FrancophonIA/ELRC3.0 huggingface dataset:
English: There is no evidence available on the effect of para-aminosalicylic acid on fertility.
Slovenian: Podatkov o učinku para-aminosalicilne kisline na plodnost ni na voljo.
English: If you are not sure, talk to your doctor or pharmacist before taking GRANUPAS.
Slovenian: Če ste negotovi, se pred uporabo zdravila GRANUPAS posvetujte z zdravnikom ali farmacevtom.
English: Most frequent adverse reactions were related to the gastrointestinal system.
Slovenian: Najpogostejši neželeni učinki so bili povezani s prebavili.
English: Thyroid function should be monitored in HIV co-infected patients before commencing treatment and regularly during treatment, in particular when para-aminosalicylic acid is co-administered with ethionamide/prothionamide.
Slovenian: Pri z virusom HIV sočasno okuženih bolnikih je treba spremaljati delovanje ščitnice že pred začetkom zdravljenja in redno med samim zdravljenjem, predvsem če bolnik prejema para-aminosalicilno kislino skupaj z etionamidom/protionamidom.
English: info@lucanepharma.com
Slovenian: info@medicalneed.com
English: Do not take a double dose to make up for a forgotten dose.
Slovenian: Če ste pozabili vzeti odmerek zdravila GRANUPAS Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: Para-aminosalicylic acid has negligible influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Para-aminosalicilna kislina ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and repeated dose toxicity.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti in toksičnosti pri ponavljajočih se odmerkih ne kažejo posebnega tveganja za človeka.
English: Gastric ulcer
Slovenian: gastrorezistentna zrnca
English: GRANUPAS is unlikely to affect your ability to drive any vehicle and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Verjetnost, da bi zdravilo GRANUPAS vplivalo na vašo sposobnost upravljanja vozil in strojev, je majhna.
English: • destruction of liver cells
Slovenian: • propad jetrnih celic,
English: • reduction in numbers of red blood cells,
Slovenian: • zmanjšanje števila rdečih krvnih celic,
English: There is insufficient information on the effects of para-aminosalicylic acid in newborns/infants..
Slovenian: Podatki o učinku para-aminosalicilne kisline na dojene novorojence/otroke so nezadostni.
English: Your physician may need to start with a lower dose to prevent possible side effects.
Slovenian: Da se preprečijo morebitni neželeni učinki, vam bo zdravnik na začetku morda predpisal manjši odmerek.
English: Do not chew or crush.
Slovenian: Ne žvečite ali drobite.
English: • soft stools,
Slovenian: • mehko blato,
English: Para-aminosalicylic acid is excreted in human milk.
Slovenian: Para-aminosalicilna kislina se izloča v materino mleko.
English: • Add the contents of the sachet to a drink of tomato or orange juice.
Slovenian: • Vsebino vrečice stresite v paradižnikov ali pomarančni sok.
English: Care must be taken in the administration of these granules to protect the acid-resistant coating by maintaining the granules in an acidic food during dosage administration.
Slovenian: Da se zaščiti obloga, odporna proti kislinam, je pri uporabi teh zrnc treba paziti, da med dajanjem odmerka zrnca ostanejo v kisli hrani.
English: Patients with severe renal disease will accumulate the inactive acetyl metabolite of paraaminosalicylic acid.
Slovenian: Pri bolnikih s hudo ledvično boleznijo se bo namreč kopičil neaktivni acetilni presnovek para aminosalicilne kisline.
English: In case it does, please report it to your doctor or pharmacist.
Slovenian: Če do tega vseeno pride, sporočite zdravniku ali farmacevtu.
English: Ethionamide
Slovenian: Etionamid
English: How to store GRANUPAS Contents of the pack and other information
Slovenian: Vsebina pakiranja in dodatne informacije
English: Para-aminosalicylic acid should be used with caution in patients with hepatic impairment.
Slovenian: Para-aminosalicilno kislino je treba previdno uporabljati pri bolnikih z želodčno razjedo.
English: Hypothyroidism in HIV co-infected patients is a very common event and occurs in ≥ 1/10 subjects, particularly when para-aminosalicylic acid is administered with ethionamide/prothionamide.
Slovenian: Hipotiroidizem pri z virusom HIV sočasno okuženih bolnikih je zelo pogost; pojavi se pri ≥1/10 bolnikih, predvsem pri bolnikih, ki prejemajo PAS skupaj z etionamidom/protionamidom.
English: The safety and efficacy of para-aminosalicylic acid in neonates have not been established.
Slovenian: Varnost in učinkovitost zdravila GRANUPAS pri novorojenčkih še ni bila dokazana.
English: Serum digoxin levels should be monitored in patients on concomitant therapy.
Slovenian: Pri bolnikih, ki sočasno prejemajo še druga zdravila, je treba spremljati serumske koncentracije digoksina.
English: Very rare Crystalluria.
Slovenian: Bolezni sečil zelo redki kristalurija
English: • bleeding in the gut,
Slovenian: • krvavitev v črevesju,
English: Rare side effects (may affect more than 1 in 10,000 people):
Slovenian: Redki neželeni učinki (lahko se pojavijo pri več kot 1 od 10.000 bolnikov):
English: Hepatic toxicity
Slovenian: Toksičnost za jetra
English: • skin redness or rash,
Slovenian: • pordelost kože ali kožni izpuščaj,
English: Warning: Do not use if sachet is swollen or the granules have lost their light brown colour and are dark brown or purple.
Slovenian: Opozorilo: ne uporabljajte zdravila, če je vrečica nabrekla ali če so zrnca izgubila svetlorjavo barvo in so postala temnorjava ali škrlatno rdeča.
English: Regular monitoring of the thyroid function is indicated for all people living with HIV.
Slovenian: Pri vseh bolnikih z virusom HIV je potrebno redno spremljanje delovanja ščitnice.
English: How to store GRANUPAS
Slovenian: Shranjevanje zdravila GRANUPAS
English: • thyroid gland problems*,
Slovenian: • težave s ščitnico*,
English: Common side effects (may affect more than 1 in 100 people):
Slovenian: Pogosti neželeni učinki (lahko se pojavijo pri več kot 1 od 100 bolnikov):
English: There are no or limited amount of data from the use of para-aminosalicylic acid in pregnant women.
Slovenian: Podatkov o uporabi para-aminosalicilne kisline pri nosečnicah ni oziroma so omejeni..
English: o Tap the spoon once on a table to give a horizontal level of granules and continue filling if necessary.
Slovenian: Upoštevajte ustrezno količino, ki jo je predpisal zdravnik; o stresite zrnca neposredno na žličko; o ko je žlička na mizi, potrkajte po njej, da poravnate zrnca, nato pa po potrebi dodajte manjkajočo količino.
English: Vitamin B12 absorption may be reduced by para-aminosalicylic acid with clinically significant erythrocyte abnormalities developing after depletion; patients on therapy of more than one month should be considered for maintenance of vitamin B12.
Slovenian: Para-aminosalicilna kislina lahko zmanjša absorpcijo vitamina B12; ko se njegova zaloga izčrpa, pa lahko pride do klinično pomembnih sprememb eritrocitov.
English: GRANUPAS 4 g gastro-resistant granules
Slovenian: GRANUPAS 4 g gastrorezistentna zrnca
English: Each sachet of gastro-resistant granules contains 4 g of para-aminosalicylic acid.
Slovenian: Ena vrečica z gastrorezistentnimi zrnci vsebuje 4 g para-aminosalicilne kisline.
English: Malabsorption syndrome*, peptic ulcer, gastrointestinal bleeding, jaundice, metallic taste.
Slovenian: gastrointestinalna krvavitev, zlatenica, kovinski okus
English: Each sachet contains 4 g of para-aminosalicylic acid.
Slovenian: Ena vrečica vsebuje 4 g para-aminosalicilne kisline.
English: Ethionamide should be withdrawn if these effects are significant.
Slovenian: Če so ti neželeni učinki izraziti, je treba uporabo etionamida prekiniti.
English: Very rare Tendon pain, headache, visual abnormalities,
Slovenian: Bolezni živčevja zelo redki bolečina v kitah, glavobol, nepravilnosti vida, periferna nevropatija, omotica pogosti vrtoglavica, vestibularni sindrom
English: Dibutyl sebacate
Slovenian: Okvara jeter
English: GRANUPAS 4 g gastro-resistant granules para-aminosalicylic acid
Slovenian: GRANUPAS 4 g gastrorezistentna zrnca para-aminosalicilna kislina
English: See section 4.2 for posology adjustments for desensitization.
Slovenian: Za navodila o tem, kako prilagajati odmerjanje za desenzibilizacijo, glejte poglavje 4.2.
English: This medicine is presented as light brown gastro-resistant granules in sachets.
Slovenian: Izgled zdravila GRANUPAS in vsebina pakiranja Zdravilo je v obliki svetlorjavih gastrorezistentnih zrnc v vrečicah.
English: • giddiness,
Slovenian: • driska,
English: • stomach ache (abdominal pain),
Slovenian: • bolečina v želodcu (bolečina v trebuhu),
English: • visual abnormalities,
Slovenian: • nepravilnosti vida,
English: Package leaflet: Information for the patient GRANUPAS 4 g gastro-resistant granules para-aminosalicylic acid
Slovenian: Navodilo za uporabo GRANUPAS 4 g gastrorezistentna zrnca para-aminosalicilna kislina
English: Methacrylic acid - Ethyl acrylate copolymer (1:1) Dispersion 30 per cent Hypromellose
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi koloidni hidratirani silicijev dioksid dibutilsebakat metakrilna kislina in etilakrilat, kopolimer 1 : 1, 30-odstotna disperzija hipromeloza mikrokristalna celuloza smukec
English: Hepatic impairment
Slovenian: Želodčna razjeda
English: • nausea,
Slovenian: • bruhanje,
English: • vomiting,
Slovenian: • napihnjenost,
English: Common abdominal pain, vomiting, nausea, bloating, diarrhea, soft stools.
Slovenian: Bolezni prebavil pogosti bolečina v trebuhu, bruhanje, navzea, napihnjenost, driska, mehko blato občasni anoreksija redki malabsorpcijski sindrom*, želodčna razjeda,
English: Increased blood alkaline phosphatase, transaminases, weight loss.
Slovenian: Preiskave zelo redki zmanjšana koncentracija protrombina, jetrna citoliza, zvišane ravni alkalne fosfataze in transaminaz v krvi, zmanjšanje telesne mase
English: Medical Need Europe AB Puh/Tel: + 46 8 533 39 500 info@medicalneed.com
Slovenian: Suomi/Finland Medical Need Europe AB Puh/Tel: + 46 8 533 39 500
English: Deutschland
Slovenian: Francija
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni jeter, žolčnika in žolčevodov neznana hepatitis
English: GRANUPAS 4g gastro-resistant granules para aminosalicylic acid Oral use
Slovenian: GRANUPAS 4 g gastrorezistentna zrnca para-aminosalicilna kislina peroralna uporaba
English: Eurocept International BV (Lucane Pharma) Trapgans 5
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Eurocept International BV (Lucane Pharma)
English: However, para-aminosalicylic acid appears to be a weak inhibitor of DHP in vitro, raising the possibility that it may have a different target.
Slovenian: Vendar pa kaže, da je para-aminosalicilna kislina in vitro šibek zaviralec
English: • dizziness,
Slovenian: • razjeda,
English: Talk to your doctor or pharmacist before taking GRANUPAS
Slovenian: Pred začetkom jemanja zdravila GRANUPAS se posvetujte z zdravnikom ali farmacevtom:
English: Contents of the pack and other information What GRANUPAS contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo GRANUPAS Zdravilna učinkovina je para-aminosalicilna kislina.
English: • reduction in blood platelets,
Slovenian: • zmanjšana koncentracija trombocitov v krvi,
English: Medical Need Europe AB Tlf: + 46 8 533 39 500 info@medicalneed.com
Slovenian: Medical Need Europe AB Tlf: + 46 8 533 39 500
English: What GRANUPAS is and what it is used for What you need to know before you take GRANUPAS How to take GRANUPAS
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo GRANUPAS
English: Common Cutaneous hypersensitivity, skin rash.
Slovenian: Bolezni kože in podkožja pogosti preobčutljivostna kožna reakcija, kožni izpuščaj redki urtikarija
English: Lucane Pharma Tél/Tel: + 33 153 868 750 info@lucanepharma.com
Slovenian: Luxembourg/Luxemburg Lucane Pharma Tél/Tel: + 33 153 868 750 info@lucanepharma.com
English: Medical Need Europe AB Tel: + 46 8 533 39 500 info@medicalneed.com
Slovenian: Medical Need Europe AB Tel: + 46 8 533 39 500
English: EU/1/17/1255/001
Slovenian: EU/1/17/1255/001 Intrarosa
English: 28 pessaries + 6 applicators
Slovenian: 28 vaginalnih globul + 6 aplikatorjev
English: Vaginal use blister (PVC/PE)
Slovenian: Vaginalna uporaba pretisni omot (PVC/PE)
English: Intrarosa
Slovenian: Jakost
English: Immediate Packaging
Slovenian: Primarna ovojnina Velikost pakiranja
English: The full EPAR for Pantoloc Control can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Pantoloc Control je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It was also of the opinion that, based on the experience of the use of pantoprazole, the availability of Pantoloc Control without medical supervision is appropriate.
Slovenian: Menil je tudi, da je glede na izkušnje z uporabo pantoprazola dostopnost zdravila Pantoloc Control brez medicinskega nadzora ustrezna.
English: The recommended dose of Pantoloc Control is one tablet once a day until symptoms have stopped.
Slovenian: Priporočeni odmerek zdravila Pantoloc Control je ena tableta enkrat na dan, dokler simptomi ne izzvenijo.
English: The European Commission granted a marketing authorisation valid throughout the EU for Pantoloc Control on 12 June 2009.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Pantoloc Control, veljavno po vsej Evropski uniji, odobrila dne 12. junija 2009.
English: The most common side effects with Pantoloc Control (seen in around 1 patient in 100) are diarrhoea and headache.
Slovenian: Najpogostejša neželena učinka zdravila Pantoloc Control (opažena pri približno 1 bolniku od 100) sta driska in glavobol.
English: This is a summary of the European public assessment report (EPAR) for Pantoloc Control.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Pantoloc Control.
English: Pantoloc Control is similar to a ‘reference medicine' already authorised in the European Union (EU) called Pantoloc.
Slovenian: Zdravilo Pantoloc Control je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Pantoloc.
English: For more information about treatment with Pantoloc Control, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Pantoloc Control preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Pantoloc Control must not be used in people who are hypersensitive (allergic) to pantoprazole, soya or any of the other ingredients.
Slovenian: Zdravila Pantoloc Control ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) pantoprazol, sojo ali katero koli drugo sestavino zdravila.
English: Pantoloc Control pantoprazole
Slovenian: Pantoloc Control pantoprazol
English: It is used for long-term treatments and is also used to treat a wider range of gastrointestinal diseases (conditions affecting the gut) than Pantoloc Control.
Slovenian: Uporablja se za dolgotrajno zdravljenje in za zdravljenje širšega spektra bolezni prebavil (stanj, ki prizadenejo črevesje) kot zdravilo Pantoloc Control.
English: 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 Pantoloc Control.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Pantoloc Control, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: The CHMP therefore decided that Pantoloc Control's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Zato je zaključil, da so koristi zdravila Pantoloc Control večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: Pantoloc Control is used for the short-term treatment of the symptoms of acid reflux in adults.
Slovenian: Zdravilo Pantoloc Control se uporablja za kratkotrajno zdravljenje simptomov kislega refluksa pri odraslih.
English: What benefit has Pantoloc Control shown during the studies?
Slovenian: Kakšne koristi je zdravilo Pantoloc Control izkazalo med študijami?
English: It must not be used with atazanavir (a medicine used to treat human immunodeficiency virus [HIV] infection).
Slovenian: Zdravilo Pantoloc Control se ne uporabljati z atazanavirjem (zdravilom za zdravljenje okužbe z virusom človeške imunske pomanjkljivosti [HIV]).
English: Pantoloc Control is a medicine that contains the active substance pantoprazole.
Slovenian: Zdravilo Pantoloc Control je zdravilo, ki vsebuje zdravilno učinkovino pantoprazol.
English: For the full list of all side effects reported with Pantoloc Control, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi pantoprazola, glejte navodilo za uporabo.
English: The active substance in Pantoloc Control, pantoprazole, is a proton pump inhibitor.
Slovenian: Zdravilna učinkovina zdravila Pantoloc Control, pantoprazol, je zaviralec protonske črpalke.
English: The reference medicine, Pantoloc, is only available with a prescription.
Slovenian: Referenčno zdravilo Pantoloc se izdaja le na recept.
English: Other information about Pantoloc Control
Slovenian: Druge informacije o zdravilu Pantoloc Control:
English: What is the risk associated with Pantoloc Control?
Slovenian: Kakšna tveganja so povezana z zdravilom Pantoloc Control?
English: Why has Pantoloc Control been approved?
Slovenian: Zakaj je bilo zdravilo Pantoloc Control odobreno?
English: What is Pantoloc Control?
Slovenian: Kaj je zdravilo Pantoloc Control?
English: What is Pantoloc Control used for?
Slovenian: Za kaj se zdravilo Pantoloc Control uporablja?
English: How has Pantoloc Control been studied?
Slovenian: Kako je bilo zdravilo Pantoloc Control raziskano?
English: How is Pantoloc Control used?
Slovenian: Kako se zdravilo Pantoloc Control uporablja?
English: How does Pantoloc Control work?
Slovenian: Kako zdravilo Pantoloc Control deluje?
English: The reference Member State was France and 12 concerned Member States were involved: Austria, Belgium, Denmark, Germany, Greece, Ireland, Italy, Luxembourg, Portugal, Slovenia, Spain and United Kingdom.
Slovenian: Referenčna država članica je bila Francija, vključenih pa je bilo še 12 zadevnih držav članic: Avstrija, Belgija, Danska, Nemčija, Grčija, Irska, Italija, Luksemburg, Portugalska, Slovenija, Španija in Združeno kraljestvo.
English: The type II variation procedure (FR/V/0201/002/II/006) started on 16 May 2012.
Slovenian: Postopek za spremembo tipa II (FR/V/0201/002/II/006) se je začel 16. maja 2012.
English: The final opinion was converted into a Decision by the European Commission on 25 September 2013.
Slovenian: Končno mnenje je bilo 25. septembra 2013 spremenjeno v sklep Evropske komisije.
English: The Committee appointed Dr B. Urbain as rapporteur and Dr M. Holzhauser-Alberti as co-rapporteur.
Slovenian: Odbor je imenoval dr. B. Urbaina za poročevalca in dr. M. Holzhauser-Albertija za soporočevalca.
English: Article 13 of Commission Regulation (EC) No. 1234/2008
Slovenian: Člen 13 Uredbe Komisije (ES) št. 1234/2008.
English: On Day 90, major issues raised by the CMS, Belgium, remained unsolved.
Slovenian: Na 90. dan so bila pomembna vprašanja, ki jih je sprožila zadevna država članica Belgija, še vedno nerešena.
English: On 3 April 2013, France referred the matter to the CVMP under Article 13(2) of Commission Regulation (EC) No 1234/2008.
Slovenian: 3. aprila 2013 je Francija zadevo napotila na CVMP v skladu s členom 13(2) Uredbe Komisije (ES) št. 1234/2008.
English: The referral procedure started on 10 April 2013.
Slovenian: Napotitveni postopek se je začel 10. aprila 2013.
English: International non-proprietary names (INN): moxidectin and triclabendazole
Slovenian: Mednarodna nelastniška imena (INN): moksidektin in triklabendazol
English: Written explanations were provided by the marketing authorisation holder on 20 May 2013.
Slovenian: Imetnik dovoljenja za promet z zdravilom je 20. maja 2013 predložil pisna pojasnila.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amendments of the relevant sections of the Summary of Product Characteristics, labelling and package leaflet in Annex III.
Slovenian: Seznam zadevnih imen zdravila je v Prilogi I. Znanstveni zaključki so podani v Prilogi II, skupaj s spremembami zadevnih poglavij povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo v Prilogi III.
English: During the variation procedure a potential serious risk to animal health was identified by Belgium and in particular that the efficacy against the lice species had been insufficiently substantiated.
Slovenian: Med postopkom je Belgija opozorila na možno resno tveganje za zdravje živali in predvsem na dejstvo, da učinkovitost proti ušem ni zadovoljivo podprta z dokazi.
English: The CVMP concluded that a satisfactory efficacy towards Linognatus vituli, Bovicola bovis and Solenopotes capillatus can be expected in the field.
Slovenian: CVMP je zaključil, da je v praksi mogoče pričakovati zadovoljivo učinkovitost proti vrstam Linognatus vituli, Bovicola bovis in Solenopotes capillatus.
English: The CVMP was requested to give its opinion on whether or not the data for the type II variation application support the new indication against lice infestations.
Slovenian: CVMP so zaprosili za mnenje o tem, ali podatki za vlogo za spremembo tipa II podpirajo novo indikacijo proti infestacijam z ušmi.
English: The product is administered topically on the back of the animal and is indicated for the treatment of mixed nematode and fluke infections in cattle.
Slovenian: Zdravilo se nanaša lokalno na hrbet živali in je indicirano za zdravljenje mešanih okužb z glistami in metljaji pri govedu.
English: Day 60 of the CMD(v) procedure was on 14 March 2013, and since there was no agreement the procedure was referred to the CVMP.
Slovenian: Ker na 60. dan postopka skupine CMD(v), 14. marca 2013, ni bilo doseženo soglasje, je bil postopek napoten na CVMP.
English: The CMD(v) 60-day referral procedure was initiated on 14 January 2013.
Slovenian: 60-dnevni napotitveni postopek se je začel 14. januarja 2013.
English: The marketing authorisation holder, Pfizer Animal Health, submitted an application for a type II variation, according to Article 16 of Commission Regulation (EC) 1234/2008, to add a new indication against lice species (Linognatus vituli, Bovicola bovis and Solenopotes capillatus) for Cydectin TriclaMox 5 mg/ml and 200 mg/ml pour-on solution for cattle.
Slovenian: Imetnik dovoljenja za promet z zdravilom, družba Pfizer Animal Health, je predložil vlogo za spremembo tipa II v skladu s členom 16 Uredbe Komisije (ES) 1234/2008 za vključitev nove indikacije proti ušem (Linognatus vituli, Bovicola bovis in Solenopotes capillatus) za zdravilo Cydectin TriclaMox 5 mg/ml in 200 mg/ml raztopina za kožni poliv za govedo.
English: Based on the evaluation of the available data, the CVMP adopted, on 16 July 2013, an opinion recommending the granting of the variation to the marketing authorisations for Cydectin TriclaMox (5 mg/ml and 200 mg/ml) pour-on solution for cattle.
Slovenian: Na podlagi ocene razpoložljivih podatkov je CVMP dne 16. julija 2013 sprejel mnenje, s katerim je priporočil odobritev spremembe dovoljenj za promet z zdravilom Cydectin TriclaMox (5 mg/ml in 200 mg/ml) raztopina za kožni poliv za govedo.