natgillin/translations-raw huggingface dataset:
MARKETING AUTHORISATION NUMBER(S) EU/2/17/223/001-006
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/17/223/001-006
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorization: 07/02/2018.
Datum pridobitve dovoljenja za promet: 07/02/2018.
CONTENTS BY WEIGHT, VOLUME OR BY NUMBER OF DOSES 25 doses
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV 25 odmerkov
Pharmacotherapeutic group: immunologicals for Suidae, inactivated viral vaccines for pigs.
Farmakoterapevtska skupina: imunološka zdravila za prašiče, inaktivirana virusna cepiva za prašiče.
In individual pigs the temperature increase compared to pre-treatment may commonly exceed 2 °C.
Pri posameznih prašičih lahko telesna temperatura, v primerjavi s tisto pred cepljenjem, pogosto naraste za 2°C.
Administer one dose of 2 ml to pigs in the neck behind the ear.
Odmerek po 2 ml dajte pujsku v vrat za uho.
The area of local tissue reactions is in general below 2 cm in diameter.
Področje premera lokalne tkivne reakcije je običajno manjše od 2 cm.
Do not use in breeding boars.
Ne uporabljajte pri plemenskih merjascih.
Local tissue reactions in the form of swelling at the injection site, which may be associated with local heat, redness and pain at palpation, are very common and may last for up to 2 days (based on laboratory safety studies).
Zelo pogosta je lokalna reakcija tkiva v obliki otekline na mestu injiciranja, ki je lahko povezana z lokalno toploto, rdečino in bolečino na otip in ki lahko traja do 2 dni (osnovano na laboratorijskih varnostnih študijah).
Duration of immunity: 23 weeks after vaccination
Trajanje imunosti: 23 tednov po cepljenju
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the vial after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini, po {kratica, ki se uporablja za datum izteka roka uporabnosti}.
Do not use during pregnancy and lactation.
Ne uporabite v obdobju brejosti ali laktacije.
Special precautions for use in animals None
Posebni previdnostni ukrepi za uporabo pri živalih Jih ni.
High density polyethylene vials of 50 ml, of 100 ml and of 250 ml (25, 50 and 125 doses), with a chlorobutyl elastomer closure and sealed with an aluminium cap.
Viale iz polietilena visoke gostote: 50 ml, 100 ml in 250 ml (s po 25, 50 ali 125 odmerki), z elastomernim zamaškom iz klorbutila, zaščitenim z aluminijasto zaporko.
In a laboratory study, a postmortem examination of the injection site, performed 4 weeks after the administration of a single dose of the vaccine, revealed a mild inflammatory response, as evidenced by the absence of tissue necrosis and little fibrosis.
V laboratorijskih študijah je pregled mesta injiciranja post-mortem 4 tedne po dajanju enega odmerka cepiva pokazal blago vnetje, brez nekroze tkiva in z manjšimi fibrozami.
Squalane Poloxamer 401 Polysorbate 80
Tiomersal Skvalan Poloksamer 401 Polisorbat 80
The safety of the veterinary medicinal product has not been established during pregnancy or lactation.
Varnost veterinarskega zdravila v obdobju brejosti in laktacije ni bila raziskana.
MANUFACTURER'S BATCH NUMBER Lot: {number}
PROIZVAJALČEVA ŠTEVILKA SERIJE
Major incompatibilities: Do not mix with any other vaccine or immunological product.
Ne uporabljajte z ostalimi cepivi ali imunološkimi zdravili.
Special precautions to be taken by the person administering the veterinary medicinal product to animals Not applicable.
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Ni smiselno.
Once broached use immediately.
Načeto uporabite takoj.
4.2 Indications for use, specifying the target species For active immunisation of pigs from 3 weeks of age against porcine circovirus type 2 (PCV2) to reduce viral load in blood and lymphoid tissues and fecal shedding caused by infection with PCV2.
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Aktivna imunizacija prašičev, starejših od 3 tednov, proti prašičjemu cirkovirusu tipa 2 (PCV2) za zmanjšanje kopičenja virusa v krvi in limfoidnem tkivu in širjenja z iztrebki, povezanih z okužbo PCV2.
For active immunisation of pigs from 3 weeks of age against Porcine Circovirus type 2 (PCV2) to reduce viral load in blood and lymphoid tissues and fecal shedding caused by infection with PCV2.
Aktivna imunizacija prašičev, starejših od 3 tednov, proti prašičjemu cirkovirusu tipa 2 (PCV2) za zmanjšanje kopičenja virusa v krvi in limfoidnem tkivu in širjenja z iztrebki, povezanih z okužbo s PCV2.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Intramuscular use.
ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABE ZDRAVILA
Name and address of the manufacturer responsible for batch release
Ime in naslov proizvajalca zdravila, odgovornega za sproščanje serije
NAME OF THE VETERINARY MEDICINAL PRODUCT Suvaxyn Circo emulsion for injection for pigs
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Suvaxyn Circo emulzija za injiciranje za prašiče
Onset of immunity: from 3 weeks after vaccination.
Nastop imunosti: od 3. tedna po cepljenju.
Vaccination schedule: One injection from 3 weeks of age.
Ena injekcija od 3. tedna starosti.
Special warnings for use in animals: Vaccinate only healthy animals.
POSEBNO(A) OPOZORILO(A) Posebni previdnostni ukrepi za uporabo pri živalih Cepite samo zdrave živali.
It is intended to stimulate active immunity against PCV2 in pigs.
Namenjeno je stimulaciji aktivne imunizacije prašičev, proti prašičjemu cirkovirusu tipa 2 (PCV2)
PACKAGE LEAFLET: Suvaxyn Circo emulsion for injection for pigs
NAVODILO ZA UPORABO Suvaxyn Circo emulzija za injiciranje za prašiče
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE (BIOLOŠKIH) UČINKOVINE (UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI) ZDRAVILA ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
Fertility No information is available on the safety of this vaccine in breeding boars.
Podatki o varnosti tega cepiva pri plemenskih merjascih niso na voljo.
BATCH NUMBER Lot {number}
Serija: {številka}
Pigs
Prašiči (pitanci).
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila
A transient increase in body temperature (on average 0.8°C) was observed 4 hours after administration of a 2-fold overdose.
4 ure po uporabi dvakrat prevelikega odmerka se lahko pojavi prehodno povečanje telesne temperature (v povprečju 0,8°C).
Cardboard box of 1 vial of 50 ml (25 doses), 100ml (50 doses) or 250 ml (125 doses).
Kartonska škatla z 1 vialo s 25 odmerki (50 ml), 50 odmerki (100ml) ali 125 odmerki (250 ml).
A transient increase in body temperature (on average 1°C) is very common during the first 24 hours after vaccination.
V prvih 24 urah po cepljenju je zelo pogosto prehodno povišanje telesne temperature (v povprečju 1°C).
Poloxamer 401
Skvalan Poloksamer 401 Polisorbat 80
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box
PODATKI NA ZUNANJI OVOJNINI IN STIČNI OZ. PRIMARNI OVOJNINI Kartonska škatla
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE HDPE vials (125 doses)
PODATKI NA STIČNI OZ. PRIMARNI OVOJNINI HDPE viale (125 odmerkov)
Single intramuscular injection in the neck behind the ear of one dose (2 ml) to pigs from 3 weeks of age.
Odmerek po 2 ml dajte pujsku v vrat za uho od 3. tedna starosti.
Local tissue reaction in the form of swelling (below 2 cm in diameter) at the injection site was commonly observed and resolved within 2 days.
Na mestu injiciranja so pogosto opažene lokalne tkivne reakcije v obliki otekline (do 2 cm premera), ki spontano izginejo v 2 dneh.
Cardboard box of 4 vials of 250 ml (125 doses)
Kartonska škatla s 4 vialami s 125 odmerki (250 ml).
Cardboard box of 10 vials of 50 ml (25 doses ) or 100ml (50 doses).
Kartonska škatla z 10 vialami s 25 odmerki (50 ml), 50 odmerki (100ml).
PHARMACEUTICAL FORM Emulsion for injection
emulzija za injiciranje
ANNEX II A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE (BIOLOŠKIH) UČINKOVINE (UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI) ZDRAVILA ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
Disodium phosphate anhydrous Sodium phosphate dibasic heptahydrate Disodium tetraborate decahydrate EDTA tetrasodium
Dinatrijev tetraborat dekahidrat
The vaccine contains an inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2 ORF2 protein.
Cepivo vsebuje inaktiviran rekombinanten himerični prašičji cirko virus tip I z izraženim proteinom ORF2 prašičjega cirkovirusa tipa 2.
10 vial pack: 10 x 25 doses (50 ml) 10 vial pack: 10 x 50 doses (100 ml) 4 vial pack: 4 x 125 doses (250 ml)
50 odmerkov (100 ml) 125 odmerkov (250 ml) Pakiranje 10 vial: 10 x 25 odmerkov (50 ml)
Monobasic potassium phosphate anhydrous Sodium chloride
Monobazični kalijev fosfat, brezvodni
Inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2 ORF2 protein
Inaktiviran rekombinanten himerični prašičji cirko virus tip I z izraženim proteinom ORF2 prašičjega cirkovirusa tipa 2
Squalane
KARENCA
Active substances:
Zdravilna učinkovina:
QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose (2 ml) contains:
KAKOVOSTNA IN KOLIČINSKA SESTAVA
STATEMENT OF THE MRLs
NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA ( MRL)
QUANTITY OF THE ACTIVE SUBSTANCES Inactivated recombinant chimeric PCV type 1 containing the PCV type 2 ORF2 protein
KOLIČINA UČINKOVIN(E) Inaktiviran rekombinanten himerični PCV tip I z izraženim proteinom ORF2 prašičjega PCV tipa 2 2,3 - 12,4 RP
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
B. POGOJI TER OMEJITVE GLEDE OSKRBE IN UPORABE
Inactivated recombinant chimeric PCV type 1 containing the PCV type 2 ORF2 protein
Inaktiviran rekombinanten himerični PCV tip I z izraženim proteinom ORF2 prašičjega PCV tipa 2 2,3 - 12,4 RP
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
NAČIN IN POT(I) UPORABE Intramuskularno dajanje.
During the procedure, the applicant further substantiated the justification.
Med postopkom je predlagatelj dodatno podprl svojo utemeljitev.
very rare
Zelo redki
N (ITT)
Št. (ITT)
Disorientation (and all aggravations)
neorientiranost (in vsa poslabšanja)
• the safety profile of pantoprazole is well established and acceptable.
• varnostni profil pantoprazola je dobro dokazan in sprejemljiv.
- to support clinical efficacy and safety, the application is based on the results of 17 clinical studies.
- Za podporo klinične učinkovitosti in varnosti vloga temelji na rezultatih 17 kliničnih študij.
Both medications were similarly effective
331 Obe zdravili sta bili podobno učinkoviti
Such exclusivity requires that the change of classification “has been authorised on the basis of significant preclinical tests or clinical trials”.
Za tovrstno izključno pravico mora biti sprememba razvrstitve „odobrena na podlagi pomembnih predkliničnih preskusov ali kliničnih preskušanj“.
Primary Objective
Primarni cilj
With reference to the above 6 studies, the CHMP made the following observations (see also comments included in the above table):
CHMP je z ozirom na zgornjih 6 študij ugotovil naslednje (glejte tudi pripombe, vključene v zgornjo tabelo):
Therefore, the 6 above-mentioned studies do not provide clinical data which has genuine impact on the assessment of the application.
Zato 6 zgoraj omenjenih študij ne zagotavlja kliničnih podatkov, ki bi imeli resničen vpliv na oceno vloge.
Secondary Objective
Sekundarni cilj
It was stated that these 6 studies support the proposed new indication and treatment duration by providing at least one symptom recording point of reflux-related symptoms during the first 14 days of treatment with pantoprazole and therefore are considered significant for the application.
Navedeno je bilo, da teh 6 študij podpira predlagano novo indikacijo in trajanje zdravljenja, saj so predložile vsaj eno točko beleženja z refluksom povezanih simptomov v prvih 14 dneh zdravljenja s pantoprazolom, in zato veljajo kot pomembne za vlogo.
Symptomatic relief was comparable between the products though no statistically significant differences could be found between the groups at the end of week 1.
Ublažitev simptomov je bila med zdraviloma primerljiva, vendar statistično pomembne razlike med skupinama ob koncu 1. tedna niso opazili.
None of the 6 above-mentioned studies provide data to support the proposed indication and treatment duration that could not be derived from the other 11 studies provided in the application.
Nobena od 6 zgoraj omenjenih študij ne daje podatkov v podporo predlagani indikaciji in trajanju zdravljenja, ki jih ne bi mogli izpeljati iz ostalih 11 študij, priloženih v vlogi.
Overall this study provides no relevant data analogous to the initial non-prescription medication period of up to 14 days.
Na splošno ta študija ne daje nikakršnih pomembnih podatkov, ki bi bili analogni prvotnemu obdobju izdajanja zdravila brez recepta do 14 dni.
• the applicant's justification to extrapolate the results of these studies to the proposed non prescription setting is acceptable
• predlagateljeva utemeljitev o prenosu rezultatov teh študij na predlagano izdajanje zdravila brez recepta je sprejemljiva;
The results showed that all of the above doses are effective and comparable in the treatment of GORD.
Rezultati so pokazali, da so vsi zgoraj omenjeni odmerki učinkoviti in primerljivi pri zdravljenju gastroezofagelane refluksne bolezni.
Based on the above results the CHMP considered the following:
CHMP je na podlagi zgornjih rezultatov ugotovil:
322 There was no statistically significant difference between the treatment groups
322 Med obema skupinama zdravljenja ni bilo pomembne statistične razlike
Quality of life, Time to heartburn relief
Kakovost življenja, čas do olajšanja zgage
Similar results were shown in the published study M3
Podobni so bili rezultati v objavljeni študiji M3-316.
The study contained a treatment phase C; days 29-56, but again, this is not relevant to a non-prescription indication of no more than 28 days.
Študija je vsebovala fazo C zdravljenja med 29. in 56. dnevom, vendar pa to ni pomembno za indikacijo izdajanja zdravila brez recepta za manj kot 28 dni.
No day 14 data was available in the study report.
V študijskem poročilu ni bilo podatkov za 14. dan.
Results are similar to published studies (FK3059, VMG306, FK3034 and BGSA006)
Rezultati so podobni objavljenim študijam (FK3059, VMG306, FK3034 in BGSA006)
14 day data was not provided by this study.
V tej študiji niso bili predloženi podatki za 14 dni.
The applicant also referred to studies BF010 (CSR 298E/99) and VMG309 (CSR 323/2004) which were considered to provide data for early onset of relief of reflux symptoms.
Predlagatelj se je prav tako skliceval na študiji BF010 (CSR 298E/99) in VMG309 (CSR 323/2004), ki naj bi zagotavljali podatke o zgodnjem nastopu lajšanja simptomov refluksa.
Pantoprazole was noninferior to lansoprazole after 4 weeks of treatment
Pantoprazol ni dosegal slabših rezultatov od lansoprazola po 4 tednih zdravljenja
The applicant, in addition to study BGI022 (CSR 257/2004), referred to study MEX020 (CSR 200/2004).
Predlagatelj se je poleg študije BGI022 (CSR 257/2004) skliceval tudi na študijo MEX020 (CSR 200/2004).
The applicant emphasised that these studies demonstrated efficacy in the non-prescription setting regarding the proposed indication and related posology which differs from that of the prescription product.
Predlagatelj je poudaril, da te študije dokazujejo učinkovitost izdajanja zdravila brez recepta za predlagano indikacijo in s tem povezano odmerjanje, ki se razlikuje od tistega pri zdravilu na recept.
Out of the 17 studies provided by the applicant, the following 6 studies formed the basis of the applicant's request for data exclusivity:
Izmed 17 študij, ki jih je predložil predlagatelj, je naslednjih 6 študij vsebovalo podlago za predlagateljevo zahtevo za izključno pravico do uporabe podatkov:
the CHMP concluded that the studies BY1023/BGI022, BY1023/BF010, BY1023/ESP009, BY1023/MEX020, BY1023/FK3037 and BY1023/VMG309 submitted by the applicant for which the claim of one year data exclusivity is sought, were not relevant and necessary to the classification of CONTROLOC Control 20 mg gastro-resistant tablets as ‘medicinal product not subject to medical prescription'.
CHMP je zaključil, da študije BY1023/BGI022, BY1023/BF010, BY1023/ESP009, BY1023/MEX020, BY1023/FK3037 in BY1023/VMG309, ki jih je predložil predlagatelj in za katere je zahteval enoletno izključno pravico do uporabe podatkov, niso pomembne in potrebne za razvrstitev zdravila CONTROLOC Control 20 mg gastrorezistente tablete v skupino „zdravil, ki se izdajajo brez recepta“.
• pantoprazole 20mg is effective in the short-term treatment of GORD symptoms
• pantoprazol 20 mg je učinkovit za kratkotrajno zdravljenje simptomov GERB;
4 weeks
4 tedne
Nycomed GmbH, D-78467 Konstanz
Nycomed GmbH Byk-Gulden-Str. 2 D-78467 Konstanz Nemčija
Endoscopic healing erosive esophagitis
Endoskopsko zdravljenje erozivnega ezofagitisa
The shortcomings of this study are the same as described above for study BF010: lack of day 14 makes this study of limited value in the non-prescription context where the patient would be self-referring to their physician if no symptomatic relief was obtained by day 14.
Slabosti te študije so enake tistim, opisanim zgoraj za študijo BF010: zaradi pomanjkanja podatkov ob 14. dnevu ima ta študija omejeno vrednost za zdravila, ki se izdajajo brez recepta, ob jemanju katerih bi se bolnik, če se simptomi do 14. dne ne bi izboljšali, sam napotil k zdravniku.
weeks
tednov
The recommended dose is 20 mg pantoprazole (one tablet) per day.
Priporočeni odmerek je 20 mg pantoprazola (1 tableta) na dan.
Primary Objective Secondary Objective Treatment Duration
Primarni cilj Sekundarni cilj Zdravljenj e
In this pivotal study the differences between pantoprazole 20 mg and ranitidine 150 mg results were significant; however the unpublished study conclusion for BGI022 were very similar to those of the published ranitidine 150 mg comparative study VMG306 and overall does not add significant value to the application.
V tej ključni študiji so bile pomembne razlike med rezultati za pantoprazol 20 mg in rezultati za ranitidin 150 mg; vendar so bili zaključki neobjavljene študije BGI022 zelo podobni zaključkom objavljene primerjalne študije VMG306 za ranitidin 150 mg, študija pa na splošno vlogi ne doda pomembne vrednosti.
The study concluded that pantoprazole 20 mg has a trend to have a faster relief of symptoms during the first 7 days of treatment compared with omeprazole 10 mg, but no statistically significant differences were found after 7 days, 4 weeks or 8 weeks treatment between the groups.
V študiji so zaključili, da ima pantoprazol 20 mg, v primerjavi z omeprazolom 10 mg, tendenco hitrejšega lajšanja simptomov v prvih 7 dneh zdravljenja, vendar pa statistično pomembne razlike med skupinama po 7 dneh, 4 tednih ali 8 tednih zdravljenja niso opazili.
Study BY1023/BGI022 was particularly emphasised.
Zlasti je bila poudarjena študija BY1023/BGI022.
Out of the 17 studies submitted in support of the application, the following 11 studies did not form the basis of the applicant's request for data exclusivity:
Izmed 17 študij, predloženih v podporo vlogi, naslednjih 11 študij ni vsebovalo podlage za predlagateljevo zahtevo za izključno pravico do uporabe podatkov:
Pan 10, 20, 40, Pla weeks
Pan 10, 20, 40, Pla tednov
RESULTS
Rezultati
Similar results were shown by study FK3059, VMG306, FK3034, BGSA006, which also showed superiority of 20 mg pantoprazole compared to 300 mg ranitidine in the treatment of reflux symptoms.
Podobni so bili rezultati študij FK3059, VMG306, FK3034, BGSA006, v katerih so prav tako pokazali večjo učinkovitost 20 mg pantoprazola v primerjavi s 300 mg ranitidina pri zdravljenju simptomov refluksa.
Tablets are yellow, oval, biconvex, film-coated and imprinted with “P20” in brown ink on one side.
Rumene, ovalne, bikonveksne filmsko obložene tablete z odtisom »P 20« v rjavi barvi na eni strani.
Pan 20, 40 4 weeks
Pan 20, 40 4 tedne
Relief of symptoms in GORD Stage A-D
Olajšanje simptomov pri GERB stopnjah A-D
Relief of GORD symptoms, Time to heartburn relief
Olajšanje simptomov GERB, čas do olajšanja zgage
270 Pantoprazole was superior to ranitidine
270 Pantoprazol je dosegal boljše rezultate od ranitidina
Study No. (CSR No.)
Št. študije (št. CSR)
The results show that symptom relief rates are largely independent of the initial GORD stage of the patients.
Zmanjšanje simptomov refluksa kisline je bilo večinoma neodvisno od začetne stopnje GERB.
The findings of this study are in line with other published studies (Study VMG305 and M3-320), which showed that the efficacy of pantoprazole is noninferior to other PPIs (such as lansoprazole and esomeprazole).
Ugotovitve te študije so v skladu z ostalimi objavljenimi študijami (študiji VMG305 in M3-320), ki so pokazale, da pantoprazol ni manj učinkovit od drugih zaviralcev protonskih črpalk (kot sta lansoprazol in esomeprazol).
Similar results were shown in the published study M3-316 which compared the efficacy of 20 and 40 mg pantoprazole in the treatment of GORD symptoms.
Podobni so bili rezultati objavljene študije M3-316, v kateri so primerjali učinkovitost 20 in 40 mg pantoprazola pri zdravljenju simptomov gastroezofagealne refluksne bolezni.
No week 2 relief rate analysis was provided.
Analize olajšanja simtomov v 2. tednu niso bile na voljo.
Treatment Duration N (ITT)
Trajanje Št. (ITT)
Overall the applicant considered that the new data from the aforementioned studies added significant support to the classification as non-prescription product as they provided both effect and relevance to the assessment.
Na splošno je predlagatelj menil, da ti novi podatki iz prej omenjenih študij zaradi svojega pomena in učinka na oceno pomembno podpirajo razvrstitev v skupino zdravil, ki se izdajajo brez recepta.
Relief of leading GORD symptoms and other GI symptoms
Olajšanje glavnih simptomov GERB in drugih gastrointestinalnih simptomov
The justification of the applicant was based on 6 ‘non-published' studies, 5 full and one published by abstract only, which have been provided in support of the application (BY1023/BGI022, BY1023/BF010, BY1023/ESP009, BY1023/MEX020, BY1023/FK3037 and BY1023/VMG309).
Študije so bile predložene kot podpora vlogi (BY1023/BGI022, BY1023/BF010, BY1023/ESP009, BY1023/MEX020, BY1023/FK3037 in BY1023/VMG309).
In the non-prescription product setting, the patient would be self-referring to their physician if no symptomatic relief was obtained by day 14, making this study of limited value in the non-prescription context.
V primeru izdajanja zdravila brez recepta bi se bolnik, če se do 14. dneva simptomi ne bi izboljšali, sam napotil k zdravniku, zaradi česar ima ta študija omejeno vrednost za zdravila, ki se izdajajo brez recepta.
• Risk and consequences of incorrect use
• POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO
With reference to Article 74a of Directive 2001/83/EC, as amended, the applicant requested one year data exclusivity for the data submitted for the change of the classification of the medicinal product
V skladu s členom 74(a) Direktive 2001/83/ES, kakor je bila spremenjena, je predlagatelj zahteval enoletno izključno pravico do uporabe podatkov, ki so bili predloženi za spremembo razvrstitve zdravila iz skupine zdravil, ki se izdajajo le na recept, v skupino zdravil, ki se izdajajo brez recepta.
Time to first symptom relief of GORDrelated symptoms in GORD Stage 0
Čas do prvega olajšanja z GERB povezanih simptomov pri GERB stopnje 0
Additionally, the usual starting dose for omeprazole in reflux disease is 20 mg; 10 mg omeprazole is not therapeutically equivalent to 20 mg pantoprazole.
Poleg tega je običajni začetni odmerek omeprazola za refluksno bolezen 20 mg; 10 mg omeprazola ni terapevtsko enakovrednih 20 mg pantoprazola.