FrancophonIA/ELRC3.0 huggingface dataset:
English: Intravitreous haemorrhages
Slovenian: Intraviteralne krvavitve
English: Follow the instruction below to expel the excess volume before injection.
Slovenian: Sledite spodnjim navodilom za odstranitev odvečnega volumna pred injiciranjem.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One pre-filled syringe provides a usable amount to deliver a single dose of 90 microlitres containing pegaptanib sodium, corresponding to 0.3 mg of the free acid form of the oligonucleotide.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena napolnjena injekcijska brizga vsebuje ustrezno količino za zagotovitev enkratnega odmerka 90 mikrolitrov, ki vsebuje natrijev pegaptanib, kar ustreza 0,3 mg oligonukleotida v obliki proste kisline.
English: • displacement or tear of a layer in the back of the eye (retina)
Slovenian: • odstop ali pretrganje plasti na zadnji strani očesa (mrežnice)
English: In clinical trials the most frequently reported ocular adverse reactions following injection of Macugen are: anterior chamber inflammation, eye pain, increased intraocular pressure, punctate keratitis,
Slovenian: V kliničnih preskušanjih so po injiciranju zdravila Macugen najpogosteje poročali o naslednjih očesnih neželenih učinkih: vnetje sprednjega prekata, bolečina v očesu, zvišan očesni tlak, točkasti keratitis, motnjave v steklovini in delci v steklovini.
English: There is a small risk of a slight lasting increased pressure inside the eye after repeated injection in the eye.
Slovenian: Po večkratnem injiciranju v oko je prisotno majhno tveganje za vztrajno, rahlo povišanje tlaka v očesu.
English: Sodium chloride, monobasic sodium phosphate monohydrate, dibasic sodium phosphate heptahydrate, sodium hydroxide and hydrochloric acid (for pH adjustment), water for injections.
Slovenian: Natrijev klorid, natrijev dihidrogenfosfat monohidrat, natrijev hidrogenfosfat heptahidrat, natrijev hidroksid in klorovodikova kislina (za uravnavanje pH), voda za injekcije.
English: In rabbits, the component nucleotide, 2'-fluorouridine is found in plasma and urine after single radiolabeled pegaptanib intravenous and intravitreal doses.
Slovenian: Pri kuncih je mogoče po enem intravenskem in intravitrealnem odmerku radioaktivno označenega zdravila Macugen najti sestavni nukleotid, 2'-fluorouridin, v plazmi in urinu.
English: These side effects are most probably caused by the injection procedure rather than the medicine, and include:
Slovenian: Ti neželeni učinki so bolj verjetno posledica postopka injiciranja kot samega zdravila.
English: Each single dose pre-filled syringe delivers a dose of 0.3 mg pegaptanib in 90 microlitres.
Slovenian: Ena enoodmerna napolnjena injekcijska brizga vsebuje 0,3 mg pegaptaniba v 90 mikrolitrih.
English: How to store Macugen
Slovenian: Kako boste prejeli zdravilo Macugen
English: • deformation of the pupil
Slovenian: • deformiranost zenice
English: No data are available to evaluate male or female mating or fertility indices.
Slovenian: Podatkov za oceno kazalcev parjenja in plodnosti pri samcih in samicah ni.
English: Increased intraocular pressure
Slovenian: Zvišanje očesnega tlaka
English: • eye inflammation, tears, inflammation of the conjunctiva (conjunctivitis), dryness, eye discharge, eye irritation, itching of the eye, eye redness or enlargement of the pupil
Slovenian: • vnetje očesa, solzenje, vnetje veznice (konjunktivitis), suhost, izcedek iz očesa, draženje očesa,
English: Uncommon contact dermatitis, eczema, hair colour changes, rash, pruritus, night sweats
Slovenian: Bolezni kože in podkožja občasni kontaktni dermatitis, ekcem, spremembe barve las, izpuščaj, pruritus, nočno znojenje neznana angioedem*
English: Active or suspected ocular or periocular infection.
Slovenian: Aktivna okužba očesa, okolice očesa ali sum na okužbo teh predelov.
English: • injection site reaction, injection site vesicles
Slovenian: • reakcija na mestu injiciranja, mehurčki na mestu injiciranja
English: • Intravitreal injection procedure pictogram • Patient information
Slovenian: • Slikovno navodilo (piktogram) s prikazom postopka intravitrealnega injiciranja
English: • disorder of the jelly portion inside the eye (vitreous disorder), such as displacement or tear
Slovenian: • spremembe zdrizastega dela v očesni notranjosti (motnje steklovine), kot npr. odstop ali pretrganje (odstop steklovine)
English: Align the third rib of the plunger stopper with the pre-printed black dosing line.
Slovenian: Poravnajte tretje rebro na gumijastem tesnilu z natisnjeno črno odmerno črto.
English: Kypropharm Ltd. Τηλ: + 357 22 43 46 99
Slovenian: Τηλ: + 357 22 43 46 99
English: There is a theoretical risk of arterial thromboembolic including stroke and myocardial infarction events following intravitreal use of VEGF inhibitors.
Slovenian: Po intravitrealni uporabi zaviralcev VEGF obstaja teoretično tveganje za arterijske trombembolične dogodke, vključno z možgansko kapjo in miokardnim infarktom.
English: Monobasic sodium phosphate monohydrate Dibasic sodium phosphate heptahydrate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Slovenian: 6.1 Seznam pomožnih snovi natrijev klorid natrijev dihidrogenfosfat monohidrat natrijev hidrogenfosfat heptahidrat natrijev hidroksid (za prilagoditev pH) klorovodikova kislina (za prilagoditev pH) voda za injekcije
English: Respiratory, thoracic and mediastinal disorders Common rhinorrhea
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti rinoreja občasni nazofaringitis
English: Cases of anaphylaxis/anaphylactoid reactions, including angioedema, have been observed within several hours after the pegaptanib intravitreal administration procedure in the post-marketing experience.
Slovenian: V izkušnjah v obdobju trženja zdravila so v nekaj urah po intravitrealni uporabi pegaptaniba opažali primere anafilaksije/anafilaktoidnih reakcij, vključno z angioedemom.
English: • bleeding in the eye or the internal portion of the eye (vitreous)
Slovenian: • krvavitev v notranjosti očesa (steklovina)
English: The syringe has a pre-attached polycarbonate plastic luer lock adaptor and the tip is sealed with an elastomeric (bromobutyl/synthetic isoprene) tip cap.
Slovenian: Injekcijska brizga ima že nameščen zaskočni nastavek „luer lock“ iz polikarbonatne plastike, na vrhu pa je zaprta z gumijasto zaporko (bromobutil/sintetični izopren).
English: Sustained small increases in intraocular pressure (IOP) have also been reported after repeated intravitreal dosing in a post marketing observational study.
Slovenian: Po večkratnem intravitrealnem odmerjanju v opazovalni študiji v obdobju trženja zdravila so poročali tudi o vztrajnem majhnem zvišanju očesnega tlaka.
English: • swelling or inflammation of the eyelid, swelling of the area on the inside of the eyelid or the outer surface of the eye (conjunctiva)
Slovenian: • oteklost ali vnetje veke, oteklost tkiva na notranji površini veke ali zunanji površini očesa
English: In the wet form of AMD, abnormal blood vessels grow under the retina and macula.
Slovenian: Pri vlažni obliki AMD pod mrežnico in makulo rastejo nenormalne žile.
English: • bloodshot eye (conjunctival haemorrhage)
Slovenian: • krvavo oko (krvavitev v veznico)
English: Pegaptanib produced no maternal toxicity and no evidence of teratogenicity or foetal mortality in mice at intravenous doses of 1 to 40 mg/kg/day.
Slovenian: Pegaptanib, uporabljen pri miših v intravenskih odmerkih od 1 mg/kg/dan do 40 mg/kg/dan, ni povzročil toksičnih učinkov pri samicah in nobenih znakov teratogenosti ali fetalne umrljivosti.
English: • eversion of the eyelid, eye movement disorder, eyelid irritation
Slovenian: • izvihanje veke, moteno gibanje zrkla, draženje vek
English: • small marks on the eye surface (punctate keratitis)
Slovenian: • drobne poškodbe na površini očesa (točkasti keratitis)
English: (vitreous detachment)
Slovenian: (veznice)
English: The pre-filled syringe is supplied with an excess product volume.
Slovenian: Napolnjena injekcijska brizga vsebuje odvečni volumen zdravila.
English: Overdose with Macugen has not been reported in clinical trials.
Slovenian: V kliničnih preskušanjih zdravila Macugen o prevelikem odmerjanju niso poročali.
English: The syringe has a pre-attached polycarbonate plastic luer lock adaptor and the tip is sealed with an elastomeric tip cap.
Slovenian: Injekcijska brizga ima že nameščen zaskočni nastavek „luer lock“ iz polikarbonatne plastike, na vrhu pa je zaprta z gumijasto zaporko.
English: • small particles or spots in your vision (vitreous floaters or opacities).
Slovenian: • drobni delci ali pike v vidnem polju (mušice ali motnjave v steklovini)
English: VEGF is a secreted protein that induces angiogenesis, vascular permeability and inflammation, all of which are thought to contribute to the progression of the neovascular (wet) form of AMD.
Slovenian: VEGF je secernirana beljakovina, ki inducira angiogenezo, žilno prepustnost in vnetje.
English: Adequate anaesthesia and a broad-spectrum topical microbicide should be administered prior to the injection.
Slovenian: Pred injiciranjem mora bolnik dobiti ustrezno anestezijo in širokospektralni lokalni antibiotik.
English: Dosing line 3rd Rib (top edge)
Slovenian: Odmerna črta Tretje rebro (zgornji rob)
English: The syringe should be checked with the needle pointing up for the presence of bubbles.
Slovenian: Injekcijsko brizgo obrnite z iglo navzgor in preverite, ali so v brizgi prisotni mehurčki.
English: • small erosion on the central part of the surface of the eye (cornea)
Slovenian: • drobna razjeda na osrednjem delu površine očesa (roženice)
English: Each pack contains a pouch in a carton containing a 1 ml pre-filled syringe, Type 1 glass, sealed with an elastomeric (brombutyl rubber) plunger stopper and a pre-attached plunger rod, held by a plastic clip.
Slovenian: Ena škatla vsebuje vrečko z napolnjeno 1-ml injekcijsko brizgo iz stekla tipa I, z že vstavljenim potisnim batom in gumijastim tesnilom (bromobutilna guma).
English: As expected with intravitreal injections, transient increases in intraocular pressure may be seen.
Slovenian: Pojavi se lahko prehodno zvišanje očesnega tlaka, kot je mogoče pričakovati pri vseh injiciranjih v steklovino.
English: Ask your doctor or pharmacist for advice before starting Macugen treatment.
Slovenian: Pred začetkom zdravljenja z zdravilom Macugen se posvetujte z zdravnikom ali farmacevtom.
English: If you get any side effects, talk to your doctor , pharmacist or nurse.
Slovenian: Če opazite kateregakoli izmed neželenih učinkov, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Gastrointestinal disorders Uncommon vomiting, dyspepsia
Slovenian: Bolezni prebavil občasni bruhanje, dispepsija
English: Prior to the administration, the syringe should be removed from the plastic clip and the tip cap removed.
Slovenian: Pred apliciranjem z injekcijske brizge odstranite plastični zatič in z vrha injekcijske brizge snemite zaporko.
English: Macugen 0.3 mg solution for injection Pegaptanib
Slovenian: Macugen 0,3 mg raztopina za injiciranje pegaptanib
English: • night sweats, back pain, tiredness, shivering, tenderness, chest pain, sudden fever and flu-like symptoms (generalised aches and pains)
Slovenian: • nočno znojenje, bolečine v hrbtu, utrujenost, drgetanje, občutljivost, bolečine v prsnem košu,
English: • visual disturbance
Slovenian: • uvlek vidnega živca
English: One pre-filled syringe provides a usable amount to deliver a single dose of 90 microlitres containing pegaptanib sodium, corresponding to 0.3 mg of the free acid form of the oligonucleotide.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena napolnjena injekcijska brizga vsebuje ustrezno količino za zagotovitev enkratnega odmerka 90 mikrolitrov, ki vsebuje natrijev pegaptanib, kar ustreza 0,3 mg oligonukleotida v obliki proste kisline.
English: • inflammation of the higher respiratory tract, vomiting, indigestion
Slovenian: • vnetje zgornjega dela dihal, bruhanje, prebavne težave
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva občasni bolečine v hrbtu
English: discontinued
Slovenian: Odmerjanje
English: No statistical difference was found in the incidence of increased IOP between patients with a history of increased IOP or glaucoma versus patients without.
Slovenian: V incidenci zvišanega očesnega tlaka med bolniki z zvišanim očesnim tlakom ali glavkomom v anamnezi in bolniki brez njiju niso ugotovili nobene statistične razlike.
English: Ear and labyrinth disorders Uncommon deafness, Meniere's disease aggravated, vertigo
Slovenian: Ušesne bolezni, vključno z motnjami labirinta občasni gluhost, poslabšanje Ménièrove bolezni, vrtoglavica
English: • eye discomfort
Slovenian: • nelagodje v očesu
English: A few cases of arterial thromboembolic events were observed in the pegaptanib clinical trials in patients with AMD, DME, and there were no major differences between the groups treated with pegaptanib compared to control.
Slovenian: Med skupino, zdravljeno s pegaptanibom, in kontrolno skupino ni bilo večjih razlik.
English: NAME OF THE MEDICINAL PRODUCT Macugen 0.3 mg solution for injection
Slovenian: Macugen 0,3 mg raztopina za injiciranje
English: • clouding of the lens (cataract)
Slovenian: • zamotnitev leče (katarakta)
English: • small lump on your eyelid due to inflammation (chalazion)
Slovenian: • zaradi vnetja nastala majhna zadebelina na veki (halazij)
English: See section 6.6 for instructions to expel the excess volume before injection.
Slovenian: Za navodila glede odstranitve odvečnega volumna pred injiciranjem glejte poglavje 6.6.
English: • eye inflammation
Slovenian: • naprezanje očesa
English: However, no special considerations are needed in this population (see section 5.2)
Slovenian: Zdravila Macugen niso preučevali pri bolnikih z okvaro jeter, vendar posebna pazljivost pri tej populaciji ni potrebna (glejte poglavje 5.2).
English: The absolute bioavailability of pegaptanib after intravitreal administration has not been assessed in humans, but is approximately 70-100% in rabbits, dogs and monkeys.
Slovenian: Pri kuncih, psih in opicah znaša približno 70-100 %.
English: There are no reproductive toxicity studies in rabbits.
Slovenian: Študij vpliva na sposobnost razmnoževanja pri kuncih ni.
English: Reductions in the growth of mean total lesion size, choroidal neovascularisation (CNV size), and fluorescein leak size, have been shown in patients with AMD treated with Macugen.
Slovenian: Pri bolnikih z AMD, ki so dobivali zdravilo Macugen, so ugotovili manjši porast srednje celotne velikosti lezije, manjšo horoidno neovaskularizacijo in manjše izstopanje fluoresceina.
English: Systemic adverse events including non-ocular haemorrhages and arterial thromboembolic events have been reported following intravitreal injection of VEGF inhibitors and there is a theoretical risk that these may relate to VEGF inhibition.
Slovenian: Po intravitrealnem injiciranju zaviralcev VEGF so poročali o sistemskih neželenih dogodkih, med drugim o izvenočesnih krvavitvah in arterijskih trombemboličnih dogodkih.
English: Product-class-related adverse reactions
Slovenian: Na skupino zdravil vezani neželeni učinki
English: Uncommon non-visual side effects reported to be possibly caused by the medicine or by the injection procedure include:
Slovenian: Med občasnimi neočesnimi neželenimi učinki, za katere je opisano, da so morda posledica zdravila ali postopka injiciranja, so:
English: PHARMACEUTICAL FORM Solution for injection (injection).
Slovenian: raztopina za injiciranje (injekcija) Raztopina je bistra in brezbarvna.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS POUCH containing pre-filled syringe, a plunger stopper and a pre-attached plunger rod
Slovenian: Vrečka, ki vsebuje napolnjeno injekcijsko brizgo z že vstavljenim potisnim batom in gumijastim tesnilom
English: NAME OF THE MEDICINAL PRODUCT Macugen 0.3 mg solution for injection pegaptanib
Slovenian: Macugen 0,3 mg injekcija pegaptanib
English: • disorder of the pupil, of the coloured part of the eye (iris)
Slovenian: • motnje zenice, obarvanega dela očesa (šarenice)
English: Other common non-visual side effects reported to be possibly caused by the medicine or by the injection procedure include:
Slovenian: Med drugimi pogostimi očesnimi neželenimi učinki, za katere je opisano, da so morda posledica zdravila ali postopka injiciranja, so:
English: 6.3 Shelf life
Slovenian: EOP 1004
English: Uncommon eye side effects reported to be possibly caused by the medicine or by the injection procedure include:
Slovenian: Med občasnimi očesnimi neželenimi učinki, za katere je opisano, da so morda posledica zdravila ali postopka injiciranja, so:
English: • eye strain
Slovenian: • vnetje očesa
English: • eye pain
Slovenian: • bolečine v očesu
English: Spontaneous resolution of such reaction was observed within 4 hours.
Slovenian: Opazili so, da je ta reakcija spontano izzvenela v 4 urah.
English: No efficacy has been demonstrated in these animals.
Slovenian: Pri teh živalih učinkovitost ni bila dokazana.
English: The impact of the vaccine in terms of public health and control of the human infection cannot be estimated from available data.
Slovenian: Vpliva cepiva v smislu javnega zdravja in nadzora nad okužbo pri ljudeh iz razpoložljivih podatkov ni mogoče oceniti.
English: Plastic box
Slovenian: Plastična škatla
English: Date of first authorisation: 20/04/2016
Slovenian: Datum pridobitve dovoljenja za promet: 20/04/2016
English: Vaccinate healthy and non-infected animals only.
Slovenian: Cepite le zdrave in neokužene živali.
English: Re-vaccination of infected dogs did not worsen the course of the disease (during the 2-month observation period).
Slovenian: Revakcinacija okuženih psov ni poslabšala poteka bolezni (v 2mesečnem obdobju opazovanja).
English: The vaccine is safe in infected dogs.
Slovenian: Cepivo je varno pri okuženih psih.
English: Primary vaccination scheme:
Slovenian: Shema primarne vakcinacije:
English: ≥ 36.7 ELISA Units (EU)* * Antigen content determined in an ELISA against an internal standard.
Slovenian: ≥ 36,7 enot ELISA (EU)* * Vsebnost antigena je določena s testom ELISA v primerjavi z internim standardom.
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Slovenian: SPC, so bodisi dovoljene snovi, za katere tabela 1 priloge Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben ali pa, ne spadajo v področje uporabe Uredbe (ES) št. 470/2009, kadar so uporabljene tako kot v tem zdravilu za uporabo v veterinarski medicini.
English: EXP {mm/yyyy} Once reconstituted use immediately.
Slovenian: EXP {mm/llll} Rekonstituirano zdravilo uporabite takoj.
English: 1 vial of lyophylisate and 1 vial of solvent (1 dose) 4 vials of lyophylisate and 4 vials of solvent (4 doses) 5 vials of lyophylisate and 5 vials of solvent (5 doses) 10 vials of lyophylisate and 10 vials of solvent (10 doses) 20 vials of lyophylisate and 20 vials of solvent (20 doses) 25 vials of lyophylisate and 25 vials of solvent (25doses) 50 vials of lyophylisate and 50 vials of solvent (50 doses) 100 vials of lyophylisate and 100 vials of solvent (100 doses)
Slovenian: 1 viala z liofilizatom in 1 viala z vehiklom (1 odmerek) 4 viale z liofilizatom in 4 viale z vehiklom (4 odmerki) 5 vial z liofilizatom in 5 vial z vehiklom (5 odmerkov) 10 vial z liofilizatom in 10 vial z vehiklom (10 odmerkov) 20 vial z liofilizatom in 20 vial z vehiklom (20 odmerkov) 25 vial z liofilizatom in 25 vial z vehiklom (25 odmerkov) 50 vial z liofilizatom in 50 vial z vehiklom (50 odmerkov) 100 vial z liofilizatom in 100 vial z vehiklom (100 odmerkov)
English: C/ Mocholi 2, Poligono Industrial Mocholi, Noain, 31110 Navarra SPAIN
Slovenian: C/ Mocholi 2, Poligono Industrial Mocholi, Noain, 31110 Navarra, ŠPANIJA
English: Duration of immunity: 1 year after vaccination.
Slovenian: Trajanje imunosti: 1 leto po cepljenju.
English: Shake gently to give a clear solution, and administer immediately the entire content (0.5 ml) of the reconstituted product.
Slovenian: Nežno mešajte, da dobite bistro raztopino, nato takoj injicirajte celotno vsebino (0,5 ml) rekonstituiranega zdravila.
English: To stimulate active immunity against disease caused by Leishmania infantum parasites.
Slovenian: Stimulacija aktivne imunosti proti bolezni, ki jo povzročajo paraziti Leishmania infantum.
English: The manufacture, import, possession, sale, supply and/or use of LETIFEND may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Slovenian: Izdelava, uvoz/vnos, posedovanje, prodaja, oskrba in/ali uporaba zdravila LETIFEND je lahko v državi članici prepovedana na njenem celotnem ozemlju ali delu ozemlja v skladu z nacionalno zakonodajo.
English: Pharmacotherapeutic group: Immunologicals for Canidae - dog - inactivated parasitic vaccinesleishmania.
Slovenian: Farmakoterapevtska skupina: Imunološko zdravilo za Canidae - psi - inaktivirana cepiva proti parazitom - lišmaniozi.
English: Diagnostic tools designed to detect Leishmania antibodies (SLA or IFAT or rk-39 rapid diagnostic tests) should be suitable to enable discrimination between dogs vaccinated with this vaccine and dogs infected with Leishmania infantum.
Slovenian: Diagnostična orodja, zasnovana za odkrivanje protiteles parazita Leishmania (hitri diagnostični testi SLA ali IFAT ali rk-39) morajo biti primerna, da omogočajo ločevanje med psi, cepljenimi s tem cepivom, in psi, okuženimi s parazitom Leishmania infantum.
English: In laboratory studies including experimental challenge with Leishmania infantum, the vaccine reduced the severity of the disease, including clinical signs and parasite burden in spleen and lymph nodes.
Slovenian: V laboratorijskih študijah, ki so vključevale eksperimentalno provokacijo s parazitom Leishmania infantum, je cepivo zmanjšalo resnost bolezni, vključno s kliničnimi znaki in obremenjenost s parazitom v vranici in bezgavkah.
English: Any person intending to manufacture, import, possess, sell, supply and use LETIFEND must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.
Slovenian: Vsakdo, ki namerava izdelovati, uvažati oziroma vnašati, posedovati, prodajati, oskrbovati in/ali uporabljati zdravilo LETIFEND, se mora posvetovati s pristojnim organom posamezne države članice o veljavnih programih cepljenja še pred izdelavo, uvozom oziroma vnosom, posedovanjem, prodajo, oskrbo in/ali uporabo.
English: The data has shown that a vaccinated dog has 9.8 times less risk to develop clinical signs, 3.5 times less risk of having detectable parasites and 5 times less risk to develop clinical disease than a non-vaccinated dog.
Slovenian: Podatki so pokazali, da je bilo tveganje razvoja kliničnih znakov pri cepljenih psih 9,8-krat manjše, tveganje za prisotnost zaznavnih parazitov 3,5-krat manjše, tveganje za razvoj klinične bolezni pa 5-krat manjše kot pri necepljenih psih.
English: ATCvet code: QI07AO01
Slovenian: Oznaka ATC vet: QI07AO01.
English: Vials are both closed with a bromobutyl stopper and an aluminium cap.
Slovenian: Viale so zaprte z bromobutilnim zamaškom in aluminijasto zaporko.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 0.5 ml vaccine contains:
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA En odmerek z 0,5 ml cepiva vsebuje:
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Slovenian: Učinkovina biološkega izvora, namenjena vzbujanju aktivne imunosti, ni vključena v Uredbo (ES) št.
English: Water for injections.
Slovenian: Vehikel: voda za injekcije
English: Therefore, the use is not recommended during pregnancy and lactation.
Slovenian: Uporaba ni priporočljiva v obdobju brejosti in laktacije.
English: Recombinant Protein Q from Leishmania infantum MON-1
Slovenian: Rekombinantni protein Q iz Leishmania infantum MON-1