natgillin/translations-raw huggingface dataset:
Treatment should be stopped if the platelet count does not rise enough to reduce the risk of bleeding after 4 weeks of treatment with the maximum dose of Nplate.
Zdravljenje z zdravilom Nplate je treba po štirih tednih zdravljenja z največjim odmerkom prekiniti, če se število trombocitov ne poveča dovolj, da bi se zmanjšalo tveganje za krvavitev.
In the body, a hormone called ‘thrombopoietin' normally stimulates the production of platelets in the bone marrow.
V telesu nastajanje trombocitov v kostnem mozgu običajno spodbuja hormon, imenovan „trombopoetin“.
The study in children involved 62 patients aged 1 to less than 18 years whose ITP had been treated previously (including some whose spleen had been removed).
V študijo pri otrocih je bilo vključenih 62 bolnikov, starih od enega leta do manj kot 18 let, pri katerih je bila imunska trombocitopenična purpura že zdravljena (vključno z nekaterimi bolniki, pri katerih je bila odstranjena vranica).
How does Nplate work?
Kako zdravilo Nplate deluje?
How is Nplate used?
Kako se zdravilo Nplate uporablja?
The active substance in Nplate, romiplostim, stimulates the production of platelets.
Učinkovina v zdravilu Nplate, romiplostim, spodbuja nastajanje trombocitov.
Platelet count rose above the threshold in 38% of patients who received Nplate (16 out of 42) compared with none of the 21 patients receiving placebo.
Število trombocitov se je zvišalo nad prag pri 38 % bolnikov, ki so prejemali zdravilo Nplate (16 od 42), v primerjavi z nobenim od 21 bolnikov, ki so prejemali placebo.
Patients with ITP have low platelet counts and are at risk of bleeding.
Bolniki z imunsko trombocitopenično purpuro imajo nizko število trombocitov in povečano tveganje za krvavitve.
The second study involved 62 patients whose ITP had been treated previously (but who did not have their spleen removed).
V drugo študijo je bilo vključenih 62 bolnikov, pri katerih so imunsko trombocitopenično purpuro predhodno zdravili (niso pa jim odstranili vranice).
Platelet count rose above the threshold in 61% of patients who received Nplate (25 out of 41) compared with 5% receiving placebo (1 out of 21).
Število trombocitov se je zvišalo nad prag pri 61 % (25 od 41) bolnikov, ki so prejemali zdravilo Nplate, v primerjavi s 5 % (1 od 21) bolnikov, ki so prejemali placebo.
Platelet count rose above the threshold in 52% of patients who received Nplate (22 out of 42) compared with 10% receiving placebo (2 out of
Število trombocitov se je zvišalo nad prag pri 52 % (22 od 42) bolnikov, ki so prejemali zdravilo Nplate, v primerjavi z 10 % (2 od 20) bolnikov, ki so prejemali placebo.
What measures are being taken to ensure the safe and effective use of Tegsedi?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Tegsedi?
The European Medicines Agency therefore decided that Tegsedi's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Tegsedi večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Why is Tegsedi authorised in the EU?
Zakaj je bilo zdravilo Tegsedi odobreno v EU?
The medicine is available as a solution for injection under the skin in pre-filled syringes (284 mg).
Zdravilo je na voljo kot raztopina za injiciranje pod kožo v napolnjenih injekcijskih brizgah (284 mg).
The first injection should be given under the supervision of a qualified healthcare professional, and patients or carers can give the subsequent injections after receiving appropriate training.
Prvo injekcijo je treba dati pod nadzorom usposobljenega zdravstvenega delavca, bolniki ali njihovi skrbniki pa lahko po opravljenem ustreznem usposabljanju injekcije dajejo sami.
What is Tegsedi and what is it used for?
Kaj je zdravilo Tegsedi in za kaj se uporablja?
Further information on Tegsedi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Nadaljnje informacije za zdravilo Tegsedi so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The recommended dose is one injection once a week, given under the skin in the belly, upper thigh or upper arm.
Priporočeni odmerek je ena injekcija enkrat tedensko, ki se daje pod kožo v trebuh, zgornji del stegen ali nadlaket.
This reduces production of transthyretin, thereby reducing the formation of amyloids and relieving the symptoms of hATTR amyloidosis.
Tako se zmanjša tvorba transtiretina, kar zmanjša nastajanje amiloidov in olajša simptome amiloidoze hATTR.
In light of the unmet medical need, the safety profile of Tegsedi was considered acceptable and the risks to be manageable with specific monitoring, dose reduction and stopping rules.
Ob upoštevanju neizpolnjene medicinske potrebe je bil varnostni profil zdravila Tegsedi ocenjen kot sprejemljiv, tveganja pa obvladljiva ob upoštevanju posebnih pravil za spremljanje, zmanjšanje odmerka in ukinitev zdravila.
Tegsedi is used in adult patients in the first two stages of the nerve damage (stage 1, when the patient is able to walk unaided, and stage 2, when the patient can still walk but needs help).
Zdravilo Tegsedi se uporablja pri odraslih bolnikih v prvih dveh stadijih poškodbe živcev (v 1. stadiju, v katerem bolnik lahko hodi brez pomoči, in 2. stadiju, v katerem bolnik še lahko hodi, vendar potrebuje pomoč).
The broken protein forms amyloid deposits in tissues and organs around the body, including around nerves, where it interferes with their normal functions.
Razgrajena beljakovina tvori amiloidne skupke v tkivih in organih po vsem telesu, tudi okoli živcev, kjer moti njihovo normalno delovanje.
The main measures of effectiveness were the changes in the patients' nerve damage and quality of life, as measured using standard scales called ‘mNIS+7' and ‘Norfolk QoL-DN' respectively.
Glavno merilo učinkovitosti so bile spremembe poškodbe živcev in kakovosti življenja bolnikov, izmerjene s standardnima lestvicama „mNIS+7“ oziroma „Norfolk QoLDN“.
As for all medicines, data on the use of Tegsedi are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Tegsedi stalno spremljajo.
What benefits of Tegsedi have been shown in studies?
Kakšne koristi zdravila Tegsedi so se pokazale v študijah?
An overview of Tegsedi and why it is authorised in the EU
Pregled zdravila Tegsedi in zakaj je odobreno v EU
Tegsedi must not be used by patients with low platelet counts (less than 100x109/l), and by patients with severe kidney or liver problems.
Zdravilo Tegsedi se ne sme uporabljati pri bolnikih z zmanjšanim številom trombocitov (pod 100 x 109/l) in pri bolnikih z resnimi težavami z ledvicami ali jetri.
Side effects reported with Tegsedi are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Tegsedi, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
The most common side effects with Tegsedi (which may affect more than 1 in 10 people) are reactions at the site of injection, nausea (feeling sick), low level of red blood cells, headache, fever, peripheral oedema (swelling, especially of the ankles and feet), chills, vomiting and low blood platelet counts which can lead to bleeding and bruising.
Najpogostejši neželeni učinki zdravila Tegsedi (ki se lahko pojavijo pri več kot 1 od 10 bolnikov) so reakcije na mestu injiciranja, navzea (siljenje na bruhanje), nizka vrednost rdečih krvnih celic, glavobol, povišana telesna temperatura, periferni edem (otekanje, zlasti gležnjev in stopal), mrzlica, bruhanje in zmanjšano število trombocitov v krvi, kar lahko privede do krvavitve in podplutb.
hATTR is rare, and Tegsedi was designated an ‘orphan medicine' (a medicine used in rare diseases) on 26 March 2014.
Bolezen hATTR je redka, zato je bilo zdravilo Tegsedi 26. marca 2014 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tegsedi have also been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Tegsedi upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
The active substance in Tegsedi, inotersen, is an ‘antisense oligonucleotide', a very short piece of synthetic genetic material that has been designed to attach to and block the genetic material of the cell responsible for producing transthyretin.
Učinkovina zdravila Tegsedi, inotersen, je „protismerni oligonukleotid“, tj. zelo kratek košček umetnega genetskega materiala, ki je bil zasnovan tako, da se pritrdi na genetski material celice, odgovorne za tvorbo transtiretina, in ga zavira.
For more information about using Tegsedi, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Tegsedi glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
The company that markets Tegsedi will provide an alert card for patients with information about the safety of the medicine and how to manage side effects.
Podjetje, ki trži zdravilo Tegsedi, bo priskrbelo opozorilno kartico za bolnike, kjer bodo navedene informacije o varnosti zdravila in obvladovanju neželenih učinkov.
After 15 months of treatment, the mNIS+7 score, used for assessing nerve damage, worsened by a lesser extent with Tegsedi (around 11 points) than with placebo (around 25 points).
Po 15 mesecih zdravljenja se je rezultat po lestvici mNIS+7, ki se uporablja za ocenjevanje poškodb živcev, pri zdravilu Tegsedi poslabšal v manjšem obsegu (za približno 11 točk) kot pri placebu (za približno 25 točk).
In patients with hATTR, a protein called transthyretin which circulates in the blood is defective and breaks easily.
Pri bolnikih s hATTR je beljakovina transtiretin v krvnem obtoku okvarjena in se hitro razgradi.
Tegsedi can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the treatment of patients with hATTR.
Predpisovanje in izdaja zdravila Tegsedi je le na recept, zdravljenje pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem bolnikov s hATTR.
How is Tegsedi used?
Kako se zdravilo Tegsedi uporablja?
Tegsedi is a medicine used to treat nerve damage caused by hereditary transthyretin amyloidosis (hATTR), a disease in which proteins called amyloids build up in tissues around the body including around the nerves.
Zdravilo Tegsedi se uporablja za zdravljenje poškodbe živcev, ki jo povzroča transtiretinska amiloidoza (hATTR), tj. bolezen, pri kateri se beljakovine, imenovane amiloidi, kopičijo v tkivih po telesu, tudi okoli živcev.
Tegsedi was shown to be effective in the treatment of stage 1 or stage 2 nerve damage in patients with hATTR; available data were not sufficient to assume a beneficial effect in stage 3 patients (those confined to a wheelchair).
Zdravilo Tegsedi se je izkazalo za učinkovito pri zdravljenju 1. ali 2. stadija poškodbe živcev pri bolnikih s hATTR; razpoložljivi podatki ne zadoščajo za izpeljavo predpostavke o koristih pri bolnikih v 3. stadiju (ki so na invalidskem vozičku).
What are the risks associated with Tegsedi?
Kakšna tveganja so povezana z zdravilom Tegsedi?
As Tegsedi can cause a reduction in the number of platelets in the blood (posing a risk of bleeding), blood platelet counts need to be monitored during treatment with Tegsedi, and the dose of the medicine and how often it is given adjusted accordingly.
Ker zdravilo Tegsedi lahko povzroči zmanjšanje števila trombocitov v krvi (kar pomeni tveganje za krvavitev), je treba med zdravljenjem z zdravilom Tegsedi spremljati število trombocitov v krvi ter skladno s tem prilagoditi odmerek in pogostnost dajanja zdravila.
Quality of life, measured by the Norfolk QoL-DN score, worsened by around 4 points in patients treated with Tegsedi, compared with around 13 points in those on placebo.
Kakovost življenja, merjena z lestvico Norfolk QoL-DN, se je pri bolnikih, zdravljenih z zdravilom Tegsedi, poslabšala za približno 4 točke, pri bolnikih, ki so prejemali placebo, pa za približno 13 točk.
In one main study involving 173 hATTR patients with stage 1 or 2 nerve damage, Tegsedi was shown to be more effective than placebo (a dummy treatment) at slowing down the nerve damage caused by the disease.
V eni glavni študiji, ki je vključevala 173 bolnikov s hATTR v 1. ali 2. stadiju poškodbe živcev, so dokazali, da je zdravilo Tegsedi pri upočasnitvi poškodbe živcev, ki jo povzroča bolezen, učinkovitejše od placeba (zdravila brez učinkovine).
How does Tegsedi work?
Kako zdravilo Tegsedi deluje?
For the full list of side effects of Tegsedi, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Tegsedi, glejte navodilo za uporabo.
Other information about Tegsedi
Druge informacije o zdravilu Tegsedi
However it is not clear whether these cases were due to the antiretroviral treatment or to the underlying HIV disease.
Vendar ni pojasnjeno, ali so bili ti primeri posledica protiretrovirusnega zdravljenja ali osnovne bolezni HIV.
Teva Finland Oy Finnland
Teva Finland Oy
Pancreatitis: Cases of pancreatitis have occurred rarely.
Pankreatitis: primeri pankreatitisa so bili redki.
Date of latest renewal: 11 September 2014
Datum prve odobritve: 10. december 2009 Datum zadnjega podaljšanja: 11. september 2014
Absorption differences have been observed between adult and paediatric populations (see “Special populations”).
Pri odraslih in pediatrični populaciji je bila opažena razlika v absorpciji (glejte »Posebne populacije«).
In vitro susceptibility testing has not been standardised and results may vary according to methodological factors.
Testiranje občutljivosti in vitro ni standardizirano in rezultati se lahko spreminjajo glede na metodološke dejavnike.
mannitol, lactitol or maltitol), if taken regularly.
manitol, laktitol, maltitol), če se jemljejo redno,
• serious allergic reaction causing swelling of the face, tongue or throat which may cause difficulty in swallowing or breathing
• resna alergijska reakcija, ki povzroči otekanje obraza, jezika in grla, kar lahko povzroči težave pri požiranju ali dihanju,
This is not considered to be of significance to patient safety and therefore no dosage adjustments are necessary.
Menijo, da to ne ogroža varnosti bolnikov, zato prilagajanje odmerkov ni potrebno.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including herbal medicines or other medicines you bought without a prescription.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, vključno z zdravili rastlinskega izvora ali drugimi zdravili, ki ste jih kupili brez recepta.
No studies on the effects on the ability to drive and use machines have been performed.
Študij o vplivu na sposobnost vožnje in uporabe strojev niso opravili.
Rare: Pancreatitis, elevations in serum amylase.
Redki: pankreatitis, povišanje vrednosti amilaz v serumu.
Manufacturer
Proizvajalci
CD4 cells are a type of white blood cells, that are important in helping your body to fight infection.
Celice CD4 so vrsta belih krvnih celic, ki opravljajo pomembno vlogo v boju z okužbo.
Children less than three months of age: The limited data available are insufficient to propose specific dosage recommendations (see section 5.2).
Otroci, mlajši od treh mesecev: Na voljo ni dovolj podatkov, da bi bilo mogoče priporočiti specifične odmerke (glejte poglavje 5.2).
These symptoms are probably caused by the body's immune system becoming stronger, so that the body starts to fight these infections.
Ti simptomi so verjetno posledica okrepitve imunskega sistema, s tem, da se organizem zopet prične boriti proti tem okužbam.
The results of long-term carcinogenicity studies in rats and mice did not show any carcinogenic potential relevant for humans.
V študijah karcinogenosti dolgoročne uporabe pri podganah in miših lamivudin ni pokazal nobenega karcinogenega potenciala, ki bi bil pomemben za ljudi.
If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.
Če opazite kakšne simptome okužbe ali druge simptome, npr. šibkost mišic, šibkost, ki se začne v dlaneh in stopalih in se širi navzgor proti trupu, razbijanje srca (palpitacije), tresenje ali čezmerno aktivnost, o tem takoj obvestite zdravnika, da boste deležni potrebnega zdravljenja.
Very rare: Pure red cell aplasia.
Zelo redki: čista aplazija rdečih krvnih celic.
• if you or your child has a kidney problem, your dose may be altered.
• če imate vi ali vaš otrok težave z ledvicami, se bo vaš odmerek morda spremenil.
When concomitant administration is warranted, patients should be monitored clinically.
Če je potrebna sočasna uporaba, je treba bolnike klinično nadzorovati.
If you notice any of these symptoms: Tell your doctor.
Če opazite katerega koli od teh simptomov: Posvetujte se z zdravnikom.
Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
Bolnikom je treba svetovati, naj poiščejo zdravniško pomoč, če imajo bolečine v sklepih, toge sklepe ali težave z gibljivostjo.
Tell your doctor or pharmacist if any of the side effects gets severe or troublesome, or if you notice any side effects not listed in this leaflet.
Obvestite zdravnika ali farmacevta, če kateri koli neželeni učinek postane resen ali moteč, ali če opazite kateri koli neželeni učinek, ki ni omenjen v tem navodilu.
However, for the treatment of HIV infection only a 300 mg daily dose of lamivudine (in combination with other antiretroviral agents) has been shown to be efficacious.
Vendar pa se je za zdravljenje okužb z virusom HIV izkazal za učinkovitega samo dnevni odmerek lamivudina 300 mg (v kombinaciji z drugimi protiretrovirusnimi zdravili).
The clinically relevant effects noted were a reduction in red blood cell count and neutropenia.
Klinično pomembna učinka, ki so ju opazili, sta bila zmanjšanje števila rdečih krvnih celic in nevtropenija.
The adverse reactions considered at least possibly related to the treatment are listed below by body system, organ class and absolute frequency.
Neželeni učinki, za katere vsaj obstaja možnost, da so povezani z zdravljenjem, so razvrščeni spodaj po organskih sistemih in absolutni pogostosti.
Very rare: Peripheral neuropathy (or paraesthesia).
Zelo redki: periferna nevropatija (ali parestezija).
Creatinine clearance (ml/min) First dose
očistek kreatinina (ml/min) prvi odmerek vzdrževalni odmerek
Lamivudine is well absorbed from the gastrointestinal tract, and the bioavailability of oral lamivudine in adults is normally between 80 and 85%.
Lamivudin se iz prebavil dobro absorbira, biološka uporabnost peroralno vnesenega lamivudina pri odraslih je običajno med 80 in 85 %.
There are limited pharmacokinetic data for patients less than three months of age.
Podatki o farmakokinetičnih lastnostih pri bolnikih, mlajših od treh mesecev, so omejeni.
The possibility of interactions with other medicinal products administered concurrently should be considered, particularly when the main route of elimination is active renal secretion via the organic cationic transport system e.g. trimethoprim.
Treba je upoštevati možnost interakcij z drugimi zdravili, ki se uporabljajo sočasno, še posebno, če je njihova glavna pot izločanja aktivna renalna sekrecija prek organskega kationskega transportnega sistema (npr. s trimetoprimom).
The therapy should be initiated by a physician experienced in the management of HIV infection.
Zdravljenje mora uvesti zdravnik, ki ima izkušnje z zdravljenjem okužb z virusom HIV.
Based on more than 200 mother/child pairs treated for HIV, serum concentrations of lamivudine in breastfed infants of mothers treated for HIV are very low (<4% of maternal serum concentrations) and progressively decrease to undetectable levels when breastfed infants reach 24 weeks of age.
Na podlagi podatkov pri več kot 200 parih mater in otrok, zdravljenih zaradi okužbe HIV, so koncentracije lamivudina v serumu dojenih otrok, mater, zdravljenih zaradi okužbe s HIV, zelo majhne (manj kot 4 % koncentracije v materinem serumu) in se progresivno zmanjšujejo do nezaznavne ravni, ko dojeni otroci dosežejo 24 tednov starosti.
If overdosage occurs the patient should be monitored, and standard supportive treatment applied as required.
V primeru prevelikega odmerjanja je treba bolnika nadzirati in po potrebi uvesti standardno podporno zdravljenje.
A modest increase in Cmax (28%) was observed for zidovudine when administered with lamivudine, however overall exposure (AUC) is not significantly altered.
Opazili so zmerno povečanje vrednosti Cmax (28-odstotno) zidovudina, če so ga uporabili sočasno z lamivudinom, vendar se celotna izpostavljenost (AUC) ni znatno spremenila.
There are no data available on the safety of lamivudine when administered to babies less than three months old.
Ni podatkov o varnosti lamivudina, kadar ga dajemo dojenčkom starih manj kot 3 mesece.
A rare side effect that may show up in blood tests is: • an increase in an enzyme called amylase.
Redek neželeni učinki, ki se lahko pokaže v preiskavah krvi, je: • povečanje encima imenovanega amilaza.
A very rare side effect that may show up in blood tests is: • a failure of the bone marrow to produce new red blood cells (pure red cell aplasia).
Zelo redek neželeni učinek, ki se lahko pokaže v preiskavah krvi, je: • nesposobnost kostnega mozga proizvajati nove rdeče krvne celice (čista aplazija rdečih krvnih celic).
If you are breast-feeding, or thinking about breast-feeding: Talk to your doctor immediately.
Če dojite ali razmišljate o dojenju: Takoj se posvetujte z zdravnikom.
An oral solution is also available for the treatment of children over 3 months of age, or for people who need a lower dose than usual, or who cannot take tablets.
Na voljo je tudi zdravilo v obliki peroralne raztopine za zdravljenje otrok, starejših od treh mesecev, in bolnikov, ki potrebujejo nižji odmerek, kot je običajno ali tablet ne morejo jemati.
Pregnancy: Following oral administration, lamivudine pharmacokinetics in late-pregnancy were similar to non-pregnant women.
Nosečnost: Farmakokinetika lamivudina po peroralnem vnosu je bila v pozni nosečnosti podobna kot pri ženskah, ki niso noseče.
• if you are allergic to lamivudine or any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na lamivudin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterium infections, and Pneumocystis jirovecii pneumonia (often referred to as PCP).
Ustrezni primeri so citomegalovirusni retinitis, generalizirane in/ali žariščne okužbe z mikobakterijami in pljučnica s povzročiteljem Pneumocystis jirovecii (pogosto omenjena kot PCP).
This does not require dose adjustment unless the patient also has renal impairment (see sections 4.5 and 4.2).
Odmerka zaradi tega ni treba prilagoditi, razen če ima bolnik tudi okvaro ledvic (glejte poglavji 4.5 in 4.2).
Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Take reakcije so ponavadi opazili v prvih nekaj tednih ali mesecih po uvedbi kombiniranega protiretrovirusnega zdravljenja.
20 film-coated tablets 30 film-coated tablets 60 film-coated tablets 80 film-coated tablets 90 film-coated tablets 100 film-coated tablets 500 film-coated tablets
20 filmsko obloženih tablet 30 filmsko obloženih tablet 60 filmsko obloženih tablet 80 filmsko obloženih tablet 90 filmsko obloženih tablet 100 filmsko obloženih tablet 500 filmsko obloženih tablet