natgillin/translations-raw huggingface dataset:
EU/2/14/177/007 - 38 mg/ 8 mg, 1 chewable tablet EU/2/14/177/008 - 38 mg/ 8 mg, 3 chewable tablets EU/2/14/177/009 - 38 mg/ 8 mg, 6 chewable tablets EU/2/14/177/018 - 38 mg/ 8 mg, 15 chewable tablets EU/2/14/177/010 - 75 mg/ 15 mg, 1 chewable tablet EU/2/14/177/011 - 75 mg/ 15 mg, 3 chewable tablets EU/2/14/177/012 - 75 mg/ 15 mg, 6 chewable tablets EU/2/14/177/019 - 75 mg/ 15 mg, 15 chewable tablets EU/2/14/177/013 -150 mg/ 30 mg, 1 chewable tablet EU/2/14/177/014 -150 mg/ 30 mg, 3 chewable tablets EU/2/14/177/015 -150 mg/ 30 mg, 6 chewable tablets EU/2/14/177/020 -150 mg/ 30 mg, 15 chewable tablets 
EU/2/14/177/008 - 38 mg/ 8 mg, 3 žvečljive tablete EU/2/14/177/009 - 38 mg/ 8 mg, 6 žvečljivih tablet EU/2/14/177/018 - 38 mg/ 8 mg, 15 žvečljivih tablet EU/2/14/177/010 - 75 mg/ 15 mg, 1 žvečljiva tableta EU/2/14/177/011 - 75 mg/ 15 mg, 3 žvečljive tablete EU/2/14/177/012 - 75 mg/ 15 mg, 6 žvečljivih tablet EU/2/14/177/019 - 75 mg/ 15 mg, 15 žvečljivih tablet EU/2/14/177/013 -150 mg/ 30 mg, 1 žvečljiva tableta EU/2/14/177/014 -150 mg/ 30 mg, 3 žvečljive tablete EU/2/14/177/015 -150 mg/ 30 mg, 6 žvečljivih tablet EU/2/14/177/020 -150 mg/ 30 mg, 15 žvečljivih tablet
Ancylostoma ceylanicum is reported as being endemic only in Southeast Asia, China, India, Japan, some Pacific islands, Australia, the Arab Peninsula, South Africa and South America. 
Ancylostoma ceylanicum je poročana kot endemična samo v jugovzhodni Aziji, na Kitajskem, v Indiji,
Therefore, the use of this product should be based on the assessment of each individual case and on local epidemiological information about the current susceptibility of the target species in order to limit the possibility of a future selection for resistance. 
Zato je potrebno upoštevati epidemiološke podatke o trenutni občutljivosti ciljnih organizmov, da se zmanjša verjetnost nastanka kasnejše selekcionirane rezistence.
These occurrences were generally self-limiting and of short duration. 
Ti neželeni učinki so prehodnega značaja in minejo sami od sebe.
Prevention of establishment of thelaziosis (adult Thelazia callipaeda eyeworm infection) with monthly administration. 
Preprečevanje razvoja telazioze (okužba z odraslimi očesnimi črvi Thelazia callipaeda) z mesečnim dajanjem zdravila.
EU/2/14/177/001 - 9 mg/ 2 mg, 1 chewable tablet EU/2/14/177/002 - 9 mg/ 2 mg, 3 chewable tablets EU/2/14/177/003 - 9 mg/ 2 mg, 6 chewable tablets EU/2/14/177/016 - 9 mg/ 2 mg, 15 chewable tablets EU/2/14/177/004 - 19 mg/ 4 mg, 1 chewable tablet EU/2/14/177/005 - 19 mg/ 4 mg, 3 chewable tablets EU/2/14/177/006 - 19 mg/ 4 mg, 6 chewable tablets EU/2/14/177/017 - 19 mg/ 4 mg, 15 chewable tablets 
EU/2/14/177/001 - 9 mg/ 2 mg, 1 žvečljiva tableta EU/2/14/177/002 - 9 mg/ 2 mg, 3 žvečljive tablete EU/2/14/177/003 - 9 mg/ 2 mg, 6 žvečljivih tablet EU/2/14/177/016 - 9 mg/ 2 mg, 15 žvečljivih tablet EU/2/14/177/004 - 19 mg/ 4 mg, 1 žvečljiva tableta EU/2/14/177/005 - 19 mg/ 4 mg, 3 žvečljive tablete EU/2/14/177/006 - 19 mg/ 4 mg, 6 žvečljivih tablet EU/2/14/177/017 - 19 mg/ 4 mg, 15 žvečljivih tablet EU/2/14/177/007 - 38 mg/ 8 mg, 1 žvečljiva tableta
Efficacy of the treatment against flea and tick infestations lasts for one month. 
Zdravilo učinkuje na bolhe in klope en mesec.
Prevention of angiostrongylosis (by reduction of the level of infection with immature adult (L5) and adult stages of Angiostrongylus vasorum) with monthly administration. 
Preprečevanje angiostrongiloze (z zmanjšanjem stopnje infestiranosti z nezrelimi odraslimi (L5) in odraslimi oblikami Angiostrongylus vasorum) z mesečnim dajanjem zdravila.
No therapeutic effect against adult Dirofilaria immitis has been established. 
Zdravilo nima terapevtskega učinka na odrasle srčen gliste.
Fleas and ticks need to start feeding on the host to become exposed to the substance afoxolaner; therefore the risk of the transmission of diseases by fleas and ticks cannot be excluded. 
Paraziti se morajo začeti hraniti, da pridejo v stik z zdravilno učinkovino afoksolaner, zato prenosa bolezni, ki jih prenašajo bolhe in klopi ni mogoče povsem izključiti.
Dogs 2-3.5 kg Dogs >3.5-7.5 kg Dogs >7.5-15 kg Dogs >15-30 kg Dogs >30-60 kg 
Psi 2 3,5 kg Psi >3,5 7,5 kg Psi >7,5-15 kg Psi >15-30 kg Psi >30-60 kg
It is active against adult fleas as well as against several tick species such as Rhipicephalus sanguineus, Dermacentor reticulatus and D. variabilis, Ixodes ricinus and I. scapularis, Amblyomma americanum, and Haemaphysalis longicornis. 
Učinkuje na odrasle bolhe kot tudi številne vrste klopov, kot so Rhipicephalus sanguineus, Dermacentor reticulatus in D. variabilis, Ixodes ricinus and I. scapularis, Amblyomma americanum, in Haemaphysalis longicornis.
In regions where heartworm disease is present, dogs should be tested for existing heartworm infestation prior to administration of NEXGARD SPECTRA. 
Na območjih, kjer je bolezen srčne gliste prisotna, bi bilo potrebno pred zdravljenjem z zdravilom NEXGARD SPECTRA pri psih diagnosticirati morebitne obstoječe infestacije.
Laboratory studies in rats and rabbits have not produced any evidence of birth defects, or any adverse effect on the reproductive capacity in males and females. 
Brejost in laktacija: Z laboratorijskimi študijami na podganah in kuncih niso bili dokazani škodljivi učinki na plod ali drugi neželeni učinki na reproduktivno sposobnost samcev in samic.
Treatment of tick infestations (Dermacentor reticulatus, Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus) in dogs for 4 weeks. 
Zdravljenje infestacije s klopi pri psih (Dermacentor reticulatus, Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus) traja do 4 tedne.
When replacing another heartworm preventative product in a heartworm prevention programme, the first treatment with NEXGARD SPECTRA should start on the date when the former medication was due to have been administered. 
V primeru menjave drugega zdravila, ki preprečuje okužbe s srčno glisto, se odmeri prvi odmerek zdravila NEXGARD SPECTRA na dan, ko bi žival morala prejeti naslednji odmerek prejšnjega zdravila.
Treatment of tick infestations (Dermacentor reticulatus, Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus) in dogs. 
Zdravljenje infestacije s klopi (Dermacentor reticulatus, Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus) pri psih.
Treatment of flea infestations (Ctenocephalides felis and C. canis) in dogs for 5 weeks. 
Zdravljenje infestacije z bolhami pri psih (Ctenocephalides felis and C. canis) traja do 5 tednov.
Name and address of the manufacturer(s) responsible for batch release 
Ime in naslov proizvajalca zdravila, odgovornega za sproščanje serij
Monthly administration of the product prevents establishment of infection with adult Thelazia callipaeda eyeworm. 
Preprečevanje telazioze: Mesečno odmerjanje zdravila prepreči razvoj okužbe z odraslimi očesnimi črvi Thelazia callipaeda.
For each strength, the chewable tablets are available in the following pack sizes: Carton with 1 thermoformed blister containing 1, 3 or 6 chewable tablets or 15 thermoformed blisters containing 1 chewable tablet. 
Škatla z 1 pretisnim toplotno oblikovanim omotom z 1, 3 ali 6 žvečljivimi tabletami ali s 15 toplotno oblikovanimi pretisnimi omoti z 1 žvečljivo tableto.
A single treatment is effective for the treatment of gastrointestinal nematodes. 
Za učinkovito zdravljenje gastrointestinalnih nematodov zadošča enkratno dajanje zdravila.
Treatment of infestations with adult gastrointestinal nematodes of the following species: roundworms (Toxocara canis and Toxascaris leonina), hookworms (Ancylostoma caninum, Ancylostoma braziliense and Ancylostoma ceylanicum) and whipworm (Trichuris vulpis). 
Zdravljenje infestacij z odraslimi gastrointestinalnimi nematodi naslednjih vrst: valjasti črvi (Toxocara canis in Toxascaris leonina), kavljasti črvi ( Ancylosotma caninum, Ancylostoma brazilienze in Ancylostoma ceylanicum), in bičeglavci (Trichuris vulpis).
Mottled red to reddish brown, circular shaped (tablets for dogs 2-3.5 kg) or rectangular shaped (tablets for dogs >3.5-7.5 kg, tablets for dogs >7.5-15 kg, tablets for dogs >15-30 kg and tablets for dogs >30-60 kg). 
Lisasto rdeče do rdečkasto rjave, okrogle (tablete za pse 2-3,5 kg) ali pravokotno oblikovane tablete (tablete za pse >3,5-7,5 kg, tablete za pse >7,5-15 kg, tablete za pse >15-30 kg in tablete za pse > 30-60 kg).
The veterinary medicinal product should be administered in accordance with the following table: 
Zdravilo uporabljajte glede na spodnjo tabelo:
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. 
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.
Further monthly administrations of the product may be required based on clinical assessment and skin scrapings. 
Na podlagi klinične ocene in kožnega ostružka je lahko potrebno z mesečnim zdravljenjem še nadaljevati.
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). 
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).
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. 
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).
In heartworm endemic areas, dogs should be tested for existing heartworm infestation prior to administration of NEXGARD SPECTRA. 
V endemičnih področjih dirofilarioze bi bilo potrebno pred zdravljenjem z zdravilom NEXGARD SPECTRA pri psih diagnosticirati morebitne obstoječe infestacije s srčno glisto.
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. 
na Japonskem, na nekaterih Pacifiških otokih, v Avstraliji, na Arabskem polotoku, v Južni Afriki in Južni Ameriki.
The recommended dose should be strictly observed in collies or related breeds. 
Pri psih pasem coli in sorodnih pasmah se je potrebno striktno držati priporočenih odmerkov.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer carton 
PODATKI NA ZUNANJI OVOJNINI Škatla
Chewable tablets Read the package leaflet before use. 
- Tablete hranite v pretisnem omotu do uporabe.
NEXGARD SPECTRA kills Dirofilaria immitis larvae (heartworm) up to one month after their transmission by mosquitoes. 
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.
A single treatment is effective for gastrointestinal worms. 
Za učinkovito zdravljenje gastrointestinalnih glist zadošča enkratno dajanje zdravila.
- Keep tablets in the blister packs until required, and keep the blisters in the outer carton. 
- Tablete hranite v omotu do uporabe.
At the discretion of the veterinarian, infested dogs should be treated with an adulticide to remove adult heartworms. 
Odpravljanje ugotovljenih odraslih srčnih glist je odgovornost lečečega veterinarja.
Macrogol 4000 
31300 Toulouse
Vomiting, diarrhoea, lethargy, anorexia, and pruritus were uncommonly observed. 
Redko so bili opaženi bruhanje, driska, letargija, neješčnost in srbečica.
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 
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
METHOD AND ROUTE(S) OF ADMINISTRATION 
NAČIN IN POT(I) UPORABE Žvečljive tablete
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 
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
Prevention of heartworm disease (Dirofilaria immitis larvae) with monthly administration. 
Preprečevanje razvoja srčne gliste (Dirofilaria immitis ličinke) z odmerjanjem enkrat mesečno.
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 
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
Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis): 
Zdravljenje garjavosti (ki jo povzroča Sarcoptes scabiei var. canis): Dajanje enkrat mesečno dva zaporedna meseca.
Maintenance of the efficacy of macrocyclic lactones is critical for Dirofilaria immitis control. 
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.
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 
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
0,3 mg/1 m Solution for Injection Intravenous use 
0,3 mg/1 m Raztopina za injiciranje Intravenska uporaba
Prolonged-Release Capsule, hard 
Kapsula s podaljšanim sproščanjem, trda
Dihydroergocryptine containing medicinal products with Marketing Authorisation in the European Union 
Zdravila, ki vsebujejo dihidroergokriptin, z dovoljenjem za promet z zdravili v Evropski uniji
Lisuride containing medicinal products with Marketing Authorisation in the European Union 
Zdravila, ki vsebujejo lizurid, z dovoljenjem za promet z zdravili v Evropski uniji
Film-coated Tablet 
Filmsko obložena tableta Peroralna uporaba
Powder for Injection 
Prašek za raztopino za injiciranje intramuskularna uporaba
Gastro-Resistant Tablet 
Gastrorezistentna tableta Peroralna uporaba
Prolonged-Release Tablet 
Tableta s podaljšanim sproščanjem
Solution for Injection Oral Use 
Raztopina za injiciranje Peroralna uporaba
Bromokin scored tablet 
Šumeča tableta
Bromocriptine containing medicinal products with Marketing Authorisation in the European Union 
Zdravila, ki vsebujejo bromokriptin, z dovoljenjem za promet z zdravili v Evropski uniji Država članica Imetnik dovoljenja za promet z zdravilom Izmišljeno ime
Oral Drops 
Peroralne kapljice
<Content (concentration)> 
Vsebina (koncentracija)
3 pre-filled syringes + 3 needles 
3 ml (10 mg/ml) 3 napolnjene injekcijske brizge + 3 igle
1 pre-filled syringe + 1 needle 
3 ml (10 mg/ml) 1 napolnjena injekcijska brizga + 1 igla
MA (EU) number (Invented) name Strength Pharmaceutical form 
Številka (EU) dovoljenja za promet
European Medicines Agency Veterinary Medicines 
Farmacevtska oblika
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 
EU/2/99/011/001 Locatim >2.8log10 /ml goveji koncentrirani laktoserum
©EMEA 2007 
Karenca
Locatim is an oral solution produced from colostrum which is given to calves in the first 12 hours of life. 
Novorojena teleta do 12 ur starosti.
Information on the prescription status of this product may be found on the label/outer package. 
Ovojnina Vsebina Velikost pakiranja
What is Locatim? 
Peroralna raztopina
Locatim is presented in a 60 ml glass bottle. 
1 Stekleničko stekla
These adverse effects are listed below. 
Ti neželeni učinki so navedeni spodaj.
Tell your doctor promptly about these or any other unusual symptoms. 
Svojega zdravnika takoj obvestite o teh ali katerih koli drugih nenavadnih simptomih.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 07/05/1999 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve pridobitve dovoljenja: 07/05/1999
- This vaccine has been prescribed for your child and you should not pass it on to others. 
- Cepivo je bilo predpisano vašemu otroku in ga ne smete dajati drugim.
If the condition persists or worsens, seek medical attention. 
Če stanje traja dalje ali se poslabša, poiščite zdravniško pomoč.
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. 
Uradna sprostitev serije: v skladu s členom 114 Direktive 2001/83/ES, serijo uradno sprosti državni laboratorij ali laboratorij, določen v ta namen.
- If you have further questions, please ask your doctor or your pharmacist. 
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.
Store in a refrigerator (2 °C - 8 °C). 
Shranjujte v hladilniku (2° C - 8° C).
Of these, 1,110 were monitored for both serious and non-serious adverse experiences. 
Od teh so jih 1110 spremljali glede resnih in ne resnih neželenih pojavov.
As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed. 
Ker je korist cepljenja v tej skupini otrok velika, cepljenja ne bi smeli odložiti ali ga izpustiti.
For paediatric use only. 
Cepivo je le za pediatrično uporabo.
All three doses must be administered to complete the vaccination regimen. 
Za dokončanje sheme cepljenja je treba dati vse tri odmerke.
Do not use after the expiry date stated on the label. 
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki.
Infants with moderate or severe febrile illness should only be vaccinated as soon as they have recovered from the acute phase of the illness. 
Dojenčke z zmerno ali hudo vročinsko boleznijo se lahko cepi, takoj ko okrevajo po akutni fazi bolezni.
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. 
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.
Potential Adverse Effects 
Možni neželeni učinki
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. 
Otroci, ki niso bili cepljeni po priporočeni shemi Shemo cepljenja za otroke, ki niso bili cepljeni po priporočeni shemi, je treba določiti individualno.
The protective efficacy of the components of PROCOMVAX has been established in field trials performed with the monovalent vaccines. 
Zaščitna učinkovitost sestavin cepiva PROCOMVAX je bila ugotovljena v terenskih preskušanjih z monovalentnima cepivoma.
Of these infants, 1,177 were involved in clinical trials in which most received PROCOMVAX concomitantly with other licensed paediatric vaccines. 
Od teh dojenčkov jih je bilo 1177 vključenih v klinične raziskave, v katerih je večina dobila PROCOMVAX sočasno z drugimi odobrenimi pediatričnimi cepivi.
Take special care with PROCOMVAX: 
Bodite posebno pozorni pri uporabi zdravila PROCOMVAX:
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. 
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.
In addition, tell your doctor if your child experienced any symptoms that suggest an allergic reaction after any dose in the vaccination series. 
Poleg tega svojemu zdravniku povejte, če otrok po katerem koli odmerku cepiva doživi simptome, ki nakazujejo alergijsko reakcijo.
PROCOMVAX is an injectable vaccine in a 0.5ml single dose vial. 
PROCOMVAX je cepivo za injiciranje v 0,5 ml enoodmerni viali.
No serious vaccine-related side effects were reported. 
Zabeležili niso nobenih resnih neželenih učinkov, povezanih s cepivom.
Like all medicines, PROCOMVAX can have side effects. 
Kot vsa zdravila ima lahko tudi zdravilo PROCOMVAX neželene učinke.
0.5 ml suspension in vial (type I flint glass). 
0,5 ml suspenzije v viali (kremenovo steklo tipa 1).
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 
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.
Immune response data are satisfactory for PROCOMVAX but are currently unavailable for DTaP. 
Izsledki o imunskem odzivu so za PROCOMVAX zadovoljivi, za DTaP pa jih trenutno še ni na voljo.
In the absence of compatibility studies, this vaccine must not be mixed with other vaccines or other medicinal products in the same syringe. 
Zaradi pomanjkanja raziskav kompatibilnosti cepiva ne smemo mešati v isti brizgi z drugimi cepivi ali drugimi zdravili.
Do not inject intravenously, intradermally, or subcutaneously 
Ne injicirajte intravensko, intradermalno ali subkutano.
Individuals who develop symptoms suggestive of hypersensitivity after an injection should not receive further injections of the vaccine. 
Osebe, pri katerih se po injiciranju pojavijo simptomi, ki nakazujejo preobčutljivost, ne smejo več dobiti injekcij tega cepiva.