FrancophonIA/ELRC3.0 huggingface dataset:
English: Vaccine should not be stored back in -70°C after storage at or below -18°C.
Croatian: Cjepivo ne vraćati natrag na -70°C nakon čuvanja na ili ispod -18°C.
English: Where antibiotics must be used, preference should be given to agents with non mycoplasma activity, such as penicillin, amoxycillin or neomycin.
Croatian: U slučajevima kada se antibiotici moraju primijeniti, prednost treba dati onima koji ne deluju protiv mikoplazmi, kao što su penicilin, amoksicilin i neomicin.
English: To avoid skin and eye injuries which may occur by manipulating the frozen bottle, personal protective equipment consisting of gloves and safety glasses should be worn.
Croatian: Kako bi se izbjegle ozljede koje mogu nastati rukovanjem smrznutom bocom, treba koristit pribor za osobnu zaštitu koji se sastoji od zaštitne rukavice i naočala.
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Croatian: Nema dostupnih podataka o neškodljivosti i djelotvornosti ovog cjepiva kada se primjenjuje s bilo kojim drugim veterinarsko-medicinskim proizvodom.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Croatian: 4.10 Predoziranje (simptomi, hitni postupci, antidoti), ako je nužno Nisu zabilježene nuspojave nakon primjene 8-strukog predoziranja.
English: Do not use in birds in lay and within 5 weeks before the onset of the laying period.
Croatian: Ne primjenjivati na pticama koje nesu i unutar 5 tjedana prije početka perioda nesenja.
English: MS-H Vaccine eye drops suspension M. synoviae strain MS-H
Croatian: MS-H Cjepivo, kapi za oči, suspenzija M. synoviae soj MS-H
English: For active immunisation of future broiler breeder chickens, future layer breeder chickens and future layer chickens from 5 weeks of age to reduce air sac lesions and reduce the number of eggs with abnormal shell formation caused by Mycoplasma synoviae.
Croatian: Za aktivnu imunizaciju pilića budućih brojlera, pilića budućih roditelja i pilića budućih nesilica starijih od 5 tjedana, kako bi se smanjile lezije zračnih vrećica i smanjio broj jaja s abnormalno formiranom ljuskom koje uzrokuje Mycoplasma synoviae.
English: Thaw the unopened bottle rapidly between 33-35°C for a time period of 10 minutes in a thermostatic water bath.
Croatian: Brzo otopiti neotvorenu bocu na temperaturi 33- 35°C u trajanju od 10 minuta u termostatskoj vodenoj kupelji.
English: Store frozen below -70°C for a maximum of 4 years.
Croatian: Čuvati zamrznuto ispod -70°C, najduže 4 godine.
English: • Thaw unopened bottles rapidly between 33-35°C for a time period of 10 minutes in a thermostatic water bath.
Croatian: • Brzo otopiti neotvorenu bocu na temperaturi 33- 35°C u trajanju od 10 minuta u termostatskoj vodenoj kupelji.
English: • Remove the aluminium seal and rubber stopper before using a plastic dropper tip or other administration device.
Croatian: • Ukloniti aluminijski zatvarač i gumeni čep prije korištenja plastične kapaljke ili drugog sredstva primjene.
English: • If vaccine is accidentally splashed into the operator's eyes, the eyes and face should be thoroughly washed with water to avoid any potential reaction to culture medium constituents.
Croatian: • Ako cjepivo slučajno prsne u oči osobe koja njime rukuje, treba temeljito oprati oči i lice vodom kako bi se izbjegla bila kakva moguća reakcija na sastojke hranjivog medija.
English: Pullets should first be tested for M. synoviae infection.
Croatian: Pilenke treba prvo testirati na M. synoviae infekciju.
English: If vaccine is accidentally splashed into the operator's eyes, the eyes and face should be thoroughly washed with water to avoid any potential reaction to culture medium constituents.
Croatian: Ako cjepivo slučajno prsne u oči, osoba koja njime rukuje, treba temeljito oprati oči i lice vodom da bi se izbjegla bilo kakva moguća reakcija na sastojke hranjivog medija.
English: Mycoplasma synoviae strain MS-H live attenuated thermosensitive, at least 105.7 CCU* *colour changing units
Croatian: Mycoplasma synoviae živi, atenuirani, termoosjetljiv soj MS-H, najmanje 105,7 CCU* * jedinice mijenjanja boje
English: • The vaccine strain can spread from vaccinated to unvaccinated birds, including wild species.
Croatian: • Cjepni soj može prijeći sa cijepljenih na necijepljene ptice, uključujući i divlje vrste.
English: The duration of immunity to reduce the number of eggs with abnormal shell formation has not yet been demonstrated
Croatian: Trajanje imuniteta za smanjivanje broja jaja s abnormalno formiranom ljuskom još nije dokazano.
English: Use calibrated dropper or device, so as to distribute 30 µl drop of vaccine.
Croatian: Koristiti baždarenu kapaljku ili drugo sredstvo da odijeli kap cjepiva od 30 µl.
English: Red orange to straw translucent suspension.
Croatian: Crveno narančasto blijedo žuta prozirna suspenzija.
English: Remove the aluminium seal and rubber stopper before using a plastic dropper tip or other administration device.
Croatian: Ukloniti aluminijski zatvarač i gumeni čep prije korištenja plastične kapaljke ili drugog sredstva primjene.
English: NOTE: There is no outer carton
Croatian: Nema vanjskog pakovanja
English: • The vaccine strain can be detected in respiratory tract of the chickens until 55 weeks after vaccination.
Croatian: • Cjepni soj može se detektirati u respiratornom traktu pilića sve do 55 tjedana nakon cijepljenja.
English: The vaccine strain can be detected in respiratory tract of the chickens until 55 weeks after vaccination.
Croatian: Cjepni soj može se pronaći u respiratornom traktu pilića do 55 tjedana nakon cijepljenja.
English: The vaccine strain can spread from vaccinated to unvaccinated birds, including wild species.
Croatian: Cjepni soj može prijeći s cijepljenih na necijepljene ptice, uključujući i divlje vrste.
English: Ocular use.
Croatian: Primjena u oko.
English: Distinguishing between field strains and the vaccine strain of M. synoviae can be performed by Hammond classification or High Resolution Melt (HRM) testing by a laboratory.
Croatian: Diferencijacija između divljih sojeva i cjepnog soja M.synoviae može se napraviti testom Hammond klasifikacije ili testom topljenja visoke rezolucije (HRM) u laboratoriju.
English: If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Croatian: Ako zamijetite bilo koju ozbiljnu nuspojavu ili druge nuspojave koje nisu opisane u uputi o VMP,
English: Batch{number}
Croatian: Lot{broj}
English: Chickens
Croatian: Pilići.
English: Pharmacotherapeutic group: immunologicals for Aves, live bacterial vaccines ATCvet code: QI01AE03
Croatian: Farmakoterapijska skupina: cjepiva za ptice, živa bakterijska cjepiva , ATCvet kod: QI01AE03 Cjepivo izaziva aktivni imunitet, na Mycoplasmu synoviae kod pilića.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LDPE BOTTLE 30 ml LABEL
Croatian: OZNAKA ZA LDPE BOCU 30 ml
English: • Infection with M. synoviae induces a transient positive antibody response to Mycoplasma gallisepticum.
Croatian: • Infekcija sa M. synoviae izaziva kratkotrajnu pozitivnu reakciju antitijela na Mycoplasmu gallisepticum.
English: Vaccination should be carried out on M. synoviae -free birds at least 4 weeks before expected exposure to virulent M. synoviae.
Croatian: synoviae, najmanje 4 tjedna prije njihovog očekivanog izlaganja zaraznoj M. synoviae.
English: Infection with M. synoviae induces a transient positive antibody response to Mycoplasma gallisepticum.
Croatian: Infekcija s M. synoviae izaziva kratkotrajnu pozitivnu reakciju antitijela na Mycoplasmu gallisepticum.
English: * colour changing units For the full list of excipients, see section 6.1
Croatian: Potpuni popis pomoćnih tvari vidjeti u odjeljku 6.1.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ BIOLOŠKI DJELATNE TVAR PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE U PROMET
English: Only flocks with no antibodies to M. synoviae should be vaccinated.
Croatian: Treba cijepiti samo jata bez antitijela za M. synoviae.
English: • Only flocks with no antibodies to MS (M. synoviae) should be vaccinated.
Croatian: • Treba cijepiti samo jata bez antitijela za M. synoviae.
English: PACKAGE LEAFLET: MS-H Vaccine eye drops suspension
Croatian: UPUTA O VMP: MS-H Cjepivo, kapi za oči, suspenzija
English: One dose of 30 µl to be administered by eye drop.
Croatian: Jednu dozu od 30 µl primijeniti kao kap u oko.
English: Other ingredients:
Croatian: NAPOMENA:
English: One dose (30 µl) contains: Mycoplasma synoviae strain MS-H live attenuated thermosensitive, at least 105.7 CCU*
Croatian: Mycoplasma synoviae živi, atenuirani, termoosjetljivi soj MS-H, s najmanje 105,7 CCU* *jedinica mijenjanja boje
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE
Croatian: UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE C. IZVJEŠĆE O MRL
English: Name and address of the manufacturer responsible for batch release
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije u promet Laboratoire LCV
English: MS-H Vaccine eye drops suspension
Croatian: MS-H Cjepivo, kapi za oči, suspenzija
English: Laboratoire LCV Z.I.
Croatian: Bioproperties Pty Ltd
English: • To avoid skin and eye injuries which may occur by manipulating the frozen bottle, personal protective equipment consisting of gloves and safety glasses should be worn.
Croatian: • Kako bi se izbjegle ozljede koje mogu nastati rukovanjem smrznutom bocom, treba koristit
English: 4.7 Use during pregnancy, lactation or lay
Croatian: 4.7 Primjena tijekom graviditeta, laktacije ili nesenja Ne primjenjivati na pticama tijekom nesenja i 5 tjedana prije početka perioda nesenja.
English: For vaccination of future broiler breeder chickens, future layer breeder chickens and future layer chickens from 5 weeks of age to reduce air sac lesions and reduce the number of eggs with abnormal shell formation caused by Mycoplasma synoviae.
Croatian: tjedana kako bi se smanjile lezije zračnih vrećica i smanjio broj jaja s abnormalno formiranom ljuskom koje uzrokuje Mycoplasma synoviae.
English: ROUTE OF ADMINISTRATION
Croatian: KLINIČKE POJEDINOSTI
English: This summary was last updated in September 2013.
Croatian: Sažetak je posljednji put dopunjen rujna 2013.
English: Contact with the application site should be avoided.
Croatian: Treba izbjegavati kontakt s mjestom primjene.
English: Certifect must not be used on rabbits and cats.
Croatian: Certifect se ne smije primjenjivati u zečeva i mačaka.
English: Gloves are recommended.
Croatian: Preporučuje se upotreba zaštitnih rukavica.
English: Children should not be allowed to play with the treated dogs until the application site is dry.
Croatian: Djeci se ne smije dopustiti igranje s tretiranim psom sve dok se mjesto primjene ne osuši.
English: Certifect should not be allowed to enter surface water, as it may be harmful for aquatic organisms.
Croatian: Ne smije se dopustiti da Certifect uđe u površinske vode jer može biti štetan za vodene organizme.
English: Treatment should be repeated every month throughout the tick and/or flea seasons.
Croatian: Terapija se treba ponoviti svaki mjesec tijekom sezone krpelja i/ili buha.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Certifect on 6 May 2011.
Croatian: Europska komisija dodijelila je odobrenje za stavljanje u promet koje je na snazi na teritoriju Europske unije za proizvod Certifect dana 6. svibnja 2011.
English: The effectiveness was measured by counting the numbers of ticks and fleas on the dogs five to eight weeks after treatment.
Croatian: Djelotvornost je izmjerena brojanjem krpelja i buha na psima pet do osam tjedana nakon liječenja.
English: Certifect fipronil/(S)-methoprene/amitraz
Croatian: Certifect fipronil/(S)-metopren/amitraz
English: Other information about Certifect:
Croatian: Druge informacije o VMP-u Certifect:
English: People applying the medicine should not smoke, eat or drink, and should wash their hands thoroughly after use.
Croatian: Za vrijeme aplikacije ne preporuča se pušiti, piti ili jesti, a nakon primjene potrebno je temeljito oprati ruke.
English: This medicine can cause skin sensitisation and allergic reactions, and people with known allergy to any of the ingredients should avoid contact with the pipette contents.
Croatian: Ovaj VMP može izazvati osjetljivost kože i alergijske reakcije, a osobe s poznatim alergijama na bilo koji sastojak moraju izbjegavati kontakt sa sadržajem pipete.
English: This means that they kill parasites that live on the skin or in the fur of animals, such as ticks, fleas and lice.
Croatian: To znači da ubijaju parazite koji žive na koži ili u krznu životinja, poput krpelja, buha i uši.
English: Both fipronil and amitraz kill adult parasites while (S)-methoprene kills parasites at the egg or larval stage.
Croatian: Fipronil i amitraz ubijaju odrasle parazite dok (S)metopren ubija parazite u stadiju jajašca ili ličinke.
English: What is Certifect?
Croatian: Što je Certifect?
English: Dogs may lack energy, show lack of muscle coordination, vomit, have a loss of appetite, diarrhoea, salivate, have blood sugar levels higher than normal, be more sensitive to stimulation, and have a slow heartbeat or slow breathing.
Croatian: Mogu se javiti manjak energije, manjak mišićne koordinacije, povraćanje, nedostatak apetita, dijareja, prekomjerna salivacija, povišene razine šećera u krvi, pojačana osjetljivost na podražaje, i usporen srčani ritam ili usporeno disanje.
English: In addition, it has been shown that ticks detach more quickly from treated dogs, which indirectly reduces the risk of transmission of certain tickborne diseases to dogs from infected ticks.
Croatian: Nadalje, dokazano je da se krpelji brže odvajaju od tretiranih pasa, što neizravno smanjuje rizik od prijenosa određenih bolesti koje se prenose krpeljima na pse sa zaraženih krpelja.
English: Amitraz stimulates the nervous system of ticks, leading to hyperactivity and death of the ticks.
Croatian: Amitraz stimulira živčani sustav krpelja, uzrokujući hiperaktivnost i smrt krpelja.
English: Certifect must not be used on sick (e.g. with systemic diseases such as diabetes, or with a fever) or recovering animals.
Croatian: Certifect se ne smije primjenjivati u bolesnih životinja (primjerice sa sistemnom bolešću, poput dijabetesa ili vrućice) ili u životinja koje se oporavljaju od bolesti.
English: It is available as a ‘spot-on' solution in pipettes already filled with the correct amount needed to treat one dog depending on its weight.
Croatian: Dostupan je kao otopina za nakapavanje na kožu u pipetama već napunjenima ispravnom količinom potrebnom za liječenje pasa ovisno o težini.
English: The active substances in Certifect act as ‘ectoparasiticides'.
Croatian: Djelatne tvari u VMP-u Certifect djeluju kao „ektoparazitici”.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Certifect outweigh the risks for the approved indications and recommended that Certifect be given a marketing authorisation.
Croatian: Povjerenstvo za veterinarsko-medicinske proizvode (CVMP) zaključio je da koristi VMP-a Certifect nadmašuju rizike za odobrene indikacije, te je preporučio da se za Certifect izda odobrenje za stavljanje VMP-a u promet.
English: The effectiveness of Certifect against ticks and fleas was investigated in both laboratory and field studies.
Croatian: Djelotvornost VMP-a Certifect protiv krpelja i buha ispitana je laboratorijskim i terenskim ispitivanjima.
English: Certifect is a medicine that contains three active substances, fipronil, (S)-methoprene and amitraz.
Croatian: Certifect je veterinarsko-medicinski proizvod koji sadrži tri djelatne tvari: fipronil, (S)-metopren i amitraz.
English: The content of one full Certifect pipette (appropriate to the dog's weight) is applied directly to the dog's skin, after parting its fur, in two separate spots (halfway down the back of the neck, and at the base of the neck).
Croatian: Sadržaj jedne pune Certifect pipete (primjeren težini psa) primjenjuje se izravno na kožu psa nakon što se razmakne krzno, i to na dvije različite točke (u sredini vrata između zatiljka i lopatica, te ispred lopatica).
English: What is the risk associated with Certifect?
Croatian: Koji su rizici povezani s VMP-om Certifect?
English: In the main field study, dogs of various breeds, age groups, gender and different weights were treated with either Certifect or a similar ‘spot-on' medicine containing fipronil and (S)-methoprene.
Croatian: U glavnom terenskom ispitivanju, psi različitih pasmina, dobnih skupina, spolova i različitih težina liječeni su VMP-om Certifect ili sličnom otopinom za nakapavanje na kožu koja sadrži fipronil i (S)-metopren.
English: The studies showed that the effect of Certifect is comparable to that of the combination of fipronil with (S)-methoprene in reducing tick and flea counts in dogs.
Croatian: Ispitivanja su pokazala da je djelovanje VMP-a Certifect usporedivo s kombinacijom fipronila sa (S)metoprenom u smanjivanju broja krpelja i buha u pasa.
English: Dogs may show some temporary reactions at the site of application (skin discolouration, hair loss, itching or redness).
Croatian: Kod pasa se mogu manifestirati privremene reakcije u mjestu primjene (promjena boje kože, opadanje dlake, svrbež ili crvenilo).
English: Other studies were performed to investigate if Certifect reduced the risk of transmission of certain tick-borne diseases.
Croatian: Druga su ispitivanja provedena kako bi se istražilo je li Certifect smanjio rizik od prijenosa određenih bolesti koje se prenose krpeljima.
English: The medicine can be used in the management of flea allergy dermatitis (an allergic reaction to flea bites).
Croatian: VMP se može primjenjivati u suzbijanju alergijskog dermatitisa pasa uzrokovanog buhama (alergijska reakcija na ugrize buha).
English: These signs generally resolve without treatment and within one day.
Croatian: Znakovi su prolazni i uglavnom sami od sebe nestaju u roku 24 sata.
English: (S)Methoprene is absorbed into flea eggs or larvae, where it stops their development.
Croatian: (S)-metopren apsorbira se u jajašca ili ličinke buha, gdje
English: Certifect is used in dogs to treat and prevent infestations with ticks and fleas, and to treat infestations with chewing lice.
Croatian: Certifect se primjenjuje u pasa za liječenje i sprječavanje infestacije krpeljima i buhama, te za liječenje infestacija pasjom uši.
English: What is Certifect used for?
Croatian: Za što se Certifect koristi?
English: If side effects are seen, immediate medical assistance should be sought and the package leaflet or label shown to the doctor.
Croatian: Ako se primijete nuspojave, odmah potražite medicinsku pomoć i liječniku pokažite uputu o VMP-u ili etiketu.
English: The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Croatian: Omjer koristi i rizika naveden je u modulu znanstvene rasprave ovog EPAR-a.
English: Studies were also carried out to look at the effect of shampooing on the effectiveness of the medicine.
Croatian: Provedena su ispitivanja kako bi se istražilo djelovanje pranja šamponom na djelovanje VMP-a.
English: No studies of Certifect in the treatment of lice were presented, as field studies previously presented for the medicine containing fipronil and (S)methoprene were considered sufficient.
Croatian: Nisu dostavljena ispitivanja djelotvornosti VMP-a Certifect u liječenju uši, s obzirom da su prethodno dostavljena terenska ispitivanja za VMP koji sadrži fipronil i (S)-metopren smatrana dostatnima.
English: Fipronil works on channels in the cells of the nervous system of ticks and fleas, blocking the transfer of ions in and out of cells,
Croatian: Fipronil djeluje na kanale u stanicama živčanog sustava krpelja i buha, blokirajući prijenos iona u stanice i iz njih, što rezultira nekontroliranom aktivnošću središnjeg živčanog sustava i smrću ovih parazita.
English: What benefit has Certifect shown during the studies?
Croatian: Koje koristi VMP-a Certifect su utvrđene tijekom ispitivanja?
English: If accidental exposure to the eyes occurs, the eyes should be rinsed with water and in case of accidental exposure to the skin the skin should be washed with soap and water.
Croatian: U slučaju nehotičnog prolijevanja na kožu, potrebno ju je oprati sapunom i vodom.
English: How has Certifect been studied?
Croatian: Kako se Certifect ispitivao?
English: The medicine should be applied in a well-ventilated area.
Croatian: Kako bi se umanjila mogućnost udisanja, primijenite na otvorenom ili u dobro prozračenom prostoru.
English: For a full list of all side effects reported with Certifect, see the package leaflet.
Croatian: Potpuni popis nuspojava prijavljenih kor primjene VMP-a Certifect dostupan je u uputama o lijeku.
English: How does Certifect work?
Croatian: Certifect djeluje?
English: Influenza virus surface antigens*, inactivated: A/Vietnam/1194/2004 (H5N1) - like strain used (NIBRG-14) 7.5 micrograms** per 0.5 ml dose * propagated in eggs ** expressed in microgram haemagglutinin.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Površinski antigeni virusa influence (hemaglutinin i neuraminidaza)* soja: A/Vietnam/1194/2004 (H5N1)- poput kojeg je korišten soj (NIBRG-14) 7,5 mikrograma** po dozi od 0,5 ml
English: 9.75 milligrams polysorbate 80 1.175 milligrams sorbitan trioleate 1.175 milligrams l t o r
Croatian: Cjepivo sadrži 9,75 mg skvalena, 1,175 mg polisorbata 80 i 1,175 mg sorbitantrioleata u 0,5 ml.
English: Route of Administration
Croatian: Plan upravljanja rizicima
English: Strength Pharmaceutical Form
Croatian: FARMAKOLOŠKA SVOJSTVA
English: EU Number
Croatian: DRUGO
English: Packaging Content (concentration) Package size
Croatian: 6.5 Vrsta i sadržaj spremnika
English: 1 pre-filled syringe
Croatian: Samo jedno cijepljenje
English: 10 pre-filled syringes
Croatian: 4.8 Nuspojave
English: (Invented) name
Croatian: NAZIV GOTOVOG LIJEKA
English: These should be submitted to the National Competent Authorities: Within 1 month of the Commission decision.
Croatian: U roku od jednog mjeseca od odluke Komisije.
English: The marketing authorisation holders shall complete the below conditions, within the stated timeframe, and competent authorities shall ensure that the following is fulfilled:
Croatian: Nositelji odobrenja za stavljanje u promet moraju ispuniti uvjete u nastavku u navedenom roku, a nadležna tijela osiguravaju ispunjavanje sljedećih uvjeta:
English: The details of the visual reminder should be agreed at national level and be subject to a user test taking into account input from local patient representatives.
Croatian: Detalje vizualnog podsjetnika treba dogovoriti na nacionalnoj razini, podložno ispitivanju korisnica i uzimajući u obzir doprinos lokalnih predstavnika bolesnika.
English: These materials should ensure that prescriber are informed and the patients understand and acknowledge the risks associated with valproate in-utero exposure.
Croatian: Tim bi se materijalima trebalo osigurati da su propisivači informirani te da bolesnice razumiju i prihvaćaju rizike povezane s in utero izlaganjem valproatu.
English: With regards to the studies abovementioned, the MAHs are strongly encouraged to collaborate and perform joint studies.
Croatian: U pogledu prethodno navedenih ispitivanja, nositelje odobrenja za stavljanje lijeka u promet snažno se potiče na suradnju i provođenje zajedničkih ispitivanja.
English: All MAHs should have in place a Risk management plan (RMP).
Croatian: Svi nositelji odobrenja za stavljanje lijeka u promet trebaju uspostaviti plan upravljanja rizikom.
English: The MAHs of medicinal products with substances related to valproate shall develop and submit educational materials according to agreed core elements.
Croatian: Nositelji odobrenja za stavljanje u promet lijekova koji sadrže tvari povezane s valproatom moraju izraditi i dostaviti edukacijske materijale u skladu s dogovorenim ključnim elementima.