FrancophonIA/ELRC3.0 huggingface dataset:
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,
Croatian: U kliničkim ispitivanjima najčešće prijavljene očne nuspojave nakon injekcije lijeka su: upala prednje komore, bol oka, povišen intraokularni tlak, točkasti keratitis, plutajuće čestice u staklovini i zamućenje staklovine.
English: The patient's medical history for hypersensitivity reactions should be carefully evaluated prior to performing the intravitreal procedure (see section 4.4).
Croatian: Prije provođenja intravitrealnoga postupka treba pažljivo ispitati postoje li reakcije preosjetljivosti u bolesnikovoj anamnezi (vidjeti dio 4.4).
English: Immediate (on the day of injection) and delayed intravitreous haemorrhages may occur following pegaptanib injections (see section 4.2).
Croatian: Nakon injekcija pegaptaniba može doći do intravitrealnog krvarenja koje se može pojaviti odmah (na dan injekcije) ili kasnije (vidjeti dio 4.2).
English: • retinal artery occlusion
Croatian: • okluziju (zatvaranje) mrežnične arterije
English: • small marks on the eye surface (punctate keratitis)
Croatian: • male mrlje na površini oka (točkasti keratitis),
English: The syringe has a pre-attached polycarbonate plastic luer lock adaptor and the tip is sealed with an elastomeric tip cap.
Croatian: Na štrcaljku je pričvršćen polikarbonatni plastični luer-lock nastavak i elastomerni zatvarač vrha štrcaljke.
English: • displacement or tear of a layer in the back of the eye (retina)
Croatian: • pomak ili razderotina sloja u stražnjem dijelu oka (mrežnice)
English: Pegaptanib does not accumulate in the plasma when administered intravitreally every 6 weeks.
Croatian: Ako se primjenjuje intravitrealno svakih 6 tjedana, pegaptanib se ne nakuplja u plazmi.
English: • increased pressure inside the eye
Croatian: • povišen tlak u oku,
English: General disorders and administration site conditions Uncommon fatigue, rigors, tenderness, chest pain, influenza like illness
Croatian: Opći poremećaji i reakcije na mjestu primjene manje često umor, tresavica, osjetljivost na dodir, bol u prsima, bolest nalik gripi
English: Uncommon contact dermatitis, eczema, hair colour changes, rash, pruritus, night sweats
Croatian: Poremećaji kože i potkožnog tkiva manje često kontaktni dermatitis, ekcem, promjene boje kose, osip, pruritus, noćno znojenje nepoznato angioedem*
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.
Croatian: TVARI Jedna napunjena štrcaljka sadrži dostatnu količinu za isporuku jedne doze od 90 mikrolitara koja sadrži pegaptanibnatrij, što odgovara 0,3 mg oligonukleotida u obliku slobodne kiseline.
English: Dosing line and top edge of 3rd rib aligned
Croatian: Linija za doziranje i gornji rub trećeg navoja su poravnati
English: Monobasic sodium phosphate monohydrate Dibasic sodium phosphate heptahydrate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Croatian: 6.1 Popis pomoćnih tvari natrijev klorid natrijev dihidrogenfosfat hidrat natrijev hidrogenfosfat heptahidrat natrijev hidroksid (za podešavanje pH) kloridna kiselina (za podešavanje pH) voda za injekcije
English: A 27 or 30 G x ½ inch needle should be attached to the luer lock adaptor, to allow the administration of the medicinal product (see Figure 1, below).
Croatian: Da bi se lijek mogao primijeniti, na luer-lock nastavak treba pričvrstiti iglu od 27 ili 30 G x 12,7 mm (vidjeti Sliku 1 u nastavku).
English: Intravitreal use.
Croatian: Za intravitrealnu primjenu.
English: In rabbits, the component nucleotide, 2'-fluorouridine is found in plasma and urine after single radiolabeled pegaptanib intravenous and intravitreal doses.
Croatian: U kunića je nakon jedne radioaktivno označene intravenske i intravitrealne doze pegaptaniba u plazmi i mokraći pronađena komponenta nukleotida, 2'-fluorouridin.
English: Intravitreous haemorrhages
Croatian: Intravitrealno krvarenje
English: Sodium chloride, monobasic sodium phosphate monohydrate, dibasic sodium phosphate heptahydrate, sodium hydroxide and hydrochloric acid (for pH adjustment), water for injections.
Croatian: POPIS POMOĆNIH TVARI Natrijev klorid, natrijev dihidrogenfosfat hidrat, natrijev hidrogenfosfat heptahidrat, natrijev hidroksid i kloridna kiselina (za podešavanje pH), voda za injekcije.
English: • bloodshot eye (conjunctival haemorrhage)
Croatian: • krvave oči (krvarenje u konjunktive)
English: Follow the instruction below to expel the excess volume before injection.
Croatian: Slijedite upute u nastavku za izbacivanje viška volumena prije injekcije.
English: • injection site reaction, injection site vesicles
Croatian: • reakciju na mjestu injekcije, mjehuriće na mjestu injekcije
English: If you have been given more Macugen than you should have In the case excess Macugen volume is injected, serious increase in intraocular pressure may occur.
Croatian: U slučaju da je injiciran veći volumen lijeka Macugen može doći do ozbiljnog povišenja očnog tlaka.
English: Macugen has not been studied in patients with hepatic impairment.
Croatian: Macugen nije ispitan u bolesnika s oštećenjem jetrene funkcije.
English: NAME OF THE MEDICINAL PRODUCT Macugen 0.3 mg solution for injection
Croatian: NAZIV LIJEKA Macugen 0,3 mg otopina za injekciju
English: Macugen therapy administered to both eyes concurrently has not been studied.
Croatian: Nije ispitivana istodobna primjena lijeka Macugen u oba oka.
English: • deformation of the pupil
Croatian: • deformaciju zjenice
English: • Intravitreal injection procedure pictogram • Patient information
Croatian: • piktogram postupka davanja intravitrealne injekcije
English: Less frequently reported serious ocular adverse reactions included endophthalmitis, retinal haemorrhage, vitreous haemorrhage and retinal detachment.
Croatian: Rjeđe prijavljene ozbiljne očne nuspojave uključivale su endoftalmitis, krvarenja mrežnice, krvarenje u staklovinu i odvajanje mrežnice.
English: Pegaptanib is metabolised by nucleases and therefore cytochrome P450 mediated drug interactions are unlikely.
Croatian: Budući da se pegaptanib metabolizira posredstvom nukleaza, nisu izgledne interakcije s lijekovima u čijem metabolizmu posreduje citokrom P450.
English: Intravitreal use
Croatian: Za intravitrealnu primjenu
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.
Croatian: Na štrcaljku je pričvršćen polikarbonatni plastični luer-lock nastavak i elastomerni (brombutil/sintetski izopren) zatvarač vrha štrcaljke.
English: Injection of the entire volume of the pre-filled syringe could result in serious adverse events; therefore, the excess volume must be expelled before injection (see sections 4.8 and 6.6).
Croatian: Stoga se prije injekcije mora izbaciti višak volumena (vidjeti dijelove 4.8 i 6.6).
English: • Intravitreal injection procedure video
Croatian: • video isječak koji opisuje postupak davanja intravitrealne injekcije
English: In the wet form of AMD, abnormal blood vessels grow under the retina and macula.
Croatian: Kod vlažnog oblika senilne makularne degeneracije ispod mrežnice i makule nastaju abnormalne krvne žile.
English: Nervous system disorders Common
Croatian: Poremećaji živčanog sustava često glavobolja
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.
Croatian: Nakon stavljanja lijeka u promet primijećeni su slučajevi anafilaksije/anafilaktoidnih reakcija, uključujući angioedem, unutar nekoliko sati nakon primjene intravitrealne injekcije pegaptaniba.
English: Needle is not provided.
Croatian: Ne sadrži iglu.
English: • disorder of the surface of the eye (cornea)
Croatian: • poremećaj površine oka (rožnice)
English: • night sweats, back pain, tiredness, shivering, tenderness, chest pain, sudden fever and flu-like symptoms (generalised aches and pains)
Croatian: • noćno znojenje, bol u leđima, umor, drhtanje, osjetljivost na dodir, bol u prsnom košu,
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Macugen 0.3 mg injection pegaptanib
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Macugen 0,3 mg injekcija pegaptanib
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.
Croatian: Kod primjene intravenskih doza od 1 do 40 mg/kg na dan u miševa pegaptanib nije bio toksičan za majku i nije izazvao teratogenost ni smrtnosti ploda.
English: Respiratory, thoracic and mediastinal disorders Common rhinorrhea
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja često rinoreja manje često nazofaringitis
English: The systemic exposure is expected to be within a well tolerated range in patients with hepatic impairment, as a 10 fold higher dose (3 mg/eye) was well tolerated.
Croatian: Budući da je podnošljivost deseterostruko veće doze (3 mg po oku) bila dobra, očekuje se da će sistemska izloženost biti unutar raspona koji bolesnici s oštećenjem jetrene funkcije mogu lako podnijeti.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINSTRATION Macugen 0.3 mg solution for injection pegaptanib
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Macugen 0,3 mg otopina za injekciju pegaptanib
English: Therefore, in case of overdose, intraocular pressure should be monitored and if deemed necessary by the treating physician, adequate treatment should be initiated.
Croatian: Nadležni liječnik uvijek treba potisnuti višak volumena otopine prema uputama u dijelu 6.6. Stoga, u slučaju predoziranja, potrebno je pratiti intraokularni tlak te započeti odgovarajuće liječenje, ako to nadležni liječnik smatra potrebnim.
English: • eye pain
Croatian: • upala oka,
English: What Macugen contains
Croatian: Kako će Vam se primijeniti Macugen
English: The pre-filled syringe is supplied with an excess product volume.
Croatian: Napunjena štrcaljka sadrži veći volumen lijeka od potrebnog.
English: Macugen has not been adequately studied in patients with severe renal impairment.
Croatian: Nisu provedena odgovarajuća ispitivanja lijeka Macugen u bolesnika s teškim oštećenjem bubrežne funkcije.
English: Dosing line 3rd Rib (top edge)
Croatian: Linija za doziranje 3. navoj (gornji rub)
English: Pharmaswiss Hellas A.E. Τλ: +30 210 8108 460
Croatian: Τλ: +30 210 8108 460
English: Macugen is not recommended during breast-feeding.
Croatian: Ne preporučuje se primjena lijeka Macugen u dojilja.
English: Other common eye side effects reported to be possibly caused by the medicine or by the injection procedure include:
Croatian: Druge česte očne nuspojave za koje je prijavljeno da bi mogle biti izazvane lijekom ili postupkom injiciranja uključuju:
English: discontinued
Croatian: Nuspojava
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.
Croatian: U oboljelih od senilne makularne degeneracije liječenih lijekom Macugen primijećeno je smanjenje rasta srednje vrijednosti ukupne veličine lezije, veličine neovaskularizacije žilnice te opsega propuštanja fluoresceina.
English: • eye inflammation
Croatian: • naprezanje očiju
English: • disorder of the pupil, of the coloured part of the eye (iris)
Croatian: • poremećaj zjenice, obojanog dijela oka (šarenice)
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.
Croatian: Sistemske nuspojave uključujući neokularna krvarenja i događaje arterijske tromboembolije prijavljene su nakon intravitrealne injekcije VEGF (od engl.
English: Uncommon nasopharyngitis
Croatian: Tablični prikaz nuspojava
English: Gastrointestinal disorders Uncommon vomiting, dyspepsia
Croatian: Poremećaji probavnog sustava manje često povraćanje, dispepsija
English: You may experience temporary visual blurring after receiving Macugen.
Croatian: U bolesnika se nakon primjene lijeka Macugen može privremeno javiti zamagljen vid.
English: Tel: +421 2 3233 4900
Croatian: Slovenská republika Valeant Slovakia s.r.o. Tel: +421 2 3233 4900
English: Other common non-visual side effects reported to be possibly caused by the medicine or by the injection procedure include:
Croatian: Druge česte nuspojave koje nisu povezane s vidom, a prijavljene su kao nuspojave koje bi mogle biti izazvane lijekom ili postupkom injiciranja uključuju:
English: • optic nerve cupping
Croatian: • atrofiju vidnog živca
English: • eye discomfort
Croatian: • nelagodu u oku
English: • scar inside the eye (retinal scar)
Croatian: • ožiljak u unutrašnjosti oka (ožiljak na mrežnici)
English: Uncommon eye side effects reported to be possibly caused by the medicine or by the injection procedure include:
Croatian: Manje česte očne nuspojave za koje je prijavljeno da bi mogle biti izazivane lijekom ili postupkom injiciranja uključuju:
English: Uncommon non-visual side effects reported to be possibly caused by the medicine or by the injection procedure include:
Croatian: Manje česte nuspojave koje nisu povezane s vidom, a prijavljene su kao nuspojave koje bi mogle biti izazvane lijekom ili postupkom injiciranja uključuju:
English: PharmaSwiss UAB Tel. + 370 5 279 0762
Croatian: PharmaSwiss Česká republika s.r.o. Tel: + 420 234 719 600
English: Mean change in VA Week
Croatian: ROK VALJANOSTI Rok valjanosti
English: Renal impairment
Croatian: • svrbež vjeđa
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva manje često bol u leđima
English: Product-class-related adverse reactions
Croatian: Nuspojave povezane sa skupinom lijeka
English: Spontaneous resolution of such reaction was observed within 4 hours.
Croatian: Spontani nestanak ove reakcije primijećen je u roku 4 sata.
English: Date of first authorisation: 20/04/2016
Croatian: Datum prvog odobrenja: 20/04/2016
English: Re-vaccination of infected dogs did not worsen the course of the disease (during the 2-month observation period).
Croatian: Ponovno cijepljenje inficiranih pasa nije pogoršalo tijek bolesti (tijekom 2-mjesečnog razdoblja opažanja).
English: Store in a refrigerator (2 ºC - 8 ºC).
Croatian: Čuvati u hladnjaku (2 ºC - 8 ºC).
English: Plastic box
Croatian: Plastična kutija
English: Vaccinate healthy and non-infected animals only.
Croatian: Cijepiti samo zdrave i neinficirane životinje.
English: ATCvet code: QI07AO01
Croatian: ATCvet kod: QI07AO01
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports)
Croatian: Učestalost nuspojava je određena sukladno sljedećim pravilima: - vrlo česte (više od 1 na 10 tretiranih životinja pokazuju nuspojavu(e)) - česte (više od 1 ali manje od 10 životinja na 100 tretiranih životinja) - manje česte (više od 1 ali manje od 10 životinja na 1.000 tretiranih životinja) - rijetke (više od 1 ali manje od 10 životinja na 10.000 tretiranih životinja) - vrlo rijetke (manje od 1 životinje na 10.000 tretiranih životinja, uključujući izolirane slučajeve)
English: Duration of immunity: 1 year after vaccination.
Croatian: Trajanje imunosti: 1 godina nakon cijepljenja.
English: Overdose (symptoms, emergency procedures, antidotes) if necessary:
Croatian: Predoziranje (simptomi, hitni postupci, antidoti), ako je nužno:
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.
Croatian: Podaci pokazuju da cijepljen pas ima 9,8 puta manji rizik od razvoja kliničkih znakova, 3,5 puta manji rizik na detekciju prisutnosti parazita i 5 puta manji rizik od razvoja kliničkog oboljenja od psa koji nije cijepljen.
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.
Croatian: Pomoćne tvari (uključujući adjuvanse), navedene u dijelu 6.1 SPC su ili dozvoljene tvari za koje je u tablici 1, Dodatka Uredbe Komisije (EU) br. 37/2010 navedeno da određivanje MRL nije nužno ili se smatra da se na njih ne primjenjuju odredbe Uredbe (EK) br. 470/2009 kada se primjenjuju u tim veterinarsko medicinskim proizvodima.
English: C/ Mocholi 2, Poligono Industrial Mocholi, Noain, 31110 Navarra SPAIN
Croatian: C/ Mocholi 2, Poligono Industrial Mocholi, Noain, 31110 Navarra, ŠPANJOLSKA
English: Shake gently to give a clear solution, and administer immediately the entire content (0.5 ml) of the reconstituted product.
Croatian: Blago promućkati dok se otopina ne razbistri i odmah aplicirati cijeli sadržaj (0,5 ml) rekonstituiranog proizvoda.
English: Onset of immunity: 4 weeks after vaccination.
Croatian: Početak imunosti: 4 tjedna nakon cijepljenja.
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)
Croatian: 1 bočica liofilizata i 1 bočica otapala (1 doza) 4 bočice liofilizata i 4 bočice otapala (4 doze) 5 bočica liofilizata i 5 bočica otapala (5 doza) 10 bočica liofilizata i 10 bočica otapala (10 doza) 20 bočica liofilizata i 20 bočica otapala (20 doza) 25 bočica liofilizata i 25 bočica otapala (25 doza) 50 bočica liofilizata i 50 bočica otapala (50 doza) 100 bočica liofilizata i 100 bočica otapala (100 doza)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 0.5 ml vaccine contains:
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka doza od 0,5 ml cjepiva sadrži:
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.
Croatian: Djelatna tvar se sastoji od tvari biološkog podrijetla, koje su namijenjene je za stvaranje aktivne imunosti i na koje se ne primjenjuju odredbe Uredbe (EK) br. 470/2009.
English: White lyophilisate.
Croatian: Bijeli liofilizat.
English: Each dose of 0.5 ml vaccine contains:
Croatian: Svaka doza od 0,5 ml cjepiva sadrži:
English: Following administration of a double dose, reactions are similar in nature to those observed following the administration of a single dose (see section 4.6).
Croatian: Nakon primjene dvostruke doze cjepiva, reakcije su slične onima koje su opažene nakon primjene jedne doze cjepiva (vidi odjeljak 4.6).
English: To stimulate active immunity against disease caused by Leishmania infantum parasites.
Croatian: Za stimuliranje aktivnog imuniteta protiv oboljenja uzrokovanog parazitom Leishmania infantum.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
Croatian: KOLIČINA DJELATNE(IH) TVARI SADRŽAJ PO TEŽINI, VOLUMENU ILI BROJU DOZA
English: No efficacy has been demonstrated in these animals.
Croatian: Kod ovih životinja nije se pokazala učinkovitost cjepiva.
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.
Croatian: Proizvodnja, uvoz, posjedovanje, prodaja, opskrba i/ili primjena LETIFEND je ili može biti zabranjena u državi članici na cijelom ili na dijelu njene teritorije sukladno nacionalnim propisima.
English: via Fratelli Cervi snc, Centro Direzionale Milano Due, Palazzo Canova
Croatian: MSD Animal Health S.r.l. via Fratelli Cervi snc, Centro Direzionale Milano Due, Palazzo Canova
English: Therefore, the use is not recommended during pregnancy and lactation.
Croatian: Stoga, ne preporuča se primjena tijekom graviditeta i laktacije.
English: For active immunisation of non-infected dogs from 6 months of age to reduce the risk of developing an active infection and/or clinical disease after exposure to Leishmania infantum.
Croatian: Za aktivnu imunizaciju neinficiranih pasa od 6 mjeseci starosti radi smanjenja rizika od razvitka aktivne infekcije i/ili kliničkog oboljenja nakon kontakta s Leishmania infantum.
English: Sodium chloride Arginine hydrochloride Boric acid.
Croatian: Liofilizat: natrijev klorid arginin hidroklorid borna kiselina.
English: Recombinant Protein Q from Leishmania infantum MON-1: ≥ 36.7 ELISA units (EU)* * Antigen content determined in an ELISA against an internal standard.
Croatian: Rekombinirana bjelančevina Q iz Leishmania infantum MON-1 : ≥ 36,7 ELISA jedinica (EU)* * Sadržaj antigena određen ELISA testom prema internom standardu.
English: Pharmacotherapeutic group: Immunologicals for Canidae - dog - inactivated parasitic vaccinesleishmania.
Croatian: Farmakoterapijska grupa: imunološki proizvodi za Canidae - pse - inaktivirano cjepivo protiv parazita - leishmania.
English: The vaccine is safe in infected dogs.
Croatian: Cjepivo je sigurno za inficirane pse.
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.
Croatian: Dijagnostički alati osmišljeni za otkrivanje protutijela na Leishmania (SLA ili IFAT ili rk-39 brzi dijagnostički testovi) omogućuju razlikovanje cijepljenih pasa od pasa zaraženih s Leishmania infantum.
English: Recombinant Protein Q from Leishmania infantum MON-1
Croatian: Rekombinirana bjelančevina Q iz Leishmania infantum MON-1
English: Lyophilisate (white lyophilisate)
Croatian: Liofilizat (bijeli liofilizat)
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.
Croatian: Tko namjerava proizvoditi, uvesti, posjedovati, prodavati, opskrbljivati i/ili primjenjivati LETIFEND mora se savjetovati s nadležnim tijelom odnosne države članice u pogledu važećih odredbi o cijepljenju prije proizvodnje, uvoza, posjedovanja, prodaje, opskrbe i/ili primjene.
English: Vials are both closed with a bromobutyl stopper and an aluminium cap.
Croatian: Obje bočice zatvorene su bromobutil čepom i zapečaćene aluminijskom kapicom.
English: Following administration of a double dose, reactions are similar in nature to those observed following the administration of a single dose.
Croatian: Nakon primjene dvostruke doze cjepiva, reakcije su slične onima koje su opažene nakon primjene jedne doze cjepiva.
English: Per dose of 0.5 ml: Recombinant Protein Q from Leishmania infantum MON-1 ≥ 36.7 EU
Croatian: Po dozi od 0,5 ml: Rekombinirana bjelančevina Q iz Leishmania infantum MON-1 ≥ 36,7 EU
English: EXP {mm/yyyy} Once reconstituted use immediately.
Croatian: EXP {mm/gggg} Primijeniti odmah nakon rekonstitucije.
English: WITHDRAWAL PERIOD(S) SPECIAL WARNING(S), IF NECESSARY
Croatian: POSEBNO(A) UPOZORENJE(A), UKOLIKO JE POTREBNO