FrancophonIA/ELRC3.0 huggingface dataset:
English: When you are treated with Kuvan, your doctor will test your blood to verify how much phenylalanine and tyrosine it contains and may decide to adjust the dose of Kuvan or your diet if needed.
Slovenian: Med zdravljenjem z zdravilom Kuvan bo zdravnik pregledal vašo kri, da bo ugotovil, kakšne vrednosti fenilalanina in tirozina vsebuje.
English: Pour the amount of water into the medicine cup, as instructed by your doctor (e.g. your doctor told you to use 20 ml for dissolving
Slovenian: V merico za zdravilo vlijte količino vode, kot vam je naročil zdravnik (npr. zdravnik vam je povedal, da za raztopitev ene tablete zdravila Kuvan uporabite 20 ml vode).
English: The mean ± SD increase in dietary phenylalanine tolerance was 17.5 ±13.3 mg/kg/day for the group treated with sapropterin dihydrochloride 20 mg/kg/day, compared to 3.3 ± 5.3 mg/kg/day for the placebo group (p=0.006).
Slovenian: Povprečna vrednost ± SD povečanja tolerance organizma na fenilalanin vnesen s hrano je znašala 17,5 ± 13,3 mg/kg/dan pri skupini, ki je prejemala sapropterinijev diklorid v odmerku 20 mg/kg/dan, v primerjavi s 3,3 ± 5,3 mg/kg/dan pri skupini, ki je prejemala placebo (p=0,006).
English: The starting dose of Kuvan in adult and paediatric patients with PKU is 10 mg/kg body weight once daily.
Slovenian: Začetni odmerek zdravila Kuvan pri odraslih in pediatričnih bolnikih s PKU je 10 mg/kg telesne mase enkrat dnevno.
English: For higher doses, your doctor may also prescibe Kuvan 500 mg powder for oral solution.
Slovenian: Za večje odmerke vam lahko zdravnik predpiše tudi zdravilo Kuvan 500 mg prašek za peroralno raztopino.
English: Hypersensitivity reactions (including serious allergic reactions) and rash Metabolism and nutrition disorders
Slovenian: Bolezni imunskega sistema neznana pogostnost: preobčutljivostne reakcije (vključno s hudimi alergijskimi reakcijami) in izpuščajem
English: - The active substance is sapropterin dihydrochloride.
Slovenian: - Zdravilna učinkovina je sapropterinijev diklorid.
English: Powder for oral solution Off-white to light yellow powder
Slovenian: prašek za peroralno raztopino belkast do svetlo rumen prašek
English: Number of tablets to be dissolved (100 mg strength only)
Slovenian: Število tablet, ki jih je treba raztopiti (samo jakost 100 mg)
English: Kuvan contains potassium citrate (E332)
Slovenian: Zdravilo Kuvan vsebuje kalijev citrat (E332)
English: Patients above 20 kg body weight
Slovenian: Bolniki s telesno maso nad 20 kg
English: • Place the prescribed number of Kuvan 100 mg sachets in the medicine cup.
Slovenian: • V merico za zdravilo dajte predpisano število vrečic zdravila Kuvan 100 mg.
English: The adjusted mean dietary phenylalanine tolerance in the Kuvan in conjunction with a phenylalanine-restricted diet group was 80.6 mg/kg/day and was statistically significantly greater (p<0.001) than the adjusted mean dietary phenylalanine tolerance in dietary phenylalanine therapy alone group (50.1 mg/kg/day).
Slovenian: Prilagojena povprečna toleranca organizma na fenilalanin vnesen s hrano je bila v skupini z zdravilom Kuvan in dieto z omejitvijo fenilalanina 80,6 mg/kg/dan in je bila statistično značilno večja (p < 0,001) kot prilagojena povprečna toleranca organizma na fenilalanin vnesen s hrano v skupini, ki se je zdravila le z omejevanjem vnosa fenilalanina s hrano (50,1 mg/kg/dan).
English: Use in children up to 20 kg body weight
Slovenian: Uporaba pri otrocih s telesno maso do 20 kg
English: • Small spoon or clean utensil for stirring
Slovenian: • žlička ali čist kuhinjski pripomoček za mešanje
English: The recommended starting dose of Kuvan in patients with PKU is 10 mg for each kg of body weight.
Slovenian: Priporočeni začetni odmerek zdravila Kuvan pri bolnikih s PKU je 10 mg na vsak kg telesne mase.
English: Following intravenous administration in rats, sapropterin dihydrochloride is mainly excreted in the urine.
Slovenian: Pri podganah se sapropterinijev diklorid po intravenskem dajanju izloča pretežno s sečem.
English: Kuvan tablets should be administered with a meal to increase the absorption.
Slovenian: Tablete Kuvan mora bolnik vzeti ob obroku, kar poveča absorbcijo.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology (CNS, respiratory, cardiovascular, genitourinary), and toxicity to reproduction.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti (CŽS, dihala, srčnožilni sistem, genitourinarni sistem) in vpliva na sposobnost razmnoževanja ne kažejo posebnega tveganja za človeka.
English: For patients with PKU, Kuvan should be administered as a single daily dose, and at the same time each day preferably in the morning.
Slovenian: Bolniki s PKU naj vzamejo Kuvan v enkratnem dnevnem odmerku, vsak dan ob istem času, najbolje zjutraj.
English: When the oral syringe is dry, the plunger should be put back into the barrel.
Slovenian: Ko je brizga za peroralno dajanje suha, je treba dati bat nazaj v telo brizge.
English: Number of sachets to be dissolved (100 mg strength only)
Slovenian: Število vrečic, ki jih je treba raztopiti (samo jakost 100 mg)
English: The powder for oral solution is clear, off-white to light yellow.
Slovenian: Prašek za peroralno raztopino je brezbarven, belkast do svetlo rumen.
English: Take Kuvan with a meal to increase the absorption.
Slovenian: Zdravilo Kuvan vzemite ob obroku hrane, ki poveča absorpcijo.
English: The powder is filled in unit dose sachets containing 500 mg sapropterin dihydrochloride.
Slovenian: Prašek je napolnjen v vrečice za posamezni odmerek, ki vsebujejo 500 mg sapropterinijevega diklorida.
English: An increased incidence of altered renal microscopic morphology (collecting tubule basophilia) was observed in rats following chronic oral administration of sapropterin dihydrochloride at exposures at or slightly above the maximal recommended human dose.
Slovenian: Pri podganah so po dolgotrajnem peroralnem dajanju sapropterinijevega diklorida, pri stopnji izpostavljenosti, ki je bila enaka ali rahlo večja od največjih priporočenih odmerkov pri ljudeh, opažali povečano pogostnost pojavljanja spremenjene ledvične mikroskopske morfologije (bazofilnost zbiralnega tubula).
English: EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: Ravnanje z zdravilom
English: Cases of convulsion, exacerbation of convulsion, increased excitability and irritability have been observed during co-administration of levodopa and sapropterin in BH4-deficient patients (see section 4.5).
Slovenian: Pri sočasni uporabi levodope in saproterina so pri bolnikih s pomanjkanjem BH4 poročali o konvulzijah, poslabšanju konvulzij ter povečani razdražljivosti in razburjenosti (glejte poglavje 4.5).
English: • Oral syringe (graduated in 1 ml divisions) (10 ml syringe for administration of volumes of
Slovenian: • brizga za peroralno dajanje (z oznakami, razdeljenimi na 1 ml) (10 ml briga za odmerjanje količin ≤ 10 ml ali 20 ml brizga za odmerjanje količin > 10 ml)
English: Remove the plunger from the barrel of the oral syringe.
Slovenian: Odstranite bat iz telesa brizge za peroralno dajanje.
English: The powder is filled in unit dose sachets containing 100 mg sapropterin dihydrochloride.
Slovenian: Prašek je napolnjen v vrečice za posamezni odmerek, ki vsebujejo 100 mg sapropterinijevega diklorida.
English: Mannitol (E421) Potassium citrate (E332) Sucralose (E955) Ascorbic acid (E300)
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi manitol (E421) kalijev citrat (E332) sukraloza (E955) askorbinska kislina (E300)
English: Caution is recommended when using such medicinal products while taking Kuvan.
Slovenian: Kadar se ta zdravila uporabljajo med jemanjem zdravila Kuvan, je potrebna previdnost.
English: Pharyngolaryngeal pain, nasal congestion, cough Gastrointestinal disorders Common:
Slovenian: faringolaringealna bolečina, kongestija nosne sluznice, kašelj
English: Caution must be exercised when prescribing to elderly patients.
Slovenian: Kadar se zdravilo predpisuje starejšim bolnikom, je potrebna previdnost.
English: Children up to 20 kg body weight
Slovenian: Otroci s telesno maso do 20 kg
English: Use a 10 ml oral syringe for administration of volumes ≤10 ml or a 20 ml oral syringe for administration of volumes >10 ml.
Slovenian: Uporabite 10 ml brizgo za peroralno dajanje količin ≤ 10 ml ali 20 ml brizgo za peroralno dajanje količin > 10 ml.
English: Point the tip of the oral syringe towards either cheek.
Slovenian: Konico brizge za peroralno dajanje usmerite v eno od lic.
English: Caution must be exercised when prescribing to such patients.
Slovenian: Kadar se zdravilo predpisuje takim bolnikom, je potrebna previdnost.
English: Rebound, as defined by an increase in blood phenylalanine levels above pre-treatment levels, may occur upon cessation of treatment.
Slovenian: Po prekinitvi zdravljenja lahko pride do pojava povratnega učinka, ki je definiran kot zvišanje ravni fenilalanina v krvi nad raven, ki je bila ugotovljena pred začetkom zdravljenja.
English: Physician-supervised restriction of dietary phenylalanine intake prior to and throughout pregnancy is the first choice of treatment in this patient group.
Slovenian: Zdravljenje prve izbire pri tej skupini bolnic je omejitev vnosa fenilalanina s hrano, pred in med nosečnostjo, pod nadzorom zdravnika.
English: Determination of response
Slovenian: Ugotavljanje odziva na zdravljenje
English: Hypophenylalaninaemia Nervous system disorders Very common:
Slovenian: Bolezni živčevja zelo pogosti:
English: A shortening of the QT interval (-8.32 msec) was observed in a study with a single supratherapeutic dose of 100 mg/kg (5 times the maximum recommended dose); this should be taken into consideration in managing patients who have a pre-existing shortened QT interval (e.g. patients with familial short QT syndrome).
Slovenian: V študiji z enim supraterapevtskim odmerkom 100 mg/kg (petkrat večji odmerek od največjega priporočenega) so opazili skrajšanje intervala QT (- 8,32 ms).
English: Each sachet contains 500 mg of sapropterin dihydrochloride (equivalent to 384 mg of sapropterin).
Slovenian: Ena vrečica vsebuje 500 mg sapropterinijevega diklorida (kar ustreza 384 mg sapropterina).
English: Each sachet contains 1.6 mmol (62.7 mg) potassium.
Slovenian: Ena vrečica vsebuje 1,6 mmol (62,7 mg) kalija.
English: 1 bottle per carton.
Slovenian: V kartonski škatli je ena plastenka.
English: Kuvan should be administered with a meal, to increase the absorption.
Slovenian: Zdravilo Kuvan mora bolnik vzeti ob obroku, kar poveča absorbcijo.
English: This medicine contains 1.6 mmol (62.7 mg) potassium per sachet.
Slovenian: To zdravilo vsebuje 1,6 mmol (62,7 mg) kalija na vrečico.
English: Ask your doctor for the medicine cup for dissolving the tablets and the 10 ml or 20 ml oral syringe if you do not have these supplies.
Slovenian: Če teh potrebščin nimate, vprašajte zdravnika za merico za raztapljanje tablet in 10 ml ali 20 ml brizgo za peroralno dajanje.
English: Potassium content
Slovenian: Vsebnost kalija
English: This medicine contains 0.3 mmol (12.6 mg) potassium per sachet.
Slovenian: To zdravilo vsebuje 0,3 mmol (12,6 mg) kalija na vrečico.
English: Each sachet contains 0.3 mmol (12.6 mg) potassium.
Slovenian: Ena vrečica vsebuje 0,3 mmol (12,6 mg) kalija.
English: Active management of dietary phenylalanine and overall protein intake while taking this medicinal product is required to ensure adequate control of blood phenylalanine levels and nutritional balance.
Slovenian: Da bi zagotovili ustrezen nadzor ravni fenilalanina v krvi in prehransko uravnoteženost, je med zdravljenjem s tem zdravilom potreben dejaven nadzor vnosa fenilalanina s hrano in skupne zaužite količine beljakovin.
English: After dissolving the powder in water, the solution must be clear, colourless to yellow.
Slovenian: Po raztopitvi praška v vodi mora biti raztopina bistra, brezbarvna do rumenkasta.
English: Headache and dizziness have been reported after the administration of sapropterin dihydrochloride above the recommended maximum dose of 20 mg/kg/day.
Slovenian: Po zaužitju sapropterinijevega diklorida v odmerku, ki je presegal priporočeni največji odmerek 20 mg/kg/dan, so poročali o glavobolu in omotici.
English: Ask your doctor for the medicine cup for dissolving the powder and the 10 ml or 20 ml oral syringe if you do not have these supplies.
Slovenian: Če teh potrebščin nimate, prosite zdravnika za merico za raztapljanje praška in 10 ml ali 20 ml brizgo za peroralno dajanje.
English: Calcium hydrogen phosphate, anhydrous Crospovidone type A Ascorbic acid (E300) Sodium stearyl fumarate Riboflavin (E101)
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi manitol (E421) brezvodni kalcijev hidrogenfosfat krospovidon tip A askorbinska kislina (E300) natrijev stearilfumarat riboflavin (E101)
English: Kuvan 500 mg powder for oral solution
Slovenian: Kuvan 500 mg prašek za peroralno raztopino
English: Kuvan 100 mg powder for oral solution Kuvan 500 mg powder for oral solution Sapropterin dihydrochloride
Slovenian: Kuvan 100 mg prašek za peroralno raztopino Kuvan 500 mg prašek za peroralno raztopino sapropterinijev diklorid
English: No increase in total biopterin concentrations in either foetuses or milk was observed in rats after oral administration of 10 mg/kg sapropterin dihydrochloride.
Slovenian: Pri podganah po peroralnem dajanju 10 mg/kg sapropterinijevega diklorida niso ugotovili povečanja skupnih koncentracij biopterina niti v zarodkih niti v mleku.
English: Kuvan 100 mg soluble tablets
Slovenian: Kuvan 100 mg tablete za peroralno raztopino
English: Number of 100 mg tablets (dose 20 mg/kg)
Slovenian: Število 100 mg tablet (odmerek 20 mg/kg)
English: Number of 100 mg tablets (dose 10 mg/kg)
Slovenian: Število 100 mg tablet (odmerek 10 mg/kg)
English: Active management of dietary phenylalanine and overall protein intake while taking Kuvan is required to ensure adequate control of blood phenylalanine and tyrosine levels and nutritional balance.
Slovenian: Da bi zagotovili ustrezen nadzor ravni fenilalanina in tirozina v krvi in prehransko uravnoteženost, je med zdravljenjem z zdravilom Kuvan potreben dejaven nadzor vnosa fenilalanina v telo s hrano in skupne zaužite količine beljakovin.
English: Discard unused solution within 20 minutes for tablet solution.
Slovenian: Neuporabljeno pripravljeno raztopino po 20 minutah zavrzite.
English: Cases of convulsion, exacerbation of convulsion, increased excitability and irritability have been observed during co-administration of levodopa and sapropterin in BH4-deficient patients.
Slovenian: Pri bolnikih s pomanjkanjem BH4 so med sočasnim dajanjem levodope in sapropterina opazili primere konvulzij, ponovnega pojava konvulzij, povečano razdražljivost in preobčutljivost.
English: Kuvan 100 mg powder for oral solution Kuvan 500 mg powder for oral solution
Slovenian: Kuvan 100 mg prašek za peroralno raztopino Kuvan 500 mg prašek za peroralno raztopino
English: Kuvan 500 mg powder for oral solution Sapropterin dihydrochloride
Slovenian: Kuvan 500 mg prašek za peroralno raztopino sapropterinijev diklorid
English: Kuvan 100 mg powder for oral solution
Slovenian: Kuvan 100 mg prašek za peroralno raztopino
English: After dissolving Kuvan powder in water, the solution must be clear, colourless to yellow.
Slovenian: Po raztopitvi praška zdravila Kuvan v vodi mora biti raztopina bistra, brezbarvna do rumenkasta.
English: Table 3: 10 mg/kg per day dosing table for children weighing up to 20 kg Weight (kg)
Slovenian: Preglednica 3: preglednica za odmerjanje 10 mg/kg na dan za otroke s telesno maso do 20 kg Telesna masa (kg)
English: Table 2: 5 mg/kg per day dosing table for children weighing up to 20 kg Weight (kg)
Slovenian: Preglednica 2: preglednica za odmerjanje 5 mg/kg na dan za otroke s telesno maso do 20 kg Telesna masa (kg)
English: Kuvan 100 mg soluble tablets Sapropterin dihydrochloride
Slovenian: Kuvan 100 mg tablete za peroralno raztopino sapropterinijev diklorid
English: Discard unused solution within 30 minutes for powder solution.
Slovenian: Neuporabljeno pripravljeno raztopino po 30 minutah zavrzite.
English: Table 4: 20 mg/kg per day dosing table for children weighing up to 20 kg Weight (kg)
Slovenian: Preglednica 4: preglednica za odmerjanje 20 mg/kg na dan za otroke s telesno maso do 20 kg Telesna masa (kg)
English: Kuvan 100 mg powder for oral solution Sapropterin dihydrochloride
Slovenian: Kuvan 100 mg prašek za peroralno raztopino sapropterinijev diklorid
English: Number of 100 mg sachets (dose 20 mg/kg)
Slovenian: Število 100 mg vrečic (odmerek 20 mg/kg)
English: Sapropterin dihydrochloride
Slovenian: - Učinkovina je sapropterinijev diklorid.
English: Number of 100 mg sachets (dose 10 mg/kg)
Slovenian: Število 100 mg vrečic (odmerek 10 mg/kg)
English: Upon dissolving Kuvan powder for oral solution in water, the solution has a clear, colourless to yellow appearance.
Slovenian: Po raztopitvi zdravila Kuvan prašek za peroralno raztopino v vodi mora biti raztopina bistra, brezbarvna do rumenkasta.
English: Each tablet contains 100 mg of sapropterin dihydrochloride (equivalent to 77 mg of sapropterin).
Slovenian: Ena tableta vsebuje 100 mg sapropterinijevega diklorida (kar ustreza 77 mg sapropterina).
English: A 10 ml oral syringe should be used for administration of volumes of ≤10 ml and a 20 ml oral syringe for administration of volumes of >10 ml.
Slovenian: Za dajanje količin ≤ 10 ml je treba uporabiti 10-ml brizgo za peroralno dajanje, za dajanje količin > 10 ml pa 20-ml brizgo za peroralno dajanje .
English: Each sachet contains 100 mg of sapropterin dihydrochloride (equivalent to 77 mg of sapropterin).
Slovenian: Ena vrečica vsebuje 100 mg sapropterinijevega diklorida (kar ustreza 77 mg sapropterina).
English: Each soluble tablet contains 100 mg of sapropterin dihydrochloride (equivalent to 77 mg of sapropterin).
Slovenian: Ena tableta za peroralno raztopino vsebuje 100 mg sapropterinijevega diklorida (kar ustreza 77 mg sapropterina).
English: Table 1: 2 mg/kg per day dosing table for children weighing up to 20 kg Weight (kg) Total dose (mg/day)
Slovenian: Preglednica 1: preglednica za odmerjanje 2 mg/kg na dan za otroke s telesno maso do 20 kg Telesna masa (kg)
English: Rhinorrhoea
Slovenian: hipofenilalaninemija
English: Immediately contact your doctor or pharmacist if you take more Kuvan than prescribed.
Slovenian: Če ste vzeli večji odmerek zdravila Kuvan od predpisanega, se takoj posvetujte z zdravnikom ali s farmacevtom.
English: The dose is adjusted, usually between 5 and 20 mg/kg/day, to achieve and maintain adequate blood phenylalanine levels as defined by the physician.
Slovenian: Da bi dosegli in ohranjali ustrezne ravni fenilalanina v krvi, je potrebno odmerek prilagoditi po navodilih zdravnika, običajno v območju od 5 do 20 mg/kg/dan.
English: Dietary intake
Slovenian: Vnos hrane
English: Intravenous use vial (glass)
Slovenian: 5 mg/ml prašek za disperzijo za infundiranje intravenska uporaba viala (steklo)
English: Safety was not assessed in this study.
Slovenian: Varnosti v tej študiji niso ocenjevali.
English: • The virus can affect any part of the body.
Slovenian: • Virus lahko prizadene kateri koli del telesa.
English: After that the tests will be done less often.
Slovenian: Pozneje bodo preiskave manj pogoste.
English: It will depend on:
Slovenian: To bo odvisno od:
English: This is to check the dose you are having is right for you.
Slovenian: Namen tega je preveriti, ali je odmerek, ki ga prejemate, pravi za vas.
English: • You will usually start by having one or two infusions every day.
Slovenian: • Na začetku boste po navadi dobivali eno ali dve infuziji vsak dan.
English: Your doctor will work out how much you need.
Slovenian: Zdravnik bo določil, koliko zdravila potrebujete.
English: Additional information on special populations
Slovenian: Dodatne informacije o posebnih populacijah
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA): http://www.ema.europa.eu.
English: • The virus can affect anyone, but it is a particular problem in people with a weak immune system.
Slovenian: • Virus lahko prizadene vsakogar, a posebno težavo pomeni za osebe z oslabelim imunskim sistemom.
English: • hallucinations - hearing or seeing things that are not real.
Slovenian: • halucinacije - slišanje ali videnje stvari, ki niso resnične.
English: For females: 0.85 x male value
Slovenian: Za ženske: 0,85 x vrednost za moške
English: This is called an intravenous infusionand it will usually take one hour.
Slovenian: To imenujemo intravenska infuzija in po navadi traja eno uro.
English: Currently available paediatric data are described in sections 5.1 and 5.2, but no recommendation on a posology can be made.
Slovenian: Pediatrični podatki, ki so trenutno na voljo, so opisani v poglavjih 5.1 in 5.2, toda priporočil za odmerjanje ni mogoče dati.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Slovenian: Če ni uporabljena takoj, so čas shranjevanja med uporabo in pogoji pred uporabo odgovornost uporabnika.
English: Of these, 25 received ganciclovir and 17 received no treatment.
Slovenian: Od teh jih je 25 prejemalo ganciklovir, 17 pa nobenega zdravila.
English: There were 9 deaths during the study, 3 in the ganciclovir group and 6 in the control group.
Slovenian: Med študijo je bilo 9 smrti: 3 v skupini z ganciklovirjem in 6 v kontrolni skupini.
English: No deaths were related to study medication.
Slovenian: Nobena smrt ni bila povezana z raziskovanim zdravilom.
English: The risk of neutropenia is not predictable on the basis of the number of neutrophils before treatment.
Slovenian: Tveganja za nevtropenijo ni mogoče napovedati na podlagi števila nevtrofilcev pred zdravljenjem.
English: In these people the CMV virus can lead to a serious disease.
Slovenian: Pri takšnih osebah lahko virus CMV povzroči resno bolezen.
English: Side effects in children and adolescents The following side effects are more likely in children:
Slovenian: Neželeni učinki pri otrocih in mladostnikih Naslednji neželeni učinki so verjetnejši pri otrocih:
English: * The frequencies of these adverse reactions are derived from post-marketing experience, all other frequency categories are based on the frequency recorded in clinical trials.
Slovenian: * Pogostnosti teh neželenih učinkov temeljijo na izkušnjah po prihodu zdravila na trg; vse druge kategorije pogostnosti temeljijo na pogosnosti, zabeleženi v kliničnih preskušanjih.
English: {Name and Address} <{tel}> <{fax}> <{e-mail}>
Slovenian: {Ime države članice}{Ime zdravila}
English: For the first 2 weeks these blood tests will be done often.
Slovenian: Prva 2 tedna bo zdravnik te preiskave opravljal pogosto.
English: This includes the retina at the back of the eye - this means the virus can cause problems with eye sight.
Slovenian: Med drugim tudi mrežnico na zadnjem delu očesa - to pomeni, da lahko ta virus povzroči težave z vidom.
English: If you are pregnant or think you might be pregnant, do not use this medicine unless your doctor tells you to.
Slovenian: Če ste noseči ali menite, da bi lahko bili noseči, ne uporabljajte tega zdravila, razen če vam tako naroči zdravnik.
English: • blood poisoning (sepsis)
Slovenian: • zastrupitev krvi (sepsa)
English: • eye infection (conjunctivitis)
Slovenian: • okužba očesa (konjunktivitis)
English: • If you have two infusions a day, this will continue for up to 21 days.
Slovenian: • Če boste dobivali dve infuziji na dan, boste zdravilo prejemali do 21 dni.
English: Hallucinations*
Slovenian: halucinacije*
English: Cymevene should not be mixed with other intravenous products.
Slovenian: Zdravila Cymevene se ne sme mešati z drugimi intravenskimi zdravili.
English: No studies have been conducted in adults older than 65 years of age.
Slovenian: Starejši bolniki Študij pri odraslih, starejših od 65 let, niso izvedli.
English: • pancreatitis - signs are severe stomach pain which spreads into your back.
Slovenian: • pankreatitis - med znaki so hude bolečine v trebuhu, ki se širijo v hrbet.