FrancophonIA/ELRC3.0 huggingface dataset:
English: Voriconazol PUREN 200 mg Filmtabletten voriconazol
Slovenian: Voriconazol PUREN 200 mg Filmtabletten vorikonazol
English: voriconazole Arrow voriconazol
Slovenian: voriconazole Arrow vorikonazol
English: Betahistin Sandoz 8 mg betahistine
Slovenian: Betahistin Sandoz 8 mg betahistin
English: Voriconazol PUREN 50 mg Filmtabletten voriconazol
Slovenian: Voriconazol PUREN 50 mg Filmtabletten vorikonazol
English: Metformin 500 mg Film-coated tablet metformin hydrochloride
Slovenian: Metformin 500 mg Film-coated tablet metforminijev hidroklorid 500 mg
English: Voriconazol Aurobindo 50 mg, filmomhulde tabletten voriconazol
Slovenian: Voriconazol Aurobindo 50 mg, filmomhulde tabletten vorikonazol
English: Hormosan Pharma GmbH
Slovenian: Nemčija Hormosan Pharma GmbH
English: Hydroxyzine EQL Pharma hydroxyzine
Slovenian: Hydroxyzine EQL Pharma hidroksizin
English: Slovak Republic SVUS Pharma a.s.
Slovenian: Portugalska SVUS Pharma a.s.
English: Aurobindo Pharma (Malta) Limited
Slovenian: Romunija Aurobindo Pharma (Malta) Limited
English: Pharmaceuticals AB
Slovenian: Farmacevtska oblika
English: Memantine Dawa 20mg filmcoated tablets memantine
Slovenian: Memantine Dawa 20mg filmcoated tablets memantin
English: Corporation, Finland
Slovenian: Danska Orion Corporation, Finland
English: Naproxen 250 mg tablets naproxen
Slovenian: Naproxen 250 mg tablets naproksen
English: Dawa Limited Carbimazole 20mg Tablets carbimazole
Slovenian: Dawa Limited Carbimazole 20mg Tablets karbimazol
English: Betahistin Sandoz 16 mg betahistine
Slovenian: Betahistin Sandoz 16 mg betahistin
English: 2 mg /0.625 mg
Slovenian: perindopril/indapamid 2 mg/0,625 mg tableta
English: Voriconazol Aurovitas voriconazol
Slovenian: Voriconazol Aurovitas vorikonazol
English: Carbimazole 20mg Tablets carbimazole
Slovenian: Carbimazole 20mg Tablets karbimazol
English: Aripiprazole 30 mg tablets aripiprazole
Slovenian: Aripiprazole 30 mg tablets aripiprazol
English: Memantine Dawa 10mg filmcoated tablets memantine
Slovenian: Memantine Dawa 10mg filmcoated tablets memantin
English: Buproprionhydrochlorid Hexal 300 mg bupropion
Slovenian: Buproprionhydrochlorid Hexal 300 mg bupropion tableta s prirejenim sproščanjem
English: 4 mg /1.25 mg
Slovenian: perindopril/indapamid 4 mg/1,25 mg tableta
English: ETRIXENAL 250 MG TABLETY naproxen
Slovenian: ETRIXENAL 250 MG TABLETY naproksen
English: EQL Pharma AB
Slovenian: Švedska EQL Pharma AB
English: Naproxen Aurobindo
Slovenian: Naproxen Aurobindo naproksen
English: Betahistine Sandoz 24 mg betahistine
Slovenian: Betahistine Sandoz 24 mg betahistin
English: Aripiprazole 5 mg tablets aripiprazole
Slovenian: Aripiprazole 5 mg tablets aripiprazol
English: Aripiprazole 10 mg tablets aripiprazole
Slovenian: Aripiprazole 10 mg tablets aripiprazol
English: 1000 mg Capsule, soft Oral use
Slovenian: 1 g kapsula, mehka
English: Arrow Génériques amlodipine / valsartan Arrow amlodipine / valsartan 5 mg/80 mg
Slovenian: Arrow Génériques amlodipine / valsartan Arrow amlodipin/valsartan
English: Betahistin Sandoz 24 mg betahistine
Slovenian: Betahistin Sandoz 24 mg betahistin
English: Etrixenal 250 mg tabletes naproxen
Slovenian: Etrixenal 250 mg tabletes naproksen
English: LABORATORIOS AUROBINDO, SLU
Slovenian: Španija LABORATORIOS AUROBINDO,
English: Beta- histina Bluefish betahistine dihydrochloride
Slovenian: Beta-histina Bluefish betahistinijev dihidroklorid 24 mg
English: Bupropion 1 A Pharma 300 mg bupropion
Slovenian: Bupropion 1 A Pharma 300 mg bupropion tableta s prirejenim sproščanjem
English: Slovak Republic Proenzi s.r.o.
Slovenian: Slovaška Proenzi s.r.o.
English: 8 mg/2.5 mg
Slovenian: perindopril/indapamid 8 mg/2,5 mg tableta
English: Hydroxyzine Sandoz hydroxyzine
Slovenian: Hydroxyzine Sandoz hidroksizin
English: BETAHISTIN SANDOZ 8 MG betahistine dihydrochloride
Slovenian: BETAHISTIN SANDOZ 8 MG betahistinijev dihidroklorid 8 mg
English: BETAHISTIN SANDOZ 24 MG betahistine dihydrochloride
Slovenian: BETAHISTIN SANDOZ 24 MG betahistinijev dihidroklorid 24 mg
English: Memantin Pharmascope 20 mg Filmtabletten memantine
Slovenian: Memantin Pharmascope 20 mg Filmtabletten memantin
English: BETAHISTIN SANDOZ 16 MG betahistine dihydrochloride
Slovenian: BETAHISTIN SANDOZ 16 MG betahistinijev dihidroklorid 16 mg
English: Memantin Pharmascope 10 mg Filmtabletten memantine
Slovenian: Memantin Pharmascope 10 mg Filmtabletten memantin
English: Aripiprazole 15 mg tablets aripiprazole
Slovenian: Aripiprazole 15 mg tablets aripiprazol
English: Capsule, soft Oral use
Slovenian: dutasterid kapsula, mehka
English: Memantine Pharmascope 10 mg filmomhulde tabletten memantine
Slovenian: Memantine Pharmascope 10 mg filmomhulde tabletten memantin
English: Memantine Pharmascope 20 mg filmomhulde tabletten memantine
Slovenian: Memantine Pharmascope 20 mg filmomhulde tabletten memantin
English: Napritum
Slovenian: Napritum naproksen
English: Tablet
Slovenian: naproksen
English: Amlodipina/Valsartan Aurobindo 5 mg/80 mg comprimate filmate amlodipine / valsartan 5 mg /80 mg
Slovenian: Amlodipina/Valsartan Aurobindo 5 mg/80 mg comprimate filmate amlodipin/valsartan
English: Metformina Almus metformin hydrochloride
Slovenian: Metformina Almus metforminijev hidroklorid 500 mg
English: Olanzapin HEC Pharm 20 mg Schmelztabletten olanzapin
Slovenian: Olanzapin HEC Pharm 20 mg Schmelztabletten olanzapin orodisperzibiln a tableta
English: Atyxine hydroxyzine
Slovenian: Atyxine hidroksizin
English: Amlodipine/ Valsartan Aurobindo 5/80 mg, filmomhulde tabletten amlodipine / valsartan 5 mg /80 mg
Slovenian: Amlodipine/ Valsartan Aurobindo 5/80 mg, filmomhulde tabletten amlodipin/valsartan
English: Amlodipine/ Valsartan Aurobindo 10/160 mg, filmomhulde tabletten amlodipine / valsartan 10 mg /160 mg
Slovenian: Amlodipine/ Valsartan Aurobindo 10/160 mg, filmomhulde tabletten amlodipin/valsartan
English: Olanzapin HEC Pharm 10 mg Schmelztabletten olanzapin
Slovenian: Olanzapin HEC Pharm 10 mg Schmelztabletten olanzapin orodisperzibiln a tableta
English: Amlodipina/Valsartan Aurobindo 10 mg/160 mg comprimate filmate amlodipine / valsartan 10 mg/160 mg
Slovenian: Amlodipina/Valsartan Aurobindo 10 mg/160 mg comprimate filmate amlodipin/valsartan
English: 1 A Pharma GmbH, Germany
Slovenian: Nemčija 1 A Pharma GmbH,
English: Amlodipine/ Valsartan Aurobindo 5/160 mg, filmomhulde tabletten amlodipine / valsartan 5 mg /160 mg
Slovenian: Amlodipine/ Valsartan Aurobindo 5/160 mg, filmomhulde tabletten amlodipin/valsartan
English: Betahistyna Bluefish betahistine dihydrochloride
Slovenian: Betahistyna Bluefish betahistinijev dihidroklorid 24 mg
English: Metformine Almus metformin hydrochloride
Slovenian: Metformine Almus metforminijev hidroklorid 500 mg
English: Olanzapin HEC Pharm 15 mg Schmelztabletten olanzapin
Slovenian: Olanzapin HEC Pharm 15 mg Schmelztabletten olanzapin orodisperzibiln a tableta
English: Amlodipina/Valsartan Aurobindo 5 mg/160 mg comprimate filmate amlodipine / valsartan 5 mg /160 mg
Slovenian: Amlodipina/Valsartan Aurobindo 5 mg/160 mg comprimate filmate amlodipin/valsartan
English: Olanzapin HEC Pharm 5 mg Schmelztabletten olanzapin
Slovenian: Olanzapin HEC Pharm 5 mg Schmelztabletten olanzapin orodisperzibiln a tableta
English: Betahistina Bluefish betahistine dihydrochloride
Slovenian: Betahistina Bluefish betahistinijev dihidroklorid 16 mg
English: Sandoz
Slovenian: Francija Sandoz
English: 10 mg Oro-dispersible tablet
Slovenian: 10 mg tableta peroralna uporaba
English: Amlodipina + Valsartan Aurovitas amlodipine / valsartan 5 mg /80 mg
Slovenian: Amlodipina + Valsartan Aurovitas amlodipin/valsartan
English: Aurobindo Pharma (Portugal), Unipessoal Lda.
Slovenian: Portugalska Aurobindo Pharma (Portugal),
English: 0.8 ml (40 mg/0.8ml) 6 (3 x2) pre-filled pens (multipack)
Slovenian: 6 (3 x2) napolnjenih injekcijskih peresnikov (skupno pakiranje)
English: 0.8 ml (40 mg/0.8ml) 6 (3 x2) pre-filled syringes with needle safety device (multipack)
Slovenian: 6 (3 x2) napolnjenih injekcijskih brizg z varnostnim pripomočkom za iglo (skupno pakiranje)
English: 0.8 ml (40 mg/0.8ml) 1 pre-filled syringe with needle safety device
Slovenian: 1 napolnjena injekcijska brizga z varnostnim pripomočkom za iglo
English: 0.8 ml (40 mg/0.8ml) 2 pre-filled syringes with needle safety device
Slovenian: 2 napolnjeni injekcijski brizgi z varnostnim pripomočkom za iglo
English: The areas harmonised include:
Slovenian: Med usklajenimi področji so:
English: 21 March 2014
Slovenian: 21. marca 2014
English: The European Commission issued a decision on 21 March 2014.
Slovenian: Evropska komisija je izdala odločbo dne 21. marca 2014.
English: This prevents the bacteria from building their cell walls, and eventually kills them.
Slovenian: S tem prepreči bakterijam, da bi si zgradile celične stene, in jih sčasoma ubije.
English: Rocephin is marketed in the following EU Member States: Belgium, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Luxembourg, Malta, the Netherlands, Portugal, Romania, Sweden and the United Kingdom, as well as Iceland.
Slovenian: Zdravilo Rocephin se trži v naslednjih državah članicah EU: v Belgiji, na Danskem, Finskem, v Franciji, Nemčiji, Grčiji, na Madžarskem, Irskem, v Italiji, Latviji, Luksemburgu, na Malti, Nizozemskem, Portugalskem, v Romuniji, na Švedskem in v Združenem kraljestvu, pa tudi na Islandiji.
English: Why was Rocephin reviewed?
Slovenian: Zakaj je bilo zdravilo Rocephin pregledano?
English: It is also available in the EU under other trade names: Rocefin, Rocephalin, Rocephalin cum lidocain, Rocephine.
Slovenian: V EU je na voljo tudi pod drugimi trgovskimi imeni: Rocefin, Rocephalin, Rocephalin cum lidocain in Rocephine.
English: Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion)
Slovenian: Vprašanja in odgovori o zdravilu Rocephin in povezanih imenih (ceftriakson, 250 mg, 500 mg, 1 g, 2 g, prašek za raztopino za injiciranje ali infundiranje)
English: Rocephin is authorised in the EU via national procedures.
Slovenian: Zdravilo Rocephin je bilo v EU odobreno po nacionalnih postopkih.
English: The CHMP concluded that Rocephin should be used to treat the following infections in adults and children, which were already approved in several but not all EU Member States:
Slovenian: Odbor CHMP je zaključil, da se mora zdravilo Rocephin uporabljati za zdravljenje naslednjih okužb pri odraslih in otrocih, ki so bile že odobrene v nekaterih, vendar ne vseh državah članicah EU:
English: On 23 January 2014, the European Medicines Agency completed a review of Rocephin.
Slovenian: Evropska agencija za zdravila je 23. januarja 2014 zaključila pregled zdravila Rocephin.
English: The CHMP also harmonised other sections of the SmPC including section 4.3 (contraindications), 4.4 (special warnings and precautions for use) and 4.6 (pregnancy and lactation).
Slovenian: Odbor CHMP je uskladil tudi druga poglavja povzetka glavnih značilnosti zdravila, vključno s poglavji 4.3 (kontraindikacije), 4.4 (posebna opozorila in previdnostni ukrepi) ter 4.6 (nosečnost in dojenje).
English: • bacterial meningitis;
Slovenian: • bakterijskega meningitisa;
English: This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
Slovenian: To je povzročilo razlike med državami članicami glede načina, kako se zdravilo lahko uporablja, kar se odraža v razlikah med povzetki glavnih značilnosti zdravila, označevanji in navodili za uporabo v državah, kjer se zdravilo trži.
English: Rocephin is a medicine that contains the active substance ceftriaxone.
Slovenian: Rocephin je zdravilo, ki vsebuje zdravilno učinkovino ceftriakson.
English: In adults and children over 12 years of age, the recommended dose varies between 1 and 4 g of Rocephin once daily depending on the condition it is used to treat.
Slovenian: Pri odraslih in otrocih, starejših od 12 let, je priporočeni odmerek zdravila Rocephin od 1 g do 4 g enkrat na dan, odvisno od tega, za zdravljenje katere bolezni se uporablja.
English: What is Rocephin?
Slovenian: Kaj je zdravilo Rocephin?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Rocephin in the European Union (EU).
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je potrebna uskladitev informacij o predpisovanju zdravila Rocephin v Evropski uniji (EU).
English: Having harmonised the indications, the CHMP also harmonised the recommendations on how to use Rocephin in adults and children.
Slovenian: Po uskladitvi indikacij je odbor CHMP uskladil še priporočila glede uporabe zdravila Rocephin pri odraslih in otrocih.
English: • hospital- and community-acquired pneumonia (infection of the lungs caught in or outside the hospital);
Slovenian: • bolnišnične in zunajbolnišnične pljučnice (okužbe pljuč, pridobljene v bolnišnici ali zunaj nje);
English: Ceftriaxone belongs to the group ‘cephalosporins'; it works by attaching to proteins on the surface of bacteria.
Slovenian: Ceftriakson spada v skupino „cefalosporinov“ in deluje tako, da se veže na beljakovine na površini bakterij.
English: It may also be used to treat disseminated Lyme borreliosis (a bacterial infection spread to humans by infected ticks) in adults and children including neonates from 15 days of age.
Slovenian: Prav tako se lahko uporablja za zdravljenje diseminirane lymske borelioze (bakterijske okužbe, ki jo na ljudi prenesejo okuženi klopi) pri odraslih in otrocih, vključno z novorojenčki, starejšimi od 15 dni.
English: The CHMP agreed that Rocephin should no longer be used to treat sinusitis (inflammation of the sinuses), pharyngitis (sore throat) and prostatitis (inflammation of the prostate, a gland of the male reproductive system) because not enough clinical data are available to support these indications.
Slovenian: Odbor CHMP se je strinjal, da se zdravilo Rocephin ne sme več uporabljati za zdravljenje sinusitisa (vnetja sinusov), faringitisa (vnetja žrela) in prostatitisa (vnetja prostate, žleze moškega reproduktivnega sistema), saj je na voljo premalo kliničnih podatkov, ki bi podpirali te indikacije.
English: Rocephin should preferably be given into a vein by injection over a period of 5 minutes or by infusion (drip) over at least 30 minutes, or else by deep intramuscular injection.
Slovenian: Zdravilo Rocephin je treba po možnosti dati v veno z injiciranjem, ki traja 5 minut, ali z infundiranjem (kapalno infuzijo), ki traja najmanj 30 minut, sicer pa z globokim intramuskularnim injiciranjem.
English: Rocephin may be used to treat acute exacerbations (flare-ups) of chronic obstructive pulmonary disease in adults.
Slovenian: Zdravilo Rocephin se lahko uporablja za zdravljenje akutnih eksacerbacij (poslabšanj) kronične obstruktivne pljučne bolezni pri odraslih.
English: In children below 12 years of age, the recommended dose of Rocephin depends on body weight and the condition it is used to treat.
Slovenian: Pri otrocih, mlajših od 12 let, je priporočeni odmerek zdravila Rocephin odvisen od telesne mase in od tega, za zdravljenje katere bolezni se uporablja.
English: Rocephin may be used to manage patients with neutropenia (low levels of neutrophils, a type of white blood cell) who also have fever suspected to be caused by bacterial infection, patients with bacteraemia (when the bacteria are detected in the blood) suspected to be caused by any of the infections mentioned above, and for the pre-operative prevention of surgical site infections.
Slovenian: Zdravilo Rocephin se lahko uporablja za zdravljenje bolnikov z nevtropenijo (nizkimi ravnmi nevtrofilcev, ki so vrsta belih krvnih celic), ki imajo tudi povišano telesno temperaturo, ki je domnevno posledica bakterijske okužbe, bolnikov z bakteriemijo (okužbo, pri kateri so bakterije prisotne v krvi), ki je domnevno posledica katere koli okužbe, navedene zgoraj, in za predoperativno preprečevanje okužb po kirurškem posegu.
English: It is an antibiotic used to treat a wide range of bacterial infections including pneumonia (infection of the lungs) and meningitis (infection of the membranes around the brain and spine).
Slovenian: To je antibiotik, ki se uporablja za zdravljenje zelo različnih bakterijskih okužb, vključno s pljučnico (okužbo pljuč) in meningitisom (okužbo ovojnic možganov in hrbtenjače).
English: • bacterial endocarditis (an infection in the heart).
Slovenian: • bakterijskega endokarditisa (okužbe srca).
English: • the sexually transmitted infections gonorrhoea and syphilis;
Slovenian: • spolno prenosljivih okužb gonoreje in sifilisa;
English: • intra-abdominal infections (infections within the abdomen);
Slovenian: • intraabdominalnih okužb (okužb v trebuhu);
English: • complicated skin and soft tissue infections;
Slovenian: • zapletenih okužb kože in mehkih tkiv;
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Slovenian: Odbor CHMP je na podlagi predloženih podatkov in interne znanstvene razprave menil, da je treba uskladiti povzetke glavnih značilnosti zdravila, označevanje in navodila za uporabo po vsej EU.
English: • complicated urinary tract infections, including pyelonephritis (kidney infection);
Slovenian: • zapletenih okužb sečil, vključno s pielonefritisom (okužbo ledvic);
English: The company that markets these medicines is Roche.
Slovenian: Ta zdravila trži farmacevtska družba Roche.
English: • infections of bones and joints;
Slovenian: • okužb kosti in sklepov;
English: On 9 December 2011, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Rocephin in the EU.
Slovenian: Da bi uskladili dovoljenja za promet z zdravilom Rocephin v EU, je Evropska komisija dne 9. decembra 2011 napotila zadevo na odbor CHMP.
English: Rocephin was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Slovenian: Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh) je ugotovila, da je za zdravilo Rocephin potrebno usklajevanje.
English: • acute otitis media (infection of the middle ear);
Slovenian: • akutnega vnetja srednjega ušesa;
English: 42 months
Slovenian: 42 meseci
English: 1 dose 5 x 1 dose 10 x 1 dose
Slovenian: 5 x 1 odmerek 10 x 1 odmerek
English: 4.6 Adverse reactions (frequency and seriousness)
Slovenian: 4.6 Neželeni učinki (pogostnost in resnost)
English: 1 Antigenic units
Slovenian: 1 antigenske enote
English: Concurrent active and passive immunisation (emergency vaccination)
Slovenian: Sočasna aktivna in pasivna imunizacija (cepljenje v nujnih situacijah)
English: Thereafter a maximum interval of two years is recommended (see scheme).
Slovenian: Nato je najdaljši priporočeni razmik dve leti (glejte shemo).
English: PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable
Slovenian: PREPOVED PRODAJE, OSKRBE IN/ALI UPORABE Ni smiselno.
English: Only healthy animals should be vaccinated.
Slovenian: Cepimo samo zdrave živali.
English: Store at 2-8°C, protected from light.
Slovenian: Shranjujte pri 2-8 °C, zaščiteno pred svetlobo.
English: A primary vaccination course may be considered necessary in horses that have not been suitably primed.
Slovenian: Osnovno cepljenje bi lahko bilo potrebno pri konjih, ki niso bili ustrezno tretirani.
English: 35 041 Marburg
Slovenian: 35 041 Marburg Nemčija
English: The periodic safety update report (PSUR) cycle should be restarted for submission of 6 monthly reports (covering all authorised presentations of the product) for two years, followed by yearly reports for the subsequent two years and thereafter at 3 yearly intervals.
Slovenian: Cikel rednih posodobljenih poročil o varnosti zdravila (PSUR) se ponovno začne z oddajo šestmesečnih poročil (vključene so vse odobrene oblike zdravila) v obdobju dveh let, ki mu sledi oddaja dveh letnih poročil za naslednji dve leti, po tem obdobju pa se poročila oddajajo v triletnih obdobjih.
English: Cholesterol
Slovenian: Holesterol
English: Allow the vaccine to reach room temperature before use.
Slovenian: Cepivo pred uporabo ogrejte na sobno temperaturo.
English: It is recommended that a single booster dose should only be administered to horses that have already received a primary vaccination course using vaccines that contain the same types of equine influenza virus included in this vaccine.
Slovenian: Priporočljivo je, da en obnovitven odmerek dobijo samo tisti konji, ki so že dobili osnovno cepljenje s cepivi, ki vsebujejo iste seve virusa influence konj, kot so v tem cepivu.
English: THE WORDS "FOR ANIMAL TREATMENT ONLY" AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
Slovenian: BESEDILO "SAMO ZA ŽIVALI" IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, če je smiselno
English: Administer one dose (1 ml), by strict intramuscular injection, according to the following schedule:
Slovenian: Po en odmerek (1 ml) strogo intramuskularno po naslednji shemi:
English: In very rare cases a local reaction exceeding 5 cm and possibly persisting longer than 2 days may occur.
Slovenian: V zelo redkih primerih se lahko pojavi lokalna reakcija, ki je večja od 5 cm in ki lahko traja dlje kot 2 dni.
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above.
Slovenian: O varnosti in učinkovitosti sočasne uporabe cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini, razen z zgoraj navedenim izdelkom, ni podatkov.
English: Name and address of the manufacturer of the biological active substance(s)
Slovenian: Ime in naslov izdelovalca (izdelovalcev) biološke zdravilne učinkovine (zdravilnih učinkovin)
English: Pain at the injection site can occur in rare cases which may result in temporary functional discomfort (stiffness).
Slovenian: V redkih primerih je možna bolečina na mestu dajanja, ki lahko povzroči začasno funkcijsko neugodje (togost).
English: MARKETING AUTHORISATION NUMBER(S) EU/2/05/057/001-004
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/05/057/001-004
English: Package size:
Slovenian: Velikost pakiranja:
English: • Primary vaccination course: first injection from 6 months of age, second injection 4 weeks later
Slovenian: • Osnovno cepljenje: prvi odmerek po 6 mesecu starosti, drugi odmerek 4 tedne pozneje.
English: 375 micrograms
Slovenian: 375 mikrogramov
English: Phosphate buffer, traces of thiomersal, traces of formaldehyde
Slovenian: Fosfatni pufer, tiomersal v sledeh, formaldehid v sledeh
English: Emil-von-Behring-Str. 76
Slovenian: GSK Vaccines GmbH Emil-von-Behring-Str. 76
English: The second dose of the vaccine (V2) should be administered 4 weeks later.
Slovenian: Drugi odmerek cepiva (C2) moramo dati 4 tedne pozneje.
English: The active substance being a principle of biological origin intended to produce active immunity is not in the scope of Regulation (EC) 470/2009.
Slovenian: Učinkovina biološkega izvora, namenjena vzbujanju aktivne imunosti ni vključena v Uredbo (ES) št.
English: This will lead to a passive protection against tetanus for at least 21 days after concurrent administration.
Slovenian: To vzbudi pasivno zaščito pred tetanusom, ki traja najmanj 21 dni po sočasnem dajanju.
English: use
Slovenian: uporaba
English: A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Slovenian: Zato se za uporabo tega cepiva pred ali po uporabi katerega koli drugega zdravila odločamo od primera do primera.
English: 125 micrograms
Slovenian: 125 mikrogramov
English: A diffuse hard or soft swelling (max. diameter 5 cm) may occur at the injection site, regressing within 2 days.
Slovenian: Lahko se pojavi neostro omejena trda ali mehka oteklina (premera največ 5 cm) na mestu vboda, ki mine v 2 dneh.
English: V1 V2
Slovenian: C1 C2