natgillin/translations-raw huggingface dataset:
Giotrif is available as tablets (20, 30, 40 and 50 mg) and is only available with a prescription.
Zdravilo Giotrif je na voljo v obliki tablet (20, 30, 40 in 50 mg) in se izdaja le na recept.
Treatment should continue for as long as possible, until the disease worsens or the side effects become too severe.
Zdravljenje mora trajati čim dlje, dokler se bolezen ne poslabša ali dokler neželeni učinki ne postanejo prehudi.
The European Commission granted a marketing authorisation valid throughout the European Union for Giotrif on 25 September 2013.
Evropska komisija je dovoljenje za promet z zdravilom Giotrif, veljavno po vsej Evropski uniji, izdala 25. septembra 2013.
The full EPAR for Giotrif 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 Giotrif je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This is a summary of the European public assessment report (EPAR) for Giotrif.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Giotrif.
What measures are being taken to ensure the safe and effective use of Giotrif?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Giotrif?
The most common side effects with Giotrif (which may affect more than 1 in 10 people) are paronychia (nail bed infection), reduced appetite, epistaxis (nosebleeds), diarrhoea, nausea (feeling sick), vomiting, stomatitis (inflammation of the lining of the mouth), rash, acneiform dermatitis (acne-like skin conditions), pruritus (itching), and dry skin.
Najpogostejši neželeni učinki zdravila Giotrif (ki lahko prizadenejo več kot 1 osebo od 10) so paronihija (okužba nohtnega ležišča), zmanjšan tek, epistaksa (krvavitve iz nosu), driska, navzeja (slabost), bruhanje, stomatitis (vnetje ustne sluznice), izpuščaj, akneiformni dermatitis (aknam podobna kožna bolezen), pruritus (srbenje) in suha koža.
Lung cancer cells with mutated EGFR proteins are particularly sensitive to afatinib.
Celice pljučnega raka z mutiranimi beljakovinami EGFR so še posebno občutljive za afatinib.
Other information about Giotrif
Druge informacije o zdravilu Giotrif
This means that it blocks the action of a group of proteins known as ‘ErbB family' which are found on the surface of cancer cells and are involved in stimulating the cells to divide.
To pomeni, da zavira delovanje posebne družine beljakovin, imenovane „družina ErbB“, ki so na površini rakavih celic in sodelujejo pri spodbujanju nenadzorovane delitve celic.
By blocking these proteins, afatinib helps to control cell division and thereby slows down the growth and spread of the non-small cell lung cancer.
Afatinib z zaviranjem teh beljakovin pomaga nadzorovati delitev celic in posledično upočasni rast in širjenje nedrobnoceličnega pljučnega raka.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Giotrif outweigh its risks and recommended that it be granted marketing authorisation in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Giotrif večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
A risk management plan has been developed to ensure that Giotrif is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Giotrif je bil pripravljen načrt obvladovanja tveganj.
In addition, the side effects of the medicine were considered to be manageable and similar to those seen with medicines of the same class.
Prav tako je menil, da so neželeni učinki zdravila obvladljivi in podobni učinkom, opaženim pri drugih zdravilih iz iste skupine.
Treatment with Giotrif should be started and supervised by a doctor experienced in the use of cancer medicines.
Zdravljenje z zdravilom Giotrif mora uvesti in nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
It is not intended to provide practical advice on how to use Giotrif.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
The recommended dose is 40 mg once daily but this may be increased to up to 50 mg per day in patients who tolerate the 40 mg dose, or interrupted and reduced in patients experiencing side effects.
Priporočeni odmerek je 40 mg enkrat na dan, ta pa se lahko pri bolnikih, ki 40-miligramski odmerek dobro prenašajo, poveča do največ 50 mg, pri bolnikih, pri katerih se pojavijo neželeni učinki, pa je treba zdravljenje prekiniti in zmanjšati odmerek.
• when the cancer is of a squamous cell type (from cells of the lining of the lungs) and has worsened despite treatment with platinum-based chemotherapy.
• če gre za raka skvamoznih celic (na pljučni mreni), ki se je poslabšal kljub zdravljenju s kemoterapijo na osnovi platine.
For the full list of all side effects and restrictions with Giotrif, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Giotrif glejte navodilo za uporabo.
For more information about treatment with Giotrif, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Giotrif preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The active substance in Giotrif, afatinib, is an ErbB family blocker.
Zdravilna učinkovina v zdravilu Giotrif, afatinib, je zaviralec družine ErbB.
What are the risks associated with Giotrif?
Kakšna tveganja so povezana z zdravilom Giotrif?
Giotrif has been shown to significantly delay disease progression in patients with non-small cell lung cancer.
Dokazano je bilo, da zdravilo Giotrif znatno upočasni napredovanje bolezni pri bolnikih z nedrobnoceličnim pljučnim rakom.
What benefits of Giotrif have been shown in studies?
Kakšne koristi je zdravilo Giotrif izkazalo v študijah?
What is Giotrif and what is it used for?
Kaj je zdravilo Giotrif in za kaj se uporablja?
In a second study in 795 patients with the squamous cell cancer type, patients treated with Giotrif lived on average for 2.6 months without their disease worsening compared with 1.9 months for patients treated with another cancer medicine, erlotinib.
V drugi študiji s 795 bolniki z rakom skvamoznih celic so bolniki, zdravljeni z zdravilom Giotrif, v povprečju živeli 2,6 meseca brez poslabšanja bolezni, v primerjavi z 1,9 meseca pri bolnikih, ki so prejemali drugo vrsto zdravila za zdravljenje raka, erlotinib.
Why is Giotrif approved?
Zakaj je bilo zdravilo Giotrif odobreno?
In a main study in 345 patients with tumours that have mutated EGFR genes, patients treated with Giotrif lived on average for 11 months without their disease getting worse compared with 7 months for patients who were treated with two other cancer medicines, pemetrexed and cisplatin.
V eni glavni študiji s 345 bolniki s tumorji, ki so imeli mutirane gene za EGFR, so bolniki, zdravljeni z zdravilom Giotrif, v povprečju živeli 11 mesecev brez poslabšanja bolezni, bolniki, ki so jih zdravili z dvema drugima zdraviloma proti raku, pemetreksedom in cisplatinom, pa sedem mesecev.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Giotrif, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu z njim so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
• when the cancer has a mutation in the gene for a protein called EGFR and has not been previously treated with tyrosine kinase inhibitor medicines.
• če ima rak mutacijo gena za beljakovino, imenovano EGFR, in bolnik še ni bil zdravljen z zaviralci tirozin-kinaze;
The CHMP considered that in patients treated with Giotrif the improvement in progression-free survival (how long they lived without the disease getting worse) was a meaningful benefit for patients.
Menil je, da je bilo za bolnike, ki so bili zdravljeni z zdravilom Giotrif, podaljšanje preživetja brez napredovanja bolezni (kako dolgo so bolniki živeli, ne da bi se bolezen poslabšala) pomembna korist zdravljenja.
EGFR proteins are part of the ErbB family.
V družino ErbB spadajo tudi beljakovine EGFR.
For practical information about using Giotrif, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Giotrif naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Giotrif is a medicine used to treat a type of lung cancer known as non-small cell lung cancer.
Uporablja se za zdravljenje vrste pljučnega raka, ki ga imenujemo nedrobnocelični pljučni rak.
How is Giotrif used?
Kako se zdravilo Giotrif uporablja?
How does Giotrif work?
Kako zdravilo Giotrif deluje?
Giotrif contains the active substance afatinib.
Vsebuje zdravilno učinkovino afatinib.
This summary was last updated in April 2012.
Povzetek je bil nazadnje posodobljen v april 2012.
EMA/CVMP/19896/2007 EMEA/V/C/000082
EMA/67111/2007 EMEA/V/C/000082
Avoid contact with eyes and skin.
Izogibajte se stiku z očmi in kožo.
The European Commission granted a marketing authorisation valid throughout the European Union for Previcox on 13 September 2004.
Evropska komisija je dovoljenje za promet z zdravilom Previcox, veljavno po vsej Evropski uniji, odobrila dne 13. septembra 2004.
Horse:
Konji:
Other information about Previcox:
Druge informacije o zdravilu Previcox:
Wash hands after use of the product.
Po uporabi tega izdelka si umijte roke.
The dose, duration of treatment and frequency will depend on the weight and type of animal and condition to be treated.
Odmerek, trajanje in pogostost zdravljenja so odvisni od teže in vrste živali ter stanja, ki ga zdravite.
These reactions are generally of a transitory nature and are reversible when the treatment is stopped.
Te reakcije so v glavnem prehodne narave in izginejo po prekinitvi zdravljenja.
What benefit has Previcox shown during the studies?
Kakšne koristi je zdravilo Previcox izkazalo med raziskavami?
After the last day of treatment with Previcox, horses should not be slaughtered for 26 days (when treated with the oral paste).
Po zadnjemu dnevu zdravljenja z zdravilom Previcox konjev ne smete zaklati še 26 dni (če jih zdravite z oralno pasto).
Previcox has been studied in laboratory animals, as well as in dogs and horses that were treated in various veterinary practices/clinics across Europe (“clinical studies”).
Zdravilo Previcox so raziskovali pri laboratorijskih živalih, kot tudi psih in konjih, ki so jih zdravili v različnih veterinarskih ustanovah in klinikah po vsej Evropi (klinične raziskave).
The Committee for Medicinal Products for Veterinary Use (CVMP) decided that the benefits of Previcox are greater than any risks of treatment and they recommended that Previcox should be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je mnenja, da so koristi zdravila Previcox večje od vseh tveganj zdravljenja, in priporoča odobritev dovoljenja za promet z zdravilom Previcox.
Previcox is presented as chewable tablets for dogs (57 mg and 227 mg) and as an oral paste for horses (8.2 mg/g).
Zdravilo Previcox je na voljo v obliki žvečljivih tablet za pse (57 mg in 227 mg), odobreno pa je tudi kot oralna pasta za konje (8,2 mg/g).
Why has Previcox been approved?
Zakaj je bilo zdravilo Previcox odobreno?
Return halved tablets to the blister and keep out of the reach of children.
Razpolovljene tablete vrnite v pretisni omot in shranjujte izven pogleda in dosega otrok.
What is the risk associated with Previcox?
Kakšna tveganja so povezana z zdravilom Previcox?
The product was shown to be comparable to other reference products (carprofen and meloxicam, respectively).
Z raziskavami so uspeli pokazati, da je izdelek primerljiv z drugimi referenčnimi izdelki (karprofen in meloksikam).
Firocoxib blocks the enzyme (cyclo-oxygenase) that is involved in the production of prostaglandins.
Firokoksib blokira encim (ciklooksigenaza), ki sodeluje pri tvorjenju prostaglandinov.
The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat or milk used for human consumption.
Karenca je časovno obdobje, ki mora preteči po uporabi zdravila, preden se lahko žival zakolje ter se meso ali mleko uporabi za prehrano ljudi.
Administration of the product in accordance with the recommended dosing schedule for a period of up to 90 days resulted in an improvement in lameness score in dogs with established osteoarthritis.
Uporaba izdelka v skladu s priporočeno shemo odmerjanja v trajanju do 90 dni je izboljšala oceno šepavosti pri psih z ugotovljeno osteoartritisom.
The use of Previcox is not permitted in mares producing milk for human consumption.
Uporaba zdravila Previcox ni dovoljena pri kobilah, ki proizvajajo mleko za prehrano ljudi.
Previcox chewable tablets for dogs were studied in two large European field studies in dogs for a period of up to 90 days.
Zdravilo Previcox v obliki žvečljivih tablet za pse so raziskovali pri psih v dveh velikih evropskih raziskavah na terenu do 90 dni.
Previcox must not be administered with corticosteroids or other NSAIDs.
Zdravila Previcox ne smete dajati skupaj s kortikosteroidi ali drugimi NSPVZ-ji.
As the prostaglandins are substances that trigger pain, inflammation and fever, Previcox, therefore, reduces those responses.
Ker so prostaglandini snovi, ki pomagajo sprožiti bolečino, nabiranje tekočine in vnetje, zdravilo Previcox zmanjša prisotnost teh odzivov.
What is Previcox used for?
Za kaj se zdravilo Previcox uporablja?
Women of child-bearing age should avoid contact with, or wear disposable gloves, when administering the product.
Nosečnice naj se izogibajo stika z zdravilom, oziroma naj pri dajanju zdravila nosijo zaščitne rokavice.
Previcox contains firocoxib, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs) belonging to the Coxib group, which acts by selective inhibition of cyclooxygenase-2 (COX-2).
Zdravilo Previcox vsebuje zdravilno učinkovino firokoksib, ki spada v razred nesteroidnih protivnetnih učinkovin (NSPVZ), natančneje v skupino koksibov, ki selektivno zavirajo encim ciklooksigenaza-2 (COX-2).
Previcox oral paste administered once daily for 14 days at a dose of 0.1 mg/kg improved clinical scores for lameness and soft tissue injuries in horses and also helped alleviate pain and inflammation associated with osteoarthritis in horses.
Zdravilo Previcox v obliki oralne paste enkrat dnevno v času 14 dni in pri odmerku 0,1 mg/kg je pri konjih izboljšalo klinične ocene šepavosti in poškodb mehkih tkiv ter pomagalo lajšati bolečine in vnetja, povezana z osteoartritisom.
In case of accidental ingestion, it is necessary to 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 nalepko na zunanji ovojnini.
For details, please see the Package Leaflet.
Za podrobnosti si oglejte Navodilo za uporabo.
The CVMP concluded that Previcox oral paste was as effective as other authorised products (phenylbutazone and vedaprofen) in the alleviation of pain and inflammation associated with osteoarthritis and the reduction of associated lameness in horses.
CVMP je zaključil, da je zdravilo Previcox v obliki oralne paste enako učinkovito kot drugi odobreni izdelki (fenilbutazon in vedaprofen) pri lajšanju bolečine in vnetij povezanih z osteoartritisom ter od teh odvisne šepavosti.
Previcox tablets for dogs improved the scores for the relief of pain and inflammation.
Zdravilo Previcox v obliki tablet za pse je izboljšalo ocene za lajšanje bolečin in vnetij.
Information on the prescription status of this product may be found on the label of the carton.
Podatki o predpisovanju tega zdravila so navedeni na nalepki/zunanji ovojnini.
How does Previcox work?
Kako zdravilo Previcox deluje?
Coxibs display pain relief, anti-inflammatory and antipyretic properties.
Koksibi lajšajo bolečino in imajo protivnetne ter protivročinske lastnosti.
Care should also be taken when used with molecules displaying action on renal flow e.g. diuretics.
Previdni morate biti tudi pri sočasni uporabi s spojinami, ki vplivajo na pretok skozi ledvice, t.j.
Previcox is used for a relief of pain and inflammation associated with osteoarthritis, soft-tissue, orthopaedic and dental surgery in dogs and for the alleviation of pain and inflammation associated with osteoarthritis and reduction of associated lameness in horses.
Zdravilo Previcox se pri psih uporablja za lajšanje bolečin in vnetij, ki so povezane z osteoartritisom, z operativnimi posegi na mehkih tkivih,ortopedskimi operativnimi posegi in zobni kirurgiji, pri konjih pa za lajšanje bolečin in vnetij povezanih z osteoartritisom ter od tega odvisne šepavosti.
Two multi-centre studies were conducted (one in the US and one in Europe) to investigate the efficacy, safety and acceptability of firocoxib under field conditions when administered to horses orally once daily for 14 days at a dose of 0.1 mg/kg.
Da bi raziskali učinkovitost, varnost in prenašanje učinkovine firokoksib v pogojih na terenu pri peroralnem dajanju konjem enkrat dnevno v trajanju 14 dni in pri odmerku 0,1 mg/kg, so izvedli dve multicentrični raziskavi (eno v ZDA in eno v Evropi).
Previcox contains the active substance firocoxib, which belongs to a class of medicines having antiinflammatory action.
Zdravilo Previcox vsebuje zdravilno učinkovino firokoksib, ki spada v razred zdravil s protivnetnimi učinki.
If it occurs, rinse affected area immediately with water.
V primeru, da pride zdravilo v stik z očmi ali kožo, prizadeto področje takoj sperite z vodo.
The results showed an improvement in lameness score in dogs with established osteoarthritis.
Izsledki so pri psih z ugotovljeno osteoartritisom pokazali izboljšanje ocene šepavosti.
How has Previcox been studied?
Kako je bilo zdravilo Previcox raziskano?
What is Previcox?
Kaj je zdravilo Previcox?
The side effects of Previcox are typical for those seen with other medicines in this product class (NSAIDs) such as oral lesions (tissue damage) in the mouth of horses, soft faeces/diarrhoea or lethargy.
Neželeni učinki zdravila Previcox, kot so oralne lezije (vrsta poškodb tkiva) v ustni votlini konj, mehko blato ali diareja in zaspanost, so značilni za vsa zdravila iz tega razreda izdelkov (NSPVZ).
The overall recovery rate was 46.7%.
Skupni delež okrevanja je bil 46,7 %.
It represents a practical approach in line with the aims of this procedure and is appropriate for the protection of consumer safety.
Predstavlja praktični pristop, skladen s cilji tega postopka, in je ustrezna za zaščito varnosti potrošnika.
These data are supported by published literature.
Ti podatki so podprti z objavljeno literaturo.
The animals were split into four groups.
Živali so razvrstili v štiri skupine.
The clinical parameters improved.
Klinični parametri so se izboljšali.
Most of the animals recovered within 2-3 days.
Večina živali je okrevala v od 2 do 3 dnevih.
No data from other European countries/regions have been submitted, so it could not been evaluated if this situation is representative of the whole EU.
Predloženi niso bili nobeni podatki iz drugih evropskih držav/območij, zato ni bilo mogoče oceniti, ali te okoliščine veljajo za celotno EU.
This might potentially lead to problems of animal welfare.
To lahko privede do težav z dobrobitjo živali.
Types and mechanisms of resistance
Vrste in mehanizmi odpornosti
are also appropriate for Grampositive infection in both species as well.
so prav tako primerna za grampozitivno okužbo pri obeh vrstah.
The clinical response rate was 92%.
Delež kliničnega odziva je bil 92-odstoten.
Data were available from two studies.
Na voljo so podatki iz dveh študij.
aureus isolates originating from other animals and humans.
aureus, ki izvirajo iz drugih živali ter ljudi.
These data come from different bibliographic publications as well as publicly available reports from European monitoring programs and cover the period between 1998 and 2009.
Ti podatki izhajajo iz različnih bibliografskih publikacij in javno dostopnih poročil iz evropskih programov spremljanja za obdobje med letoma 1998 ter 2009.
No mortality was observed in the treatment groups.
V zdravljenih skupinah niso opazili umrljivosti.
Several publications and proprietary studies were reviewed.
Pregledali so več publikacij in lastniških študij.
Although the scientific justification for this indication is not as robust as desirable, a clinical cure (response to treatment) of 87.5% was obtained in infections involving Staph.
Čeprav znanstvena utemeljitev za to indikacijo ni trdna, kot bi želeli, so klinično ozdravitev (odziv na zdravljenje) dosegli pri 87,5 % okužb, ki vključujejo Staph.
Neither was appropriate for analysis using the statistical method.
Nobena ni bila primerna za analizo s statistično metodo.
Filiala Filipesti SRL Str. Principala nr. 944 Filipestii de Padure Jud.
Romunija PASTEUR Filiala Filipesti SRL Str. Principala nr. 944 Filipestii de Padure Jud.
21 Montee De La Garde 69340 Francheville France
21 Montee De La Garde 69340 Francheville Francija
Do not use in birds intended for human consumption.
Ne uporabljajte pri pticah, namenjenih za prehrano ljudi.
Therefore, the recommendations made here can only be used as a starting point for individual dose setting.
Priporočila v tem povzetku lahko zato služijo zgolj kot izhodišče za določitev odmerka za posamezno žival.
The term ‘young stock' should be replaced with ‘Cattle (calves)'.
Izraz „mlada živina“ je treba nadomestiti z izrazom „govedo (teleta)“.
Add, to all products and delete the existing text: 5.1 Pharmacodynamic properties
Dodajte vsem zdravilom in izbrišite obstoječe besedilo: 5.1 Farmakodinamične lastnosti
ESTEVE FARMA, LDA Av. Do Forte, 3
Portugalska ESTEVE FARMA, LDA Av. Do Forte, 3
The risk on individual level might be increased for rabbit as compared to other species.
Tveganje na individualni stopnji je lahko pri kuncih povečano v primerjavi z drugimi vrstami.
In other cases, a combination of parenteral and oral administration or the parenteral route alone was used.
V drugih primerih so uporabili kombinacijo parenteralnega in peroralnega odmerjanja ali samo parenteralno odmerjanje.
Special warnings and precautions
Posebna opozorila in previdnostni ukrepi
The results from an experimental study and a field study were provided.
Predloženi so bili rezultati iz eksperimentalne študije in terenske študije.
Bayer Hungária Kft. Alkotás u. 50.
Madžarska Bayer Hungária Kft. Alkotás u. 50.
- In another study 56 Staph.
- V drugi študiji so 56 sevov Staph.
An untreated group was included.
Vključili so nezdravljeno skupino.
Antibacterial spectrum
Protibakterijski spekter
The provided data on efficacy are adequate to demonstrate efficacy against this bacteria.
Predloženi podatki o učinkovitosti so zadostni za potrditev učinkovitosti proti tej bakteriji.
8501 Novo Mesto Slovenia
8501 Novo mesto Slovenija
The percentage of bacteriological cure (Staph.
Odstotek bakteriološke ozdravitve (Staph.
The study also unveiled very high resistance to quinolones (around 38% for ciprofloxacin).
Študija je prav tako pokazala zelo veliko odpornost proti kinolonom (približno 38-odstotno proti ciprofloksacinu).
No field studies were submitted to support the indications in goats.
Predložene niso bile nobene terenske študije, ki bi podprle indikacije pri kozah.
Using the alternative approach8 this represents an unusually high safety span in relation to the data generated with the recommended dose but a reasonable safety span (20%) in relation to the lower dose study.
Pri uporabi alternativnega pristopa8 to predstavlja nenavadno velik varnostni razpon glede na podatke, pridobljene s priporočenim odmerkom, toda razumen varnostni razpon (20 %) v povezavi s študijo z manjšim odmerkom.