FrancophonIA/ELRC3.0 huggingface dataset:
English: For the treatment of flea and tick infestations in dogs when the concurrent prevention of heartworm disease (Dirofilaria immitis larvae), angiostrongylosis (reduction in level of immature adults (L5) and adults of Angiostrongylus vasorum), thelaziosis (adult Thelazia callipaeda) and/or treatment of gastrointestinal nematode infestations is indicated.
Slovenian: Zdravljenje infestacije z bolhami in klopi pri psih, kjer je indicirano sočasno preprečevanje srčne gliste (ličinke Dirofilaria immitis), angiostrongiloze (zmanjšanje stopnje infestiranosti z nezrelimi odraslimi (L5) in odraslimi oblikami Angiostrongylus vasorum), telazioze (odrasli Thelazia callipaeda) in /ali zdravljenje infestacije z gastrointestinalnimi nematodi.
English: Further monthly administrations of the product may be required based on clinical assessment and skin scrapings.
Slovenian: Na podlagi klinične ocene in kožnega ostružka je lahko potrebno z mesečnim zdravljenjem še nadaljevati.
English: Milbemycin oxime is active against several gastrointestinal worms (Toxocara canis, Toxascaris leonina, Ancylostoma caninum, Ancylostoma braziliense, Ancylostoma ceylanicum, Trichuris vulpis), the adults and immature adults (L5) of lungworm Angiostrongylus vasorum and heartworm (Dirofilaria immitis larvae).
Slovenian: Milbemicin oksim deluje na več vrst gastrointestinalnih parazitov (Toxacara canis, Toxascaris leonina, Ancylostoma caninum, Ancylostoma braziliense, Ancylostoma ceylanicum, Trichuris vulpis), na odrasle in nezrele odrasle (L5) pljučnih črvov Angiostrongylus vasorum in srčne gliste (ličinke Dirofilaria immitis).
English: It is active against several gastrointestinal worms (Toxocara canis, Toxascaris leonina, Ancylostoma caninum, Ancylostoma braziliense, Ancylostoma ceylanicum, Trichuris vulpis), the adults and immature adults (L5) of lungworm Angiostrongylus vasorum and larvae of the heartworm Dirofilaria immitis.
Slovenian: Deluje na številne gastrointestinalne gliste(Toxocara canis in Toxascaris leonina, Ancylosotma caninum, Ancylostoma brazilienze, Ancylostoma ceylanicum, Trichuris vulpis), na odrasle in nezrele odrasle (L5) pljučnih črvov Angiostrongylus vasorum in srčne gliste (ličinke Dirofilaria immitis).
English: In heartworm endemic areas, dogs should be tested for existing heartworm infestation prior to administration of NEXGARD SPECTRA.
Slovenian: V endemičnih področjih dirofilarioze bi bilo potrebno pred zdravljenjem z zdravilom NEXGARD SPECTRA pri psih diagnosticirati morebitne obstoječe infestacije s srčno glisto.
English: Ancylostoma ceylanicum is reported as being endemic only in South-East Asia, China, India, Japan, some Pacific islands, Australia, the Arab Peninsula, South Africa and South America.
Slovenian: na Japonskem, na nekaterih Pacifiških otokih, v Avstraliji, na Arabskem polotoku, v Južni Afriki in Južni Ameriki.
English: The recommended dose should be strictly observed in collies or related breeds.
Slovenian: Pri psih pasem coli in sorodnih pasmah se je potrebno striktno držati priporočenih odmerkov.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer carton
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla
English: Chewable tablets Read the package leaflet before use.
Slovenian: - Tablete hranite v pretisnem omotu do uporabe.
English: NEXGARD SPECTRA kills Dirofilaria immitis larvae (heartworm) up to one month after their transmission by mosquitoes.
Slovenian: Zdravilo NEXGARD SPECTRA ubija ličinke Dirofilaria immitis do enega meseca po njihovem prenosu s komarji, zato je potrebno zdravilo odmerjati redno v mesečnih intervalih v celotnem obdobju izpostavljenosti komarjem.
English: A single treatment is effective for gastrointestinal worms.
Slovenian: Za učinkovito zdravljenje gastrointestinalnih glist zadošča enkratno dajanje zdravila.
English: - Keep tablets in the blister packs until required, and keep the blisters in the outer carton.
Slovenian: - Tablete hranite v omotu do uporabe.
English: At the discretion of the veterinarian, infested dogs should be treated with an adulticide to remove adult heartworms.
Slovenian: Odpravljanje ugotovljenih odraslih srčnih glist je odgovornost lečečega veterinarja.
English: Macrogol 4000
Slovenian: 31300 Toulouse
English: Vomiting, diarrhoea, lethargy, anorexia, and pruritus were uncommonly observed.
Slovenian: Redko so bili opaženi bruhanje, driska, letargija, neješčnost in srbečica.
English: NEXGARD SPECTRA 9 mg/ 2 mg dogs 2-3.5 kg NEXGARD SPECTRA 19 mg/ 4 mg dogs >3.5-7.5 kg NEXGARD SPECTRA 38 mg/ 8 mg dogs >7.5-15 kg NEXGARD SPECTRA 75 mg/ 15 mg dogs >15-30 kg NEXGARD SPECTRA 150 mg/ 30 mg dogs >30-60 kg afoxolaner / milbemycin oxime Tablets
Slovenian: NEXGARD SPECTRA 9 mg/ 2 mg psi 2-3,5 kg NEXGARD SPECTRA 19mg/ 4 mg psi >3,5 -7,5 kg NEXGARD SPECTRA 38 mg/ 8 mg psi >7,5 -15 kg NEXGARD SPECTRA 75 mg/ 15 mg psi >15-30 kg NEXGARD SPECTRA 150 mg/ 30 mg psi >30-60 kg afoxolaner/milbemicyn oxime tablete
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Slovenian: NAČIN IN POT(I) UPORABE Žvečljive tablete
English: NEXGARD SPECTRA 9 mg/ 2 mg chewable tablets for dogs 2-3.5 kg NEXGARD SPECTRA 19 mg/ 4 mg chewable tablets for dogs >3.5-7.5 kg NEXGARD SPECTRA 38 mg/ 8 mg chewable tablets for dogs >7.5-15 kg NEXGARD SPECTRA 75 mg/ 15 mg chewable tablets for dogs >15-30 kg NEXGARD SPECTRA 150 mg/ 30 mg chewable tablets for dogs >30-60 kg afoxolaner / milbemycin oxime
Slovenian: NEXGARD SPECTRA 9 mg/ 2 mg žvečljive tablete za pse 2-3,5 kg NEXGARD SPECTRA 19mg/ 4 mg žvečljive tablete za pse >3,5-7,5 kg NEXGARD SPECTRA 38 mg/ 8 mg žvečljive tablete za pse >7,5 -15 kg NEXGARD SPECTRA 75 mg/ 15 mg žvečljive tablete za pse >15-30 kg NEXGARD SPECTRA 150 mg/ 30 mg žvečljive tablete za pse >30-60 kg afoxolaner/milbemycin oxime
English: Prevention of heartworm disease (Dirofilaria immitis larvae) with monthly administration.
Slovenian: Preprečevanje razvoja srčne gliste (Dirofilaria immitis ličinke) z odmerjanjem enkrat mesečno.
English: NEXGARD SPECTRA 9 mg / 2 mg chewable tablets for dogs 2-3.5 kg NEXGARD SPECTRA 19 mg / 4 mg chewable tablets for dogs >3.5-7.5 kg NEXGARD SPECTRA 38 mg / 8 mg chewable tablets for dogs >7.5-15 kg NEXGARD SPECTRA 75 mg / 15 mg chewable tablets for dogs >15-30 kg NEXGARD SPECTRA 150 mg / 30 mg chewable tablets for dogs >30-60 kg
Slovenian: NEXGARD SPECTRA 9 mg/ 2 mg žvečljive tablete za pse 2-3,5 kg NEXGARD SPECTRA 19mg/ 4 mg žvečljive tablete za pse >3,5-7,5 kg NEXGARD SPECTRA 38 mg/ 8 mg žvečljive tablete za pse >7,5-15 kg NEXGARD SPECTRA 75 mg/ 15 mg žvečljive tablete za pse >15-30 kg
English: Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis):
Slovenian: Zdravljenje garjavosti (ki jo povzroča Sarcoptes scabiei var. canis): Dajanje enkrat mesečno dva zaporedna meseca.
English: Maintenance of the efficacy of macrocyclic lactones is critical for Dirofilaria immitis control.
Slovenian: Vzdrževanje učinkovitosti makrolitičnih laktonov je kritičnega pomena za nadzor nad Dirofilaria immitis.Za zmanjšanje možnosti pojava selekcije rezistence, je priporočljivo diagnosticiranje tako prostih antigenov kot mikrofilarij v krvi pri psih na začetku vsake sezone preventivnega zdravljenja.
English: NEXGARD SPECTRA 9 mg / 2 mg chewable tablets for dogs 2-3.5 kg NEXGARD SPECTRA 19 mg / 4 mg chewable tablets for dogs >3.5-7.5 kg NEXGARD SPECTRA 38 mg / 8 mg chewable tablets for dogs >7.5-15 kg NEXGARD SPECTRA 75 mg / 15 mg chewable tablets for dogs >15-30 kg NEXGARD SPECTRA 150 mg / 30 mg chewable tablets for dogs >30-60 kg Afoxolaner, milbemycin oxime
Slovenian: NEXGARD SPECTRA 19mg/ 4 mg žvečljive tablete za pse >3,5-7,5 kg NEXGARD SPECTRA 38 mg/ 8 mg žvečljive tablete za pse >7,5 -15 kg NEXGARD SPECTRA 75 mg/ 15 mg žvečljive tablete za pse >15-30 kg NEXGARD SPECTRA 150 mg/ 30 mg žvečljive tablete za pse >30-60 kg afoksolaner, milbemicin oksim
English: United Kingdom GENERICS (UK) Limited, Station Close, Potters Bar, Herts EN6 1TL, UK
Slovenian: GENERICS (UK) Limited, Station Close, Potters Bar, Herts EN6 1TL, UK
English: 0,3 mg/1 m Solution for Injection Intravenous use
Slovenian: 0,3 mg/1 m Raztopina za injiciranje Intravenska uporaba
English: Prolonged-Release Capsule, hard
Slovenian: Kapsula s podaljšanim sproščanjem, trda
English: CENTRAFARM SERVICES B.V.; Nieuwe Donk 9; 4879 AC ETTENLEUR/NL, Netherlands
Slovenian: ; Nieuwe Donk 9; 4879 AC ETTENLEUR/NL, Netherlands
English: MEDA PHARMA B.V. Krijgsman 20, 1186 DM AMSTELVEEN/NL, Netherlands
Slovenian: Krijgsman 20, 1186 DM AMSTELVEEN/NL, Netherlands
English: Novartis Farma S.P.A. Largo Umberto Boccioni 1 21040 Origgio Varese, Italy
Slovenian: Largo Umberto Boccioni 1 21040 Origgio Varese, Italy
English: Dihydroergocryptine containing medicinal products with Marketing Authorisation in the European Union
Slovenian: Zdravila, ki vsebujejo dihidroergokriptin, z dovoljenjem za promet z zdravili v Evropski uniji
English: Lisuride containing medicinal products with Marketing Authorisation in the European Union
Slovenian: Zdravila, ki vsebujejo lizurid, z dovoljenjem za promet z zdravili v Evropski uniji
English: Meda Pharma S.A. - N.V. Chaussee de la Hulpe 166 - B-1170 Brussels
Slovenian: Chaussee de la Hulpe 166 - B-1170 Brussels
English: Czech Republic MEDA PHARMA s.r.o., Záhřebská, 577, 120 00, Praha 2, Czech Republic
Slovenian: MEDA PHARMA s.r.o., Záhřebská, 577, 120 00, Praha 2, Czech Republic
English: Film-coated Tablet
Slovenian: Filmsko obložena tableta Peroralna uporaba
English: Powder for Injection
Slovenian: Prašek za raztopino za injiciranje intramuskularna uporaba
English: Gastro-Resistant Tablet
Slovenian: Gastrorezistentna tableta Peroralna uporaba
English: Prolonged-Release Tablet
Slovenian: Tableta s podaljšanim sproščanjem
English: Solution for Injection Oral Use
Slovenian: Raztopina za injiciranje Peroralna uporaba
English: Bromokin scored tablet
Slovenian: Šumeča tableta
English: MEDA PHARMA GmbH & Co. KG, Benzstr.
Slovenian: MEDA PHARMA GmbH & Co.
English: Bromocriptine containing medicinal products with Marketing Authorisation in the European Union
Slovenian: Zdravila, ki vsebujejo bromokriptin, z dovoljenjem za promet z zdravili v Evropski uniji Država članica Imetnik dovoljenja za promet z zdravilom Izmišljeno ime
English: Oral Drops
Slovenian: Peroralne kapljice
English: <Content (concentration)>
Slovenian: Vsebina (koncentracija)
English: 3 pre-filled syringes + 3 needles
Slovenian: 3 ml (10 mg/ml) 3 napolnjene injekcijske brizge + 3 igle
English: 1 pre-filled syringe + 1 needle
Slovenian: 3 ml (10 mg/ml) 1 napolnjena injekcijska brizga + 1 igla
English: MA (EU) number (Invented) name Strength Pharmaceutical form
Slovenian: Številka (EU) dovoljenja za promet
English: European Medicines Agency Veterinary Medicines
Slovenian: Farmacevtska oblika
English: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Slovenian: EU/2/99/011/001 Locatim >2.8log10 /ml goveji koncentrirani laktoserum
English: ©EMEA 2007
Slovenian: Karenca
English: Locatim is an oral solution produced from colostrum which is given to calves in the first 12 hours of life.
Slovenian: Novorojena teleta do 12 ur starosti.
English: Information on the prescription status of this product may be found on the label/outer package.
Slovenian: Ovojnina Vsebina Velikost pakiranja
English: Page 2/2
Slovenian: 60 ml
English: What is Locatim?
Slovenian: Peroralna raztopina
English: Locatim is presented in a 60 ml glass bottle.
Slovenian: 1 Stekleničko stekla
English: These adverse effects are listed below.
Slovenian: Ti neželeni učinki so navedeni spodaj.
English: Tell your doctor promptly about these or any other unusual symptoms.
Slovenian: Svojega zdravnika takoj obvestite o teh ali katerih koli drugih nenavadnih simptomih.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 07/05/1999
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve pridobitve dovoljenja: 07/05/1999
English: - This vaccine has been prescribed for your child and you should not pass it on to others.
Slovenian: - Cepivo je bilo predpisano vašemu otroku in ga ne smete dajati drugim.
English: If the condition persists or worsens, seek medical attention.
Slovenian: Če stanje traja dalje ali se poslabša, poiščite zdravniško pomoč.
English: Official batch release: in accordance with Article 114 Directive 2001/83/EEC, the official batch release will be undertaken by a state laboratory or a laboratory disignated for that purpose.
Slovenian: Uradna sprostitev serije: v skladu s členom 114 Direktive 2001/83/ES, serijo uradno sprosti državni laboratorij ali laboratorij, določen v ta namen.
English: - If you have further questions, please ask your doctor or your pharmacist.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.
English: Store in a refrigerator (2 °C - 8 °C).
Slovenian: Shranjujte v hladilniku (2° C - 8° C).
English: Of these, 1,110 were monitored for both serious and non-serious adverse experiences.
Slovenian: Od teh so jih 1110 spremljali glede resnih in ne resnih neželenih pojavov.
English: As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Slovenian: Ker je korist cepljenja v tej skupini otrok velika, cepljenja ne bi smeli odložiti ali ga izpustiti.
English: For paediatric use only.
Slovenian: Cepivo je le za pediatrično uporabo.
English: All three doses must be administered to complete the vaccination regimen.
Slovenian: Za dokončanje sheme cepljenja je treba dati vse tri odmerke.
English: Do not use after the expiry date stated on the label.
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki.
English: Infants with moderate or severe febrile illness should only be vaccinated as soon as they have recovered from the acute phase of the illness.
Slovenian: Dojenčke z zmerno ali hudo vročinsko boleznijo se lahko cepi, takoj ko okrevajo po akutni fazi bolezni.
English: If the recommended schedule cannot be followed exactly, the interval between the first two doses should be approximately two months and the interval between the second and third dose should be as close as possible to eight to eleven months.
Slovenian: Če priporočene sheme ni mogoče natančno upoštevati, mora biti presledek med prvima odmerkoma približno dva meseca, presledek med drugim in tretjim odmerkom pa čim bliže osmim do enajstim mesecem.
English: Potential Adverse Effects
Slovenian: Možni neželeni učinki
English: Children not vaccinated according to recommended schedule Vaccination schedules for children not vaccinated according to the recommended schedule should be considered on an individual basis.
Slovenian: Otroci, ki niso bili cepljeni po priporočeni shemi Shemo cepljenja za otroke, ki niso bili cepljeni po priporočeni shemi, je treba določiti individualno.
English: The protective efficacy of the components of PROCOMVAX has been established in field trials performed with the monovalent vaccines.
Slovenian: Zaščitna učinkovitost sestavin cepiva PROCOMVAX je bila ugotovljena v terenskih preskušanjih z monovalentnima cepivoma.
English: Of these infants, 1,177 were involved in clinical trials in which most received PROCOMVAX concomitantly with other licensed paediatric vaccines.
Slovenian: Od teh dojenčkov jih je bilo 1177 vključenih v klinične raziskave, v katerih je večina dobila PROCOMVAX sočasno z drugimi odobrenimi pediatričnimi cepivi.
English: Take special care with PROCOMVAX:
Slovenian: Bodite posebno pozorni pri uporabi zdravila PROCOMVAX:
English: Because of the potential for immune tolerance (impaired ability to respond to subsequent exposure to the PRP antigen) PROCOMVAX is not recommended for use in infants younger than 6 weeks of age.
Slovenian: Zaradi možnosti imunske tolerance (okvarjene zmožnosti za odziv na poznejši stik z antigenom PRP) uporaba cepiva PROCOMVAX ni priporočljiva pri otrocih, mlajših od 6 tednov.
English: In addition, tell your doctor if your child experienced any symptoms that suggest an allergic reaction after any dose in the vaccination series.
Slovenian: Poleg tega svojemu zdravniku povejte, če otrok po katerem koli odmerku cepiva doživi simptome, ki nakazujejo alergijsko reakcijo.
English: PROCOMVAX is an injectable vaccine in a 0.5ml single dose vial.
Slovenian: PROCOMVAX je cepivo za injiciranje v 0,5 ml enoodmerni viali.
English: No serious vaccine-related side effects were reported.
Slovenian: Zabeležili niso nobenih resnih neželenih učinkov, povezanih s cepivom.
English: Like all medicines, PROCOMVAX can have side effects.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo PROCOMVAX neželene učinke.
English: 0.5 ml suspension in vial (type I flint glass).
Slovenian: 0,5 ml suspenzije v viali (kremenovo steklo tipa 1).
English: Marketing Authorisation Holder: Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F-69007 Lyon Manufactured by: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Slovenian: Imetnik dovoljenja za promet z zdravilom: Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F-69007 Lyon Izdelovalec: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, Nizozemska.
English: Immune response data are satisfactory for PROCOMVAX but are currently unavailable for DTaP.
Slovenian: Izsledki o imunskem odzivu so za PROCOMVAX zadovoljivi, za DTaP pa jih trenutno še ni na voljo.
English: In the absence of compatibility studies, this vaccine must not be mixed with other vaccines or other medicinal products in the same syringe.
Slovenian: Zaradi pomanjkanja raziskav kompatibilnosti cepiva ne smemo mešati v isti brizgi z drugimi cepivi ali drugimi zdravili.
English: Do not inject intravenously, intradermally, or subcutaneously
Slovenian: Ne injicirajte intravensko, intradermalno ali subkutano.
English: Individuals who develop symptoms suggestive of hypersensitivity after an injection should not receive further injections of the vaccine.
Slovenian: Osebe, pri katerih se po injiciranju pojavijo simptomi, ki nakazujejo preobčutljivost, ne smejo več dobiti injekcij tega cepiva.
English: 1 WHAT PROCOMVAX IS AND WHAT IT IS USED FOR
Slovenian: KAJ JE ZDRAVILO PROCOMVAX IN ZA KAJ GA UPORABLJAMO
English: After thorough agitation, PROCOMVAX is a slightly opaque, white suspension.
Slovenian: Dobro pretreseni PROCOMVAX je rahlo motna, bela suspenzija.
English: PROCOMVAX must not be mixed with other vaccines in the same syringe.
Slovenian: Cepiva PROCOMVAX se ne sme mešati z drugimi cepivi v isti brizgi.
English: PROCOMVAX - single dose in vial - Pack of 1
Slovenian: ŠKATLA PROCOMVAX - enoodmerna viala - pakiranje po 1
English: PROCOMVAX must be injected into the muscle of the thigh.
Slovenian: PROCOMVAX je treba injicirati v mišico na stegnu.
English: As for any vaccine, adequate treatment provisions, including adrenaline, should be available for immediate use should an anaphylactic or anaphylactoid reaction occur.
Slovenian: Tako kot velja za vsa cepiva, mora biti za takojšnjo uporabo na voljo ustrezna oprema, vključno z adrenalinom, če bi se pojavila anafilaktična ali anafilaktoidna reakcija.
English: PROCOMVAX will not prevent hepatitis caused by other viruses known to infect the liver.
Slovenian: PROCOMVAX ne prepreči hepatitisa, povzročenega z drugimi virusi, ki okužijo jetra.
English: Since PROCOMVAX has not been studied in persons who have malignancies or are otherwise immunocompromised, the extent of the immune response in such persons is unknown.
Slovenian: Delovanje cepiva PROCOMVAX ni raziskano pri osebah z malignomi in pri osebah, ki so drugače imunsko oslabele, zato stopnja imunskega odziva pri takšnih ljudeh ni znana.
English: The vaccine should be used as supplied; no reconstitution is necessary.
Slovenian: 6.6 Navodila za pripravo in ravnanje z zdravilom Cepivo je treba uporabiti, kot je dobavljeno; rekonstitucija ni potrebna.
English: PROCOMVAX may not induce protective antibody levels immediately following vaccination and may not result in a protective antibody response in all individuals given the vaccine.
Slovenian: Mogoče je, da PROCOMVAX ne povzroči nastanka zaščitne vrednosti protiteles takoj po cepljenju; prav tako je mogoče, da zaščitnega odziva protiteles ne povzroči pri vseh prejemnikih cepiva.
English: No increase in the frequency or severity of adverse events was seen with subsequent doses.
Slovenian: Po nadaljnjih odmerkih niso opažali večje pogostnosti ali izrazitosti neželenih učinkov.
English: PROCOMVAX is indicated for vaccination against invasive disease caused by Haemophilus influenzae type b and against infection caused by all known subtypes of hepatitis B virus in infants 6 weeks to 15 months of age.
Slovenian: PROCOMVAX je indiciran za cepljenje proti invazivni bolezni, ki jo povzroča Haemophilus influenzae tipa b, in proti okužbi, ki jo povzročajo vsi znani podtipi virusa hepatitisa B, in sicer pri otrocih, starih od 6 tednov do 15 mesecev.
English: In clinical trials involving the administration of 7,350 doses of PROCOMVAX to 2,993 healthy infants 6 weeks to 15 months of age, PROCOMVAX was generally well tolerated.
Slovenian: V kliničnih raziskavah 7350 odmerkov cepiva PROCOMVAX, danih 2993 zdravim dojenčkom, starim od 6 tednov do 15 mesecev, so dojenčki PROCOMVAX na splošno dobro prenašali.
English: NAME OF THE MEDICINAL PRODUCT AND IF NECESSARY ROUTE(S) OF ADMINISTRATION
Slovenian: IME ZDRAVILA IN POT(I) UPORABE
English: Respiratory, thoracic and mediastinal disorders Apnoea in very premature infants (≤ 28 weeks of gestation) (see section 4.4)
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora Apneja pri veliko prezgodaj rojenih nedonošenčkih (rojenih pred ali v 28. tednu nosečnosti) (glejte poglavje 4.4).
English: Other side effects include irritability, sleepiness, fever, diarrhoea, vomiting, loss of appetite, middle ear infection, and unusual high-pitched crying.
Slovenian: Med drugimi neželenimi učinki so razdražljivost, zaspanost, zvišana telesna temperatura, driska, bruhanje, izguba teka, okužba srednjega ušesa in jok z nenavadno visokim glasom.
English: In one of these trials, a randomized, multicenter study, 882 infants were assigned in a 3:1 ratio to receive either PROCOMVAX or Merck Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (Merck PRP-OMPC Vaccine) plus Merck Hepatitis B (Recombinant) Vaccine at 2, 4, and 12-15 months of age, with the children monitored daily for five days after each injection for local reactions and systemic complaints.
Slovenian: V eni od teh raziskav, ki je bila randomizirana in multicentrična, so 882 dojenčkov v razmerju 3:1 razvrstili tako, da so prejemali PROCOMVAX ali pa Merckovo konjugirano cepivo proti hemofilusu b (meningokokni beljakovinski konjugat) (cepivo Merck PRP - OMPC) in Merckovo (rekombinantno) cepivo proti hepatitisu B. Otroke so cepili v starosti 2., 4. in od 12. do 15. meseca in jih glede lokalnih reakcij in sistemskih težav spremljali pet dni po vsaki injekciji.
English: The following local reactions and systemic complaints were reported in ≥1.0 % of children within five days after any injection of PROCOMVAX: pain/soreness, erythema, swelling/induration at the injection site; fever (>38.3 °C, rectal equivalent); anorexia, vomiting, diarrhoea; irritability, somnolence, crying including unusual high-pitched crying, prolonged crying (>4hrs), and crying not otherwise specified; otitis media.
Slovenian: V petih dneh po kateri koli injekciji cepiva PROCOMVAX so pri ≥ 1,0 % otrok opisali naslednje lokalne reakcije in sistemske težave: bolečine/občutljivost, eritem, oteklost/zatrdelost na mestu vboda; zvišano telesno temperaturo ( > 38,3°C, rektalni ekvivalent); anoreksijo, bruhanje, drisko; razdražljivost, zaspanost, jok (vključno z jokom z nenavadno visokim glasom), dolgotrajen jok ( > 4 ure) in ne drugače opredeljen jok; otitis media.
English: MANUFACTURER'S BATCH NUMBER Batch
Slovenian: IZDELOVALČEVA ŠTEVILKA SERIJE IZDELAVE ZDRAVILA
English: The vaccine may not prevent hepatitis B in such patients.
Slovenian: Pri takšnih bolnikih se lahko zgodi, da cepivo ne prepreči hepatitisa B.