natgillin/translations-raw huggingface dataset:
The doctor should ensure that the patient is observed for adverse reactions for at least 30 minutes following the infusion.
Zaradi neželenih učinkov mora zdravnik zagotoviti, da se bolnika opazuje še vsaj 30 minut po vsakem infundiranju.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Rienso.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Patients should have their blood and iron levels tested after at least one month following treatment.
Vsaj en mesec po zdravljenju je treba pri bolnikih opraviti preiskave krvi in ravni železa.
Iron deficiency is a common cause of anaemia in patients with long-term kidney disease and is itself caused by many factors including the poor absorption of dietary iron from food.
Pomanjkanje železa je običajen vzrok za anemijo pri bolnikih z dolgotrajnim obolenjem ledvic, povzročijo pa ga številni dejavniki, med drugim slaba absorpcija železa iz živil.
The most frequently reported side effects were symptoms affecting the gut (diarrhoea, constipation, nausea and vomiting), headache, dizziness and hypotension (low blood pressure), all occurring in less than 2.5% of patients.
Najpogosteje zabeleženi neželeni učinki so simptomi, povezani s črevesjem (driska, zaprtje, slabost in bruhanje), glavobol, omotica in hipotenzija (nizek krvni tlak).
Rienso is used to treat anaemia (low levels of red blood cells or haemoglobin) caused by a deficiency of iron in patients with chronic kidney disease (long-term, progressive decrease in the ability of the kidneys to work properly).
Zdravilo Rienso se uporablja za zdravljenje anemije (nizke ravni rdečih krvničk ali hemoglobina), ki ga povzroča pomanjkanje železa pri bolnikih s kroničnim obolenjem ledvic (dolgotrajnim, postopnim zmanjšanjem sposobnosti pravilnega delovanja ledvic).
Rienso should only be given when healthcare professionals trained to manage anaphylactic (severe allergic) reactions and full resuscitation facilities are available.
Zdravilo Rienso se daje samo ob navzočnosti zdravstvenih delavcev, izkušenih v obravnavi anafilaktičnih (hudih alergijskih) reakcij, in kadar je na voljo popolna oprema za oživljanje.
Rienso must not be used in people with a history of drug allergy, including allergy to ferumoxytol or any other iron preparation.
Zdravila Rienso ne smejo uporabljati osebe z anamnezo alergije na zdravilo, vključno z alergijo na ferumoksitol ali kateri koli drug železov pripravek.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Rienso, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom 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.
It must not be used in patients with evidence of excess iron in the body or in patients whose anaemia is not caused by iron deficiency.
Ne sme se uporabiti pri ljudeh, ki izkazujejo presežek železa v krvi ali katerih anemija ni posledica pomanjkanja železa.
To maintain normal haemoglobin levels, patients may be re-treated with Rienso if they are confirmed to be lacking iron.
Za vzdrževanje običajnih ravni hemoglobina se lahko zdravljenje z zdravilom Rienso ponovi, če se pri bolniku ugotovi ponovno pomanjkanje železa.
What is the risk associated with Rienso?
Kakšna tveganja so povezana z zdravilom Rienso?
In addition, the company that market Rienso will provide educational material to patients and doctors expected to use Rienso, with information on the risk of allergic reactions.
Poleg tega bo družba, ki trži zdravilo Rienso, bolnikom in zdravnikom, ki naj bi uporabljali to zdravilo, priskrbela izobraževalno gradivo, v katerem bodo pojasnjena tveganja za pojav alergijskih reakcij.
For the full list of all side effects reported with Rienso, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Rienso, glejte navodilo za uporabo.
Why has Rienso been approved?
Zakaj je bilo zdravilo Rienso odobreno?
Rienso is an iron preparation that contains the active substance ferumoxytol.
Zdravilo Rienso je železov pripravek, ki vsebuje zdravilno učinkovino ferumoksitol.
The active substance in Rienso, ferumoxytol, is an iron-containing compound.
Zdravilna učinkovina v zdravilu Rienso, ferumoksitol, je spojina, ki vsebuje železo.
Rienso was shown to be superior to iron taken by mouth in treating iron deficiency anaemia in patients with chronic kidney disease.
Zdravilo Rienso se je izkazalo za boljše v primerjavi s peroralnimi železovimi pripravki za zdravljenje anemije, ki je posledica pomanjkanja železa pri bolnikih s kroničnim ledvičnim obolenjem.
Rienso was more effective at increasing haemoglobin levels than the iron treatment taken by mouth.
Zdravilo Rienso je bilo pri zviševanju ravni hemoglobina učinkovitejše od peroralnih zdravil.
Three main studies involving 838 chronic kidney disease patients with iron deficiency anaemia have been carried out to compare Rienso with an iron treatment taken by mouth.
Za primerjavo zdravila Rienso z drugo vrsto peroralnega zdravljenja so bile opravljene tri glavne študije, v katerih je sodelovalo 838 bolnikov s kroničnim ledvičnim obolenjem z anemijo zaradi pomanjkanja železa.
What is Rienso used for?
Za kaj se zdravilo Rienso uporablja?
What is Rienso?
Kaj je zdravilo Rienso?
How has Rienso been studied?
Kako je bilo zdravilo Rienso raziskano?
How does Rienso work?
Kako zdravilo Rienso deluje?
When injected into the blood, it is taken up by cells in the liver, spleen and the bone marrow, at which point the iron is released from the compound and replaces the body's depleted iron stores.
Ko se ferumoksitol injicira v kri, se veže na celice v jetrih, vranici in kostnem mozgu.
How is Rienso used?
Kako se zdravilo Rienso uporablja?
The final opinion was converted into a Decision by the European Commission on 26 March 2010.
Končno mnenje je bilo spremenjeno v odločbo Evropske komisije dne 26. marca 2010.
The Rapporteur and Co-Rapporteur appointed were: Dr A. Holm and Dr B. Kolar, respectively.
Poročevalec in soporočevalec sta bila: dr. A. Holm oziroma dr. B. Kolar.
The Decentralised Procedure FR/V/195/01/DC started on 29 February 2008.
Decentralizirani postopek FR/V/195/01/DC se je začel 29. februarja 2008.
The application was submitted in the framework of Article 32 of Directive 2001/82/EC, where the Reference Member State was France and the Concerned Member States were Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland, Portugal, Romania, Slovakia, Spain and United Kingdom.
Vloga je bila predložena v skladu s členom 32 Direktive 2001/82/ES, kakor je bila spremenjena, pri čemer je bila Francija referenčna država članica, Avstrija, Belgija, Bolgarija, Ciper, Češka republika, Danska, Estonija, Nemčija, Grčija, Madžarska, Irska, Italija, Latvija, Litva, Luksemburg, Malta, Nizozemska, Poljska, Portugalska, Romunija, Slovaška, Španija in Združeno kraljestvo pa zadevne države članice.
Oral explanations were given on 8 December 2009.
Ustna pojasnila so bila podana 8. decembra 2009.
The referral procedure started on 12 May 2009.
Napotitveni postopek se je začel 12. maja 2009.
Written explanations were provided by the Applicant on 18 August 2009.
Pisna pojasnila je predlagatelj predložil 18. avgusta 2009.
Toltrazuril is a triazinon derivative administered orally to piglets for the prevention of clinical signs of coccidiosis in neonatal piglets on farms with a confirmed history of coccidiosis caused by Isospora suis.
Toltrazuril je derivat triazinona, ki se daje peroralno pujskom, za preprečevanje kliničnih znakov poporodne kokcidioze pri pujskih na kmetijah, na katerih je bila v preteklosti že potrjena kokcidioza, ki jo povzroča Isospora suis.
On 6 May 2009 France, referred the matter to the Agency under Article 33(4) of Directive 2001/82/EC, due to concerns, raised by Germany, Spain, Portugal, Poland and the United Kingdom, that the marketing authorisation of CEVAZURIL 50 mg/ml oral suspension for piglets may present a potential serious risk to the environment.
Francija je 6. maja 2009 v skladu s členom 33(4) Direktive 2001/82/ES zadevo napotila na agencijo EMA zaradi zadržkov, ki so jih izpostavile Nemčija, Španija, Portugalska, Poljska in Združeno kraljestvo, in sicer, da utegne dovoljenje za promet z zdravilom CEVAZURIL 50 mg/ml peroralna suspenzija za pujske predstavljati možno resno tveganje za okolje.
Based on the evaluation of the rapporteur's assessment of the currently available data, on 9 December 2009 the CVMP considered that the objections raised during the decentralised procedure should not prevent the granting of a Marketing Authorisation for CEVAZURIL 50 mg/ml oral suspension for piglets.
Na podlagi ocene poročevalčevega vrednotenja trenutno razpoložljivih podatkov je 9. decembra 2009 Odbor za zdravila za uporabo v veterinarski medicini (CVMP) menil, da zadržki, izpostavljeni med decentraliziranim postopkom, ne bi smeli preprečiti izdaje dovoljenja za promet z zdravilom CEVAZURIL 50 mg/ml peroralna suspenzija za pujske.
The Applicant, Ceva Santé Animale, submitted an application for a decentralised procedure for CEVAZURIL 50 mg/ml oral suspension for piglets.
Predlagatelj Ceva Santé Animale je predložil vlogo za pridobitev dovoljenja po decentraliziranem postopku za zdravilo CEVAZURIL 50 mg/ml peroralna raztopina za pujske.
referral for CEVAZURIL 50 mg/ml oral suspension for piglets
Mnenje v zvezi z napotitvijo v skladu s členom 33(4)1 za zdravilo CEVAZURIL 50 mg/ml peroralna suspenzija za pujske
On this basis, no further revisions were warranted.
Na podlagi tega niso bile potrebne nobene druge spremembe.
• The committee considered the referral under Article 30 of Directive 2001/83/EC
• Odbor je obravnaval napotitev v skladu s členom 30 Direktive 2001/83/ES;
Readability testing has been performed at a national level.
Opravljeno je bilo tudi preverjanje berljivosti na nacionalni ravni.
Lyme Borreliosis
Lymska borelioza
Section 4.7 - Effects on ability to drive and use machines
Poglavje 4.7 - Vpliv na sposobnosti vožnje in upravljanja strojev
Overall summary of the scientific evaluation of Rocephin and associated names (see Annex I)
Splošni povzetek znanstvenega vrednotenja zdravila Rocephin in povezanih imen (glejte Prilogo I)
Gonorrhoea, gonococcal arthritis, gonococcal eye infection
Gonoreja, gonokokni artritis, gonokokna okužba očesa
Information on absorption, distribution, metabolism and elimination has been provided.
Predloženi so bili podatki o absorpciji, porazdelitvi, presnovi in izločanju.
Infections with impaired defence mechanisms
Okužbe z oslabljenimi obrambnimi mehanizmi
The half-life increases in the elderly, and in older people aged over 75 years the average elimination half-life is usually two to three times that of young adults.
Razpolovni čas se pri starejših podaljša, pri čemer je pri osebah, starejših od 75 let, povprečen razpolovni čas izločanja običajno dva- do trikrat daljši kot pri mlajših odraslih.
The elimination half-life of total ceftriaxone in adults is about 8 hours.
Razpolovni čas izločanja celotnega ceftriaksona pri odraslih je približno osem ur.
Dose recommendations have been listed in tabular format according to dosage schedules for each indication for: Adults and children over 12 years of age (≥ 50 kg), Neonates, infants and children 15 days to 12 years of age (< 50 kg) and Neonates 0-14 days.
Priporočila za odmerjanje so navedena v preglednici glede na režime odmerjanja pri posamezni indikaciji za: odrasle in otroke, starejše od 12 let (≥ 50 kg), novorojenčke, dojenčke in otroke, stare od 15 dni do 12 let (< 50 kg), ter novorojenčke, stare od 0 do 14 dni.
It is stated that the treatment of overdose should be symptomatic.
Navedeno je tudi, da mora biti zdravljenje prevelikega odmerjanja simptomatsko.
However the changes are generally small and dose reduction is not required if renal and hepatic function is satisfactory.
Vendar so spremembe običajno majhne, zato zmanjšanje odmerka ni potrebno, če je delovanje ledvic in jeter zadovoljivo.
Ceftriaxone has utility in cases of AECB, although the supporting study was small.
Ceftriakson je uporaben v primeru AEKB, četudi je bila podporna študija majhna.
Syphilis including neurosyphilis
Sifilis, vključno z nevrosifilisom
Rocephin is approved in 19 EU Member States with different nationally approved Summaries of Product Characteristics (SmPCs).
Zdravilo Rocephin je odobreno v 19 državah članicah EU, ki so zanj na nacionalni ravni odobrile različne povzetke glavnih značilnosti zdravila (SmPC).
Due to the divergent national decisions taken by Member States concerning the authorisation of Rocephin and associated names, the European Commission notified the EMA of an official referral under Article 30 of Directive 2001/83/EC in order to resolve divergences amongst the nationally authorised product informations for the above-mentioned products and thus to harmonise them across the EU.
Zaradi različnih odločitev, ki so jih države članice na nacionalni ravni sprejele v zvezi z odobritvijo zdravila Rocephin in povezanih imen, je Evropska komisija obvestila Evropsko agencijo za zdravila o uradni napotitvi v skladu s členom 30 Direktive 2001/83/ES, z namenom odprave razlik med nacionalno odobrenimi informacijami o zdravilu za zgoraj navedena zdravila in uskladitve teh informacij po vsej EU.
One paediatric study was also submitted by the MAH, which enrolled 48 patients aged 2 months to 5 years.
Imetnik dovoljenja za promet z zdravilom je predložil tudi eno pediatrično študijo, v kateri je sodelovalo 48 bolnikov, starih od dveh mesecev do pet let.
Special populations such as patients with renal and hepatic impairment and the paediatric population have also been included.
Vključene so bile tudi posebne populacije, kot so na primer bolniki z okvaro ledvic ali jeter in pediatrična populacija.
Taking into account the additional amendments to bring the wording is in line with the recommendations made in the Guideline on the Summary of Product Characteristics (2009), this section was considered to be acceptable by the CHMP.
Ob upoštevanju dodatnih sprememb za uskladitev besedila s priporočili smernic za povzetek glavnih značilnosti zdravila (2009) je odbor CHMP menil, da je to poglavje sprejemljivo.
In addition the draft addendum to the Note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 rev 2) refers to IAI only.
Poleg tega se osnutek dodatka k dokumentu Navodila za vrednotenje zdravil, indiciranih za zdravljenje bakterijskih okužb (CPMP/EWP/558/95 rev 2), nanaša samo na intraabdominalne okužbe.
Strengths available are 250 mg, 500 mg, 1g and 2g.
Jakosti, ki so na voljo, so 250 mg, 500 mg, 1 g in 2 g. Na trgu v nekaterih državah članicah EU ni vseh navedenih jakosti.
There is a low incidence of cross allergy between penicillins and 2nd or 3rd generation cephalosporins.
Obstaja majhna incidenca navzkrižne alergije na peniciline in cefalosporine 2. ali 3. generacije.
Based on the above, the CHMP considers the benefit/risk ratio of Rocephin and associated names to be favourable and the harmonised Product Information documents to be approvable.
Na podlagi zgoraj navedenega je odbor CHMP menil, da je razmerje med tveganji in koristmi zdravila Rocephin in povezanih imen ugodno in da se usklajeni dokumenti z informacijami o zdravilu lahko odobrijo.
Section 4.6 - Fertility, pregnancy and lactation The pregnancy statements suggest that there is limited human experience, that animal studies do not indicate an embryotoxic or teratogenic effect, and that caution should be exercised if using during pregnancy.
Poglavje 4.6 - Plodnost, nosečnost in dojenje V zvezi z nosečnostjo je navedeno, da je izkušenj pri ljudeh malo, da študije na živalih niso pokazale embriotoksičnega ali teratogenega učinka in da je pri uporabi zdravila med nosečnostjo potrebna previdnost.
The statement on the lack of a disulfiram- like interaction with alcohol has been deleted as there is insufficient evidence to rule it out.
Trditev o odsotnosti medsebojnega delovanja z alkoholom, ki je podobno kot pri disulfiramu, je bila izbrisana, saj ni zadostnih dokazov, da bi ga lahko izključili.
It was noted that the proposal for the indication is aligned with the wording previously agreed on for similar antibiotics.
Odbor CHMP je upošteval, da je predlagano besedilo za indikacijo usklajeno z besedilom, ki je že bilo odobreno za podobne antibiotike.
Solvent vials contain either sterile water for injections or 1% lidocaine hydrochloride solution.
Viale z vehiklom vsebujejo bodisi sterilno vodo za injekcije bodisi 1-odstotno raztopino lidokainijevega klorida.
Therefore CHMP agreed with the wording proposed of “complicated skin and soft tissue infections”.
Odbor CHMP se je zato strinjal s predlaganim besedilom „zapletene okužbe kože in mehkih tkiv“.
However in cases of severe renal and hepatic impairment, close clinical monitoring for efficacy and safety has been recommended.
Kljub temu so v primeru hude okvare ledvic ali jeter priporočili skrbno klinično spremljanje učinkovitosti in varnosti zdravila.
Ceftriaxone distributes primarily into the extracellular space.
Ceftriakson se porazdeli predvsem v zunajcelični prostor.
Total and renal plasma clearance (of total, i.e. free plus protein bound) ceftriaxone is dose dependent, while renal clearance of free ceftriaxone clearance is not.
Skupni in ledvični plazemski očistek (celotnega, tj. prostega in na beljakovine vezanega) ceftriaksona je odvisen od odmerka, medtem ko ledvični očistek prostega ceftriaksona ni.
Rocephin can be administered by intravenous infusion over at least 30 minutes (preferred route) or by slow intravenous injection over 5 minutes, or by deep intramuscular injection.
Zdravilo Rocephin se lahko daje z najmanj 30-minutnim intravenskim infundiranjem (priporočena pot uporabe), počasnim intravenskim injiciranjem, ki traja 5 minut, ali globokim intramuskularnim injiciranjem.
The MAH's clinical trial data all stem from open, retrospective or observational uncontrolled studies enrolling small numbers of patients.
Vsi podatki iz kliničnih preskušanj, ki jih je predložil imetnik dovoljenja za promet z zdravilom, izhajajo iz odprtih, retrospektivnih ali opazovalnih nekontroliranih študij, ki so vključevale majhno število bolnikov.
The MAH's proposal ‘Infections in patients with impaired defence mechanisms' was not considered to be sufficiently supported by data.
Indikacija „okužbe pri bolnikih z oslabljenimi obrambnimi mehanizmi“, ki jo je predlagal imetnik dovoljenja za promet z zdravilom, ni zadostno podprta s podatki.
It is not expected that a parenteral antibacterial agent would be prescribed or appropriate in truly uncomplicated UTIs (uUTI).
Vendar ni pričakovati, da bi se parenteralni antibiotik predpisoval ali da bi ga bilo primerno uporabljati pri zares nezapletenih okužbah sečil.
Prophylaxis of perioperative infections
Preprečevanje perioperativnih okužb
Section 4.5- Interaction with other medicinal products and other forms of interaction In order to comply with the Guideline on the Summary of product Characteristics, the statement mentioning incompatibilities with amsacrine, vancomycin, fluconazole & aminoglycosides (which is included in the EU CSP) has been moved to Section 6.2 (Incompatibilities).
Poglavje 4.5 - Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Da bi zagotovili skladnost s smernicami za povzetek glavnih značilnosti zdravila, je bilo besedilo o inkompatibilnosti z amsakrinom, vankomicinom, flukonazolom in aminoglikozidi (ki je vključeno v dokument EU „Ključna informacija o varnosti zdravila“) prestavljeno v poglavje 6.2 (Inkompatibilnosti).
The amended wording was considered to be acceptable by the CHMP.
Odbor CHMP je menil, da je spremenjeno besedilo sprejemljivo.
At the request of the CHMP, information on drug-drug interactions (DDI) with anticoagulants was included, with a recommendation that the INR (international normalised ratio) is monitored frequently.
Na zahtevo odbora CHMP so bile vključene informacije o medsebojnem delovanju zdravila z antikoagulanti, skupaj s priporočilom o rednem spremljanju mednarodnega normiranega razmerja (INR).
Current guidelines require indications to be specific where possible, as it was recognised that different clinical conditions summarised under LRTI have different etiology and therefore may require different treatment.
Trenutno veljavne smernice zahtevajo, da so indikacije specifične, kadar je to mogoče, saj je bilo ugotovljeno, da imajo različna klinična stanja, združena pod pojmom „okužbe spodnjih dihal“, različne vzroke in jih je zato včasih treba različno zdraviti.
Section 4.4 - Special warnings and precautions for use The information on C. difficile and antibiotic- associated colitis was re-worded in line with previous Article 30 harmonisation procedures for beta- lactams and to include hypersensitivity reactions and interactions with calcium-containing products.
Poglavje 4.4 - Posebna opozorila in previdnostni ukrepi Besedilo z informacijami o bakteriji C. difficile in kolitisu, povezanem z uporabo antibiotikov, so spremenili v skladu s predhodnimi postopki usklajevanja po členu 30 za betalaktame in vključili preobčutljivostne reakcije ter interakcije z zdravili, ki vsebujejo kalcij.
From the data presented for the various indications it appears that sufficient patients with bacteraemia were included in the clinical studies, which allow the conclusion that ceftriaxone can be used in the authorised indications when bacteraemia is present.
Podatki, ki so bili predloženi za različne indikacije, kažejo, da je bilo v klinične študije vključenih dovolj bolnikov z bakteriemijo, da je mogoče zaključiti, da se ceftriakson lahko uporablja pri odobrenih indikacijah, kadar je prisotna bakteriemija.
‘Purpura fulminans' was deleted as an indication as it was agreed that the condition is a manifestation of specific infections, all of which are already covered in the list of indications.
Izbrisali so tudi indikacijo „purpura fulminans“, saj so se strinjali, da je ta bolezen znak določenih okužb, ki so že zajete v navedenih indikacijah.
The MAH has reassigned adverse events that have not been observed in studies to the additional category, ‘Not known', with an added explanatory footnote.
Imetnik dovoljenja za promet z zdravilom je neželene učinke, ki jih v študijah niso opazili, prerazporedil v dodatno kategorijo „neznana“ in dodal opombo s pojasnilom.
Adverse events such biliary lithiasis, biliary stasis and renal lithiasis have also been included with a cross reference to section 4.8 (undesirable effects).
Prav tako so bili vključeni neželeni dogodki, kot so žolčni kamni, zastoj žolča in ledvični kamni, s sklicevanjem na poglavje 4.8 (neželeni učinki).
Bacteraemia
Bakteriemija
Taking into account the data from clinical studies and considerable clinical experience with ceftriaxone in the treatment of meningitis in adults and children the CHMP agreed with the harmonised indication of “Bacterial meningitis”.
Odbor CHMP se je ob upoštevanju podatkov iz kliničnih študij in obsežnih kliničnih izkušenj s ceftriaksonom pri zdravljenju meningitisa pri odraslih in otrocih strinjal z usklajeno indikacijo „bakterijski meningitis“.
• Acute exacerbations of chronic bronchitis (AECB)
• Akutne eksacerbacije kroničnega bronhitisa (AEKB)
Data to determine the frequency of Rocephin adverse drug reactions was derived from clinical trials.
Podatki za določitev pogostnosti neželenih učinkov zdravila Rocephin so bili pridobljeni v kliničnih preskušanjih.