natgillin/translations-raw huggingface dataset:
Each pack with 28 film-coated tablets for a 4 week treatment schedule contains: 7 x Memantine Accord 5 mg
Vsako pakiranje z 28 filmsko obloženimi tabletami za štiri tedne trajajočo shemo zdravljenja.
The 10 mg film-coated tablets are white, oblong, coated and scored tablets, debossed with "MT" divided by the score on one side and "10" divided by the score on the other side.
10 mg filmsko obložene tablete so bele, podolgovate obložene tablete z razdelilno zarezo z vtisnjeno oznako "MT" na eni strani zareze in vtisnjeno številko "10" na drugi strani zareze.
Memantine Accord 5 mg film-coated tablets are presented as white, oblong, coated tablet, debossed with “MT” on one side and “5” on the other side.
Memantin Accord 5 mg filmsko obložene tablete so bele, ovalne obložene tablete z vtisnjeno oznako "MT" na eni strani in vtisnjeno številko "5" na drugi strani.
Week 1 (day 1-7): The patient should take one 5 mg film-coated tablet per day (white) for 7 days.
1. teden (1.-7. dan): Bolnik naj 7 dni jemlje eno 5 mg filmsko obloženo tableto na dan (bela).
Memantine Accord 20 mg film-coated tablets are presented as pale red to greyred, oblong, coated and scored tablet, debossed with “MT” divided by the score on one side and “20” divided by the score on the other side.
Memantin Accord 20 mg filmsko obložene tablete so bledo rdeče do sivo rdeče, ovalne obložene tablete z razdelilno zarezo z vtisnjeno oznako "MT" na eni strani zareze in vtisnjeno številko "20" na drugi strani zareze.
EU/1/13/880/009 28 fim-coated tablets EU/1/13/880/010 42 fim-coated tablets EU/1/13/880/011 56 fim-coated tablets EU/1/13/880/012 98 fim-coated tablets EU/1/13/880/015 14 fim-coated tablets
EU/1/13/880/009 28 filmsko obloženih tablet EU/1/13/880/010 42 filmsko obloženih tablet EU/1/13/880/011 56 filmsko obloženih tablet EU/1/13/880/012 98 filmsko obloženih tablet EU/1/13/880/015 14 filmsko obloženih tablet
Memantine Accord film-coated tablets are presented as white, oblong, coated and scored tablet,debossed with "MT" divided by the score on one side and “10” divided by the score on the other side.
Memantin Accord filmsko obložene tablete so bele, podolgovate, obložene tablete z razdelilno zarezo in vtisnjeno oznako "MT" na eni strani zareze in vtisnjeno številko "10" na drugi strani zareze.
What is Memantine Accord used for
Za kaj uporabljamo zdravilo Memantin Accord
Pale red to grey-red, oblong, scored, coated tablet, debossed with “MT” divided by the score on one side and "20" divided by the score on the other side.
Bledo rdeče do sivo rdeče, podolgovate obložene tablete z razdelilno zarezo z vtisnjeno oznako "MT" na eni strani zareze in vtisnjeno številko "20" na drugi strani zareze.
What is in this leaflet
Kaj vsebuje navodilo?
The patient should take one 20 mg film-coated tablet per day for 7 days.
Bolnik naj 7 dni jemlje eno 20 mg filmsko obloženo tableto na dan (bledo rdeča do sivo rdeča z razdelilno zarezo).
Magnesium stearate
Način jemanja
Iron oxide yellow and red (E 172)
Obloga tablete hipromeloza polisorbat 80 makrogol 400 titanov dioksid (E 171) rumeni in rdeči železov oksid (E 172)
Memantine Accord film-coated tablets are presented as pale red to greyred, oblong, coated and scored tablet, debossed with "MT" divided by the score on one side and “20” divided by the score on the other side.
Memantin Accord filmsko obložene tablete so bledo rdeče do sivo rdeče, ovalne obložene tablete z razdelilno zarezo in vtisnjeno oznako "MT" na eni strani zareze in vtisnjeno številko "20" na drugi strani zareze.
This includes any possible side effects not listed in this leaflet.See section 4.
Seznam neželenih učinkov, prikazan v preglednici
Week 2 (day 8-14): The patient should take one 10 mg film-coated tablet (10 mg) per day for 7 days.
2. teden (8.-14. dan): Bolnik naj sedem dni jemlje eno 10 mg filmsko obloženo tableto na dan.
• Seizures
• epileptični napadi
White, oblong, coated and scored tablet, debossed with “MT” divided by the score on one side and "10" divided by the score on the other side.
Bele, podolgovate filmsko obložene tablete, z razdelilno zarezo in vtisnjeno oznako "MT" na eni strani zareze in številko "10" na drugi strani zareze.
NAME OF THE MEDICINAL PRODUCT Memantine Accord 5 mg film-coated tablets
Memantin Accord 5 mg filmsko obložene tablete.
• prostate cancer, when the cancer does not respond to hormonal treatment.
• raka prostate, kadar se rak ne odziva na hormonsko zdravljenje.
The full EPAR for Docetaxel Kabi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Docetaxel Kabi je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Docetaxel Kabi is only used when the neutrophil count (the level of a type of white blood cell in the blood) is normal (at least 1,500 cells/mm3).
Zdravilo Docetaxel Kabi se uporablja le, kadar je število nevtrofilcev (raven vrste belih krvnih celic v krvi) normalno (vsaj 1 500 celic/mm3).
This is a summary of the European public assessment report (EPAR) for Docetaxel Kabi.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Docetaxel Kabi.
Docetaxel blocks the ability of cells to destroy the internal ‘skeleton' that allows them to divide and multiply.
Docetaksel zavira sposobnost celic, da uničijo notranje „ogrodje“, ki celicam omogoča deljenje in razmnoževanje.
The European Commission granted a marketing authorisation valid throughout the European Union for Docetaxel Kabi on 22 May 2012.
Evropska komisija je dovoljenje za promet z zdravilom Docetaxel Kabi, veljavno po vsej Evropski uniji, odobrila dne 22. maja 2012.
The company provided data from published literature on docetaxel.
Družba je predstavila podatke o docetakselu iz objavljene literature.
It is available as a concentrate to be made up into a solution for infusion (drip into a vein).
Na voljo je v obliki koncentrata za pripravo raztopine za infundiranje (kapalne infuzije v veno).
• non-small-cell lung cancer.
• nedrobnoceličnega pljučnega raka.
Docetaxel Kabi is given as a one-hour infusion every three weeks.
Zdravilo Docetaxel Kabi se daje v obliki enourne infuzije vsake tri tedne.
The dose, duration of treatment and the medicines it is used with depend on the type of cancer being treated.
Odmerek, trajanje zdravljenja in njegova souporaba z drugimi zdravili so odvisni od vrste raka, ki se zdravi.
The CHMP concluded that, in accordance with EU requirements, Docetaxel Kabi has been shown to be comparable to Taxotere.
CHMP je zaključil, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Docetaxel Kabi primerljivo z zdravilom Taxotere.
For more information about treatment with Docetaxel Kabi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Docetaxel Kabi preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
This means that Docetaxel Kabi is similar to a ‘reference medicine' already authorised in the European Union (EU) called Taxotere.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Taxotere.
Because Docetaxel Kabi is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Docetaxel Kabi generično zdravilo, se šteje, da so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
Docetaxel Kabi is used to treat the following types of cancer:
Zdravilo Docetaxel Kabi se uporablja za zdravljenje naslednjih vrst raka:
An anti-inflammatory medicine such as dexamethasone should also be given to the patient, starting on the day before the Docetaxel Kabi infusion.
Bolniku je treba dati tudi protivnetno zdravilo, kot je na primer deksametazon, in sicer dan pred infuzijo zdravila Docetaxel Kabi.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Docetaxel Kabi.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Docetaxel Kabi, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Docetaxel Kabi docetaxel
Docetaxel Kabi docetaksel
It can also be used with other anticancer medicines (doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients who have not yet received any treatment for their cancer or after other treatments have failed, depending on the type and stage of the breast cancer being treated;
Prav tako se lahko uporablja sočasno z drugimi zdravili proti raku (doksorubicinom, ciklofosfamidom, transtuzumabom ali kapecitabinom) pri bolnikih, ki proti raku še niso prejeli nobenih zdravil ali pri katerih so bile druge oblike zdravljenja neuspešne, odvisno od vrste in stadija raka dojke, ki se zdravi;
What are the benefits and risks of Docetaxel Kabi?
Kakšne so koristi in tveganja, povezani z zdravilom Docetaxel Kabi?
Docetaxel Kabi is a ‘generic medicine'.
Docetaxel Kabi je „generično zdravilo“.
Docetaxel Kabi can be used on its own after other treatments have failed.
Zdravilo Docetaxel Kabi se lahko uporablja kot samostojno zdravilo, kadar druge oblike zdravljenja niso bile uspešne.
Other information about Docetaxel Kabi
Druge informacije o zdravilu Docetaxel Kabi
Docetaxel Kabi should be used in wards specialising in chemotherapy (using medicines to treat cancer) under the supervision of a doctor who is qualified in the use of chemotherapy.
Zdravilo Docetaxel Kabi se sme uporabljati samo na specializiranih oddelkih za kemoterapijo (kjer se uporabljajo zdravila proti raku) in se daje le pod nadzorom zdravnika, usposobljenega za uporabo kemoterapije.
The Committee recommended that Docetaxel Kabi be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Docetaxel Kabi odobri dovoljenje za promet.
Therefore, the CHMP's view was that, as for Taxotere, the benefit outweighs the identified risk.
Zato je menil, da njegove koristi, tako kot pri zdravilu Taxotere, odtehtajo znana tveganja.
It can also be used with cisplatin (another anticancer medicine) in patients who have not yet received any treatment for their cancer;
Uporablja se lahko tudi v kombinaciji s cisplatinom (drugim zdravilom proti raku) pri bolnikih, ki se zaradi raka še niso zdravili;
The active substance in Docetaxel Kabi, docetaxel, belongs to the group of anticancer medicines known as the taxanes.
Zdravilna učinkovina zdravila Docetaxel Kabi, docetaksel, spada v skupino zdravil proti raku, imenovanih taksani.
The company also showed that the Docetaxel Kabi solution for infusion has comparable quality to that of Taxotere.
Poleg tega je predstavila tudi dokaze o tem, da je raztopina za infundiranje zdravila Docetaxel Kabi primerljive kakovosti kot zdravilo Taxotere.
Docetaxel Kabi is used with prednisone or prednisolone (anti-inflammatory medicines);
Zdravilo Docetaxel Kabi se uporablja sočasno s prednizonom ali prednizolonom (protivnetnima zdraviloma);
Docetaxel Kabi is a medicine that contains the active substance docetaxel.
Docetaxel Kabi je zdravilo, ki vsebuje zdravilno učinkovino docetaksel.
Why has Docetaxel Kabi been approved?
Zakaj je bilo zdravilo Docetaxel Kabi odobreno?
• head and neck cancer in patients whose cancer is locally advanced (a cancer that has grown but has not spread).
• raka glave in vratu pri bolnikih, katerih rak je lokalno napredoval (rakava tvorba je zrasla, vendar se še ni razširila po telesu).Zdravilo Docetaxel Kabi se uporablja v kombinaciji s cisplatinom in 5-fluoroacilom.
No additional studies were needed as Docetaxel Kabi is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Taxotere.
Ker je zdravilo Docetaxel Kabi generično zdravilo, ki se daje z infundiranjem in vsebuje isto zdravilno učinkovino kot referenčno zdravilo Taxotere, niso bile potrebne nobene dodatne študije.
What is Docetaxel Kabi used for?
Za kaj se zdravilo Docetaxel Kabi uporablja?
What is Docetaxel Kabi?
Kaj je zdravilo Docetaxel Kabi?
How has Docetaxel Kabi been studied?
Kako je bilo zdravilo Docetaxel Kabi raziskano?
Docetaxel Kabi is used with cisplatin and 5-fluorouracil (other anticancer medicines);
• adenokarcinoma želodca (vrste želodčnega raka) pri bolnikih, ki se zaradi raka še niso zdravili.Zdravilo Docetaxel Kabi se uporablja v kombinaciji s cisplatinom in 5-fluoroacilom (drugima zdraviloma proti raku);
How does Docetaxel Kabi work?
Kako zdravilo Docetaxel Kabi deluje?
How is Docetaxel Kabi used?
Kako se zdravilo Docetaxel Kabi uporablja?
This summary was last updated in December 2014.
Povzetek je bil nazadnje posodobljen decembra 2014.
Protection prevents mortality and reduces infection and disease.
Zaščita preprečuje smrtnost ter zmanjšuje tveganje okužbe in bolezni.
This will help to protect against the disease.
To bo živali pomagalo pri zaščiti pred boleznijo.
Protection lasted at least six months after vaccination.
Zaščita je trajala vsaj šest mesecev po cepljenju.
The laboratory studies showed that the vaccine had its full effect against CSFV by two weeks.
Laboratorijske študije so pokazale, da je cepivo svoj polni učinek proti KPK doseglo v dveh tednih.
The vaccine is given to pigs from seven weeks of age as a single injection into the muscle.
Cepivo se daje pujskom, starejšim od sedmih tednov, kot enkratna injekcija v mišico.
The main measure of effectiveness was development of antibodies against E2 protein 14 days after vaccination.
Glavno merilo učinkovitosti je bil razvoj protiteles proti beljakovini E2 14 dni po cepljenju.
The European Commission granted a marketing authorisation valid throughout the European Union, for Suvaxyn CSF Marker on 10/02/2015.
Evropska komisija je dovoljenje za promet z zdravilom Suvaxyn CSF Marker, veljavno po vsej Evropski uniji, izdala 10/02/2015.
As CSF is a notifiable disease, it is not possible to conduct standard field studies.
Ker je KPK bolezen, ki jo je treba obvezno prijaviti, izvedba standardnih terenskih študij ni mogoča.
This disease causes fever, skin lesions, convulsions and often leads to death of the animals.
Bolezen povzroča povišano telesno temperaturo, kožne lezije in krče ter pogosto vodi k poginu živali.
The purpose of these studies was to establish how long it took for pigs to be fully protected and the length of time protection lasts against CSFV.
Namen teh študij je bil ugotoviti, po kolikem času je nastopila popolna zaščita prašičev pred virusom KPK in kako dolgo je ta zaščita trajala.
Protection starts two weeks after vaccination and lasts for at least six months.
Učinkovati začne dva tedna po cepljenju in traja najmanj šest mesecev.
The effectiveness of Suvaxyn CSF Marker was further investigated in a small scale study with 30 eight-week-old piglets.
Učinkovitost zdravila Suvaxyn CSF Marker so nadalje raziskovali v manjši študiji, v katero je bilo vključenih 30 pujskov, starih osem tednov.
The vaccine is available as a lyophilisate (freeze dried powder) and solvent for injection.
Cepivo je na voljo je v obliki liofilizata (praška, sušenega z zamrzovanjem) in vehikla za injiciranje.
When the vaccine is given to a healthy pig, the animal's immune system recognises the vaccine virus as ‘foreign' and makes antibodies against it.
Ko se zdravilo da zdravemu prašiču, imunski sistem živali virus cepiva prepozna kot tujek in začne proti njemu tvoriti protitelesa.
In the future, if the animals are exposed to CSFV, their immune system will be triggered by the virus and be able to respond more quickly.
Ob morebitni ponovni izpostavitvi živali virusu KPK v prihodnosti bo virus sprožil imunski sistem, ki se bo lahko odzval hitreje.
The field study showed that vaccination with Suvaxyn CSF Marker resulted in 19 out of 20 piglets developing antibodies against E2 protein.
Terenska študija je pokazala, da je ob cepljenju z zdravilom Suvaxyn CSF Marker 19 od 20 pujskov razvilo protitelesa proti beljakovini E2.
Suvaxyn CSF Marker should not be used to vaccinate sows.
Zdravilo Suvaxyn CSF Marker se ne sme uporabljati za cepljenje svinj.
Twenty piglets were given Suvaxyn CSF Marker and 10 piglets were given a placebo (dummy) injection.
20 pujskov je prejelo zdravilo Suvaxyn CSF Marker, 10 pujskov pa injekcijo s placebom (brez zdravilne učinkovine).
Suvaxyn CSF Marker is a vaccine containing bovine viral diarrhoea virus, which can infect pigs but does not normally cause disease in them.
Zdravilo Suvaxyn CSF Marker je cepivo, ki vsebuje virus goveje virusne driske, s katerim se prašiči lahko okužijo, vendar pri njih običajno ne povzroči bolezni.
The CVMP concluded that the benefits of Suvaxyn CSF Marker exceed the risks for the approved indication and recommended that Suvaxyn CSF Marker be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Suvaxyn CSF Marker večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Other information about Suvaxyn CSF Marker:
Druge informacije o zdravilu Suvaxyn CSF Marker:
This is because if given to pregnant sows it does not prevent them from passing CSFV infection to their offspring but can hide signs of infection in the piglets, allowing them to spread the disease.
Cepljenje s tem zdravilom namreč ne preprečuje prenašanja okužbe s KPK s svinj na potomce, lahko pa zakrije znake okužbe pri pujskih, zaradi česar lahko ti širijo bolezen.
Suvaxyn CSF Marker is used to protect pigs against outbreaks of classical swine fever, a very severe and highly contagious viral disease of both wild and domestic pigs.
Zdravilo Suvaxyn CSF Marker se uporablja za zaščito prašičev pred izbruhom klasične prašičje kuge, zelo hude in izjemno nalezljive virusne bolezni, ki prizadene divje in domače prašiče.
What benefit has Suvaxyn CSF Marker shown during the studies?
Kakšne koristi je zdravilo Suvaxyn CSF Marker izkazalo med študijami?
The vaccine virus in Suvaxyn CSF Marker has been modified so that it will produce the E2 protein, which is part of the outer coat of the closely related virus CSFV, which it provides protection against.
Virus v cepivu Suvaxyn CSF Marker je bil spremenjen tako, da tvori beljakovino E2, ki je del zunanje ovojnice zelo sorodnega virusa klasične prašičje kuge, proti kateremu cepivo zagotavlja zaščito.
Suvaxyn CSF Marker is a recombinant veterinary vaccine that contains live bovine viral diarrhoea virus (BVDV) which has been modified to replace the envelope (E2) gene of BVDV with the corresponding gene of classical swine fever virus (CSFV).
Zdravilo Suvaxyn CSF Marker je rekombinantno cepivo za uporabo v veterinarski medicini, ki vsebuje živi virus goveje virusne driske, pri katerem je gen goveje virusne driske, ki kodira beljakovino virusne ovojnice (E2), nadomeščen z ustreznim genom klasične prašičje kuge (KPK).
The withdrawal period for Suvaxyn CSF Marker for pigs is zero days.
Karenca za zdravilo Suvaxyn CSF Marker pri prašičih je nič dni.
The vaccine has potential marker properties which may allow detection of pigs infected with field CSFV as distinct from Suvaxyn CSF Marker vaccinated pigs, in accordance with the DIVA principle (differentiation of infection from vaccination).
Cepivo ima morebitne lastnosti markerja, kar lahko v skladu z načelom DIVA (razlikovanje med okuženimi in cepljenimi živalmi) omogoči razlikovanje med živalmi, okuženimi s terenskim virusom KPK, in živalmi, cepljenimi z zdravilom Suvaxyn CSF Marker.
What is the risk associated with Suvaxyn CSF Marker?
Kakšna tveganja so povezana z zdravilom Suvaxyn CSF Marker?
Why has Suvaxyn CSF Marker been approved?
Zakaj je bilo zdravilo Suvaxyn CSF Marker odobreno?
There are no known side effects with Suvaxyn CSF Marker when it is used according to the approved indication of the product information.
Če se zdravilo Suvaxyn CSF Marker uporablja v skladu z odobrenimi indikacijami, navedenimi v informacijah o zdravilu, nima znanih neželenih učinkov.
What is Suvaxyn CSF Marker?
Kaj je zdravilo Suvaxyn CSF Marker?
Classical swine fever vaccine (live recombinant)
Suvaxyn CSF Marker cepivo proti klasični prašičji kugi (živi rekombinantni virus)
How has Suvaxyn CSF Marker been studied?
Kako je bilo zdravilo Suvaxyn CSF Marker raziskano?
What is Suvaxyn CSF Marker used for?
Za kaj se zdravilo Suvaxyn CSF Marker uporablja?
How does Suvaxyn CSF Marker work?
Kako zdravilo Suvaxyn CSF Marker deluje?
What is the withdrawal period?
Kako dolgo traja karenca?
The final opinion was converted into a Decision by the European Commission on 3 August 2009.
Končno mnenje je bilo spremenjeno v odločbo Evropske komisije dne 3 August 2009.
The application was submitted in the framework of Article 32 of Directive 2001/82/EC, as amended, where the Reference Member State was the United Kingdom and the Concerned Member States were Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, The Netherlands, Portugal and Spain.
Vloga je bila predložena v skladu s členom 32 Direktive 2001/82/ES, kakor je bila spremenjena, pri čemer je bilo Združeno kraljestvo referenčna država članica, Avstrija, Belgija, Danska, Francija, Nemčija, Grčija, Irska, Italija, Nizozemska, Portugalska in Španija pa zadevne države članice.
The rapporteur and co-rapporteur appointed were: Dr Bruno Urbain and Dr Michael Holzhauser-Alberti, respectively.
Imenovana poročevalec oziroma soporočevalec sta bila: dr. Bruno Urbain oziroma dr. Michael Holzhauser-Alberti.
The Mutual Recognition Procedure started on 28 February
Postopek medsebojnega priznavanja se je začel 28. februarja 2008.
3 August 2009 Doc.
3. avgust 2009 Sklic dok.
Florfenicol is a synthetic broad spectrum antibiotic with a range of activity, including many Gramnegative and Gram-positive organisms.
Florfenikol je sintetični antibiotik s širokim spektrom delovanja, tudi proti mnogim gramnegativnim in grampozitivnim organizmom.
Oral explanations were given on 16 April 2009.
Ustna pojasnila so bila podana 16. aprila 2009.
Written explanations were provided by the Marketing Authorisation Holder on 15 January 2009.
Pisna pojasnila je imetnik dovoljenja za promet z zdravilom predložil 15. januarja 2009.
Based on the evaluation of the rapporteurs' assessment of the currently available data, the CVMP considered that the use of the product as recommended for therapeutic use only does not constitute a risk for the environment.
Na podlagi ocene poročevalčevega vrednotenja trenutno razpoložljivih podatkov je Odbor za zdravila za uporabo v veterinarski medicini (CVMP) menil, da uporaba zdravila, kot je priporočena samo za terapevtske namene, ne pomeni tveganja za okolje.
However, the CVMP also considered that the wording of the therapeutic indication as authorised in the Reference Member State should be amended to clearly state the limitations of the approved use and avoid incorrect interpretation.
Vendar pa je CVMP tudi menil, da bi bilo treba besedilo terapevtske indikacije, kot jo je odobrila referenčna država članica, spremeniti, da bi bile v njem jasno navedene omejitve glede odobrene uporabe in bi se izognili nepravilni razlagi.
Due to concerns raised by Germany and The Netherlands during the Mutual Recognition Procedure that Shotaflor 300 mg/ml solution for injection for cattle could present a potential serious risk to the environment, the United Kingdom referred the matter to the EMEA on 31 July 2008 under Article 33(4) of Directive 2001/82/EC.
Zaradi zadržkov, ki sta jih med postopkom z medsebojnim priznavanjem izrazili Nemčija in Nizozemska, da bi lahko zdravilo Shotaflor 300 mg/ml, raztopina za injiciranje za govedo, pomenilo možno resno tveganje za okolje, je Združeno kraljestvo dne 31. Julija 2008 zadevo napotilo na agencijo EMEA v skladu s členom 33(4) Direktive 2001/82/ES.
OPINION FOLLOWING AN ARTICLE 33 (4)1 REFERRAL FOR SHOTAFLOR 300 MG/ML SOLUTION FOR INJECTION FOR CATTLE International Non-Proprietary Name (INN): Florfenicol
MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 33(4)1 ZA ZDRAVILO SHOTAFLOR 300 MG/ML, RAZTOPINA ZA INJICIRANJE ZA GOVEDO Mednarodno nelastniško ime (INN): florfenikol