme (CYP1A2).
Slovenian: Zgoraj omenjene snovi presnavlja poseben encim (CYP1A2).
English: Further intravenous administration is not contraindicated unless the reactions reoccur or worsen.
Slovenian: Nadaljnje intravensko infundiranje ni kontraindicirano, razen če se reakcije pojavijo znova ali se poslabšajo.
English: Monitoring the level of active substance in the blood provides the most reliable basis for dose adjustment.
Slovenian: Spremljanje ravni zdravilne učinkovine v krvi je najzanesljivejša osnova za prilagajanje odmerka.
English: Before starting treatment - if you suffer or have suffered from one of the following diseases:
Slovenian: Pred začetkom zdravljenja - če imate ali ste imeli katero izmed naslednjih bolezni:
English: The recommended duration of treatment is 10 - 14 days.
Slovenian: Priporočeno trajanje zdravljenja je 10-14 dni.
English: For information on mixing with other solutions: see sections 6.2 and 6.6.
Slovenian: Za informacije o mešanju z drugimi raztopinami glejte poglavji 6.2 in 6.6.
English: • increased skin sensitivity to sunlight or UV light.
Slovenian: • povečana občutljivost kože za sončno svetlobo ali UV-svetlobo.
English: If a prolonged treatment is necessary, a reassessment of treatment should be done at 2 months at the latest.
Slovenian: Če je dolgotrajno zdravljenje nujno, je treba učinek zdravljenja oceniti najpozneje po 2 mesecih.
English: • If you are pregnant or wish to become pregnant
Slovenian: • če ste noseči ali želite zanositi;
English: As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.
Slovenian: Po potrebi je treba poiskati nasvet strokovnjaka, kadar je lokalna prevalenca rezistence taka, da je uporaba zdravila vsaj pri nekaterih vrstah okužb vprašljiva.
English: • children under 5 years of age.
Slovenian: • otrocih, mlajših od 5 let.
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Slovenian: Pozorni morate biti na uradne smernice za ustrezno uporabo antibiotikov.
English: Very rare: psychotic reactions (which may progress to self-endangering behaviour).
Slovenian: Zelo redki: psihotične reakcije (ki lahko napredujejo do samomorilskega vedenja).
English: In very rare cases these allergic reactions may lead to life-threatening shock.
Slovenian: V zelo redkih primerih lahko te alergijske reakcije povzročijo smrtno nevaren šok;
English: Average duration of treatment can be 4-6 weeks.
Slovenian: Povprečno trajanje zdravljenja je lahko 4 do 6 tednov.
English: Local reaction:
Slovenian: Lokalne reakcije:
English: However, if this is not possible the patient is recommended to use a sun-protection cream.
Slovenian: Če to ni mogoče, je treba bolniku svetovati uporabo kreme za zaščito proti soncu.
English: Lactic acid (E 270)
Slovenian: Mlečna kislina (E 270)
English: The following undesirable reactions have been observed:
Slovenian: Opazili so naslednje neželene učinke:
English: Other preclinical effects were observed only at exposures that were sufficiently in excess of the maximum human exposure so that concern for human safety is negligible.
Slovenian: Druge predklinične učinke so opazili samo pri izpostavljenosti, ki je bila bistveno večja od največje izpostavljenosti pri človeku, zato je skrb za varnost človeka zanemarljiva.
English: Pack sizes: 1.5 10 or 20 vials.
Slovenian: Velikosti pakiranj: 1, 5, 10 ali 20 vial.
English: Teratogenic effects have not been observed in animal experimental research.
Slovenian: V raziskavah na živalih niso opazili teratogenih učinkov.
English: This medicine may cause these side effects, particularly if you are older or take a medicine of the socalled steroid group, such as hydrocortisone.
Slovenian: To zdravilo lahko povzroči neželene učinke, zlasti če ste starejši ali če jemljete zdravila iz tako imenovane skupin steroidov, na primer hidrokortizon;
English: When photosensibility occurs the treatment must be discontinued.
Slovenian: Če se pojavi fotosenzitivnost, je treba zdravljenje prekiniti.
English: Your doctor will monitor you for signs of methotrexate overdose.
Slovenian: Zdravnik vas bo opazoval zaradi znakov prevelikega odmerjanja metotreksata;
English: Depression or psychoses lead to self-endangering behaviour in some cases.
Slovenian: V nekaterih primerih depresija in psihoze povzročajo samomorilsko vedenje.
English: This relatively high distribution volume indicates an effective tissue and fluid penetration.
Slovenian: Ta sorazmerno velik volumen porazdelitev kaže na učinkovito penetracijo v tkiva in tekočine.
English: Unless compatibility is proven, the solution for infusion should always be administered separately.
Slovenian: Če združljivost ni dokazana, je treba raztopino za infundiranje vedno dajati ločeno.
English: The enzyme DNA-gyrase plays a crucial role in this process.
Slovenian: Pri tem ima DNA-giraza ključno vlogo.
English: Amp-C producing Escherichia coli
Slovenian: ki proizvaja Amp-C Escherichia coli
English: These events were observed predominantly among patients with further risk factors for QTc prolongation.
Slovenian: Te učinke so opazili predvsem pri bolnikih z dodatnimi dejavniki tveganja za podaljšanje intervala QTc.
English: When undesirable effects on the central nervous system, like dizziness, occur, it is prohibited to drive a vehicle or to operate machines.
Slovenian: Kadar se pojavijo neželeni učinki na osrednje živčevje, kot je omotica, je prepovedano voziti ali upravljati stroje.
English: Up to now, no evidence has been found of an increased risk of congenital abnormalities or other undesirable effects following use of ciprofloxacin or other quinolones during the first trimester.
Slovenian: Do sedaj niso našli dokazov o povečanem tveganju za kongenitalne abnormalnosti ali druge neželene učinke po uporabi ciprofloksacina ali drugih kinolonov v prvem trimesečju.
English: The plasma protein binding of ciprofloxacin is situated between 16% and 28% and is not dependent on the concentration and pH (determined by means of ultrafiltration).
Slovenian: Vezava na beljakovine v plazmi je med 16 in 28 % ter ni odvisna od koncentracije in vrednosti pH (določena z ultrafiltracijo).
English: • local reactions after administration of this medicine.
Slovenian: • lokalne reakcije po uporabi zdravila.
English: Signs of anaemia are a feeling of weakness and in more severe cases breathlessness and pale skin.
Slovenian: Znaki anemije so občutek šibkosti in, v hujših primerih, zasoplost in bleda koža.