FrancophonIA/ELRC3.0 huggingface dataset:
English: The time to last vomit ranged from 30 to 82 minutes following ocular administration in a pharmacokinetic study in dogs.
Slovenian: V študiji farmakokinetike pri psih se je čas do zadnjega bruhanja gibal med 30 in 82 minutami po dajanju v oko.
English: Excretion in the urine occurs mainly as metabolites.
Slovenian: Učinkovina se izloča z urinom predvsem v obliki presnovkov.
English: Dog bodyweight (kg)
Slovenian: Telesna masa psa (kg)
English: Ropinirole is rapidly absorbed into the systemic circulation of dogs after administration as a solution on their eye surface.
Slovenian: Pri psih se ropinirol po dajanju raztopine na očesno površino hitro absorbira v sistemski krvni obtok.
English: Uncommon adverse reactions: Corneal ulceration.
Slovenian: Občasni neželeni učinki: Razjede roženice.
English: (µg/kg)
Slovenian: Ropinirol (µg/kg)
English: Clevor 30 mg/ml eye drops, solution is supplied in single-dose containers containing 0.6 ml.
Slovenian: Zdravilo Clevor 30 mg/ml kapljice za oko, raztopina, je na voljo v enoodmernih vsebnikih po 0,6 ml. Vsak vsebnik je zaprt v posamezno vrečko iz laminirane aluminijaste folije.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains:
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Clevor 30 mg/ml eye drops, solution in single-dose container for dogs Ropinirole (ropinirol)
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Clevor 30 mg/ml kapljice za oko, raztopina v enoodmernem vsebniku za pse Ropinirol (ropinirole)
English: Ask your veterinarian or pharmacist how to dispose of medicines no longer required.
Slovenian: ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO Glede odstranjevanja zdravil, ki jih ne uporabljate več, se posvetujte z veterinarjem ali farmacevtom.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Clevor ropinirole
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Clevor 30 mg/ml eye drops, solution for dogs ropinirole
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Clevor 30 mg/ml kapljice za oko, raztopina za pse ropinirol
English: PACKAGE LEAFLET: Clevor 30 mg/ml eye drops, solution in single-dose container for dogs
Slovenian: NAVODILO ZA UPORABO Clevor 30 mg/ml kapljice za oko, raztopina v enoodmernem vsebniku za pse
English: Instructions for administration
Slovenian: Navodila za dajanje
English: The safety of the product has not been studied in dogs with hepatic impairment.
Slovenian: Pri psih z okvaro jeter varnosti zdravila niso preučili.
English: Squeeze the prescribed number of drops into the eye(s).
Slovenian: Stisnite predpisano število kapljic v eno ali obe očesi.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Clevor 30 mg/ml eye drops, solution in single-dose container for dogs
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Clevor 30 mg/ml kapljice za oko, raztopina v enoodmernem vsebniku za pse
English: WASTE MATERIALS, IF ANY
Slovenian: UPORABE, ČE JE SMISELNO
English: 72 hours.
Slovenian: 72 ur.
English: Human albumin.
Slovenian: Humani albumin.
English: Date of first authorisation: 23 March 2018
Slovenian: Datum prve odobritve: 23. marec 2018
English: • These shall contain the following key elements:
Slovenian: • Ta gradiva morajo vsebovati naslednje ključne elemente:
English: EXP {XX-XXX-XXXX at XX:XX CET}
Slovenian: EXP {XX-XXX-XXXX ob XX:XX CET}
English: In addition a long term follow-up was conducted up to Week 52.
Slovenian: Poleg tega je potekalo še dolgoročno spremljanje do 52. tedna.
English: • The educational material for health professionals should contain:
Slovenian: • Izobraževalno gradivo za zdravstvene delavce mora vsebovati:
English: Do not give this medicine to children and adolescents (i.e. aged under 18 years) because the potential benefits and risks are unknown.
Slovenian: Tega zdravila ne smete dati otrokom in mladostnikom (tj. osebam, mlajšim od 18 let), ker morebitne koristi in tveganja niso znani.
English: In general, these side effects are quite mild and disappear in the days following the fistula procedure.
Slovenian: Na splošno so ti neželeni učinki dokaj blagi in izginejo v dneh po postopku na fistuli.
English: The safety and efficacy of darvadstrocel in children and adolescents aged 0 to 17 years have not yet been established.
Slovenian: Varnost in učinkovitost darvadstrocela pri otrocih in mladostnikih, starih od 0 do 17 let, še nista bili dokazani.
English: This medicine contains cells of human origin.
Slovenian: Zdravilo vsebuje celice humanega izvora.
English: This should be considered if you are allergic to these antibiotics, as these antibiotics are used in the manufacturing process of this medicine.
Slovenian: To je treba upoštevati, če ste alergični na ta antibiotika, saj se antibiotika uporabljata pri postopku izdelave zdravila.
English: Final Report to EMA: 2Q/3Q 2022
Slovenian: Končno poročilo za agencijo EMA: 2Q/3Q 2022
English: The recommended dose is 120 million cells.
Slovenian: Priporočeni odmerek je 120 milijonov celic.
English: 6 mL 30 million cells
Slovenian: 6 ml 30 milijonov celic
English: The efficacy of Alofisel was assessed in the ADMIRE-CD study.
Slovenian: Učinkovitost zdravila Alofisel so ocenili v študiji ADMIRE-CD.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor/surgeon for advice before you are given this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom/kirurgom, preden vam dajo to zdravilo.
English: Common side effects (may affect up to 1 to 10 patients):
Slovenian: Pogosti neželeni učinki (lahko se pojavijo pri največ 1 od 10 bolnikov):
English: The frequency of adverse reactions is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000) and not known (cannot be estimated from available data).
Slovenian: Pogostnost neželenih učinkov je opredeljena na naslednji način: 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); zelo redki (< 1/10.000) in neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: *Conditioning reactions occurring up to seven days after the fistula cleaning for treatment administration.
Slovenian: * Reakcije na pripravo, ki se pojavijo največ sedem dni po čiščenju fistule za dajanje zdravila.
English: The product is checked at different stages during its manufacture to ensure that it is free of infection.
Slovenian: Zdravilo v različnih fazah izdelave preverjajo, da zagotovijo, da ni okuženo.
English: • procedural pain (pain after fistula cleaning)
Slovenian: • bolečina zaradi postopka (bolečina po čiščenju fistule)
English: This should be considered in patients with known hypersensitivity to these classes of antibiotics.
Slovenian: To je treba upoštevati pri bolnikih z znano preobčutljivostjo na te skupine antibiotikov.
English: Injection
Slovenian: injekcija
English: Women of childbearing age should use effective contraception during treatment with Alofisel.
Slovenian: Ženske v rodni dobi morajo med zdravljenjem z zdravilom Alofisel uporabljati učinkovito kontracepcijo.
English: Control group (Placebo+standard of care*) N= 102
Slovenian: Kontrolna skupina (placebo + standardna oskrba*) N = 102
English: • Guide for health professionals providing information on potential for microbial information and advice on steps to follow in case a positive culture is identified.
Slovenian: • Vodnik za zdravstvene delavce, ki zagotavlja informacije o možnosti mikrobne kontaminacije in nasvete za ukrepe v primeru identifikacije pozitivne kulture.
English: This means that with a dose of 120 million cells it is possible to treat up to three fistula tracts that open to the perianal area.
Slovenian: To pomeni, da je z odmerkom 120 milijonov celic mogoče zdraviti največ tri trakte fistule, ki se odpirajo v perianalno območje.
English: Pharmacotherapeutic group: {not yet assigned}, ATC code: {not yet assigned}.
Slovenian: Farmakoterapevtska skupina: {še ni bila dodeljena}, oznaka ATC: {še ni bila dodeljena}.
English: Once you have been anaesthetised (general or regional anaesthesia), your surgeon will:
Slovenian: Ko boste pod anestezijo (splošno ali regionalno), bo kirurg:
English: In the unlikely event that the results detected an infection, your treatment team will be informed who will tell you if you need any laboratory tests of treatment for the infection.
Slovenian: Če rezultati slučajno pokažejo okužbo, bo vaša zdravniška ekipa obveščena in vam bodo povedali, ali potrebujete kakršne koli laboratorijske teste ali zdravljenje okužbe.
English: 2.1 General description
Slovenian: 2.1 Splošen opis
English: Adult stem cells are a special type of cells found in many adult tissues, whose primary role is the repair of the tissue in which they are found.
Slovenian: Odrasle matične celice so posebne celice, ki jih najdemo v številnih odraslih tkivih, njihova prvotna naloga pa je popravljanje tkiva, v katerem se nahajajo.
English: C/ Marconi, 1, Parque Tecnológico de Madrid, 28760 Tres Cantos, Madrid, Spain
Slovenian: C/ Marconi, 1, Parque Tecnológico de Madrid, 28760 Tres Cantos, Madrid, Španija
English: • clean the fistulas with salt water and remove any scar tissue.
Slovenian: • očistil fistule s slano vodo in odstranil brazgotinasto tkivo.
English: Parque Tecnológico de Madrid 28760 Tres Cantos, Madrid Spain
Slovenian: Parque Tecnológico de Madrid 28760 Tres Cantos, Madrid Španija
English: The aim of the educational programme is to provide information on how to correctly administer the product in order to minimise the risk of medication errors and to increase awareness about the potential transmission of infectious agents.
Slovenian: Namen izobraževalnega programa je zagotoviti informacije o pravilni uporabi zdravila, da se zmanjša tveganje za napake pri zdravljenju, in povečati zavedanje o morebitnem prenašanju povzročiteljev okužb.
English: GLASS VIAL
Slovenian: STEKLENA VIALA
English: Do not irradiate or otherwise sterilise.
Slovenian: Ne obsevajte ali drugače sterilizirajte.
English: Combined remission at Week 24 (% patients) Combined remission at Week 52 (% patients)
Slovenian: Kombinirana remisija v 24. tednu (% bolnikov) Kombinirana remisija v 52. tednu (% bolnikov)
English: Because the final check takes place just before Alofisel is sent to the hospital, the results of this last check are not known when it is given to you.
Slovenian: Zadnji nadzor se izvaja tik preden zdravilo Alofisel pošljejo v bolnišnico, zato v trenutku, ko vam dajo zdravilo, rezultati tega zadnjega preverjanja niso znani.
English: • Guide for surgeons and other health professionals describing the method of administration
Slovenian: • Vodnik za kirurge in druge zdravstvene delavce, ki opisuje način uporabe
English: Before scheduling Alofisel administration, the surgeon must ensure that no abscesses are present.
Slovenian: Pred načrtovanjem uporabe zdravila Alofisel mora kirurg zagotoviti, da ni prisotnih abscesov.
English: • Relevant information on the risk of medication errors and the potential for transmission of infectious agents and details on how to minimise these, including reception, storage and administration instructions (i.e. fistula conditioning, preparation and injection).
Slovenian: • Ustrezne informacije o tveganju za napake pri zdravljenju in nevarnosti prenašanja povzročiteljev okužb ter podrobna navodila za njihovo zmanjšanje, vključno z navodili za prevzem, shranjevanje in dajanje (tj. pripravo fistule ter pripravo in injiciranje zdravila).
English: Therefore, no dose adjustment is required in elderly patients.
Slovenian: Zato prilagoditev odmerka pri starejših bolnikih ni potrebna.
English: After perianal and intrarectal injection of human eASC in athymic rats, cells were present in the rectum and jejunum at the site of injection for at least 14 days and were undetectable after 3 months.
Slovenian: Po perianalnem in intrarektalnem injiciranju človeških celic eASC atimičnim podganam so bile celice prisotne v rektumu in jejunumu na mestu injiciranja vsaj 14 dni, po 3 mesecih pa jih ni bilo mogoče zaznati.
English: See the end of Section 4 for how to report side effects.
Slovenian: Glejte na koncu poglavja 4, kako poročati o neželenih učinkih.
English: This leaflet was last revised in <MM/YYYY>
Slovenian: Navodilo je bilo nazadnje revidirano dne MM/LLLL
English: • proctalgia (pain in the rectum or anus).
Slovenian: • proktalgija (bolečina v rektumu ali anusu).
English: Alofisel is used when the fistulas have not responded sufficiently well to previous treatment.
Slovenian: Zdravilo Alofisel se uporablja, kadar se fistule ne odzivajo dobro na predhodno zdravljenje.
English: The product is intended for local injection.
Slovenian: To zdravilo je namenjeno lokalnemu injiciranju.
English: The vials are placed inside a cardboard box.
Slovenian: Viale so pakirane v kartonsko škatlo.
English: Immediately prior to the administration of Alofisel, the fistula tracts should be conditioned as follows: a) If setons are in place, they must be removed.
Slovenian: Neposredno pred uporabo zdravila Alofisel je treba trakte fistule pripraviti na naslednji način: a) Odstraniti je treba setone, če so vstavljeni.
English: b) Identify the location of the internal openings.
Slovenian: b) Identificirajte mesto notranjih odprtin.
English: The efficacy or safety of repeat administration of Alofisel has not been established.
Slovenian: Učinkovitost in varnost večkratne uporabe zdravila Alofisel ni bila dokazana .
English: Patients should be followed up for potential signs of infection after administration.
Slovenian: Po uporabi je treba bolnike spremljati glede morebitnih znakov okužbe.
English: Animal studies are not available with respect to reproductive toxicity (see section 5.3).
Slovenian: Študije škodljivih učinkov na sposobnost razmnoževanja pri živalih niso na voljo (glejte poglavje 5.3).
English: The nature and intended clinical use of darvadstrocel are such that conventional studies of pharmacokinetics (absorption, distribution, metabolism and elimination) are not applicable.
Slovenian: Narava in predvidena klinična uporaba darvadstrocela sta takšni, da običajne študije farmakokinetike (absorpcija, porazdelitev, presnova in izločanje) smiselno niso potrebne.
English: • massage softly for 20 to 30 seconds the area where the fistula opens on to the skin near your anus.
Slovenian: • 20 do 30 sekund nežno masiral območje, kjer se fistula odpira v kožo v bližini anusa.
English: * Including abscess drainage, seton placement/removal, curettage, suture of internal openings and medical treatments
Slovenian: * Vključuje drenažo abscesa, vstavitev/odstranjevanje setona, kiretažo, šivanje notranjih odprtin in zdravljenje z zdravili.
English: Each vial should be used immediately after re-suspension to prevent the cells from re-sedimenting.
Slovenian: Vsako vialo je treba uporabiti takoj po vnovičnem suspendiranju, da se prepreči vnovična sedimentacija celic.
English: Before treatment with Alofisel, you will be given an anaesthetic.
Slovenian: Pred zdravljenjem z zdravilom Alofisel vam bodo dali anestetik.
English: Hypersensitivity to the product, bovine serum or any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na zdravilo, goveji serum ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: A total of 212 patients were randomised, and 205 patients received a local injection of either Alofisel 120 million cells or placebo in a 1:1 design.
Slovenian: Randomizirali so skupno 212 bolnikov, 205 bolnikov pa je prejelo lokalno injekcijo zdravila Alofisel 120 milijonov celic ali placebo v skupinah, razdeljenih v razmerju 1 : 1.
English: For injection in the fistula tract tissue in a surgical environment under anaesthesia (general or regional (see section 4.4)) as described below.
Slovenian: Za injiciranje v tkivo traktov fistule v kirurškem okolju pod anestezijo (splošno ali regionalno (glejte poglavje 4.4)), kot je opisano v nadaljevanju.
English: The effect of ex vivo expansion on the genetic stability of cells has been assessed in vitro without any indication of carcinogenic potential.
Slovenian: Učinek razmnoževanja ex vivo na genetsko stabilnost celic so ocenili in vitro, kjer niso ugotovili nobenih znakov kancerogenega potenciala.
English: Alofisel is a living cell therapy and, therefore, the final product cannot be sterilised.
Slovenian: Zdravilo Alofisel je terapija, ki vsebuje žive celice, zato končnega izdelka ni mogoče sterilizirati.
English: It is recommended that at least 2 to 3 weeks before the administration day, preparatory surgery is performed comprising exploration (under anaesthesia) of fistula anatomy (number of existing fistulas and openings), topography (extent and relationship with the sphincters and other pelvic muscles), potential associated complications (such as abscesses) and whether local mucosal disease is mild or inactive.
Slovenian: Priporoča se, da se vsaj 2 do 3 tedne pred dnem prve uporabe zdravila izvede pripravljalna operacija, ki zajema proučitev (pod anestezijo) anatomije fistule (število obstoječih fistul in odprtin), topografije (obseg ter povezava s sfinktri in drugimi medeničnimi mišicami), morebitnih povezanih zapletov (npr. abscesov) in tega, ali je lokalna bolezen sluznice blaga ali neaktivna.
English: As this medicine will be used during surgery, the hospital staff is responsible for the correct storage of the medicine before and during its use, as well as for its correct disposal.
Slovenian: To zdravilo bo uporabljeno med kirurškim posegom, zato je za pravilno shranjevanje zdravila pred uporabo in med njo ter njegovo pravilno odstranjevanje odgovorno osebje v bolnišnici.
English: If after the procedure you feel ill or have fever, please inform your physician as soon as you can.
Slovenian: Če boste po postopku zboleli ali imeli povišano telesno temperaturo, čim prej obvestite zdravnika.
English: The key secondary endpoints were defined as clinical remission (clinical closure of all treated fistula) and response (clinical closure of at least 50% of all treated fistulas) at Week 24.
Slovenian: Ključna sekundarna opazovana dogodka sta bila opredeljena kot klinična remisija (klinično zaprtje vseh zdravljenih fistul) in odziv (klinično zaprtje vsaj 50% vseh zdravljenih fistul) v 24. tednu.
English: Alofisel is indicated only for injection in the fistula tract tissue as described in section 4.2.
Slovenian: Zdravilo Alofisel je indicirano samo za injiciranje v tkivo traktov fistule, kot je opisano v poglavju 4.2.
English: Suspension for injection 1 dose consists of 4 vials of 6 mL (in total 24 mL)
Slovenian: suspenzija za injiciranje 1 odmerek sestavljajo 4 viale po 6 ml (skupno 24 ml)
English: Perianal fistulas are described as complex if they have multiple channels and openings, if they penetrate deep inside your body or if they are associated with other complications such as collections of pus (infected liquid also called abscesses).
Slovenian: Perianalne fistule se opisujejo kot zapletene, če vsebujejo več kanalov in odprtin, če segajo globoko v telo, ali če so povezane z drugimi zapleti, kot so ognojki (okužena tekočina, imenovana tudi absces).
English: No case of overdose has been reported.
Slovenian: Poročil o primerih prevelikega odmerjanja ni.
English: The following listing of adverse reactions is based on the clinical trial experience and is displayed by system organ class.
Slovenian: Naslednji seznam neželenih učinkov temelji na izkušnjah iz kliničnih preskušanj, razvrščen pa je po organskih sistemih.
English: Patients had draining complex perianal fistulas with an inadequate response to at least one of the following treatments: antibiotics, immunosuppressants or anti-TNFs.
Slovenian: Bolniki so imeli drenirajoče zapletene perianalne fistule in neustrezni odziv na vsaj eno izmed naslednjih zdravljenj: antibiotiki, zdravila za zaviranje imunske odzivnosti ali zaviralci TNF.
English: There are no data from the use of darvadstrocel in pregnant women.
Slovenian: Podatkov o uporabi darvadstrocela pri nosečnicah ni.
English: Local anaesthesia is not recommended due to the unknown effect of local anaesthetics on the injected cells (see section 4.2).
Slovenian: Lokalna anestezija ni priporočljiva, ker učinek lokalnih anestetikov na injicirane celice ni znan (glejte poglavje 4.2).
English: As Alofisel is a living stem cell therapy it cannot be sterilised, and therefore could contain potentially infected biological material although the risk is considered to be low and controlled in the manufacturing.
Slovenian: Zdravilo Alofisel je terapija z živimi matičnimi celicami, zato ga ni mogoče sterilizirati, torej lahko vsebuje potencialno okužen biološki material, čeprav se domneva, da je to tveganje majhno in nadzorovano pri izdelavi.
English: Darvadstrocel has no or negligible influence on the ability to drive and use machines.
Slovenian: Darvadstrocel nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: - If there are two or three external openings, inject the content of the remaining two vials equally between the associated tracts.
Slovenian: - Če obstajajo dve ali tri zunanje odprtine, enakomerno razporedite vsebino preostalih dveh vial med njihove trakte.
English: Concomitant use of stable doses of immunosuppressants (18% of patients) or anti-TNFs (33%) or both (28%) was allowed during the study.
Slovenian: Med študijo je bila dovoljena sočasna uporaba stabilnih odmerkov zdravil za zaviranje imunske odzivnosti (18% bolnikov) ali zaviralcev TNF (33%) ali obeh vrst zdravil (28%).
English: Also contains: Dulbecco's Modified Eagle´s Medium (DMEM) and Human albumin.
Slovenian: Vsebuje tudi: Eaglov medij, modificiran po Dulbeccu (DMEM) in humani albumin.
English: Perianal fistulas are abnormal channels that connect parts of the lower bowel (rectum and anus) and the skin near the anus, so that one or more openings appear near the anus.
Slovenian: Perianalne fistule so nenormalni kanali, ki povezujejo dele spodnjega dela črevesa (rektuma in anusa) in kože ob anusu, tako da se ob anusu pojavi ena ali več odprtin.
English: For this, injection of a sodium chloride 9 mg/mL (0.9%) solution through the external openings until it gets out through the internal openings is recommended.
Slovenian: Za to se priporoča injiciranje 0,9-odstotne raztopine natrijevega klorida (9 mg/ml) skozi zunanje odprtine, dokler ne priteče skozi notranje odprtine.
English: This was a randomised, double blind, parallel group, placebo-controlled, multicentre clinical trial to assess efficacy and safety of Alofisel for the treatment of complex perianal fistulas in Crohn's disease patients.
Slovenian: To je bilo randomizirano, dvojno slepo, vzporedno, multicentrično klinično preskušanje, nadzorovano s placebom, za oceno učinkovitosti in varnosti zdravila Alofisel pri zdravljenju zapletenih perianalnih fistul pri bolnikih s Crohnovo boleznijo.
English: For further information on the use of Alofisel see section 4.2.
Slovenian: Za dodatne informacije o uporabi zdravila Alofisel glejte poglavje 4.2.
English: This immunoregulatory activity reduces inflammation, which may allow the tissues around the fistula tract to heal.
Slovenian: Ta imunoregulacijska aktivnost zmanjšuje vnetje, kar omogoča celjenje tkiv okoli trakta fistule.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Alofisel in one or more subsets of the paediatric population in the treatment of anal fistula (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Alofisel za eno ali več podskupin pediatrične populacije pri zdravljenju analne fistule (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: What Alofisel is and what it is used for 2.
Slovenian: Kaj je zdravilo Alofisel in za kaj ga uporabljamo 2.