natgillin/translations-raw huggingface dataset:
The medicine is currently marketed in the following Member States of the EU: Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Latvia, Luxembourg, Malta, Netherlands, Poland, Portugal, Spain, Sweden and United Kingdom, as well as in Iceland and Norway.
Zdravilo se trenutno trži v naslednjih državah članicah EU: v Avstriji, Belgiji, na Cipru, v Češki republiki, na Danskem, Finskem, v Franciji, Nemčiji, Grčiji, na Irskem, v Italiji, Latviji, Luksemburgu, na Malti, Nizozemskem, Poljskem, Portugalskem, v Španiji, na Švedskem in v Združenem kraljestvu ter na Islandiji in Norveškem.
The company that markets these medicines is Astra Zeneca.
Družba, ki trži ta zdravila, je Astra Zeneca.
The European Commission issued an EU-wide legally binding decision on 28 November 2014.
Evropska komisija je 28. novembra 2014 izdala pravno zavezujoč sklep, veljaven v vsej Evropski uniji.
What is EMLA cream?
Kaj je krema EMLA?
Why was EMLA cream reviewed?
Zakaj je bila krema EMLA pregledana?
It is used as a local anaesthetic to prevent pain during medical or superficial surgical procedures.
Uporablja se kot lokalni anestetik za preprečevanje bolečine med zdravniškimi ali površinskimi kirurškimi posegi.
EMLA cream has been nationally authorised in EU Member States since 1984.
Krema EMLA je odobrena na nacionalni ravni v državah članicah EU od leta 1984.
EMLA cream is authorised in the EU via national procedures.
Krema EMLA je v EU odobrena z nacionalnimi postopki.
The CHMP also harmonised other sections of the SmPC including sections 4.4 (special warning and precautions for use), 4.6 (fertility, pregnancy and lactation) and 4.8 (side effects).
CHMP je uskladil tudi druga poglavja povzetka glavnih značilnosti zdravila, vključno s poglavjem 4.4 (Posebna opozorila in previdnostni ukrepi), 4.6 (Plodnost, nosečnost in dojenje) in 4.8 (Neželeni učinki).
After reviewing the available data supporting the medicine's use, the CHMP agreed that EMLA cream can be used for the following:
Po pregledu razpoložljivih podatkov v podporo uporabi zdravila se je CHMP strinjal, da se krema EMLA lahko uporablja za:
Having harmonised the indications, the CHMP also harmonised recommendations on the doses and the duration of application of EMLA cream before different medical or surgical procedures in children, adolescents or adults.
Po uskladitvi indikacij je CHMP uskladil tudi priporočila glede odmerkov in časa nanosa kreme EMLA pred različnimi zdravniškimi ali kirurškimi posegi pri otrocih, mladostnikih ali odraslih.
The CHMP agreed that hypersensitivity (allergy) to lidocaine and/or prilocaine or similar local anaesthetics or to any other ingredients in EMLA cream should be the only contraindication.
CHMP se je strinjal, da je preobčutljivost za (alergija na) lidokain in/ali prilokain ali podoben lokalni anestetik ali katero koli drugo sestavino kreme EMLA edina kontraindikacija.
In addition, information has been included to explain that studies did not show that EMLA cream is effective at providing adequate pain relief for circumcision (surgical removal of the foreskin).
Poleg tega je bila vključena informacija, ki pojasnjuje, da študije niso dokazale, da krema EMLA zadostno olajša bolečine pri obrezovanju (kirurški odstranitvi kožice penisa).
This has led to divergences across Member States in the way the medicine can be used, as seen in differences in the SmPCs (Summary of Product Characteristics), labelling and package leaflets in the countries where the medicine is marketed.
To je privedlo do razhajanj glede uporabe zdravila po posameznih državah članicah, kot je razvidno iz povzetkov glavnih značilnosti zdravila, označevanja in navodil za uporabo v državah, kjer se zdravilo trži.
On 25 September 2014, the European Medicines Agency completed a review of EMLA cream.
Evropska agencija za zdravila je 25. septembra 2014 zaključila pregled kreme EMLA.
In view of this, on 11 October 2013 the German medicines regulatory agency referred the matter to the CHMP in order to harmonise the marketing authorisations for EMLA cream in the EU.
Zaradi tega je nemška regulatorna agencija za zdravila 11. Oktobra 2013 zadevo napotila na CHMP, da bi ta uskladil dovoljenja za promet s kremo EMLA v EU.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for EMLA cream in the European Union (EU).
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je treba v Evropski uniji (EU) uskladiti podatke o predpisovanju kreme EMLA.
EMLA cream is a topical (skin) cream that contains the active substances lidocaine and prilocaine.
Krema EMLA je krema za lokalni (kožni) nanos, ki vsebuje zdravilni učinkovini lidokain in prilokain.
• topical anaesthesia of the skin in adults and children;
• lokalno anestezijo kože pri odraslih in otrocih;
• topical anaesthesia of the genital mucosa in adults and adolescents;
• lokalno anestezijo genitalne sluznice pri odraslih in mladostnikih;
• topical anaesthesia of leg ulcers in adults only.
• lokalno anestezijo ulkusov na nogi izključno pri odraslih.
This summary was last updated on 18/02/2011.
Povzetek je bil nazadnje posodobljen dne 18/02/2011.
Dogs can be treated for up to six months.
Psi se lahko zdravijo do šest mesecev.
It is available as oblong chewable tablets, in three different strengths (8 mg, 30 mg and 80 mg).
Na voljo je v obliki podolgovatih žvečljivih tablet v treh različnih jakostih (8 mg, 30 mg in 80 mg).
A study in dogs (average age 8.8 years old) with chronic osteoarthritis lasted for up to 90 days.
Študija pri psih (starih povprečno 8,8 let) s kroničnim osteoartritisom je trajala do 90 dni.
The first dose was given two hours before surgery, and treatment was continued for several days.
Prvi odmerek so prejeli dve uri pred operacijo, zdravljenje pa se je nadaljevalo še nekaj dni.
For longer-term treatment, regular monitoring should be undertaken by the veterinary surgeon.
Dolgotrajno zdravljenje mora potekati pod rednim veterinarskim nadzorom.
Pain was assessed by the veterinarian (up to 24 hours after surgery and at the end of the follow-up treatment).
Bolečino je ocenil veterinar (do 24 ur po operaciji in na koncu nadaljevalnega zdravljenja).
It works mainly by blocking an enzyme called cyclo-oxygenase-2 (COX2).
Deluje predvsem tako, da zavira encim, imenovan ciklooksigenaza 2 (COX-2).
These field studies involved dogs of different age groups, genders and breeds.
V terenske študije so bili vključeni psi različnih starostnih skupin, spolov in pasem.
The European Commission granted a marketing authorisation valid throughout the European Union, for Cimalgex to Vétoquinol SA on 18/02/2011.
Evropska komisija je dovoljenje za promet z zdravilom Cimalgex, veljavno po vsej Evropski uniji, odobrila družbi Vétoquinol SA dne 18/02/2011.
Cimalgex must not be used in dogs aged less than 10 weeks old, and if the dog is less than 6 months of age careful monitoring by the veterinarian is recommended.
Zdravilo Cimalgex se ne sme uporabljati pri psih, mlajših od 10 tednov; če je pes mlajši od šest mesecev, pa se priporoča, da zdravljenje skrbno spremlja veterinar.
The owner also noted pain-related observations.
Tudi lastnik je podal ocene v zvezi z bolečino.
Information on the prescription status of this product may be found on the label/outer package.
Podatki o predpisovanju tega zdravila so navedeni na nalepki/zunanji ovojnini zdravila.
The effectiveness was determined based on both examinations by a veterinarian and assessments by the animal's owner of some signs of osteoarthritis (such as lameness, pain or difficulty moving).
Učinkovitost je bila ugotovljena na podlagi pregledov veterinarjev in ocen lastnikov živali glede določenih znakov osteoartritisa (na primer šepavost, bolečine ali težave pri gibanju).
It must not be used together with corticosteroids or other NSAIDs.
Ne sme se uporabljati skupaj s kortikosteroidi ali z drugimi nesteroidnimi protivnetnimi zdravili.
It is also used for the management of pain and inflammation associated with surgery to the bones or soft tissues (such as muscles).
Uporablja se tudi za obvladovanje bolečine in vnetja, povezanega z operacijo kosti ali mehkih tkiv (na primer mišic).
Cimalgex is a veterinary medicine that contains cimicoxib.
Cimalgex je veterinarsko zdravilo, ki vsebuje cimikoksib.
Cimalgex cimicoxib
Cimalgex cimikoksib
Cimalgex has been studied in laboratory animals, as well as in dogs that were treated in various veterinary practices and clinics across Europe (“field studies”) in which Cimalgex was compared with other licensed veterinary NSAID medicines.
Zdravilo Cimalgex so proučevali na laboratorijskih živalih in psih, ki so bili zdravljeni v različnih veterinarskih ambulantah in klinikah po Evropi („terenske študije“), pri katerih so zdravilo Cimalgex primerjali z drugimi odobrenimi veterinarskimi nesteroidnimi protivnetnimi zdravili.
People with a known hypersensitivity (allergy) to cimicoxib should avoid contact with Cimalgex tablets.
Osebe z znano preobčutljivostjo za (alergijo na) cimikoksib naj se izogibajo stiku s tabletami zdravila Cimalgex.
When used with surgery, the tablets are given to the dog around two hours before the start of the operation at a dose of 2 mg/kg body weight, using the appropriate tablet(s) according to the dog's weight, and then once a day for the following three to seven days, based on the judgment of the veterinary surgeon.
Pri uporabi zdravila v okviru operacije se dajo tablete psu okoli dve uri pred pričetkom operativnega posega v odmerku 2 mg/kg telesne mase, pri čemer se uporabijo ustrezne tablete glede na telesno maso psa, nato pa po presoji veterinarja enkrat na dan v naslednjih treh do sedmih dneh.
Cimicoxib may cause skin sensitisation and people should wash their hands after handling the tablets.
Cimikoksib lahko povzroči kožno preobčutljivost, zato naj si ljudje po uporabi tablet umijejo roke.
Once a day the dogs were given either Cimalgex or firocoxib, a medicine authorised for use for this condition.
Psom so enkrat na dan dali zdravilo Cimalgex ali firokoksib, zdravilo, ki je odobreno za uporabo pri tem stanju.
This enzyme is involved in producing substances called prostaglandins, which are involved in pain and inflammation.
Ta encim sodeluje pri tvorbi snovi, imenovanih prostaglandini, ki se sproščajo pri bolečini in vnetju.
Other information about Cimalgex:
Druge informacije o zdravilu Cimalgex:
The benefit-risk balance may be found in the Scientific Discussion part of this EPAR.
Razmerje med koristmi in tveganji najdete v znanstveni razpravi tega evropskega javnega poročila o oceni zdravila (EPAR).
The CVMP decided that the benefits of Cimalgex are greater than its risks for the treatment of pain and inflammation associated with osteoarthritis, and the management of peri-operative pain due to orthopaedic or soft tissue surgery, and recommended that Cimalgex be given a marketing authorisation.
CVMP je zaključil, da so koristi zdravila Cimalgex večje od z njim povezanih tveganj pri zdravljenju bolečine in vnetij, povezanih z osteoartritisom, ter obvladovanju peri-operativne bolečine zaradi ortopedskih operacij ali operacij mehkih tkiv, in priporočil, da se za zdravilo Cimalgex odobri dovoljenje za promet.
A second study involved dogs (various ages from four months upwards) undergoing either orthopaedic or soft tissue surgery.
V drugo študijo so bili vključeni psi (različnih starosti, od štirih mesecev naprej), pri katerih je bila potrebna ortopedska operacija ali operacija mehkih tkiv.
Cimalgex should not be used in dogs that are pregnant, breeding or lactating, or in dogs with problems affecting the stomach or gut, including ulcers or bleeding, or in dogs that have signs of bleeding problems.
Zdravilo Cimalgex naj se ne uporablja pri psicah, ki so breje, vzrejne ali v obdobju laktacije, pri psih s težavami, ki vplivajo na želodec in črevesje, vključno z razjedami ali krvavitvami, ali pri psih, pri katerih se kažejo znaki težav s krvavitvami.
When used for osteoarthritis, the tablets are given to the dog once a day, with or without food, at a dose of 2 mg/kg body weight, using the appropriate tablet(s) according to the dog's weight.
Pri zdravljenju osteoartritisa se dajejo tablete psu enkrat na dan s hrano ali brez nje v odmerku 2 mg/kg telesne mase, pri čemer se uporabijo ustrezne tablete glede na telesno maso psa.
What benefit has Cimalgex shown during the studies?
Kakšne koristi je zdravilo Cimalgex izkazalo med študijami?
The active substance in Cimalgex, cimicoxib, belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Zdravilna učinkovina v zdravilu Cimalgex, cimikoksib, spada v skupino zdravil, imenovanih nesteroidna protivnetna zdravila (NSAID).
Cimalgex must also not be used in dogs that are hypersensitive (allergic) to cimicoxib or any of the other ingredients in the tablets.
Zdravilo Cimalgex se prav tako ne sme uporabljati pri psih, ki so preobčutljivi za (alergični na) cimikoksib ali katero koli drugo sestavino tablet.
Cimalgex is used in dogs to treat the pain and inflammation associated with osteoarthritis (a long term disease causing damage and pain in the joints).
Zdravilo Cimalgex se uporablja pri psih za zdravljenje bolečine in vnetja, ki sta povezana z osteoartritisom (dolgotrajno boleznijo, ki povzroča poškodbe in bolečine v sklepih).
By blocking the production of prostaglandins, cimicoxib reduces the pain and inflammation caused by osteoarthritis or surgery on the bones or soft tissues.
Z zaviranjem tvorjenja prostaglandinov cimikoksib zmanjšuje bolečino in vnetje, ki ju povzroča osteoartritis ali operacija kosti ali mehkih tkiv.
Given daily, Cimalgex reduced pain and inflammation (and the signs of these, such as lameness) in dogs with chronic osteoarthritis, and was as effective as the comparator NSAID, firocoxib.
Pri vsakodnevni uporabi je zdravilo Cimalgex zmanjšalo bolečino in vnetje (in njune znake, kot je na primer šepavost) pri psih s kroničnim osteoartritisom ter je bilo enako učinkovito kot primerjalno nesteroidno protivnetno zdravilo firokoksib.
For a full list of all side-effects reported with Cimalgex, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Cimalgex, glejte navodilo za uporabo.
The dogs received either Cimalgex or a comparator product (carprofen).
Psi so prejeli zdravilo Cimalgex ali primerjalno zdravilo (karprofen).
What is the risk associated with Cimalgex?
Kakšna tveganja so povezana z zdravilom Cimalgex?
Why has Cimalgex been approved?
Zakaj je bilo zdravilo Cimalgex odobreno?
The most common side effects with Cimalgex are mild and transient vomiting or diarrhoea.
Najpogostejša neželena učinka zdravila Cimalgex sta blago in prehodno bruhanje ali driska.
Cimalgex was also shown to be as effective as the comparator NSAID, carprofen, in the management of peri-operative pain due to orthopaedic or soft tissue surgery during the first 24 hours after surgery.
Izkazalo se je tudi, da je zdravilo Cimalgex pri obvladovanju peri-operativne bolečine zaradi ortopedskih operacij ali operacij mehkih tkiv pri psih v prvih 24 urah po operaciji prav tako učinkovito kot primerjalno nesteroidno protivnetno zdravilo karprofen.
What is Cimalgex used for?
Za kaj se zdravilo Cimalgex uporablja?
How has Cimalgex been studied?
Kako je bilo zdravilo Cimalgex raziskano?
What is Cimalgex?
Kaj je zdravilo Cimalgex?
How does Cimalgex work?
Kako zdravilo Cimalgex deluje?
Re-examination procedure
Postopek ponovne presoje
According to Article 62(1) of Regulation (EC) 726/2004, such new data cannot be considered in the context of the re-examination.
V skladu s členom 62(1) Uredbe (ES) 726/2004 tovrstnih podatkov ni mogoče upoštevati med postopkom ponovne presoje.
In the European Union, it was considered that this could potentially impact the marketing authorisations of a number of medicinal products.
V Evropski uniji so menili, da bi to lahko vplivalo na dovoljenja za promet s številnimi zdravili.
Overall conclusion and benefit-risk balance
Splošni zaključek ter razmerje med tveganji in koristmi
It is used to reduce cholesterol levels in patients at risk of cardiovascular disease.
Uporablja se za zniževanje ravni holesterola pri bolnikih s tveganjem srčno-žilnih bolezni.
The MAHs therefore stated their intention to repeat the study, with a study report expected to be available by 15th November 2012.
Zato je navedel, da je pripravljen ponoviti študijo, pri čemer bo poročilo o njej na voljo do 15. novembra 2012.
Other Cetero Research sites were not affected.
Drugi centri raziskovalne ustanove Cetero Research niso bili prizadeti.
On 01 August 2012, the United Kingdom triggered a referral under Article 31 of Directive 2001/83/EC for the identified nationally authorised products.
Združeno kraljestvo je 1. avgusta 2012 začelo napotitveni postopek v skladu s členom 31 Direktive 2001/83/ES za ugotovljena nacionalno odobrena zdravila.
The inspection identified significant instances of misconduct and violations of federal regulations, including falsification of documents and manipulation of samples.
Pri pregledu so odkrili pomembne primere kršitev zveznih predpisov, vključno s ponarejanjem dokumentov in manipulacijo z vzorci.
The conditions for the lifting of the suspension of the Marketing Authorisations are set out in Annex III of the CHMP opinion.
Pogoji za preklic začasnega umika dovoljenj za promet z zdravilom so določeni v Prilogi III mnenja odbora CHMP.
It is used alone or in conjunction with statins in the treatment of hypercholesterolemia and hypertriglyceridemia.
Samostojno ali v kombinaciji s statini se uporablja za zdravljenje hiperholesterolemije in hipertrigliceridemije.
• The Committee considered the procedure under Article 31 of Directive 2001/83/EC for Fenofibrato Pensa and Fenofibrato Ranbaxy.
• Odbor je obravnaval postopek v skladu s členom 31 Direktive 2001/83/ES za zdravili Fenofibrato Pensa in Fenofibrato Ranbaxy.
The single pivotal bioequivalence study 10540314 using the 160 mg tablets was conducted by the Cetero Research facilities in Houston in 2005.
Edina ključna študija biološke enakovrednosti 10540314 s 160-miligramskimi tabletami je bila opravljena leta 2005 v ustanovi Cetero Research v Houstonu.
In light thereof, the CHMP therefore confirmed its previous conclusions.
Odbor CHMP je zato potrdil svoje prvotno mnenje.
The EMA, CMD(h) and CHMP initiated a process to identify and assess all medicinal product dossiers that include studies conducted at the above mentioned facility during the identified time period.
EMA, CMD(h) in CHMP so začeli postopek, s katerim želijo odkriti in oceniti vso dokumentacijo zdravil, ki vključujejo študije, opravljene v zgoraj omenjeni ustanovi v navedenem časovnem obdobju.
The US Food and Drug Administration informed the European Medicines Agency that following an inspection, concerns have been raised about the conduct of bio-analytical studies performed by the Cetero Research facilities in Houston (Texas, USA) during the period from April 2005 to June 2010.
Ameriška agencija za hrano in zdravila (FDA) je Evropsko agencijo za zdravila obvestila, da so bili po inšpekcijskem pregledu izraženi pomisleki o izvedbi bioanalitičnih študij, opravljenih v ustanovi Cetero Research v Houstonu (Teksas, ZDA) v obdobju od aprila 2005 do junija 2010.
Overall summary of the scientific evaluation of Fenofibrato Pensa and Fenofibrato Ranbaxy (see Annex I)
Splošni povzetek znanstvenega vrednotenja zdravil Fenofibrato Pensa in Fenofibrato Ranbaxy (glejte Prilogo I)
Following the adoption of the CHMP opinion during the September 2012 CHMP meeting, a request for re-examination was received from the MAH.
Po sprejetju mnenja na sestanku septembra 2012 je odbor CHMP prejel zahtevo imetnika dovoljenja za promet za ponovno presojo.
The CHMP therefore recommended the suspension of the marketing authorisations until adequate bioequivalence data is made available.
Odbor CHMP je zato predlagal začasni umik dovoljenj za promet z zdravilom, dokler ne bodo na voljo ustrezni podatki o biološki enakovrednosti.
The Committee, as a consequence, recommended the suspension of the marketing authorisations for Fenofibrato Pensa and Fenofibrato Ranbaxy, pursuant to Article 116 of Directive 2001/83/EC; as a. the risk-benefit balance cannot be considered favourable and b. the particulars supporting the application as provided in Article 10 of Directive 2001/83/EC cannot be considered correct
je odbor CHMP priporočil začasen umik dovoljenj za promet z zdravilom Fenofibrato Pensa in Fenofibrato Ranbaxy v skladu s členom 116 Direktive 2001/83/ES, ker a. razmerje med tveganji in koristmi ni pozitivno ter b. podatkov, ki naj bi podprli vlogo v skladu s členom 10 Direktive 2001/83/ES, ni mogoče upoštevati kot pravilne.
In response to the CHMP list of questions, the MAHs stated that no samples were available to carry out a re-analysis.
Kot odgovor na seznam vprašanj odbora CHMP je imetnik dovoljenja za promet z zdravilom pojasnil, da ni na voljo nobenih vzorcev, s katerimi bi lahko opravili ponovno analizo.
Following the assessment of the grounds for the re-examination, the CHMP noted that the results from the new bioequivalence study became available after the CHMP adopted its opinion and were therefore not available to the CHMP during its initial assessment.
Odbor CHMP je ovrednotil gradivo za ponovno presojo in ugotovil, da so izsledki nove študije biološke enakovrednosti postali dostopni po sprejetju mnenja in odboru CHMP torej niso bili na voljo med njegovo prvotno oceno.
Grounds for suspension of the marketing authorisations
Podlaga za začasni umik dovoljenj za promet z zdravilom
The CHMP was requested to assess whether the deficiencies in conduct of bio-analytical studies performed by the Cetero Research facilities in Houston (Texas, USA) have impact on the benefit/risk of the concerned medicinal products and to give its opinion on whether the marketing authorisations for authorised medicinal products for which studies have been carried out or samples analysed by Cetero Research, during the identified time period, should be maintained, varied, suspended or withdrawn.
Odbor CHMP je bil naprošen, da oceni, ali pomanjkljivosti v izvedbi bioanalitičnih študij, opravljenih v ustanovi Cetero Research v Houstonu (Teksas, ZDA), vplivajo na razmerje med tveganji in koristmi pri uporabi zadevnih zdravil, ter za mnenje o tem, ali je treba dovoljenja za promet z odobrenimi zdravili, za katera so bile v ustanovi Cetero Research v navedenem časovnem obdobju opravljene študije ali analizirani vzorci , ohraniti, spremeniti, začasno umakniti ali ukiniti.
The CHMP noted the absence of samples from the critical pivotal bioequivalence study 10540314 and that there is therefore no possibility to reanalyse the data.
Odbor CHMP je upošteval odsotnost vzorcev iz kritične ključne študije biološke enakovrednosti 10540314 in dejstvo, da zaradi tega ni mogoče ponovno analizirati podatkov.
The CHMP was of the opinion that the previous conclusions regarding bioequivalence will need to be confirmed by repeating the bioequivalence study.
Menil je, da bo treba prejšnje zaključke glede biološke enakovrednosti potrditi s ponovno izvedbo študije biološke enakovrednosti.
Annex II Scientific conclusions and grounds for suspension of the marketing authorisations
Znanstveni zaključki in podlaga za začasni umik dovoljenj za promet z zdravilom
The MAH submitted grounds for the re-examination, which consisted of a new bioequivalence study (study 2016_FENOF_11), carried out to replace the pivotal bioequivalence study (study 10540314), for which serious doubts were raised regarding the reliability and the correctness of the data.
Imetnik dovoljenja za promet je predložil gradivo za ponovno presojo, in sicer podatke iz nove študije biološke enakovrednosti (študija 2016_FENOF_11), ki je bila opravljena kot nadomestilo za ključno študijo biološke enakovrednosti (študijo 10540314) v zvezi s katero so bili izraženi pomisleki glede njene zanesljivosti in pravilnosti podatkov.