FrancophonIA/ELRC3.0 huggingface dataset:
English: Duaklir Genuair reduced the use of rescue medication over 6 months compared to placebo (by 0.9 puffs per day [p<0.0001]), aclidinium (by 0.4 puffs/day [p<0.001]) and formoterol (by 0.2 puffs/day [p=0.062]).
Croatian: Uporaba lijekova za hitno ublažavanje simptoma Duaklir Genuair je smanjio uporabu lijekova za hitno ublažavanje simptoma tijekom 6 mjeseci u usporedbi s placebom (za 0,9 udisaja dnevno [p < 0,0001]), aklidinijem (za 0,4 udisaja dnevno [p < 0,001]) i formoterolom (za 0,2 udisaja dnevno[p=0,062]).
English: a) Before first use, tear open the sealed bag and remove the inhaler.
Croatian: d) Prije prve uporabe otvorite zatvorenu vrećicu i izvadite inhalator.
English: - If you have thyroid gland problems (thyrotoxicosis).
Croatian: - ako imate tegobe sa štitnjačom (tirotoksikoza).
English: Renal impairment No dose adjustments are required in patients with renal impairment (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu za bolesnike s oštećenjem bubrega (vidjeti dio 5.2).
English: How to store Duaklir Genuair
Croatian: Kako primjenjivati Duaklir Genuair
English: There is limited evidence on the management of overdose with Duaklir Genuair.
Croatian: Podaci o zbrinjavanju predoziranja Duaklir Genuairom su ograničeni.
English: Hepatic impairment No dose adjustments are required in patients with hepatic impairment (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu za bolesnike s oštećenjem jetre (vidjeti dio 5.2).
English: Pull off the cap by lightly squeezing the arrows marked on each side (Figure B).
Croatian: f) Da biste skinuli kapicu, lagano pritisnite strelice na njezinim bočnim stranama i povucite kapicu (Slika B).
English: What Duaklir Genuair is used for
Croatian: Za što se koristi Duaklir Genuair
English: Duaklir Genuair 340 mcg/12 mcg inhalation powder aclidinium/formoterol fumarate dihydrate
Croatian: Duaklir Genuair 340/12 μg, prašak inhalata aklidinij/formoterolfumarat dihidrat
English: Manufacturer: Industrias Farmacéuticas Almirall, S.A.
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet Industrias Farmacéuticas Almirall, S.A.
English: Duaklir Genuair 340 micrograms/12 micrograms inhalation powder aclidinium/formoterol fumarate dihydrate
Croatian: Duaklir Genuair 340/12 mikrograma, prašak inhalata aklidinij/formoterolfumarat dihidrat
English: Duaklir Genuair should be discontinued in case of overdose.
Croatian: U slučaju predoziranja, primjenu Duaklir Genuaira treba prekinuti.
English: Before first use, tear open the sealed bag and remove the inhaler.
Croatian: Pokazivač doze a) Prije prve uporabe otvorite zatvorenu vrećicu i izvadite inhalator.
English: See the end of section 4 for how to report side effects.
Croatian: Za postupak prijavljivanja nuspojava, pogledajte dio 4 .
English: How to store Duaklir Genuair 6.
Croatian: Kako čuvati Duaklir Genuair
English: Milk: 5 days.
Croatian: Mlijeko: 5 dana.
English: The following instructions should therefore be followed carefully.
Croatian: Stoga je potrebno pažljivo slijediti upute u nastavku.
English: Wash the udder if it is dirty.
Croatian: Operite vime ako je prljavo.
English: Date of last renewal: 08/02/2006
Croatian: Datum posljednjeg produljenjaodobrenja: 08/02/2006
English: Hold eyelids open to ensure complete contact with water.
Croatian: Kapke držite otvorenima kako biste osigurali potpuni kontakt s vodom.
English: Flush eyes with water for 15 minutes immediately after exposure.
Croatian: Ispirite oči vodom 15 minuta odmah nakon izlaganja.
English: Susceptibility testing of the target bacteria should be carried out prior to treatment.
Croatian: Testiranje osjetljivosti ciljnih bakterija treba provesti prije liječenja.
English: The product is indicated for use in lactating dairy cows and can be used during pregnancy.
Croatian: Ovaj proizvod je namijenjen za primjenu u mliječnih krava u laktaciji i može se primjenjivati tijekom graviditeta.
English: Do not store above 25 °C.
Croatian: Ne čuvati iznad 25° C.
English: Similar concentrations were reached at 12 and 24 hours after a second infusion at a 24 hour interval.
Croatian: Slične koncentracije dosegnute su 12 i 24 sata nakon drugog infundiranja u intervalu od 24 sata.
English: The excipients listed in section 6.1 of the SPC are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Croatian: Smatra se da su pomoćne tvari navedene u odjeljku 6.1 u SPC-u unutar okvira regulative (EK) br. 470/2009 kada su upotrijebljene na način kao u ovom veterinarsko medicinskom proizvodu.
English: This means it will be more active in an acid environment and tends to concentrate, relative to plasma, in areas with lower pH, such as abscesses.
Croatian: To znači da će biti aktivniji u kiselom okolišu i da je sklon koncentriranju, u odnosu na plazmu, u područjima s nižim pH, na primjer u apscesima.
English: Of the dose infused, 10-13% is excreted in the urine, and 24-30% via the faeces; the remainder is excreted in the milk.
Croatian: Od infundirane doze 10-13% izlučuje se u urinu, 24-30% u izmetu, a ostatak u mlijeku.
English: Insertion: Remove the white end cap by pulling straight up.
Croatian: Uvođenje: Uklonite bijeli čep povlačenjem ravno prema gore.
English: Pirlimycin has a basic pKa (8.5).
Croatian: Pirlimicin ima bazični pH (8,5).
English: Do not treat cows with palpable udder changes due to chronic subclinical mastitis.
Croatian: Ne davati kravama s opipljivim promjenama vimena zbog kroničnog subkliničkog mastitisa.
English: Clean hands before handling the cow's udder.
Croatian: Operite ruke prije diranja vimena krave.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Croatian: 4.10 Predoziranje (simptomi, hitni postupci, antidoti), ako je nužno Nema dostupnih podataka o predoziranju.
English: EXPIRY DATE EXP {month/year}
Croatian: EXP {mjesec, godina}
English: Meat and offal: 23 days.
Croatian: Meso i iznutrice: 23 dana.
English: Shelf life of the veterinary medicinal product as packaged for sale: 3 years 6.4.
Croatian: Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju:: 3 godine.
English: The active substance in Pirsue 5mg/ml intramammary solution for cattle is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Croatian: Djelatna tvar u Pirsue 5 mg/ml intramamarne otopine za goveda je dopuštena kao što je opisano u tablici 1 Dodatka Uredbe Vijeća (EU) Br. 37/2010.
English: Treatment of infections due to Gram-negative bacteria such as E. coli.
Croatian: Liječenje infekcija uzrokovanih gram-negativnim bakterijama kao što je E. coli.
English: Pirlimycin
Croatian: Pirlimicin
English: SPECIAL STORAGE CONDITIONS Do not store above 25 °C.
Croatian: 11. POSEBNI UVJETI ČUVANJA Ne čuvati iznad 25° C.
English: The treatment consists of eight infusions of one syringe every 24 hours.
Croatian: Liječenje se sastoji od osam infundiranja po jedne štrcaljke svaka 24 sata.
English: The teat end should be cleaned until no more dirt appears on the swab.
Croatian: Kraj sise treba čistiti dok na vati više ne bude prljavštine.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 29/01/2001
Croatian: Datum prvog odobrenja: 29/01/2001
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Croatian: Posebne mjere opreza k koje mora poduzeti osoba koja primjenjuje veterinarsko-medicinski proizvod na životinjama
English: Wash hands and any exposed skin with soap and water and remove contaminated clothing immediately after use.
Croatian: Operite ruke i svu izloženu površinu kože sapunom i vodom i skinite onečišćenu odjeću odmah nakon upotrebe.
English: After intramammary infusion, mean parent concentrations in milk were 10.3 µg/ml at 12 hours and 0.77 µg/ml at 24 hours.
Croatian: Nakon intramamarne primjene srednje ishodišne koncentracije u mlijeku iznosile su 10,3 µg/ml nakon 12 sati i 0,77 µg/ml nakon 24 sata.
English: Enteric bacteria such as E. coli are intrinsically resistant to pirlimycin.
Croatian: Crijevne bakterije poput E. coli intrinzično su otporne na pirlimicin.
English: Any unused veterinary medical product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with the local requirements.
Croatian: Bilo koji neupotrijebljeni veterinarsko-medicinski proizvod ili otpadni materijali dobiveni primjenom tih veterinarsko-medicinskih proizvoda trebaju se odlagati u skladu s lokalnim propisima.
English: Resistance against pirlimycin.
Croatian: Otpornost na pirlimicin.
English: TARGET SPECIES Cattle (lactating dairy cows)
Croatian: CILJNE VRSTE ŽIVOTINJA Goveda (mliječne krave u laktaciji)
English: They work by binding to the 50S ribosomal subunit, therefore hindering the aminoacyl-tRNA binding and inhibiting the peptidyltransferase reaction, which interferes with protein synthesis within the bacteria.
Croatian: Mycoplasme spp. Djeluju vezivanjem 50S ribosomne podjedinice, sprečavajući tako vezivanje aminoaciltRNA i inhibirajući reakciju peptidiltransferaze, što interferira sa sintezom proteina unutar bakterija.
English: Administration: by intramammary infusion only.
Croatian: Primjena: samo intramamarnom infuzijom.
English: Keep the syringes in the original container.
Croatian: Čuvati štrcaljke u originalnom spremniku.
English: Infuse one syringe (50 mg pirlimycin) into each infected quarter.
Croatian: Infundirajte jednu štrcaljku (50 mg pirlimicina) u svaku inficiranu četvrt.
English: 6.2 Major incompatibilities
Croatian: 6.2 Glavne inkompatibilnosti Nisu poznate.
English: For the treatment of subclinical mastitis in lactating cows due to Gram-positive cocci susceptible to pirlimycin including staphylococcal organisms such as Staphylococcus aureus, both penicillinase-positive and penicillinase-negative, and coagulase-negative staphylococci; streptococcal organisms including Streptococcus agalactiae, Streptococcus dysgalactiae and Streptococcus uberis.
Croatian: Za liječenje subkliničkog mastitisa u krava u laktaciji zbog gram-pozitivnih koka osjetljivih na pirlimicin, uključujući stafilokoke kao što su Staphylococcus aureus (penicilinaza-pozitivan i penicilinaza-negativan) te koagulaza-negativne stafilokoke i streptokokne organizme, uključujući Streptococcus agalactiae, Streptococcus dysgalactiae i Streptococcus uberis.
English: Push plunger with continuous pressure gently and slowly to dispense entire contents into the gland and massage the quarter to distribute the product into the milk cistern.
Croatian: Nježno i polako neprestano gurajte klip da biste istisnuli čitav sadržaj u žlijezdu i masirajte četvrtinu da bi se proizvod distribuirao u mliječnu cisternu.
English: Pirlimycin has been shown to accumulate in polymorphonuclear cells, however, intracellular killing of Staphylococcus aureus was not demonstrated.
Croatian: Dokazano je da se pirlimicin akumulira u polimorfonuklearnim stanicama, međutim, unutarstanično ubijanje zlatnog stafilokoka nije dokazano.
English: Gram-positive isolates with an MIC > 2 µg/ml are to be considered resistant.
Croatian: Gram-pozitivni izolati kod kojih je minimalna inhibitorna koncentracija veća od 2 µg/ml trebaju se smatrati otpornima.
English: Do not touch cleaned teat ends before administering the infusion substance.
Croatian: Ne dodirujte očišćene krajeve sisa prije primjene tvari za infundiranje.
English: Avoid contact with the solution.
Croatian: Izbjegavajte kontakt s otopinom.
English: Also packaged as 120 x 10 ml syringes in a plastic bucket.
Croatian: Dostupna su i pakovanja od 120 x 10 ml štrcaljki u plastičnom spremniku.
English: The lincosamides (clindamycin, lincomycin, and pirlimycin) inhibit protein synthesis in Gram-positive and in anaerobic bacteria as well as in Mycoplasma spp.
Croatian: Linkozamidi (klindamicin, linkomicin i pirlimicin) inhibiraju sintezu proteina u gram-pozitivnih i anaerobnih bakterija, kao i u
English: Where necessary, wash teats thoroughly with warm water containing a suitable dairy cleansing agent and dry them thoroughly.
Croatian: Ako je to potrebno, temeljito operite sise toplom vodom s dodatkom sredstva za čišćenje koje je prikladno za upotrebu u proizvodnji mlijeka, a zatim ih temeljito osušite.
English: Norbrook Laboratories Limited Station Works, Camlough Road, Newry, County Down, BT35 6JP
Croatian: Norbrook Laboratories Limited Station Works, Camlough Road,
English: Keep the syringes in the outer carton.
Croatian: Držati štrcaljke u vanjskoj kartonskoj kutiji.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label and the container.
Croatian: Ne koristite veterinarsko-medicinski proizvodposlijeisteka roka valjanosti naznačenogna etiketi i spremniku.
English: Intramammary use.
Croatian: Intramamarna primjena.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE 8 x 10 ml syringes in an outer carton box 24 x 10 ml syringes in an outer carton box, including 3 package inserts 120 x 10 ml syringes in a plastic bucket, including 15 package inserts
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU 8 štrcaljki od 10 ml u vanjskoj kartonskoj kutiji 24 štrcaljke od 10 ml u vanjskoj kartonskoj kutiji, uključujući 3 upute o VMP 120 štrcaljki od 10 ml u plastičnom spremniku, uključujući 15 uputa o VMP
English: Keep out of the sight and reach of children
Croatian: Držatiizvan dosega i pogleda djece.
English: WITHDRAWAL PERIOD(S) Meat and offal: 23 days.
Croatian: KARENCIJA(E) Meso i iznutrice: 23 dana.
English: Pirlimycin hydrochloride is a semi-synthetic lincosamide antibiotic.
Croatian: Pirlimicin hidroklorid polusintetski je antibiotik iz skupine linkozamida.
English: Therapeutic classification
Croatian: Terapijska klasifikacij a
English: Gently insert the cannula into the teat canal; carefully infuse the product.
Croatian: Nježno uvedite kanilu u sisni kanal , pažljivo infundirajte proizvod.
English: ATC vet code: QJ51FF90
Croatian: Farmakoterapijska grupa: antibakterijsko sredstvo za intramamarnu primjenu ATC vet kod: QJ51FF90
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {label on the syringe}
Croatian: OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA MALIM UNUTARNJIM PAKOVANJIMA
English: EU/2/00/027/002
Croatian: EU/2/00/027/001 EU/2/00/027/002 EU/2/00/027/003
English: 4.6 Adverse reactions (frequency and seriousness)
Croatian: 4.6 Nuspojave (učestalost i ozbiljnost) Nisu poznate.
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Croatian: Tiskana uputa o VMPmora sadržavati ime i adresu proizvođača odgovornog za puštanje dotične serije u promet.
English: Special precautions for use in animals
Croatian: Posebne mjere opreza prilikom primjene nna životinjama
English: Cross-resistance may occur between pirlimycin and other lincosamides or macrolides.
Croatian: Između pirlimicina i ostalih linkozamida ili makrolida može doći do križne rezistencije.
English: Use a separate disinfectant towelette for each teat.
Croatian: Za svaku sisu upotrijebite zasebni dezinfekcijski rupčić.
English: PACKAGE SIZE 8 x 10 ml intramammary syringes 24 x 10 ml intramammary syringes 120 x 10 ml intramammary syringes
Croatian: 8 intramamarnih štrcaljki od 10 ml 24 intramamarne štrcaljke od 10 ml 120 intramamarnih štrcaljki od 10 ml
English: Ensure adequate cleansing of the teat (and udder - if needed) before infusion.
Croatian: Prije infundiranja osigurajte odgovarajuću čistoću sise (i vimena, prema potrebi).
English: Pirlimycin Bovine 100 µg/kg 100 µg/kg
Croatian: 100 μg/kg 100 μg/kg 1000 μg/kg 400 μg/kg 100 μg/kg
English: Following infusion, dip all teats with a disinfectant teat dip.
Croatian: Nakon infudiranja umočite sve sise u tekućinu za dezinfekciju sisa.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Intramammary use
Croatian: DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, NAČIN I PUT(EVI) PRIMJENE
English: STATEMENT OF ACTIVE SUBSTANCES Pirlimycin hydrochloride equivalent to 50 mg pirlimycin per 10 ml syringe
Croatian: SASTAV DJELATNIH TVARI Pirlimicin hidroklorid ekvivalentan količini od 50 mg pirlimicina po štrcaljki od 10 ml
English: Disinfect teat end using a suitable cleansing agent.
Croatian: Dezinficirajte kraj sise prikladnim sredstvom za čišćenje.
English: PACKAGE LEAFLET: Pirsue 5 mg/ml intramammary solution for cattle
Croatian: UPUTA O VMP: Pirsue 5 mg/ml intramamarna otopina za goveda
English: 4.2 Indications for use, specifying the target species
Croatian: Goveda (mliječne krave u laktaciji) 4.2 Indikacije za primjenu, navesti ciljne vrste životinja
English: None known
Croatian: Nema unosa
English: Antiinfectious agents/ Antibiotics
Croatian: Antiinfekcij ski agensiIantibi otici
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Pirsue 5 mg/ml intramammary solution for cattle
Croatian: Pirsue 5 mg/ml intramamarna otopina za goveda
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Pirsue 5 mg/ml
Croatian: Pirsue 5 mg/ml
English: Liver Kidney Milk
Croatian: Salo Jetra Bubrezi
English: 4.8 Interaction with other medicinal products and other forms of interaction
Croatian: 4.8 Interakcije s drugim medicinskim proizvodima i drugi oblici interakcija Između pirlimicina i ostalih linkozamida ili makrolida može doći do križne otpornosti.
English: 6.5 Nature and composition of immediate packaging Sterile aqueous solution in 10 ml polyethylene intramammary syringes, packaged as 8 x 10 ml, 24 x 10 ml in an outer cardboard box.
Croatian: Sterilna vodena otopina u polietilenskim intramamarnim štrcaljkama od 10 ml, u pakovanjima od 8 x
English: Care must be taken not to introduce pathogens into the teat in order to reduce the risk of E. coli infections.
Croatian: Radi smanjenja opasnosti od infekcija E. coli potreban je oprez kako se u sise ne bi unijeli patogeni.
English: Pirlimycin hydrochloride equivalent to 50 mg pirlimycin per 10 ml syringe For the full list of excipients see Section 6.1
Croatian: Pirlimicin hidroklorid ekvivalentan količini od 50 mg pirlimicina po štrcaljki od 10 ml
English: Anhydrous citric acid
Croatian: Bezvodna limunska kiselina Natrijev citrat Voda za injekcije
English: Name and address of the manufacturers responsible for batch release
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije u promet: Norbrook Laboratories Limited
English: Animal species
Croatian: Pirlimicin goveda
English: PHARMACEUTICAL FORM Intramammary solution
Croatian: Farmakološki djelatna tvar
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) 50 mg Pirlimycin
Croatian: 50 mg pirlimicina
English: BATCH NUMBER Lot{number}
Croatian: PUT(EVI) PRIMJENE
English: Water for injection
Croatian: Intramamarna otopina
English: CONTRAINDICATIONS
Croatian: DODATAK
English: WITHDRAWAL PERIOD(S) Withdrawal period(s):
Croatian: Karencija(e):
English: Strength Pharmaceutical form
Croatian: Izmišljeno ime Jačina Farmaceutski oblik Ciljne vrste životinja
English: Tablet
Croatian: Pakovanje
English: EU (MA)Number
Croatian: EU broj odobrenja
English: --1 Porcine circovirus type 2 ORF2 protein RP 1.0-3.75 * Relative potency (ELISA test) by comparison with a reference vaccine
Croatian: --1 Svinjski cirkovirus tip 2, bjelančevina ORF2 RP* 1.0-3.75 * Relativna potentnost (ELISA test) u usporedbi s referentnim cjepivom
English: Suspension for
Croatian: Karencija
English: Strength Pharmaceutical Form
Croatian: Ime lijeka Jačina
English: Pack size l t o r
Croatian: Veličina pakiranja k i
English: EU/1/16/1102/001 Bortezomib SUN 3.5 mg Powder for solution for injection Intravenous use, Subcutaneous use vial (glass)
Croatian: EU/1/16/1102/001 Bortezomib SUN
English: Intravenous use vial (glass) concentrate: 1.2 ml; solvent: 1.8 ml
Croatian: 30 mg koncentrat i otapalo za otopinu za infuziju intravenska primjena bočica (staklo) koncentrat: 1.2 ml; otapalo: 1.8 ml
English: MA (EU) number
Croatian: <Broj (EU) odobrenja>
English: 1 vial + 1 vial
Croatian: 1 bočica+1 bočica
English: 4 March 2019
Croatian: 4. ožujka 2019.
English: 3 January 2019
Croatian: 3. siječnja 2019.
English: The results showed that among the study population compliance is very satisfactory; no firm conclusion could be drawn in special populations.
Croatian: Rezultati su pokazali da je u ispitivanoj populaciji suradljivost vrlo zadovoljavajuća, dok za posebne populacije nije bilo moguće donijeti čvrst zaključak.
English: The applicant will submit a draft study protocol within 3 months after approval, in Q2 2013 in order to be ready at the time of product launch in 2014.
Croatian: Podnositelj zahtjeva dostavit će nacrt protokola ispitivanja u roku od tri mjeseca nakon dobivanja odobrenja, u drugom tromjesečju 2013. godine, kako bi se ispitivanje moglo provesti u vrijeme stavljanja lijeka u promet tijekom 2014. godine.
English: November 2018 CMDh meeting
Croatian: Sastanak CMDh-a u studenom 2018.
English: The marketing authorisation holder(s) shall remove the following condition(s) (new text underlined and in bold, deleted text strike through):
Croatian: Nositelj(i) odobrenja za stavljanje lijeka u promet uklonit će sljedeći(e) uvjet(e) (novi tekst je podcrtan i podebljan, obrisani tekst je precrtan):
English: Therefore, in view of available data regarding the PASS final study report, the PRAC considered that changes to the conditions of the marketing authorisation were warranted.
Croatian: Stoga, s obzirom na dostupne podatke završnog izvješća PASS-a, PRAC smatra da su izmjene uvjeta odobrenja za stavljanje lijeka u promet opravdane.
English: The Applicant commits to perform a post authorisation safety study (PASS) to assess drug utilisation in real life setting in a representative sample of the European target population.
Croatian: Podnositelj zahtjeva obvezuje se da će provesti ispitivanje sigurnosti primjene lijeka nakon stavljanja u promet (PASS) kako bi procijenio potrošnju lijeka u okruženju stvarnog života na reprezentativnom uzorku ciljne europske populacije.
English: As part of the initial MA procedure (FR/H/511/01/DC), the MAH Ipsen Pharma committed to conduct a DUS to assess drug utilisation in the real life setting in a representative sample of the European target population.
Croatian: Kao dio postupka davanja odobrenja za stavljanje lijeka u promet (FR/H/511/01/DC), nositelj odobrenja za stavljanje lijeka u promet Ipsen Pharma obvezao se da će provesti ispitivanje potrošnje lijeka kako bi procijenio potrošnju lijeka u okruženju stvarnog života na reprezentativnom uzorku ciljne europske populacije.
English: The final study report has been endorsed by the PRAC, and the related condition of the marketing authorisation has been fulfilled.
Croatian: PRAC je odobrio završno izvješće o ispitivanju, čime je ispunjen s njime povezan uvjet odobrenja za stavljanje lijeka u promet.
English: On the basis of the scientific conclusions for the results of the study for the medicinal product(s) containing the active substance magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate and concerned by the PASS final report , the CMDh is of the opinion that the benefit-risk balance of the medicinal product(s) mentioned above is unchanged subject to the proposed changes to the product information.
Croatian: Na temelju znanstvenih zaključaka o rezultatima ispitivanja za lijek(ove) koji sadrži(e) djelatne tvari magnezijev sulfat heptahidrat, bezvodni natrijev sulfat i kalijev sulfat, a koje su obuhvaćene završnim izvješćem PASS-a, CMDh smatra da je omjer koristi i rizika gore navedenog(ih) lijeka(ova) nepromijenjen, uz predložene izmjene informacija o lijeku.