FrancophonIA/ELRC3.0 huggingface dataset:
English: Intervet PortugalSaúde Animal, Lda Rua Agualva dos Açores, n.º 16,
Slovenian: Portugalska Intervet PortugalSaúde Animal, Lda Rua Agualva dos
English: In order to ascertain that there is no significant decrease in the titre right after mixing (i.e., at t=0), it was considered important to know the titre at release (or after reconstitution in the diluent fraction of Porcilis PRRS).
Slovenian: Za zagotovitev, da ni bistvenega zmanjšanja titra neposredno po mešanju (tj. pri času t=0), je bilo bistvenega pomena poznavanje titra ob sprostitvi (ali po rekonstituciji v raztopljeni frakciji zdravila Porcilis PRRS).
English: Product name
Slovenian: Lastniško ime
English: Since the protective immunity against viraemia is not altered by the mixed administration, the marketing authorisation holder considered that all the other efficacy parameters will also not be altered, and therefore, no more data are required in support of the duration of immunity for the mixed administration.
Slovenian: Ker dajanje mešanega cepiva ne spremeni zaščitne imunosti proti viremiji, je imetnik dovoljenja za promet z zdravilom menil, da tudi noben drug parameter učinkovitosti ne bo spremenjen, zato niso potrebni nadaljnji podatki za podporo trajanja imunosti ob dajanju mešanega cepiva.
English: Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Slovenian: Wim de Körverstraat 35 5831 AN Boxmeer Nizozemska
English: 4.9 Amounts to be administered and administration route Reconstitute the vaccine with the corresponding adjuvating diluent (use only Diluvac Forte).
Slovenian: 4.9 Odmerjanje in pot uporabe Cepivo rekonstituirajte z ustreznim vehiklom (uporabljajte samo Diluvac Forte).
English: In addition to the above mentioned laboratory studies, the marketing authorisation holder has provided efficacy data for the mixed products of two field studies.
Slovenian: Poleg omenjenih laboratorijskih študij je imetnik dovoljenja za promet predložil tudi podatke o učinkovitosti iz dveh terenskih študij za mešano zdravilo.
English: 12 months (after storage by the manufacturer at ≤-20°C during maximum 12 months) Diluent: in glass vials 4 years, in PET vials 24 months After reconstitution: 3 hours at room temperature.
Slovenian: 12 mesecev (po shranjevanju pri izdelovalcu pri ≤-20 °C največ 12 mesecev) Vehikel: v steklenih vialah: 4 leta, v vialah iz PET: 24 mesecev Po rekonstituciji: 3 ure pri sobni temperaturi Po mešanju s Porcilisom M Hyo: 1 uro pri sobni temperaturi
English: As regards why the stability studies were not performed with batches approaching the end of their shelf-life, the marketing authorisation holder has commented that there is no impact on the existing minimum titre proven to be efficacious:
Slovenian: Na vprašanje, zakaj študije stabilnosti s serijami, ki so se bližale izteku roka uporabnosti, niso bile izvedene, je imetnik dovoljenja za promet z zdravilom odgovoril, da se noben učinek na obstoječi minimalni titer ni izkazal za učinkovitega:
English: Breeding pigs: For gilts a (re)vaccination 2-4 weeks before mating is recommended.
Slovenian: Vzrejni prašiči: Pri mladicah priporočajo (re)vakcinacijo 2 do 4 tedne pred parjenjem.
English: Nevertheless, absence of immunological interference has not been inferred but has been clearly demonstrated by providing laboratory challenge data which showed that there is no significant difference in protection between animals vaccinated with the mixed products and those vaccinated with single products.
Slovenian: Odsotnost imunološkega medsebojnega vpliva ni bila rezultat sklepanja, temveč je bila jasno dokazana s predloženimi podatki iz dodatne laboratorijske študije, ki so pokazali, da ni bistvene razlike med zaščito živali, ki so bile cepljene z mešanim zdravilom, in živali, ki so prejele samo eno cepivo.
English: RUE OLIVIER DE SERRES ANGERS TECHNOPOLE 49071 BEAUCOUZE France
Slovenian: ANGERS TECHNOPOLE 49071 BEAUCOUZE Francija
English: The efficacy studies using appropriate challenges for Porcilis PRRS and Porcilis M Hyo have shown that there is no affect of simultaneous administration on the efficacy parameters of reduced viraemia and a reduction in lung lesions.
Slovenian: Študije učinkovitosti, ki so vključevale ustrezne izzive za zdravili Porcilis M Hyo in Porcilis PRRS, so pokazale, da sočasna uporaba ne vpliva na parametra učinkovitosti zmanjšanje viremije in zmanjšanje lezij pljuč.
English: These can be regarded as demonstrating equivalence of immune response and it would not be expected that if the immune response is not altered at one point in time that the duration of that response will be any different.
Slovenian: Te študije dokazujejo ekvivalenco imunskega odziva, poleg tega ni pričakovati spremembe trajanje odziva, če se v določeni časovni točki imunski odziv ne spremeni.
English: In addition, it was considered that potency of the Porcilis M Hyo component after mixing should have been analysed in order to the exclude a quality interference right after mixing (at t=0) and after the proposed in-use shelf life.
Slovenian: Poleg tega velja, da bi bilo treba analizirati jakost komponente Porcilis M Hyo po mešanju, da bi bilo mogoče izključiti vpliv na kakovost neposredno po mešanju (pri času t=0) in po izteku predlaganega roka uporabnosti mešanice.
English: The results indicated that there was a limited drop in the PRRS virus titre after mixing with Porcilis M Hyo (average drop after the claimed 1 hour in-use shelf life of 0.05 log).
Slovenian: Rezultati so pokazali omejeno zmanjšanje titra virusa PRRS po mešanju z zdravilom Porcilis M Hyo (povprečno zmanjšanje po predlaganem roku uporabnosti 1 ure za 0,05 log).
English: Therefore, the specific claim for finishing pigs of “a significant improvement of rearing results (reduced morbidity due to PRRS infection and a better daily growth and feed conversion) until the end of the fattening period” has not been demonstrated and the efficacy of the mixed product has not been proved.
Slovenian: Zato posebne navedbe za prašiče za zakol, tj. „ znatno izboljšanje rezultatov pri vzreji (zmanjšana morbidnost, ki jo povzroča okužba z virusom PRRS in boljša dnevna rast in sprememba krme) do konca dobe vzreje“, niso bila prikazane, učinkovitost mešanega zdravila pa ni bila dokazana.
English: The lyophilised fraction of Porcilis PRRS (containing the live virus antigen) would be reconstituted in the inactivated vaccine Porcilis M Hyo.
Slovenian: Liofilizirana frakcija zdravila Porcilis PRRS (ki vsebuje antigen živega virusa) bi bila rekonstituirana v inaktiviranem cepivu Porcilis M Hyo.
English: The live vaccine is composed of a lyophilised fraction, which includes the antigen, and a solvent for suspension for injection.
Slovenian: Živo cepivo je sestavljeno iz liofilizirane frakcije, ki vsebuje antigen in vehikel za supenzijo za injiciranje.
English: Pregnant sows should only be vaccinated after previous exposure to European PRRS virus.
Slovenian: Breje svinje smemo cepiti samo, če so že bile izpostavljene evropskemu virusu PRRS.
English: Data on two laboratory efficacy studies were provided showing that reduction of PRRS viraemia of pigs vaccinated with the mixed product is similar to the reduction of PRRS viraemia of pigs vaccinated with Porcilis PRRS alone.
Slovenian: Predloženi so bili podatki iz dveh študij laboratorijske učinkovitostI, ki so pokazali, da je zmanjšanje viremije zaradi PRRS pri prašičih, ki so prejeli mešano cepivo, podobno zmanjšanju viremije zaradi PRRS pri prašičih, ki so prejeli samo cepivo Porcilis PRRS.
English: The claims of Porcilis PRRS, indications section of SPC (section 4.2) are: “For active immunisation of clinically healthy pigs in a PRRS virus contaminated environment, to reduce viraemia caused by infection with European strains of PRRS virus.
Slovenian: Navedbe za zdravilo Porcilis PRRS, razdelek z navedbami v povzetku glavnih značilnosti zdravila (razdelek 4.2) so: „za aktivno imunizacijo klinično zdravih prašičev v okolju, kjer je prisoten virus PRRS, za zmanjšanje viremije, ki jo povzročajo okužbe z evropskimi sevi virusa PRRS.
English: The serological response to PRRS vaccination was also found similar in both groups of pigs.
Slovenian: V obeh skupinah prašičev je bil podoben tudi serološki odziv na cepljenje s PRRS.
English: The marketing authorisation holder has justified the absence of data demonstrating all efficacy claims for the mixed product.
Slovenian: Imetnik dovoljenja za promet z zdravilom je utemeljil pomanjkanje podatkov, ki bi dokazovali vse navedbe za mešano zdravilo.
English: For finishing pigs a single dose is given, which may be administered intradermally or intramuscularly.
Slovenian: Pri prašičih, ki se redijo za zakol, se daje en odmerek, in sicer intradermalno ali intramuskularno.
English: The marketing authorisation holder was requested to provide additional data and justification that the efficacy claims and duration of immunity of Porcilis PRRS are not altered when the vaccine is administered mixed with Porcilis M Hyo.
Slovenian: Imetnik dovoljenja za promet z zdravilom je bil pozvan, naj predloži dodatne podatke in utemeljitev, da se zahteve učinkovitosti in trajanje imunosti za zdravilo Porcilis PRRS ne spremenijo, če se cepivo daje mešano s cepivom Porcilis M Hyo.
English: Freeze-dried vaccine:
Slovenian: Cepivo v obliki liofilizata:
English: 2.1 In-use shelf-life proposed after mixing the two products (Porcilis PRRS and Porcilis M Hyo)
Slovenian: 2.1 Predlagani rok uporabnosti po mešanju obeh zdravil (Porcilis PRRS in Porcilis M Hyo)
English: 4.8 Interaction with other medicinal products and other forms of interaction Safety and efficacy data for intramuscular injection are available in finishing pigs from 4 weeks of age onwards, which demonstrate that this vaccine can be mixed with Porcilis M Hyo.
Slovenian: 4.8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Na voljo so podatki o varnosti in učinkovitosti pri prašičih pitancih od 4 tednov starosti, ki dokazujejo, da lahko cepivo mešamo s cepivom Porcilis Hyo.
English: The marketing authorisation holder considered that, based on the Guideline on requirements for concurrent administration of immunological veterinary medicinal products1, the efficacy data of the individual products, including duration of immunity, can be applied for the concurrent use of them if absence of immunological interference is demonstrated.
Slovenian: Imetnik dovoljenja za promet z zdravilom je menil, da je na podlagi smernice glede zahtev za sočasno uporabo imunoloških zdravil za uporabo v veterinarski medicini1 podatke o učinkovitosti posameznih zdravil, vključno s trajanjem imunosti, mogoče uporabiti za sočasno uporabo teh zdravil, če je dokazana odsotnost imunološkega medsebojnega vpliva.
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS
Slovenian: DOPOLNILA, KI NAJ BODO VKLJUČENA V USTREZNE RAZDELKE POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA
English: As regards justifying why no potency test of the Porcilis M Hyo component has been carried out on the mixed vaccines both immediately after mixing and after the proposed in-use shelf life, the marketing authorisation holder has justified not performing a potency test for the Porcilis M Hyo component on the mixed vaccines that by provision of safety and efficacy studies using the mixed product the marketing authorisation holder has shown that there are no interactions within the mixture affecting the potency of the mixed product.
Slovenian: Kar zadeva vprašanje, zakaj ni bil izveden preskus jakosti komponente Porcilis M Hyo z mešanimi cepivi neposredno po mešanju in po izteku predlaganega roka uporabnosti, je imetnik dovoljenja za promet z zdravilom odgovoril, da preskusa jakosti komponente Porcilis M Hyo z mešanimi cepivi ni izvedel, ker je že s predložitvijo študij varnosti in učinkovitosti z uporabo mešanega zdravila pokazal, da v mešanici ni interakcij, ki bi vplivale na jakost mešanega zdravila.
English: Duration of immunity of Porcilis PRRS has also not been demonstrated for simultaneous administration.
Slovenian: Prav tako ni bilo dokazano trajanje imunosti po dajanju zdravila Porcilis PRRS za sočasno uporabo.
English: List of the names, pharmaceutical form, strength of the Veterinary medicinal products, animal species, routes of administration, withdrawal period, marketing authorisation holders in the Member states
Slovenian: SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, NAČINOV
English: Newly introduced PRRS virus-naïve animals (e.g. replacement gilts from PRRS virusnegative herds) should be vaccinated prior to pregnancy.
Slovenian: Nove živali, ki niso okužene z virusom PRRS (npr. nadomestne mladice iz čred, ki niso okužene z virusom PRRS), je treba cepiti pred brejostjo.
English: It is indicated for use in breeding and finishing pigs from 2 weeks of age.
Slovenian: Namenjeno je za uporabo pri prašičih, namenjenih za razplod in za zakol, starejših od 2 tednov.
English: 1 CVMP Guideline on data requirements to support in-use stability claims for veterinary vaccines (EMEA/CVMP/IWP/250147/2008-CONSULTATION) - http://www.ema.europa.eu/pdfs/vet/iwp/25014708en.pdf
Slovenian: 1 CVMP Guideline on data requirements to support in-use stability claims for veterinary vaccines (Smernica o zahtevah glede podatkov v podporo zahtevkov po stabilnosti cepiv za uporabo v veterinarski medicini) (EMEA/CVMP/IWP/250147/2008-CONSULTATION) - http://www.ema.europa.eu/pdfs/vet/iwp/25014708en.pdf opaziti znatno izboljšanje rezultatov pri vzreji (zmanjšana morbidnost, ki jo povzroča okužba z virusom PRRS in boljša dnevna rast in sprememba krme) do konca dobe vzreje.
English: Maternally derived antibodies may interfere with the response to vaccination.
Slovenian: Na odgovor na cepljenje lahko vplivajo od matere pridobljene protitelesa.
English: The variation of concern consists of allowing the mixing of two vaccines, Porcilis PRRS and Porcilis M Hyo, before administration.
Slovenian: Zadevna sprememba vključuje dovoljenje za mešanje dveh cepiv, Porcilis PRRS in Porcilis M Hyo, pred uporabo.
English: Scientific conclusions and grounds for the granting of the variation of the marketing authorisations
Slovenian: ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA ODOBRITEV SPREMEMBE DOVOLJENJ ZA PROMET Z ZDRAVILOM
English: Vaccination scheme: A single dose is given to pigs from 2 weeks of age onwards.
Slovenian: Shema cepljenja: Enkratni odmerek prašičem od starosti 2 tednov.
English: 2.2 Justification of the current claim for Porcilis PRRS concerning a significant improvement of rearing results (reduced morbidity due to PRRS infection, and a better daily growth and feed conversion) until the end of the fattening period when mixed with Porcilis M Hyo.
Slovenian: 2.2 Utemeljitev trenutne navedbe za zdravilo Porcilis PRRS, ki zadeva znatno izboljšanje rezultatov pri vzreji (zmanjšana morbidnost, ki jo povzroča okužba z virusom PRRS in boljša dnevna rast in sprememba krme) do konca dobe vzreje, kadar je mešano z zdravilom Porcilis M Hyo.
English: Concerning Porcilis M Hyo the marketing authorisation holder has submitted data of adjuvant content (dl-α-tocopherol acetate), pH and sterility of the mixture after reconstitution of 2 batches of Porcilis PRRS in 2 batches of Porcilis M Hyo after storage for 3 hours at room temperature.
Slovenian: Za zdravilo Porcilis M Hyo je imetnik dovoljenja za promet z zdravilom predložil podatke o vsebini adjuvansa (dl--tokoferol acetat), vrednosti pH in sterilnosti mešanice po rekonstituciji dveh serij zdravila Porcilis PRRS v dveh serijah zdravila Porcilis M Hyo po 3 urah hranjenja pri sobni temperaturi.
English: The marketing authorisation holder has justified that the current duration of immunity for Porcilis PRRS is still supported when the two products are mixed.
Slovenian: Imetnik dovoljenja za promet z zdravilom je utemeljil, da je trenutno trajanje imunosti za zdravilo Porcilis PRRS ob mešanju obeh zdravil še vedno podprto.
English: The proposed vaccination scheme for finishing pigs with the mixed product is: first administration of Porcilis M Hyo from one week of age followed by the administration of Porcilis PRRS mixed with Porcilis M Hyo from 4 weeks of age.
Slovenian: Predlagana shema cepljenja za prašiče, ki se redijo za zakol, v mešanem zdravilu je: prvo dajanje zdravila Porcilis M Hyo od starosti enega tedna dalje, čemur sledi dajanje mešanice zdravil Porcilis PRRS in Porcilis M Hyo od starosti 4 tednov dalje.
English: A single dose (2 ml) of Porcilis PRRS mixed with Porcilis M Hyo is given intramuscularly in the neck.
Slovenian: Cepimo z enkratnim odmerkom (2 ml) Porcilisa PRRS, pomešanega s Porcilisom H Hyo, intramuskularno na vratu.
English: - the CVMP considered that stability of the mixed product up to 1 hour after mixing as claimed on the Summary of Product Characteristics was supported by the data provided, - the CVMP considered that the efficacy of the mixed vaccine regarding the PRRS component was sufficiently supported by the data provided, the CVMP has recommended the granting of the variation of the Marketing Authorisations for Porcilis PRRS and associated names (see Annex I).
Slovenian: - CVMP meni, da so predloženi podatki zadostno podprli učinkovitost mešanega cepiva z vidika komponente PRRS, je CVMP priporočil odobritev spremembe dovoljenj za promet z zdravilom Porcilis PRRS in povezanimi imeni (glejte Dodatek I).
English: The marketing authorisation holder has provided data of the PRRS virus titration after mixing Porcilis PRRS with Porcilis M Hyo at 0, 1, 2 and 3 hours.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil podatke o titraciji virusa PRRS po mešanju zdravila Porcilis PRRS z zdravilom Porcilis M Hyo po 0, 1, 2 in 3 urah.
English: Safety and efficacy data for intramuscular injection are available in finishing pigs from 4 weeks of age onwards, which demonstrate that this vaccine can be mixed with Porcilis M Hyo.
Slovenian: Na voljo so podatki o varnosti in učinkovitosti pri prašičih pitancih od 4 tednov starosti, ki dokazujejo, da lahko cepivo mešamo s cepivom Porcilis Hyo.
English: However, it was considered that all the claims to appear in the SPC should be demonstrated.
Slovenian: Vendar so menili, da bi morale biti dokazane vse navedbe v povzetku glavnih značilnosti zdravila.
English: The marketing authorisation holder provided data for PRRS virus titres of two batches of Porcilis PRRS reconstituted with each of ten batches of Porcilis M Hyo after 0, 1, 2 and 3 hours of storage at room temperature.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil podatke za titre virusa PRRS za dve seriji zdravila Porcilis PRRS, ki sta bili rekonstituirani z vsako od desetih serij zdravila Porcilis M Hyo po 0, 1, 2 in 3 urah hranjenja pri sobni temperaturi.
English: Porcilis M Hyo
Slovenian: Porcilis PRRS Porcilis M Hyo
English: No information is available on the safety and efficacy of the use of Porcilis PRRS mixed with Porcilis M Hyo in breeding animals or during pregnancy.
Slovenian: O varnosti in učinkovitosti uporabe Porcilisa PRRS, pomešanega s cepivom Porcilis M Hyo, pri vzrejnih živalih in med brejostjo ni podatkov
English: The marketing authorisation holder has justified by reference to the available data that the current efficacy claims for Porcilis PRRS are still supported when the two products are mixed.
Slovenian: S sklicevanjem na razpoložljive podatke je utemeljeval, da so trenutne navedbe o učinkovitosti za zdravilo Porcilis PRRS ob mešanju obeh zdravil še vedno podprte.
English: 1 CVMP Guideline on requirements for concurrent administration of immunological veterinary medicinal products (EMEA/CVMP/550/02-FINAL) - http://www.ema.europa.eu/pdfs/vet/iwp/055002en.pdf vaccines were mixed resulting in maintenance of the same level of efficacy by investigating one efficacy parameter, reduction in viraemia (reduction of 70-75% after simultaneous use and reduction of 72-75% after use of Porcilis PRRS alone).
Slovenian: Imetnik dovoljenja za promet z zdravilom je dokazal, da ni imunološkega medsebojnega vpliva ob mešanju cepiv, kar pomeni, da se ohrani ista raven učinkovitosti ob proučevanju enega parametra učinkovitosti „zmanjšanje viremije“ (zmanjšanje za 70-75 % po sočasni uporabi in zmanjšanje za 72-75 % po samostojni uporabi zdravila Porcilis PRRS).
English: The vaccine may be reconstituted shortly before vaccination for simultaneous use with Porcilis M Hyo in finishing pigs from 4 weeks of age and the following instructions should be used:
Slovenian: Pri simultani uporabi s Porcilisom M Hyo cepivo rekonstituiramo tik pred cepljenjem prašičev pitancev od starosti 4 tednov po naslednjih navodilih:
English: Batch release protocols for the in-use stability studies of Porcilis PRRS and Porcilis M Hyo were provided.
Slovenian: Protokoli za sproščanje serije, ki veljajo za študije stabilnosti zdravil Porcilis PRRS in Porcilis M Hyo med uporabo, so bili predloženi.
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE PACKAGE LEAFLET
Slovenian: DOPOLNILA, KI NAJ BODO VKLJUČENA V USTREZNE RAZDELKE NAVODILA ZA UPORABO
English: 85701 Unterschleißheim Germany
Slovenian: Unterschleißheim Nemčija
English: Luxembourg Intervet International BV Wim de Körverstraat 35
Slovenian: Luksemburg Intervet International BV
English: + 20 ml
Slovenian: 10 odmerkov + 20 ml
English: + 50 ml
Slovenian: 25 odmerkov + 50 ml
English: + 200 ml
Slovenian: 100 odmerkov + 200 ml
English: The marketing authorisation holder has demonstrated that the degree of protection conveyed by the individual products has not been altered by mixing the products by several laboratory challenge studies and field studies.
Slovenian: Z več dodatnimi laboratorijskimi študijami in terenskimi študijami je dokazal, da se z mešanjem zdravil stopnja zaščite posameznega zdravila ni spremenila.
English: Belgium Intervet International BV Wim de Körverstraat 35
Slovenian: Wim de Körverstraat 35
English: + 100 ml
Slovenian: 50 odmerkov + 100 ml
English: Whereas
Slovenian: nič dni
English: Amendments to the summary of product characteristics and package leaflet
Slovenian: DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODILA ZA UPORABO
English: Withdrawal period
Slovenian: 6.3 Rok uporabnosti
English: The product literature of Porcilis M Hyo should also be consulted before administration of the mixed product.
Slovenian: Pred dajanjem mešanega cepiva je treba prebrati informacije o cepivu Porcilis Hyo.
English: Member State/EEA
Slovenian: Država članica
English: Deseril Tablets 1mg 1mg
Slovenian: Tablete Deseril 1 mg 1 mg
English: Annex I List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, marketing authorisation holders in the member states
Slovenian: Priloga I Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila,
English: 2 Bath Road, Chippenham
Slovenian: Alliance Pharmaceuticals Ltd Avonbridge House 2 Bath Road, Chippenham Wiltshire, SN15 2BB United Kingdom
English: Marketing Authorisation Holder Invented name
Slovenian: Izmišljeno ime
English: Long-term exposure (at least 48 weeks)
Slovenian: Dolgotrajna izpostavljenost (najmanj 48 tednov)
English: (See sections 4.5 and 5.2.)
Slovenian: (gl. poglavji 4.5 in 5.2).
English: , increased appetite.
Slovenian: , povečan apetit
English: Date of first authorisation: 27 September 2007 Date of latest renewal: 26 July 2012
Slovenian: Datum prve odobritve: 27. september 2007 Datum zadnjega podaljšanja: 26. julij 2012
English: There are no adequate and well-controlled studies in pregnant women.
Slovenian: Pri nosečnicah niso bile opravljene dovolj dobro kontrolirane raziskave.
English: Your doctor will tell you how many Zalasta tablets to take and how long you should continue to take them.
Slovenian: Zdravnik vam bo povedal, koliko tablet Zalasta morate vzeti in kako dolgo naj bi jih jemali.
English: Interaction studies have only been performed in adults.
Slovenian: Raziskave interakcij so izvajali samo pri odraslih.
English: If this happens do not drive or operate any tools or machines.
Slovenian: Če se to zgodi, ne vozite in ne upravljajte orodij ali strojev.
English: Close medical supervision and monitoring should continue until the patient recovers.
Slovenian: S skrbnim zdravstvenim nadzorovanjem in opazovanjem je treba nadaljevati, dokler si bolnik ne opomore.