FrancophonIA/ELRC3.0 huggingface dataset:
English: To obtain pain relief for cattle and pigs during surgery co-medication with an appropriate anaesthetic/sedative/analgesic is needed.
Slovenian: Za lajšanje bolečine pri govedu in prašičih med operacijo je treba sočasno uporabiti ustrezen anestetik/sedativ/analgetik.
English: For dogs, cats and cattle it is also a major biliary excretion product whereas urine contains only traces of the parent compound.
Slovenian: Pri psih, mačkah in govedu je tudi pomembna sestavina pri izločanju zdravila z žolčem, medtem ko vsebuje urin samo sledi matične spojine.
English: Comparatively low concentrations are detectable in skeletal muscle and fat.
Slovenian: Razmeroma majhne koncentracije so zaznane v skeletnih mišicah in maščevju.
English: Pregnancy and lactation: Dogs and cats: Do not use in pregnant or lactating dogs or cats.
Slovenian: Psi in mačke: Pri psih ali mačkah ne uporabite v obdobju brejosti in laktacije.
English: Marketing authorisation holder: Le Vet Beheer B.V.
Slovenian: Imetnik dovoljenja za promet z zdravilom Le Vet Beheer B.V.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY”
Slovenian: BESEDILO ''SAMO ZA ŽIVALI''
English: Cattle:
Slovenian: Govedo:
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
Slovenian: NAVEDBA UČINKOVIN(E) IN DRUGE(IH) SESTAVIN(E) En ml vsebuje:
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Slovenian: Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency), http://www.ema.europa.eu/.
English: During anaesthesia, monitoring and fluid therapy should be considered as standard practice.
Slovenian: Treba bi bilo razmisliti o rutinskem spremljanju in tekočinskem zdravljenju med anestezijo.
English: For the relief of post-operative pain associated with minor soft tissue surgery such as castration.
Slovenian: Za lajšanje postoperativnih bolečin, povezanih z manjšimi operacijami mehkega tkiva, na primer s kastracijo.
English: Meloxicam is eliminated with a half-life of 26 hours after subcutaneous injection in young cattle.
Slovenian: Razpolovna doba izločanja meloksikama pri mladem govedu je 26 ur po subkutanem injiciranju.
English: For use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of over one week of age and young, non-lactating cattle.
Slovenian: Za umirjanje kliničnih znakov driske, v kombinaciji s peroralnim rehidracijskim zdravljenjem, pri teletih, starejših od enega tedna, in mladem govedu, ki ni v obdobju laktacije.
English: Label for 10 ml and 20 ml
Slovenian: Nalepka za 10 ml in 20 ml
English: Meloxicam 20 mg/ml
Slovenian: Meloksikam 20 mg/ml
English: Meloxicam Meloxicam Bovine, caprine, porcine, rabbit,
Slovenian: Terapevtske indikacije meloksikam meloksikam govedo, koze, prašiči, kunci, kopitarji
English: Any oral follow-up therapy using meloxicam or other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) should not be administered in cats, as appropriate dosage regimens for such follow-up treatments have not been established.
Slovenian: Pri mačkah zdravljenja ne smete nadaljevati s peroralno obliko meloksikama ali drugega nesteroidnega protivnetnega zdravila (NSAID), ker pri njih še ni določen ustrezen odmerek za takšno nadaljevalno zdravljenje.
English: People with known hypersensitivity to NonSteroidal Anti-Inflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
Slovenian: Osebe z znano preobčutljivostjo za nesteroidna protivnetna zdravila (NSAID) naj se izogibajo stiku z zdravilom.
English: Typical adverse reactions of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as loss of appetite, vomiting, diarrhoea, faecal occult blood, lethargy and renal failure have rarely been reported.
Slovenian: Redko so poročali o značilnih neželenih učinkih nesteroidnih protivnetnih zdravil (NSAID), kot so izguba teka, bruhanje, driska, kri v blatu (okultna krvavitev), letargija in ledvična odpoved.
English: Any oral follow-up therapy using meloxicam or other NSAIDs should not be administered in cats, as appropriate dosage regimens for such follow-up treatments have not been established.
Slovenian: Pri mačkah zdravljenja ne smete nadaljevati s peroralno obliko meloksikama ali drugega nesteroidnega protivnetnega zdravila, ker pri njih še ni določen ustrezen odmerek za takšno nadaljevalno zdravljenje.
English: Following subcutaneous administration, meloxicam is completely bioavailable and maximal mean plasma concentrations of 0.73 g/ml in dogs and 1.1 µg/ml in cats were reached approximately 2.5 hours and 1.5 hours post administration, respectively.
Slovenian: Meloksikam je po podkožnem dajanju v celoti biološko uporaben in doseže največjo srednjo koncentracijo v plazmi, ki je 0,73 µg/ml pri psih in 1,1 µg/ml pri mačkah, približno 2,5 ure oz. 1,5 ure po dajanju.
English: Oral suspensions of meloxicam for dogs may be used for continuation of treatment at a dosage of 0.1 mg meloxicam/kg body weight, 24 hours after administration of the injection.
Slovenian: Zdravljenje lahko nadaljujemo s peroralno suspenzijo meloksikama, ki jo damo v odmerku po 0,1 mg meloksikama na kilogram telesne mase 24 ur po injekciji.
English: In animals at anaesthetic risk (e.g. aged animals) intravenous or subcutaneaous fluid therapy during anaesthesia should be taken into consideration.
Slovenian: Pri živalih, pri katerih je večja verjetnost, da bodo potrebovale anestezijo (npr. pri starejših živalih), je treba presoditi o potrebi po intravenskem ali podkožnem dajanju tekočine med anestezijo.
English: In very rare cases anaphylactic reactions, which may be serious (including fatal), may occur and should be treated symptomatically.
Slovenian: Zelo redko se lahko pojavijo anafilaktoidne reakcije, ki so lahko resne (vključno s smrtnimi) in jih je treba zdraviti simptomatsko.
English: Active substance: Meloxicam 20 mg
Slovenian: Učinkovina: Meloksikam 20 mg
English: Reduction of post-operative pain:
Slovenian: Lajšanje pooperativne bolečine:
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Slovenian: Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi):
English: THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”
Slovenian: POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK
English: Do not use in dogs and cats suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Slovenian: Ne uporabite pri psih in mačkah z obolenji prebavil, kot so vzdraženost prebavil in krvavitev, pri motnjah jetrne, srčne ali ledvične funkcije in hemoragičnih obolenjih.
English: Sodium hydroxide Hydrochloric acid Glycofurol Meglumine Water for injections
Slovenian: 6.1 Seznam pomožnih snovi etanol poloksamer 188 natrijev klorid glicin natrijev hidroksid klorovodikova kislina glikofurol meglumin voda za injekcije
English: Meloxidolor must not be administered in conjunction with other NSAIDs or glucocorticosteroids.
Slovenian: Zdravila Meloxidolor ne smemo dajati z drugimi nesteroidnimi protivnetnimi zdravili ali glukokortikosteroidi.
English: Meloxicam is eliminated with a half-life of 26 hours and 17.5 hours after subcutaneous injection in young cattle and lactating cows, respectively.
Slovenian: Razpolovna doba izločanja meloksikama je po podkožni injekciji pri mladem govedu 26 ur, pri kravah v obdobju laktacije pa 17,5 ure.
English: To obtain the best possible pain relieving effect post-surgery Meloxidolor should be administered 30 minutes before surgical intervention.
Slovenian: Najboljše možno lajšanje bolečine po operaciji se doseže z uporabo zdravila Meloxidolor 30 minut pred kirurškim posegom.
English: People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.
Slovenian: Osebe z znano preobčutljivostjo za nesteroidna protivnetna zdravila naj se izogibajo stiku z zdravilom.
English: Shelf-life after first opening the immediate packaging: 28 days
Slovenian: Rok uporabnosti po prvem odpiranju stične ovojnine: 28 dni.
English: In very rare cases, haemorrhagic diarrhoea, haematemesis and gastrointestinal ulceration have been reported.
Slovenian: Zelo redko so poročali o hemoragični driski, hematemezi in razjedi prebavil.
English: After two intramuscular doses of 0.4 mg meloxicam/kg, a Cmax value of 1.9 µg/ml was reached after 1 hour in pigs.
Slovenian: Po dveh intramuskularnih odmerkih meloksikama po 0,4 mg/kg je bila raven Cmax 1,9 g/ml pri prašičih dosežena po 1 uri.
English: For use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of over one week of age.
Slovenian: Za umirjanje kliničnih znakov driske v kombinaciji s peroralnim rehidracijskim zdravljenjem pri teletih, starejših od enega tedna.
English: Following single intramuscular doses of 0.4 mg meloxicam/kg, a Cmax value of 1.1 to 1.5 μg/ml was reached within 1 hour in pigs.
Slovenian: Po enkratnem intramuskularnem odmerku meloksikama 0,4 mg/kg je bila raven Cmax od 1,1 do 1,5 μg/ml pri prašičih dosežena po 1 uri.
English: Carton for 50 ml and 100 ml
Slovenian: Škatla za 50 ml in 100 ml
English: Pregnancy and lactation:
Slovenian: Brejost in laktacija
English: Cattle: Meat and offal: 15 days Pigs:
Slovenian: Govedo: meso in organi: 15 dni Prašiči:
English: 4.10 Overdose (symptoms, emergency procedures, antidotes if necessary)
Slovenian: 4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Pri prevelikem odmerjanju uvedemo simptomatsko zdravljenje.
English: Active substance: Meloxicam 5 mg
Slovenian: Učinkovina: Meloksikam 5 mg
English: Disodium edetate Sodium hydroxide Hydrochloric acid Meglumine Water for injections
Slovenian: 6.1 Seznam pomožnih snovi etanol poloksamer 188 makrogol 300 glicin dinatrijev edetat natrijev hidroksid klorovodikova kislina meglumin voda za injekcije
English: After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmax values of 2.1 μg/ml were reached after 7.7 hours in young cattle.
Slovenian: Po enkratnem podkožnem odmerku meloksikama 0,5 mg/kg je bila raven Cmax 2,1 g/ml pri mladem govedu dosežena po 7,7 ure.
English: MRL Target tissues
Slovenian: MRL Ciljna tkiva Druge določbe
English: Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anticoagulant agents.
Slovenian: Zdravila ne uporabljajte hkrati z glukokortikosteroidi, drugimi nesteroidnimi protivnetnimi zdravili ali z antikoagulansi.
English: Cattle: Meat and offal: 15 days Pigs: Meat and offal: 5 days
Slovenian: Govedo: meso in organi: 15 dni Prašiči: meso in organi: 5 dni
English: Concurrent administration of potential nephrotoxic veterinary medicinal products should be avoided.
Slovenian: Sočasnemu dajanju zdravil za uporabo v veterinarski medicini, ki lahko imajo nefrotoksične učinke, se je treba izogibati.
English: Do not use in cattle and pigs suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of ulcerogenic gastrointestinal lesions.
Slovenian: Ne uporabite pri govedu in prašičih z motnjami jetrne, srčne ali ledvične funkcije in s hemoragičnimi motnjami ter pri dokazanih ulkusnih lezijah v prebavilih.
English: One ml contains:
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA En ml vsebuje:
English: Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of ulcerogenic gastrointestinal lesions.
Slovenian: Ne uporabite pri živalih z motnjami jetrne, srčne ali ledvične funkcije in s hemoragičnimi motnjami ter pri dokazanih ulkusnih lezijah v prebavilih.
English: Cattle: SC, IV Pigs: IM
Slovenian: Govedo: s.c. ali i.v.
English: THE WORDS "KEEP OUT OF SIGHT AND REACH OF CHILDREN"
Slovenian: BESEDILO “ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM ”
English: EXP (month/year) Once broached, use by….
Slovenian: EXP (mesec/leto) Načeto zdravilo porabite do ...
English: After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmax values of 2.1 µg/ml and 2.7 µg/ml were reached after 7.7 hours and 4 hours in young cattle and lactating cows, respectively.
Slovenian: Po enkratnem podkožnem odmerku meloksikama po 0,5 mg/kg je bila Cmax 2,1 g/ml pri mladem govedu dosežena po 7,7 ure, pri kravah v obdobju laktacije pa je bila raven Cmax 2,7 g/ml dosežena po 4 urah.
English: meat and offal: 15 days; milk: 5 days Pigs, horses: meat and offal: 5 days Not authorised for use in horses producing milk for human consumption.
Slovenian: Govedo: meso in organi: 15 dni; mleko: 5 dni Prašiči, konji: meso in organi: 5 dni
English: EXP {month/year} Once broached, use by ….
Slovenian: EXP {mesec/leto} Načeto zdravilo porabite do ...
English: Meloxidolor 5 mg/ml solution for injection for dogs, cats, cattle and pigs
Slovenian: Meloxidolor 5 mg/ml raztopina za injiciranje za pse, mačke, govedo in prašiče
English: Horses: Do not use in pregnant or lactating mares.
Slovenian: Ne uporabite pri brejih kobilah ali kobilah v obdobju laktacije.
English: Meat and offal: 5 days
Slovenian: meso in organi: 5 dni
English: Carton for the 10 ml, 20 ml and 100 ml
Slovenian: Škatla za 10 ml, 20 ml in 100 ml Nalepka za 100 ml
English: Colourless type I glass vials of 10 ml, 20 ml or 100 ml, closed with a rubber stopper and sealed with an aluminium cap.
Slovenian: Brezbarvne viale iz stekla tipa I po 10 ml, 20 ml ali 100 ml, zaprte z gumijastim zamaškom in zatesnjene z aluminijasto zaporko.
English: Cats: Reduction of post-operative pain:
Slovenian: Za lajšanje pooperativne bolečine:
English: Single intravenous or subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e. 0.4 ml/10 kg body weight) before surgery, for example at the time of induction of anaesthesia.
Slovenian: Enkratna intravenska ali podkožna injekcija v odmerku po 0,2 mg meloksikama na kilogram telesne mase (tj. 0,4 ml/10kg telesne mase) pred operacijo, na primer ob indukciji anestezije.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE AND THE IMMEDIATE PACKAGE
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
English: Single subcutaneous or intravenous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e. 2.5 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
Slovenian: Enkratna podkožna ali intravenska injekcija odmerka po 0,5 mg meloksikama na kilogram telesne mase (to je 2,5 ml/100 kg telesne mase), po potrebi v kombinaciji z antibiotičnim zdravljenjem ali s peroralno rehidracijsko terapijo.
English: Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2 ml/100 kg body weight) in combination with antibiotic therapy, as appropriate.
Slovenian: Enkratna intramuskularna injekcija odmerka po 0,4 mg meloksikama na kilogram telesne mase (to je 2 ml/100 kg telesne mase), po potrebi v kombinaciji z antibiotičnim zdravljenjem.
English: Meloxidolor 20 mg/ml solution for injection for cattle, pigs and horses
Slovenian: Meloxidolor 20 mg/ml raztopina za injiciranje za govedo, prašiče in konje
English: Colourless type I glass vials of 50 ml or 100 ml, closed with a rubber stopper and sealed with an aluminium cap.
Slovenian: Brezbarvnime viale iz stekla tipa I po 50 ml ali 100 ml, zaprte z gumijastim zamaškom in zatesnjene z aluminijasto zaporko.
English: Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 0.4 ml/5 kg body weight) before surgery.
Slovenian: Enkratna intramuskularna injekcija v odmerku 0,4 mg meloksikama na kilogram telesne mase (t.j.0,4 ml/5 kg telesne mase) pred operacijo.
English: Cattle: meat and offal: 15 days; milk: 5 days Pigs:
Slovenian: meso in organi: 15 dni; mleko: 5 dni
English: Meloxidolor 20 mg/ml solution for injection for cattle, pigs and horses meloxicam
Slovenian: Meloxidolor 20 mg/ml raztopina za injiciranje za govedo, prašiče in konje meloksikam
English: Meloxidolor 5 mg/ml solution for injection for dogs, cats, cattle and pigs meloxicam
Slovenian: Meloxidolor 5 mg/ml raztopina za injiciranje za pse, mačke, govedo in prašiče meloksikam
English: Single intravenous injection at a dosage of 0.6 mg meloxicam/kg body weight (i.e. 3 ml/100 kg body weight).
Slovenian: Enkratna intravenska injekcija odmerka po 0,6 mg meloksikama na kilogram telesne mase (to je 3 ml/100 kg telesne mase).
English: Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2 ml/25 kg body weight).
Slovenian: Enkratna intramuskularna injekcija odmerka 0,4 mg meloksikama na kilogram telesne mase (to je 2 ml/25 kg telesne mase).
English: Horses: meat and offal: 5 days.
Slovenian: meso in organi: 5 dni.
English: Batch {number}
Slovenian: Rp-Vet..
English: QUANTITY OF THE ACTIVE SUBSTANCE(S)
Slovenian: NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL)
English: Meloxicam is a Non-Steroidal Anti-Inflammatory Drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, anti-exudative, analgesic and antipyretic effects.
Slovenian: Meloksikam je nesteroidno protivnetno zdravilo (NSAID) iz skupine oksikamov.
English: Glycine
Slovenian: KARENCA
English: Multi-packs of 5 x 20 ml and 10 x 20 ml.
Slovenian: Skupna pakiranja po 5 x 20 ml in 10 x 20 ml. Ni nujno, da so v prometu vsa navedena pakiranja.
English: meat and offal: 5 days
Slovenian: meso in organi: 15 dni
English: Cattle: single subcutaneous or intravenous injection Pigs: single intramuscular injection Horses: single intravenous injection Read the package leaflet before use.
Slovenian: Govedo: enkratna subkutana ali intravenska injekcija.
English: 20 μg/kg 65 μg/kg 65 μg/kg
Slovenian: 20 µg/kg 65 µg/kg 65 µg/kg mišice jetra ledvice ni vnosa Protivnetna zdravila/ nesteroidna protivnetna zdravila govedo, koze
English: PACKAGE LEAFLET:
Slovenian: Meso in organi:
English: The European Commission issued a decision on 2 October 2009.
Slovenian: Evropska komisija je odločbo izdala dne 2. oktobra 2009.
English: Dr. Hudson (United Kingdom)
Slovenian: dr Hudson (Združeno kraljestvo)
English: Dr. Broich (Germany)
Slovenian: dr Broich (Nemčija)
English: Ref. EMEA/CHMP/150525/2009 rev.1 EMEA/H/A-29/1083
Slovenian: EMEA/CHMP/150525/2009 rev.1 EMEA/H/A-29/1083
English: 25 June 2009
Slovenian: 25. junij 2009
English: Article 29 of Directive 2001/83/EC as amended, referral on the grounds of potential serious risk to public health
Slovenian: 1 Člen 29 Direktive 2001/83/ES Evropskega parlamenta in Sveta, kakor je bila spremenjena, napotitev zaradi možnega resnega tveganja za javno zdravje.
English: The company wanted the authorisation to be recognised in France and Portugal (the ‘concerned Member States').
Slovenian: Družba je želela, da se odobritev prizna v Franciji in na Portugalskem (zadevnih državah članicah).
English: London, 2 October 2009 Doc.
Slovenian: London, 2. oktobra 2009 Sklic dok.
English: However, the Member States were not able to reach an agreement and the German medicines regulatory agency referred the matter to the CHMP for arbitration on 10 October 2008.
Slovenian: Vendar državi članici nista mogli doseči sporazuma, zato je nemška regulatorna agencija za zdravila dne 10. oktobra 2008 zadevo napotila na CHMP v arbitražo.
English: Questions and answers on the referral for Octegra solution for infusion containing moxifloxacin 400 mg/250 ml
Slovenian: Vprašanja in odgovori v zvezi z napotitvenim postopkom za zdravilo Octegra raztopina za infundiranje, ki vsebuje moksifloksacin 400 mg/250 ml
English: Bayer Vital GmbH submitted Octegra solution for infusion for mutual recognition on the basis of the initial authorisation granted by Germany on 30 April 2002.
Slovenian: Družba Bayer Vital GmbH je predložila zdravilo Octegra raztopina za infundiranje v postopek medsebojnega priznavanja na podlagi prvotne odobritve v Nemčiji dne 30. aprila 2002.
English: By doing this, it stops the bacteria from growing and multiplying.
Slovenian: S tem zaustavi rast in razmnoževanje bakterij.
English: The grounds for the referral were concerns from France regarding the medicine's risk of causing problems with the heart rhythm (QT-interval prolongation).
Slovenian: Podlaga za napotitveni postopek so bili zadržki Francije glede tveganja zdravila za povzročanje težav s srčnim ritmom (podaljšanje intervala QT).
English: The review was carried out under an ‘Article 29' referral1.
Slovenian: Pregled je bil izveden skladno z napotitvenim postopkom iz člena 291.
English: It works by blocking enzymes that bacteria use to make more DNA.
Slovenian: Deluje tako, da zavira encime, ki jih bakterije uporabljajo za proizvodnjo dodatne DNK.
English: It can be used to treat the following bacterial infections: - community-acquired pneumonia (an infection of the lungs that is caught outside of hospital); - complicated infections of the skin and the soft tissues below the skin.
Slovenian: Uporablja se lahko za zdravljenje spodnjih bakterijskih okužb: - izvenbolnišnično pridobljena pljučnica (okužba pljuč, do katere ne pride v bolnišnici), - zapletene okužbe kože in mehkih podkožnih tkiv.
English: The active substance in Octegra solution for infusion, moxifloxacin, belongs to the group ‘fluoroquinolones'.
Slovenian: Zdravilna učinkovina zdravila Octegra raztopina za infundiranje, moksifloksacin, spada v skupino „fluorokinolonov“.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Octegra solution for infusion outweigh its risks, and the marketing authorisation granted in Germany can be recognised in other Member States of the EU, namely France and Portugal.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da koristi zdravila Octegra raztopina za infundiranje odtehtajo njegova tveganja in da se lahko dovoljenje za promet z zdravilom, odobreno v Nemčiji, prizna tudi v drugih državah članicah Evropske unije, in sicer v Franciji in na Portugalskem.
English: The CHMP also recommended that the product information for the medicine should be amended in all the Member States where it is authorised.
Slovenian: CHMP je prav tako priporočil, da se informacije o zdravilu dopolnijo v vseh državah članicah, kjer je zdravilo odobreno.
English: Octegra solution for infusion is an antibiotic given by infusion (drip into a vein).
Slovenian: Zdravilo Octegra raztopina za infundiranje je antibiotik, ki se daje z infuzijo (kapalno infuzijo v veno).
English: Complicated means that the infection is difficult to treat because it has spread to the deep tissues below the skin, treatment with surgery might be needed, or the patient has other conditions that might affect the response to treatment.
Slovenian: ker se je razširila na globoka tkiva pod kožo, zato bo morda potreben operativni poseg, ali pa so pri bolniku prisotna druga stanja, ki lahko vplivajo na odziv na zdravljenje.
English: Why was Octegra solution for infusion reviewed?
Slovenian: Zakaj je bilo zdravilo Octegra raztopina za infundiranje pregledano?
English: Company responses provided on: 26 January 2009; 27 April 2009; 28 May 2009 Opinion date:
Slovenian: 26. januar 2009; 27. april 2009; 28. maj 2009
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Octegra solution for infusion outweigh its risks, and therefore the marketing authorisation for Octegra solution for infusion should be granted in all concerned Member States.
Slovenian: CHMP je na podlagi ocenjevanja trenutno razpoložljivih podatkov in znanstvenih razprav zaključil, da koristi zdravila Octegra raztopina za infundiranje odtehtajo z njim povezana tveganja, zato se odobri dovoljenje za promet z zdravilom Octegra raztopina za infundiranje v vseh zadevnih državah članicah.