natgillin/translations-raw huggingface dataset:
• severe allergic reaction (may include swelling of the face, lips, mouth, tongue, or throat that may lead to difficulty breathing or swallowing). 
Redki (lahko se pojavijo pri največ 1 od 1.000 bolnikov) • hude alergijske reakcije (lahko vključujejo otekanje obraza, ustnic, ust, jezika, grla, zaradi česar je lahko oteženo dihanje ali požiranje).
Urinary tract infections were more frequently reported for canagliflozin 100 mg and 300 mg (5.9% versus 4.3%, respectively) compared to 4.0% with placebo. 
Okužbe sečil O okužbah sečil so pogosteje poročali pri bolnikih, ki so prejemali 100 mg oziroma 300 mg kanagliflozina (5,9% oziroma 4,3%) v primerjavi s 4,0% pri tistih, ki so prejemali placebo.
• if you are allergic to canagliflozin or any of the other ingredients of this medicine (listed in section 6). 
Kaj morate vedeti, preden boste vzeli zdravilo Invokana Ne jemljite zdravila Invokana - če ste alergični na kanagliflozin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Add-on therapy with insulind (18 weeks) Canagliflozin + insulin 
Dodatno zdravljenje pri zdravljenju z insulinomd (18 tednov) kanagliflozin + insulin placebo + insulin (n = 565)
The most commonly reported adverse reactions during treatment were hypoglycaemia in combination with insulin or a sulphonylurea, vulvovaginal candidiasis, urinary tract infection, and polyuria or pollakiuria 
so bili hipoglikemija pri kombinaciji z insulinom ali s sulfonilsečnino, vulvovaginalna kandidoza, okužba sečil in poliurija ali polakisurija (torej pogosto uriniranje).
A substudy of patients with baseline HbA1c > 10% to ≤ 12% with canagliflozin as monotherapy resulted in reductions from baseline in HbA1c (not placebo-adjusted) of -2.13% and -2.56% for canagliflozin 100 mg and 300 mg, respectively. 
V podštudiji z bolniki z izhodiščno ravnijo HbA1c od > 10% do ≤ 12% je v monoterapiji s kanagliflozinom prišlo do znižanja od izhodiščne vrednosti HbA1c (ni bila prirejena glede na placebo) za -2,13% pri uporabi odmerka 100 mg in za -2,56% pri uporabi odmerka 300 mg.
i Mean percent increases from baseline for canagliflozin 100 mg and 300 mg versus placebo, respectively, were total cholesterol 3.4% and 5.2% versus 0.9%; HDL-cholesterol 9.4% and 10.3% versus 4.0%; LDL-cholesterol 5.7% and 
i Povprečni odstotek povečanja glede na začetno vrednost za 100 mg kanagliflozina in 300 mg kanagliflozina v primerjavi s placebom je bil za celokupni holesterol 3,4% in 5,2% v primerjavi z 0,9%; HDL-holesterol 9,4% in 10,3% v primerjavi s 4,0%; LDL-holesterol 5,7% in 9,3% v primerjavi z 1,3%; ne-HDL-holesterol 2,2% in 4,4% v primerjavi z 0,7%; trigliceride 2,4% in 0,0% v primerjavi z 7,6%.
Renal impairment (eGFR < 60 mL/min/1.73 m2 or CrCl < 60 mL/min) Patients with a baseline eGFR < 60 mL/min/1.73 m2 or CrCl < 60 mL/min had a higher incidence of adverse reactions associated with volume depletion (e.g., postural dizziness, orthostatic hypotension, hypotension) with incidences of 4.7%, 8.1%, and 1.5% on canagliflozin 100 mg, canagliflozin 300 mg, and placebo, respectively (see sections 4.2 and 4.4). 
Pri bolnikih z izhodiščno vrednostjo ocenjene glomerulne filtracije < 60 ml/min/1,73 m2 ali z očistkom kreatinina < 60 ml/min so opazili večjo pogostnost neželenih učinkov, povezanih s hipovolemijo (kot so položajna omotica, ortostatska hipotenzija in hipotenzija), in sicer 4,7% pri 100 mg kanagliflozina in 8,1% pri 300 mg kanagliflozina ter 1,5% pri placebu (glejte poglavji 4.2 in 4.4).
Triple therapy with metformin and sulphonylurea (26 weeks) Canagliflozin + metformin and sulphonylurea 
Trotirno zdravljenje z metforminom in s sulfonilsečnino (26 tednov) kanagliflozin + metformin in sulfonilsečnina placebo + metformin in sulfonilsečnina
Sitagliptin 100 mg + metformin and sulphonylurea (N = 378) 
sitagliptin 100 mg + metformin in sulfonilsečnina
For patients receiving canagliflozin, in case of intercurrent conditions that may lead to volume depletion (such as a gastrointestinal illness), careful monitoring of volume status (e.g., physical examination, blood pressure measurements, laboratory tests including renal function tests), and serum electrolytes is recommended. 
(na primer s telesnim pregledom, z meritvami krvnega tlaka, z laboratorijskimi preiskavami vključno s testi delovanja ledvic) in določanje koncentracije elektrolitov v serumu.
In the dedicated cardiovascular study and the larger pooled analysis, discontinuations due to adverse reactions related to volume depletion and serious adverse reactions related to volume depletion were not increased with canagliflozin. 
V posebni kardiovaskularni študiji in po podatkih združene analize pogostnost prekinitve zdravljenja zaradi neželenega učinka, povezanega s hipovolemijo, in pogostnost resnih neželenih učinkov,
Elderly (≥ 65 years old) Renal function and risk of volume depletion should be taken into account (see section 4.4). 
Upoštevati je treba stanje ledvic in tveganje za pojav hipovolemije (glejte poglavje 4.4).
Invokana 100 mg film-coated tablets Each tablet contains canagliflozin hemihydrate, equivalent to 100 mg canagliflozin. 
Invokana 100 mg filmsko obložene tablete Ena tableta vsebuje kanagliflozinijev hemihidrat v količini, ki ustreza 100 mg kanagliflozina.
Diabetic ketoacidosis (rare, may affect up to 1 in 1,000 people) These are the signs of diabetic ketoacidosis (see also section 2 Warnings and precautions): increased levels of “ketone bodies” in your urine or blood rapid weight loss feeling sick or being sick stomach pain excessive thirst fast and deep breathing confusion unusual sleepiness or tiredness a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat. 
povečane koncentracije “ketonskih teles” v urinu in krvi hitra izguba telesne mase slabost ali bruhanje bolečine v trebuhu huda žeja hitro in globoko dihanje zmedenost nenavadna zaspanost ali utrujenost sladkast zadah, sladek ali kovinski okus v ustih ali spremenjen vonj seča ali znoja
After single-dose oral administration of 100 mg and 300 mg in healthy subjects, canagliflozin was rapidly absorbed, with peak plasma concentrations (median Tmax) occurring 1 hour to 2 hours post-dose. 
Pri zdravih osebah je po enkratnem peroralnem odmerku 100 mg oziroma 300 mg prišlo do hitre absorpcije kanagliflozina, pri čemer je do največje koncentracije v plazmi prišlo
Approximately 33% of the administered radioactive dose was excreted in urine, mainly as O-glucuronide metabolites (30.5%). 
Približno 33% danega radioaktivno označenega odmerka se je izločilo z urinom, največ v obliki
Monotherapy (26 weeks) Canagliflozin 
Monoterapija (26 tednov) kanagliflozin placebo (n = 192)
Patients (%) achieving HbA1c < 7% Body weight 
N/Ac bolniki (%), ki so dosegli raven HbA1c
Canagliflozin-induced renal tubule tumours and pheochromocytomas in rats appear to be caused by carbohydrate malabsorption as a consequence of intestinal SGLT1 inhibitory activity of canagliflozin in the gut of rats; mechanistic clinical studies have not demonstrated carbohydrate malabsorption in humans at canagliflozin doses of up to 2-times the maximum recommended clinical dose. 
ki jih pri podganah povzroča kanagliflozin, prihaja zaradi malabsorpcije ogljikovih hidratov, do katere pride zaradi zaviralnega delovanja kanagliflozina na črevesni prenašalec SGLT1 v črevesju podgan.
Relative to subjects with normal hepatic function, the geometric mean ratios for Cmax and AUC∞ of canagliflozin were 107% and 110%, respectively, in subjects with Child-Pugh class A (mild hepatic impairment) and 96% and 111%, respectively, in subjects with Child-Pugh class B (moderate) hepatic impairment following administration of a single 300 mg dose of canagliflozin. 
Pri bolnikih z blago okvaro jeter (Child-Pugh razreda A) oziroma z zmerno okvaro jeter (Child-Pugh razreda B) so po enkratnem odmerku 300 mg kanagliflozina vrednosti geometričnega povprečja Cmax kanagliflozina znašale 107% oziroma 96% teh vrednosti pri osebah z normalno jetrno funkcijo,
EU/1/13/884/007 (90 tablets) 
EU/1/13/884/007 (90 tablet)
EU/1/13/884/002 (30 tablets) 
EU/1/13/884/002 (30 tablet)
EU/1/13/884/008 (100 tablets) 
EU/1/13/884/008 (100 tablet)
EU/1/13/884/003 (90 tablets) 
EU/1/13/884/003 (90 tablet)
EU/1/13/884/004 (100 tablets) 
EU/1/13/884/004 (100 tablet)
EU/1/13/884/006 (30 tablets) 
EU/1/13/884/006 (30 tablet)
Elimination Following administration of a single oral [14C]canagliflozin dose to healthy subjects, 41.5%, 7.0%, and 
Po odmerjanju enkratnega s [14C] označenega peroralnega odmerka kanagliflozina zdravim osebam so 41,5% danega radioaktivnega odmerka prestregli v blatu v obliki kanagliflozina, 7,0% v obliki hidroksiliranega metabolita in 3,2% v obliki O-glukuronidnega presnovka.
In two 52-week active-controlled studies comparing canagliflozin to glimepiride and sitagliptin, sustained and statistically significant mean reductions in the percentage of body weight for canagliflozin as add-on therapy to metformin were -4.2% and -4.7% for canagliflozin 100 mg and 300 mg, respectively, compared to the combination of glimepiride and metformin (1.0%) and -2.5% for canagliflozin 300 mg in combination with metformin and a sulphonylurea compared to sitagliptin in combination with metformin and a sulphonylurea (0.3%). 
V dveh 52-tedenskih aktivno nadzorovanih študijah, v katerih so kanagliflozin primerjali z glimepiridom oziroma s sitagliptinom, je 100 mg oziroma 300 mg kanagliflozina kot dodatno zdravilo pri zdravljenju z metforminom povzročilo trajno in statistično značilno zmanjšanje telesne mase s povprečno spremembo odstotka telesne mase -4,2% oziroma
Pregnancy 
Izločanje
Renal impairment For patients with an eGFR 60 mL/min/1.73 m2 to < 90 mL/min/1.73 m2 or CrCl 60 mL/min to 
Pri bolnikih z ocenjeno glomerulno filtracijo 60 ml/min/1,73 m2 do < 90 ml/min/1,73 m2 ali z očistkom kreatinina 60 ml/min do < 90 ml/min ni potrebno prilagajati odmerka.
Stop taking Invokana and see a doctor as soon as possible if you have any of the following serious side effects: 
Če se pri vas pojavi kateri od naslednjih resnih neželenih učinkov, prenehajte jemati zdravilo in čimprej poiščite zdravnika:
• constipation 
• zaprtje
Therefore, the canagliflozin dose should be limited to 100 mg once daily in patients with eGFR < 60 mL/min/1.73 m2 or CrCl < 60 mL/min and canagliflozin should not be used in patients with an eGFR < 45 mL/min/1.73 m2 or CrCl < 45 mL/min (see section 4.2). 
Zato je treba dnevni odmerek kanagliflozina pri bolnikih z ocenjeno glomerulno filtracijo < 60 ml/min/1,73 m2 ali očistkom kreatinina < 60 ml/min omejiti na 100 mg.
Baseline (mean) in kg % change from baseline (adjusted mean) 
24,7b telesna masa izhodiščna (povprečna) vrednost v kg % spremembe od izhodiščne vrednosti (prilagojena povprečna vrednost)
Hypoglycaemia in combination with insulin or sulphonylurea uncommon 
Presnovne in prehranske motnje zelo pogosti hipoglikemija pri uporabi v kombinaciji z insulinom in sulfonilsečnino občasni dehidracija*
However, dilatation of the renal pelvis was noticed with a No Observed Effect Level (NOEL) at exposures 2.4 times and 0.6 times the clinical exposures at 100 mg and 300 mg doses, respectively, and did not fully reverse within the approximately 1-month recovery period. 
Pri izpostavljenostih, ki so 2,4-krat in 0,6-krat presegale klinične izpostavljenosti pri odmerkih 100 mg in
Canagliflozin 300 mg + metformin and sulphonylurea (N = 377) 
kanagliflozin 300 mg +
b b 
PRILOGA I
In patients tolerating canagliflozin whose eGFR falls persistently below 60 mL/min/1.73 m or CrCl 60 mL/min, the dose of canagliflozin should be adjusted to or maintained at 100 mg once daily. 
Pri bolnikih, ki dobro prenašajo kanagliflozin, pri katerih se ocenjena glomerulna filtracija zmanjša in ostane pod 60 ml/min/1,73 m ali očistek kreatinina pod
for placebo. 
razlika v primerjavi s placebom
In this pooled analysis, patients on loop diuretics, patients with a baseline eGFR 30 mL/min/1.73 m2 
Rezultati te združene analize so pokazali večinoma večjo pogostnost teh neželenih učinkov pri bolnikih, ki so jemali diuretike Henleyeve zanke, pri bolnikih z izhodiščno vrednostjo ocenjene glomerulne filtracije od 30 ml/min/1,73 m2 do < 60 ml/min/1,73 m2 in pri bolnikih, ki so bili stari ≥ 75 let.
Content Pack size 
Pot uporabe Stična ovojnina Vsebina
This summary was last updated in November 2014. 
Povzetek je bil nazadnje posodobljen novembra 2014.
This document cannot replace a face-to-face discussion with your veterinarian. 
Dokument ne more nadomestiti osebnega pogovora z veterinarjem.
The European Commission granted a marketing authorisation valid throughout the European Union, for Coxevac on 30 September 2010. 
Evropska komisija je dovoljenje za promet z zdravilom Coxevac, veljavno po vsej Evropski uniji, izdala 30. septembra 2010.
The duration of protection was established to be 280 days in cattle and one year in goats. 
Ugotovljeno trajanje zaščite pri govedu je 280 dni in eno leto pri kozah.
Coxevac was initially authorised under ‘exceptional circumstances'. 
Zdravilo Coxevac je prvotno pridobilo dovoljenje za promet v „izjemnih okoliščinah“.
Other information about Coxevac: 
Druge informacije o zdravilu Coxevac:
The effectiveness of Coxevac was investigated in both laboratory and field studies. 
Učinkovitost zdravila Coxevac so proučevali v laboratorijskih in terenskih študijah.
In 2014 the CVMP considered that the submitted data were adequate for the authorisation of Coxevac to convert to a normal status. 
Leta 2014 je odbor CVMP menil, da predloženi podatki zadostujejo, da se dovoljenje za promet s cepivom Coxevac spremeni v običajno dovoljenje.
The vaccine is given to cattle and goats from three months of age. 
Cepivo se govedu in kozam daje od starosti treh mesecev dalje.
In goats it is also very common to observe a slight increase of rectal temperature for 4 days post-vaccination without other general signs. 
Pri kozah se zelo pogosto pojavi tudi rahel dvig rektalne temperature do štiri dni po cepljenju brez drugih splošnih znakov.
The withdrawal period is the time allowed after administration of the medicine before the animal can be slaughtered and the meat or the milk used for human consumption. 
Karenca je čas, ki mora preteči po uporabi zdravila, preden se lahko žival zakolje in meso ali mleko uporabi za prehrano ljudi.
Nine months later, two additional injections should be given to cattle, again three weeks apart. 
Po devetih mesecih je treba govedu ponovno injicirati dva odmerka, tudi tokrat v tritedenskem razmiku.
The withdrawal period for Coxevac for meat and milk is zero days. 
Karenca za cepivo Coxevac za meso in mleko je nič dni.
In cattle it is very common to see a swelling of maximum diameter of 9 to 10 cm at the injection site, which may last for 17 days. 
Pri govedu se zelo pogosto pojavi oteklina premera največ 9 do 10 cm na mestu vboda, ki lahko traja 17 dni.
Coxevac is a bacterial vaccine. 
Zdravilo Coxevac je bakterijsko cepivo.
What benefit has Coxevac shown during the studies? 
Kakšne koristi je zdravilo Coxevac izkazalo med študijami?
Coxiella burnetii is a bacterium that affects animals, including cattle and goats, and man. 
Coxiella burnetii je bakterija, ki napade živali, med drugim govedo in koze, ter človeka.
The European Medicines Agency (EMA) reviewed additional information according to an agreed timetable on the efficacy of the vaccine. 
Evropska agencija za zdravila (EMA) je pregledala vse nove podatke o učinkovitosti cepiva, ki so bili predloženi po dogovorjenem časovnem razporedu.
The vaccine is given as two injections under the skin, three weeks apart. 
Injicira se dvakrat pod kožo v razmiku treh tednov.
In the case of accidental self-injection, medical advice should be sought immediately and the package leaflet or the label shown to the doctor. 
V primeru nenamernega samoinjiciranja takoj poiščite zdravniško pomoč in zdravniku pokažite navodilo za uporabo ali nalepko.
A field study determined the effectiveness of the vaccine in cattle that came from farms where Coxiella burnetii was present. 
V terenski študiji so ugotavljali učinkovitost cepiva pri govedu, ki je prihajalo iz kmetij, na katerih je bila prisotna bakterija Coxiella burnetii.
In goats it is very common to see a palpable reaction of 3 to 4 cm diameter at the injection site which may last for 6 days. 
Pri kozah se zelo pogosto pojavi otipljiva reakcija tkiva premera 3 do 4 cm na mestu vboda, ki lahko traja šest dni.
The studies conducted in cattle and goats showed that Coxevac reduces bacteria shedding (which is a major factor in spreading the disease) in vaginal discharge and milk, whilst in goats Coxevac reduced bacteria shedding in faeces and the placenta as well. 
Študije pri govedu in kozah so pokazale, da cepivo Coxevac zmanjšuje prenos bakterij (ki je glavni dejavnik širjenja bolezni) v nožnično sluz in mleko, medtem ko je pri kozah zdravilo zmanjšalo tudi prenos bakterij v iztrebke in posteljico.
This is of particular importance because Coxiella burnetii can lead to a disease in humans called Qfever and decreasing the disease in animals will decrease the likelihood of transmitting the disease to humans. 
To je zlasti pomembno, saj lahko bakterija Coxiella burnetii pri ljudeh povzroči bolezen, imenovano mrzlica Q, z zmanjšanjem okužbe pri živalih pa se bo zmanjšala tudi verjetnost, da bi se bolezen prenesla na ljudi.
What is the risk associated with Coxevac? 
Kakšna tveganja so povezana z zdravilom Coxevac?
The CVMP concluded that the benefits of Coxevac exceed the risks for the approved indication and recommended that Coxevac be given a marketing authorisation. 
CVMP je zaključil, da so koristi zdravila Coxevac večje od z njim povezanih tveganj, kadar se uporablja za odobrene indikacije, in priporočil, da se zanj izda dovoljenje za promet.
Inactivated Coxiella burnetii vaccine 
Coxevac cepivo z inaktivirano bakterijo Coxiella burnetii
Coxevac is a veterinary vaccine that contains inactivated (killed) Coxiella burnetii bacteria. 
Coxevac je cepivo za uporabo v veterinarski medicini, ki vsebuje inaktivirane (uničene) bakterije Coxiella burnetii.
The studies in goats also showed a lower proportion of abortions in the goats that were vaccinated compared with unvaccinated goats. 
Študije pri kozah so pokazale tudi nižji delež splavitev pri cepljenih kozah v primerjavi z necepljenimi.
Coxevac is used in cattle to lower the risk of spreading Coxiella burnetii infection and in goats to reduce abortions caused by the infection as well as reduce spreading the infection. 
Zdravilo Coxevac se uporablja pri govedu za zmanjšanje tveganja širjenja okužbe z bakterijo Coxiella burnetii ter pri kozah za zmanjšanje splavitev zaradi okužbe in zmanjšanje širjenja bolezni.
Why has Coxevac been approved? 
Zakaj je bilo zdravilo Coxevac odobreno?
Coxevac is available as a suspension for injection. 
Na voljo je v obliki suspenzije za injiciranje.
For goats, one injection should be given one year later. 
Koze en odmerek cepiva ponovno prejmejo po enem letu.
When Coxevac is given to cattle and goats, their immune system recognises the bacteria contained in the vaccine as ‘foreign' and makes antibodies to defend against them. 
Ko govedo ali koza prejme zdravilo Codevax, imunski sistem prepozna bakterijo v cepivu kot „tujek“ in proti njej razvije protitelesa.
In the future, if the animals are exposed to Coxiella burnetii bacteria, the immune system will be able to respond more quickly. 
Ob ponovni izpostavitvi živali bakteriji Coxiella burnetii v prihodnosti se bo imunski sistem tako hitreje odzval, kar bo pripomoglo k obrambi pred boleznijo.
This means that it was not possible to obtain complete information about Coxevac at the time of the initial authorisation. 
To pomeni, da ob prvotni izdaji dovoljenja za promet z njim ni bilo mogoče pridobiti vseh podatkov o njem.
The effectiveness of the vaccine in goats has been determined in two field studies with pregnant goats exposed to Coxiella burnettii. 
Učinkovitost cepiva pri kozah so ugotavljali v dveh terenskih študijah z brejimi kozami, izpostavljenimi bakteriji Coxiella burnetii.
What is Coxevac used for? 
Za kaj se zdravilo Coxevac uporablja?
How has Coxevac been studied? 
Kako je bilo zdravilo Coxevac raziskano?
What is Coxevac? 
Kaj je zdravilo Coxevac?
How does Coxevac work? 
Kako zdravilo Coxevac deluje?
In cattle and goats Q-fever can cause abortions, still births and pneumonia. 
Povzroča bolezen, ki je znana kot mrzlica Q. Ta lahko pri govedu in kozah povzroči spontani splav, mrtvorojenost in pljučnico.
448 (4 x 112) capsules 
448 (4 x 112) kapsul
Capsule, hard bottle (HDPE) 
50 mg kapsula, trda peroralna uporaba plastenka (HDPE)
1 Regulation (EC) No 1394/2007 
1 Uredba (ES) št. 1394/2007
Some of the concerns were linked to the manufacturing process. 
Nekateri pomisleki so bili povezani s proizvodnim postopkom.
Patients who have any questions should speak to their doctor. 
Bolniki, ki imajo kakršna koli vprašanja, naj se pogovorijo s svojim zdravnikom.
What was the recommendation of the CAT at that time? 
Kakšno je bilo takrat priporočilo CAT?
What consequences does this withdrawal have for patients? 
Kakšne so posledice umika za bolnike?
On 14 January 2013, Anika Therapeutics S.r.l. 
Družba Anika Therapeutics S.r.l.
This is a type of medicine containing cells or tissues that have been manipulated so that they can be used to repair, regenerate or replace tissue. 
Gre za vrsto zdravila, ki vsebuje celice ali tkiva, ki so bili spremenjeni tako, da se lahko uporabljajo za obnovitev, regeneracijo ali nadomeščanje tkiva.
Overall, the results from studies in patients did not justify the proposed use of the product and its safety could not be ascertained conclusively from the data that had so far been presented. 
Na splošno rezultati študij pri bolnikih ne upravičujejo predlagane uporabe zdravila, poleg tega pa iz podatkov, ki so bili predloženi do tega trenutka, ni bilo mogoče dokončno potrditi njegove varnosti.
There were also questions about the way the main studies were conducted, such as the failure to randomly select patients for each treatment group, which led to uncertainties about how the results should be interpreted. 
Pojavila pa so se tudi vprašanja glede načina izvedbe glavnih študij, saj družba na primer ni zagotovila naključnega izbora bolnikov za posamezne skupine, ki so prejemale zdravljenje, zato so se pojavile nejasnosti glede razlage rezultatov.
Hyalograft C autograft has been used in the following EU countries: Austria, Bulgaria, Czech Republic, Germany, Greece, Hungary, Italy, Lithuania, Poland and Romania, before the introduction of the EU 
Madžarskem, v Italiji, Litvi, na Poljskem in v Romuniji.
The main measures of effectiveness were based on the evaluation of patients' cartilage and knee function after treatment. 
Glavna merila učinkovitosti so temeljila na oceni delovanja hrustanca in kolena pri bolnikih po zdravljenju.
This application was withdrawn after the CAT had assessed the initial documentation provided by the company and had formulated a list of questions. 
Vlogo so umaknili po tem, ko je odbor CAT ocenil začetno dokumentacijo, ki jo je predložila družba, in oblikoval seznam vprašanj.
It was for use in adults experiencing symptoms caused by sudden or repetitive trauma to the cartilage. 
Uporabljal naj bi se pri odraslih s simptomi, ki jih povzroči nenadna ali ponavljajoča se poškodba hrustanca.
In its letter notifying the Agency of the withdrawal of application, the company stated that the decision to withdraw the application was based on the outcome of the CAT's preliminary assessment. 
Družba je v dopisu, s katerim agencijo obvešča o umiku vloge, navedla, da se je za umik vloge odločila na podlagi rezultatov predhodnega ocenjevanja odbora CAT.
Following this withdrawal, Hyalograft C autograft will no longer be available and healthcare professionals will need to consider other treatment options for patients with femoral cartilage defects. 
Zaradi umika vloge avtologni presadek Hyalograft C ne bo več na voljo, zato bodo morali zdravstveni delavci preučiti druge možnosti zdravljenja bolnikov z okvarami hrustanca femoralnega kondila.