natgillin/translations-raw huggingface dataset:
The tolerability of the ring after 28 days is also not expected to raise concerns given that the test and reference medicinal products have a similar polymer, active amounts and ring dimensions.
Prav tako ni pričakovati pomislekov o prenašanju obročka po 28 dneh, saj so polimer, količine učinkovin in mere obročka pri testnem in referenčnem zdravilu podobni.
The recommended period of use of this product is 21 days; however, according to the summary of product characteristics (SmPC) of the reference medicinal product, even though not the recommended regimen, the contraceptive efficacy of the reference product is maintained for up to 28 days.
Priporočeni čas uporabe tega zdravila je 21 dni, vendar se skladno s povzetkom glavnih značilnosti zdravila referenčnega zdravila kontracepcijska učinkovitost referenčnega zdravila ohrani do 28 dni, čeprav to ni priporočena shema.
To address the issue of extended use up to 28 days, which is included in the SmPC of NuvaRing as a deviation to the recommended use, the applicant has additionally conducted IVIVC modelling to demonstrate that the behaviour of the ring does not change between 21 and 28 days, based on data from the test product for 21 days and from published data on reference product for 28 days.
Da bi obravnavali vidik podaljšanja uporabe do 28. dne, vključen v povzetek glavnih značilnosti zdravila NuvaRing kot odmik od priporočene uporabe, je predlagatelj dodatno opravil modeliranje IVIVC, da bi na podlagi podatkov o testnem zdravilu za 21 dni in objavljenih podatkov o referenčnem zdravilu za 28 dni dokazal, da se obnašanje obročka med 21. in 28. dnem ne spremeni.
• The Committee was of the view that the totality of data submitted justified the maintenance of the contraceptive efficacy up to 28 days for Perlinring, in line with the reference medicinal product NuvaRing.
• odbor je presodil, da predloženi podatki kot celota utemeljujejo ohranitev kontracepcijske učinkovitosti obročka do 28 dni za zdravilo Perlinring, skladno z referenčnim zdravilom NuvaRing odbor zato ocenjuje, da je razmerje med tveganji in koristmi zdravila Perlinring in povezanih imen ugodno, in priporoča izdajo dovoljenja (dovoljenj) za promet z zdravili, navedenimi v Prilogi I k mnenju odbora CHMP.
The etonogestrel/ethinylestradiol combined contraceptive vaginal ring provides continuous delivery of contraceptive steroids through the vagina, avoiding the need for daily drug administration.
Vaginalni kontracepcijski obroček, ki vsebuje kombinacijo etonogestrela in etinilestradiola, stalno dovaja kontracepcijske steroide skozi vagino, zato zdravila ni treba dajati vsak dan. Etonogestrel (ENG) je iz 19-nortestosterona pridobljeni progestagen, ki se z veliko afiniteto veže na progesteronske receptorje v ciljnih organih.
Manual stress (in-process control) and tensile strength (finished product specification) are performed on the ring during manufacture and the ring is not expected to lose its integrity after 3 weeks of use.
Med proizvodnjo se na obročku opravita ročna obremenitev (procesna kontrola) in preizkus napetostne moči (specifikacija končnega izdelka).
Elderly patients (> 65 years of age)
Starejši bolniki (> 65 let)
48 tablets
48 tablet
It shall address the following key elements:
Vsebovati mora naslednje ključne elemente:
Date of first authorisation: 28 April 2014 Date of latest renewal: 2 April 2019
Datum prve odobritve: 28. april 2014 Datum zadnjega podaljšanja: 2. april 2019
• Increased need to urinate at night
• povečana potreba po uriniranju ponoči
Short title: OTSUKA
Kratek naziv: OTSUKA
It is important to tell your doctor if you are pregnant, think you may be pregnant, or are planning to get pregnant.
Pomembno je, da zdravnika nemudoma obvestite, če ste noseči, ali menite, da bi lahko bili noseči, ali če načrtujete zanositev.
• you have HIV.
• če imate HIV
If you forget a dose, take it as soon as you remember it.
Če ste pozabili vzeti odmerek, ga vzemite takoj, ko se spomnite.
You may be more at risk for dangerous changes of the heart rhythm.
Morda je pri vas tveganje za nevarne spremembe srčnega ritma večje.
Elderly patients (≥ 65 years) No patients of ≥ 65 years of age were included in clinical trials.
Starejši bolniki (≥ 65 let) Bolniki ≥ 65 let v klinična preskušanja niso bili vključeni.
Your doctor may also perform a blood test to check the concentration of some minerals and proteins which are important for the function of your heart.
Vaš zdravnik lahko opravi tudi krvne preiskave, da ugotovi koncentracijo nekaterih mineralov in beljakovin, ki so pomembni za delovanje srca.
This prolongation increases slowly over time in the first 6-10 weeks of treatment and remains stable therafter.
To podaljšanje se sčasoma počasi povečuje prvih 6-10 tednov zdravljenja, nato pa se stabilizira.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Upoštevati je treba uradna navodila glede ustrezne uporabe protibakterijskih zdravil.
• Intense lack of energy
• močno pomanjkanje energije
No data are available in the elderly.
Podatkov za starejše ni na voljo.
The finding was shown to be partially reversible; the clinical relevance of this finding is unknown.
Pokazalo se je, da je izsledek delno reverzibilen, klinični pomen tega izsledka ni znan.
- if you have very low levels of albumin, in the blood.
- če imate zelo nizke ravni albumina v krvi
General recommendations
Splošna priporočila
The recommended dose is two 50 mg tablets taken twice a day (morning and evening) as advised by your doctor.
Priporočeni odmerek je dve tableti 50 mg, ki se vzameta dvakrat na dan (zjutraj in zvečer), kot vam je svetoval vaš zdravnik.
However, patients should be advised not to drive or use machines if they experience any adverse reaction with a potential impact on the ability to perform these activities (e.g. headache and tremor are very common).
Vendar pa je treba bolnikom svetovati, naj ne vozijo in ne uporabljajo strojev, če doživijo neželene učinke, ki lahko vplivajo na njihovo sposobnost izvajanja teh dejavnosti (zelo pogosta sta npr. glavobol in tremor).
Elimination Delamanid disappears from plasma with a t1/2 of 30-38 hours.
Delamanid iz plazme izgine z razpolovnim časom t1/2 30-38 ur.
The safety and efficacy of delamanid in children and adolescents below 18 years has not yet been established.
Varnost in učinkovitost delamanida pri otrocih in mladostnikih starih do 18 let nista bili dokazani.
The tablets should be taken during or just after a meal.
Tablete morate vzeti med obrokom ali takoj zatem.
If you experience side effects that might affect your ability to concentrate and react, do not drive or use machines.
Če doživite neželene učinke, ki bi lahko vplivali na vašo sposobnost koncentracije in reagiranja, ne vozite in ne upravljajte strojev.
Data from clinical studies
Podatki iz kliničnih študij
It is not usually recommended for use during pregnancy.
Zdravilo se običajno ne priporoča med nosečnostjo.
Delamanid has a large apparent volume of distribution (Vz/F of 2,100 L).
Delamanid ima velik navidezni volumen porazdelitve (Vz/F 2.100 L).
• Increased sweating
• povečano znojenje
Do not use this medicine after the expiry date which is stated on the carton or blister after “EXP:”.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli ali pretisnem omotu poleg oznake "EXP:".
- if you are allergic to delamanid or any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na delamanid ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
carbamazepine).
karbamazepin).
Frequent ECG monitoring should be performed.
EKG je treba pogosto spremljati.
These four patients were only receiving two other medicinal products in addition to delamanid.
Ti štirje bolniki so razen delamanida prejemali le še dve drugi zdravili.
Before you start taking Deltyba, and during the treatment, your doctor may check your heart's electrical activity using an ECG (electrocardiogram) machine (electrical recording of the heart).
Preden začnete jemati zdravilo Deltyba in med zdravljenjem bo morda zdravnik preveril električno aktivnost vašega srca z elektrokardiogramom (EKG) (beleženje električne aktivnosti srca).
DO NOT stop taking the tablets unless your doctor tells you to.
NE prenehajte jemati zdravila, razen če vam je zdravnik tako naročil.
The PRAC requests a cumulative review of this risk in next PSUR, using appropriate PT terms, in order to assess whether an update of the risk is needed.
Odbor PRAC zahteva kumulativni pregled tega tveganja v naslednjem poročilu PSUR z uporabo ustreznih prednostnih izrazov za oceno potrebe po posodobitvi navedb o tem tveganju.
• Increase of libido
• povečan libido
Delamanid highly binds to all plasma proteins with a binding to total proteins of ≥99.5%.
Delamanid se močno veže na vse beljakovine v plazmi s skupno vezavo na beljakovine ≥ 99,5 %.
Hereford, HR3 5PG United Kingdom
Hereford, HR3 5PG Velika Britanija
Deltyba may cause harm to an unborn baby.
Zdravilo Deltyba lahko škodi nerojenemu otroku.
• Changes found in investigations (electrocardiogram, ECG) of the heart
• spremembe, ugotovljene pri preiskavah srca (elektrokardiogram, EKG)
The Educational material for Healthcare Providers (HCPs) shall address the following key elements:
Izobraževalno gradivo za zdravstvene delavce mora vsebovati naslednje ključne elemente:
Deltyba is not suitable for children under age 18.
Zdravilo Deltyba ni primerno za otroke, stare manj kot 18 let.
Treatment with delamanid should not be initiated in patients with the following risk factors unless the possible benefit of delamanid is considerd to outweigh the potential risks.
Zdravljenja z delamanidom se ne sme uvesti pri bolnikih z naslednjimi dejavniki tveganja, razen če so možne koristi delamanida ocenjene kot večje od možnih tveganj.
Liver disorders is categorised as an important potential risk.
Tveganje bolezni jeter je sedaj razvrščeno med pomembna možna tveganja.
• Itchy or red skin including around the hair roots.
• srbeča ali rdeča koža, vključno z lasnimi koreninami
Delamanid is not excreted in urine.
Delamanid se ne izloča v urin.
Delamanid and/or its metabolites have the potential to affect cardiac repolarisation via blockade of hERG potassium channels.
Delamanid in/ali njegovi presnovki lahko vplivajo na repolarizacijo srca z blokiranjem hERG kalijevih kanalov.
Delamanid does not show cross-resistance with any of the currently used anti-tuberculosis drugs.
Delamanid ne kaže navzkrižne odpornosti z nobenim od zdravil proti tuberkulozi, ki se trenutno uporabljajo.
• Feeling of emotional and mental discomfort
• občutek čustvenega in duševnega nelagodja
Resistance to delamanid
Odpornost na delamanid
Your doctor will weigh up the benefits to you against the risks to your baby of taking Deltyba whilst you are pregnant.
Vaš zdravnik bo ocenil prednosti za vas glede na tveganja za otroka, povezane z jemanjem zdravila Deltyba, če ste noseči.
There are no data on treatment with delamanid for more than 24 consecutive weeks.
Podatkov o zdravljenju z delamanidom, ki traja dlje kot 24 zaporednih tednov, ni.
However, since the concentrations in the gut can potentially be much greater than these multiples of the Cmax, there is a potential for delamanid to have an effect on these transporters.
Ker pa je lahko koncentracija v črevesju veliko večja kot ti večkratniki Cmax, lahko delamanid vpliva na te prenašalce.
If a QTcF >500 ms is observed either before the first dose of delamanid or during delamanid treatment, treatment with delamanid should either not be started or should be discontinued.
Če se pred prvim odmerkom delamanid ali med zdravljenjem z delamanidom opazi QTcF > 500 ms, zdravljenja z delamanidom ni dovoljeno začeti ali ga je treba prekiniti.
In lactating rats, the Cmax for delamanid in breast milk was 4-fold higher than that of the blood.
Pri podganah v laktaciji je bila Cmax za delamanid v mleku 4-krat višja kot v krvi.
Albeit, some reactions were observed at a higher frequency and the rate of QT prolongation increased in a dose-related manner.
Vendar pa so nekatere reakcije opazili z večjo pogostnostjo, stopnja povečanja podaljšanja intervala QT pa se je povečala v odvisnosti od odmerka.
Stopping too early could allow the bacteria to recover and to become resistant to delamanid.
Predčasno prenehanje jemanja bi bakteriji omogočilo, da okreva, in postane odporna za delamanid.
• you have been told that you have heart problems, for example a slow heart rhythm (bradycardia) or have a history of heart attack (myocardial infarction)
• povedali so vam, da imate težave s srcem, na primer počasen srčni ritem (bradikardijo) ali imate srčni napad (miokardni infarkt) v anamnezi
Delamanid plasma exposure increases less than proportionally with increasing dose.
Izpostavljenost delamanida v plazmi se zvišuje manj kot sorazmerno z večanjem odmerkom.
- Electrolyte disturbances, particularly hypokalaemia, hypocalcaemia or hypomagnesaemia.
- Motnje elektrolitov, zlasti hipokaliemija, hipokalciemija ali hipomagneziemija.
Therefore the potential for drug-drug interactions of clinical significance to occur with delamanid and the possible consequences, including the total effect on the QTc interval, cannot be predicted with confidence.
Zato možnosti klinično pomembnega delovanja med zdravili, ki bi se lahko pojavilo z delamanidom, in njegovih posledic, vključno s skupnim učinkom na interval QTc, ni mogoče z gotovostjo predvideti.
Two sensitivity analyses were conducted - a last-observation-carried-forward (LOCF) analysis and an analysis using “bookending” methodology (which required that the previous and subsequent cultures were both observed negative cultures to impute a negative result, otherwise a positive result was imputed).
Izvedeni sta bili dve analizi občutljivosti - analiza zadnjega opazovanja (LOCF, last-observation-carried-forward) in analiza z metodo »knjiženja« (angl. bookending, po kateri sta morali biti za pripis negativnega rezultata prejšnja in naslednja kultura negativni, sicer je rezultat veljal za pozitivnega).
Concentrations of the identified metabolites progressively increase to steady state after 6 to 10 weeks.
Koncentracije opredeljenih presnovkov se postopoma večajo do stanja dinamičnega ravnovesja po 6 do 10 tednih.
In-vitro studies showed that delamanid and metabolites did not have any effect on the transporters MDR1(pgp), BCRP, OATP1, OATP3, OCT1, OCT2, OATP1B1, OATP1B3 and BSEP, at concentrations of approximately 5 to 20 fold greater than the Cmax at steady state.
V študijah in-vitro so opazili, da delamanid in presnovki niso vplivali na prenašalce MDR1 (p-gp), BCRP, OATP1, OATP3, OCT1, OCT2, OATP1B1, OATP1B3 in BSEP, pri koncentracijah, približno 5- do 20-krat višjih kot Cmax v stanju dinamičnega ravnovesja.
• Regional pain
• regionalna bolečina
Less than 5% of an oral dose of delamanid is recovered from urine.
Manj kot 5 % peroralnega odmerka je najti v urinu.
- if you are taking medicines that strongly induce a certain liver enzyme called “CYP450 3A4” (e.g.
- če jemljete zdravila, ki močno inducirajo določen jetrni encim, imenovan »CYP450 3A4« (npr.
On the basis of the scientific conclusions for delamanid the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing delamanid is unchanged subject to the proposed changes to the product information.
Na podlagi znanstvenih zaključkov za delamanid odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) delamanid nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
Mild renal impairment (50 mL/min < CrCLN < 80 mL/min) does not appear to affect delamanid exposure.
Kaže, da blaga ledvična okvara (50 ml/min < CrCLN < 80 ml/min) ne vpliva na izpostavljenost delamanidu.
It is recommended that electrocardiograms (ECG) should be obtained before initiation of treatment and monthly during the full course of treatment with delamanid.
Priporoča se, da se elektrokardiogram (EKG) opravi pred začetkom zdravljenja in nato vsak mesec ves čas zdravljenja delamanidom.
In-vitro studies showed that delamanid did not inhibit CYP450 isozymes.
V študijah in-vitro so opazili, da delamanid ne zavira izoencima CYP450.
The identified metabolites do not show anti-mycobacterial activity but some contribute to QTc prolongation, mainly DM6705.
Opredeljeni presnovki ne kažejo aktivnosti proti mikobakterijam, vendar pa nekateri prispevajo k podaljšanju intervala QTc, pretežno DM-6705.
If the QTc interval duration exceeds 450/470 ms for male/female patients during delamanid treatment, these patients should be administered more frequent ECG monitoring.
Če trajanje intervala QTc med zdravljenjem z delamanidom preseže 450/470 ms za moške/ženske bolnike, je treba te bolnike pogosteje spremljati s pomočjo EKG-ja.
• if you have a condition called congenital long QT syndrome or have a serious heart disease or problems with heart rhythm.
• če imate stanje, imenovano sindrom prirojenega podaljšanega intervala QT ali resno bolezen srca ali težave s srčnim ritmom
• Drug use during pregnancy
• uporaba zdravila med nosečnostjo
Aluminium/Aluminium blister: 48 tablets.
Pretisni omot aluminij/aluminij: 48 tablet
It is recommended that delamanid is administered by directly observed therapy (DOT).
Priporoča se, da se delamanid daje kot neposredno nadzorovano zdravljenje (DOT, directly observed therapy).
Frequency very common
Pogostnost zelo pogosti
• Allergic conjunctivitis
• alergijski konjunktivitis
• Adjustment disorder with depressed mood
• motnje prilagajanja z depresivnim razpoloženjem
• Nerve damage causing numbness or pain (burning) or tingling feeling in hands or feet
• okvara živcev, ki povzroči odrevenelost ali bolečino (žarenje) ali mravljinčenje v rokah in nogah
Both showed a 13-day shorter median time to SCC in the delamanid + OBR group (p=0.0281 for LOCF and p=0.0052 for “bookending”).
Obe sta pokazali 13 dni krajši mediani čas do SCC v skupini delamanid + OBR (p = 0,0281 za LOCF in p = 0,0052 za »knjiženje«).
However, if it is nearly time for the next dose, just skip the missed dose.
Če je že skoraj čas za naslednji odmerek, preskočite odmerek, ki ste ga pozabili vzeti.
Delamanid resistance emerged in 4 of 341 patients (1.2%) randomised to receive delamanid for 6 months in Trial 213.
Odpornost na delamanid se je pojavila pri 4 od 341 bolnikih (1,2 %), randomiziranih za 6-mesečno prejemanje delamanida v preskušanju 213.
All missing cultures up to the time of SCC were assumed to be positive cultures in the primary analysis.
V primarni analizi velja, da so vse manjkajoče kulture do časa izvedbe SCC pozitivne.
The educational material for Patients to be provided via the HCPs to reinforce and supplement the information provided in the patient information leaflet.
Izobraževalno gradivo za bolnike bodo razdeljevali zdravstveni delavci z namenom okrepitve in dopolnitve informacij, ki so na voljo v navodilu za uporabo.
* The frequency for these events was lower for the combined delamanid plus OBR group in comparison to the placebo plus OBR group.
* Pogostnost teh dogodkov je bila nižja pri skupini s kombinacijo delamanida in OBR v primerjavi s skupino s placebom in OBR.
• Abnormal values for blood investigations related to coagulation (prolonged APPT)
• nenormalne vrednosti krvnih preiskav glede koagulacije (podaljšan APPT)
The frequency of the side effects listed below is defined using the following definitions: Very common: may affect more than 1 in 10 people Common: may affect up to 1 in 10 people
Pogostnost spodaj naštetih možnih neželenih učinkov je opredeljena po naslednjem dogovoru: zelo pogosti: pojavijo se pri več kot 1 od 10 bolnikov pogosti: pojavijo se pri največ 1 od 10 bolnikov občasni: pojavijo se pri največ 1 od 100 bolnikov
The MAH shall ensure that all healthcare professionals involved in the prescribing, dispensing, handling or administration of Deltyba are provided with educational material.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo vsi zdravstveni delavci, ki zdravilo Deltyba predpisujejo, izdajajo, z njim rokujejo ali ga dajejo, seznanjeni z izobraževalnim gradivom.
• Abnormal blood values related to the function of the liver, biliary system or pancreas
• nenormalne vrednosti v krvi, povezane z delovanjem jeter, žolčnega sistema ali trebušne slinavke
• Increase in immature red blood cells
• zvišanje nezrelih rdečih krvnih celic
• Panic attacks
• napadi panike
QTc prolongation is very closely correlated with the major delamanid metabolite DM-6705.
Podaljšanje intervala QTc zelo tesno korelira z glavnim presnovkom delamanida, DM-6705.
Within each System Organ Class, adverse reactions are listed under frequency categories of very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
(≥1/10), pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki, <1/10.000, neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
What Deltyba is and what it is used for
Kaj je zdravilo Deltyba in za kaj ga uporabljamo
- Any predisposing cardiac conditions for arrhythmia such as severe hypertension, left ventricular hypertrophy (including hypertrophic cardiomyopathy) or congestive cardiac failure accompanied by reduced left ventricle ejection fraction.
- Vsakršna bolezen srca, ki poveča nagnjenost k aritmijam, kot je huda hipertenzija, hipertrofija levega prekata (vključno s hipertrofično kardiomiopatijo) ali kongestivna srčna odpoved, ki jo spremlja zmanjšan iztisni delež levega prekata.
In each Member State, the Marketing Authorisation Holder (MAH) shall agree the content and format of the educational material with the national competent authority and implement it prior to launch.
Imetnik dovoljenja za promet z zdravilom se mora v vsaki državi članici s pristojnim nacionalnim organom dogovoriti glede vsebine in oblike izobraževalnega gradiva in ga uvesti pred prihodom na trg.
However, additional clinical data showed that in patients receiving 200 mg twice daily, i.e. total 400 mg delamanid per day, the overall safety profile is comparable to that in patients receiving the recommended dose of 100 mg twice daily.
Vendar pa so dodatni klinični podatki pokazali, da je bil pri bolnikih, ki so prejemali 200 mg dvakrat na dan, tj. 400 mg delamanida na dan, splošni profil varnosti primerljiv s tistim pri bolnikih, ki so prejeli priporočeni odmerek
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Bolniki z redkimi dednimi težavami neprenašanja galaktoze, laponsko obliko zmanjšane aktivnosti laktaze ali slabo absorpcijo glukoze-galaktoze ne smejo jemati tega zdravila.
Effects of Deltyba on other medicinal products
Učinki zdravila Deltyba na druga zdravila
Delamanid given in combination with the anti-HIV-medicines, tenofovir disoproxil, lopinavir/ritonavir and efavirenz, did not affect the exposure to these medicinal products.
Delamanid v kombinaciji z zdravili proti HIV-u, tj. tenofovir dizoproksilom, lopinavirom/ritonavirom in efavirenzom, ni vplival na izpostavljenost tem zdravilom.
The time to SCC for the group randomised to 100 mg BID was also found to be faster than for the group randomised to receive placebo + OBR (p=0.0056).
Čas do SCC v skupini, ki je bila randomizirana za prejemanje 100 mg BID, je bil prav tako krajši kot pri skupini, ki je bila randomizirana za prejemanje placeba + OBR (p = 0,0056).
• Painful urination
• boleče uriniranje
Contents of the pack and other information What Deltyba contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Deltyba
No studies have been performed in paediatric patients.
Pediatrična populacija Študij pri pediatričnih bolnikih niso opravili.
Posology The recommended dose for adults is 100 mg twice daily for 24 weeks.
Odmerjanje Priporočeni odmerek za odrasle je 100 mg dvakrat na dan, ki se jemlje 24 tednov.
• Shaking (tremor)
• tresenje (tremor)
There are very limited data from the use of delamanid in pregnant women.
Podatki o uporabi delamanida pri nosečnicah so zelo omejeni.