FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmachemie B.V. Swensweg 5, Postbus
Slovenian: Pharmachemie B.V.
English: There was no significant difference in survival (HR=1.05 (CI=0.81-1.36), p=0.669) or in the interval until progression (HR=1.20 (CI 0.96-1.51), p=0.107) between the group treated with bicalutamide 150 mg and the group treated with castration.
Slovenian: Med skupino, ki je bila zdravljena s 150 mg biklautamidom, in skupino, ki je bila zdravljena s kastracijo, v preživetju (koeficient tveganja=1,05, (IZ=0,81-1,36), p=0,669) ali v obdobju do napredovanja (koeficient tveganja=1,20, (IZ=0,96-1,51), p=0,107) ni bilo bistvenih razlik.
English: A general trend with respect to quality of life in favour of bicalutamide 150 mg in comparison with castration was observed; the subgroups that provided these data showed significantly higher sexual appetence (p=0.029) and fitness (p=0.046).
Slovenian: Podskupine, na katerih so bili podatki pridobljeni, so pokazale značilno večje spolno poželenje (p=0,029) in boljše zdravstveno stanje (p=0,046).
English: 2740-264 Porto Salvo, Portugal
Slovenian: Lagoas Park, Edifício 1, Piso 3, 2740-264 Porto Salvo Portugalska
English: Watchful waiting
Slovenian: Nadzorovano opazovanje
English: WHAT BICALUTAMIDE IS AND WHAT IT IS USED FOR Bicalutamide belongs to the group of anti-androgens.
Slovenian: Bikalutamid spada v skupino zdravil, imenovani antiandrogeni.
English: Table 2 Overall survival in locally advanced disease by therapy sub-group Analysis population Deaths (%) in Bicalutamide patients
Slovenian: Preglednica 2 Celotno preživetje pri lokalno napredovali bolezni po terapevtskih podskupinah
English: Table 1 Progression-free survival in locally advanced disease by therapy sub-group Analysis population Events (%) in Bicalutamide patients
Slovenian: Preglednica 1 Preživetje brez napredovanja pri lokalno napredovali bolezni po terapevtskih podskupinah
English: 2003 RN Haarlem The Netherlands
Slovenian: Swensweg 5, Postbus 552 2003 RN Haarlem Nizozemska
English: TEVA Pharma B.V., Industrieweg 23, P.O.
Slovenian: Teva Pharma B.V.
English: BicamidGRY 150 mg Filmtabletten
Slovenian: Bicamid-GRY 150 mg Filmtabletten
English: BicalutamideTEVA
Slovenian: Jakost
English: PACKAGE LEAFLET
Slovenian: Analizirana populacija
English: Bicalutamide 150 mg Filmcoated
Slovenian: Bicalutamide 150 mg Film-coated Tablets
English: TEVA
Slovenian: Ime
English: London, 21 June 2007 Doc.
Slovenian: London, 21. junij 2007 Sklic na dok.
English: Ref. EMEA/287136/2008
Slovenian: EMEA/381412/2007
English: The studies in human involved a total of 222 patients in two main studies.
Slovenian: Študije na ljudeh so zajele skupno 222 bolnikov, vključene v dve glavni študiji.
English: International non-proprietary name (INN): glucarpidase
Slovenian: Mednarodno nelastniško ime (INN): glukarpidaza
English: The company also plans to continue their compassionate use programme.
Slovenian: Podjetje poleg tega namerava nadaljevati s programom sočutne uporabe.
English: Methotrexate is used to treat a number of diseases, including some types of cancer.
Slovenian: Metotreksat se uporablja za zdravljenje številnih bolezni, vključno z nekaterimi vrstami raka.
English: The letter from the company notifying the EMEA of the withdrawal of the application is available here.
Slovenian: Dopis podjetja, v katerem agencijo EMEA obvešča o umiku vloge, je na voljo tukaj.
English: These toxic effects can be life-threatening.
Slovenian: Ti toksični učinki so lahko smrtno nevarni.
English: The Committee had concerns that this move was not yet fully organised, especially with regards to the way the production would be controlled (validation), and that the consequences of the move on the product's purity were not been fully understood.
Slovenian: Odbor je imel pomisleke, da ta selitev še ni bila v celoti urejena, zlasti v zvezi z načinom nadzora proizvodnje (validiranjem), ter da posledice selitve za čistost izdelka niso popolnoma jasne.
English: The production of the medicine had moved from the factory that made the medicine used in the studies, to another factory that was to make the commercial product.
Slovenian: Proizvodnja zdravila je bila preseljena iz tovarne, ki je izdelala zdravilo, uporabljeno v študijah, v drugo tovarno, ki bi naj proizvajala komercialni izdelek.
English: The main measure of effectiveness was the reduction in blood levels of methotrexate.
Slovenian: Glavno merilo učinkovitosti je bilo zmanjšanje koncentracije metotreksata v krvi.
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for VORAXAZE
Slovenian: VPRAŠANJA IN ODGOVORI GLEDE UMIKA VLOGE ZA DOVOLJENJE ZA PROMET za zdravilo VORAXAZE
English: This helps the body eliminate excess methotrexate, and therefore reduces the potential for toxic effects.
Slovenian: To telesu pomaga pri izločanju presežnega metotreksata ter posledično zmanjšuje tveganje za pojav toksičnih učinkov.
English: Voraxaze was not compared to another treatment.
Slovenian: Zdravila Voraxaze niso primerjali z nobenim drugim zdravljenjem.
English: Because the number of patients with this condition is low, it is considered ‘rare', and glucarpidase was designated an ‘orphan medicine' (a medicine used in rare diseases) on 3 February 2003.
Slovenian: Ker je število bolnikov s tem stanjem majhno, velja ta bolezen za redko, zato je bila glukarpidaza 3. februarja 2003 določena kot „zdravilo sirota“ (zdravilo, ki se uporablja pri redkih boleznih).
English: The recombinant enzyme acts in the same way as the natural carboxypeptidase G2.
Slovenian: Rekombinantni encim deluje na enak način kot naravna karboksipeptidaza G2.
English: The effects of Voraxaze were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Voraxaze so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues outstanding.
Slovenian: Po tem, ko je CHMP ocenil odgovore podjetja na seznam vprašanj, so nekatera tehtna vprašanja še vedno ostala nerešena.
English: The main concerns of the CHMP were related to the manufacture of Voraxaze.
Slovenian: Glavni pomisleki CHMP so bili povezani s proizvodnjo zdravila Voraxaze.
English: The company informed the CHMP that there are no consequences for patients currently included in the clinical trials of Voraxaze.
Slovenian: Podjetje je CHMP obvestilo, da ni posledic za bolnike, ki trenutno sodelujejo v kliničnih preizkušanjih zdravila Voraxaze.
English: The Committee also had some concern regarding the use of Voraxaze with folinic acid.
Slovenian: Odbor je imel tudi določene zadržke v zvezi z uporabo zdravila Voraxaze s folno kislino.
English: What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with Voraxaze?
Slovenian: Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preizkušanjih/programih sočutne uporabe zdravila Voraxaze?
English: Some cancer patients receive high doses, and, because of this, can experience toxic effects, such as damage to the kidneys, bone marrow suppression (leading to anaemia, an increased risk of infection and bleeding) and mucositis (an inflammation of the mucosa, the lining of organs such as the mouth, with soreness, redness and ulceration).
Slovenian: Nekateri rakavi bolniki prejemajo velike odmerke in posledično se utegnejo pri njih pojaviti toksični učinki, kot so poškodbe ledvic, supresija kostnega mozga (ki povzroča slabokrvnost, povečano tveganje za okužbe in krvavenje) in mukozitis (vnetje mukoze, sluznice organov, kot so usta, vključno z občutljivostjo, pordelostjo in ulkusom).
English: The glucarpidase in Voraxaze is made by a method known as ‘recombinant DNA technology': it is made by a bacterium that has received a gene (DNA) that makes it able to produce it.
Slovenian: Glukarpidaza v zdravilu Voraxaze se proizvaja po metodi, imenovani „tehnologija rekombinantne DNA“: tvori jo bakterija, ki je prejela gen (DNA), kar ji omogoča tvorbo tega encima.
English: The active substance in Voraxaze, glucarpidase, is a copy of the naturally-occurring enzyme carboxypeptidase G2. Carboxypeptidase G2 was originally found in a Pseudomonas bacterium.
Slovenian: Zdravilna učinkovina v zdravilu Voraxaze, glukarpidaza, je kopija naravno prisotnega encima karboksipeptidaza G2. Karboksipeptidazo G2 so prvotno našli v bakterijah Pseudomonas.
English: It contains the active substance glucarpidase.
Slovenian: Vsebuje zdravilno učinkovino glukarpidaza.
English: On 21 May 2007, Protherics PLC officially notified the Committee for Medicinal Products for Human Use (CHMP) that they wish to withdraw their application for a marketing authorisation for Voraxaze, for the adjunctive treatment of patients experiencing or at risk of methotrexate toxicity.
Slovenian: Podjetje Protherics PLC je dne 21. maja 2007 obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti svojo vlogo za izdajo dovoljenja za promet z zdravilom Voraxaze, namenjenim dopolnilnemu zdravljenju bolnikov, pri katerih prihaja do toksičnih učinkov metotreksata oziroma obstaja tveganje zanje.
English: Voraxaze was to be used as an add-on treatment in patients already receiving a medicine, methotrexate, to prevent or treat the toxic effects of methotrexate.
Slovenian: Zdravilo Voraxaze bi se naj uporabljalo kot dopolnilno zdravljenje pri bolnikih, ki že prejemajo zdravilo metotreksat, za preprečevanje ali zdravljenje toksičnih učinkov metotreksata.
English: All patients received the medicine as part of a compassionate use programme: the doctor requested Voraxaze from the manufacturer as soon as they encountered a patient with methotrexate toxicities who could possibly benefit from the medicine.
Slovenian: Vsi bolniki so zdravilo prejemali v okviru programa sočutne uporabe: zdravnik je proizvajalca zaprosil za zdravilo Voraxaze, ko je ugotovil toksičnost metotreksata pri bolniku, ki bi utegnil imeti korist od zdravila.
English: Voraxaze is a powder to be made up into a solution for injection.
Slovenian: Zdravilo Voraxaze je prašek, namenjen za pripravo raztopine za injiciranje.
English: The application was at day 180 when the company withdrew.
Slovenian: Podjetje je vlogo umaknilo na 180. dan postopka.
English: Based on the review of the data and the company's response to the CHMP list of questions at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Voraxaze could not have been approved for the adjunctive treatment of patients experiencing or at risk of methotrexate toxicity.
Slovenian: Na podlagi pregleda podatkov in odgovorov podjetja na seznam vprašanj, ki jih je zastavil CHMP, je imel Odbor v času umika vloge zadržke in bil začasnega mnenja, da za zdravilo Voraxaze ni mogoče odobriti dovoljenja za dopolnilno zdravljenje bolnikov, pri katerih prihaja do toksičnih učinkov metotreksata oziroma obstaja tveganje zanje.
English: Folinic acid can also be broken down in the body by Voraxaze, and further studies should be carried out to look at the consequences of this when managing patients with methotrexate toxicities.
Slovenian: Zdravilo Voraxaze lahko v telesu razgradi tudi folno kislino, zato so potrebne nadaljnje študije, ki bi preučile posledice tega učinka pri zdravljenju bolnikov, pri katerih prihaja do toksičnih učinkov metotreksata.
English: Voraxaze would have been used either as a treatment in patients who had developed such toxic effects, or as prevention in patients who were at risk of developing them, such as patients who have high levels of methotrexate in their blood, or those who have poorly functioning kidneys (when methotrexate may be eliminated more slowly).
Slovenian: Zdravilo Voraxaze bi se naj uporabljalo bodisi za zdravljenje bolnikov, pri katerih so se razvili omenjeni toksični učinki, ali pa za preprečevanje teh učinkov pri bolnikih, pri katerih obstaja tveganje za njihov nastanek, kot npr. pri bolnikih z velikimi koncentracijami metotreksata v krvi ali pri bolnikih s slabim delovanjem ledvic (zaradi česar se metotreksat utegne počasneje izločati).
English: Voraxaze was to be given to adults or children as a single injection if the level of methotrexate in the patient's blood was above a given ‘threshold' at certain times after administration of methotrexate.
Slovenian: Zdravilo Voraxaze bi se naj dajalo odraslim ali otrokom v obliki enkratne injekcije v primerih, ko koncentracija metotreksata v krvi bolnika v določenem času po aplikaciji metotreksata preseže določen prag.
English: Another medicine, folinic acid, is often given after the methotrexate to help control the toxicities (‘rescue' treatment) but these may still develop despite the rescue treatment.
Slovenian: Za nadzor toksičnosti se po aplikaciji metotreksata pogosto daje drugo zdravilo, folna kislina, vendar pa se toksični učinki lahko vseeno razvijejo, kljub uporabi tovrstnega „reševalnega“ zdravljenja.
English: It can break down methotrexate into substances that do not have any toxic effects.
Slovenian: Karboksipeptidazo G2 lahko metotreksat razgradi v spojine, ki nimajo toksičnih učinkov.
English: What was Voraxaze expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Voraxaze uporabljalo?
English: How is Voraxaze expected to work?
Slovenian: Kako naj bi zdravilo Voraxaze delovalo?
English: What is Voraxaze?
Slovenian: Kaj je zdravilo Voraxaze?
English: This summary was last updated in March 2012.
Slovenian: Ta povzetek je bil nazadnje posodobljen marcu 2012.
English: This document is a summary of the European Public Assessment Report.
Slovenian: Ta dokument je povzetek Evropskega javnega poročila o oceni zdravila.
English: There are no precautions necessary.
Slovenian: Za zdravilo ni posebnih previdnostnih ukrepov.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Oxyglobin on 14 July 1999.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Oxyglobin, veljavno po vsej Evropski uniji, odobrila dne 14. julija 1999.
English: Haemoglobin glutamer 200
Slovenian: Hemoglobin glutamer-200
English: The most appropriate dose depends on the severity of the anaemia and how long the dog has been anaemic, as well as the desired duration of the medicine's effect.
Slovenian: Najprimernejši odmerek je odvisen od resnosti anemije in trajanja anemičnosti psa, kot tudi želenega trajanja učinkovanja zdravila.
English: Oxyglobin should be used for at least 24 hours.
Slovenian: Zdravilo Oxyglobin je treba uporabljati najmanj 24 ur.
English: Information on the prescription status of this product may be found on the label of the carton.
Slovenian: Podatki o predpisovanju tega zdravila so navedeni na nalepki na škatli zdravila.
English: Additional studies supported these results, showing that Oxyglobin can take up, transport and release oxygen in animals other than cows.
Slovenian: Dodatne študije so potrdile te rezultate in pokazale, da lahko zdravilo Oxyglobin kisik zajame, prenaša in sprošča tudi pri živalih, ki niso krave.
English: This oxygen can then be supplied to tissues such as muscle.
Slovenian: Ta kisik je na razpolago tkivom, kot je mišičje.
English: In the main study in dogs, 95% of the animals treated with Oxyglobin needed no other type of oxygen-carrying treatment after 24 hours, compared with 32% of the dogs that did not receive any treatment.
Slovenian: V glavni študiji pri psih 95 % živali, ki so jih zdravili z zdravilom Oxyglobin, po 24 urah ni potrebovalo druge vrste oksifornega zdravljenja medtem ko je druge vrste oksiforno zdravljenje potrebovalo 32 % psov, ki niso bili deležni nobenega zdravljenja.
English: Other information about Oxyglobin:
Slovenian: Druge informacije o zdravilu Oxyglobin:
English: The medicine also increased levels of haemoglobin in the blood and improved the dogs' physical condition.
Slovenian: Zdravilo je tudi povečalo ravni hemoglobina v krvi in izboljšalo telesno stanje psov.
English: This increases the amount of oxygen carried in the blood in the arteries, helping to reduce the symptoms of anaemia.
Slovenian: S tem se poveča količina kisika, ki se prenaša po krvi v arterijah, kar povzroči ublažitev simptomov anemije.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Oxyglobin exceed the risks for the provision of oxygen-carrying support to dogs improving the clinical signs of anaemia for at least 24 hours, independent of the underlying condition, and recommended that Oxyglobin be given a marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Oxyglobin pri zagotavljanju oksiforne podpore psom, blaženju kliničnih znakov anemije najmanj 24 ur neodvisno od vzročnega stanja, večje od z njim povezanih tveganj in priporočil, da se za zdravilo Oxyglobin odobri dovoljenje za promet.
English: Oxyglobin is first warmed to 37°C, then given to the dog as 30 ml per kilogram body weight, administered at a rate of up to 10 ml/kg per hour.
Slovenian: Zdravilo Oxyglobin morate najprej segreti na 37 °C in ga nato dati psu v odmerku 30 ml na kilogram telesne mase s hitrostjo do 10 ml/kg na uro.
English: Oxyglobin contains bovine haemoglobin glutamer-200 (at a strength of 130 mg/ml), which belongs to a class of medicines having an oxygen-carrying action.
Slovenian: Zdravilo Oxyglobin vsebuje goveji hemoglobin glutamer-200 (jakosti 130 mg/ml), ki spada v razred zdravil z oksifornim učinkom.
English: What benefit has Oxyglobin shown during the studies?
Slovenian: Kakšne koristi je zdravilo Oxyglobin izkazalo med študijami?
English: Other common side effects are vomiting, loss of appetite and fever.
Slovenian: Drugi pogosti neželeni učinki so bruhanje, izguba teka in povišana temperatura.
English: Oxyglobin should not be used in animals that have received Oxyglobin in the past, or in dogs that are at an increased risk of circulatory overload with conditions such as oliguria or anuria (infrequent or no urination) or advanced heart disease.
Slovenian: Zdravila Oxyglobin se ne sme uporabljati pri živalih, ki so zdravilo že prejele v preteklosti, ali pri psih s povečanim tveganjem preobremenitve krvnega obtoka in s stanji, kot so oligurija ali anurija (redko uriniranje ali odsotnost uriniranja) ali napredovala bolezen srca.
English: Oxyglobin has been tested in a study of dogs with short or long-term anaemia due to conditions such as blood loss, the abnormal breakdown of red blood cells or low levels of red blood cell production.
Slovenian: Zdravilo Oxyglobin so preizkusili v študiji pri psih s kratkotrajno ali dolgotrajno anemijo zaradi stanj, kot so izguba krvi, nenormalna razgradnja rdečih krvnih celic ali nizka stopnja tvorjenja rdečih krvnih celic.
English: They include discoloration of the skin, mucous membranes (lining of body cavities) and sclera (whites of the eyes), dark faeces and discoloured or turbid (opaque) urine.
Slovenian: Neželeni učinki vključujejo razbarvanje kože, sluzničnih membran (sloja celic, ki oblaga telesne votline) in beločnice (belih delov oči), temni iztrebki in razbarvan ali moten urin.
English: It contains haemoglobin glutamer-200, which is made from haemoglobin (the protein in red blood cells that carries oxygen around the body) extracted from cows' blood and diluted in a standard solution (Ringer's lactate) used to replace blood volume.
Slovenian: Vsebuje hemoglobin glutamer-200, ki se pridobiva iz hemoglobina (beljakovine v rdečih krvnih celicah, ki po telesu prenaša kisik), pridobljenega iz krvi krav in razredčenega s standardno raztopino (Ringerjev laktat), ki se uporablja za zamenjavo krvne prostornine.
English: What is the risk associated with Oxyglobin?
Slovenian: Kakšna tveganja so povezana z zdravilom Oxyglobin?
English: A common side effect is ‘circulatory overload' (when the blood fluid leaks out of the blood vessels), which causes tachypnea (rapid breathing), dyspnea (shortness of breath), harsh lung sounds and pulmonary oedema (fluid accumulation in the lungs).
Slovenian: Pogost neželen učinek je „preobremenitev krvnega obtoka“ (kadar tekoči del krvi pronica iz žil), kar povzroči tahipnejo (hitro dihanje), dispnejo (zasopljenost), rezke glasove v pljučih in pljučni edem (zbiranje tekočine v pljučih).
English: When Oxyglobin is given to dogs, it increases the amount of haemoglobin in the blood, as well as increasing the volume of blood in the body.
Slovenian: Ko zdravilo Oxyglobin daste psom, poveča količino hemoglobina v krvi ter prostornino krvi v telesu.
English: For a full list of all side effects reported with Oxyglobin, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Oxyglobin, glejte Navodilo za uporabo.
English: The side effects seen with Oxyglobin are caused both by the medicine and by the underlying cause of the anaemia.
Slovenian: Neželene učinke, ki so povezani z zdravilom Oxyglobin, povzročata tako zdravilo kot tudi osnovno stanje, ki je vzrok anemije.
English: Oxyglobin is intended for a single use only.
Slovenian: Zdravilo Oxyglobin je namenjeno za enkratno uporabo.
English: Oxyglobin is a solution for infusion (drip into a vein).
Slovenian: Zdravilo Oxyglobin je raztopina za infundiranje (dajanje tekočine v veno).
English: Oxyglobin is used to increase the oxygen content of the blood in dogs with anaemia (low red blood cell count).
Slovenian: Zdravilo Oxyglobin se uporablja za povečanje količine kisika v krvi pri psih z anemijo (majhnim številom rdečih krvnih celic).
English: Oxyglobin is a haemoglobin-based oxygen-carrying solution.
Slovenian: Zdravilo Oxyglobin je oksiforna raztopina, ki temelji na hemoglobinu.
English: Why has Oxyglobin been approved?
Slovenian: Zakaj je bilo zdravilo Oxyglobin odobreno?
English: The study compared the effects of Oxyglobin with no treatment.
Slovenian: V študiji so primerjali učinke zdravila Oxyglobin glede na stanje živali, ki niso bile deležne zdravljenja.
English: What is Oxyglobin used for?
Slovenian: Za kaj se zdravilo Oxyglobin uporablja?
English: How has Oxyglobin been studied?
Slovenian: Kako je bilo zdravilo Oxyglobin raziskano?
English: How does Oxyglobin work?
Slovenian: Kako zdravilo Oxyglobin deluje?
English: What is Oxyglobin?
Slovenian: Kaj je zdravilo Oxyglobin?
English: It took longer until additional treatment was needed in dogs treated with Oxyglobin.
Slovenian: Psi, ki so jih zdravili z zdravilom Oxyglobin, so dalj časa zdržali brez potrebe po dodatnem zdravljenju .
English: Oxyglobin does not need to be matched to the dog's blood type.
Slovenian: Pri dajanju zdravila Oxyglobin ni treba preverjati krvne skupine psa. Za nadaljnje informacije si oglejte Navodilo za uporabo.
English: 1 vial l t o r
Slovenian: Viala (steklena) 1 viala o č
English: The recommended dose is 0.25 mg given every 24 hours, either in the morning or in the evening.
Slovenian: Priporočeni odmerek je 0,25 mg vsakih 24 ur, bodisi zjutraj ali zvečer.
English: Further information on Cetrotide can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/cetrotide.
Slovenian: Nadaljnje informacije za zdravilo Cetrotide so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/cetrotide.
English: Cetrotide (cetrorelix)
Slovenian: Cetrotide (cetroreliks)
English: The European Medicines Agency therefore decided that Cetrotide's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Cetrotide večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: Cetrotide received a marketing authorisation valid throughout the EU on 13 April 1999.
Slovenian: Za zdravilo Cetrotide je bilo 13. aprila 1999 izdano dovoljenje za promet, veljavno po vsej EU.
English: What measures are being taken to ensure the safe and effective use of Cetrotide?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Cetrotide?
English: The medicine should be injected slowly at different places on the abdomen every day.
Slovenian: Zdravilo je treba injicirati počasi v različne predele trebuha vsak dan.