natgillin/translations-raw huggingface dataset:
The pack sizes of 5 and 10 are only available as multipacks comprising of 5 or 10 packs, each containing 1 bottle.
Na voljo je v pakiranjih po 1, 5 in 10 plastenk.V pakiranjih po 5 in 10 plastenk je vsaka plastenka posebej pakirana v zunanjo ovojnino.
Zoledronic acid (N=3,875) event rate
Zoledronska kislina (N=1.065) delež dogodkov (%)
What Zoledronic acid Teva Pharma contains - The active substance is zoledronic acid.
Kaj vsebuje zdravilo Zoledronska kislina Teva Pharma - Zdravilna učinkovina je zoledronska kislina.
• Transient increase in serum creatinine may be greater in patients with underlying impaired renal
• Pri bolnikih s predhodno zmanjšanim delovanjem ledvic je lahko prehodno zvišanje koncentracije kreatinina v serumu bolj izrazito.
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Druga zdravila in zdravilo Zoledronska kislina Teva Pharma Obvestite zdravnika, farmacevta ali medicinsko sestro, če jemljete ali ste pred kratkim jemali katero koli zdravilo, tudi če ste ga dobili brez recepta.
Zoledronic acid significantly reduced the mean days of limited activity and the days of bed rest due to back pain by 17.9 days and 11.3 days respectively compared to placebo and significantly reduced the mean days of limited activity and the days of bed rest due to fractures by 2.9 days and 0.5 days respectively compared to placebo (all p<0.01).
Poleg tega je v primerjavi s placebom statistično značilno znižala povprečno število dni z omejeno aktivnostjo zaradi zlomov za 2,9 dni in število dni, v katerih je zaradi zlomov potreben počitek v postelji, za 0,5 dni (v vseh primerih p < 0,01).
Treatment with a 5 mg annual dose of zoledronic acid significantly reduced BSAP by 30% relative to baseline at 12 months which was sustained at 28% below baseline levels at 36 months.
Zdravljenje z odmerkom zoledronske kisline 5 mg na leto je statistično značilno znižalo vrednosti kostno specifične alkalne fosfataze po 12 mesecih za 30 % glede na izhodišče.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each bottle with 100 ml of solution contains 5 mg zoledronic acid (as monohydrate).
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena plastenka s 100 ml raztopine vsebuje 5 mg zoledronske kisline (v obliki monohidrata).
Puh/Tel: +358 20 180 5900
Sími: +358 20 180 5900
At least one new vertebral fracture (0-2 year)
vsaj en nov zlom vretenca (v prvih dveh letih)
At least one new vertebral fracture (0-3 year)
vsaj en nov zlom vretenca (v prvih treh letih)
Cases of ONJ have been reported in the postmarketing setting for Zoledronic acid Teva Pharma.
O osteonekrozi čeljustnic so poročali tudi v okviru uporabe v času trženja zdravila Zoledronska kislina Teva Pharma.
Zoledronic acid Teva Pharma contains the active substance zoledronic acid.
Zdravilo Zoledronska kislina Teva Pharma vsebuje zdravilno učinkovino zoledronsko kislino.
In addition, in patients with Paget's disease, it is strongly advised that adequate supplemental calcium corresponding to at least 500 mg elemental calcium twice daily is ensured for at least 10 days following Zoledronic acid Teva Pharma administration (see section 4.2).
Skupaj z dajanjem zdravila Zoledronska kislina Teva Pharma je priporočeno zadostno uživanje kalcija in vitamina D. Poleg tega je zelo priporočljivo bolnikom s Pagetovo boleznijo zagotoviti zadostno dodajanje kalcija, ki ustreza vsaj 500 mg elementarnega kalcija, dvakrat na dan vsaj 10 dni po uporabi zdravila Zoledronska kislina Teva Pharma (glejte poglavje 4.2).
How to prepare and administer Zoledronic acid Teva Pharma
Kako pripraviti in dati bolniku zdravilo Zoledronska kislina Teva Pharma
- Do not use this medicine after the expiry date which is stated on the carton and bag after EXP. - Store below 30°C.
- Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na vreči poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
- After opening the bottle, chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8ºC and 25ºC.
- Po odprtju plastenke sta kemična in fizikalna stabilnost med uporabo dokazani za 24 ur pri temperaturi 2 °C - 8 °C in 25 °C.
The increases in BMD were significantly greater in the zoledronic acid-treated group at the lumbar spine and femoral neck at 12 months compared to risedronate (all p<0.03).
Po 12 mesecih je bilo povečanje mineralne gostote kosti ledvene hrbtenice in vratu stegnenice statistično značilno večje v skupini bolnikov, ki so prejemali zoledronsko kislino, v primerjavi s tistimi, ki so prejemali risedronat (vse vrednosti p < 0,03).
Solution for infusion
Način uporabe intravenska uporaba
Measurement of serum calcium before infusion of Zoledronic acid Teva Pharma is recommended for patients with Paget´s disease.
Bolnikom s Pagetovo boleznijo je priporočljivo izmeriti vrednost kalcija v serumu pred infuzijo zdravila Zoledronska kislina Teva Pharma.
How Zoledronic acid Teva Pharma is given
Kako se daje zdravilo Zoledronska kislina Teva Pharma
Your doctor should do a blood test to check your kidney function (levels of creatinine) before each dose of Zoledronic acid Teva Pharma.
Zdravnik mora pred vsakim odmerkom zdravila Zoledronska kislina Teva Pharma opraviti krvne preiskave, da preveri delovanje vaših ledvic (raven kreatinina).
Vitamin D levels were not routinely measured but a loading dose of vitamin D (50,000 to 125,000 IU orally or via the intramuscular route) was given to the majority of patients 2 weeks prior to infusion.
Zoledronsko kislino so prejemali enkrat na leto, dokler ni vsaj pri 211 bolnikih v študiji prišlo do dokazanega kliničnega zloma. Koncentracij vitamina D niso merili rutinsko, vendar je večina bolnikov 2 tedna pred infuzijo prejela večji začetni odmerek vitamina D (50.000 do 125.000 i.e. peroralno ali intramuskularno).
Unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur rarely.
Redki: pojavijo se lahko pri največ 1 od 1. 000 bolnikov Redko se lahko pojavijo neobičajni zlomi stegnenice, še posebno pri bolnikih, ki so na dolgotrajnem zdravljenju osteoporoze.
EU/1/12/772/001 multipack with 5 bottles EU/1/12/772/002 multipack with 10 bottles EU/1/12/772/005 1 bottle
EU/1/12/772/001 skupno pakiranje po 5 plastenk EU/1/12/772/002 skupno pakiranje po 10 plastenk EU/1/12/772/005 1 plastenka
QUALITATIVE AND QUANTITATIVE COMPOSITION Each bag contains 5 mg zoledronic acid (as monohydrate).
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena vreča vsebuje 5 mg zoledronske kisline (v obliki monohidrata).
- Do not use this medicine after the expiry date which is stated on the carton and bag after EXP.
- Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in
• Patients, especially elderly patients and those receiving diuretic therapy, should be appropriately hydrated prior to administration of Zoledronic acid Teva Pharma.
• Pred odmerjanjem zdravila Zoledronska kislina Teva Pharma morajo biti bolniki, zlasti starejši in tisti, ki jemljejo diuretike, primerno hidrirani.
How to store Zoledronic acid Teva Pharma
Shranjevanje zdravila Zoledronska kislina Teva Pharma
Rare cases of renal failure requiring dialysis and rare cases with a fatal outcome have been reported in patients with pre-existing renal dysfunction or other risk factors such as advanced age, concomitant nephrotoxic medicinal products, concomitant diuretic therapy, or dehydration in the post infusion period (see sections 4.4 and 4.8
Bolezni sečil zvišana vrednost kreatinina v krvi, polakisurija, proteinurija okvara ledvic; pri bolnikih s predhodno ledvično disfunkcijo ali z drugimi dejavniki tveganja, kot so višja starost bolnika, sočasna uporaba nefrotoksičnih zdravil, diuretičnega zdravljenja ali dehidracija v času po infuziji, so poročali o redkih primerih odpovedi ledvic, pri kateri je potrebna dializa, in redkih primerih s smrtnim izidom (glejte poglavji 4.4 in 4.8 odstavek Učinki po skupinah)
Ocular hyperaemia Uncommon Conjunctivitis, eye pain Uveitis, episcleritis, iritis Not known** Scleritis and parophthalmia
Očesne bolezni očesna hiperemija konjunktivitis, bolečina v očesu uveitis, episkleritis, iritis neznana** vnetje beločnice in vnetje obočesnih tkiv
EU/1/12/772/001 multipack with 5 bottles EU/1/12/772/002 multipack with 10 bottles
EU/1/12/772/001 skupno pakiranje po 5 plastenk EU/1/12/772/002 skupno pakiranje po 10 plastenk
Uncommon Dyspepsia, abdominal pain upper, abdominal pain, gastroesophageal reflux disease, constipation, dry mouth,
Bolezni prebavil navzea, bruhanje, driska dispepsija, bolečine v zgornjem delu trebuha, bolečine v trebuhu, gastroezofagealna refluksna bolezen, obstipacija, suha usta,
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF UNIT PACK (with blue box)
PODATKI NA ZUNANJI OVOJNINI ŠKATLA POSAMIČNEGA PAKIRANJA (z modrim okencem)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING IMMEDIATE CARTON (without blue box)
PODATKI NA ZUNANJI OVOJNINI PRIMARNA ŠKATLA (brez modrega okenca)
A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported in the post-marketing setting in patients receiving Zoledronic acid Teva Pharma for osteoporosis.
Pri bolnikih, ki so zaradi osteoporoze prejemali zdravilo Zoledronska kislina Teva Pharma v času trženja zdravila, so poročali o neželenem učinku, ki ga imenujemo osteonekroza čeljustnic (odmiranje kosti v čeljustnic).
Placebo (N=3,861) event rate
Izid placebo (N=3.861) delež dogodkov absolutno znižanje deleža zlomov % (IZ)
- if you have hypocalcaemia (this means that the levels of calcium in your blood are too low).
Zoledronska kislina Teva Pharma (navedeni v poglavju 6), - če imate hipokalciemijo (to pomeni, da je koncentracija kalcija v vaši krvi prenizka), - če imate hude težave z ledvicami, - če ste noseči, - če dojite.
Non-vertebral fracture (1) *p-value <0.05, **p-value <0.01 (1) Excluding finger, toe and facial fractures (2) Including clinical thoracic and clinical lumbar vertebral fractures
kateri koli klinični zlom (1) klinični zlom vretenca (2) nevretenčni zlom (1) *vrednost p < 0,05, **vrednost p < 0,01
Patients must be appropriately hydrated prior to administration of Zoledronic acid Teva Pharma.
Preden bolniki dobijo zdravilo Zoledronska kislina Teva Pharma, morajo biti primerno hidrirani.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BAG
PODATKI NA PRIMARNI OVOJNINI VREČA
Women of childbearing potential Zoledronic acid Teva Pharma is not recommended in women of childbearing potential.
Ženske v rodni dobi Zdravila Zoledronska kislina Teva Pharma ne uporabljajte pri ženskah v rodni dobi.
Nausea, vomiting, diarrhoea
vnetje požiralnika, zobobol, gastritis#
In the pooled results, a similar decrease in pain severity and pain interference scores relative to baseline were observed over 6 months for zoledronic acid and risedronate.
V združenih rezultatih so v teku 6 mesecev za zoledronsko kislino in risedronat ugotovili podobno zmanjšanje rezultatov ugotavljanja intenzivnosti bolečine in njenega oviranja vsakdanjih aktivnosti glede na izhodišče.
Renal impairment has been observed following the administration of zoledronic acid, especially in patients with pre-existing renal dysfunction or additional risk factors (e.g. advanced age, oncology patients with chemotherapy, concomitant nephrotoxic medicinal products, concomitant diuretic therapy, severe dehydration), with the majority of them receiving a 4 mg dose every 3-4 weeks, but it has been observed in patients after a single administration.
Po uporabi zoledronske kisline so opazili okvaro ledvic, posebno pri bolnikih s predhodno ledvično disfunkcijo ali z dodatnimi dejavniki tveganja (npr. višja starost bolnika, onkološki bolniki s kemoterapijo, spremljajoča nefrotoksična zdravila, spremljajoče diuretično zdravljenje, huda dehidracija).
NAME OF THE MEDICINAL PRODUCT Zoledronic acid Teva Pharma 5 mg solution for infusion in bags
IME ZDRAVILA Zoledronska kislina Teva Pharma 5 mg raztopina za infundiranje v vrečah
- Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP. - The unopened bottle does not require any special storage conditions.
- Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in plastenki poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
You may eat normally on the day you are treated with Zoledronic acid Teva Pharma, This is especially important in patients who take diuretics (“water pills”) and in elderly patients (age 65 years or over).
To je zlasti pomembno pri bolnikih, ki jemljejo diuretike (zdravila za odvajanje vode), in pri starejših bolnikih (starih 65 let ali več).
proteinuria
Dojenje
You must not be given Zoledronic acid Teva Pharma if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, ne smete dobiti zdravila Zoledronska kislina Teva Pharma.
Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving Zoledronic acid Teva Pharma for the treatment of postmenopausal osteoporosis.
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov) Pri bolnicah, ki so prejemale zdravilo Zoledronska kislina Teva Pharma zaradi postmenopavzalne osteoporoze, so poročali o nepravilnem bitja srca (atrijski fibrilaciji).
One bag contains 5 mg zoledronic acid (as monohydrate).
Ena plastenka vsebuje 5 mg zoledronske kisline (v obliki monohidrata).
Each bag contains 5 mg zoledronic acid (as monohydrate).
Ena vreča vsebuje 5 mg zoledronske kisline (v obliki monohidrata).
Adequate calcium and vitamin D intake are recommended in association with Zoledronic acid Teva Pharma administration.
Skupaj z dajanjem zdravila Zoledronska kislina Teva Pharma se priporoča zadostno uživanje kalcija in vitamina D.
Zoledronic acid Teva Pharma 5 mg solution for infusion in bottles zoledronic acid
Zoledronska kislina Teva Pharma 5 mg raztopina za infundiranje v vrečah zoledronska kislina
Your doctor should do a blood test to check your kidney function before each dose of Zoledronic acid Teva Pharma.
Zdravnik mora pred vsakim odmerjanjem zdravila Zoledronska kislina Teva Pharma s krvnimi preiskavami pregledati delovanje vaših ledvic.
Skin and subcutaneous tissue disorders Uncommon Rash, hyperhidrosis, pruritus, erythema Musculoskeletal and connective tissue disorders
Očesne bolezni očesna hiperemija konjunktivitis, bolečina v očesu uveitis, episkleritis, iritis vnetje beločnice in vnetje obočesnih tkiv
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (with blue box)
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA (z modrim okencem)
Very rare
EDINSTVENA OZNAKA
Uncommon Peripheral oedema, thirst, acute phase reaction, non-cardiac chest pain Not known** Dehydration secondary to post-dose symptoms such as fever, vomiting and diarrhoea
Splošne težave in spremembe na mestu aplikacije zelo pogosti pireksija gripi podobna bolezen, mrzlica, utrujenost, astenija, bolečine, splošno slabo počutje, reakcija na mestu injiciranja periferni edemi, žeja, reakcija akutne faze vnetja, nekardiogena bolečina v prsnem košu neznana** dehidracija zaradi simptomov po odmerjanju, kot so zvišana telesna temperatura, bruhanje in driska
You may eat normally on the day you are treated with Zoledronic acid Teva Pharma.
Na dan, ko dobite zdravilo Zoledronska kislina Teva Pharma, lahko normalno jeste.
STATEMENT OF ACTIVE SUBSTANCE(S) Each bag contains 5 mg zoledronic acid (as monohydrate).
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena plastenka vsebuje 5 mg zoledronske kisline (v obliki monohidrata).
NAME OF THE MEDICINAL PRODUCT Zoledronic acid Teva Pharma 5 mg solution for infusion zoledronic acid
Zoledronska kislina Teva Pharma 5 mg raztopina za infundiranje zoledronic acid
Tell your doctor and dentist immediately if you experience such symptoms while being treated with Zoledronic acid Teva Pharma or after stopping treatment.
Če pride do navedenih simptomov v času zdravljenja ali po zaključku zdravljenja z zdravilom Zoledronska kislina Teva Pharma, takoj obvestite svojega zdravnika in zobozdravnika.
EU/1/12/772/004 multipack with 10 bags
EU/1/12/772/003 skupno pakiranje po 5 vreč EU/1/12/772/004 skupno pakiranje po 10 vreč
Medicinal product subject to medical prescription.
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
The recommended dose is 210 mg given once a week for the first 3 weeks and then every 2 weeks.
Priporočeni odmerek je 210 mg enkrat na teden prve tri tedne, nato pa vsaka dva tedna.
The doctor may decide to stop treatment if the condition does not improve after 12 to 16 weeks.
Zdravnik se lahko odloči za prenehanje zdravljenja, če se stanje po 12 do 16 tednih ne izboljša.
What measures are being taken to ensure the safe and effective use of Kyntheum?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Kyntheum?
The full EPAR for Kyntheum 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) za zdravilo Kyntheum je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Other information about Kyntheum
Druge informacije o zdravilu Kyntheum
This is a summary of the European public assessment report (EPAR) for Kyntheum.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Kyntheum.
Although there have been recent advances in the treatment of plaque psoriasis, there remains a need for new treatment options.
Čeprav je v zadnjem času prišlo do napredka pri zdravljenju psoriaze v plakih, še vedno ostaja potreba po novih možnostih zdravljenja.
Studies have shown that Kyntheum was highly effective at clearing the skin and the positive effects were maintained with continued use.
Študije so pokazale, da je zdravilo Kyntheum zelo učinkovito pri čiščenju kože, pozitivni učinki pa so se z nadaljnjo uporabo ohranili.
The most common side effects with Kyntheum (which may affect more than 1 in 100 people) are joint pain, headache, tiredness, diarrhoea and oropharyngeal pain (pain in the mouth and throat).
Najpogostejši neželeni učinki zdravila Kyntheum (ki se lahko pojavijo pri več kot 1 bolniku od 100) so bolečine v sklepih, glavobol, utrujenost, driska in orofaringealna bolečina (bolečina v ustih in grlu).
After training, patients may inject Kyntheum if their doctor considers it appropriate.
Bolniki si lahko po opravljenem usposabljanju sami injicirajo zdravilo Kyntheum, če zdravnik meni, da je to primerno.
The European Medicines Agency therefore decided that Kyntheum's benefits are greater than its risks and recommended that it be approved for use in the EU.
Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Kyntheum večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
Kyntheum has been shown to be effective at treating plaque psoriasis in 3 main studies involving over 4,300 patients who required systemic treatment.
Zdravilo Kyntheum se je pokazalo kot učinkovito pri zdravljenju psoriaze v plakih v treh glavnih študijah, ki so vključevale več kot 4 300 bolnikov, ki so potrebovali sistemsko zdravljenje.
The active substance in Kyntheum, brodalumab, is a monoclonal antibody, a protein designed to block the activity of certain substances called interleukins 17 (A, F and A/F), which are messengers in the body's immune system (the body's natural defences).
Zdravilna učinkovina zdravila Kyntheum, brodalumab, je monoklonsko protitelo, beljakovina, zasnovana tako, da zavira delovanje določenih snovi, imenovanih interlevkini 17 (A, F in A/F), ki so prenašalci sporočil v imunskem sistemu telesa (naravni obrambi telesa).
Data from one study also showed that the benefits of treatment with Kyntheum were maintained when treatment was continued for one year.
Podatki ene študije so pokazali tudi, da so se koristi zdravljenja z zdravilom Kyntheum ohranile, če so bolniki nadaljevali z zdravljenjem eno leto.
What are the risks associated with Kyntheum?
Kakšna tveganja so povezana z zdravilom Kyntheum?
What benefits of Kyntheum have been shown in studies?
Kakšne koristi je zdravilo Kyntheum izkazalo v študijah?
What is Kyntheum and what is it used for?
Kaj je zdravilo Kyntheum in za kaj se uporablja?
By blocking the action of interleukin 17 substances, brodalumab reduces the inflammation and symptoms associated with the disease.
Z zaviranjem delovanja interlevkinov 17 brodalumab zmanjša vnetje in simptome, povezane z boleznijo.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kyntheum have been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Kyntheum upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Also, 79% of patients given Kyntheum had clear or nearly clear skin after 12 weeks, compared with 3% of patients given placebo and 70% of patients given ustekinumab.
Poleg tega je imelo 79 % bolnikov, ki so prejemali zdravilo Kyntheum, po 12 tednih čisto oziroma skoraj čisto kožo v primerjavi s 3 % bolnikov, ki so prejemali placebo, in 70 % bolnikov, ki so prejemali ustekinumab.
Kyntheum must not be given to patients who have potentially serious infections such as tuberculosis and to patients with active Crohn's disease (an inflammatory disease affecting the gut).
Zdravilo Kyntheum se ne sme dajati bolnikom s potencialno resnimi okužbami, kot je tuberkuloza, in bolnikom z aktivno Crohnovo boleznijo (vnetno črevesno boleznijo).
Side effects are similar to those of other medicines that target interleukin molecules.
Neželeni učinki so podobni kot pri drugih zdravilih, ki delujejo proti interlevkinskim molekulam.
It is not intended to provide practical advice on how to use Kyntheum.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Kyntheum should be stopped in patients who show new symptoms of depression or anxiety or in case they worsen.
Zdravljenje z zdravilom Kyntheum je treba prekiniti pri bolnikih, pri katerih se pojavijo novi simptomi depresije ali anksioznosti oziroma se obstoječi poslabšajo.
Why is Kyntheum approved?
Zakaj je bilo zdravilo Kyntheum odobreno?
It is used in adults whose disease is moderate to severe and who require systemic treatment (treatment with medicines given by mouth or by injection).
Uporablja se pri odraslih z zmerno do hudo boleznijo, ki potrebujejo sistemsko zdravljenje (zdravljenje z zdravili, ki se dajejo peroralno ali z injiciranjem).
For the full list of all side effects and restrictions with Kyntheum, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Kyntheum glejte navodilo za uporabo.
Kyntheum can only be obtained with a prescription and should be used under the supervision of a doctor experienced in diagnosing and treating psoriasis.
Predpisovanje in izdaja zdravila Kyntheum je le na recept, zdravilo pa se mora uporabljati pod nadzorom zdravnika, ki ima izkušnje z diagnosticiranjem in zdravljenjem psoriaze.
Although there is no evidence of a link to the medicine, the decision to start Kyntheum in patients who have had suicidal behaviour in the past or suffered from depression or anxiety should be made after carefully looking at all the risks and benefits for that patient.
Čeprav ni dokazov za povezavo z zdravilom, je treba pri odločanju za začetek zdravljenja z zdravilom Kyntheum pri bolnikih, ki v preteklosti izkazovali samomorilno vedenje ali imeli depresijo ali anksioznost, skrbno pretehtati tveganja in koristi za bolnika.
For more information about treatment with Kyntheum, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Kyntheum preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
This compares with 6% of those given placebo and with 70% of patients given ustekinumab.
Ta delež je pri bolnikih, ki so prejemali placebo, znašal 6 %, pri bolnikih, ki so prejemali ustekinumab, pa 70 %.