FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP, having considered the matter as set out in the appended referral assessment report recommended the suspension of the Marketing Authorisations for all parenteral medicinal products referred to in Annex I to be effected within 15 months of the Commission Decision in order to allow healthcare professionals to prepare for a potential switch to using alternatives.. For the suspension to be lifted the Marketing Authorisation Holders would need to provide evidence of a patient population in which the benefit-risk balance of parenteral dextropropoxyphene medicinal products is positive.
Slovenian: CHMP je po obravnavi zadeve, kakor je navedena v priloženem ocenjevalnem poročilu napotitvenega postopka, priporočil umik dovoljenj za promet z vsemi parenteralnimi zdravili, navedenimi v Dodatku I, kar se izvede v 15 mesecih od odločbe Komisije, s čimer bo zdravstvenim delavcem omogočeno, da se pripravijo na morebiten prehod na alternativna zdravila.
English: Nevertheless, the CHMP also took the well-established narrow therapeutic index into account, as well as other known risks associated with the use of parenteral opioids and potentially associated with the use of parenteral dextropropoxyphene such as abuse and dependence and given that the efficacy of parenteral dextropropoxyphene containing medicinal products has not been established, the CHMP concluded that the benefit-risk balance for the parenteral dextropropoxyphene containing medicinal products was negative and recommended the suspension of the Marketing Authorisations to be effected within 15 months of the Commission Decision to allow healthcare professionals to prepare for a potential switch to using alternatives.
Slovenian: Ker učinkovitost zdravil, ki vsebujejo parenteralni dekstroproposkifen, ni bila dokazana, je CHMP zaključil, da je razmerje med koristmi in tveganji za zdravila, ki vsebujejo parenteralni dekstropropoksifen, negativno, in je priporočil, da se dovoljenja za promet z zdravilom umaknejo v 15 mesecih od odločbe Komisije, kar bi zdravstvenim delavcem omogočilo, da se pripravijo na prehod na alternativno zdravilo.
English: - The Committee considered that the efficacy of parenteral dextropropoxyphene containing medicinal products has not been established;
Slovenian: - Odbor je menil, da učinkovitost zdravil, ki vsebuje parenteralni dekstropropoksifen, ni bila ugotovljena; - Odbor je obravnaval tveganje prevelikega odmerjanja s smrtnim izidom z dekstropropoksifenom.
English: Member State Marketing Authorisation Holder Product Name
Slovenian: Imetnik dovoljenja za promet z zdravilom
English: Immediate Packaging Pack size bottle (HDPE)
Slovenian: (HDPE) plastični vsebnik
English: 100 tablets
Slovenian: Farmacevtska oblika
English: EU/2/14/172/002
Slovenian: EU/2/14/172/001 EU/2/14/172/002
English: ATC vet code: QI07AI08.
Slovenian: Oznaka ATC vet: QI07AI08.
English: Date of last renewal: 11/04/2019.
Slovenian: Datum zadnjega podaljšanja dovoljenja za promet: 11/04/2019.
English: Pharmacotherapeutic group: Immunologicals for canidae, live viral and inactivated bacterial vaccines.
Slovenian: Farmakoterapevtska skupina: Imunološka zdravila za pse (canidae), živa virusna in inaktivirana bakterijska cepiva.
English: Suspension: whitish colour with fine sediment.
Slovenian: Suspenzija: bele barve s finim sedimentom.
English: Duration of immunity: At least one year following the primary vaccination course for all components of Versican Plus Pi/L4.
Slovenian: Trajanje imunosti: Vsaj eno leto po osnovnem cepljenju proti vsem komponentam cepiva Versican Plus Pi/L4.
English: Reconstituted vaccine: pinkish or yellowish colour with a slight opalescence.
Slovenian: Rekonstituirano cepivo: rožnate ali rumenkaste barve, rahlo opalescentno.
English: Primary vaccination scheme: Two doses of Versican Plus Pi/L4 3-4 weeks apart from 6 weeks of age.
Slovenian: Osnovno cepljenje: Dva odmerka Versican Plus Pi/L4 v razmaku 3-4 tednov od starosti 6 tednov naprej.
English: Adjuvant: Aluminium hydroxide
Slovenian: Aluminijev hidroksid
English: The vaccine is intended for the active immunisation of healthy puppies and dogs against diseases caused by canine parainfluenza virus, Leptospira interrogans serogroup Australis serovar Bratislava, Leptospira interrogans serogroup Canicola serovar Canicola, Leptospira kirschneri serogroup Grippotyphosa serovar Grippotyphosa and Leptospira interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae.
Slovenian: Cepivo je namenjeno aktivni imunizaciji zdravih pasjih mladičev in odraslih psov proti boleznim, ki jih povzročajo virus pasje parainfluence, Leptospira interrogans serološka skupina Australis serovar Bratislava, Leptospira interrogans serološka skupina Canicola serovar Canicola, Leptospira kirschneri serološka skupina Grippotyphosa serovar Grippotyphosa, in Leptospira interrogans serološka skupina Icterohaemorrhagiae serovar Icterohaemorrhagiae.
English: − 4 weeks after the completion of primary course for Leptospira components.
Slovenian: − 3 tedne po zaključku osnovnega cepljenja proti CpiV in − 4 tedne po zaključku osnovnega cepljenja proti komponentam Leptospira.
English: Re-vaccination scheme: A single dose of Versican Plus Pi/L4 to be given annually.
Slovenian: Ponovno cepljenje: Enkratni odmerek Versican Plus Pi/L4 letno.
English: Lyophilisate: Trometamol Edetic acid Sucrose Dextran 70
Slovenian: Liofilizat: trometamol edetinska kislina saharoza dekstran 70
English: ALR ** titre ≥ 1:40
Slovenian: titer ALR** ≥ 1:40
English: − to prevent clinical signs and reduce infection and urinary excretion caused by L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa.
Slovenian: − za preprečevanje kliničnih znakov, zmanjšanje okužbe in izločanja virusa z urinom, ki jih povzroča L. kirschneri, serološka skupina Grippotyphosa, serovar Grippotyphosa.
English: SPECIAL WARNING(S)
Slovenian: POSEB NO(A) OPOZORILO(A)
English: ALR ** titre ≥ 1:51
Slovenian: titer ALR** ≥ 1:51
English: − to prevent clinical signs and urinary excretion and reduce infection caused by L. interrogans serogroup Canicola serovar Canicola and L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, and
Slovenian: − za preprečevanje kliničnih znakov, izločanja virusa z urinom in zmanjšanje okužb, ki jih povzroča L. interrogans, serološka skupina Canicola,serovar Canicola ter L. interrogans, serološka skupina Icterohaemorrhagiae, serovar Icterohaemorrhagiae in
English: PACKAGE LEAFLET: Versican Plus Pi/L4 lyophilisate and suspension for suspension for injection for dogs
Slovenian: Versican Plus Pi/L4 liofilizat in suspenzija za suspenzijo za injiciranje za pse
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus Pi/L4 lyophilisate and suspension for suspension for injection for dogs
Slovenian: NAVODILO ZA UPORABO Versican Plus Pi/L4 liofilizat in suspenzija za suspenzijo za injiciranje za pse
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus Pi/L4 lyophilisate for dogs
Slovenian: Versican Plus Pi/L4 liofilizat za pse
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus Pi/L4 suspension for dogs
Slovenian: Versican Plus Pi/L4 suspenzija za pse
English: Name and address of the manufacturer responsible for batch release
Slovenian: Ime in naslov proizvajalca (proizvajalcev) zdravila, odgovornega (odgovornih) za sprosščanje serij: Bioveta, a.s.,
English: The Committee appointed Mr G. Johan Schefferlie as rapporteur and Dr Michael Holzhauser-Alberti as co-rapporteur.
Slovenian: Odbor je imenoval Johana Schefferliea kot poročevalca in dr. Michaela Holzhauser-Albertija kot soporočevalca.
English: International non-proprietary name (INN): tilmicosin
Slovenian: Mednarodno nelastniško ime (INN): tilmikozin
English: Oral explanations were given on 11 June 2013.
Slovenian: Ustna pojasnila so bila podana 11. junija 2013.
English: Written explanations were provided by the marketing authorisation holders on 18 September 2012, 11 February 2013 and 26 May 2013.
Slovenian: Pisna pojasnila so imetniki dovoljenja za promet z zdravilom predložili 18. septembra 2012, 11. februarja 2013 in 26. maja 2013.
English: The Committee adopted a positive opinion by consensus on 18 July 2013.
Slovenian: Odbor je 18. julija 2013 soglasno sprejel pozitivno mnenje.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amended Summary of Product Characteristics, labelling and package leaflet in Annex III.
Slovenian: Seznam zadevnih imen zdravil je naveden v Prilogi I. Znanstveni zaključki so podani v Prilogi II skupaj s spremenjenim povzetkom glavnih značilnosti zdravila, označevanjem in navodilom za uporabo v Prilogi III.
English: Tilmicosin is a macrolide antibiotic synthesized from tylosin which has an antibacterial spectrum similar to tylosin with enhanced activity against Pasteurella multocida and Mannheimia haemolytica.
Slovenian: Tilmikozin je makrolidni antibiotik, sintetiziran iz tilozina, in ima podoben spekter protibakterijskega delovanja kot tilozin, vendar z okrepljenim delovanjem zoper bakteriji Pasteurella multocida in Mannheimia haemolytica.
English: Due to divergent national decisions taken by Member States concerning the authorisations of Micotil 300 Injectie and its associated names, on 24 April 2012 the Netherlands referred the issue to the CVMP under Article 34(1) of Directive 2001/82/EC, in order to resolve discrepancies in the product information across the European Union.
Slovenian: Zaradi različnih nacionalnih odločitev, ki so jih sprejele države članice v zvezi z odobritvijo zdravila Micotil 300 Injectie in povezana imena, je Nizozemska na podlagi člena 34(1) Direktive 2001/82/ES zadevo napotila v arbitražo na CVMP, da bi razrešila razhajanja v informacijah o zdravilu po vsej Evropski uniji.
English: Based on the currently available data, the CVMP considered that the benefit-risk profile of Micotil 300 Injectie and its associated names remains positive, subject to variation of the marketing authorisations in accordance with the recommended product information.
Slovenian: CVMP je na podlagi trenutno razpoložljivih podatkov menil, da razmerje med koristmi in tveganji zdravila Micotil 300 Injectie in povezana imena ostaja pozitivno pod pogojem, da se spremenijo dovoljenja za promet z zdravilom v skladu s priporočenimi informacijami o zdravilu.
English: Micotil 300 Injectie and its associated names are veterinary medicinal products authorised for use in the target species cattle, sheep and rabbits for treatment of various infections caused by microorganisms susceptible to tilmicosin.
Slovenian: Zdravilo Micotil 300 Injectie in povezana imena je zdravilo za uporabo v veterinarski medicini, odobreno za uporabo pri govedu, ovcah in kuncih za zdravljenje različnih okužb, ki jih povzročajo mikroorganizmi, občutljivi za tilmikozin.
English: Micotil 300 Injectie is a solution for injection containing tilmicosin with a strength of 300 mg per ml.
Slovenian: Zdravilo Micotil 300 Injectie je raztopina za injiciranje, ki vsebuje tilmikozin v jakosti 300 mg na mililiter.
English: 18 October 2013
Slovenian: 18. oktober 2013 EMA/539469/2013
English: Opinion following an Article 341 referral for Micotil 300 Injectie and its associated names
Slovenian: za zdravilo Micotil 300 Injectie in povezana imena
English: Opinion following an Article 340F referral for Micotil 300 Injectie and its associated names
Slovenian: Mnenje v zvezi z napotitvijo v skladu s členom 340F za zdravilo Micotil 300 Injectie in povezana imena EMA/696386/2013
English: Erysipelothrix rhusiopathiae, strain R32E11, ELISA > 3.34 IE50%
Slovenian: 10 odmerkov (20 ml)
English: Target species
Slovenian: 1 stekle no vialo z
English: Posaconazole SP 40 mg/ml Oral suspension Oral use
Slovenian: Posaconazole SP 40 mg/ml Peroralna suspenzija Peroralna uporaba Steklenička (steklo)
English: Content (concentration) Package size
Slovenian: Ovojnina Vsebina (koncentracija)
English: 270 capsules blister (PVC/Aclar (PCTFE)) Initiation pack: 63 (1 x 21 and 2 x 21) tablets
Slovenian: 270 kapsul začetno pakiranje: 63 (1 x 21 in 2 x 21) tablet
English: Immediate Packaging Pack size blister (PVC/PE/PCTFE/alu) Initiation pack: 63 (7 x 3 and 7 x 6) capsules blister (PVC/PE/PCTFE/alu) 252 x 1 capsules (unit dose)
Slovenian: (PVC/PE/PCTFE/alu) začetno pakiranje: 63 (7 x 3 in 7 x 6) kapsul
English: This overview was last updated in 03-2019
Slovenian: Pregled je bil nazadnje posodobljen 03-2019.
English: Further information on Instanyl can be found on the Agency's website: ema.europa.eu/medicines/Human/EPAR/Instanyl.
Slovenian: Nadaljnje informacije za zdravilo Instanyl so na voljo na spletni strani agencije: ema.europa.eu/medicines/Human/EPAR/Instanyl.
English: It is a well-known substance, which has been used to control pain for many years.
Slovenian: To je dobro znana snov, ki se že mnogo let uporablja za obvladovanje bolečin.
English: What measures are being taken to ensure the safe and effective use of Instanyl?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Instanyl?
English: Instanyl received a marketing authorisation valid throughout the EU on 20 July 2009.
Slovenian: Za zdravilo Instanyl je bilo 20. julija 2009 izdano dovoljenje za promet, veljavno po vsej EU.
English: The European Medicines Agency decided that Instanyl's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Instanyl večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: What benefits of Instanyl have been showed in studies?
Slovenian: Kakšne koristi zdravila Instanyl so se pokazale v študijah?
English: Other information about Instanyl
Slovenian: Druge informacije o zdravilu Instanyl
English: As for all medicines, data on the use of Instanyl are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Instanyl stalno spremljajo.
English: Why is Instanyl authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Instanyl odobreno v EU?
English: What are the risks associated with Instanyl?
Slovenian: Kakšna tveganja so povezana z zdravilom Instanyl?
English: The doctor should keep in mind the potential for Instanyl to be abused.
Slovenian: Zdravnik se mora zavedati, da obstaja možnost zlorabe zdravila Instanyl.
English: The medicine can only be obtained by ‘special' prescription.
Slovenian: Predpisovanje in izdaja zdravila je le na „poseben“ recept.
English: An overview of Instanyl and why it is authorised in the EU
Slovenian: Pregled zdravila Instanyl in zakaj je odobreno v EU
English: The company that markets Instanyl will also provide educational materials to be supplied to patients, doctors and pharmacists, explaining the correct and safe use of the medicine.
Slovenian: Podjetje, ki trži zdravilo Instanyl, bo priskrbelo izobraževalno gradivo za bolnike, zdravnike in farmacevte, kjer bo obrazložena pravilna in varna uporaba zdravila.
English: It is available in singledose containers and in multidose containers.
Slovenian: Na voljo je v enoodmernem ali večodmernem vsebniku.
English: Side effects reported with Instanyl are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Instanyl, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: What is Instanyl what is it used for?
Slovenian: Kaj je zdravilo Instanyl in za kaj se uporablja?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Instanyl have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Instanyl upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Side effects are similar to those of other medicines containing fentanyl, and measures have been put in place to minimise the risk of misuse and overdose.
Slovenian: Neželeni učinki so podobni kot pri drugih zdravilih, ki vsebujejo fentanil, uvedeni pa so tudi ukrepi za zmanjšanje tveganj zlorabe in prevelikega odmerjanja.
English: Because fentanyl has been in use for many years, the company presented data from the scientific literature, as well as from studies that it had carried out, which showed that Instanyl was more effective than placebo (a dummy treatment) at treating breakthrough pain in cancer patients.
Slovenian: Ker se fentanil uporablja že mnogo let, je podjetje predložilo podatke iz znanstvene literature, pa tudi podatke iz študij, ki jih je izvedlo samo in so pokazale, da je zdravilo Instanyl pri zdravljenju prebijajoče bolečine pri rakavih bolnikih učinkovitejše od placeba (zdravila brez učinkovine).
English: The most common side effects with Instanyl (which may affect up to 1 in 10 people) are somnolence (sleepiness), dizziness, headache, vertigo (a spinning sensation), flushing (reddening of the skin), hot flushes, throat irritation, nausea (feeling sick), vomiting and hyperhidrosis (excessive sweating).
Slovenian: Najpogostejši neželeni učinki zdravila Instanyl (ki se lahko pojavijo pri največ 1 od 10 bolnikov) so somnolenca (zaspanost), omotica, glavobol, vrtoglavica (občutek vrtenja), rdečica (pordelost kože), navali vročine, draženje v žrelu, navzeja (siljenje na bruhanje), bruhanje in hiperhidroza (prekomerno potenje).
English: In another main study, 128 patients were given increasing doses of Instanyl until the adequate dose for pain relief was reached.
Slovenian: V drugi glavni študiji je 128 bolnikov prejemalo čedalje večje odmerke zdravila Instanyl, dokler niso dosegli zadostnega olajšanja bolečine.
English: In a third study, which involved 139 patients and compared Instanyl with ‘transmucosal' fentanyl (absorbed through the lining of the mouth), patients who received Instanyl had faster pain relief than patients who received transmucosal fentanyl .
Slovenian: V tretji študiji, ki je vključevala 139 bolnikov in v kateri so zdravilo Instanyl primerjali s transmukoznim fentanilom (ki se absorbira skozi sluznico ustne votline), je pri bolnikih, ki so prejemali zdravilo Instanyl, do olajšanja bolečine prišlo hitreje kot pri bolnikih, ki so prejemali transmukozni fentanil.
English: Before starting treatment with Instanyl, the patient's long-term pain should be well controlled by opioid pain killers and they should have no more than 4 episodes of breakthrough pain a day.
Slovenian: Pred začetkom zdravljenja z zdravilom Instanyl mora biti dolgotrajna bolečina pri bolnikih dobro uravnana z opioidnimi protibolečinskimi zdravili in bolniki ne smejo imeti več kot štiri epizode prebijajoče bolečine na dan.
English: In one main study, 178 adult cancer patients with breakthrough pain took one spray of either Instanyl (50, 100 or 200 microgram) or placebo when they experienced breakthrough pain.
Slovenian: V eni glavni študiji je 178 odraslih bolnikov z rakom in prebijajočo bolečino ob pojavu prebijajoče bolečine prejemalo po en vpih zdravila Instanyl (50, 100 ali 200 mikrogramov) ali placeba.
English: Instanyl is available as a nasal spray (50, 100 and 200 micrograms per dose).
Slovenian: Zdravilo Instanyl je na voljo v obliki pršila za nos (50, 100 in 200 mikrogramov na odmerek).
English: The active substance in Instanyl, fentanyl, is an opioid.
Slovenian: Učinkovina v zdravilu Instanyl, fentanil, je opioid.
English: When the patient sprays Instanyl into the nose, a dose of fentanyl is absorbed into the blood stream through the blood vessels in the nose.
Slovenian: Ko si bolnik naprši zdravilo Instanyl v nos, se odmerek fentanila skozi krvne žile v nosu hitro absorbira v krvni obtok.
English: Treatment with Instanyl should be started by and remain under the supervision of a doctor who has experience in the management of opioid treatment in cancer patients.
Slovenian: Zdravljenje z zdravilom Instanyl sme uvesti in ves čas nadzorovati le zdravnik, ki ima izkušnje z vodenje zdravljenja z opioidi pri bolnikih z rakom.
English: Instanyl has been shown to provide rapid relief of pain in patients with cancer.
Slovenian: Za zdravilo Instanyl je bilo dokazano, da hitro olajša bolečine pri bolnikih z rakom.
English: If there has been insufficient pain relief, the same dose can be given again at the earliest after 10 minutes.
Slovenian: Če lajšanje bolečine ni zadostno, se lahko po preteku najmanj desetih minut znova uporabi enak odmerek.
English: Instanyl is used in patients who are already using opioids (a group of painkillers that includes morphine and fentanyl) to control long-term cancer pain.
Slovenian: Zdravilo Instanyl se uporablja pri bolnikih, ki že jemljejo opioide (zdravila iz skupine protibolečinskih zdravil, kamor spadata morfin in fentanil) za obvladovanje dolgotrajne bolečine pri raku.
English: How is Instanyl used?
Slovenian: Kako se zdravilo Instanyl uporablja?
English: Instanyl must not be used in patients who are not already taking opioids to maintain pain control, who have severe respiratory depression (inhibition of breathing) or who have severe obstructive lung conditions (diseases that severely impede breathing).
Slovenian: Zdravila Instanyl ne smejo uporabljati bolniki, ki še ne jemljejo opioidov za uravnavanje bolečine, in bolniki, ki imajo resno depresijo dihanja (oteženo dihanje) ali obolenje s hudo obstrukcijo pljuč (bolezen, pri kateri je dihanje močno ovirano).
English: The highest dose was 200 microgram given as one spray in one nostril and the patients were allowed to take a second spray after 10 minutes if there had been insufficient pain relief.
Slovenian: Največji odmerek je bil 200 mikrogramov, ki so ga bolniki jemali kot en vpih v eno nosnico, nato pa so lahko po desetih minutah prejeli še en vpih, če bolečina ni bila zadostno ublažena.
English: Instanyl contains the active substance fentanyl.
Slovenian: Zdravilo Instanyl vsebuje učinkovino fentanil.
English: Once in the bloodstream, fentanyl acts on receptors in the brain and spinal cord to relieve pain.
Slovenian: Fentanil začne z vstopom v krvni obtok delovati na receptorje v možganih in hrbtenjači ter tako olajša bolečino.
English: It must not be used in patients treated with medicines containing sodium oxybate (used to treat narcolepsy, a sleep disorder).
Slovenian: Ne smejo ga uporabljati niti bolniki, ki se zdravijo z zdravili, ki vsebujejo natrijev oksibat (uporablja se za zdravljenje narkolepsije, motnje spanja).
English: A patient's breakthrough pain was considered to have responded to treatment if there was a reduction of at least 2 points.
Slovenian: Kot bolnik, ki se je odzval na zdravljenje, je bil opredeljen bolnik s prebijajočo bolečino, pri katerem je prišlo do zmanjšanja bolečine za vsaj dve točki.
English: The reduction in pain intensity after 10 minutes was between 1.8 and 2.7 points on an 11-point pain scale for patients who took Instanyl, compared with 1.4 for patients who took placebo.
Slovenian: Zmanjšanje intenzivnosti bolečine po desetih minutah, ocenjene na podlagi 11-točkovne bolečinske lestvice, je bilo pri bolnikih, ki so prejeli zdravilo Instanyl, med 1,8 in 2,7 točke, pri bolnikih, ki so prejeli placebo, pa 1,4 točke.
English: The number of breakthrough pain episodes that responded to treatment was also higher among patients who received Instanyl than those who received placebo.
Slovenian: Število epizod prebijajoče bolečine, pri katerih je prišlo do odziva na zdravljenje, je bilo višje pri bolnikih, ki so prejemali zdravilo Instanyl, kot pri bolnikih, ki so prejemali placebo.
English: It must also not be used in patients who have had facial radiotherapy (treatment with radiation to the face) or who have recurrent episodes of epistaxis (nosebleeds).
Slovenian: Prav tako ga ne smejo uporabljati bolniki, ki so pred tem imeli radioterapijo (zdravljenje z obsevanjem) v predelu obraza, ali bolniki s ponavljajočimi se epizodami krvavitev iz nosu.
English: Instanyl is a medicine used to treat breakthrough pain in adults with cancer.
Slovenian: Zdravilo Instanyl se uporablja za zdravljenje prebijajoče bolečine pri odraslih bolnikih z rakom.