natgillin/translations-raw huggingface dataset:
Repeated dosing of pigs with daily oral doses of 22 mg lincomycin/kg body weight for 3 days indicated no accumulation of lincomycin in the species, with no detectable serum levels of antibiotic after 24 hours post administration.
Ponovljena primjena svinjama dnevne doze 22 mg linkomicina/kg tjelesne mase tijekom 3 dana nije pokazala nakupljanje linkomicinai nije se više mogao otkriti u serumu 24 sata nakon primjene.
Lincomycin
Linkomicin
Any medicated water which is not consumed within 24 hours should be discarded.
Vodu s otopljenim VMP-om koja nije popijena unutar 24 sata treba neškodljivo ukloniti.
Whereas * the CVMP considered the scope of the referral was the harmonisation of the summary of product characteristics, labelling and package leaflet; * the CVMP reviewed the summary of product characteristics, labelling and package leaflet proposed by the marketing authorisation holders and considered all the overall submitted data;
• je CVMP pregledao sažetak opisa svojstava VMP-a, etiketu i uputu o VMP-u koje je predložio nositelj odobrenja za stavljanje VMP-a u promet te je razmotrio sve dostavljene podatke;
Not authorised for use in birds producing eggs for human consumption, including replacement chicks which are intended to produce eggs for human consumption.
Nije odobrena primjena VMP-a konzumnim nesilicama, uključujući pilenke namijenjene za konzumne nesilice.
“For the treatment and prevention of chronic respiratory disease (CRD) caused by Mycoplasma gallisepticum and Escherichia coli, and associated with a low mortality rate.
„Za liječenje i prevenciju kronične respiratorne bolesti (KRB) koju uzrokuju Mycoplasma gallisepticum i Escherichia coli, povezano s niskom stopom smrtnosti.
150 g of the veterinary medicinal product corresponds to the dose for 2,000 kg of body weight per day.
U kokoši, 150 g VMP-a odgovara propisanoj dozi za 2 000 kg tjelesne mase na dan.
There is often complete cross-resistance between lincomycin and clindamycin.
Pojava potpune križne rezistencija na linkomicin i klindamicin je česta.
This amounts to 15 mg powder/kg bw/day for 7 days.
To odgovara 15 mg praška/kg tjelesne mase dnevno tijekom 7 dana.
Lay:
Budući da:
Scientific conclusions and grounds for amendment of the summary of product characteristics, labelling and package leaflet
Znanstveni zaključci i razlozi za dopunu sažetka opisa svojstava VMP-a, etikete i upute o VMP-u
Oral powder
Oralni prašak
Do not use this veterinary medicinal product after the expiry date which is stated on the bottle or bag.
VMP se ne smije koristiti poslije isteka roka valjanosti naznačenog na boci ili spremniku poslije EXP.
Pigs: Meat and offal: Zero days.
Svinje: Meso i jestive iznutrice: 0 dana.
Several old challenge laboratory studies showed efficacy of the combination against experimental inoculations with Mycoplasma spp.
Nekoliko starijih laboratorijskih ispitivanja provokacije dokazalo je djelotvornost kombinacije protiv eksperimentalnih inokulacija s bakterijom Mycoplasma spp. i/ili E. coli u pilića.
In chickens treated with “product name (to be completed nationally)” in drinking water at the target dose of 50 mg/kg body weight of total activity (at a ratio of 1:2 lincomycin:spectinomycin) for seven consecutive days, Cmax after first offering of medicated water was calculated to be 0.0631 µg/ml.
u propisanoj dozi 50 mg ukupne aktivnosti antibiotika (u omjeru linkomicina i spektinomicina 1:2)/kg tjelesne mase) tijekom 7 uzastopnih dana, najveća koncentracija u plazmi (Cmax) nakon prve primjene vode s VMP-om bila je 0,0631 µg/mL.
A single oral administration of lincomycin hydrochloride, at dose levels of approximately 22, 55 and 100 mg/kg body weight in pigs, resulted in dose related lincomycin serum levels, detected for 24-36 hours after administration.
Dvadeset i četiri do trideset i šest sati nakon jednokratne primjene linkomicinklorida svinjama kroz usta, u dozi oko 22, 55 i 100 mg/kg tjelesne mase, utvrđene su serumske koncentracije linkomicina, čije su vrijednosti ovisile o primijenjenim dozama.
the MIC distribution appears to be bimodal, with a significant number of strains showing high values; this could partly correspond to natural (intrinsic) resistance.
Čini se da je raspodjela MIK-a za sojeve E. coli i Salmonella spp. bimodalna, sa značajnim brojem sojeva koji pokazuju velike vrijednosti, što može biti povezano s prirodnom (intrinzičnom) rezistencijom.
Germany Zoetis Deutschland GmbH Schellingstraße 1,
Njemačka Zoetis Deutschland GmbH Schellingstraße 1, D-10785 Berlin Njemačka
Pharmacokinetic particulars
Farmakokinetički podaci
Pharmacotherapeutic group: antibacterials for systemic use, lincomycin combinations.
Farmakoterapijska skupina: antibakterijske tvari za sustavne infekcije, linkomicin u kombinaciji ATCvet kod: QJ01FF52
In the new MIC survey using 25 isolates from Belgium, a lincomycinspectinomycin MIC range of 1:2 to 32:64 µg/ml was obtained, with a MIC50 of 16:32 and a MIC90 of 32:64 µg/ml.
U novom MIC ispitivanju pomoću 25 izolata iz Belgije ostvaren je raspon MIC za linkomicin-spektinomicin od 1:2 do 32:64 µg/ml, s MIC50 od 16:32 te s MIC90 od 32:64 µg/ml, što ukazuje na to da bakterije spremno stječu rezistentne determinante.
Meat and offal: 5 days.
Meso i jestive iznutrice: 5 dana.
It has little or no action against gram-negative bacteria such as Escherichia coli.
Slabo je učinkovit ili uopće nije učinkovit protiv gram-negativnih bakterija kao što je E. coli.
Due to technical constraints the susceptibility of Lawsonia intracellularis is difficult to test in vitro, and data about the resistance status in that species are lacking.
Zbog tehničkih ograničenja teško je ispitati osjetljivost Lawsonia intracellularis in vitro, te stoga podatci o rezistenciji te vrste nisu dostupni.
In general mixture with other medicines should be avoided.
Općenito, treba izbjegavati miješanje ovog VMP-a s drugim VMP-ima.
* The inclusion of information about resistance status and warnings about prudent use as regards resistance, in SPC sections 4.4 Special warnings for each target species, 4.5 (i) Special precautions for use in animals and 5.1 Pharmacodynamic properties.
- Posebna upozorenja za sve ciljne vrste, 4.5. (i.) - Posebne mjere opreza za primjenu u životinja i 5.1. - Farmakodinamička svojstva.
Chickens: Meat and offal: 5 days.
Kokoši: meso i jestive iznutrice: 5 dana.
NAME OF THE VETERINARY MEDICINAL PRODUCT <Invented name> 222 mg/g + 444.7 mg/g powder for use in drinking water for pigs and chickens
NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA < Izmišljeni naziv>, 222 mg/g + 444,7 mg/g, prašak za primjenu u vodi za piće, za svinje i kokoši
Older field studies typically used a dose regimen of 150 mg/kg bw in a first phase followed by 50 mg/kg bw in a second phase; they were considered poorly relevant as they focus on systematic prophylaxis and zootechnical/economical endpoints.
Starija terenska ispitivanja uobičajeno su koristila režime doziranja od 150 mg/kg tjelesne težine u prvoj fazi nakon čega je slijedila doza od 50 mg/kg tjelesne težine u drugoj fazi.
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED To be completed nationally.
DATUM KADA JE UPUTA O VMP ZADNJI PUTA ODOBRENA
Special precautions for storage
POSEBNE MJERE PRI ČUVANJU
The efficacy appeared better than with lincomycin alone, and slightly better than with spectinomycin alone.
Djelotvornost se učinila boljom nego u slučaju monoterapije linkomicinom, te neznatno boljom nego u slučaju monoterapije spektinomicinom.
No recent
To je bilo jedino
PHARMACEUTICAL FORM Powder for use in drinking water
3. FARMACEUTSKI OBLIK Prašak za primjenu u vodi za piće
Do not leave access to the medicated water for other animals.
Drugim životinjskim vrstama ne smije se dozvoliti pristup vodi koja sadržava VMP.
Due to technical constraints the susceptibility of L. intracellularis is difficult to test in vitro, and data about the lincomycin-spectinomycin resistance status in that species are lacking.
Zbog tehničkih ograničenja teško je ispitati osjetljivost L. intracellularis in vitro te stoga podatci o rezistenciji te vrste na linkomicini spektinomicin nisu dostupni.
PACKAGE LEAFLET FOR: <Invented name> 222 mg/g + 444.7 mg/g powder for use in drinking water for pigs and chickens
UPUTA O VMP ZA: < Izmišljeni naziv>, 222 mg/g + 444,7 mg/g, prašak za primjenu u vodi za piće, za svinje i kokoši
The combination was shown to be superior to lincomycin alone.
Dokazano je da je kombinacija djelotvornija u odnosu na monoterapiju linkomicinom.
Chickens Do not use in birds in lay.
Kokoši VMP se ne smije primjenjivati za vrijeme nesenja.
Slovenia Zoetis Belgium SA, Rue Laid Burniat 1, 1348 Louvain-la-Neuve Belgium
Slovenija Zoetis Belgium SA, Rue Laid Burniat 1, 1348 Louvain-la-Neuve Belgija
To determine the volume of dilution (in litres of drinking water) required for 150 g of the veterinary medicinal product, use the following formula:
Da bi se odredio volumen vode za piće (u litrama), potreban za otapanje 150 g VMP-a, treba koristiti sljedeću formulu:
The spectinomycin exhibits little tendency to protein binding and is poorly liposoluble.
Spektinomicin pokazuje slabu sklonost vezanja za bjelančevine i slabo je topljiv u mastima.
Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve Belgium
Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve Belgija
Pigs and chickens.
Svinja i kokoš
This study is the only formal demonstration of the benefit of the 50 mg/kg bw dose, and the obtained challenge was only mild to moderate, with no observed mortality.
Ovo je ispitivanje jedina formalna demonstracija koristi doze od 50 mg/kg tjelesne težine, a dobivena provokacija bila je samo blaga do umjerena, bez uočene smrtnosti.
This study was the only formal demonstration of the benefit of the 50 mg/kg bw dose, and the obtained challenge was only mild to moderate, with no observed mortality.
Ovo je ispitivanje bilo jedina formalna demonstracija koristi doze od 50 mg/kg tjelesne težine, a dobivena provokacija bila je samo blaga do umjerena, bez uočene smrtnosti.
Use only accordingly to benefit-risk assessment by the responsible veterinarian.
VMP treba primijeniti samo nakon procjene veterinara o odnosu koristi/rizika.
For the treatment and prevention of dysentery caused by Brachyspira hyodysenteria and for the treatment and prevention of ileitis (porcine proliferative enteropathy) caused by Lawsonia intracellularis, and associated enteric pathogens (Escherichia coli).
Liječenje i sprječavanje dizenterije uzrokovane s Brachyspira hyodysenteriae i proliferativne enteropatije (ileitisa) uzrokovane s Lawsonia intracellulari, u kombinaciji s drugim patogenim crijevnim bakterijama (E. coli).
It is speculated by the marketing authorisation holder that spectinomycin might have an effect on associated pathogens related to swine dysentery; however, such an effect has not been formally demonstrated in vivo on specific pathogens.
Nositelj odobrenja za stavljanje VMP-a u promet nagađa da spektinomicin može imati djelovanje na povezane patogene povezane sa svinjskom dizenterijom.
INDICATION(S) Read the package leaflet before use.
Pročitati uputu o VMP-u prije primjene.
NAME OF THE VETERINARY MEDICINAL PRODUCT <Invented name> 222 mg/g + 444.7 mg/g powder for use in drinking water lincomycin (as lincomycin hydrochloride)/spectinomycin (as spectinomycin sulphate).
NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA < Izmišljeni naziv>, 222 mg/g + 444,7 mg/g, prašak za primjenu u vodi za piće, za svinje i kokoši Linkomicin (u obliku linkomicinklorida)/spektinomicin (u obliku spektinomicinsulfata)
This is indicative of a significant rate of high-level resistance although no firm clinical breakpoint has been set.
To je indikativno za značajni raspon otpornosti visoke razine, iako čvrsta klinička prijelomnica nije utvrđena, što bi moglo biti djelomično povezano s prirodnom rezistencijom na ove bakterijske vrste.
The possible impact on clinical efficacy of the high in vitro resistance rate evidenced in B. hyodysenteriae was not assessed in recent clinical studies; however, in the context of this Article 34 referral procedure, aiming at harmonising the conditions of authorisation of an already approved product, it was considered that the indication should not be removed on that basis.
No, u kontekstu ovog postupka upućivanja u skladu sa člankom 34., usmjerenog na usklađivanje uvjeta odobrenja već odobrenog proizvoda, smatra se da se indikacija ne smije ukloniti po toj osnovi.
Marketing authorisation holder and manufacturer responsible for batch release: To be completed nationally
Nositelj odobrenja za proizvodnju odgovoran za puštanje serije u promet:
Pale yellow to light tan soluble powder
Blijedo žuti do svjetlo smeđi prašak.
2,500 L of drinking water
2 500 L vode za piće
Water consumption
Unos vode
Cases of diarrhoea or soft faeces and/or perianal region inflammation have been encountered in healthy pigs at the start of treatment.
Nakon početka primjene VMP-a zdravim svinjama, u nekih životinja su primijećeni proljev ili mekani feces i/ili edem perianalnog područja.
Grounds for amendment of the summary of product characteristics, labelling and package leaflet
Razlozi za izmjenu sažetka opisa svojstava VMP-a, etikete i upute o VMP-u
Store in a dry place.
Čuvati na suhom.
Although the mechanism of action at the systemic level of spectinomycin administered orally is not elucidated, its clinical benefit and the benefit of the combination seems to be demonstrated in several older laboratory challenge studies; however, the dosing regimens applied in these studies can only be estimated and likely range from the harmonised dose of 50 mg/kg bw/day to at least the highest approved dose of 150 mg/kg bw/day.
No, režimi doziranja primijenjeni u ovim ispitivanjima počivaju samo na procjenama i izgledno je da se kreću od usklađene doze od 50 mg/kg tjelesne težine/danu do barem najviše odobrene doze od 150 mg/kg tjelesne težine/danu.
Poultry: For dosing via the drinking water.
Perad: za primjenu putem vode za piće.
Ingestion by these species may result in severe gastrointestinal effects.
Unos linkomicina kroz usta u tih životinja može uzrokovati teške želučano-crijevne poremećaje.
10,000 x [daily water consumption per animal (L)] average body weight of one pig (kg) In pigs 150 g of the veterinary medicinal product corresponds to the dose for 10,000 kg of body weight per day.
U svinja, 150 g veterinarsko-medicinskog proizvoda VMP-a odgovara propisanoj dozi za 10 000 kg tjelesne mase na dan.
Chickens:
Pilići:
Chickens Turkeys Duck Pigeon
Svinje pilići pure patke golubovi
Sodium benzoate Lactose
Natrijev benzoat Laktoza hidrat
SPECIAL WARNING(S)
POSEBNA UPOZORENJA
ZOETIS ITALIA S.r.l.
Zoetis Hellas SA L.
Use of the product deviating from the instructions given in the summary of product characteristics may increase the prevalence of bacteria resistant to lincomycin and spectinomycin and may decrease the effectiveness of treatment with other antimicrobials of the same or related classes, due to the potential for cross resistance.
U slučaju odstupanja od uputa za primjenu VMP-a, navedenih u Sažetku opisa svojstava, može se povećati rizik od razvoja i selekcije rezistentnih bakterija te smanjiti učinkovitosti liječenja s makrolidima zbog moguće pojave križne rezistencije.
Spectinomycin is an aminocyclitol antibiotic derived from Streptomyces spectabilis, it has bacteriostatic activity and is active against Mycoplasma spp.
Spektinomicin je aminociklitolni antibiotik koji se dobiva od Streptomyces spectabilis.
1,500 L of drinking water
1 500 L vode za piće
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Active substances:
KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNE(IH) TVARI I DRUGIH SASTOJAKA
Powder for solution in drinking water
Prašak za otapanje u vodi za piće
* A detrimental shift to the use of other molecules considered as more important to public health (e.g. fluoroquinolones) might occur in case the product is withdrawn in chickens.
• štetan pomak u primjeni drugih molekula koji se smatra značajnijim za javno zdravstvo
and other atypical gut organisms, is probably dependent on conditions established in the gut by other bacteria.
Nadalje, L. intracellularis, poput Brachyspira spp. i drugih atipičnih organizama crijeva vjerojatno ovisi o stanjima u crijevima koja su ovisna o drugim bakterijama.
Benefit-Risk assessment
Ocjena koristi i rizika
Spectinomycin
Spektinomicin
1,000 L of drinking water
1 000 L vode za piće
In E. coli, a significant part of the strains show high MIC values (minimum inhibitory concentrations) against the lincospectin-spectinomycin combination and may be clinically resistant, although no breakpoint is defined.
Za značajan broj sojeva E. coli utvrđene su velike minimalne inhibitorne koncentracije (MIK) za kombinaciju linkomicin-spektinomicin.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER To be completed nationally
15. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET
2,000 L of drinking water
2 000 L vode za piće
Summary of product characteristics, labelling and package leaflet
Sažetak opisa svojstava VMP-a, etikete i upute za uporabu
Oral powder for use in drinking water
Oralani prašak za primjenu u void za piće
Pigs Chicken (broiler, pullet) Turkey
Svinja, kokoši (tovni pilići, pilenke), purani (purići)
MARKETING AUTHORISATION HOLDER To be completed nationally.
biti će dovršeno na nacionalnoj razini
Spain
Danska
If co-administration is mandatory, respect a delay of two hours between intakes.
Ako je primjena spomenute kombinacije neophodna, razmak između primjena VMP-a i kaolina ili pektina mora biti dva sata.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION For use in drinking water.
DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, NAČIN I PUT(EVI)
Spectinomycin is classified as an aminocyclitol antibiotic, close to aminoglycosides; it inhibits protein synthesis by binding to the 30S ribosomal subunit.
Linkomicin je linkozamidni antibiotik, koji je usko povezan s antimikrobnim lijekovima makrolidom i streptograminom B. Inhibira sintezu proteina vezujući se na 50S bakterijsku ribosomsku podjedinicu.
Excipients: Sodium benzoate, lactose.
Natrijev benzoat i laktoza hidrat
Withdrawal period:
ROK VALJANOSTI EXP:
Soluble powder Pigs Chickens
Opralni prašak Svinje perad
and against some gram-negative bacteria such as E. coli.
Djeluje bakteriostatski i učinkovit je protiv Mycoplasma spp. te protiv nekih gram-negativnih bakterija kao što je E. coli.
MARKETING AUTHORISATION NUMBER(S) To be completed nationally
BROJ ODOBRENJA ZA STAVLJANJE U PROMET
0.1 L/kg bw/day
0,1 L/kg t.m./dan
Not authorised for use in birds producing or intended to produce eggs for human consumption.
Nije odobrena primjena VMP-a konzumnim, uključujući pilenke namijenjene za konzumne nesilice.
Medicated water should be removed every day and replaced by a new solution.
Nepopijenu vodu s otopljenim VMP-om od prethodnog dana treba neškodljivo ukloniti i zamijeniti ju sa svježom otopinom VMP-a u vodi za piće.
Poultry (broilers, pullets and turkeys)
Svinje perad (brojleri, kokice i pure)
The mechanism by which spectinomycin administered orally acts on pathogens at the systemic level despite a poor absorption is not fully elucidated, and might rely partly on indirect effects on the gut flora, or on effects of metabolite(s).
Moguće je da je djelovanje spektinomicina u tom slučaju djelomično neizravno, odnosno da ovisi o učincima na crijevnu mikrofloru ili o učincima metabolita.
0.2 L/kg bw/day
0,2 L/kg t.m./dan
Powder for oral solution.
Prašak za oralnu otopinu.
Zoetis
NUSPOJAVE
0.15 L/kg bw/day
0,15 L/kg t.m./dan
0.25 L/kg bw/day
0,25 L/kg t.m./dan
Soluble Powder Pigs Poultry (nonlayers)
Svinje perad (ne nesilice)
A single oral dose of 10 mg/kg body weight was administered to pigs to determine the bioavailability.
U svrhu određivanja bioraspoloživosti svinjama je kroz usta jednokratno primijenjena doza 10 mg/kg tjelesne mase.
For the treatment and prevention of chronic respiratory disease (CRD) caused by Mycoplasma gallisepticum and Escherichia coli, and associated with a low mortality rate.
Chronic Respiratory Disease, CRD) koju uzrokovane s Mycoplasma gallisepticum i E. coli, u okolnostima niske razine pomora.
Special warnings for each target species of the summary of product characteristics (SPC).
Posebna upozorenja za svaku od ciljnih vrsta životinja:
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Lincomycin (as lincomycin hydrochloride)
I DRUGIH TVARI Linkomicin (u obliku linkomicinklorida)
Do not use in case of hepatic dysfunction.
VMP se ne smije primjenjivati za vrijeme nesenja.
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
NAČIN I PUT(EVI) PRIMJENE
Poultryhens, chickens and turkeys
Svinje peradkokoši, pilići i pure
Turkeys
Cipar
WITHDRAWAL PERIOD
DATUM REVIZIJE TEKSTA
Soluble Powder is formulated for administration via drinking water.
Svinje: LincoSpectin 100 topivi prašak je formuliran za primjenu putem vode za piće.
Lincomycin (as lincomycin hydrochloride)
Linkomicin (u obliku linkomicinklorida)
Whereas,
Budući da
Seasonique is authorised in some countries outside the European Union (EU).
Seasonique je odobren u pojedinim državama izvan Europske unije (EU).
Risk management plan
Plan upravljanja rizikom
Bleeding pattern
Obrazac krvarenja
Grounds for positive opinion
Razlozi za pozitivno mišljenje
Critical evaluation
Kritička evaluacija
Contraceptive efficacy
Djelotvornost kontraceptiva
No additional modifications were made by the CHMP.
CHMP nije proveo dodatne izmjene.
Scientific conclusions and grounds for positive opinion presented by the European Medicines Agency
Znanstveni zaključci i razlozi za pozitivno mišljenje Europske agencije za lijekove
Germany considered that the granting of the marketing authorisation constitutes a potential serious risk to public health.
Njemačka je smatrala da izdavanje odobrenja za stavljanje lijeka u promet predstavlja potencijalan ozbiljan rizik za javno zdravlje.
In spite of these limitations, this publication at least does not support a reduced contraceptive efficacy associated with the 84/7 regimen.
Usprkos ovim ograničenjima, ova publikacija u najmanju ruku ne podržava smanjenu djelotvornost kontraceptiva povezanu s režimom 84/7.
The CHMP requested advice from the Biostatistics Working Party (BSWP) on the validity of this method in the present case.
CHMP je zatražio savjet Biostatističke radne grupe (BSWP) o valjanosti ove metode u aktualnom slučaju.
Both active substances are already authorised in this combination, at this dosage and at a lower dosage (LGN 100 µg/ EE 20 µg).
Obje djelatne tvari već su odobrene u ovoj kombinaciji i u manjem doziranju (LGN 100 µg/ EE 20 µg).
• The Committee considered the notification of the referral triggered by France under Article 29(4) of Directive 2001/83/EC.
• je Odbor razmotrio obavijest o postupku upućivanja koji je pokrenula Francuska u skladu s člankom 29. stavkom 4. Direktive 2001/83/EZ.
The decentralised marketing authorisation application was submitted under Article 28(3) of Directive 2001/83/EC in accordance with Article 10b of Directive 2001/83/EC.
Decentralizirani zahtjev za izdavanje odobrenja za stavljanje lijeka u promet dostavljen je u skladu s člankom 28. stavkom 3. Direktive 2001/83/EZ u skladu s člankom 10b Direktive 2001/83/EZ.
For the analysis, this period was split in two 28-day and a 35-day periods.
Za potrebe analize, ovo je razdoblje podijeljeno u razdoblja od 28 dana i 35 dana.
The decentralised procedure was closed on day 210, with most of the Concerned Member States (CMS) agreeing with the conclusions of the RMS except Germany which raised a potential serious risk to public health.
Decentralizirani postupak zaključen je 210. dana, nakon što se većina država članica sudionica u postupku (CMS) suglasila sa zaključcima RMS-a, osim Njemačke koja je istaknula potencijalan ozbiljan rizik za javno zdravlje.
Indeed the LNG 150 µg/ EE 30 µg hormonal combination has been approved as a contraceptive in the EU for over 35 years and its efficacy is well documented.
Uistinu, hormonalna kombinacija LNG 150 µg/ EE 30 µg odobrena je kao kontraceptiv u EU-u tijekom više od 35 godina i djelotvornost je dobro dokumentirana.