natgillin/translations-raw huggingface dataset:
The usual recommended dose is: one 100mg film-coated tablet once a day by mouth
Običajni priporočeni odmerek je: - ena 100 mg filmsko obložena tableta, - enkrat na dan,
Since co-administration of a high-fat meal with sitagliptin had no effect on the pharmacokinetics, TESAVEL may be administered with or without food.
Sočasno zaužitje sitagliptina ter obroka z veliko maščobami ni vplivalo na farmakokinetiko, zato se zdravilo TESAVEL lahko jemlje s hrano ali brez nje.
TESAVEL is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.
Zdravilo TESAVEL je indicirano tudi kot dodatno zdravljenje k insulinu (z metforminom ali brez), če z dieto in s telesno aktivnostjo ter stabilnim odmerkom insulina urejenost glikemije ni zadostna.
TESAVEL has no or negligible influence on the ability to drive and use machines.
Zdravilo TESAVEL nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
It is important to stay on the diet and exercise recommended by your doctor while taking TESAVEL.
Med jemanjem zdravila TESAVEL je pomembno, da se držite diete in telesne aktivnosti, ki vam ju je priporočil zdravnik.
Hypoglycaemia when used in combination with other anti-hyperglycaemic medicinal products In clinical trials of TESAVEL as monotherapy and as part of combination therapy with medicinal products not known to cause hypoglycaemia (i.e. metformin and/or a PPAR agonist), rates of hypoglycaemia reported with sitagliptin were similar to rates in patients taking placebo.
Hipoglikemija pri zdravljenju v kombinaciji z ostalimi antihiperglikemiki V kliničnih preskušanjih zdravila TESAVEL kot samostojnega zdravila in v kombinaciji z drugimi zdravili za katere ni znano, da povzročijo hipoglikemijo (tj. metforminom in/ali agonistom PPAR), so pri bolnikih, ki so jemali sitagliptin, poročali o podobnih deležih hipoglikemije kot pri bolnikih, ki so jemali placebo.
If a dose of TESAVEL is missed, it should be taken as soon as the patient remembers.
Če bolnik izpusti odmerek zdravila TESAVEL, ga mora vzeti takoj, ko se spomni.
For patients with severe renal impairment (GFR ≥ 15 to <30 mL/min) or with end-stage renal disease (ESRD) (GFR < 15 mL/min), including those requiring haemodialysis or peritoneal dialysis, the dose of TESAVEL is 25 mg once daily.
Pri bolnikih s hudo ledvično okvaro (GFR ≥ 15 do < 30 ml/min) ali bolnikih s končno ledvično odpovedjo (ESRD - end-stage renal disease) (GFR < 15 ml/min), vključno s tistimi, ki potrebujejo hemodializo ali peritonealno dializo, je odmerek zdravila TESAVEL 25 mg enkrat na dan.
What TESAVEL looks like and contents of the pack
Izgled zdravila TESAVEL in vsebina pakiranja
When TESAVEL is used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia (see section 4.4).
Pri uporabi zdravila TESAVEL v kombinaciji s sulfonilsečnino ali z insulinom lahko po potrebi zmanjšate odmerek sulfonilsečnine ali insulina, da se tako zmanjša tveganje za pojav hipoglikemije (glejte poglavje 4.4).
How to take TESAVEL
Kako jemati zdravilo TESAVEL
TESAVEL has not been studied in patients with severe hepatic impairment and care should be exercised (see section 5.2).
Pri bolnikih s hudo jetrno okvaro uporaba zdravila TESAVEL ni raziskana, zato je potrebna previdnost (glejte poglavje 5.2).
For patients with moderate renal impairment (GFR  30 to < 45 mL/min), the dose of TESAVEL is 50 mg once daily.
Pri bolnikih z zmerno ledvično okvaro (GFR ≥ 30 do < 45 ml/min) je odmerek zdravila TESAVEL 50 mg enkrat na dan.
Cases of inflammation of the pancreas (pancreatitis) have been reported in patients receiving TESAVEL (see section 4).
Pri bolnikih, ki so prejemali zdravilo TESAVEL, so poročali o primerih vnetja trebušne slinavke (pankreatitisa) (glejte poglavje 4).
Method of administration TESAVEL can be taken with or without food.
Način uporabe Zdravilo TESAVEL lahko bolnik jemlje skupaj s hrano ali brez nje.
What TESAVEL contains
Kaj vsebuje zdravilo TESAVEL
TESAVEL is a member of a class of oral anti-hyperglycaemic agents called dipeptidyl peptidase 4 (DPP-4) inhibitors.
Zdravilo TESAVEL spada v skupino peroralnih antidiabetikov, imenovanih zaviralci dipeptidil peptidaze 4 (DPP-4).
If a hypersensitivity reaction is suspected, TESAVEL should be discontinued.
Če obstaja sum na preobčutljivostno reakcijo, morate prenehati zdravljenje z zdravilom TESAVEL.
The level of digoxin in your blood may need to be checked if taking with TESAVEL.
Med sočasnim jemanjem z zdravilom TESAVEL vam bodo morda morali preveriti vrednosti digoksina v krvi.
Paediatric No studies with TESAVEL have been performed in paediatric patients.
Otroci Pri otrocih študij z zdravilom TESAVEL niso izvedli.
TESAVEL should not be used during breast-feeding.
Med dojenjem se zdravila TESAVEL ne sme jemati.
If pancreatitis is suspected, TESAVEL and other potentially suspect medicinal products should be discontinued; if acute pancreatitis is confirmed, TESAVEL should not be restarted.
Ob sumu na pankreatitis je treba prenehati z jemanjem zdravila TESAVEL in drugih zdravil, ki bi lahko povzročila pankreatitis.
TESAVEL contains the active substance sitagliptin which is a member of a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood sugar levels in adult patients with type 2 diabetes mellitus.
Zdravilo TESAVEL vsebuje učinkovino sitagliptin, ki spada v skupino zdravil, imenovano zaviralci DPP-4 (zaviralci dipeptidil peptidaze 4).
Placebo-corrected mean change in HbA1c (%) (95 % CI)
S placebom korigirana srednja sprememba vrednosti HbA1c
No dose adjustment for TESAVEL is necessary for patients with mild or moderate hepatic impairment (Child-Pugh score  9).
Pri bolnikih z blago ali zmerno jetrno okvaro (ocena po Child-Pugh-u  9) odmerka ni treba prilagoditi.
- type 1 diabetes - diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss,
- sladkorno bolezen tipa 1 - diabetično ketoacidozo (zaplet sladkorne bolezni z visokim krvnim sladkorjem, hitrim hujšanjem, siljenjem na bruhanje ali bruhanjem) - kakršne koli težave z ledvicami v sedanjosti ali v preteklosti - alergijsko reakcijo na zdravilo TESAVEL (glejte poglavje 4)
In addition, patients should be alerted to the risk of hypoglycaemia when TESAVEL is used in combination with a sulphonylurea or with insulin.
Poleg tega je treba bolnike, ki jemljejo zdravilo TESAVEL skupaj s sulfonilsečnino ali z insulinom, opozoriti na tveganje za pojav hipoglikemije.
If bullous pemphigoid is suspected, TESAVEL should be discontinued.
Ob sumu na bulozni pemfigoid je treba zdravljenje z zdravilom TESAVEL prekiniti.
To achieve plasma concentrations of sitagliptin similar to those in patients with normal renal function, lower dosages are recommended in patients with GFR < 45 mL/min, as well as in ESRD patients requiring haemodialysis or peritoneal dialysis.
Za doseg podobnih plazemskih koncentracij sitagliptina, kot so pri bolnikih z normalno ledvično funkcijo, se pri bolnikih z GFR < 45 ml/min ter bolnikih s končno ledvično odpovedjo, ki potrebujejo hemodializo ali peritonealno dializo, priporočajo manjši odmerki zdravila (glejte poglavji 4.2 in 5.2).
EU/1/07/435/013 14 film-coated tablets EU/1/07/435/014 28 film-coated tablets EU/1/07/435/023 30 film-coated tablets EU/1/07/435/015 56 film-coated tablets EU/1/07/435/016 84 film-coated tablets EU/1/07/435/024 90 film-coated tablets EU/1/07/435/017 98 film-coated tablets EU/1/07/435/018 50 x 1 film-coated tablets
EU/1/07/435/013 14 filmsko obloženih tablet EU/1/07/435/014 28 filmsko obloženih tablet EU/1/07/435/023 30 filmsko obloženih tablet EU/1/07/435/015 56 filmsko obloženih tablet EU/1/07/435/016 84 filmsko obloženih tablet EU/1/07/435/024 90 filmsko obloženih tablet EU/1/07/435/017 98 filmsko obloženih tablet EU/1/07/435/018 50 x 1 filmsko obložena tableta
EU/1/07/435/007 14 film-coated tablets EU/1/07/435/008 28 film-coated tablets EU/1/07/435/021 30 film-coated tablets EU/1/07/435/009 56 film-coated tablets EU/1/07/435/010 84 film-coated tablets EU/1/07/435/022 90 film-coated tablets EU/1/07/435/011 98 film-coated tablets EU/1/07/435/012 50 x 1 film-coated tablets
EU/1/07/435/007 14 filmsko obloženih tablet EU/1/07/435/008 28 filmsko obloženih tablet EU/1/07/435/021 30 filmsko obloženih tablet EU/1/07/435/009 56 filmsko obloženih tablet EU/1/07/435/010 84 filmsko obloženih tablet EU/1/07/435/022 90 filmsko obloženih tablet EU/1/07/435/011 98 filmsko obloženih tablet EU/1/07/435/012 50 x 1 filmsko obložena tableta
EU/1/07/435/001 14 film-coated tablets EU/1/07/435/002 28 film-coated tablets EU/1/07/435/019 30 film-coated tablets EU/1/07/435/003 56 film-coated tablets EU/1/07/435/004 84 film-coated tablets EU/1/07/435/020 90 film-coated tablets EU/1/07/435/005 98 film-coated tablets EU/1/07/435/006 50 x 1 film-coated tablets
EU/1/07/435/001 14 filmsko obloženih tablet EU/1/07/435/002 28 filmsko obloženih tablet EU/1/07/435/019 30 filmsko obloženih tablet EU/1/07/435/003 56 filmsko obloženih tablet EU/1/07/435/004 84 filmsko obloženih tablet EU/1/07/435/020 90 filmsko obloženih tablet EU/1/07/435/005 98 filmsko obloženih tablet EU/1/07/435/006 50 x 1 filmsko obložena tableta
How to store TESAVEL
Shranjevanje zdravila TESAVEL
- If you get any side effects gets talk to your doctor, pharmacist, or nurse.
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
TESAVEL 25 mg film-coated tablets
TESAVEL 25 mg filmsko obložene tablete
TESAVEL 100 mg film-coated tablets
TESAVEL 100 mg filmsko obložene tablete
TESAVEL 25 mg film-coated tablets Sitagliptin
TESAVEL 25 mg filmsko obložene tablete sitagliptin
TESAVEL 50 mg film-coated tablets
TESAVEL 50 mg filmsko obložene tablete
TESAVEL 100 mg film-coated tablets Sitagliptin
TESAVEL 100 mg filmsko obložene tablete sitagliptin
TESAVEL 50 mg film-coated tablets Sitagliptin
TESAVEL 50 mg filmsko obložene tablete sitagliptin
12 vials + 72 injection syringes with attached needle + 144 cleansing swabs
12 vial + 72 injekcijskih brizg s pritrjeno iglo + 144 čistilnih tamponov
2 vials + 12 injection syringes with attached needle + 24 cleansing swabs
2 viali + 12 injekcijskih brizg s pritrjeno iglo + 24 čistilnih tamponov
1 vial + 6 injection syringes with attached needle + 12 cleansing swabs
1 viala + 6 injekcijskih brizg s pritrjeno iglo + 12 čistilnih tamponov
2 vials
Stična ovojnina
1 150 mg indoxacarb + 480 mg permethrin/ml
1 150 mg indoksakarba + 480 mg permetrina/ml
Influenza virus surface antigens (haemagglutinin and neuraminidase)* , inactivated, of the following strains: A/Brisbane/02/2018 (H1N1)pdm09 - like strain (A/Idaho/07/2018) 15 micrograms HA** A/Kansas/14/2017 (H3N2) - like strain (A/Indiana/08/2018) 15 micrograms HA** B/Colorado/06/2017 - like strain (B/Iowa/06/2017) 15 micrograms HA** B/Phuket/3073/2013 - like strain (B/Singapore/INFTT-16-0610/2016) 15 micrograms HA**
A/Brisbane/02/2018 (H1N1)pdm09 podoben sev (A/Idaho/07/2018) 15 mikrogramov HA** A/Kansas/14/2017 (H3N2) podoben sev (A/Indiana/08/2018) 15 mikrogramov HA** B/Colorado/06/2017 podoben sev (B/Iowa/06/2017) 15 mikrogramov HA** B/Phuket/3073/2013 podoben sev (B/Singapore/INFTT-16-0610/2016) 15 mikrogramov HA** na 0,5 mililitrski odmerek
--¹ 1 Each 0.5 ml dose contains:
--¹ En 0,5 ml odmerek vsebuje:
* propagated in Madin Darby Canine Kidney (MDCK) cells ** haemagglutinin
* razmnoženi v celicah pasjih ledvic Madin Darby Canine Kidney (MDCK) ** hemaglutinina
Intramuscular use Pre-filled syringe (glass) without needle
Sevi* virusa influence s površinskimi antigeni (hemaglutinin in nevraminidaza), inaktivirani:
They may also have episodes of depression.
Imajo pa lahko tudi epizode depresije.
The European Commission granted a marketing authorisation valid throughout the European Union for Aripiprazole Zentiva on 25 June 2015.
Evropska komisija je dovoljenje za promet z zdravilom Aripiprazol Zentiva, veljavno po vsej Evropski uniji, izdala dne 25. junija 2015.
The full EPAR and risk management plan summary for Aripiprazole Zentiva 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) in povzetek načrta obvladovanja tveganj za zdravilo Aripiprazol Zentiva sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
To prevent manic episodes in adults, the same dose should be continued.
Za preprečevanje maničnih epizod pri odraslih je treba nadaljevati z jemanjem enakega odmerka.
Aripiprazole Zentiva aripiprazole
Aripiprazol Zentiva aripiprazol
Aripiprazole Zentiva is available as tablets (5, 10, 15 and 30 mg) and orodispersible tablets (tablets that dissolve in the mouth; 10, 15 and 30 mg).
Zdravilo Aripiprazol Zentiva je na voljo v obliki tablet (5, 10, 15 in 30 mg) in orodisperzibilnih tablet (tablete, ki se raztopijo v ustih; 10, 15 in 30 mg).
• schizophrenia, a mental illness with a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).
• shizofrenijo, tj. duševno boleznijo s številnimi simptomi, ki vključujejo neorganizirano mišljenje in govor, halucinacije (bolnik vidi in sliši stvari, ki jih ni), sumničavost ter blodnje (zmotna prepričanja).
The Committee recommended that Aripiprazole Zentiva be approved for use in the EU.
Priporočil je, da se zdravilo Aripiprazol Zentiva odobri za uporabo v EU.
A risk management plan has been developed to ensure that Aripiprazole Zentiva is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Aripiprazol Zentiva je bil pripravljen načrt obvladovanja tveganj.
In addition, the company that markets Aripiprazole Zentiva will provide educational materials to be supplied to patients or their caregivers and to doctors to explain the safe use of the medicine in patients between 13 and 17 years.
Poleg tega bo družba, ki trži zdravilo Aripiprazol Zentiva, priskrbela izobraževalno gradivo, ki ga bodo prejeli bolniki ali njihovi negovalci ter zdravniki, v katerem bo pojasnjena varna uporaba zdravila pri bolnikih, starih od 13 do 17 let.
This means that Aripiprazole Zentiva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Abilify.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Abilify.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Aripiprazole Zentiva has been shown to have comparable quality and to be bioequivalent to Abilify.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Aripiprazol Zentiva primerljivo raven kakovosti kot zdravilo Abilify ter da mu je biološko enakovredno.
The dose should be adjusted in patients who are taking other medicines that affect the way Aripiprazole Zentiva is broken down in the body.
Odmerek je treba prilagoditi pri bolnikih, ki jemljejo druga zdravila, ki vplivajo na presnovo zdravila Aripiprazol Zentiva v telesu.
Aripiprazole Zentiva is used in adults to treat moderate to severe manic episodes and to prevent new manic episodes in adults who have responded to the medicine in the past.
Zdravilo Aripiprazol Zentiva se uporablja pri odraslih za zdravljenje zmernih in hudih maničnih epizod ter za preprečevanje pojava novih maničnih epizod pri odraslih, ki so se v preteklosti že odzvali na zdravilo.
Because Aripiprazole Zentiva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Aripiprazol Zentiva generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
Aripiprazole Zentiva is used in patients with the following mental illnesses:
Zdravilo Aripiprazol Zentiva se uporablja pri bolnikih z naslednjimi duševnimi boleznimi:
The orodispersible tablets can be used in patients who have difficulty swallowing tablets.
Pri bolnikih, ki težko pogoltnejo tableto, se lahko uporabljajo orodisperzibilne tablete.
Aripiprazole Zentiva is used in patients aged 15 years or over;
Zdravilo Aripiprazol Zentiva se uporablja pri bolnikih, starih 15 let ali več;
For more information about treatment with Aripiprazole Zentiva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Aripiprazol Zentiva preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Other information about Aripiprazole Zentiva
Druge informacije o zdravilu Aripiprazol Zentiva
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Aripiprazole Zentiva, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Aripiprazol Zentiva in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Because Aripiprazole Zentiva is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Abilify.
Ker je zdravilo Aripiprazol Zentiva generično zdravilo, so bile študije pri ljudeh omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Abilify.
For treating manic episodes in bipolar disorder, the recommended starting dose in adults is 15 mg by mouth once a day, either on its own or in combination with other medicines.
Za zdravljenje maničnih epizod pri bipolarni motnji pri odraslih je priporočeni začetni odmerek 15 mg peroralno enkrat na dan, samostojno ali v kombinaciji z drugimi zdravili.
Aripiprazole Zentiva contains the active substance aripiprazole and is a ‘generic medicine'.
Zdravilo Aripiprazol Zentiva vsebuje zdravilno učinkovino aripiprazol in je „generično zdravilo“.
For schizophrenia, the recommended starting dose is 10 or 15 mg by mouth per day in adults, followed by a ‘maintenance' dose of 15 mg once a day.
Pri shizofreniji je priporočeni začetni odmerek pri odraslih 10 ali 15 mg peroralno na dan, ki mu sledi „vzdrževalni odmerek“ 15 mg enkrat na dan.
In patients aged between 15 and 17 years, the starting dose is 2 mg a day (using an aripiprazole product available in liquid form), which is gradually increased to the recommended dose of 10 mg once a day.
Pri bolnikih, starih od 15 do 17 let, je začetni odmerek 2 mg na dan (pri čemer se uporablja zdravilo z aripiprazolom v tekoči obliki), postopoma pa se povečuje na priporočeni 10-miligramski odmerek enkrat na dan.
The active substance in Aripiprazole Zentiva, aripiprazole, is an antipsychotic medicine.
Zdravilna učinkovina v zdravilu Aripiprazol Zentiva, aripiprazol, je antipsihotik.
Aripiprazole Zentiva is also used for up to 12 weeks to treat moderate to severe manic episodes in patients aged 13 years or over.
Zdravilo se uporablja tudi za zdravljenje zmernih do hudih maničnih epizod pri bolnikih, starih 13 let ali več, v obdobju do 12 tednov.
Dr. Hudson (United Kingdom)
dr. Hudson (Združeno kraljestvo)
Dr. Broich (Germany)
dr. Broich (Nemčija)
Article 29 of Directive 2001/83/EC as amended, referral on the grounds of potential serious risk to public health
Člen 29 Direktive 2001/83/ES, kakor je bila spremenjena, napotitev zaradi možnega resnega tveganja za javno zdravje.
The company wanted the authorisation to be recognised in Cyprus, the Czech Republic, France, Italy, Poland, Portugal, Spain and the United Kingdom (the ‘concerned Member States').
Družba je želela, da se odobritev prizna na Cipru, v Češki republiki, v Franciji, v Italiji, na Poljskem, na Portugalskem, v Španiji in v Združenem kraljestvu (v zadevnih državah članicah).
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.
Vendar države članice niso mogle doseči sporazuma, zato je nemški regulatorni organ za zdravila dne 10. oktobra 2008 zadevo napotil na CHMP v arbitražo.
The review was carried out under an ‘Article 29' referral1.
Pregled je bil izveden v skladu z napotitvenim postopkom iz člena 291.
Questions and answers on the referral for Avalox solution for infusion containing moxifloxacin 400 mg/250 ml
Vprašanja in odgovori v zvezi z napotitvenim postopkom za zdravilo Avalox raztopina za infundiranje, ki vsebuje moksifloksacin 400 mg/250 ml
Bayer Vital GmbH submitted Avalox solution for infusion for mutual recognition on the basis of the initial authorisation granted by Germany on 30 April 2002.
Družba Bayer Vital GmbH je predložila zdravilo Avalox raztopina za infundiranje v postopek medsebojnega priznavanja na podlagi prvotne odobritve v Nemčiji dne 30. aprila 2002.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Avalox solution for infusion outweigh its risks, and the marketing authorisation granted in Germany can be recognised in other Member States of the EU, namely Cyprus, the Czech Republic, France, Italy, Poland, Portugal, Spain and the United Kingdom.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da koristi zdravila Avalox 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 na Cipru, v Češki republiki, v Franciji, v Italiji, na Poljskem, na Portugalskem, v Španiji in v Združenem kraljestvu.
The grounds for the referral were concerns expressed by the United Kingdom that the use of intravenous moxifloxacin in community acquired pneumonia and complicated skin and soft tissues infections should be limited to when the standard treatments for these infections are not appropriate, and concerns from France regarding the medicine's risk of causing problems with the heart rhythm (QT-interval prolongation).
Podlaga za napotitveni postopek so bili zadržki Združenega kraljestva, da bi bilo treba uporabo intravenskega moksifloksacina pri izvenbolnišnično pridobljeni pljučnici ter zapletenih okužbah kože in mehkih tkiv omejiti na tiste primere, ko standardna zdravljenja takih okužb niso primerna, in zadržek Francije glede tveganja zdravila za povzročitev težav s srčnim ritmom (podaljšanje intervala QT).
It is 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.
Uporablja se lahko za zdravljenje naslednjih bakterijskih okužb: - izvenbolnišnično pridobljena pljučnica (okužba pljuč, do katere ne pride v bolnišnici), - zapletene okužbe kože in mehkih podkožnih tkiv.
Company responses provided on: 26 January 2009; 27 April 2009; 28 May 2009 Opinion date:
26. januarja 2009; 27. aprila 2009; 28. maja 2009
Avalox solution for infusion is an antibiotic given by infusion (drip into a vein).
Avalox raztopina za infundiranje je antibiotik, ki se daje z infuzijo (kapalna infuzija v veno).
The active substance in Avalox solution for infusion, moxifloxacin, belongs to the group ‘fluoroquinolones'.
Zdravilna učinkovina zdravila Avalox raztopina za infundiranje, moksifloksacin, spada v skupino „fluorokinolonov“.
Why was Avalox solution for infusion reviewed?
Zakaj je bilo zdravilo Avalox raztopina za infundiranje pregledano?
The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Avalox solution for infusion.
Evropska agencija za zdravila je po nesoglasju med državami članicami Evropske unije glede odobritve zdravila Avalox raztopina za infundiranje zaključila postopek arbitraže.