natgillin/translations-raw huggingface dataset:
Do not use more than one drop in the affected eye(s) 2 times daily.
Ne uporabite več kot ene kapljice na prizadeto oko dvakrat na dan. Kapljice začnite uporabljati en dan po kirurški odstranitvi katarakte.
Contents of the pack and other information What Yellox contains
Shranjevanje zdravila Yellox Vsebina pakiranja in dodatne informacije
If you get any side effects, talk to your doctor or pharmacist.
Če opazite kateregakoli izmed neželenih učinkov, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Excipients
Odmerek
Several conjugated and unconjugated metabolites have been identified with the cyclic amide being the major urinary metabolite.
Med njimi je ciklični amid večinski presnovek v urinu.
- if you have bleeding problems (e.g. haemophilia) or have had them in the past, or you are taking other medicines which may prolong bleeding time (e.g. warfarin, clopidogrel, acetylsalicylic acid).
Pred začetkom uporabe tega zdravila se posvetujte z zdravnikom ali farmacevtom, - če uporabljate topične steroide (npr. kortizon), saj to lahko povzroči neželene učinke; - če imate težave s krvavitvami (npr. hemofilijo) ali ste jih imeli v preteklosti ali jemljete druga zdravila, ki lahko podaljšajo čas krvavitve (npr. varfarin, klopidogrel, acetilsalicilno kislino); - če imate težave z očmi (npr. sindrom suhega očesa, težave z roženico); - če imate sladkorno bolezen; - če imate revmatoidni artritis; - če so vam večkrat v kratkem časovnem obdobju opravili kirurški poseg na očesu.
eye drops, solution 1x5 ml
FARMACEVTSKA OBLIKA IN VSEBINA kapljice za oko, raztopina 1 x 5 ml
Rare
Pogostnost
GR
MedDRA
Yellox 0.9 mg/ml eye drops solution
IME ZDRAVILA Yellox 0,9 mg/ml kapljice za oko, raztopina
Sodium sulphite, anhydrous (E221) Tyloxapol
6.1 Seznam pomožnih snovi borova kislina boraks natrijev sulfit, brezvodni (E 221) tiloksapol povidon (K30) benzalkonijev klorid dinatrijev edetat voda za injekcije natrijev hidroksid (za uravnavanje pH)
Package leaflet: Information for the user Yellox 0.9 mg/ml eye drops, solution
IME ZDRAVILA IN POT(I) UPORABE Yellox 0,9 mg/ml kapljice za oko, raztopina bromfenak okularna uporaba
Damage of the eye surface, redness of the eye, asthma.
Bolezni dihal, prsnega koša in mediastinalnega prostora občasni epistaksa, kašelj, izcedek iz nosnih sinusov redki astma*
Rinse out your eye with warm water.
Če ste uporabili večji odmerek zdravila Yellox, kot bi smeli Oko izplaknite s toplo vodo.
LIST OF EXCIPIENTS
NALEPKA NA PLASTENKI
These measures should help to protect the environment.
Ti ukrepi pomagajo varovati okolje.
7 days.
7 dni.
Take off any contaminated clothes.
Odstranite vsa kontaminirana oblačila.
United Kingdom and
Združeno kraljestvo in
It is recommended that product is used not more than twice in one year.
Priporoča se, da se zdravilo ne uporabi več kot dvakrat v enem letu.
DATE OF REVISION OF THE TEXT {MM/YYYY}
DATUM REVIZIJE BESEDILA {MM/LLLL}
Isolated cases of resistance against monepantel have been identified within the European Union.
Posamezni primeri odpornosti proti monepantelu so bili ugotovljeni znotraj Evropske unije.
However, the administration may be repeated, depending on the epidemiological situation in different areas.
Dajanje se lahko ponovi glede na epidemiološko stanje na različnih območjih.
Afterwards blood concentrations decrease with a half life of about five days.
Potem se nivo v krvi znižuje z razpolovnim časom približno petih dni.
• Too frequent and repeated use of anthelmintics from the same class, over an extended period of time.
• Prepogosta in ponavljajoča se uporaba antihelmintikov istega razreda, v predolgem časovnem obdobju.
Feeding or fasting before or shortly after treatment does not influence efficacy.
Hranjenje ali postenje pred ali takoj po zdravljenju ne vpliva na učinkovitost.
However, this should be considered only after advice has been taken from an animal health advisor.
Vendar je treba to upoštevati šele po posvetu s svetovalcem za zdravje živali.
PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable.
PREPOVED PRODAJE, OSKRBE IN/ALI UPORABE Ni smiselno.
QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance:
KAKOVOSTNA IN KOLIČINSKA SESTAVA Učinkovina:
1 ml for each additional 10 kg
1 ml za vsakih dodatnih 10 kg
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Če opazite kakršne koli stranske učinke, tudi tiste, ki niso navedeni v tem navodilu za uporabo, ali mislite, da zdravilo ni delovalo, obvestite svojega veterinarja.
The active substance in ZOLVIX is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Učinkovina v ZOLVIX-u je dovoljena učinkovina, kot je navedena v tabeli 1 (dovoljene snovi) priloge Uredbe Komisije (EU) št.37/2010:
Spectrum of activity includes fourth larvae and adults of:
Spekter delovanja vključuje četrto larvalno stopnjo in odrasle parazite:
Care should be taken to avoid the following practices because they increase the risk of development of resistance and could ultimately result in ineffective therapy:
Paziti moramo, da se izognemo naslednjim načinom uporabe antihelmintikov, ker ti povečujejo tveganje za razvoj odpornosti in vodijo v neučinkovito zdravljenje:
Increasing refugia (i.e. a source of parasites which have not been exposed to the anthelmintic) has been demonstrated to delay the development of resistance.
Dokazano je bilo, da povečanje refugij (tj. izvora parazitov, ki niso bili izpostavljeni antihelmintiku) upočasni razvoj odpornosti.
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 (European Medicines Agency) (http://www.ema.europa.eu/).
Not authorised for use in animals producing milk for human consumption.
Ni dovoljena uporaba pri živalih, katerih mleko je namenjeno prehrani ljudi.
Dose, ml
Odmerek, ml
Do not use this veterinary medicinal product after the expiry date which is stated on the label.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini.
Body weight, kg
Telesna masa, kg
If animals are to be treated collectively rather than individually, they should be grouped according to their bodyweight and dosed according to the heaviest animal within the group, in order to avoid underdosage.
Če se živali zdravi skupinsko in ne posamezno, jih je treba razvrstiti po skupinah glede na njihovo telesno maso in jim dati odmerke glede na najtežjo žival v skupini, da se izognemo premajhnim odmerkom.
Disposal: read the package leaflet.
Odstranjevanje: preberite navodilo za uporabo.
Drenching equipment should be cleaned after use.
Opremo za peroralno vbrizgavanje zdravila je treba po uporabi očistiti.
Do not eat, drink or smoke whilst handling the veterinary medicinal product.
Med rokovanjem z zdravilom za uporabo v veterinarski medicini ne jejte, pijte ali kadite.
Monepantel is an anthelmintic belonging to the amino-acetonitrile derivative (AAD) class of molecules.
Monepantel je antihelmintik, ki pripada razredu amino-acetonitrilnih derivatov (AAD).
For any information about this veterinary medicinal product, please contact the marketing authorisation holder.
Za vse nadaljnje informacije o tem zdravilu se obrnite na imetnika dovoljenja za promet z zdravilom.
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/.
DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) (http://www.ema.europa.eu/).
Manufacturer responsible for batch release: Argenta Dundee Limited Kinnoull Road
Proizvajalec, odgovoren za sproščanje serij: Argenta Dundee Limited Kinnoull Road
Medicines should not be disposed of via wastewater or household waste.
Ne odvrzite zdravila v odpadno vodo ali med gospodinjske odpadke.
Antiparasitic agents/ Agents acting against endoparasites
Učinkovine, ki delujejo proti parazitom/Učin kovine, ki delujejo proti endoparazitom
MRLs
(MRL)
Peak blood concentrations are reached within a day.
Najvišji nivo v krvi je dosežen v enem dnevu.
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
BESEDILO “SAMO ZA ŽIVALI” IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN
Liver Kidney Milk
Jetra Ledvice Mleko
Suspected clinical cases of resistance to anthelmintics should be further investigated using appropriate tests (e.g. Faecal Egg Count Reduction Tests) in discussion with their animal health advisor.
Pri domnevni odpornosti na antihelmintike je treba izvesti dodatno testiranje (npr. Test za redukcijsko štetje jajčec v iztrebkih), v dogovoru z vašim svetovalcem za zdravje živali.
PACKAGE SIZE
VELIKOST PAKIRANJA
In case of accidental spillage onto skin or into eyes, wash immediately with water.
V primeru nenamernega razlitja po koži ali če zdravilo pride v oči, takoj izperite z vodo.
Orange clear solution.
Oranžna bistra raztopina.
This is the first biological function to be described for the Hco-MPTL-1 receptor and therefore monepantel is effective against nematodes resistant to other anthelmintic classes.
To je prva biološka funkcija, opisana za Hco-MPTL-1 receptor, zaradi česar je monepantel učinkovit pri glistah,
Pack sizes of 250 ml, 500 ml, 1 l, 2.5 l, and 5 l.
Velikost pakiranja: 250 ml, 500 ml, 1 l, 2,5 l in 5 l.
Where the results of the tests strongly suggest resistance to a particular anthelmintic, an anthelmintic belonging to another pharmacological class and having a different mode of action should be used.
Če rezultati testov jasno kažejo na odpornost na določen antihelmintik, je treba uporabiti antihelmintik iz drugega farmakološkega razreda z drugačnim načinom delovanja.
Special precautions for use in animals: The safety has not been established in sheep weighing less than 10 kg or under 2 weeks of age.
Posebni previdnostni ukrepi za uporabo pri živalih: Pri ovcah, lažjih od 10 kg oziroma mlajših od 2 tednov, varnost ni bila dokazana.
• Underdose, which may be due to underestimation of body weight, misadministration of the veterinary medicinal product, or lack of calibration of the dose device.
• Premajhno odmerjanje zaradi napačne ocene telesne mase, napačno dajanje zdravila za uporabo v veterinarski medicini ali slabo kalibriranje pripomočka za odmerjanje.
In addition, the product was shown to be effective against 4th stage larvae of a strain of H. contortus in a laboratory study where a combination of abamectin with derquantel was not effective.
Poleg tega je bilo v laboratorijski študiji dokazano, da je zdravilo učinkovito proti ličinkam 4. stopnje seva H. contortus, pri katerih kombinacija abamektina in derkvantela ni bila učinkovita.
This veterinary medicinal product does not require any special storage conditions.
Za shranjevanje zdravila niso potrebna posebna navodila.
Argenta Dundee Limited Kinnoull Road Dunsinane Industrial Estate Dundee, DD2 3XR United Kingdom
Argenta Dundee Limited Kinnoull Road Dunsinane Industrial Estate Dundee, DD2 3XR Združeno kraljestvo
Elanco France S.A.S 26 Rue de la Chapelle F-68330 Huningue France
26 Rue de la Chapelle F-68330 Huningue Francija
MANUFACTURER'S BATCH NUMBER Lot
PROIZVAJALČEVA ŠTEVILKA SERIJE
Shelf life of the veterinary medicinal product as packaged for sale: Bottle (HDPE): 3 years
Rok uporabnosti zdravila v pakiranju za prodajo: Plastenka (HDPE): 3 leta.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary No adverse effects were observed after a 10-fold overdose.
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi), če je potrebno Po 10-kratnem prekoračenem odmerku zdravila ni bilo opaziti nobenih neželenih učinkov.
Overdose (symptoms, emergency procedures, antidotes): No adverse effects were observed after a 10-fold overdose.
Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi): Po 10-kratnem prekoračenem odmerku zdravila ni bilo opaziti nobenih neželenih učinkov.
To ensure administration of a correct dose, bodyweight should be determined as accurately as possible.
Za zagotovitev pravilnega odmerka mora biti čim bolj natančno določena telesna masa živali ter preverjena natančnost in pravilnost delovanja pripomočka za odmerjanje.
* including inhibited larvae
* vključno z inhibiranimi ličinkami
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER PROIZVAJALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ, ČE STA
PHARMACEUTICAL FORM Oral solution.
FARMACEVTSKA OBLIKA Peroralna raztopina.
Shelf life after first opening the container: 1 year.
Rok uporabnosti po prvem odpiranju vsebnika: 1 leto.
After oral administration monepantel is readily absorbed and oxidised to a sulfone metabolite.
Po peroralnem vnosu se monepantel takoj absorbira in oksidira v presnovek sulfona.
In order to help delay the development of resistance, users are advised to check the success of the treatment (e.g. clinical appearance, faecal egg counts).
Za čim kasnejši razvoj odpornosti je treba preverjati uspeh zdravljenja (npr. klinične znake, štetje jajčec v iztrebkih).
Pregnancy and lactation: Can be used in breeding sheep including pregnant and lactating ewes.
Brejost in laktacija: Lahko se uporablja pri vzrejnih ovcah, tudi v obdobju brejosti in laktacije.
The veterinary medicinal product is administered as a single treatment.
Zdravilo za uporabo v veterinarski medicini se daje v enkratnem odmerku.
Special warnings for each target species:
POSEBNO(A) OPOZORILO(A) Posebna opozorila za vsako ciljno živalsko vrsto:
In case of accidental ingestion seek medical advice immediately and show the package leaflet or the label to the physician.
V primeru nenamernega zaužitja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
To assure complete swallowing of this low volume solution, administer orally on the back of the tongue.
Za zagotovitev popolnega zaužitja dajte to raztopino majhnega volumna peroralno na koren jezika.
Excretion is mainly via the faeces but also via the urine.
Izloča se pretežno z blatom, delno tudi z urinom.
Marketing authorisation holder: Elanco GmbH
Imetnik dovoljenja za promet z zdravilom: Elanco GmbH
Fluorinated high density polyethylene (HDPE) bottles with a polypropylene cap.
Plastenka iz fluoriranega polietilena visoke gostote (HDPE) s polipropilensko zaporko.
Wash hands and exposed skin after handling the veterinary medicinal product.
Po uporabi zdravila za uporabo v veterinarski medicini si umijte roke in izpostavljeno kožo.
Each ml of ZOLVIX orange clear oral solution contains 25 mg of monepantel
Vsak ml ZOLVIX oranžne bistre peroralne raztopine vsebuje 25 mg monepantela.
The veterinary medicinal product can be used in breeding sheep including pregnant and lactating ewes.
Zdravilo za uporabo v veterinarski medicini se lahko uporablja pri vzrejnih ovcah, tudi v obdobju brejosti in laktacije.
ZOLVIX oral solution is a broad spectrum anthelmintic for the treatment and control of gastrointestinal nematode infections and associated diseases in sheep including lambs, hoggets, breeding rams and ewes.
INDIKACIJA(E) ZOLVIX peroralna raztopina je širokospektralni antihelmintik za zdravljenje in nadzor nad želodčno-črevesnimi okužbami in z njimi povezanimi boleznimi pri ovcah, vključno z jagnjeti,
The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this product.
Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben, ali pa ne spadajo v področje uporabe
Monepantel acts on the nematode specific nicotinic acetylcholine receptor sub-unit HcoMPTL-1.
Monepantel deluje na podenoto Hco-MPTL-1 specifičnih nikotinskih acetilholinskih receptorjev glist.
Personal protective equipment consisting of gloves should be worn when handling the veterinary medicinal product.
Pri ravnanju z zdravilom nosite osebno zaščitno opremo, ki sestoji iz zaščitnih rokavic.
The safety has not been established in sheep weighing less than 10 kg or under 2 weeks of age.
Pri ovcah, lažjih od 10 kg oziroma mlajših od 2 tednov, varnost ni bila dokazana.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE AND IMMEDIATE PACKAGE Cardboard box and HDPE bottle
PODATKI NA ZUNANJI IN STIČNI OZ. PRIMARNI OVOJNINI Kartonska škatla in HDPE plastenka
ATCvet code: QP52AX09.
FARMAKOLOŠKE LASTNOSTI Farmakoterapevtska skupina: antihelmintiki Oznaka ATCvet: QP52AX09
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE Veterinary medicinal product subject to prescription.
B. POGOJI TER OMEJITVE GLEDE OSKRBE IN UPORABE Rp-Vet.
THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out of the sight and reach of children.
BESEDILO “ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM” Zdravilo shranjujte nedosegljivo otrokom.
SPECIAL STORAGE PRECAUTIONS Keep out of the sight and reach of children.
POSEBNA NAVODILA ZA SHRANJEVANJE Zdravilo shranjujte nedosegljivo otrokom.
The efficacy has not been established in sheep weighing less than 10 kg.
Pri ovcah, lažjih od 10 kg, učinkovitost ni bila dokazana.
Interaction with other medicinal products and other forms of interaction: No interaction with other medicinal products and other forms of interaction are known.
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij:
The dose is 2.5 mg/kg bodyweight of monepantel.
Odmerek je 2,5 mg monepantela na kg telesne mase.
4.3 Contraindications
4.3 Kontraindikacije Jih ni.
MARKETING AUTHORISATION HOLDER Elanco GmbH
IMETNIK(I) DOVOLJENJ(A) ZA PROMET Elanco GmbH
ZOLVIX was shown to be effective against strains of gastro-intestinal parasites, listed in section 4.2, resistant to (pro)benzimidazoles, levamisole, morantel, macrocyclic lactones and H. contortus strains resistant to salicylanilides.
4.2, ki so odporni na (pro)benzimidazole, levamizol, morantel in makrociklične laktone, ter proti sevom H. contortus, odpornim na salicilanilide.
RRR-α-tocopherol
Pomožna snov: (RRR)-α-tokoferol
NAME OF THE VETERINARY MEDICINAL PRODUCT ZOLVIX 25 mg/ml oral solution for sheep Monepantel
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI ZOLVIX 25 mg/ml peroralna raztopina za ovce monepantel
A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALEC (PROIZVAJALCI) ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use.
POSEBNO(A) OPOZORILO(A), ČE JE/SO POTREBNO(A)
NAME OF THE VETERINARY MEDICINAL PRODUCT ZOLVIX 25 mg/ml oral solution for sheep
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI ZOLVIX 25 mg/ml peroralna raztopina za ovce
Name and address of the manufacturers responsible for batch release
Ime in naslov proizvajalca (proizvajalcev) zdravila, odgovornega (odgovornih) za sproščanje serij
Shelf life after first opening the immediate packaging: 1 year
Rok uporabnosti po prvem odpiranju stične ovojnine: 1 leto.
Each ml contains 25 mg of monepantel Excipient:
Vsak ml vsebuje 25 mg monepantela.
Therapeutic classification
Druge določbe Terapevtske indikacije
PACKAGE LEAFLET: ZOLVIX 25 mg/ml oral solution for sheep
NAVODILO ZA UPORABO ZOLVIX 25 mg/ml peroralna raztopina za ovce
EXPIRY DATE EXP {month/year} Once opened use within 1 year.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP: {mesec/leto}
ZOLVIX was shown to be effective against strains of gastro-intestinal parasites, listed in section 4, resistant to (pro)benzimidazoles, levamisole, morantel, macrocyclic lactones and H. contortus strains resistant to salicylanilides.
ki so odporni na (pro)benzimidazole, levamizol, morantel in makrociklične laktone, ter proti sevom H.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Dose table Bodyweight, kg
ZDRAVILA Tabela odmerkov: Telesna masa, kg
Macrogolglycerol hydroxystearate Polysorbate 80
(RRR)-α-tokoferol betakaroten koruzno olje propilenglikol makrogolglicerol hidroksistearat polisorbat 80 propilenglikol monokaprilat propilenglikol dikaprilat/dikaprat
The dose rate is 2.5 mg/kg bodyweight of monepantel.
NASVET O PRAVILNI UPORABI ZDRAVILA Odmerek je 2,5 mg monepantela na kg telesne mase.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 04/11/2009
Monepantelsulfone
Monepantelsulfon
C. STATEMENT OF THE MRLs
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL)
WITHDRAWAL PERIOD(S) 7 days.
Karenca: 7 dni.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABE
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
NAČIN IN POT(I) UPORABE
Thus, the risk assessment is based on a potential worst case scenario, which would be a partially combined exposure to the highest levels of NDEA for 4 years (2011 - 2015) and to NDMA for 6 years (2012 - 2018) reported from a sartan, resulting in a cumulative theoretical excess cancer risk of 29.5:100,000 or 1:3390 (0.029%) when extrapolated from the available rat studies according to ICH M7(R1).
Zato ocena tveganja temelji na morebitnem najslabšem možnem scenariju, kar je delno kombinirana izpostavljenost najvišjim ravnem NDEA v obdobju štirih let (2011-2015) in najvišjim ravnem NDMA v obdobju šestih let (20122018), o katerih so poročali za sartan; to ob ekstrapolaciji iz razpoložljivih študij pri podganah v skladu s smernicami ICH M7(R1) kumulativno privede do teoretičnega čezmernega tveganja za raka 29,5 : 100 000 ali 1 : 3 390 (0,029 %).
• Based on the analysis of potential root causes the CHMP considered that all the MAHs should perform risk assessment of the manufacturing processes used for the APIs in their finished products to evaluate the risk of N-nitrosamine formation and contamination.
• na podlagi analize morebitnih osnovnih vzrokov je odbor CHMP presodil, da morajo vsi imetniki dovoljenj za promet z zdravili opraviti oceno tveganja postopkov proizvodnje, ki se uporabljajo za učinkovine v njihovih končnih zdravilih, in tako ovrednotiti tveganje za nastajanje Nnitrozaminov in onesnaženje z njimi;
Olmesartan 40
Priloga IV
1 June 2018
1. junij 2018
What consequences does this withdrawal have for patients in clinical trials?
Kakšne so posledice umika vloge za bolnike, ki sodelujejo v kliničnih preskušanjih?
The active substance in Restaysis, ciclosporin, reduces the activity of cells of the immune system (the body's natural defences) that are involved in the processes that cause inflammation.
Učinkovina v zdravilu Restaysis, ciklosporin, zmanjša delovanje celic imunskega sistema (naravnega obrambnega mehanizma telesa), ki sodelujejo pri procesih, ki povzročajo vnetje.
Withdrawal of the marketing authorisation application for Restaysis (ciclosporin) EMA/275525/2018
Umik vloge za pridobitev dovoljenja za promet z zdravilom Restaysis (ciklosporin) EMA/275525/2018
Withdrawal of the marketing authorisation application for Restaysis (ciclosporin)
Umik vloge za pridobitev dovoljenja za promet z zdravilom Restaysis (ciklosporin)
It was to be available as eye drops.
Na voljo naj bi bilo v obliki kapljic za oči.
On 25 April 2018, Allergan Pharmaceuticals International Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application for a marketing authorisation for Restaysis, for the treatment of moderate dry eye disease.
Podjetje Allergan Pharmaceuticals International Limited je 25. aprila 2018 uradno obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Restaysis, namenjenim zdravljenju zmerne bolezni suhega očesa.
After the CHMP had assessed the company's responses to the last round of questions, there were still some unresolved issues.
Potem ko je odbor CHMP ocenil odgovore podjetja na zadnji sklop vprašanj, so nekatera vprašanja še vedno ostala nerešena.