natgillin/translations-raw huggingface dataset:
After evaluating data from studies and post-marketing data from outside the EU, the CHMP was of the view that there was adequate evidence that Seasonique is an effective contraceptive.
Po oceni podatkov iz študij in podatkov, pridobljenih v obdobju trženja zdravila zunaj EU, je CHMP menil, da so na voljo ustrezni dokazi, da je zdravilo Seasonique učinkovit kontraceptiv.
It is available as blister packs containing 91 tablets to be taken once a day in the order shown on the pack.
Na voljo je v pretisnih omotih, ki vsebujejo 91 tablet, ki jih je treba vzeti enkrat dnevno v vrstnem redu, prikazanem na omotu.
Because the treatment cycle of 91 days is longer than that of most other combined contraceptives (which is normally 28 days), Seasonique is known as an extended cycle oral contraceptive.
Ker je cikel jemanja, ki traja 91 dni, daljši kot pri večini drugih kombiniranih kontraceptivih (običajno traja 28 dni), se zdravilo Seasonique uvršča med peroralne kontraceptive s podaljšanim ciklom.
For 84 days the woman takes the tablets containing levonorgestrel and ethinylestradiol and then for the remaining 7 days she takes tablets containing only ethinylestradiol.
Ženska 84 dni jemlje tablete, ki vsebujejo levonorgestrel in etinilestradiol, preostalih 7 dni pa tablete, ki vsebujejo le etinilestradiol.
However, the Member States were not able to reach an agreement and the French medicines agency referred the matter to the CHMP for arbitration on 3 February 2014.
članice niso uspele doseči soglasja, zato je francoska agencija za zdravila dne 3. februarja 2014 zadevo napotila na CHMP v arbitražo.
The Committee therefore concluded that the benefits of Seasonique outweigh its risks and recommended that marketing authorisation be granted in the reference and concerned Member States.
Odbor je zato zaključil, da so koristi zdravila Seasonique večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet v referenčni in zadevnih državah članicah.
Seasonique is an oral contraceptive for women.
Zdravilo Seasonique je peroralni kontraceptiv za ženske.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Seasonique outweigh its risks and that marketing authorisation should be granted in France and in the following EU Member States: Austria, Belgium, Germany, Italy, Poland, Romania, Slovakia and Slovenia.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Seasonique večje od z njim povezanih tveganj ter da bi bilo treba zanj odobriti dovoljenje za promet v Franciji in v naslednjih državah članicah EU: Avstriji, Belgiji, Nemčiji, Italiji, na Poljskem, v Romuniji, na Slovaškem in v Sloveniji.
Teva Pharma submitted an application to the French medicines agency (ANSM) for Seasonique to be authorised in a decentralised procedure.
Družba Teva Pharma je francoski agenciji za zdravila (ANSM) predložila vlogo za odobritev zdravila Seasonique po decentraliziranem postopku.
Women taking Seasonique will have longer intervals between withdrawal bleeding but may experience more irregular bleeding.
Ženske, ki jemljejo Seasonique, bodo imele daljše intervale med prekinitvenimi krvavitvami, vendar pa lahko pri njih pride do več nerednih krvavitev.
Levonorgestrel (a progestogen) and ethinylestradiol (an oestrogen) are both hormones and Seasonique is what is known as a ‘combined hormonal contraceptive'.
Tako levonorgestrel (progestogen) kot etinilestradiol (estrogen) sta hormona, zdravilo Seasonique pa je „kombiniran hormonski kontraceptiv“.
Combined hormonal contraceptives work by stopping the release of eggs from the ovaries and by causing changes in the cervix and the lining of the womb that make it harder for a sperm to reach an egg and for a fertilised egg to implant in the womb.
Kombinirani hormonski kontraceptivi delujejo tako, da ustavijo sproščanje jajčec iz jajčnikov ter povzročijo spremembe materničnega vratu in maternične sluznice, ki spermijem otežijo dostop do jajčeca, oplojenemu jajčecu pa otežijo ugnezditev v maternico.
What is Seasonique?
Kaj je zdravilo Seasonique?
The grounds for the referral related to concerns raised by the German medicines agency about the effectiveness of Seasonique in preventing pregnancy and the irregular bleeding experienced by women taking the contraceptive.
Razlogi za napotitev so bili pomisleki nemške agencije za zdravila o učinkovitosti zdravila Seasonique pri preprečevanju nosečnosti in o nerednih krvavitvah pri ženskah, ki so ga jemale.
The Committee also noted that the irregular bleeding reported with Seasonique has not made women less likely to keep to their treatment and adequate information about the risk of irregular bleeding is included in the package leaflet.
Odbor je prav tako ugotovil, da se ženske zaradi nerednih krvavitev, o katerih so poročale pri zdravilu Seasonique, niso pogosteje odločale za prekinitev jemanja in da so ustrezne informacije o tveganju za neredne krvavitve vključene v navodilo za uporabo.
Treatment should be started and monitored by a doctor who has experience in the management of chronic hepatitis C.
mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem kroničnega hepatitisa C.
The dose and duration of treatment is based on the patient's body weight and on the medicine used in combination with it.
Odmerek in trajanje zdravljenja sta odvisna od bolnikove telesne mase in zdravila, ki je uporabljeno v kombinaciji z njim.
Ribavirin Teva Pharma B.V. is used in patients who have not been treated before for all types of hepatitis C except for genotype 1, as long as the liver is still working normally and hepatitis C virus can be found in the blood.
Uporablja se pri bolnikih, ki se pred tem še niso zdravili zaradi katere koli vrste virusa hepatitisa C, razen genotipa 1, dokler jetra še delujejo normalno in je virus hepatitisa C prisoten v krvi.
Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Rebetol and do not need to be repeated for Ribavirin Teva Pharma B.V.
Študije o koristih in tveganjih zdravilne učinkovine pri dovoljenih načinih uporabe so že bile izvedene z referenčnim zdravilom Rebetol, zato jih ni treba ponoviti za zdravilo Ribavirin Teva Pharma B.V.
Ribavirin Teva Pharma B.V. must never be used on its own but only together with interferon alfa 2b (another medicine used in hepatitis).
se ne sme nikoli uporabljati samostojno, ampak samo v kombinaciji z interferonom alfa 2b (drugim zdravilom za zdravljenje hepatitisa).
Ribavirin Teva Pharma B.V. is taken with food each day in two divided doses (morning and evening).
se jemlje s hrano vsak dan v dveh deljenih odmerkih (zjutraj in zvečer).
Therefore, the CHMP's view was that, as for Rebetol, the benefits outweigh the identified risks.
Zato je menil, da njegove koristi enako kot pri zdravilu Rebetol odtehtajo znana tveganja.
The full EPAR for Ribavirin Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Ribavirin Teva Pharma B.V. is a medicine used to treat long-term hepatitis C (a disease of the liver due to infection with the hepatitis C virus) in patients aged three years and older.
je zdravilo za zdravljenje dolgotrajnega hepatitisa C (bolezni jeter, ki nastane zaradi okužbe z virusom hepatitisa C) pri bolnikih, starejših od treh let.
This means that Ribavirin Teva Pharma B.V. contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Rebetol.
To pomeni, da vsebuje enako zdravilno učinkovino in ima enak način delovanja kot „referenčno zdravilo“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilo Rebetol.
Ribavirin Teva Pharma B.V. can also be used in adults (aged 18 years and older) whose disease has come back after previous treatment.
se lahko uporablja tudi pri odraslih (starejših od 18 let), pri katerih se je bolezen po predhodnem zdravljenju ponovila.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Ribavirin Teva Pharma B.V. has been shown to have comparable quality and to be bioequivalent to Rebetol.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Ribavirin Teva Pharma B.V.
The European Commission granted a marketing authorisation valid throughout the EU for Ribavirin Teva Pharma B.V. on 1 July 2009.
Evropska komisija je dovoljenje za promet z zdravilom Ribavirin Teva Pharma B.V., veljavno po vsej Evropski uniji, izdala 1. julija 2009.
Because Ribavirin Teva Pharma B.V. is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
The dose may need to be adjusted for patients who experience side effects.
Pri bolnikih, pri katerih se pojavijo neželeni učinki, bo morda treba odmerek prilagoditi.
What measures are being taken to ensure the safe and effective use of Ribavirin Teva Pharma B.V.?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ribavirin Teva Pharma B.V.
This is a summary of the European public assessment report (EPAR) for Ribavirin Teva Pharma B.V.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ribavirin Teva Pharma B.V.
The active substance in Ribavirin Teva Pharma B.V., ribavirin, is an antiviral belonging to the class ‘nucleoside analogues'.
Zdravilna učinkovina zdravila Ribavirin Teva Pharma B.V., ribavirin, je protivirusna učinkovina, ki spada v razred nukleozidnih analogov.
Ribavirin Teva Pharma B.V. available as tablets (200 and 400 mg).
Na voljo je v obliki tablet (200 in 400 mg).
As for every medicine, the company provided studies on the quality of Ribavirin Teva Pharma B.V.
Kot to velja za vsako zdravilo, je družba zagotovila študije o kakovosti zdravila Ribavirin Teva Pharma B.V.
Ribavirin Teva Pharma B.V. on its own has no effect on eliminating the hepatitis C virus from the body.
kot samostojno zdravilo nima nikakršnega učinka na odstranitev virusa hepatitisa C iz telesa.
What are the benefits and risks of Ribavirin Teva Pharma B.V.?
Kakšne so koristi in tveganja, povezani z zdravilom Ribavirin Teva Pharma B.V.
For more information about treatment with Ribavirin Teva Pharma B.V., read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Ribavirin Teva Pharma B.V.is thought to interfere with the production or action of viral DNA and RNA, which are needed for viruses to survive and multiply.
naj bi vplivalo na nastajanje ali delovanje virusnih DNK in RNK, brez katerih virusi ne morejo preživeti ali se razmnoževati.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ribavirin Teva Pharma B.V. have 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 Ribavirin Teva Pharma B.V.
For practical information about using Ribavirin Teva Pharma B.V., patients should read the package leaflet or contact their doctor or pharmacist.
naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Other information about Ribavirin Teva Pharma B.V.
Druge informacije o zdravilu Ribavirin Teva Pharma B.V.
It is not intended to provide practical advice on how to use Ribavirin Teva Pharma B.V.
Za praktične informacije o uporabi zdravila Ribavirin Teva Pharma B.V.
Why is Ribavirin Teva Pharma B.V. approved?
Zakaj je bilo zdravilo Ribavirin Teva Pharma B.V.
How is Ribavirin Teva Pharma B.V. used?
Kako je bilo zdravilo Ribavirin Teva Pharma B.V.
The Committee recommended that Ribavirin Teva Pharma B.V. be approved for use in the EU.
Priporočil je, da se zdravilo Ribavirin Teva Pharma B.V.
How does Ribavirin Teva Pharma B.V. work?
Kako se zdravilo Ribavirin Teva Pharma B.V.
Intravenous use vial (glass)
Viala (steklena)
It may also cause damage to your unborn baby.
Prav tako lahko škoduje vašemu nerojenemu otroku.
Date of first authorisation: 19 December 2014 Date of latest renewal: 26 September 2019
Datum pridobitve dovoljenja za promet: 19. december 2014 Datuma zadnje spremembe dovoljenja za promet: 26. september 2019
Infection (sepsis) may be severe and could lead to death.
Okužba (sepsa) je lahko huda in lahko povzroči smrt.
- have high blood pressure.
- imate visok krvni tlak.
There are very limited efficacy and safety data available in these patients.
Pri teh bolnikih so na voljo omejeni podatki o učinkovitosti in varnosti.
Treatment cycles on both arms were repeated every 2 weeks.
Cikli zdravljenja v obeh skupinah so se ponavljali na vsaka 2 tedna.
Cyramza should not be given to patients under the age of 18 years because there is no information about how it works in this age group.
Zdravila Cyramza se ne sme dajati bolnikom, mlajšim od 18 let, saj ni podatkov o njegovem delovanju v tej starostni skupini.
Alcobendas 28108 Madrid Spain
28108 Madrid Španija
- Elderly people with lung cancer: Your doctor will carefully evaluate the most appropriate treatment for you.
Starejše osebe s pljučnim rakom: Zdravnik bo natančno ovrednotil najustreznejše zdravljenje za vas.
REACH-2
Študija REACH-2
The safety and efficacy of Cyramza in children and adolescents (<18 years) has not been established.
Varnost in učinkovitost zdravila Cyramza pri otrocih in mladostnikih (starih < 18 let) nista bili dokazani.
These and other factors investigated had < 20 % effect on ramucirumab disposition.
Ti in drugi preučevani dejavniki so imeli < 20-odstoten učinek na dispozicijo ramucirumaba.
Lilly France Fegersheim 2 rue du Colonel Lilly 67640 Fegersheim France
Lilly France Fegersheim 2 rue du Colonel Lilly 67640 Fegersheim Francija
The number of infusions you will receive depends on how you are responding to treatment.
Število infuzij, ki jih boste prejeli, je odvisno od vašega odziva na zdravljenje.
(see section 4.4).
(glejte poglavje 4.8).
This one sub-group is a group which can be considered to have aggressive disease that is relatively refractory to first-line treatment.
Ta podskupina je skupina, za katero se lahko šteje, da je imela agresivno bolezen, ki je relativno odporna proti zdravljenju prve izbire.
In most cases hypertension was managed using standard antihypertensive treatment.
V večini primerov so hipertenzijo obvladali z uporabo standardnega antihipertenzivnega zdravljenja.
In such cases, your doctor will perform regular blood tests to monitor the risk of bleeding.
V takih primerih bo zdravnik opravil redne krvne teste, da bo spremljal tveganje za krvavitev.
Please read the package leaflets for the other medicines that are part of your treatment, to see if they are suitable for you.
Preberite navodila za uporabo drugih zdravil, ki so del vašega zdravljenja, da boste videli, ali so primerna za vas.
Permanent discontinuation
Trajna prekinitev
This leaflet was last revised in .
Navodilo je bilo nazadnje revidirano
The ECOG PS was 1 for 72% of patients.
Ocena stanja zmogljivosti po ECOG je bila 1 za 72 % bolnikov.
A limited number of non-Caucasian, especially Black patients (2.6%) were included.
Vključeno je bilo omejeno število nebelcev, zlasti temnopoltih bolnikov (2,6 %).
The majority of events occurred during or following a first or second ramucirumab infusion.
Večina dogodkov je nastopila med ali po prvem ali drugem infundiranju ramucirumaba.
Your doctor or hospital pharmacist will calculate your body surface area by measuring your height and weight and will work out the right dose for you.
Vaš zdravnik ali bolnišnični farmacevt bo izračunal površino vašega telesa, tako da bo izmeril vašo višino in telesno maso ter določil pravi odmerek za vas.
This is equivalent to approximately 4% of the recommended maximum daily dietary intake of sodium for an adult.
To je enako približno 4% priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe.
Excretion in milk and oral absorption is expected to be low.
Pričakovati je, da sta izločanje v mleko in peroralna absorpcija majhna.
Also tell your doctor if you are taking any medicines which may increase the risk of bleeding or which affect blood clotting ability.
Zdravniku povejte tudi, če jemljete kakršna koli zdravila, ki bi lahko povečala tveganje za krvavitev ali ki vplivajo na zmožnost strjevanja krvi.
Aspartate aminotransferase (AST) /Alanine aminotransferase (ALT)
Aspartat-aminotransferaza (AST)/alaninaminotransferaza (ALT)
You should not use this medicine during pregnancy.
Med nosečnostjo tega zdravila ne smete jemati.
Baseline demographics and disease characteristics were balanced.
Izhodiščni demografski podatki in lastnosti bolezni so bili uravnoteženi.
In 32 of the 33 pre-specified sub-group analyses for OS, the HR was < 1.0.
V 32 od 33 vnaprej določenih analiz podskupin za celokupno preživetje je bil RT < 1,0.
The patient should be monitored during infusion for signs of infusion-related reactions (see section 4.4) and the availability of appropriate resuscitation equipment should be ensured.
Bolnika je med infundiranjem treba spremljati glede znakov reakcij, povezanih z infuzijo (glejte poglavje 4.4), zagotoviti pa je treba tudi razpoložljivost ustrezne opreme za oživljanje.
If you are unsure, ask your doctor, pharmacist or nurse if there are any reasons why you can't use these medicines.
Če ste v dvomih, se z zdravnikom, farmacevtom ali medicinsko sestro posvetujte o tem, ali obstajajo razlogi, da ne bi smeli uporabljati teh zdravil.
This includes medicines obtained without a prescription and herbal medicines.
To vključuje zdravila brez recepta in zeliščna zdravila.
<1.5 x upper limit of normal value (ULN)
< 1,5-kratna zgornja meja normalne vrednosti (ULN - upper limit of normal)
This receptor is needed in the development of new blood vessels.
Ta receptor je potreben za razvoj novih krvnih žil.
You should not receive Cyramza for at least 4 weeks before you undergo planned surgery and your doctor will decide when to re-start treatment.
Zdravila Cyramza ne boste prejeli vsaj 4 tedne pred načrtovano operacijo in vaš zdravnik se bo odločil, kdaj lahko znova začnete z zdravljenjem.
Median OS in patients who did not experience neutropenia was 10.7 months in both arms.
Mediana celokupnega preživetja pri bolnikih, ki niso imeli nevtropenije je bila 10,7 meseca v obeh skupinah zdravljenja.
- Fever or infection: You may develop a temperature of 38 ºC or greater during treatment (since you might have fewer white blood cells than normal which is very common).
Vročina ali okužba: Med zdravljenjem lahko vaša telesna temperatura naraste na 38 ºC ali več (ker imate morda manj belih krvničk, kot je normalno, kar je zelo pogosto).
In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Da bi izboljšali sledljivost bioloških zdravil, je potrebno jasno zapisati ime in številko serije uporabljenega zdravila.
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Preden prejmete zdravilo natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
Prepare the infusion solution using aseptic technique to ensure the sterility of the prepared solution.
Pripravite raztopino za infundiranje z uporabo aseptične tehnike, da boste zagotovili sterilnost pripravljene raztopine.
Patients should be monitored for clinical signs and symptoms of hepatic encephalopathy.
Bolnike je treba spremljati glede kliničnih znakov in simptomov hepatične encefalopatije.
See leaflet for further information.
Za nadaljnje informacije glejte navodila.
A second reduction of 15 mg/m2 is recommended if these toxicities persist or reoccur.
Drugo zmanjšanje za 15 mg/m2 je priporočljivo, če te toksičnosti vztrajajo ali se ponovijo.
h Includes cases of nephrotic syndrome.
h Vključuje primere nefrotskega sindroma.
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≥2 patients Patients with ECOG score ≥2 were excluded from the pivotal studies in all indications, therefore the safety and efficacy of Cyramza in this patient population is unknown.
Bolniki s stanjem zmogljivosti po ECOG (Eastern Cooperative Oncology Group) ≥ 2 Bolniki z oceno ECOG ≥ 2 so bili izključeni iz ključnih študij za vse indikacije, zato varnost in učinkovitost zdravila Cyramza v tej populaciji bolnikov nista znani.
Your doctor may prescribe treatment to help with the symptoms.
Vaš zdravnik vam bo morda predpisal zdravljenje, ki vam bo pomagalo ublažiti te simptome.
26% had squamous histology.
% bolnikov je imelo ploščatocelično histologijo.
The decision to resume ramucirumab following surgical intervention should be based on clinical judgment of adequate wound healing.
Odločitev za ponovno uvedbo ramucirumaba po kirurškem posegu mora temeljiti na klinični presoji o zadovoljivem celjenju rane.
Store in a refrigerator (2 °C - 8 °C).
Shranjujte v hladilniku (2° C-8 °C).
A minimal grade of inflammation and/or mononuclear cell infiltration was seen in several organs.
Pri več organih so opazili minimalno stopnjo vnetja in/ali infiltracijo mononuklearnih celic.
Keep the vial in the outer carton in order to protect from light.
Vialo shranjujte v zunanji ovojnini, da zagotovite zaščito pred svetlobo.
No dose reductions are recommended (see sections 4.4 and 5.1).
Zmanjšanja odmerkov niso potrebna (glejte poglavji 4.4 in 5.1).
Consider use of colonystimulating factor prior to next cycle.
Pred naslednjim ciklom razmislite o uporabi dejavnika za stimulacijo kolonij.
Samples were tested from 956 patients: 527 ramucirumab treated patients and 429 control treated patients.
Testirali so vzorce, pridobljene pri 956 bolnikih: 527 bolnikov je bilo zdravljenih z ramucirumabom, 429 pa s kontrolnim zdravilom.
- have severe kidney problems.
- imate hude težave z ledvicami.
Demographic and baseline characteristics for the ITT population were similar between treatment arms.
Demografske in izhodiščne lastnosti za ITT populacijo so bile podobne v obeh skupinah zdravljenja.
To achieve the required infusion duration of approximately 60 minutes, the maximum infusion rate of 25 mg/minute should not be exceeded, instead the infusion duration should be increased.
Da boste dosegli zahtevano trajanje infundiranja približno 60 minut, največja hitrost infundiranja ne sme preseči 25 mg/minuto, saj morate sicer podaljšati trajanje infundiranja.
If you become pregnant during treatment with Cyramza, your doctor will discuss with you if the benefit of treatment for you is greater than any possible risk to you or your unborn baby.
Če zanosite med zdravljenjem z zdravilom Cyramza, se bo zdravnik z vami pogovoril, ali so koristi zdravljenja za vas večje od vseh morebitnih tveganj za vas in vašega nerojenega otroka.
In the pivotal studies there is limited evidence that patients 65 years of age or older are at increased risk of adverse events compared to patients younger than 65 years old.
V ključnih študijah so dokazi, da bi obstajalo pri bolnikih, starih 65 let in več, povečano tveganje za neželene dogodke v primerjavi z bolniki, mlajšimi od 65 let, omejeni.
Cyramza should only be used if the potential benefit to the mother justifies the potential risk during pregnancy.
Zdravilo Cyramza se lahko uporablja le, če možne koristi za mater upravičujejo možna tveganja med nosečnostjo.
Includes hepatic encephalopathy and hepatic coma.
Vključuje hepatično encefalopatijo in hepatično komo.
Vascular Endothelial Growth Factor (VEGF) Receptor 2 is the key mediator of VEGF induced angiogenesis.
Mehanizem delovanja Receptor rastnega faktorja za žilni endotelij (VEGF - Vascular Endothelial Growth Factor) 2 je ključni posrednik pri angiogenezi, ki jo povzroča VEGF.