FrancophonIA/ELRC3.0 huggingface dataset:
English: The differences in terms of safety (in terms of tolerability) observed in the EAGER trial between the nebuliser solution and the inhalation powder, favouring the nebuliser solution regarding the occurrence of cough and discontinuation of treatment, are relevant and support the claim of greater safety (in terms of tolerability), as per article Article 8(3)(c) of Regulation (EC) No 141/2000, of Tobramycin VVB in those patients who develop intolerance to TOBI Podhaler.
Slovenian: Razlike v smislu varnosti (v smislu prenašanja), med inhalacijsko raztopino za nebulator in praškom za inhalacijo, opažene v preskušanju EAGER, ki glede na pojavnost kašlja in prekinitev zdravljenja dajejo prednost inhalacijski raztopini za nebulator, so pomembne in v skladu s členom 8(3)(c) Uredbe (ES) št. 141/2000 podpirajo trditev o večji varnosti (v smislu prenašanja) zdravila Tobramycin VVB pri bolnikih, pri katerih je pojavi intoleranca za zdravilo TOBI Podhaler.
English: Overall, in the context of the claim of clinical superiority based on a greater safety according to Article 8(3)(c) of Regulation (EC) No 141/2000 read in combination with Article 3(3)(d)(2) of Regulation (EC) No 847/2000, CHMP considered that a substantial portion of the target population experiences greater safety (in terms of tolerability) with Tobramycin VVB in terms of the incidence of cough and treatment discontinuation, as compared to TOBI Podhaler.
Slovenian: Skupaj je odbor CHMP, v smislu trditve o klinični superiornosti na podlagi večje varnosti v skladu s členom 8(3)(c) Uredbe ES št. 141/2000 v povezavi s členom 3(3)(d)(2) Uredbe (ES) št. 847/200, menil, da je znaten delež ciljne populacije deležen večje varnosti (v smislu prenašanja) z zdravilom Tobramycin VVB v smislu pojavnosti kašlja in prekinitve zdravljenja kot z zdravilom TOBI Podhaler.
English: UAB “VVB” submitted on 2 May 2014 a marketing authorisation application for Tobramycin VVB 300 mg/5 ml nebuliser solution (hereinafter “Tobramycin VVB”) as an abridged application in accordance with Article 10(3) of Directive 2001/83/EC, referring to Nebcin solution for injection (PL 13621/0059) for the purpose of the data exclusivity, and to TOBI 300 mg/5 ml nebuliser solution (hereinafter “TOBI”; PL 00101/0935) for the purpose of the SmPC/clinical comparator.
Slovenian: Družba UAB “VVB” je 2. maja 2014 predložila skrajšano vlogo za pridobitev dovoljenja za promet z zdravilom Tobramycin VVB 300 mg/5 ml inhalacijska raztopina za nebulator (v nadaljevanju „Tobramycin VVB“) v skladu s členom 10(3) Direktive 2001/83/ES, ki se nanaša na referenčno zdravilo Nebcin raztopina za injiciranje (PL 13621/0059) za namen ekskluzivnosti podatkov in na referenčno zdravilo TOBI 300 mg/5 ml inhalacijska raztopina za nebulator (v nadaljevanju „TOBI“;
English: RMS and CMSs agreed that Tobramycin VVB is comparable to TOBI 300 mg/5 ml nebuliser solution and therefore available efficacy and safety data for TOBI can be extrapolated to Tobramycin VVB.
Slovenian: Referenčna država članica in zadevne države članice so se strinjale, da je zdravilo Tobramycin VVB primerljivo z zdravilom TOBI 300 mg/5 ml inhalacijska raztopina za nebulator, zato se razpoložljivi podatki o učinkovitosti in varnosti zdravila TOBI lahko ekstrapolirajo na zdravilo Tobramycin VVB.
English: For these patients, tobramycin nebuliser solution is an alternative.
Slovenian: Ti bolniki imajo drugo možnost, inhalacijsko raztopino tobramicina za nebulator.
English: The post hoc subgroup analysis of EAGER trial data confirmed the
Slovenian: Naknadna analiza podskupin podatkov iz preskušanja EAGER je potrdila razlike v stopnjah pojavnosti kašlja v vseh starostnih skupinah.
English: 3 inhalers with 60 actuations
Slovenian: 3 inhalatorji s 60 sprožitvami
English: This summary was last updated in September 2013.
Slovenian: Povzetek je bil nazadnje posodobljen septembra 2013.
English: It is available as chewable tablets in five strengths (90 mg, 140 mg, 180 mg, 270 mg, 425 mg) for dogs and cats and in three additional strengths for larger dogs (665 mg, 1040 mg and 1620 mg).
Slovenian: Na voljo je v obliki žvečljivih tablet v petih različnih jakostih za pse in mačke (90 mg, 140 mg, 180 mg, 270 mg, 425 mg) in v treh dodatnih jakostih za večje pse (665 mg, 1 040 mg in 1 620 mg).
English: Comfortis is given as a single dose which can be repeated every month.
Slovenian: Zdravilo se daje kot enojni odmerek, kar se lahko ponovi vsak mesec.
English: People who give the medicine should wash their hands after handling Comfortis.
Slovenian: Osebe, ki dajejo zdravilo, naj si po uporabi zdravila Comfortis umijejo roke.
English: Other information about Comfortis:
Slovenian: Druge informacije o zdravilu Comfortis:
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Comfortis on 11/02/2011.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Comfortis, veljavno po vsej Evropski uniji, odobrila dne 11. februarja 2011.
English: The studies also showed that the preventive effect of spinosad against new flea infestations (which results from its residual insecticidal activity) lasts for up to 4 weeks.
Slovenian: Študije so tudi pokazale, da preprečevalni učinek spinosada pred ponovno infestacijo z bolhami (ki je posledica rezidualne insekticidne aktivnosti) traja do štiri tedne.
English: Use of Comfortis tablets in dogs or cats which have epilepsy may involve additional risks.
Slovenian: Uporaba tablet zdravila Comfortis pri psih ali mačkah, ki imajo epilepsijo, lahko vključuje dodatna tveganja.
English: The CVMP concluded that the benefits of Comfortis outweigh the risks when used for the approved indications and recommended that Comfortis be given a marketing authorisation.
Slovenian: CVMP je zaključil, da so koristi zdravila Comfortis večje od z njim povezanih tveganj, kadar se uporablja za odobrene indikacije, in priporočil, da se zanj odobri dovoljenje za promet.
English: What benefit has Comfortis shown during the studies?
Slovenian: Kakšne koristi je zdravilo Comfortis izkazalo med študijami?
English: Comfortis is a veterinary medicine that contains spinosad.
Slovenian: Comfortis je zdravilo za uporabo v veterinarski medicini, ki vsebuje spinosad.
English: The studies involved dogs and cats of different age groups, genders, breeds and weights.
Slovenian: V študije so bili vključeni psi in mačke različnih starostnih skupin, spolov, pasem in telesne mase.
English: Accidental ingestion, including by children, may cause adverse reactions.
Slovenian: Nenamerno zaužitje, tudi pri otrocih, lahko povzroči neželene učinke.
English: The active substance in Comfortis, spinosad, is an insecticide which works by interfering with certain receptors (nicotinic acetylcholine receptors) in the fleas' nervous system, which results in their subsequent paralysis and death.
Slovenian: Zdravilna učinkovina v zdravilu Comfortis, spinosad, je insekticid, ki deluje tako, da ovira nekatere receptorje (nikotinske receptorje acetilholina) v živčnem sistemu bolh, kar pri njih posledično povzroči paralizo in smrt.
English: Similarly Comfortis tablets should be given with a meal or immediately after feeding in cats.
Slovenian: Podobno je treba tudi pri mačkah tablete zdravila Comfortis dajati skupaj s hrano ali nemudoma po njihovem hranjenju.
English: What is the risk associated with Comfortis?
Slovenian: Kakšna tveganja so povezana z zdravilom Comfortis?
English: Comfortis tablets are not recommended for use in dogs weighing less than 1.3 kg or in cats weighing less than 1.2 kg (as accurate dosing of the product in such small dogs or cats is not possible and they may be accidentally overdosed).
Slovenian: Uporaba tablet zdravila Comfortis ni priporočljiva pri psih, ki tehtajo manj kot 1,3 kg, in mačkah, ki tehtajo manj kot 1,2 kg (natančno odmerjanje zdravila pri tako majhnih psih in mačkah namreč ni mogoče, zato lahko nenamerno pride do prevelikega odmerka).
English: Comfortis has been studied in laboratory animals, as well as in dogs or cats that were treated in various veterinary practices and clinics across Europe (“clinical studies”).
Slovenian: Zdravilo Comfortis so proučevali na laboratorijskih živalih ter psih in mačkah, ki so bili zdravljeni v različnih veterinarskih ambulantah in klinikah po Evropi („klinične študije“).
English: The effectiveness of the product was measured by looking at the number of fleas that were alive at various times after treatment.
Slovenian: Učinkovitost zdravila je bila merjenja s preverjanjem števila živih bolh v različnih obdobjih po uporabi zdravila.
English: The most common side effect is vomiting, which is mild and transient in most dogs and cats.
Slovenian: Najpogostejši neželeni učinek je bruhanje, ki je pri večini psov in mačk blago in prehodno.
English: The clinical studies, carried out for between one and three months, showed that Comfortis is as effective as the comparator medicine in the treatment of flea infestations in dogs and cats.
Slovenian: Klinične študije, ki so trajale od enega do treh mesecev, so pokazale, da je zdravilo Comfortis enako učinkovito kot primerjalno zdravilo pri zdravljenju infestacije z bolhami pri psih in mačkah.
English: Comfortis tablets must not be used in dogs or cats aged less than 14 weeks, or in dogs or cats that are hypersensitive (allergic) to spinosad or any of the other ingredients in the tablets.
Slovenian: Tablete zdravila Comfortis se ne smejo uporabljati pri psih in mačkah, mlajših od 14 tednov, ali psih in mačkah, ki so preobčutljivi za (alergični na) spinosad ali katero koli drugo sestavino v tabletah.
English: Comfortis can also be used as part of a treatment strategy for flea allergic dermatitis (an allergic reaction to flea bites).
Slovenian: Lahko se uporablja tudi kot del strategije zdravljenja alergijskega dermatitisa, ki ga povzročajo bolhe (alergijske reakcije na ugrize bolh).
English: Why has Comfortis been approved?
Slovenian: Zakaj je bilo zdravilo Comfortis odobreno?
English: In the clinical studies, Comfortis was compared with a veterinary medicine authorised in the EU for the treatment and prevention of flea infestations (selamectin, a ‘spot-on' applied to the skin of the dog or cat).
Slovenian: V kliničnih študijah so zdravilo Comfortis primerjali z veterinarskim zdravilom, odobrenim v EU za zdravljenje in preprečevanje infestacije z bolhami (selamektin, zdravilo za kožni nanos za pse ali mačke).
English: The medicine starts killing fleas on the dog or cat 30 minutes after giving the tablet(s) and it remains active for up to four weeks.
Slovenian: Zdravilo začne bolhe pri psih ali mačkah uničevati v 30 minutah po zaužitju tablete in učinkuje do štiri tedne.
English: In case of accidental ingestion, medical advice should be sought immediately and the package leaflet or the label shown to the doctor.
Slovenian: V primeru nenamernega zaužitja se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali ovojnino.
English: Comfortis is used to treat and prevent flea infestations in dogs and cats.
Slovenian: Zdravilo Comfortis se uporablja za zdravljenje in preprečevanje infestacije z bolhami pri psih in mačkah.
English: Studies also showed that the frequency and severity of flea allergy dermatitis (an allergic reaction to flea bites) is significantly decreased in dogs and cats treated with Comfortis and so its use as part of a treatment strategy for the control of this condition is justified.
Slovenian: Pri psih in mačkah, zdravljenih z zdravilom Comfortis, so študije pokazale tudi bistveno zmanjšano pogostnost in resnost alergijskega dermatitisa, ki ga povzročajo bolhe (alergijske reakcije na ugrize bolh), zato je uporaba tega zdravila kot dela strategije zdravljenja za nadzor tega obolenja upravičena.
English: The appropriate strength tablet(s) should be used according to the dog's or cat's weight (the dose differs between dogs and cats).
Slovenian: Uporabiti je treba ustrezno jakost tablet glede na maso psa ali mačke (odmerek se razlikuje glede na to, ali se daje psom ali mačkam).
English: How has Comfortis been studied?
Slovenian: Kako je bilo zdravilo Comfortis raziskano?
English: Laboratory studies were carried out to look at the effectiveness of Comfortis in killing the fleas on dogs and cats with existing flea infestations, and at the speed of killing fleas on the treated animals.
Slovenian: V laboratorijskih študijah so proučevali učinkovitost zdravila Comfortis pri uničevanju bolh na psih in mačkah z obstoječo infestacijo z bolhami ter hitrost uničevanja bolh pri zdravljenih živalih.
English: For a full list of all side effects reported with Comfortis, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Comfortis, glejte navodilo za uporabo.
English: Comparative studies on fed/fasted dogs indicated that Comfortis tablets should be given with a meal to increase the amount of the active substance absorbed by the dog.
Slovenian: Primerjalne študije na psih, ki so zaužili hrano, in teščih psih so pokazale, da je tablete zdravila Comfortis treba jemati s hrano, saj se tako poveča količina zdravilne učinkovine, ki jo pes absorbira.
English: Other common side effects in cats include diarrhoea and loss of appetite.
Slovenian: Druga pogosta neželena učinka zdravila pri mačkah sta driska in izguba teka.
English: What is Comfortis used for?
Slovenian: Za kaj se zdravilo Comfortis uporablja?
English: The results of laboratory studies demonstrated that the product was effective at killing the fleas on dogs or cats with existing flea infestations within 24 hours after treatment.
Slovenian: Rezultati laboratorijskih študij so pokazali, da zdravilo v 24 urah po nanosu zdravila učinkovito uniči bolhe pri psih ali mačkah z obstoječo infestacijo z bolhami.
English: The safety for suckling puppies or kittens has not been sufficiently established, therefore Comfortis should only be used in breeding, pregnant or lactating dogs or cats if the veterinary surgeon has specifically recommended it.
Slovenian: Ker dokazi o varnosti za pasje ali mačje mladiče, ki se dojijo, niso zadostni, se lahko zdravilo Comfortis pri psih in mačkah za razplod oziroma brejih ali doječih psicah in mačkah uporablja samo po izrecnem priporočilu veterinarja.
English: How does Comfortis work?
Slovenian: Kako zdravilo Comfortis deluje?
English: The safety of Comfortis has not been sufficiently established in dogs or cats that are pregnant or breeding (male or female).
Slovenian: Varnost zdravila Comfortis ni bila ustrezno proučena pri brejih psicah ali mačkah ali psih in mačkah za razplod (samcih ali samicah).
English: What is Comfortis?
Slovenian: Kaj je zdravilo Comfortis?
English: This difference was not statistically significant.
Slovenian: Ta razlika ni bila statistično značilna.
English: Two patients were positive at only a single time point.
Slovenian: Dva bolnika sta bila pozitivna le v eni časovni točki.
English: There are also links to other websites about rare diseases and treatments.
Slovenian: Obstajajo tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
English: The educational material should contain:
Slovenian: Izobraževalno gradivo mora vsebovati:
English: Children and adults
Slovenian: Otroci in odrasli
English: Elderly population (≥ 65 years old)
Slovenian: Starejša populacija (≥ 65 let)
English: Aseptic technique should be used.
Slovenian: Uporabiti je treba aseptično tehniko.
English: Infants (< 6 months of age)
Slovenian: Dojenčki (< 6 mesecev starosti)
English: The age range at study entry was 1-6 months.
Slovenian: Starostni razpon ob vstopu v študijo je bil od 1 do 6 mesecev.
English: This is known as an infusion reaction which can sometimes be severe, and may include an allergic reaction.
Slovenian: To je znano kot reakcija na infuzijo, ki je lahko včasih resna in vključuje alergijsko reakcijo.
English: Each infusion will take approximately 1 to 2 hours.
Slovenian: Vsaka infuzija traja približno 1 do 2 uri.
English: Additional risk minimisation measures
Slovenian: Dodatni ukrepi za zmanjševanje tveganj
English: Final study report expected in July 2019
Slovenian: študiji se pričakuje julija 2019
English: If you have any further questions, ask your doctor.
Slovenian: Če imate dodatna vprašanja, se posvetujte z zdravnikom.
English: These increases have generally occurred within the first 2 to 4 weeks and improved within a further 8 weeks of treatment.
Slovenian: Ta povečanja so se načeloma pojavila v prvih 2 do 4 tednih in so se v naslednjih 8 tednih zdravljenja izboljšala.
English: The Guide for healthcare professionals shall contain the following key elements:
Slovenian: Navodilo za zdravstvene delavce mora vsebovati naslednje ključne elemente:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1033/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1033/001
English: KANUMA should be started at as young an age as possible and is intended for long-term use.
Slovenian: Zdravilo KANUMA je treba začeti dajati kar se da zgodaj v mladosti, in je namenjeno za dolgotrajno uporabo.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 28 August 2015
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM 28. avgust 2015
English: Unopened vials: 2 years.
Slovenian: Neodprte viale: 2 leti
English: With continued treatment beyond 12 months of age, 1 additional patient died at age 15 months.
Slovenian: Z nadaljevanjem zdravljenja po 12. mesecu starosti je v starosti 15 mesecev umrl še 1 bolnik.
English: Store in a refrigerator (2°C to 8°C).
Slovenian: Shranjujte v hladilniku (2 ºC do 8 ºC).
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Slovenian: Pred začetkom dobivanja zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: Frequency, type and severity of adverse reactions in children are the same as in adults.
Slovenian: Pogostnost, vrsta in resnost neželenih učinkov pri otrocih so enaki kot pri odraslih.
English: What KANUMA is and what it is used for
Slovenian: Kaj je zdravilo KANUMA in za kaj ga uporabljamo
English: Pre-treatment with antipyretics and/or antihistamines may prevent subsequent reactions in those cases where symptomatic treatment was required.
Slovenian: Premedikacija z antipiretiki in/ali antihistaminiki lahko prepreči nadaljnje reakcije v primerih, kjer je bilo potrebno simptomatsko zdravljenje.
English: In the absence of more clinical data, this dose is not recommended.
Slovenian: Ker več kliničnih podatkov ni na voljo, ta odmerek ni priporočljiv.
English: Based on the limited data currently available the development of ADA seems to occur more frequently in infants.'
Slovenian: Na podlagi omejenih podatkov se zdi, da ADA razvije pogosteje pri dojenčkih.
English: From a microbiological point of view, the diluted solution should be used immediately.
Slovenian: Z mikrobiološkega vidika je treba razredčeno raztopino porabiti takoj.
English: Posology It is important to initiate treatment as early as possible after diagnosis of LAL deficiency.
Slovenian: Odmerjanje Pomembno je, da se zdravljenje uvede čim prej po postavitvi diagnoze pomanjkanja LAL.
English: Studies to evaluate the mutagenic and carcinogenic potential of sebelipase alfa have not been performed.
Slovenian: Študij za oceno mutagenega in kancerogenega potenciala sebelipaze alfa niso opravili.
English: The efficacy objectives are assessment of hepatic function overtime up to 3 years and survival at 12 months.
Slovenian: Cilji za učinkovitost so ocena delovanja jeter skozi čas do 3 let in preživetje pri 12 mesecih starosti.
English: Sebelipase alfa has not been investigated in patients 2 to 4 years of age or patients aged 65 years or older.
Slovenian: Sebelipaze alfa niso preučili pri bolnikih, starih od 2 do 4 let ali pri bolnikih, starih 65 let ali več.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden prejmete to zdravilo.
English: The age range at randomisation was 4-58 years old (71% were < 18 years old).
Slovenian: Starostni razpon ob randomizaciji je bil 4 do 58 let (71% jih je bilo starih < 18 let).
English: Study LAL-CL02 - Children and Adults 1 mg/kg once every other week
Slovenian: Študija LAL-CL02 - otroci in odrasli 1 mg/kg enkrat vsak drugi teden
English: * The infusion volume should be based on the prescribed dose and should be prepared to a final sebelipase alfa concentration of 0.1-1.5 mg/ml.
Slovenian: * Količina za infundiranje mora temeljiti na predpisanem odmerku; pripraviti je treba končno koncentracijo sebelipaze alfa 0,1 do 1,5 mg/ml.
English: Prior to launch of Kanuma in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational material including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Slovenian: Pred začetkom trženja zdravila Kanuma v vsaki od držav članic se mora imetnik dovoljenja za promet z zdravilom dogovoriti s pristojnim nacionalnim organom o vsebini in obliki izobraževalnega gradiva, vključno s komunikacijskimi mediji, načini distribucije, in vsemi drugimi vidiki programa.
English: Total infusion volume (ml)
Slovenian: Skupna količina za infundiranje (ml)
English: 4-11 years old N=24
Slovenian: 4 do 11 let starosti n=24
English: In cases of severe infusion reactions and in cases of lack or loss of effect, patients should be tested for the presence of antibodies.
Slovenian: V primerih hude reakcije ob infundiranju in v primeru pomanjkanja ali izgube učinka, je treba bolnike testirati na prisotnostprotiteles.
English: For study entry, patients were required to have ALT levels of ≥1.5 X upper limit of normal (ULN).
Slovenian: Za vstop v študijo so bolniki morali imeti ravni ALT ≥ 1,5 X zgornja meja normalne vrednosti (ULN-upper limit of normal).
English: Proportion of patients who achieved normalisation defined as 34-59 U/l, depending on age and gender.
Slovenian: Delež bolnikov, ki so dosegli normalizacijo, opredeljeno kot 34 do 59 e./l, odvisno od starosti in spola.
English: • Guide for healthcare professionals
Slovenian: • navodilo za zdravstvene delavce.
English: The infusion period may be extended in the event of dose escalation.
Slovenian: Obdobje infundiranja se lahko v primeru povečanja odmerka podaljša.
English: The majority of reactions occurred during or within 4 hours of the completion of the infusion.
Slovenian: Večina reakcij se je pojavila med infundiranjem ali v 4 urah po njem.
English: Patients also had rapidly progressive liver disease and severe hepatosplenomegaly.
Slovenian: Bolniki so imeli tudi hitro napredujočo bolezen jeter in resno hepatosplenomegalijo.
English: The dose you or your child receives is based on your or your child's body weight.
Slovenian: Odmerek, ki ga bosta vi oziroma vaš otrok prejela, je odvisen od vaše oziroma otrokove telesne mase.
English: Patients with known egg allergies were excluded from clinical studies (see section 4.3).
Slovenian: Bolniki z znano alergijo na jajca so bili iz kliničnih študij izključeni (glejte poglavje 4.3).
English: The vials should not be left outside the refrigerator longer than 24 hours prior to dilution for infusion.
Slovenian: Vial ni dovoljeno pustiti zunaj hladilnika dlje kot 24 ur pred razredčitvijo za infundiranje.
English: The association between the development of ADA to sebelipase alfa and reductions in treatment effect or the occurrence of adverse reactions has not been determined.
Slovenian: Povezava med razvojem ADA na sebelipazo alfa in zmanjšanjem učinka zdravljenja ali pojavom neželenih učinkov ni bila ugotovljena.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na posebni recept (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).