FrancophonIA/ELRC3.0 huggingface dataset:
English: The dose may need to be adjusted over time, depending on change in body weight and response to treatment.
Slovenian: Morda bo treba sčasoma prilagoditi odmerek, odvisno od spremembe telesne mase in odziva na zdravljenje.
English: • are short because they have long-term kidney disease or a genetic disorder called Turner syndrome;
Slovenian: • so premajhne rasti, ker imajo dolgotrajno bolezen ledvic ali genetsko motnjo, imenovano Turnerjev sindrom;
English: Omnitrope is given to improve their growth and body composition (by reducing fat and improving muscle mass).
Slovenian: Zdravilo Omnitrope se daje za izboljšanje rasti in sestave telesa (z zmanjšanjem maščobe in izboljšanjem mišične mase).
English: In adults, side effects related to fluid retention, such as peripheral oedema (swelling, especially of the ankles and feet), paraesthesia (numbness or tingling), joint and muscle pain, and stiffness of the limbs are common (may affect between 1 and 10 patients in 100).
Slovenian: Pri odraslih so neželeni učinki, ki so povezani z zastajanjem tekočine v telesu in se kažejo kot periferni edem (otekanje, zlasti gležnjev in nog), parestezija (odrevenelost ali mravljinčenje), bolečine v sklepih in mišicah ter okorelost okončin, pogosti (lahko se pojavijo pri 1 do 10 bolnikov od 100).
English: This means that Omnitrope is highly similar to a biological medicine (the ‘reference medicine') that is already authorised in the EU.
Slovenian: To pomeni, da je zelo podobno biološkemu zdravilu (t. i. „referenčnemu zdravilu“), ki je že odobreno v Evropski uniji (EU).
English: This is a summary of the European public assessment report (EPAR) for Omnitrope.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Omnitrope.
English: As with all protein medicines, some patients may develop antibodies (proteins that are produced in response to Omnitrope).
Slovenian: Kot pri vseh zdravilih, ki vsebujejo beljakovine, se lahko pri nekaterih bolnikih pojavijo protitelesa (beljakovine, ki se tvorijo kot odziv na zdravilo Omnitrope).
English: It is important for growth during childhood and adolescence, and it also affects how the body handles proteins, fat and carbohydrates.
Slovenian: Pomemben je za rast v otroštvu in adolescenci, vpliva pa tudi na presnovo beljakovin, maščob in ogljikovih hidratov v telesu.
English: What measures are being taken to ensure the safe use of Omnitrope?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Omnitrope?
English: Omnitrope is a medicine used to treat children who:
Slovenian: Zdravilo Omnitrope se uporablja za zdravljenje otrok, ki:
English: What is Omnitrope and what is it used for?
Slovenian: Kaj je zdravilo Omnitrope in za kaj se uporablja?
English: The European Medicines Agency considered that, in accordance with EU requirements for biosimilar medicines, Omnitrope has been shown to have a comparable quality, safety and effectiveness to Genotropin.
Slovenian: Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU glede podobnih bioloških zdravil dokazano, da je zdravilo Omnitrope po kakovosti, varnosti in učinkovitosti primerljivo zdravilu Genotropin.
English: • are short and were born small for their gestational age, and have not caught up by the age of
Slovenian: • so premajhne rasti in so se rodili majhni za svojo gestacijsko starost ter do starosti 4 let ali več niso nadomestili zaostanka;
English: Somatropin is produced by a method known as ‘recombinant DNA technology': the hormone is made by bacteria into which a gene (DNA) has been introduced that makes them able to produce somatropin.
Slovenian: Proizvaja se z metodo, imenovano „tehnologija rekombinantne DNK“, pri kateri hormon tvorijo bakterije, ki so prejele gen (DNK), kar jim omogoča tvorjenje somatropina.
English: Results showed that, after treatment for 9 months, Omnitrope was as effective as Genotropin in improving growth.
Slovenian: Rezultati so pokazali, da je bilo po 9-mesečnem zdravljenju zdravilo Omnitrope enako učinkovito kot zdravilo Genotropin pri izboljšanju rasti.
English: Other information about Omnitrope
Slovenian: Druge informacije o zdravilu Omnitrope
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Omnitrope have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Omnitrope upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: Omnitrope was compared with Genotropin in 89 children with a lack of growth hormone who had not been treated before.
Slovenian: Zdravilo Omnitrope so primerjali z zdravilom Genotropin pri 89 otrocih s pomanjkanjem rastnega hormona, ki predhodno še niso bili zdravljeni.
English: For more information about treatment with Omnitrope, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Omnitrope preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: What benefits of Omnitrope have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Omnitrope izkazalo v študijah?
English: The patient or caregiver can inject Omnitrope, after being trained by a doctor or a nurse.
Slovenian: Bolnik ali negovalec lahko zdravilo Omnitrope injicirata sama, potem ko sta ju za to usposobila zdravnik ali medicinska sestra.
English: What are the risks associated with Omnitrope?
Slovenian: Kakšna tveganja so povezana z zdravilom Omnitrope?
English: Omnitrope must not be used if the patient has an active tumour or an acute life-threatening illness.
Slovenian: Zdravilo Omnitrope se ne sme uporabljati pri bolnikih, ki imajo aktiven tumor ali akutno smrtno nevarno bolezen.
English: The doctor calculates the dose for each patient individually according to the body weight and the condition being treated.
Slovenian: Zdravnik izračuna odmerek za vsakega bolnika posebej glede na njegovo telesno maso in bolezen, zaradi katere se zdravi.
English: The active substance in Omnitrope, somatropin, is identical to the human growth hormone, which it replaces.
Slovenian: Zdravilna učinkovina v zdravilu Omnitrope, somatropin, je enaka človeškemu rastnemu hormonu, ki ga nadomešča.
English: Omnitrope is also used as replacement therapy in adult patients with pronounced growth hormone deficiency.
Slovenian: Zdravilo Omnitrope se uporablja tudi kot nadomestno zdravljenje pri odraslih bolnikih z izrazitim pomanjkanjem rastnega hormona.
English: For practical information about using Omnitrope, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Omnitrope naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: It is not intended to provide practical advice on how to use Omnitrope.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: The medicine is available as a powder and solvent, which are made up into a solution for injection, or as a ready-to-use solution in a cartridge.
Slovenian: Zdravilo je na voljo v obliki praška in vehikla za pripravo raztopine za injiciranje ali v obliki pripravljene raztopine v vložku.
English: Why is Omnitrope approved?
Slovenian: Zakaj je bilo zdravilo Omnitrope odobreno?
English: Omnitrope can only be obtained with a prescription and treatment should be started and monitored by a doctor experienced in the management of patients with growth disorders.
Slovenian: Predpisovanje in izdaja zdravila Omnitrope je le na recept, zdravljenje z njim pa mora uvesti in spremljati zdravnik, ki ima izkušnje z zdravljenjem bolnikov z motnjami rasti.
English: The reference medicine for Omnitrope is Genotropin.
Slovenian: Referenčno zdravilo za zdravilo Omnitrope je zdravilo Genotropin.
English: Omnitrope was studied to show that it is comparable to the reference medicine, Genotropin.
Slovenian: Zdravilo Omnitrope so proučevali, da bi dokazali, ali je primerljivo z referenčnim zdravilom Genotropin.
English: Omnitrope contains the active substance somatropin and is a ‘biosimilar' medicine.
Slovenian: Zdravilo Omnitrope vsebuje zdravilno učinkovino somatropin in je „podobno biološko zdravilo“.
English: The Omnitrope cartridges should only be used with the special Omnitrope injection device.
Slovenian: Zdravilo Omnitrope v obliki vložkov se lahko uporablja samo s posebno pripravo za injiciranje zdravila Omnitrope.
English: For the full list of side effects of Omnitrope, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Omnitrope, glejte navodilo za uporabo.
English: How is Omnitrope used?
Slovenian: Kako se zdravilo Omnitrope uporablja?
English: Growth hormone is released by the pituitary gland (a gland at the base of the brain).
Slovenian: Rastni hormon izloča hipofiza (žleza v možganskem dnu).
English: Therefore, the Agency's view was that, as for Genotropin, the benefit outweighs the identified risk and it recommended that Omnitrope be given marketing authorisation.
Slovenian: Zato je menila, da njegove koristi enako kot pri zdravilu Genotropin odtehtajo znana tveganja.
English: How does Omnitrope work?
Slovenian: Kako zdravilo Omnitrope deluje?
English: Howeve,r these antibodies do not have an effect on how well Omnitrope works.
Slovenian: Vendar pa ta ne vplivajo na to, kako dobro deluje zdravilo Omnitrope.
English: LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Slovenian: SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH
English: 100mg/cap Capsule, soft
Slovenian: 100mg/cap kapsula, mehka peroralna uporaba
English: Belgium N.V. Novartis Pharma S.A. Medialaan 40,
Slovenian: Novartis Pharma S.A. Medialaan 40, B-1800 Vilvoorde Belgium
English: 50mg/cap Capsule, soft
Slovenian: 50mg/cap kapsula, mehka peroralna uporaba
English: 25mg/cap Capsule, soft
Slovenian: 25mg/cap kapsula, mehka peroralna uporaba
English: 500mg/5ml Oral solution
Slovenian: 500mg/5ml peroralna raztopina peroralna uporaba 100 mg/ml
English: 21 March 2014
Slovenian: 21. marec 2014
English: The Committee appointed C. Ibrahim as rapporteur and H. Jukes as co-rapporteur.
Slovenian: Odbor je za poročevalko imenoval C. Ibrahim, za soporočevalko pa H. Jukes.
English: The United Kingdom is the reference Member State and Germany and the Netherlands are concerned Member States.
Slovenian: Referenčna država članica je Združeno kraljestvo, zadevni državi članici pa sta Nemčija in Nizozemska.
English: International non-proprietary name (INN): eprinomectin
Slovenian: Mednarodno nelastniško ime (INN): eprinomektin
English: The opinion was converted into a Decision by the European Commission on 21 March 2014.
Slovenian: Mnenje je bilo spremenjeno v sklep Evropske komisije dne 21. marca 2014.
English: The decentralised procedure started on 21 February 2012.
Slovenian: Decentralizirani postopek se je začel 21. februarja 2012.
English: Written explanations were provided by the applicant on 19 November
Slovenian: Predlagatelj je 19. novembra 2013 podal pisna pojasnila.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the summary of product characteristics and package leaflet in Annex III.
Slovenian: Seznam zadevnih imen zdravila je v Prilogi I. Znanstveni zaključki so podani v Prilogi II, skupaj s povzetkom glavnih značilnosti zdravila in navodilom za uporabo v Prilogi III.
English: Potential serious risks were identified during the decentralised procedure by Germany regarding the environmental safety of the product.
Slovenian: Med decentraliziranim postopkom je Nemčija ugotovila možnost resnega tveganja, povezanega z varnostjo zdravila za okolje.
English: Day 60 of the CMD(v) procedure was on 18 April 2013, and since the Member States concerned failed to reach an agreement regarding the product the procedure was referred to the CVMP.
Slovenian: Šestdeseti dan postopka skupine CMD(v) je bil 18. april 2013 in ker zadevne države članice niso uspele doseči soglasja v zvezi z zdravilom, je bil postopek napoten na odbor CVMP.
English: On 26 April 2013, the reference Member State, the United Kingdom, notified the Agency that the CMD(v) had failed to reach an agreement regarding the product and referred the matter to the CVMP pursuant to Article 33(4) of Directive 2001/82/EC.
Slovenian: Referenčna država članica, Združeno kraljestvo, je 26. aprila 2013 obvestila agencijo, da skupina CMD(v) ni dosegla soglasja v zvezi z zdravilom, in zadevo napotila na odbor CVMP, skladno s členom 33(4) Direktive 2001/82/ES.
English: Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle contains eprinomectin as an active substance and is intended for use in cattle as a topical application for the treatment and control of infections from gastrointestinal roundworms (adults and fourth stage larvae), lungworms (adults and fourth stage larvae), warbles (parasitic stages), mange mites, lice and horn flies.
Slovenian: Zdravilo Norbonex 5 mg/ml kožni poliv, raztopina za govedo, namenjeno za proizvodnjo mesa in mleka, vsebuje zdravilno učinkovino eprinomektin in je namenjeno za lokalno uporabo pri govedu za zdravljenje in nadzorovanje okužb z želodčno-črevesnimi glistami (odraslimi in ličinkami v četrti fazi razvoja), pljučnimi črvi (odraslimi in ličinkami v četrti fazi razvoja), govejimi zolji (v parazitskem stadiju), garjami, ušmi in muhami Haematobia irritans.
English: On day 210, these issues remained unsolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the Coordination group for Mutual recognition and Decentralised procedures (veterinary) (CMD(v)) was started on 18 February 2013.
Slovenian: Ker ti pomisleki na 210. dan še vedno niso bili rešeni, je bila zadeva 18. februarja 2013 v skladu s členom 33(1) Direktive 2001/82/ES napotena na Usklajevalno skupino za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v veterinarski medicini (CMD(v)).
English: Therefore, the Committee adopted by consensus a positive opinion on 15 January 2014 recommending the granting of the marketing authorisations for Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle with amendment to the summary of product characteristics and package leaflet of the reference Member State.
Slovenian: Odbor je zato 15. januarja 2014 soglasno sprejel pozitivno mnenje in priporočil odobritev dovoljenja za promet z zdravilom Norbonex 5 mg/ml kožni poliv, raztopina za govedo, namenjeno za proizvodnjo mesa in mleka, skupaj s spremembo povzetka glavnih značilnosti zdravila in navodila za uporabo referenčne države članice.
English: This is a ‘hybrid' application according to Article 13(3) of Directive 2001/82/EC, as amended, referring to the reference product Eprinex PourOn Solution for Beef and Dairy Cattle.
Slovenian: Vloga je v skladu s členom 13(3) Direktive 2001/82/ES, kakor je bila spremenjena, „hibridna vloga“, ki se nanaša na referenčno zdravilo Eprinex kožni poliv, raztopina za govedo, namenjeno za proizvodnjo mesa in mleka.
English: Based on the evaluation of the currently available data, the CVMP considered that the benefit-risk profile of Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle is positive.
Slovenian: Na podlagi ocene trenutno razpoložljivih podatkov je odbor CVMP menil, da je razmerje med tveganji in koristmi za zdravilo Norbonex 5 mg/ml kožni poliv, raztopina za govedo, namenjeno za proizvodnjo mesa in mleka, pozitivno.
English: The applicant, Norbrook Laboratories Ltd, submitted an application for a decentralised procedure for Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle.
Slovenian: Predlagatelj, družba Norbrook Laboratories Ltd, je predložil vlogo za decentralizirani postopek za zdravilo Norbonex 5 mg/ml kožni poliv, raztopina za govedo, namenjeno za proizvodnjo mesa in mleka.
English: Opinion following an Article 33(4)0F referral for Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle
Slovenian: Mnenje v zvezi z napotitvijo v skladu s členom 33(4)0F za zdravilo Norbonex 5 mg/ml kožni poliv, raztopina za govedo, namenjeno za proizvodnjo mesa in mleka EMA/128538/2014
English: Such data should be submitted to the Agency together with the periodic safety update reports.
Slovenian: Te rezultate je treba predložiti Agenciji skupaj z rednimi posodobljenimi poročili o varnosti.
English: It can cause:
Slovenian: Povzroči lahko:
English: Reversal should occur rapidly within 1-2 minutes.
Slovenian: Reverzija mora nastopiti hitro v 1-2 minutah.
English: • Your dog to feel cold when touched (for example the ears).
Slovenian: • Pes je hladen na dotik (npr. na ušesih).
English: MARKETING AUTHORISATION NUMBER(S) EU/2/11/127/001
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET EU/2/11/127/001
English: 3.0 to 4.2 4.3 to 6.1 6.2 to 8.0 8.1 to 9.9 10.0 to 11.7 11.8 to 13.6 13.7 to 15.5 15.6 to 17.4 17.5 to 19.3 19.4 to 21.2 21.3 to 23.1 23.2 to 25.0 25.1 to 26.9 27.0 to 28.8 28.9 to 30.6 30.7 to 32.5 32.6 to 34.4 34.5 to 36.3 36.4 to 38.2 38.3 to 40.1 40.2 to 42.0 42.1 to 43.9 44.0 to 45.8 45.9 to 47.7 47.8 to 49.6 49.7 to 51.4 51.5 to 53.3 53.4 to 55.2 55.3 to 57.0
Slovenian: 4,3 do 6,1 6,2 do 8,0 8,1 do 9,9 10,0 do 11,7 11,8 do 13,6 13,7 do 15,5 15,6 do 17,4 17,5 do 19,3 19,4 do 21,2 21,3 do 23,1 23,2 do 25,0 25,1 do 26,9 27,0 do 28,8 28,9 do 30,6 30,7 do 32,5 32,6 do 34,4 34,5 do 36,3 36,4 do 38,2 38,3 do 40,1 40,2 do 42,0 42,1 do 43,9 44,0 do 45,8 45,9 do 47,7 47,8 do 49,6 49,7 do 51,4 51,5 do 53,3 53,4 do 55,2 55,3 do 57,0
English: The unbroached vial does not require any special storage conditions.
Slovenian: Neodprta viala ne zahteva posebnih pogojev shranjevanja.
English: The systemic bioavailability of the veterinary medicinal product is approximately 40%.
Slovenian: Sistemska biološka razpoložljivost zdravila je približno 40 %.
English: Your veterinarian can best describe these for you.
Slovenian: Najbolje jih lahko opiše vaš veterinar.
English: • Loss of appetite or drinking less water.
Slovenian: • Izgubo teka ali pitje manj vode.
English: For transdermal use.
Slovenian: Za transdermalno uporabo.
English: Recuvyra should only be used for dogs.
Slovenian: Recuvyra se sme uporabljati samo za pse.
English: Recuvyra like any other medicine may cause adverse reactions.
Slovenian: Recuvyra lahko kot vsako drugo zdravilo povzroča neželene učinke.
English: Bodyweight (kilograms)
Slovenian: Telesna teža (kilogrami)
English: Your dog should not be given Recuvyra if it:
Slovenian: Psu se ne sme dati Recuvyre, če:
English: It is important that both tips make direct contact with the skin.
Slovenian: Pomembno je, da se obe konici neposredno dotikata kože.
English: 50 mg/ml For a full list of excipients, see section 6.1.
Slovenian: 50 mg/ml Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
English: Within 5 minutes, the product dries on the skin.
Slovenian: V 5 minutah se zdravilo na koži posuši.
English: Remove the plastic protective cover from the top of the glass vial.
Slovenian: Odstranite plastičen zaščitni pokrovček z vrha steklene viale.
English: Thoroughly clean any contaminated clothing before reuse.
Slovenian: Pred ponovno uporabo temeljito očistite vsa onesnažena oblačila.
English: For the attention of dog owner
Slovenian: Opozorilo lastniku psa
English: ATCvet code: QN02AB03
Slovenian: Oznaka ATC vet: QN02AB03
English: Your veterinarian received a separate information sheet (summary of product characteristics) with more details on the correct and safe administration of Recuvyra.
Slovenian: Vaš veterinar je prejel posebne informacijske (Povzetek glavnih značilnosti zdravila) z več podrobnostmi o pravilnem in varnem dajanju Recuvyre.
English: Time to 1.0 ng/ml (hrs)
Slovenian: Čas do 1,0 ng/ml (ure)
English: Shelf life after first broaching the vial: 30 days.
Slovenian: Rok uporabnosti po prvem odpiranju viale: 30 dni.
English: The pharmacokinetic profile of the veterinary medicinal product is primarily characterised by the long period of systemic absorption.
Slovenian: Za farmakokinetičen profil zdravila je predvsem značilno dolgo obdobje sistemske absorpcije.
English: This dog was treated on: Date
Slovenian: Ta pes je bil zdravljen: Datum ura
English: Your veterinarian will ensure the product is stored correctly and safely for up to 3 years, but the contents of a bottle should be used within 30 days of the first dose being withdrawn.
Slovenian: Veterinar bo zagotovil pravilno in varno shranjevanje zdravila do 3 leta, a po odvzemu prvega odmerka se mora vsebina stekleničke porabiti v 30 dneh.
English: Facilities for the maintenance of a patent airway, intermittent positive pressure ventilation (IPPV) and oxygen supplementation should be available.
Slovenian: Na razpolago morajo biti naprave za vzdrževanje prehodnih dihalnih poti, intermitentno ventilacijo s pozitivnim tlakom (IPPV) in preskrbo s kisikom.
English: • Decreased stool production and some temporary weight loss.
Slovenian: • Zmanjšano izločanje blata in začasno manjšo izgubo teže.
English: Pharmacotherapeutic group: Analgesic, opioid, phenylpiperidene derivative.
Slovenian: Farmakoterapevtska skupina: analgetik, opioid, derivat fenilpiperidina.
English: Once seated, do not remove the adaptor.
Slovenian: Ko adapter sedi, ga ne odstranjujte več.
English: Attaching the adaptor
Slovenian: Pritrjevanje adapterja
English: The safety of the veterinary medicinal product in animals less than 6 months of age has not been established.
Slovenian: Varnost zdravila ni ugotovljena pri živalih, starih manj od 6 mesecev.
English: The veterinary medicinal product should not be used in animals with systemic illness.
Slovenian: Zdravilo se ne sme uporabljati pri živalih s sistemsko boleznijo.
English: Centre the adaptor directly over the top of the vial.
Slovenian: Namestite adapter točno nad sredino vrha viale.
English: It is important that you do not allow any other dogs or pets you may have to lick or come into contact with the area between your dog's shoulder blades where your veterinarian has applied Recuvyra for at least 3 days (72 hours) following treatment, as this might cause adverse reactions in these animals.
Slovenian: Pomembno je, da ne dovolite, da bi drugi psi ali domače živali, ki jih morda imate, lizali ali prihajali v stik z območjem med lopaticama vašega psa, kjer je veterinar nanesel Recuvyro, najmanj 3 dni (72 ur) po dajanju, ker lahko to povzroči neželene učinke pri teh živalih.
English: Rarely (i.e. in 0,01 to 0,1% of treated dogs) • Dysphoria and urinary retention.
Slovenian: Redko (tj. od 0,01 do 0,1% zdravljenih psov • Disforija in zadrževanje urina.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Slovenian: Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency, EMEA) http://www.ema.europa.eu/.
English: The ranges (90% interval) of pharmacokinetic parameters in dogs are given below:
Slovenian: Območja farmakokinetičnih parametrov (90 %-ni intervali) pri psih so prikazana spodaj:
English: Recuvyra is supplied to your veterinarian in an amber glass bottle containing 10 ml of product.
Slovenian: Recuvyra se dobavlja veterinarju v rjavi steklenički, ki vsebuje 10 ml izdelka.
English: If there is a risk of contact with the application site, suitable protective gloves must be worn.
Slovenian: Če obstaja nevarnost stika z mestom dajanja, je treba nositi primerne zaščitne rokavice.
English: Each pack is supplied with one vial adaptor, 15 syringes and 15 applicator tips, as well as 15 package leaflets for animal owners, and 1 SPC (for the veterinarian).
Slovenian: Vsako pakiranje vsebuje en adapterza viale, 15 brizg in 15 aplikacijskih nastavkov, 15 navodili za uporabo za lastnike živali in 1 Povzetkom glavnih značilnosti zdravila (za veterinarja).