FrancophonIA/ELRC3.0 huggingface dataset:
English: The CMDh, a medicines regulatory body representing the EU Member States, agreed that these medicines should only be used to relieve symptoms of nausea and vomiting, that doses and length of treatment should be restricted and that they should be adjusted carefully by the patient's weight where available for use in children.
Slovenian: CMDh, regulativni organ za zdravila, ki zastopa države članice EU, se je strinjal, da se smejo ta zdravila uporabljati samo za lajšanje simptomov navzee (slabosti) in bruhanja, da je treba odmerke ter trajanje zdravljenja omejiti in da jih je treba skrbno prilagoditi bolnikovi telesni masi, če so na voljo za uporabo pri otrocih.
English: • Overall there was sufficient evidence to support the use of oral domperidone 10 mg up to three times a day in a general indication of treatment of nausea and vomiting in adults.
Slovenian: • Na splošno so bili dokazi za podporo uporabe peroralnega domperidona 10 mg do trikrat na dan pri splošni indikaciji za zdravljenje navzee in bruhanja pri odraslih zadostni.
English: Domperidone will no longer be authorised to treat other conditions such as bloating or heartburn.
Slovenian: Domperidon ne bo več odobren za zdravljenje drugih stanj, kot sta napihnjenost ali zgaga.
English: Domperidone-containing medicines have been authorised nationally in individual Member States of the EU for the treatment of nausea and vomiting of various causes but also for the management of symptoms such as bloating, discomfort and heartburn.
Slovenian: Zdravila, ki vsebujejo domperidon, so bila v posameznih državah članicah EU nacionalno odobrena za zdravljenje navzee in bruhanja zaradi različnih vzrokov ter tudi za obravnavo simptomov, kot so napihnjenost, neugodje in zgaga.
English: • A review of the safety database of the originator product involving 342 serious reports of cardiac events or vascular investigations highlighted the high frequency of associated cardiovascular risk factors, cardiovascular history, and concomitant medications associated with cardiac arrhythmias in the patients concerned.
Slovenian: • Pregled varnostne podatkovne zbirke za originatorsko zdravilo, ki vključuje 342 poročil o resnih srčnih dogodkih ali vaskularnih raziskavah, je izpostavil veliko pogostnost povezanih kardiovaskularnih dejavnikov tveganja, kardiovaskularno anamnezo in sočasna zdravila, povezane s srčnimi aritmijami pri zadevnih bolnikih.
English: In order to accurately measure doses to paediatric patients, oral suspensions should be given using an adapted graduated oral syringe.
Slovenian: Za natančno merjenje odmerkov pri pediatričnih bolnikih je treba peroralne suspenzije dajati s prilagojeno brizgo z oznakami za peroralno dajanje.
English: • Because a review has shown that the risks of domperidone are greatest at high doses or when it is used for a longer period, the medicine should only be approved for use in low doses to treat symptoms of nausea and vomiting (feeling or being sick).
Slovenian: • Ker je presoja pokazala, da je tveganje domperidona največje pri velikih odmerkih ali ob daljši uporabi, se sme zdravilo odobriti samo za uporabo v majhnih odmerkih za zdravljenje simptomov slabosti in bruhanja.
English: Domperidone works by blocking receptors for the neurotransmitter dopamine found in the gut and in the part of the brain linked to vomiting.
Slovenian: Domperidon deluje tako, da zavira receptorje za nevrotransmitor, dopamin, ki je v črevesu in delu možganov, povezanem z bruhanjem.
English: A higher risk was observed in patients older than 60 years, adults taking daily oral doses of more than 30 mg, and those taking QT-prolonging medicines or CYP3A4 inhibitors concomitantly.
Slovenian: Večje tveganje so opazili pri bolnikih, starejših od 60 let, odraslih, ki prejemajo dnevne peroralne odmerke, večje od 30 mg, in bolnikih, ki sočasno jemljejo zdravila za podaljševanje intervala QT ali zaviralce CYP3A4.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom abnormalnostmi električne aktivnosti srca ali srčnega ritma ali bolnikih s povečanim tveganjem takih učinkov.
English: Adults may also be given 30 mg twice daily rectally as suppositories.
Slovenian: Odrasli lahko prejmejo tudi 30 mg dvakrat na dan v obliki svečk.
English: • The benefit-risk balance of domperidone remains positive in the relief of the symptoms of nausea and vomiting.
Slovenian: • Razmerje med tveganji in koristmi domperidona pri lajšanju simptomov navzee in bruhanja ostaja pozitivno.
English: The CMDh confirmed by majority the PRAC recommendation that domperidone-containing medicines should remain available and may continue to be used in the EU for the management of the symptoms of nausea and vomiting, but that the recommended dose should be reduced to 10 mg up to three times daily by mouth for adults and adolescents weighing 35 kg or more.
Slovenian: Odbor CMDh je večinsko potrdil priporočilo odbora PRAC, naj zdravila, ki vsebujejo domperidon, ostanejo na voljo in se lahko še naprej uporabljajo v EU za obravnavo simptomov navzee ter bruhanja, vendar pa je treba priporočeni odmerek za odrasle in mladostnike s telesno maso, večjo od 35 kg, zmanjšati na 10 mg, peroralno, do trikrat na dan. Ti bolniki lahko zdravilo prejmejo tudi v obliki 30miligramske svečke dvakrat na dan.
English: There were limited data to support paediatric use in this indication, and although the mechanism of action is not expected to differ between adults and children studies to provide further data to support efficacy in the paediatric population have been requested.
Slovenian: Čeprav ni pričakovati, da se bo mehanizem delovanja razlikoval med odraslimi in otroci, so potrebne dodatne študije za podporo učinkovitosti pri pediatrični populaciji.
English: • The new recommended dose in adults (and adolescents ≥ 35 kg where licensed) is 10 mg orally up to three times daily (maximum dose of 30 mg daily).
Slovenian: • Nov priporočeni odmerek pri odraslih (in mladostnikih s telesno maso ≥ 35 kg, kjer je to odobreno) je 10 mg, peroralno, do trikrat na dan (največji dnevni odmerek 30 mg).
English: • A review of the evidence confirms a small increased risk of serious cardiac adverse drug reactions related to the use of domperidone, including QTc prolongation, torsade de pointes, serious ventricular arrhythmia and sudden cardiac death.
Slovenian: • Presoja dokazov je potrdila rahlo povečano tveganje resnih srčnih neželenih učinkov, povezanih z uporabo domperidona, vključno s podaljšanjem intervala QTc, torsade de pointes, resno ventrikularno aritmijo in nenadno srčno smrtjo.
English: • Domperidone products are contraindicated in patients with severe hepatic impairment, conditions where cardiac conduction is, or could be, impaired or where there is underlying cardiac disease such as congestive heart failure, and when co-administered with QT-prolonging medicines or potent CYP3A4 inhibitors.
Slovenian: • Zdravila, ki vsebujejo domperidon, so kontraindicirana pri bolnikih s hudo jetrno okvaro, stanji, pri katerih je (lahko) srčno prevajanje poslabšano, ali osnovno srčno boleznijo, kot je kongestivna srčna odpoved, in pri sočasni uporabi z zdravili, ki podaljšajo interval QT, ali močnimi zaviralci CYP3A4.
English: • Where suitable domperidone products are available for children, the recommended dose is 0.25 mg/kg bodyweight up to three times daily by mouth.
Slovenian: • Če so na razpolago ustrezna zdravila, ki vsebujejo domperidon, za otroke, je priporočeni odmerek 0,25 mg/kg telesne mase do trikrat na dan, peroralno.
English: Treatment should generally only be given for up to one week.
Slovenian: Zdravljenje sme navadno trajati samo en teden.
English: • A significant number of cases have been reported with concomitant or co-suspect medication known to prolong QT interval, CYP3A4 inhibitors, or potassium-wasting diuretics.
Slovenian: • Poročali so o pomembnem številu primerov s sočasnimi zdravili ali sumom na sočasna zdravila, za katera je znano, da podaljšajo interval QT, zaviralce CYP3A4 ali kaliuretične duiretike.
English: They are available as tablets, oral suspension and suppositories under various trade names (such as Motilium).
Slovenian: Na voljo so pod različnimi imeni (na primer Motilium) v obliki tablet, peroralne suspenzije in svečk.
English: Products licensed in children and adolescents weighing less than 35 kg should be given by mouth at a dose of 0.25 mg per kg bodyweight up to three times daily.
Slovenian: Zdravila, odobrena za otroke in mladostnike s telesno maso, manjšo od 35 kg, je treba dajati peroralno v odmerku 0,25 mg na kg telesne mase do trikrat na dan. Formulacijam v obliki tekočine bodo priloženi merilni pripomočki, ki bodo omogočali natančno odmerjanje glede na telesno maso.
English: It must not be given to patients with moderate or severe impairment of liver function, or in those who have existing abnormalities of electrical activity in the heart or heart rhythm, or who are at increased risk of such effects.
Slovenian: Prav tako se ne sme uporabljati pri bolnikih z zmerno ali hudo okvaro jetrnega delovanja, bolnikih z obstoječimi
English: • The recommended dose in adults is 10 mg by mouth up to three times a day, or 30 mg as a suppository twice a day.
Slovenian: • Priporočeni odmerek za odrasle je 10 mg, peroralno, do trikrat na dan, ali 30 mg v obliki svečke dvakrat na dan. Kjer so ustrezna zdravila na voljo za otroke, je treba odmerke izračunati glede na telesno maso in dajati s pripomočkom, ki omogoča natančno merjenje.
English: BUDAPEST TÓ U. 1-5 Hungary
Slovenian: BUDAPEST TÓ U. 1-5 Madžarska
English: Bucureşti, Romania
Slovenian: Bucureşti, Romunija
English: 11317 Tallinn, Estonia
Slovenian: 11317 Tallinn, Estonija
English: Letališka 29 A 1000 Ljubljana Slovenia
Slovenian: Letališka 29 A 1000 Ljubljana Slovenija
English: 1831 Diegem, Belgium
Slovenian: 1831 Diegem, Belgija
English: Empreendimento Lagoas Park, Edifício 7 - 3º Piso 2740-244 Porto Salvo Portugal
Slovenian: Empreendimento Lagoas Park, Edifício 7 - 3º Piso 2740-244 Porto Salvo Portugalska
English: Heinzelova 70, 10000 Zagreb, Croatia
Slovenian: Heinzelova 70, 10000 Zagreb, Hrvaška
English: 2970 Hørsholm Denmark
Slovenian: 2970 Hørsholm Danska
English: 104 25 Stockholm Sweden
Slovenian: 104 25 Stockholm Švedska
English: A.Juozapaviciaus 6/2, LT-09310 Vilnius, Lithuania
Slovenian: A.Juozapaviciaus 6/2, LT-09310 Vilnius, Litva
English: Einsteinova 24, 85101 Bratislava Slovak Republic
Slovenian: Einsteinova 24, 85101 Bratislava Slovaška
English: Kampenringweg 45 D-E 2803 PE Gouda The Netherlands
Slovenian: Kampenringweg 45 D-E 2803 PE Gouda Nizozemska
English: Estonia sanofi-aventis Estonia OÜ Pärnu mnt. 139 E/2
Slovenian: Estonija sanofi-aventis Estonia OÜ Pärnu mnt. 139 E/2
English: Viale L. Bodio 37/b 20158 Milan, Italy
Slovenian: Viale L. Bodio 37/b 20158 Milan, Italija
English: SANOFI BULGARIA EOOD 90 Tsarigradsko chaussee Blvd. Office building Capital Fort, section A, 10th floor Sofia 1784, Bulgaria
Slovenian: SANOFI BULGARIA EOOD 90 Tsarigradsko chaussee Blvd. Office building Capital Fort, section A, 10th floor Sofia 1784, Bolgarija
English: Sanofi Oy Huopalahdentie 24 00350 Helsinki Finland
Slovenian: Sanofi Oy Huopalahdentie 24 00350 Helsinki Finska
English: Greece sanofi-aventis AEBE 348, Syngrou Av. - Building A, 176 74 Kallithea - Athens Greece
Slovenian: Grčija sanofi-aventis AEBE 348, Syngrou Av. - Building A, 176 74 Kallithea - Athens
English: Latvia sanofi - aventis Latvia SIA
Slovenian: Latvija sanofi - aventis Latvia SIA
English: Aventis Pharma Limited One Onslow Street Guildford, Surrey GU1 4YS United Kingdom
Slovenian: Aventis Pharma Limited One Onslow Street Guildford, Surrey GU1 4YS Združeno kraljestvo
English: Netherlands sanofi-aventis Netherlands B.V.
Slovenian: Nizozemska sanofi-aventis Netherlands B.V.
English: Austria sanofi-aventis GmbH, Leonard-Bernstein-Straße 10, A-1220 Vienna, Austria
Slovenian: Avstrija sanofi-aventis GmbH, Leonard-Bernstein-Straße 10, A-1220 Vienna, Austria
English: Solution for injection Intravenous use
Slovenian: raztopina za injiciranje Intravenska uporaba
English: Sanofi-aventis France 82 avenue Raspail 94250 Gentilly FRANCE
Slovenian: Sanofi-aventis France 82 avenue Raspail 94250 Gentilly Francija
English: Sanofi-Aventis France 82, Avenue Raspail 94250 Gentilly France
Slovenian: Sanofi-Aventis France 82, Avenue Raspail 94250 Gentilly Francija
English: 150 mg (15000 IU)
Slovenian: 150 mg (15000 i.e.)
English: 120 mg (12000 IU)
Slovenian: 120 mg (12000 i.e.)
English: Croatia sanofi-aventis Croatia d.o.o.
Slovenian: Hrvaška sanofi-aventis Croatia d.o.o.
English: 100 mg (10 000 IU)
Slovenian: 100 mg (10 000 i.e.)
English: Spain sanofi-aventis, S.A. C/ Josep Pla, 2 08019 Barcelona Spain
Slovenian: Španija sanofi-aventis, S.A. C/ Josep Pla, 2
English: 40 mg (4000 IU)
Slovenian: 40 mg (4000 i.e.)
English: 80 mg (8000 IU)
Slovenian: 80 mg (8000 i.e.)
English: Solution for injection Subcutaneous use; Extracorporeal use
Slovenian: raztopina za injiciranje Subkutana uporaba; Zunajtelesna uporaba
English: 60 mg (6000 IU)
Slovenian: 60 mg (6000 i.e.)
English: 10 000 anti-Xa IU /1.0 ml (100 mg/1 ml)
Slovenian: 10 000 anti-Xa i.e. /1,0 ml (100 mg/1 ml)
English: 20 mg (2000 IU)
Slovenian: 20 mg (2000 i.e.)
English: 2000 anti-Xa IU /0.2 ml (20 mg/0.2 ml)
Slovenian: 2000 anti-Xa i.e. /0,2 ml (20 mg/0,2 ml)
English: 30 000 anti-Xa IU /3.0 ml (300 mg/3 ml)
Slovenian: 30 000 anti-Xa i.e. /3,0 ml (300 mg/3 ml)
English: 4000 anti-Xa IU /0.4 ml (40 mg/0.4 ml)
Slovenian: 4000 anti-Xa i.e. /0,4 ml (40 mg/0,4 ml)
English: 8000 anti-Xa IU /0.8 ml (80 mg/0.8 ml)
Slovenian: 8000 anti-Xa i.e. /0,8 ml (80 mg/0,8 ml)
English: 6000 anti-Xa IU /0.6 ml (60 mg/0.6 ml)
Slovenian: 6000 anti-Xa i.e. /0,6 ml (60 mg/0,6 ml)
English: 0.6 ml; 0.8 ml; 1.0 ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)
Slovenian: 0,6 ml; 0,8 ml; 1,0 ml (100 mg/ml, kar ustreza 10 000 antiXa i.e./ml)
English: 0.8 ml; 1.0 ml (150 mg/ml equivalent to 15000 anti-Xa IU/ml)
Slovenian: 0,8 ml; 1.0 ml (150 mg/ml, kar ustreza 15000 anti-Xa i.e./ml)
English: 300 mg /3 ml Solution for injection Subcutaneous use; Intravenous use;
Slovenian: 300 mg /3 ml raztopina za injiciranje Subkutana uporaba; Intravenska uporaba;
English: 1 ml (150 mg/ml equivalent to 15000 IU anti-Xa activity/ml)
Slovenian: 1 ml (150 mg/ml, kar ustreza aktivnosti 15 000 i.e. anti-Xa/ml)
English: 40 mg/ 0.4 ml Solution for injection Subcutaneous use
Slovenian: 40 mg/ 0,4 ml raztopina za injiciranje Subkutana uporaba
English: 150 mg/1.0 ml Solution for injection Subcutaneous use
Slovenian: 150 mg/1,0 ml raztopina za injiciranje Subkutana uporaba
English: 60 mg/ 0.6 ml Solution for injection Subcutaneous use
Slovenian: 60 mg/ 0,6 ml raztopina za injiciranje Subkutana uporaba
English: 20 mg/ 0.2 ml Solution for injection Subcutaneous use
Slovenian: 20 mg/ 0,2 ml raztopina za injiciranje Subkutana uporaba
English: 40 mg/0.4 ml Solution for injection Subcutaneous use; Intravenous use
Slovenian: 40 mg/0,4 ml raztopina za injiciranje Subkutana uporaba; Intravenska uporaba
English: 1 ml (100 mg/ml equivalent to 10000 IU anti-Xa activity/ml)
Slovenian: 1 ml (100 mg/ml, kar ustreza aktivnosti 10 000 i.e. anti-Xa/ml)
English: 100 mg /1 ml Solution for injection Subcutaneous use; Extracorporeal use
Slovenian: 100 mg /1 ml raztopina za injiciranje Subkutana uporaba; Zunajtelesna uporaba
English: Clexane 2 000 antiXa TV/0,2 ml injekcinis tirpalas užpildytame švirkšte
Slovenian: Clexane 2 000 antiXa TV/0,2 ml injekcinis tirpalas užpildytame švirkšte raztopina za injiciranje Subkutana uporaba; Zunajtelesna uporaba
English: 0.8 ml (150 mg/ml equivalent to 15000 IU anti-Xa activity/ml)
Slovenian: 0,8 ml (150 mg/ml, kar ustreza aktivnosti 15 000 i.e. antiXa/ml)
English: Clexane 4 000 antiXa TV/0,4 ml injekcinis tirpalas užpildytame švirkšte
Slovenian: Clexane 4 000 antiXa TV/0,4 ml injekcinis tirpalas užpildytame švirkšte raztopina za injiciranje Subkutana uporaba; Zunajtelesna uporaba
English: 40 mg /0.4 ml Solution for injection Subcutaneous use; Extracorporeal use
Slovenian: 40 mg /0,4 ml raztopina za injiciranje Subkutana uporaba; Zunajtelesna uporaba
English: 80 mg/ 0.8 ml Solution for injection Subcutaneous use
Slovenian: 80 mg/ 0,8 ml raztopina za injiciranje Subkutana uporaba
English: 20 mg/ 0.2 ml Solution for injection Subcutaneous use; Extracorporeal use
Slovenian: 20 mg /0,2 ml raztopina za injiciranje Subkutana uporaba; Zunajtelesna uporaba
English: 20 mg /0.2 ml Solution for injection Subcutaneous use; Extracorporeal use
Slovenian: 20 mg/ 0,2 ml raztopina za injiciranje Subkutana uporaba; Zunajtelesna uporaba
English: 120 mg/0.8 ml Solution for Injection Subcutaneous use; Intravenous use
Slovenian: 120 mg/0,8 ml raztopina za injiciranje Subkutana uporaba; Intravenska uporaba
English: 120 mg/ 0.8 ml Solution for injection Subcutaneous use
Slovenian: 120 mg/0,8 ml raztopina za injiciranje Subkutana uporaba
English: 120 mg/0.8 ml Solution for injection Subcutaneous use
Slovenian: 120 mg/ 0,8 ml raztopina za injiciranje Subkutana uporaba
English: 150 mg /1 ml Solution for injection Subcutaneous use; Extracorporeal use
Slovenian: 150 mg /1 ml raztopina za injiciranje Subkutana uporaba; Zunajtelesna uporaba
English: 60 mg /0.6 ml Solution for injection Subcutaneous use; Extracorporeal use
Slovenian: 60 mg /0,6 ml raztopina za injiciranje Subkutana uporaba; Zunajtelesna uporaba
English: 0.8 ml (100 mg/ml equivalent to 10 000 IU anti-Xa activity/ml)
Slovenian: 0,8 ml (100 mg/ml, kar ustreza aktivnosti 10 000 i.e. antiXa/ml)
English: 150 mg/1.0 ml Solution for Injection Subcutaneous use; Intravenous use
Slovenian: 150 mg/1,0 ml raztopina za injiciranje Subkutana uporaba; Intravenska uporaba
English: 100 mg/1.0 ml Solution for injection Subcutaneous use; Intravenous use;
Slovenian: 100 mg/1,0 ml raztopina za injiciranje Subkutana uporaba; Intravenska uporaba;
English: 150 mg/1.0 ml Solution for injection Subcutaneous use; Extracorporeal use
Slovenian: 150 mg/1,0 ml raztopina za injiciranje Subkutana uporaba; Zunajtelesna uporaba
English: 60 mg/0.6 ml Solution for injection Subcutaneous use; Intravenous use
Slovenian: 60 mg/0,6 ml raztopina za injiciranje Subkutana uporaba; Intravenska uporaba
English: Germany
Slovenian: Grčija
English: 60 mg/0.6 ml Solution for injection Subcutaneous use; Intravenous use;
Slovenian: 60 mg /0,6 ml raztopina za injiciranje Subkutana uporaba; Intravenska uporaba;
English: 60 mg /0.6 ml Solution for injection Subcutaneous use; Intravenous use;
Slovenian: 60 mg/0,6 ml raztopina za injiciranje Subkutana uporaba; Intravenska uporaba;
English: 0.2 ml (100 mg/ml equivalent to 10 000 IU anti-Xa activity/ml)
Slovenian: 0,2 ml (100 mg/ml, kar ustreza aktivnosti 10 000 i.e. antiXa/ml)
English: Belgium Sanofi Belgium Leonardo Da Vincilaan 19
Slovenian: Sanofi Belgium Leonardo Da Vincilaan 19 1831 Diegem, Belgija
English: 100 mg/1.0 ml Solution for injection Subcutaneous use; Intravenous use
Slovenian: 100 mg/1,0 ml raztopina za injiciranje Subkutana uporaba; Intravenska uporaba
English: 80 mg /0.8 ml Solution for injection Subcutaneous use; Extracorporeal use
Slovenian: 80 mg /0,8 ml raztopina za injiciranje Subkutana uporaba; Zunajtelesna uporaba
English: 80 mg/0.8 ml Solution for injection Subcutaneous use; Intravenous use
Slovenian: 80 mg/0,8 ml raztopina za injiciranje Subkutana uporaba; Intravenska uporaba
English: 0.4 ml (100 mg/ml equivalent to 10 000 IU anti-Xa activity/ml)
Slovenian: 0,4 ml (100 mg/ml, kar ustreza aktivnosti 10 000 i.e. antiXa/ml)
English: 80 mg /0.8 ml Solution for injection Subcutaneous use; Intravenous use;
Slovenian: 80 mg /0,8 ml raztopina za injiciranje Subkutana uporaba; Intravenska uporaba;
English: 0.6 ml (100 mg/ml equivalent to 10 000 IU anti-Xa activity/ml)
Slovenian: 0,6 ml (100 mg/ml, kar ustreza aktivnosti 10 000 i.e. antiXa/ml)
English: Clexane 8 000 antiXa TV/0,8 ml injekcinis tirpalas užpildytame švirkšte
Slovenian: Clexane 8 000 antiXa TV/0,8 ml injekcinis tirpalas užpildytame švirkšte raztopina za injiciranje Subkutana uporaba; Intravenska uporaba; Zunajtelesna uporaba
English: Clexane 10 000 antiXa TV/1,0 ml injekcinis tirpalas užpildytame švirkšte
Slovenian: Clexane 10 000 antiXa TV/1,0 ml injekcinis tirpalas užpildytame švirkšte raztopina za injiciranje Subkutana uporaba; Intravenska uporaba; Zunajtelesna uporaba
English: Clexane 6 000 antiXa TV/0,6 ml injekcinis tirpalas užpildytame švirkšte
Slovenian: Clexane 6 000 antiXa TV/0,6 ml injekcinis tirpalas užpildytame švirkšte raztopina za injiciranje Subkutana uporaba; Intravenska uporaba; Zunajtelesna uporaba
English: 120 mg /0.8 ml Solution for injection Subcutaneous use; Extracorporeal use
Slovenian: 120 mg/0,8 ml raztopina za injiciranje Subkutana uporaba; Zunajtelesna uporaba
English: 120 mg/0.8 ml Solution for injection Subcutaneous use; Extracorporeal use
Slovenian: 120 mg /0,8 ml raztopina za injiciranje Subkutana uporaba; Zunajtelesna uporaba
English: LOVENOX 30 000 UI Anti-Xa/3 ml, solution injectable en flacon multidose
Slovenian: LOVENOX 30 000 UI Anti-Xa/3 ml, solution injectable en flacon multidose raztopina za injiciranje Subkutana uporaba; Intravenska uporaba; Zunajtelesna uporaba
English: LOVENOX 2000 UI anti-Xa/0,2 ml, solution injectable en seringue préremplie
Slovenian: LOVENOX 2000 UI anti-Xa/0,2 ml, solution injectable en seringue préremplie raztopina za injiciranje Subkutana uporaba; Zunajtelesna uporaba
English: LOVENOX 4000 UI anti-Xa/0,4 ml, solution injectable en seringue préremplie
Slovenian: LOVENOX 4000 UI anti-Xa/0,4 ml, solution injectable en seringue préremplie raztopina za injiciranje Subkutana uporaba; Zunajtelesna uporaba
English: Invented name Strengths Pharmaceutical forms Route of administration Packaging
Slovenian: Farmacevtska oblika Pot uporabe Ovojnina
English: 5 mg/ml
Slovenian: 5 mg/ml peroralna raztopina peroralno plastenka (HDPE)
English: EU Numbers
Slovenian: Številka EU Izmišljeno ime Jakost
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Fungitraxx on 12/03/2014.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Fungitraxx, veljavno po vsej Evropski uniji, izdala 12/03/2014.
English: Some fungal infections of birds can also infect humans.
Slovenian: Z nekaterimi glivičnimi okužbami pri pticah se lahko okužijo tudi ljudje.
English: These effects are usually mild and related to the dose, and can be managed by reducing the dose or if necessary stopping treatment.
Slovenian: Ti neželeni učinki so običajno blagi in povezani z odmerkom ter jih je mogoče obvladati z zmanjšanjem odmerka ali prekinitvijo zdravljenja, če je to potrebno.
English: In case of accidental contact with the eyes, they should be rinsed thoroughly with water.
Slovenian: Če zdravilo pride v stik z očmi, jih je treba temeljito sprati z vodo.
English: It is given by mouth at a dose of 5 to 10 mg itraconazole per kg bodyweight each day for 8 weeks for aspergillosis, and 10 mg per kg daily for 2 weeks for candidiasis.
Slovenian: Pri aspergilozi se daje v odmerku od 5 do 10 mg itrakonazola na kg telesne mase na dan v obdobju osem tednov, pri kandidozi pa v odmerku 10 mg na kg na dan v obdobju dveh tednov.
English: It works by blocking the production of a compound in the fungus called ergosterol which is an important part of fungal cell membranes.
Slovenian: Deluje tako, da zavira tvorbo spojine v glivicah, imenovane ergosterol, ki je pomembna sestavina celičnih membran glivic.
English: If suspected signs of disease (such as lumps or red pimples on the skin, or symptoms such as coughing or wheezing) appear in people a doctor should be consulted.
Slovenian: Če se pri ljudeh pojavijo znaki, ki bi lahko bili povezani s to boleznijo (na primer zatrdline ali rdeče bunčice na koži ali simptomi, kot sta kašelj in zasoplost), se je treba posvetovati z zdravnikom.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Fungitraxx exceed the risks for the approved indications and recommended that Fungitraxx be given a marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Fungitraxx večje od z njim povezanih tveganj za odobrene indikacije, in priporočil, da se zanj izda dovoljenje za promet.