natgillin/translations-raw huggingface dataset:
The most serious side effects were thrombocytopenia and neutropenia (low levels of neutrophils, a type of white blood cell that fights infection).
Najresnejša neželena učinka sta bila trombocitopenija in nevtropenija (nizko število nevtrofilcev, vrste belih krvnih celic, ki se borijo proti okužbam).
Side effects reported with Xofigo are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Xofigo, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
What benefits of Xofigo have been shown in studies?
Kakšne koristi zdravila Xofigo so se pokazale v študijah?
Why is Xofigo authorised in the EU?
Zakaj je bilo zdravilo Xofigo odobreno v EU?
An overview of Xofigo and why it is authorised in the EU
Pregled zdravila Xofigo in zakaj je odobreno v EU
The dose of Xofigo is calculated to provide a specific dose of radioactivity based on the patient's body weight.
Odmerek zdravila Xofigo se izračuna za zagotovitev točnega odmerka radioaktivnosti na podlagi bolnikove telesne mase.
Xofigo is used on its own or in combination with a medicine known as an ‘LHRH analogue'.
Zdravilo Xofigo se uporablja samostojno ali v kombinaciji z zdravilom, imenovanim analog LHRH.
Xofigo has been shown to prolong life and delaying signs and symptoms of progressive disease.
Dokazano je, da zdravilo Xofigo podaljša življenje in odloži pojav znakov in simptomov napredujoče bolezni.
The company that markets Xofigo will have to conduct studies to further characterise the safety profile of the medicine, in particular with regard to the risk of fractures and the risk of new metastases that do not affect the bone in patients treated with Xofigo.
Podjetje, ki trži zdravilo Xofigo, bo moralo izvesti študije za nadaljnjo opredelitev varnostnega profila tega zdravila, zlasti kar zadeva tveganje za zlome in tveganje za nove zasevke, ki ne prizadenejo kosti, pri bolnikih, zdravljenih s tem zdravilom.
For more information about using Xofigo, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Xofigo glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Xofigo is a radiopharmaceutical (a medicine containing a radioactive substance) that is used to treat adults with cancer of the prostate (a gland of the male reproductive system).
Zdravilo Xofigo je radiofarmak (zdravilo, ki vsebuje radioaktivno snov), ki se uporablja za zdravljenje odraslih z rakom prostate (žleze moškega reproduktivnega sistema).
What are the risks associated with Xofigo?
Kakšna tveganja so povezana z zdravilom Xofigo?
Xofigo is used when castration (to stop the production of male hormones) by surgery or with medicines does not work, and when the cancer has spread to the bones (bone metastases) and is causing symptoms such as pain, but has not spread to other internal organs.
Zdravilo Xofigo se uporablja, kadar je kastracija (za prenehanje tvorbe moških hormonov) s kirurškim posegom ali zdravili neučinkovita ali kadar se je rak razširil na kosti (kostne metastaze) in povzroča simptome, kot je bolečina, ni pa se razširil na druge notranje organe.
Xofigo can only be obtained with a prescription and should only be handled and given by someone who is authorised to use radioactive medicines and after evaluation of the patient by a qualified doctor.
Predpisovanje in izdaja zdravila Xofigo je le na recept, z njim pa sme ravnati in ga dajati samo oseba, ki je pooblaščena za uporabo radioaktivnih zdravil, in sicer po tem, ko je bolnika pregledal usposobljeni zdravnik.
What is Xofigo and what is it used for?
Kaj je zdravilo Xofigo in za kaj se uporablja?
Xofigo can increase the risk of having fractures.
Zdravilo Xofigo lahko poveča tveganje za pojav zlomov.
Xofigo (radium-223 dichloride)
Xofigo ([223Ra]radijev klorid)
Xofigo was compared with placebo (a dummy treatment) as an addition to standard care in a main study involving 921 men with cancer of the prostate that had spread to the bones and for which suppression of male hormones using medicines or surgery did not work.
Zdravilo Xofigo so s placebom (zdravilom brez učinkovine) poleg standardne nege primerjali v glavni študiji, v katero je bilo vključenih 921 moških z rakom prostate, ki se je razširil na kosti, pri katerih supresija moških hormonov z zdravili ali kirurškim posegom ni bila učinkovita.
The most common side effects with Xofigo (which may affect more than 1 in 10 people) are diarrhoea, nausea (feeling sick), vomiting, thrombocytopenia (low blood-platelet counts) and bone fractures.
Najpogostejši neželeni učinki zdravila Xofigo (ki se lahko pojavijo pri več kot 1 bolniku od 10) so driska, navzeja (slabost), bruhanje, trombocitopenija (nizko število trombocitov) in zlomi kosti.
The active substance in Xofigo, radium-223, emits short-range radiation known as alpha particles.
Učinkovina v zdravilu Xofigo, [223Ra]radij, oddaja sevanje kratkega dosega, imenovano delci alfa.
How does Xofigo work?
Kako zdravilo Xofigo deluje?
How is Xofigo used?
Kako se zdravilo Xofigo uporablja?
For the full list of side effects of Xofigo, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Xofigo, glejte navodilo za uporabo.
Regarding its safety, several measures have been put in place to minimise the risks of the medicine such as bone fractures1 The radiation emitted by Xofigo has a shorter range than the radiation of currently available radiopharmaceuticals.
Kar zadeva njegovo varnost, je bilo sprejetih več ukrepov za zmanjšanje tveganj pri tem zdravilu, na primer zlomov kosti1.
Xofigo contains the active substance radium-223 dichloride.
Zdravilo Xofigo vsebuje učinkovino [223Ra]radijev klorid.
The signs and symptoms of progressive disease such as bone pain also took longer to develop in patients given Xofigo.
Pri bolnikih, ki so prejemali zdravilo Xofigo, je trajalo dalj tudi do pojava znakov in simptomov napredujoče bolezni, na primer bolečine v kosteh.
Take your dose once a day.
Odmerek vzemite enkrat na dan.
These changes were each in the direction of improved lipid responses and were sustained over 2 years.
Vse te spremembe so bile v smeri izboljšanih odzivov lipidov in so se ohranile v obdobju 2 let.
Children younger than 6 years
Otroci, mlajši od 6 let
Your doctor may increase your dose to find the right amount of CRESTOR for you.
Vaš zdravnik lahko poveča vaš odmerek, da bi našel ustrezen odmerek zdravila CRESTOR za vas.
This trial (n=176) was not suited for comparison of rare adverse drug events.
To preskušanje (n = 176) ni bilo primerno za primerjavo redkih neželenih učinkov zdravila.
This means you are at risk from a heart attack or stroke.
To pomeni, da vas ogroža srčni infarkt ali možganska kap.
What you need to know before you take CRESTOR
Kaj morate vedeti, preden boste vzeli zdravilo CRESTOR
• You have other factors that increase your risk of having a heart attack, stroke or related health problems.
• imate druge dejavnike, ki povečajo tveganje za srčni infarkt, možgansko kap ali podobne zdravstvene težave.
Treatment of hypercholesterolaemia
Zdravljenje hiperholesterolemije
Rosuvastatin exposure was predictable with respect to dose and time over a 2-year period.
Izpostavljenost rosuvastatinu je bila v 2-letnem obdobju predvidljiva, kar zadeva odmerek in čas.
You have been prescribed CRESTOR because:
Zdravnik vam je predpisal zdravilo CRESTOR, ker imate:
• You have a high cholesterol level.
• visok holesterol.
The 40 mg tablet is not suitable for use in paediatric patients.
40 mg tablete niso primerne za uporabo pri pediatričnih bolnikih.
Crestor is used in adults, adolescents and children 6 years or older to treat high cholesterol.
Zdravilo CRESTOR se uporablja pri odraslih, mladostnikih in otrocih, starih 6 let ali več, za zdravljenje visokega holesterola.
The safety and efficacy of use in children younger than 6 years has not been studied.
Varnost in učinkovitost uporabe pri otrocih, mlajših od 6 let, nista raziskani.
The starting dose for all patients was 5 mg rosuvastatin once daily.
Začetni odmerek je bil za vse bolnike 5 mg rosuvastatina enkrat na dan.
• If the patient is under 6 years old: CRESTOR should not be given to children younger than 6 years.
• Če je bolnik mlajši od 6 let: Zdravila CRESTOR ne smemo dajati otrokom mlajšim od 6 let.
You have been advised to take a statin, because changing your diet and taking more exercise were not enough to correct your cholesterol levels.
Zdravnik vam je svetoval jemanje statina, ker sprememba prehrane in povečanje telesne dejavnosti pri vas nista zadoščala za ureditev koncentracije holesterola.
Experience in children with homozygous familial hypercholesterolaemia is limited to a small number of children aged between 8 and 17 years.
Izkušnje pri otrocih s homozigotno družinsko hiperholesterolemijo so omejene na majhno število otrok, starih od 8 do 17 let.
• If the patient is below 18 years of age: The CRESTOR 40 mg tablet is not suitable for use in children and adolescents below 18 years of age.
• Če je bolnik mlajši od 18 let: Zdravilo CRESTOR 40 mg tablete niso primerne za uporabo pri otrocih in mladostnikih mlajših od 18 let.
The European Medicines Agency has waived the obligation to submit the results of studies with rosuvastatin in all subsets of the paediatric population in the treatment of homozygous familial hypercholesterolaemia, primary combined (mixed) dyslipidaemia and in the prevention of cardiovascular events (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z rosuvastatinom za vse podskupine pediatrične populacije, za zdravljenje homozigotne družinske hiperholesterolemije, primarne kombinirane (mešane) dislipidemije in preprečevanje kardiovaskularnih dogodkov (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Therefore, Crestor is not recommended for use in children younger than 6 years.
Zato zdravila CRESTOR ni priporočljivo uporabljati za otroke, mlajše od 6 let.
Titration should be conducted according to the individual response and tolerability in paediatric patients, as recommended by the paediatric treatment recommendations (see Section 4.4).
Prilagajanje je treba pri pediatričnih bolnikih narediti v skladu z odzivom in prenašanjem posameznika, tako kot svetujejo priporočila za pediatrično zdravljenje (glejte poglavje 4.4).
CRESTOR 40 mg tablet should not be used by children.
Zdravila CRESTOR 40 mg tablete otroci ne smejo uporabljati.
Safety and efficacy of doses greater than 20 mg have not been studied in this population.
Varnost in učinkovitost odmerkov nad 20 mg v tej populaciji nista raziskani.
This Summary of Product Characteristics and package leaflet is the outcome of the referral procedure and valid at the time of the Commission Decision.
Ta Povzetek glavnih značilnosti zdravila in Navodilo za uporabo sta rezultat napotitvenega postopka.
In a clinical trial of children and adolescents receiving rosuvastatin for 52 weeks, CK elevations >10xULN and muscle symptoms following exercise or increased physical activity were observed more frequently compared to observations in clinical trials in adults (see Section 4.8).
V kliničnih preskušanjih pri otrocih in mladostnikih, ki so prejemali rosuvastatin 52 tednov, so zvišanje kreatin-kinaze > 10-kratno ULN in mišične simptome po telesni vadbi ali intenzivnejši telesni dejavnosti opažali pogosteje kot v kliničnih preskušanjih pri odraslih (glejte poglavje 4.8).
Safety and efficacy of doses greater than 10 mg have not been studied in this population.
Varnost in učinkovitost odmerkov nad 10 mg v tej populaciji nista raziskani.
The maximum daily dose of CRESTOR is 10 mg for children aged 6 to 9 years and 20 mg for children aged 10 to 17 years.
Največji dnevni odmerek zdravila CRESTOR je 10 mg za otroke, stare od 6 do 9 let, in 20 mg za otroke, stare od 10 do 17 let.
The evaluation of linear growth (height), weight, BMI (body mass index), and secondary characteristics of sexual maturation by Tanner staging in paediatric patients 6 to 17 years of age taking rosuvastatin is limited to a two-year period.
Ocena linearne rasti (telesne višine), telesne mase, ITM (indeksa telesne mase) in sekundarnih značilnosti spolnega dozorevanja po Tannerjevi razvrstitvi pri pediatričnih bolnikih v starosti od 6 do 17 let, ki jemljejo rosuvastatin, je omejena na dvoletno obdobje.
Rosuvastatin was also studied in a 2-year open-label, titration-to-goal study in 198 children with heterozygous familial hypercholesterolaemia aged 6 to 17 years (88 male and 110 female, Tanner stage <II-V).
Rosuvastatin so raziskali tudi v 2-letni odprti, do cilja titrirani študiji pri 198 otrocih s heterozigotno družinsko hiperholesterolemijo, starih od 6 do 17 let (88 fantov in 110 deklet, stopnja po Tannerju < II-V).
[The wording of the indication for treatment of hypercholesterolaemia should be replaced with the following:]
[Obstoječe informacije glede indikacije zdravljenja hiperholesterolemije se zamenjajo s sledečimi:]
Rosuvastatin 5 mg, 10 mg, and 20 mg also achieved statistically significant mean changes from baseline for the following secondary lipid and lipoprotein variables: HDL-C, TC, non-HDL-C,LDL-C/HDLC, TC/HDL-C, TG/HDL-C, non HDL C/HDL-C, ApoB, ApoB/ApoA-1.
Rosuvastatin v odmerkih 5 mg, 10 mg in 20 mg je v primerjavi z izhodiščem dosegel tudi statistično značilne povprečne spremembe naslednjih sekundarnih lipidnih in lipoproteinskih spremenljivk: HDLholesterol, trigliceridi, ne-HDL-holesterol, LDL-holesterol/HDL-holesterol, trigliceridi/HDL-holesterol, trigliceridi/HDL-holesterol, ne-HDL-holesterol/HDL-holesterol, ApoB, ApoB/ApoA-1.
Adults, adolescents and children aged 6 years or older with primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb) as an adjunct to diet when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate.
Odrasli, mladostniki in otroci, stari 6 let ali več s primarno hiperholesterolemijo (tipa IIa vključno s heterozigotno družinsko hiperholesterolemijo) in mešano dislipidemijo (tipa IIb) - kot dodatek dieti, kadar odziv nanjo ali druge nefarmakološke ukrepe (npr. telesna vadba, hujšanje) ni bil zadovoljiv.
In a double-blind, randomized, multi-centre, placebo-controlled, 12-week study (n=176, 97 male and 79 female) followed by a 40-week (n=173, 96 male and 77 female), open-label, rosuvastatin dosetitration phase, patients 10-17 years of age (Tanner stage II-V, females at least 1 year postmenarche) with heterozygous familial hypercholesterolaemia received rosuvastatin 5, 10 or 20 mg or placebo daily for 12 weeks and then all received rosuvastatin daily for 40 weeks.
V dvojno slepi, randomizirani, multicentrični, s placebom kontrolirani 12-tedenski študiji (n = 176, 97 fantov in 79 deklet), ki ji je sledila 40-tedenska odprta faza s titriranjem odmerka rosuvastatina (n = 173, 96 fantov in 77 deklet), so bolniki v starosti od 10 do 17 let (s stopnjo od II do V po Tannerju, dekleta vsaj 1 leto po menarhi) s heterozigotno družinsko hiperholesterolemijo dobivali 5, 10 ali 20 mg rosuvastatina ali placeba na dan 12 tednov potem pa so vsi dobivali rosuvastatin vsak dan 40 tednov.
AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS FOR CRESTOR AND ASSOCIATED NAMES
SPREMEMBE KI BODO VKLJUČENE V USTREZNA POGLAVJA POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA CRESTOR IN Z NJIM POVEZANIH IMEN
Children and adolescents should be placed on standard cholesterol-lowering diet before rosuvastatin treatment initiation; this diet should be continued during rosuvastatin treatment.
Pred uvedbo zdravljenja z rosuvastatinom je treba otrokom in mladostnikom predpisati standardno dieto za znižanje holesterola, ki jo morajo nadaljevati tudi med zdravljenjem z rosuvastatinom.
AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE PACKAGE LEAFLET FOR CRESTOR AND ASSOCIATED NAMES
SPREMEMBE KI BODO VKLJUČENE V USTREZNA POGLAVJA NAVODILA ZA UPORABO ZDRAVILA CRESTOR IN Z NJIM POVEZANIH IMEN
Homozygous familial hypercholesterolaemia as an adjunct to diet and other lipid lowering treatments (e.g. LDL apheresis) or if such treatments are not appropriate.
Homozigotna družinska hiperholesterolemija pri odraslih - kot dodatek dieti in drugim ukrepom za zmanjšanje vrednosti lipidov (npr. afereza LDL) ali kadar ti ukrepi niso primerni.
At the end of the 40-week, open-label, titration to goal, dosing up to a maximum of 20 mg once daily, 70 of 173 patients (40.5%) had achieved the LDL-C goal of less than 2.8 mmol/l.
Na koncu 40-tedenske odprte faze s titriranjem do cilja, je z odmerkom do največ 20 mg enkrat na dan, 70 od 173 bolnikov (40,5 %) doseglo ciljni holesterol LDL manj kot 2,8 mmol/l.
After 24 months of treatment with rosuvastatin, the LS mean percent reduction from the baseline value in LDL-C was -43% (Baseline: 236 mg/dL, Month 24: 133 mg/dL).
Po 24 mesecih zdravljenja z rosuvastatinom je bil povprečni odstotek (po metodi najmanjših kvadratov) zmanjšanja holesterola LDL od izhodišča -43 % (izhodišče: 236 mg/dl, 24. mesec: 133 mg/dl).
LDL-C was reduced 38.3%, 44.6%, and 50.0% by rosuvastatin 5, 10 and 20 mg, respectively, compared to 0.7% for placebo.
Holesterol LDL se je s 5 mg rosuvastatina znižal za 38,3 %, z 10 mg za 44,6 % in z 20 mg za 50,0 %, s placebom pa za 0,7 %.
Patients aged 6 to 9 years (n=64) could titrate to a maximum dose of 10 mg once daily and patients aged 10 to 17 years (n=134) to a maximum dose of 20 mg once daily.
do 9 let (n = 64), so lahko odmerek titrirali do največjega odmerka 10 mg enkrat na dan, bolnikom, starim od 10 do 17 let (n = 134) pa do največjega odmerka 20 mg enkrat na dan.
For each age group, the LS mean percent reductions from baseline values in LDL-C were -43% (Baseline: 234 mg/dL, Month 24: 124 mg/dL), -45% (Baseline: 234 mg/dL, 124 mg/dL ), and -35% (Baseline: 241 mg/dL, Month 24: 153 mg/dL) in the 6 to <10, 10 to <14, and 14 to <18 age groups, respectively.
Povprečni odstotki znižanja (po metodi najmanjših kvadratov) holesterola LDL od izhodišča so bili po posameznih skupinah: 6 do < 10 let -43 % (izhodišče: 234 mg/dl, 24. mesec: 124 mg/dl), od 10 do < 14 let -45% (izhodišče: 234 mg/dl, 24. mesec: 124 mg/dl) in od 14 do < 18 let -35% (izhodišče: 241 mg/dl, 24. mesec: 153 mg/dl).
• In children 10 to 17 years of age with heterozygous familial hypercholesterolaemia, the usual dose range is 5-20 mg orally once daily.
• Za otroke, stare od 10 do 17 let, s heterozigotno družinsko hiperholesterolemijo, je običajen razpon odmerkov od 5 do 20 mg peroralno enkrat na dan.
• In children 6 to 9 years of age with heterozygous familial hypercholesterolaemia, the usual dose range is 5-10 mg orally once daily.
• Za otroke, stare od 6 do 9 let, s heterozigotno družinsko hiperholesterolemijo, je običajen razpon odmerkov od 5 do 10 mg peroralno enkrat na dan.
After two years of study treatment, no effect on growth, weight, BMI or sexual maturation was detected (see Section 5.1).
Po dveh letih zdravljenja v študiji niso odkrili nobenih učinkov na rast, telesno maso, ITM ali spolno dozorevanje (glejte poglavje 5.1).
Amendments to the Summary of Product Characteristics and Package Leaflet
Spremembe Povzetka glavnih značilnosti zdravila in Navodila za uporabo,
How to take CRESTOR [Existing information on the paediatric population should be replaced with the following:]
5.2 Farmakokinetične lastnosti [Obstoječe informacije glede pediatrične populacije se zamenjajo s sledečimi:]
After 52 weeks of study treatment, no effect on growth, weight, BMI or sexual maturation was detected (see Section 4.4).
Po 52 tednih zdravljenja v študiji niso odkrili nobenih učinkov na rast, telesno maso, ITM ali spolno dozorevanje (glejte poglavje 4.4).
At study entry, approximately 30% of the patients were 10-13 years and approximately 17%, 18%, 40%, and 25% were Tanner stage II, III, IV, and V, respectively.
Ob vključitvi v študijo je bilo približno 30 % bolnikov starih od 10 do 13 let, porazdelitev po stopnjah po Tannerju pa je bila: približno 17 % II.
What CRESTOR is and what it is used for [Existing wording of this section should be replaced with the following:] CRESTOR belongs to a group of medicines called statins.
Zdravilo CRESTOR spada v skupino zdravil, imenovanih statini.
[Existing information on the paediatric population should be replaced with the following:]
[Obstoječe informacije tega poglavja se zamenjajo s sledečimi:]
You should continue with your cholesterol-lowering diet and exercise while you are taking CRESTOR.
Medtem, ko jemljete zdravilo CRESTOR, bi morali nadaljevati z dieto za zniževanje holesterola in telesno vadbo.
Paediatric population Paediatric use should only be carried out by specialists.
Otroke mora zdraviti specialist.
5.2 Pharmacokinetic properties [Existing information on the paediatric population should be replaced with the following:] Paediatric population: Two pharmacokinetic studies with rosuvastatin (given as tablets) in paediatric patients with heterozygous familial hypercholesterolaemia 10-17 or 6-17 years of age (total of 214
Pediatrična populacija: Dve farmakokinetični študiji z rosuvastatinom (danim v obliki tablet) pri pediatričnih bolnikih s heterozigotno družinsko hiperholesterolemijo, starih od 10 do 17 ali od 6 do 17 let (skupaj 214 bolnikov), sta pokazali, da je izpostavljenost pediatričnih bolnikov podobna ali manjša kot izpostavljenost odraslih bolnikov.
Use in children and adolescents aged 6-17 years
Uporaba pri otrocih in mladostnikih, starih od 6-17 let Priporočeni začetni odmerek je 5 mg.
No effect on growth, weight, BMI or sexual maturation was detected after 24 months of treatment (see Section 4.4).
Po 24 mesecih zdravljenja niso ugotovili nobenega vpliva na rast, telesno maso, ITM ali spolno dozorevanje (glejte poglavje 4.4).
Children and adolescents 6 to 17 years of age (Tanner Stage <II-V) In children and adolescents with heterozygous familial hypercholesterolaemia the usual start dose is 5 mg daily.
Otroci in mladostniki v starosti od 6 do 17 let (s stopnjo po Tannerju <II-V).
The recommended dose is 200 mg once a day for 6 days.
Priporočeni odmerek je 200 mg enkrat dnevno v trajanju šest dni.
It works by preventing certain bacteria from making proteins, thereby stopping their growth.
Deluje tako, da določenim bakterijam preprečuje tvorbo beljakovin, s čimer ustavi njihovo rast.
The European Commission granted a marketing authorisation valid throughout the European Union for Sivextro on 23 March 2015.
Evropska komisija je dovoljenje za promet z zdravilom Sivextro, veljavno po vsej Evropski uniji, izdala 23. marca 2015.
Although the infections in the studies were not severe, the CHMP considered that the results also apply to severe infections.
Čeprav okužbe, obravnavane v študijah, niso bile hude, je CHMP menil, da rezultati veljajo tudi za hude okužbe.
85.5% of patients treated with Sivextro in the first study and 88.0% in the second study were cured, compared with 86.0% and 87.7% respectively of patients treated with linezolid.
V prvi študiji je bilo ozdravljenih 85,5 % bolnikov, zdravljenih z zdravilom Sivextro, v drugi študiji pa 88,0 %, v primerjavi s 86,0 oz. 87,7 % bolnikov, zdravljenih z linezolidom.
Patients who are started on the infusion may be switched to the tablets when appropriate.
Bolniki, ki so začeli zdravljenje z infuzijo, lahko preidejo na tablete, če je to primerno.
What measures are being taken to ensure the safe and effective use of Sivextro?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Sivextro?
This is a summary of the European public assessment report (EPAR) for Sivextro.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Sivextro.
The full EPAR and risk management plan summary for Sivextro 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 Sivextro sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.