natgillin/translations-raw huggingface dataset:
The half-life of elimination (t½) is 4 hours after intravenous administration to dogs. 
Razpolovni čas izločanja (t½) pri psih je po intravenskem dajanju 4 ure.
The veterinary medicinal product should not be administered by pregnant or breast-feeding women. 
Tega zdravila za uporabo v veterinarski medicini ne smejo dajati nosečnice ali doječe matere.
Dopamine antagonists (such as metoclopramide), neuroleptics (e.g., chlorpromazine, acepromazine) and other medicinal products with antiemetic properties (e.g., maropitant or antihistamines) may reduce the effectiveness of this veterinary medicinal product. 
Antagonisti dopamina (npr. metoklopramid), nevroleptiki (npr. klorpromazin, acepromazin) in druga zdravila z antiemetičnimi lastnostmi (npr. maropitant ali antihistaminiki) lahko zmanjšajo učinkovitost tega zdravila za uporabo v veterinarski medicini.
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
PROIZVAJALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
The dose is equivalent to 2-15 µl/kg bw in dogs. 
Pri psih odmerek ustreza 2-15 µl/kg telesne mase.
Ropinirole inhibits prolactin secretion by activation of dopamine D2 receptors located in the striatum and on lactotroph cells of pituitary gland. 
Ropinirol zavira izločanje prolaktina z aktiviranjem receptorjev dopamina D2, ki so v striatumu in na laktotropnih celicah hipofize.
EU/2/17/222/001 - 1 single-dose container EU/2/17/222/002 - 2 single-dose containers EU/2/17/222/003 - 4 single-dose containers EU/2/17/222/004 - 5 single-dose containers EU/2/17/222/005 - 6 single-dose containers EU/2/17/222/006 - 8 single-dose containers EU/2/17/222/007 - 10 single-dose containers EU/2/17/222/008 - 3 single-dose containers 
EU/2/17/222/001 - 1 enoodmerni vsebnik EU/2/17/222/002 - 2 enoodmerna vsebnika EU/2/17/222/003 - 4 enoodmerni vsebniki EU/2/17/222/004 - 5 enoodmernih vsebnikov EU/2/17/222/005 - 6 enoodmernih vsebnikov EU/2/17/222/006 - 8 enoodmernih vsebnikov EU/2/17/222/007 - 10 enoodmernih vsebnikov EU/2/17/222/008 - 3 enoodmernih vsebnikov
Transient, mild conjunctival swelling, itching of the eyes, tachypnoea, tremors, diarrhoea, ataxia and uncoordinated movement. 
Prehodno blago otekanje veznice, srbenje oči, tahipneja, tremor, driska, ataksija in nekoordinirano gibanje.
Ropinirole is metabolised by the liver. 
Ropinirol se presnavlja v jetrih.
The veterinary medicinal product should only be administered by a veterinarian or under their close supervision. 
Zdravilo za uporabo v veterinarski medicini sme dajati samo veterinar oziroma se sme dajati samo pod natančnim nadzorom veterinarja.
Ropinirole might reduce the level of prolactin due to its inhibitory effect on prolactin secretion as a dopamine agonist. 
Ropinirol lahko zniža raven prolaktina, saj ima kot agonist dopamina zaviralni učinek na izločanje prolaktina.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box 
PODATKI NA ZUNANJI OVOJNINI Kartonasta škatla
No direct correlation between ropinirole concentration in plasma and the duration of vomiting was observed after ocular administration. 
Po dajanju v oko niso opazili neposredne korelacije med koncentracijo ropinirola v plazmi in trajanjem bruhanja.
Administer the product with caution. 
Pri dajanju tega zdravila je potrebna previdnost.
Be careful not to touch the dropper tip after opening the container in case a second dose is necessary. 
Pazite, da se po odprtju vsebnika ne dotaknete konice kapalke; to je pomembno, če bo potreben še drugi odmerek.
EU/2/17/222/001 - 1 single-dose container EU/2/17/222/002 - 2 single-dose containers EU/2/17/222/003 - 4 single-dose containers EU/2/17/222/004 - 5 single-dose containers EU/2/17/222/005 - 6 single-dose containers 
EU/2/17/222/001 - 1 enoodmerni vsebnik EU/2/17/222/002 - 2 enoodmerna vsebnika EU/2/17/222/003 - 4 enoodmerni vsebnik EU/2/17/222/004 - 5 enoodmernih vsebnikov EU/2/17/222/005 - 6 enoodmernih vsebnikov EU/2/17/222/006 - 8 enoodmernih vsebnikov EU/2/17/222/007 - 10 enoodmernih vsebnikov EU/2/17/222/008 - 3 enoodmernih vsebnikov
Ropinirole (µg/body surface area) 
Ropinirol (μg/telesno površino)
The safety of the product has not been studied in dogs with diagnosed cardiac disease/dysfunction. 
Pri psih z diagnosticirano boleznijo/disfunkcijo srca varnosti zdravila niso preučili.
THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only. 
BESEDILO „SAMO ZA ŽIVALI“ Samo za živali.
PHARMACEUTICAL FORM Eye drops, solution in single-dose container 
FARMACEVTSKA OBLIKA Kapljice za oko, raztopina v enoodmernem vsebniku
The safety of the veterinary medicinal product has not been established during pregnancy and lactation in the target species. 
Varnost zdravila v obdobju brejosti in laktacije pri ciljni živalski vrsti ni bila ugotovljena.
QUANTITY OF THE ACTIVE SUBSTANCE(S) 30 mg/ml ropinirole 
KOLIČINA UČINKOVIN(E) 30 mg/ml ropinirola
The safety and efficacy of the product have not been studied in dogs with ocular disease or injury. 
Pri psih z boleznijo ali poškodbo oči niso preučili varnosti in učinkovitosti zdravila.
If the dog does not vomit within 15 minutes after administration of the initial dose, a second dose may be given 15 to 20 minutes after administration of the initial dose. 
Če pes ne bruha v 15 minutah po dajanju začetnega odmerka, mu lahko od 15 do 20 minut po začetnem odmerku daste še drugi odmerek.
EXPIRY DATE EXP {month/year} Once opened use within 30 minutes. 
Odprto zdravilo uporabite v 30 minutah.
Common reactions: temporary, mild swelling of the mucous membranes of the eyelids, itching of the eyes, rapid breathing, shivering, diarrhoea and/or irregular or uncoordinated bodily movements. 
Pogosti neželeni učinki: začasno blago otekanje sluznice vek, srbenje oči, hitro dihanje, drgetanje, driska in/ali neenakomerno ali nekoordinirano gibanje telesa.
Ropinirole is mainly eliminated by hepatic metabolism. 
Ropinirol se v glavnem izloča s presnovo v jetrih.
Common adverse reactions: 
Pogosti neželeni učinki:
Therefore, use of the product is not recommended during pregnancy or lactation. 
Zato uporaba zdravila v obdobju brejosti in laktacije ni priporočljiva.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Pouch label 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
The following dosing table provides the dose in drops to be administered corresponding to the dog's bodyweight. 
V naslednji preglednici za odmerjanje so navedeni odmerki v kapljicah, ki jih je treba uporabiti glede na telesno maso psa.
PHARMACEUTICAL FORM Eye drops solution in single-dose container. 
FARMACEVTSKA OBLIKA Kapljice za oko, raztopina v enoodmernem vsebniku.
30 mg (equivalent to 34.2 mg ropinirole hydrochloride) Excipients: 
Ropinirol (ropinirole) 30 mg (ustreza 34,2 mg ropinirolijevega hidroklorida)
The following dosing table provides the dose volume in drops to be administered corresponding to the dog's bodyweight. 
V naslednji preglednici za odmerjanje so navedeni volumni odmerkov v kapljicah, ki jih je treba uporabiti glede na telesno maso psa.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s) - common (more than 1 but less than 10 animals in 100 animals treated) 
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) - pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živali od 1000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali)
After opening place the container back into the pouch, in case a second dose is necessary. 
SHRANITEV ODPRTEGA VSEBNIKA: Po odprtju dajte vsebnik nazaj v vrečko, če bo potreben še en odmerek.
Very common adverse reactions: Transient mild or moderate hyperaemia of the eye, ocular discharge, protrusion of the 3rd eyelid and blepharospasm. 
Prehodna blaga ali zmerna hiperemija očesa, izcedek iz oči, protruzija tretje veke in blefarospazem.
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports). 
- zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri).
STATEMENT OF ACTIVE SUBSTANCES 30 mg/ml ropinirole 
NAVEDBA UČINKOVIN(E) 30 mg/ml ropinirola
The time to last vomit ranged from 30 to 82 minutes following ocular administration in a pharmacokinetic study in dogs. 
V študiji farmakokinetike pri psih se je čas do zadnjega bruhanja gibal med 30 in 82 minutami po dajanju v oko.
Excretion in the urine occurs mainly as metabolites. 
Učinkovina se izloča z urinom predvsem v obliki presnovkov.
Dog bodyweight (kg) 
Telesna masa psa (kg)
Ropinirole is rapidly absorbed into the systemic circulation of dogs after administration as a solution on their eye surface. 
Pri psih se ropinirol po dajanju raztopine na očesno površino hitro absorbira v sistemski krvni obtok.
Uncommon adverse reactions: Corneal ulceration. 
Občasni neželeni učinki: Razjede roženice.
Clevor 30 mg/ml eye drops, solution is supplied in single-dose containers containing 0.6 ml. 
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.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains: 
KAKOVOSTNA IN KOLIČINSKA SESTAVA
NAME OF THE VETERINARY MEDICINAL PRODUCT Clevor 30 mg/ml eye drops, solution in single-dose container for dogs Ropinirole (ropinirol) 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Clevor 30 mg/ml kapljice za oko, raztopina v enoodmernem vsebniku za pse Ropinirol (ropinirole)
Ask your veterinarian or pharmacist how to dispose of medicines no longer required. 
ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO Glede odstranjevanja zdravil, ki jih ne uporabljate več, se posvetujte z veterinarjem ali farmacevtom.
NAME OF THE VETERINARY MEDICINAL PRODUCT Clevor ropinirole 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
NAME OF THE VETERINARY MEDICINAL PRODUCT Clevor 30 mg/ml eye drops, solution for dogs ropinirole 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Clevor 30 mg/ml kapljice za oko, raztopina za pse ropinirol
PACKAGE LEAFLET: Clevor 30 mg/ml eye drops, solution in single-dose container for dogs 
NAVODILO ZA UPORABO Clevor 30 mg/ml kapljice za oko, raztopina v enoodmernem vsebniku za pse
Instructions for administration 
Navodila za dajanje
The safety of the product has not been studied in dogs with hepatic impairment. 
Pri psih z okvaro jeter varnosti zdravila niso preučili.
Squeeze the prescribed number of drops into the eye(s). 
Stisnite predpisano število kapljic v eno ali obe očesi.
NAME OF THE VETERINARY MEDICINAL PRODUCT Clevor 30 mg/ml eye drops, solution in single-dose container for dogs 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Clevor 30 mg/ml kapljice za oko, raztopina v enoodmernem vsebniku za pse
WASTE MATERIALS, IF ANY 
UPORABE, ČE JE SMISELNO
72 hours. 
72 ur.
Human albumin. 
Humani albumin.
Date of first authorisation: 23 March 2018 
Datum prve odobritve: 23. marec 2018
• These shall contain the following key elements: 
• Ta gradiva morajo vsebovati naslednje ključne elemente:
EXP {XX-XXX-XXXX at XX:XX CET} 
EXP {XX-XXX-XXXX ob XX:XX CET}
In addition a long term follow-up was conducted up to Week 52. 
Poleg tega je potekalo še dolgoročno spremljanje do 52. tedna.
• The educational material for health professionals should contain: 
• Izobraževalno gradivo za zdravstvene delavce mora vsebovati:
Do not give this medicine to children and adolescents (i.e. aged under 18 years) because the potential benefits and risks are unknown. 
Tega zdravila ne smete dati otrokom in mladostnikom (tj. osebam, mlajšim od 18 let), ker morebitne koristi in tveganja niso znani.
In general, these side effects are quite mild and disappear in the days following the fistula procedure. 
Na splošno so ti neželeni učinki dokaj blagi in izginejo v dneh po postopku na fistuli.
The safety and efficacy of darvadstrocel in children and adolescents aged 0 to 17 years have not yet been established. 
Varnost in učinkovitost darvadstrocela pri otrocih in mladostnikih, starih od 0 do 17 let, še nista bili dokazani.
This medicine contains cells of human origin. 
Zdravilo vsebuje celice humanega izvora.
This should be considered if you are allergic to these antibiotics, as these antibiotics are used in the manufacturing process of this medicine. 
To je treba upoštevati, če ste alergični na ta antibiotika, saj se antibiotika uporabljata pri postopku izdelave zdravila.
Final Report to EMA: 2Q/3Q 2022 
Končno poročilo za agencijo EMA: 2Q/3Q 2022
The recommended dose is 120 million cells. 
Priporočeni odmerek je 120 milijonov celic.
6 mL 30 million cells 
6 ml 30 milijonov celic
The efficacy of Alofisel was assessed in the ADMIRE-CD study. 
Učinkovitost zdravila Alofisel so ocenili v študiji ADMIRE-CD.
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. 
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom/kirurgom, preden vam dajo to zdravilo.
Common side effects (may affect up to 1 to 10 patients): 
Pogosti neželeni učinki (lahko se pojavijo pri največ 1 od 10 bolnikov):
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). 
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).
*Conditioning reactions occurring up to seven days after the fistula cleaning for treatment administration. 
* Reakcije na pripravo, ki se pojavijo največ sedem dni po čiščenju fistule za dajanje zdravila.
The product is checked at different stages during its manufacture to ensure that it is free of infection. 
Zdravilo v različnih fazah izdelave preverjajo, da zagotovijo, da ni okuženo.
• procedural pain (pain after fistula cleaning) 
• bolečina zaradi postopka (bolečina po čiščenju fistule)
This should be considered in patients with known hypersensitivity to these classes of antibiotics. 
To je treba upoštevati pri bolnikih z znano preobčutljivostjo na te skupine antibiotikov.
Injection 
injekcija
Women of childbearing age should use effective contraception during treatment with Alofisel. 
Ženske v rodni dobi morajo med zdravljenjem z zdravilom Alofisel uporabljati učinkovito kontracepcijo.
Control group (Placebo+standard of care*) N= 102 
Kontrolna skupina (placebo + standardna oskrba*) N = 102
• Guide for health professionals providing information on potential for microbial information and advice on steps to follow in case a positive culture is identified. 
• Vodnik za zdravstvene delavce, ki zagotavlja informacije o možnosti mikrobne kontaminacije in nasvete za ukrepe v primeru identifikacije pozitivne kulture.
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. 
To pomeni, da je z odmerkom 120 milijonov celic mogoče zdraviti največ tri trakte fistule, ki se odpirajo v perianalno območje.
Pharmacotherapeutic group: {not yet assigned}, ATC code: {not yet assigned}. 
Farmakoterapevtska skupina: {še ni bila dodeljena}, oznaka ATC: {še ni bila dodeljena}.
Once you have been anaesthetised (general or regional anaesthesia), your surgeon will: 
Ko boste pod anestezijo (splošno ali regionalno), bo kirurg:
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. 
Če rezultati slučajno pokažejo okužbo, bo vaša zdravniška ekipa obveščena in vam bodo povedali, ali potrebujete kakršne koli laboratorijske teste ali zdravljenje okužbe.
2.1 General description 
2.1 Splošen opis
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. 
Odrasle matične celice so posebne celice, ki jih najdemo v številnih odraslih tkivih, njihova prvotna naloga pa je popravljanje tkiva, v katerem se nahajajo.
C/ Marconi, 1, Parque Tecnológico de Madrid, 28760 Tres Cantos, Madrid, Spain 
C/ Marconi, 1, Parque Tecnológico de Madrid, 28760 Tres Cantos, Madrid, Španija
• clean the fistulas with salt water and remove any scar tissue. 
• očistil fistule s slano vodo in odstranil brazgotinasto tkivo.
Parque Tecnológico de Madrid 28760 Tres Cantos, Madrid Spain 
Parque Tecnológico de Madrid 28760 Tres Cantos, Madrid Španija
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. 
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.
GLASS VIAL 
STEKLENA VIALA
Do not irradiate or otherwise sterilise. 
Ne obsevajte ali drugače sterilizirajte.
Combined remission at Week 24 (% patients) Combined remission at Week 52 (% patients) 
Kombinirana remisija v 24. tednu (% bolnikov) Kombinirana remisija v 52. tednu (% bolnikov)
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. 
Zadnji nadzor se izvaja tik preden zdravilo Alofisel pošljejo v bolnišnico, zato v trenutku, ko vam dajo zdravilo, rezultati tega zadnjega preverjanja niso znani.
• Guide for surgeons and other health professionals describing the method of administration 
• Vodnik za kirurge in druge zdravstvene delavce, ki opisuje način uporabe
Before scheduling Alofisel administration, the surgeon must ensure that no abscesses are present. 
Pred načrtovanjem uporabe zdravila Alofisel mora kirurg zagotoviti, da ni prisotnih abscesov.
• 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). 
• 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).
Therefore, no dose adjustment is required in elderly patients. 
Zato prilagoditev odmerka pri starejših bolnikih ni potrebna.
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. 
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.
See the end of Section 4 for how to report side effects. 
Glejte na koncu poglavja 4, kako poročati o neželenih učinkih.
This leaflet was last revised in <MM/YYYY> 
Navodilo je bilo nazadnje revidirano dne MM/LLLL
• proctalgia (pain in the rectum or anus). 
• proktalgija (bolečina v rektumu ali anusu).
Alofisel is used when the fistulas have not responded sufficiently well to previous treatment. 
Zdravilo Alofisel se uporablja, kadar se fistule ne odzivajo dobro na predhodno zdravljenje.
The product is intended for local injection. 
To zdravilo je namenjeno lokalnemu injiciranju.
The vials are placed inside a cardboard box. 
Viale so pakirane v kartonsko škatlo.
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. 
Neposredno pred uporabo zdravila Alofisel je treba trakte fistule pripraviti na naslednji način: a) Odstraniti je treba setone, če so vstavljeni.
b) Identify the location of the internal openings. 
b) Identificirajte mesto notranjih odprtin.
The efficacy or safety of repeat administration of Alofisel has not been established. 
Učinkovitost in varnost večkratne uporabe zdravila Alofisel ni bila dokazana .
Patients should be followed up for potential signs of infection after administration. 
Po uporabi je treba bolnike spremljati glede morebitnih znakov okužbe.
Animal studies are not available with respect to reproductive toxicity (see section 5.3). 
Študije škodljivih učinkov na sposobnost razmnoževanja pri živalih niso na voljo (glejte poglavje 5.3).
The nature and intended clinical use of darvadstrocel are such that conventional studies of pharmacokinetics (absorption, distribution, metabolism and elimination) are not applicable. 
Narava in predvidena klinična uporaba darvadstrocela sta takšni, da običajne študije farmakokinetike (absorpcija, porazdelitev, presnova in izločanje) smiselno niso potrebne.
• massage softly for 20 to 30 seconds the area where the fistula opens on to the skin near your anus. 
• 20 do 30 sekund nežno masiral območje, kjer se fistula odpira v kožo v bližini anusa.
* Including abscess drainage, seton placement/removal, curettage, suture of internal openings and medical treatments 
* Vključuje drenažo abscesa, vstavitev/odstranjevanje setona, kiretažo, šivanje notranjih odprtin in zdravljenje z zdravili.
Each vial should be used immediately after re-suspension to prevent the cells from re-sedimenting. 
Vsako vialo je treba uporabiti takoj po vnovičnem suspendiranju, da se prepreči vnovična sedimentacija celic.
Before treatment with Alofisel, you will be given an anaesthetic. 
Pred zdravljenjem z zdravilom Alofisel vam bodo dali anestetik.
Hypersensitivity to the product, bovine serum or any of the excipients listed in section 6.1. 
Preobčutljivost na zdravilo, goveji serum ali katero koli pomožno snov, navedeno v poglavju 6.1.
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. 
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.
For injection in the fistula tract tissue in a surgical environment under anaesthesia (general or regional (see section 4.4)) as described below. 
Za injiciranje v tkivo traktov fistule v kirurškem okolju pod anestezijo (splošno ali regionalno (glejte poglavje 4.4)), kot je opisano v nadaljevanju.
The effect of ex vivo expansion on the genetic stability of cells has been assessed in vitro without any indication of carcinogenic potential. 
Učinek razmnoževanja ex vivo na genetsko stabilnost celic so ocenili in vitro, kjer niso ugotovili nobenih znakov kancerogenega potenciala.
Alofisel is a living cell therapy and, therefore, the final product cannot be sterilised. 
Zdravilo Alofisel je terapija, ki vsebuje žive celice, zato končnega izdelka ni mogoče sterilizirati.
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. 
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.