natgillin/translations-raw huggingface dataset:
• You experience symptoms such as difficulty in breathing or dizziness, swelling of the tongue, lip or throat while using Effentora. 
• Se med uporabo zdravila Effentora pojavijo simptomi, kot so težave z dihanjem ali omotica, otekanje jezika, ustnic ali žrela.
Effentora should not be used in pregnancy unless clearly necessary. 
Jemanje zdravila Effentora med nosečnostjo je dovoljeno le, če je to nujno potrebno.
You should discontinue Effentora when you no longer have any breakthrough pain. 
Prenehajte uporabljati zdravilo Effentora, če nimate več prebijajoče bolečine.
In animal studies, male fertility was impaired (See Section 5.3). 
Študije na živalih so pokazale okvaro plodnosti pri samcih (glejte poglavje 5.3).
Effentora must not be prescribed in patients below 18 years of age 
Zdravila Effentora ni dovoljeno predpisati bolnikom, mlajšim od 18 let Izobraževalno gradivo za bolnike mora vsebovati naslednje tri postavke:
You must however continue to take your usual opioid pain relieving medicine to treat your persistent cancer pain as advised by your doctor. 
Za lajšanje stalne bolečine še naprej jemljite svoje običajno opioidno zdravilo za zdravljenje trajne bolečine pri raku.
Titration in patients not switching from other fentanyl containing products The initial dose of Effentora should be 100 micrograms, titrating upwards as necessary through the range of available tablets strengths (100, 200, 400, 600, 800 micrograms). 
Po potrebi naj se postopoma povišuje glede na razpon jakosti tablet, ki je na voljo (100, 200, 400, 600, 800 mikrogramov).
serotonin norepinephrine reuptake inhibitors [SNRIs], monoamine oxidase (MAO) inhibitors; see section 2 under “Do not use Effentora” and “Other medicines and Effentora”). 
• Če uporabljate antidepresive ali antipsihotike (selektivne zaviralce ponovnega privzema serotonina [SSRI - selective serotonin reuptake inhibitors], selektivne zaviralce privzema noradrenalina [SNRI - serotonin norepinephrine reuptake inhibitors], zaviralce monoamin oksidaze (MAO); glejte poglavje 2 pod »Ne uporabljajte zdravila Effentora« in »Druga zdravila in zdravilo Effentora«).
Some changes that can be seen include an increase in serum prolactin, and decreases in plasma cortisol and testosterone. 
Opioidi lahko vplivajo na os hipotalamus-hipofiza-nadledvična žleza ali gonadno os. Nekatere spremembe, ki jih je mogoče opaziti, vključujejo povečanje serumskega prolaktina in zmanjšanje kortizola in testosterona v plazmi.
Therefore they must keep all tablets out of the sight and reach of children. 
Zato je treba vse tablete hraniti nedosegljivo otrokom.
Risks of concomitant administration with benzodiazepines or related drugs Concomitant use of opioids, including Effentora, with benzodiazepines or related drugs may result in profound sedation, respiratory depression, coma, and death. 
Sočasna uporaba opioidov, vključno z zdravilom Effentora, z benzodiazepini ali povezanimi zdravili, lahko povzroči globoko sedacijo, respiratorno depresijo, komo in smrt.
Effentora 100 micrograms buccal tablets contain 10 mg sodium per tablet. 
Zdravilo Effentora 100 mikrogramov bukalne tablete vsebujejo 10 mg natrija na tableto.
• You may feel a gentle bubbling sensation between your cheek and gum as the tablet dissolves. 
• Morda boste zaradi razkrajanja tablete čutili rahle mehurčke med licem in dlesnijo.
Place in buccal cavity. 
Vstavite v ustno votlino.
• inflammation of the oesophagus, paralysis of the gut, gall bladder disorder 
• vnetje ezofagusa, paraliza črevesja, bolezni žolčnika
You could experience symptoms of withdrawal syndrom (nausea, vomiting, diarrhoea, anxiety, chills, tremor, and sweating) while using these medicines. 
Med uporabo teh zdravil se lahko pojavij odtegnitveni sindrom (siljenje na bruhanje, bruhanje, driska, tesnoba, mrzlica, tremor in znojenje).
Sedative medicines such as benzodiazepines or related drugs The concomitant use of opioids with sedative medicines such as benzodiazepines or related drugs increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect. 
Sočasna uporaba opioidov s sedativnimi zdravili, kot so benzodiazepini ali povezana zdravila, poveča tveganje za sedacijo, respiratorno depresijo, komo in smrt zaradi aditivnega učinka na depresijo OŽS.
Very common: may affect more than 1 in 10 people 
Zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov • omotica, glavobol
Effentora like other fentanyl products can cause very severe breathing problems which can lead to death. 
Kot vsa druga zdravila, ki vsebujejo fentanil, lahko zdravilo Effentora povzroči zelo resne težave z dihanjem, ki lahko povzročijo smrt.
Tablet administration 
Apliciranje tablete
The development of a potentially life-threatening serotonin syndrome may occur with the concomitant use of serotonergic drugs such as Selective Serotonin Re-uptake Inhibitors (SSRIs) and Serotonin Norepinephrine Re-uptake Inhibitors (SNRIs), and with drugs which impair metabolism of serotonin (including Monoamine Oxidase Inhibitors [MAOIs]). 
(SSRI, Selective Serotonin Re-uptake Inhibitors) in zaviralci ponovnega privzema serotonina in noradrenalina (SNRI, Serotonin Norepinephrine Re-uptake Inhibitors) ter zdravili, ki vplivajo na presnovo serotonina (vključno z zaviralci monoaminoksidaze [MAOI, Monoamine Oxidase
Blood and lymphatic system disorders 
Bolezni krvi in limfatičnega sistema anemija, nevtropenija trombocitopenija
Tolerance and physical and/or psychological dependence may develop upon repeated administration of opioids such as fentanyl. 
Po ponavljajočih se apliciranjih opioidov, kot je fentanil, se lahko razvije toleranca in fizična in/ali psihološka odvisnost.
Euphoric mood 
nespečnost evforično razpoloženje,
• Certain type of strong pain killers, calledpartial agonist/antagonists e.g. buprenorphine, nalbuphine and pentazocine (medicines for treatment of pain). 
npr. buprenorfin, nalbufin in pentazocin (zdravila za zdravljenje bolečine).
It is important you know how you react to Effentora before driving or operating machinery. 
Pomembno je, da pred vožnjo ali upravljanjem strojev poznate odziv svojega organizma na zdravilo Effentora.
• at the site of tablet application: pain, ulcer, irritation, bleeding, numbness, loss of sensation, 
• občutek slabosti, bruhanje • na mestu aplikacije tablete: bolečina, razjeda, draženje, krvavitev, otopelost, izguba občutenja,
Muscle twitching Muscular weakness 
mišična oslabelost
Oromucosal use. 
oralna uporaba
Sodium starch glycolate type A Sodium hydrogen carbonate Sodium carbonate anhydrous Citric acid anhydrous Magnesium stearate 
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi manitol natrijev karboksimetilškrob (vrsta A) natrijev hidrogenkarbonat brezvodni natrijev karbonat brezvodna citronska kislina magnezijev stearat
• Peel the blister backing to expose the tablet. 
• Odluščite hrbtno stran pretisnega omota in izpostavite tableto.
As a result, the dose of Effentora should be individually titrated to achieve the desired effect (see section 4.2). 
da se doseže želen učinek (glejte poglavje 4.2).
Fentanyl 
Effentora.
Oral pustule 
Oralna uporaba
Treatment should be initiated by and remain under the guidance of a physician experienced in the management of opioid therapy in cancer patients. 
Zdravljenje mora uvesti zdravnik z izkušnjami pri ravnanju z opioidno terapijo pri bolnikih s karcinomom, ki mora zdravljenje ves čas tudi voditi.
• sleepiness, sedation, excessive tiredness, weakness, migraine, numbness, swelling of arms or legs, 
• nenormalni okus, zmanjšanje telesne mase • zaspanost, sediranost, izjemna utrujenost, slabost, migrena, otopelost, oteklost nog ali rok,
Visual disturbance Ocular hyperaemia Blurred vision Visual acuity reduced 
očesna hiperemija, zamegljen vid, zmanjšana ostrina vida nenormalen občutek v očesu,
Drug dependence (addiction)*, Drug abuse, Delirium 
halucinacije, vizualne halucinacije, spremembe mentalnega stanja, dezorientacija odvisnost od zdravil (zasvojenost)*, zloraba zdravila, delirij
• delirium (symptoms may include a combination of agitation, restlessness, disorientation, 
• delirij (simptomi lahko vključujejo kombinacijo agitacije, nemira, dezorientacija, zmedenosti, strahu, videnje ali slišanje neobstoječih stvari, motnje spanca, nočne more)
Partial opioid agonists/antagonists 
• Nekatere vrste močnih protibolečinskih zdravil, imenovane delni agonisti/antagonisti opioidov,
Increased intracranial pressure, impaired consciousness Effentora should only be administered with extreme caution in patients who may be particularly susceptible to the intracranial effects of CO2 retention, such as those with evidence of increased intracranial pressure or impaired consciousness. 
Povečan intrakranialni tlak, zmanjšana zavest Zdravilo Effentora je treba bolnikom, ki so posebno občutljivi na intrakranialne učinke zadrževanja
Musculoskel etal and connective tissue disorders 
Bolezni mišično skeletnega sistema in vezivnega tkiva mialgija,
The length of time that the tablet takes to fully disintegrate following oromucosal administration does not appear to affect early systemic exposure to fentanyl. 
Ni znakov, da bi se s časom, potrebnim za popoln razkroj tablete po oralni aplikaciji, podaljšal čas do sistemske izpostavljenosti fentanilu.
Cognitive disorder Motor dysfunction 
motorična disfunkcija izguba zavesti*, konvulzije
Contents of the pack and other information 
Shranjevanje zdravila Effentora Vsebina pakiranja in dodatne informacije
Agents that can increase CNS depressant effects 
Zdravila, ki lahko povečajo pomirjevalne učinke na osrednji živčni sistem
How to store Effentora 
Shranjevanje zdravila Effentora
You may drink some water before using Effentora to help moisten your mouth, but you should not drink or eat anything while taking the medicine. 
Preden uporabite zdravilo Effentora, lahko spijete nekaj vode, da navlažite svoja usta.
• fatigue 
• zardevanje
The concomitant use of alcohol with fentanyl can produce increased depressant effects which may result in a fatal outcome (see section 4.5). 
Sočasna uporaba alkohola in fentanila lahko poveča pomirjevalne učinke, kar lahko povzroči smrt
Medicinal product subject to special and restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). 
Povzetek glavnih značilnosti zdravila, poglavje 4.2).
Effentora must not be prescribed in patients with short term pain only 3. 
Zdravila Effentora ni dovoljeno predpisati bolnikom z bolečino, ki traja kratek čas
Opioid withdrawal symptoms such as nausea, vomiting, diarrhoea, anxiety, chills, tremor and sweating have been observed with transmucosal fentanyl. 
Pri uporabi transmukoznega fentanila so opazili opioidne odtegnitvene sindrome, kot so navzea, bruhanje, driska, ansioznost, mrzlica, tremor in znojenje.
If you notice any of these, contact your doctor. 
Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom.
The educational material for patients shall consist of the following three items: 
prejeli izobraževalni paket z naslednjo vsebino:
• unusually low heart rate, feeling very warm (hot flushes), 
• moten ali zameglen vid, rdeče oko • neobičajno počasen srčni utrip, občutek vročine (vročinski oblivi)
It is recommended that increased caution should be exercised in titrating the dose of Effentora in elderly patients. 
Pri titriranju odmerka zdravila Effentora pri starejših bolnikih se priporoča pazljivost.
Effentora 400 micrograms buccal tablets EU/1/08/441/005-006 
Effentora 400 mikrogramov bukalne tablete EU/1/08/441/005-006
• The tablet should be left between the cheek and gum until dissolved, which usually takes approximately 14 to 25 minutes. 
To običajno traja 14 do 25 minut.
The concomitant use of Effentora with strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, and nelfinavir) or moderate CYP3A4 inhibitors (e.g., 
Hkratno jemanje zdravila Effentora z močnimi zaviralci CYP3A4 (npr. ritonavir, ketokonazol,
• constipation, inflammation of the mouth, dry mouth, diarrhoea, heartburn, loss of appetite, 
• zaprtost, vnetje ust, suha usta, diareja, zgaga, izguba apetita, bolečina v trebuhu, nelagodje v trebuhu, prebavne motnje, zobobol, ustni oprh
Effentora 200 micrograms buccal tablets EU/1/08/441/003-004 
Effentora 200 mikrogramov bukalne tablete EU/1/08/441/003-004
Effentora 800 micrograms buccal tablets Each buccal tablet contains 800 micrograms fentanyl (as citrate). 
Effentora 800 mikrogramov bukalne tablete Ena bukalna tableta vsebuje 800 mikrogramov fentanila (v obliki citrata).
Dose readjustment 
Ponovna prilagoditev odmerka
Hypotension Hypertension 
Žilne bolezni hipotenzija, hipertenzija zardevanje,
• Allergic reactions such as rash, redness, swollen lip and face, hives 
• alergijske reakcije kot so izpuščaj, rdečina, otekle ustnice in obraz, koprivnica Neznana: pogostnosti ni mogoče oceniti iz razpoložljivih podatkov
Dose titration 
Odmerjanje Titriranje odmerka
Taking the medicine 
Pri apliciranju zdravila
Effentora 800 micrograms buccal tablets EU/1/08/441/009-010 
Effentora 800 mikrogramov bukalne tablete EU/1/08/441/009-010
Patients should wait at least 4 hours before treating another BTP episode with Effentora during maintenance therapy. 
Pred zdravljenjem naslednje epizode PBB z zdravilom Effentora mora bolnik med vzdrževalno terapijo počakati vsaj 4 ure.
Dizziness Headache 
bolečino,
Effentora 600 micrograms buccal tablets EU/1/08/441/007-008 
Effentora 600 mikrogramov bukalne tablete EU/1/08/441/007-008
• Contact your doctor immediately if you experience a combination of the following symptoms 
• Če se pojavi kombinacija spodnjih simptomov, se takoj obrnite na zdravnika
Effentora 100 micrograms buccal tablets EU/1/08/441/001-002 
Effentora 100 mikrogramov bukalne tablete EU/1/08/441/001-002
Driving and using machines 
(npr. vožnja avtomobila ali upravljanje strojev).
Effentora 200 micrograms buccal tablets Each buccal tablet contains 200 micrograms fentanyl (as citrate). 
Effentora 200 mikrogramov bukalne tablete Ena bukalna tableta vsebuje 200 mikrogramov fentanila (v obliki citrata).
Effentora 400 micrograms buccal tablets Each buccal tablet contains 400 micrograms fentanyl (as citrate). 
Effentora 400 mikrogramov bukalne tablete Ena bukalna tableta vsebuje 400 mikrogramov fentanila (v obliki citrata).
Depression Anxiety Confusional state 
Psihiatrične motnje depresija, tesnoba, stanje zmedenosti,
These might be early symptoms of a serious allergic reaction (anaphylaxis, hypersensitivity; see section 4 under “Serious side effects”) 
(anafilaksa, preobčutljivost; glejte poglavje 4 pod »Resni neželeni učinki«).
Effentora 100 micrograms buccal tablets Each buccal tablet contains 100 micrograms fentanyl (as citrate). 
Effentora 100 mikrogramov bukalne tablete Ena bukalna tableta vsebuje 100 mikrogramov fentanila (v obliki citrata).
Skin and subcutaneous tissue disorders 
Bolezni kože in podkožja pruritus, hiperhidroza,
• EFFENTORA prescribing guide 
• Vodnika za predpisovanje zdravila EFFENTORA • Vodnika za orodje za titriranje
Effentora should be placed and retained within the buccal cavity for a period sufficient to allow disintegration of the tablet which usually takes approximately 14-25 minutes. 
Zdravilo Effentora se vstavi v ustno votlino, kjer naj ostane dovolj dolgo, da se tableta razkroji.
• Any medicines that might have an effect on the way in which your body breaks down Effentora, such as ritonavir, nelfinavir, amprenavir, and fosamprenavir (medicines that help control HIV infection) or other so-called CYP3A4 inhibitors such as ketoconazole, itraconazole, or fluconazole (used for treatment of fungal infections), troleandomycine, clarithromycine, or erythromycine (medicines for treatment of bacterial infections), aprepitant (used for severe nausea) and diltiazem and verapamil (medicines for treatment of high blood pressure or heart diseases). 
itrakonazol, troleandomicin, klaritromicin in nelfinavir) ali zmernimi zaviralci CYP3A4 (npr. amprenavir, aprepitant, diltiazem, eritromicin, flukonazol, fosamprenavir, sok grenivke in verapamil)
• If you suffer from short-term pain other than breakthrough pain 
• če imate drugo kratkotrajno bolečino, ki ni prebijajoča bolečina, kot je bolečina zaradi poškodb ali operacije, glavobola ali migrene.
Effentora tablet once exposed to moisture utilises an effervescent reaction to deliver the active substance. 
Ko so tablete Effentora izpostavljene vlagi, se razkrojijo in sprostijo učinkovino.
• 800 micrograms fentanyl (as citrate) 
• 800 mikrogramov fentanila (v obliki citrata)
Each buccal tablet contains 800 micrograms fentanyl (as citrate) 
Ena bukalna tableta vsebuje 800 mikrogramov fentanila (v obliki citrata).
Patients should wait at least 4 hours before treating another BTP episode with Effentora during titration. 
Pred zdravljenjem naslednje epizode PBB z zdravilom Effentora mora bolnik med titriranjem počakati vsaj 4 ure.
Effentora 800 micrograms buccal tablets 
Effentora 800 mikrogramov bukalne tablete fentanil
• 200 micrograms fentanyl (as citrate) 
• 200 mikrogramov fentanila (v obliki citrata)
Effentora 100 micrograms buccal tablets Fentanyl 
Effentora 100 mikrogramov bukalne tablete fentanil
Each buccal tablet contains 200 micrograms fentanyl (as citrate) 
Ena bukalna tableta vsebuje 200 mikrogramov fentanila (v obliki citrata).
Nausea Vomiting 
vročinski valovi
Flat-faced, white, round bevelled-edge tablet, embossed on one side with a “C” and on the other side with “8”. 
Effentora 800 mikrogramov bukalne tablete Ploska, bela, okrogla prirezana tableta z oznako ‘C' na eni strani in na drugi strani ‘8'.
• 600 micrograms fentanyl (as citrate) 
• 600 mikrogramov fentanila (v obliki citrata)
Each buccal tablet contains 600 micrograms fentanyl (as citrate) 
Ena bukalna tableta vsebuje 600 mikrogramov fentanila (v obliki citrata).
• 400 micrograms fentanyl (as citrate) 
• 400 mikrogramov fentanila (v obliki citrata)
Effentora 200 micrograms buccal tablets Fentanyl 
Effentora 200 mikrogramov bukalne tablete fentanil
Each buccal tablet contains 400 micrograms fentanyl (as citrate) 
Ena bukalna tableta vsebuje 400 mikrogramov fentanila (v obliki citrata).
Each buccal tablet contains 100 micrograms fentanyl (as citrate) 
Ena bukalna tableta vsebuje 100 mikrogramov fentanila (v obliki citrata).
Effentora 600 micrograms buccal tablets 
Effentora 600 mikrogramov bukalne tablete fentanil
It is very important that you use Effentora exactly as the doctor tells you The initial dose is 100 micrograms. 
Zelo pomembno je, da zdravilo Effentora uporabljate natančno po navodilih zdravnika.
Constipation Stomatitis Dry mouth Diarrhoea Abdominal pain Gastrooesophageal reflux disease Stomach discomfort Dyspepsia Toothache 
Bolezni dihal, prsnega koša in mediastinaln ega prostora dispneja, faringolaringal na bolečina respiratorna depresija, sindrom spalne apneje respiratorni arest*
Effentora 400 micrograms buccal tablets 
Effentora 400 mikrogramov bukalne tablete fentanil
• 100 micrograms fentanyl (as citrate) 
• 100 mikrogramov fentanila (v obliki citrata)
Effentora 600 micrograms buccal tablets Each buccal tablet contains 600 micrograms fentanyl (as citrate). 
Effentora 600 mikrogramov bukalne tablete Ena bukalna tableta vsebuje 600 mikrogramov fentanila v obliki citrata).
Application site reactions including bleeding, pain, ulcer, irritation, paraesthesia, anaesthesia, erythema, oedema, swelling and vesicles 
razjedo, draženjem, parestezijo, anesezijo, eritemom, edemom, oteklostjo in mehurčki periferni edem, utrujenost, astenija, odtegnitveni sindrom*, mrzlica splošno slabo počutje,
Flat-faced, white, round bevelled-edge tablet, embossed on one side with a “C” and on the other side with “1”. 
Effentora 100 mikrogramov bukalne tablete Ploska, bela, okrogla prirezana tableta z oznako ‘C' na eni strani in na drugi strani ‘1'.
Flat-faced, white, round bevelled-edge tablet, embossed on one side with a “C” and on the other side with “6”. 
Effentora 600 mikrogramov bukalne tablete Ploska, bela, okrogla prirezana tableta z oznako ‘C' na eni strani in na drugi strani ‘6'.
Peripheral oedema Fatigue Asthenia Drug withdrawal syndrome* Chills 
Infekcijske in parazitske bolezni ustna kandidiaza faringitis oralne pustule
vomiting, diarrhoea, anxiety, chills, tremor, and sweating), shaking, falls, chills 
odtegnitveni sindrom, (lahko se kaže s pojavom naslednjim neželenih učinkov: siljenje na bruhanje, bruhanje, driska, tesnoba, mrzlica, tremor in znojenje) tresenje, padci, mrzlice
Chronic obstructive pulmonary disease 
Bolezni sečil zastajanje urina
Vertigo Tinnitus Ear discomfort 
vključno z motnjami labirinta vrtoglavica, tinitus, nelagodje v ušesu
Flat-faced, white, round bevelled-edge tablet, embossed on one side with a “C” and on the other side with “2”. 
Effentora 200 mikrogramov bukalne tablete Ploska, bela, okrogla prirezana tableta z oznako ‘C' na eni strani in na drugi strani ‘2'.
If your breakthrough pain is not relieved after 30 minutes, use only 1 more tablet of Effentora during the titration period. 
30 minut, tokrat uporabite samo 1 dodatno tableto zdravila Effentora v obdobju titriranja.
Fall 
Olupite
Flat-faced, white, round bevelled-edge tablet, embossed on one side with a “C” and on the other side with “4”. 
Effentora 400 mikrogramov bukalne tablete Ploska, bela, okrogla prirezana tableta z oznako ‘C' na eni strani in na drugi strani ‘4'.
This medicine must be kept out of the sight and reach of children. 
To zdravilo shranjujte nedosegljivo otrokom!
Hypersensitivity reactions have been reported in post-marketing experience, including rash, erythema, lip and face swelling, and urticaria (see section 4.4). 
eritemom, otekanjem ustnic in obraza in urtikarijo (glejte poglavje 4.4).
Platelet count decreased Heart rate increased Haematocrit decreased Haemoglobin decreased 
Preiskave zmanjšanje telesne mase zmanjšanje števila trombocitov, hitro utripanje srca, zmanjšanje hematokrita, zmanjšanje hemoglobina
• Titration guide tool Key elements to be included in the educational material for healthcare professionals: - Prescription of EFFENTORA only by physicians experienced in the management of opioid therapy in cancer patients - Prescription of EFFENTORA only to critically selected patients with close following on 
- Zdravilo EFFENTORA lahko predpisujejo samo zdravniki z izkušnjami v vodenju opioidnega zdravljenja pri bolnikih z rakom
Patients should not consume any food and drink when a tablet is in the buccal cavity. 
S tableto v ustni votlini bolniki ne smejo niti jesti niti piti.
Mouth ulceration Oral hypoaesthesia Oral discomfort Oral mucosal discolouration Oral soft tissue disorder Glossodynia Tongue blistering Gingival pain Tongue ulceration Tongue disorder Oesophagitis Chapped lips Tooth disorder 
bolečine v trebuhu, gastroezofagealna refluksna bolezen, nelagodje v trebuhu, dispepsija, zobobol ileus, razjede v ustih, oralna hipoestezija, nelagodje v ustih, obarvanje ustne sluznice, bolezni mehkih ustnih tkiv,, glosodinija,
Strength Pharmaceutical Form 
Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina
London, 24 May 2007 Doc. 
London, 24. maj 2007 Sklic na dok.
The Committee was also concerned over the safety of the medicine and the consistency of the medicine between batches. 
Odbor je imel tudi zadržke v zvezi z varnostjo zdravila in konsistentnostjo zdravila med serijami.
The main measure of effectiveness was the improvement in vision three months after the injection, assessed using a standard letter chart. 
Glavno merilo učinkovitosti je bilo izboljšanje vida tri mesece po injekciji, ki je bilo ocenjeno s standardnim listom s črkovnimi znaki.
International non-proprietary name (INN): hyaluronidase (ovine) 
Mednarodno nelastniško ime (INN): hialuronidaza (ovčja)
Ref. EMEA/195786/2007 
EMEA/253858/2007
The effects of Vitragan were first tested in experimental models before being studied in humans. 
Učinki zdravila Vitragan so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for VITRAGAN 
VPRAŠANJA IN ODGOVORI GLEDE UMIKA VLOGE ZA DOVOLJENJE ZA PROMET za zdravilo VITRAGAN