FrancophonIA/ELRC3.0 huggingface dataset:
English: Bronchospam was reported in one patient treated with vinflunine for a different setting from the indication.
Slovenian: Pri bolniku, ki je prejemal vinflunin, vendar ne zaradi indikacije zdravila Javlor, se je pojavil bronhospazem.
English: For subsequent administrations, vinflunine is contraindicated in subjects with baseline ANC < 1,000/mm3 or platelets < 100,000/mm3.
Slovenian: V študijah reprodukcije so ugotovili, da ima vinflunin embrioletalne in teratogene učinke, zlasti pri kuncih v odmerkih nad 1,3 mg/kg (14,3 mg/m²).
English: Uncommon Tumour pain
Slovenian: občasni nevtropenična sepsa
English: Doctors and patients must be aware of this possibility.
Slovenian: Zdravniki in bolniki se morajo te možnosti zavedati.
English: This medicine is the same as Puregon, which is already authorised in the European Union (EU).
Slovenian: To zdravilo je enako zdravilu Puregon, ki je že odobreno v Evropski uniji (EU).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Fertavid on 19 March 2009.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Fertavid, veljavno po vsej Evropski uniji, odobrila dne 19. marca 2009.
English: The full EPAR for Fertavid can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Fertavid je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Other information about Fertavid
Slovenian: Druge informacije o zdravilu Fertavid
English: This is a summary of the European public assessment report (EPAR) for Fertavid.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Fertavid.
English: The patient or their partner may carry out the injections.
Slovenian: Injiciranje lahko izvedejo bolniki sami ali njihovi partnerji.
English: It must not be used in men with testicular failure.
Slovenian: Ne smejo ga uporabljati moški z odpovedjo testisov.
English: Fertavid is given as an injection under the skin or into a muscle.
Slovenian: Zdravilo Fertavid se daje z injekcijo pod kožo ali v mišico.
English: The dose and frequency of administration of Fertavid depend on its use (see above) and the patient's response to treatment.
Slovenian: Odmerjanje in pogostnost dajanja zdravila Fertavid sta odvisna od načina uporabe (glejte zgoraj) in bolnikovega odziva na zdravljenje.
English: • women who are anovulatory (do not produce eggs) and do not respond to treatment with clomiphene citrate (another medicine that stimulates ovulation);
Slovenian: • pri ženskah z anovulacijo (ki ne proizvajajo jajčec) in ženskah, ki se niso odzvale na zdravljenje s klomifen citratom (drugim zdravilom, ki spodbuja ovulacijo);
English: The number of eggs recovered and the ongoing pregnancy rate were the main measures of effectiveness.
Slovenian: Glavni merili učinkovitosti sta bili število nastalih jajčec ter število doseženih in potekajočih nosečnosti.
English: For more information about treatment with Fertavid, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Fertavid preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Fertavid's use in women undergoing fertility treatment has been studied in 981 patients.
Slovenian: Uporaba zdravila Fertavid pri ženskah, ki se zdravijo zaradi neplodnosti, je bila raziskana pri 981 bolnicah.
English: Fertavid can also be used to stimulate sperm production in men who have hypogonadotrophic hypogonadism (a rare hormone deficiency disease).
Slovenian: Zdravilo Fertavid se prav tako lahko uporablja za spodbujanje proizvajanja semenčic pri moških, ki imajo hipogonadotropni hipogonadizem (redka bolezen pomanjkanja hormonov).
English: Fertavid was studied in 172 anovulatory women, measuring how many cycles of treatment were needed for these women to ovulate.
Slovenian: Zdravilo Fertavid so proučevali pri 172 ženskah brez ovulacije, merili pa so, koliko ciklov zdravljenja so potrebovale, da je prišlo do ovulacije.
English: What benefit has Fertavid shown during the studies?
Slovenian: Kakšne koristi je zdravilo Fertavid izkazalo med študijami?
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Fertavid.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Fertavid, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Treatment with Fertavid should be carried out by a doctor who has experience in the treatment of fertility problems.
Slovenian: Zdravljenje z zdravilom Fertavid mora izvajati zdravnik z izkušnjami na področju zdravljenja neplodnosti.
English: In the body, FSH regulates reproductive function: in women, it stimulates the production of eggs, and in men, it stimulates the production of sperm by the testicles.
Slovenian: V telesu FSH uravnava funkcijo reprodukcije: pri ženskah spodbuja nastajanje jajčec, pri moških pa nastajanje semenčic v modih.
English: Fertavid should not be used in people who may be hypersensitive (allergic) to follitropin beta or any of the other ingredients.
Slovenian: Zdravila Fertavid ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) na folitropin beta ali katero koli drugo sestavino zdravila.
English: Fertavid can only be obtained with a prescription.
Slovenian: Zdravilo Fertavid se dobi samo na recept.
English: Ovarian hyperstimulation syndrome occurs when the ovaries over-respond to treatment.
Slovenian: Sindrom hiperstimulacije jajčnikov se pojavi, če je odziv jajčnikov na zdravljenje pretiran.
English: The CHMP decided that Fertavid's benefits are greater than its risks and recommended that Fertavid be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Fertavid večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: • women who are undergoing fertility treatment (assisted reproductive techniques, such as in vitro fertilisation).
Slovenian: • pri ženskah, ki se zdravijo zaradi neplodnosti (postopki asistirane reprodukcije, kot je oploditev in vitro).
English: In all of the studies, Fertavid was compared with the natural FSH hormone that was extracted from urine.
Slovenian: Pri vseh študijah so zdravilo Fertavid primerjali z naravnim hormonom FSH, pridobljenim iz urina.
English: Fertavid is administered to stimulate the ovaries to produce more than one egg at a time.
Slovenian: Zdravilo Fertavid se daje za spodbujanje delovanja jajčnikov, da bi v njih nastalo več kot eno jajčece hkrati.
English: In 4% of the women treated with Fertavid in clinical studies, signs and symptoms related to ovarian hyperstimulation syndrome (e.g. feeling sick, weight gain and diarrhoea) have been reported.
Slovenian: Pri štirih odstotkih žensk, ki so v kliničnih študijah prejemale zdravilo Fertavid, so poročali o znakih in simptomih, podobnih sindromu hiperstimulacije jajčnikov (kot so občutek slabosti, povečanje telesne mase, driska).
English: Fertavid must not be used in patients with tumours of the ovary, breast, womb, testicle, pituitary gland or hypothalamus.
Slovenian: Zdravila Fertavid ne smejo uporabljati bolniki s tumorjem jajčnikov, dojk, maternice, testisov, hipofize ali hipotalamusa.
English: What is the risk associated with Fertavid?
Slovenian: Kakšna tveganja so povezana z zdravilom Fertavid?
English: Previously, the FSH used as a medicine was extracted from urine.
Slovenian: V preteklosti so v medicini uporabljali FSH, pridobljen iz urina.
English: In women, it must not be used when there is ovarian failure, ovarian enlargement or the presence of cysts that are not due to polycystic ovarian disease, or vaginal bleeding.
Slovenian: Pri ženskah se ne sme uporabljati pri odpovedi jajčnikov, povečanju jajčnikov ali prisotnosti cist, ki niso posledica policističnega obolenja jajčnikov, ali pri krvavitvi iz nožnice.
English: In men, Fertavid was studied to see its effect on sperm production in 49 patients.
Slovenian: Pri moških so vpliv zdravila Fertavid na proizvajanje sperme proučevali pri 49 bolnikih.
English: Fertavid is used to treat infertility in women in the following situations:
Slovenian: Zdravilo Fertavid se uporablja za zdravljenje neplodnosti v naslednjih primerih:
English: Fertavid should only be administered by people who have been trained by the doctor and have access to expert advice.
Slovenian: Zdravilo Fertavid lahko dajejo samo osebe, ki jih je za to usposobil zdravnik in ki imajo možnost posvetovati se s strokovnjakom.
English: The most common side effects with Fertavid are a reaction and pain at the injection site.
Slovenian: Najpogostejši neželeni učinki, o katerih so poročali pri uporabi zdravila Fertavid, so reakcije in bolečine na mestu injiciranja.
English: Fertavid is a solution for injection that contains the active substance follitropin beta.
Slovenian: Zdravilo Fertavid je raztopina za injiciranje, ki vsebuje zdravilno učinkovino folitropin beta.
English: The company that makes Puregon has agreed that its scientific data can be used for Fertavid.
Slovenian: Družba, ki izdeluje zdravilo Puregon, je privolila, da se znanstveni podatki tega zdravila uporabljajo tudi za zdravilo Fertavid.
English: For a full list of all side effects reported with Fertavid, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Fertavid, glejte navodilo za uporabo.
English: Why has Fertavid been approved?
Slovenian: Zakaj je bilo zdravilo Fertavid odobreno?
English: Fertavid was as effective as the comparator in all of the studies.
Slovenian: V vseh študijah je bilo zdravilo Fertavid enako učinkovito kot primerjalno zdravilo.
English: EPAR summary for the public follitropin beta
Slovenian: folitropin beta
English: The active substance in Fertavid, follitropin beta, is a copy of the natural hormone follicle stimulating hormone (FSH).
Slovenian: Zdravilna učinkovina zdravila Fertavid, folitropin beta, je posnetek naravnega hormona FSH (folikle stimulirajočega hormona).
English: Fertavid was as effective as urinary FSH as a fertility treatment, in producing ovulation and in producing sperm.
Slovenian: Zdravilo Fertavid je bilo pri zdravljenju neplodnosti, spodbujanju ovulacije in nastajanju sperme enako učinkovito kot FSH, pridobljen iz urina.
English: How has Fertavid been studied?
Slovenian: Kako je bilo zdravilo Fertavid raziskano?
English: For a full description of the doses, see the package leaflet.
Slovenian: Za celoten opis odmerjanja glejte navodilo za uporabo.
English: What is Fertavid used for?
Slovenian: Za kaj se zdravilo Fertavid uporablja?
English: The follitropin beta in Fertavid is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce human FSH.
Slovenian: Folitropin beta, ki ga vsebuje zdravilo Fertavid, je pridobljen z metodo, imenovano „tehnologija rekombinantne DNK“,.
English: How is Fertavid used?
Slovenian: Kako se zdravilo Fertavid uporablja?
English: How does Fertavid work?
Slovenian: Kako zdravilo Fertavid deluje?
English: What is Fertavid?
Slovenian: Kaj je zdravilo Fertavid?
English: What you need to know before you take [x]
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo [x]
English: • Oral contraception
Slovenian: • Peroralna kontracepcija
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Slovenian: Informacije o zdravilu bodo morda pristojni organi držav članic v sodelovanju z referenčno državo članico kasneje posodobili v skladu s postopki, določenimi v poglavju 4 naslova III Direktive 2001/83/ES.
English: The existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below.
Slovenian: Obstoječe informacije o zdravilu je treba spremeniti (vstaviti, nadomestiti ali izbrisati besedilo, kot je ustrezno) tako, da vsebujejo dogovorjeno besedilo, kot je navedeno spodaj.
English: The decision to prescribe [x] should take into consideration the individual woman's current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with [x] compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4).
Slovenian: Pri odločitvi za predpisovanje zdravila [x] je treba upoštevati že obstoječe dejavnike tveganja pri posamezni ženski, predvsem dejavnike tveganja za vensko trombembolijo (VTE - venous thromboembolism), in kakšno je tveganje za VTE z zdravilom [x] v primerjavi s tveganjem pri drugih kombiniranih hormonskih kontraceptivih (CHC - combined hormonal contraceptives) (glejte poglavji 4.3 in 4.4).
English: What [x] is and what it is used for
Slovenian: Kaj je zdravilo [x] in za kaj ga uporabljamo
English: Annex III Amendments to relevant sections of the Product Information
Slovenian: Priloga III Dopolnitev ustreznih poglavij v informacijah o zdravilu
English: C. Package Leaflet This wording regarding the acne indication should be revised to read as follows:
Slovenian: C. Navodilo za uporabo To besedilo glede indikacije za akne je treba spremeniti tako, da se glasi:
English: Women should be assessed 3-6 months after treatment initiation and periodically thereafter to review the need for continuation of treatment.
Slovenian: 3 - 6 mesecev po začetku zdravljenja in nato ponovno v rednih časovnih presledkih je treba oceniti, če ženska potrebuje nadaljnje zdravljenje.
English: These amendments to the relevant sections of the Product Information are the outcome of the referral procedure.
Slovenian: Ta dopolnitev ustreznih poglavij informacij o zdravilu je bila dogovorjena v postopku napotitve.
English: Amendments to relevant sections of the Product Information
Slovenian: Dopolnitev ustreznih poglavij v informacijah o zdravilu
English: o For treatment of women with moderate acne who agree to receive a contraceptive pill after failure of suitable local or oral antibiotic treatments.
Slovenian: • Zdravljenje zmerno hudih aken pri ženskah, ki so se odločile za uporabo peroralnega kontraceptiva in pri katerih ustrezno lokalno zdravljenje ali peroralno zdravljenje z antibiotiki ni bilo uspešno.
English: You should discuss with your doctor the need to continue your treatment three to six months after the start and regularly thereafter.
Slovenian: Tri do šest mesecev po začetku zdravljenja se posvetujte z zdravnikom, če je potrebno zdravljenje nadaljevati in nato se z njim ponovno posvetujte v rednih časovnih presledkih.
English: Your acne will usually improve between three and six months of treatment, and could continue to improve even after six months.
Slovenian: Do izboljšanja aken običajno pride v treh do šestih mesecih zdravljenja.
English: Section 4.1 Therapeutic indications The acne indication should be revised to read as follows:
Slovenian: Poglavje 4.1 Terapevtske indikacije
English: Apparent improvement of acne usually takes at least three months and further improvement has been reported after six months of treatment.
Slovenian: V zvezi z indikacijo za akne je treba spremeniti odmerjanje tako, da se doda naslednje besedilo: Do očitnega izboljšanja aken običajno pride po treh mesecih.
English: [x] is a medicinal product o to prevent pregnancy (contraceptive “pill”).
Slovenian: [x] je zdravilo o za preprečevanje nosečnosti (“kontracepcijske tablete”), o za zdravljenje žensk z zmerno hudimi aknami, ki so se odločile za uporabo kontracepcijskih tablet in pri katerih ustrezno lokalno ali peroralno zdravljenje z antibiotiki ni bilo uspešno.
English: The applicant was requested to provide the following information:
Slovenian: Odbor je od predlagatelja zahteval naslednje podatke:
English: Ireland considers that, due to the absence of efficacy documentation it cannot be assumed that the product is efficacious and that this as such presents a potential serious risk to animal health.
Slovenian: Irska meni, da zaradi pomanjkanja dokumentacije o učinkovitosti ni možno domnevati, da je zdravilo učinkovito in zaradi tega predstavlja možno resno tveganje za zdravje živali.
English: The applicant submitted written responses to the List of Questions on 10 January 2008 and the clock was re-started.
Slovenian: Predlagatelj je 10. januarja 2008 predložil pisne odgovore na seznam vprašanj in ura se je ponastavila.
English: A List of Questions was adopted by CVMP and sent to the applicant on 12 December 2007.
Slovenian: CVMP je sprejel seznam vprašanj ter jih predlagatelju poslal 12. decembra 2007.
English: Pursuant to Article 33(4) of Council Directive 2001/82/EC, as amended, the matter was referred to the CVMP.
Slovenian: Zadeva je bila v skladu s členom 33(4) Direktive Sveta 2001/82/ES, kakor je bila spremenjena, napotena na Odbor za zdravila za uporabo v veterinarski medicini (CVMP).
English: Conclusions and Recommendations
Slovenian: Zaključki in priporočila
English: The aim of the assessment is to establish whether marketing authorisations of veterinary medicinal products included in the referral procedure should be maintained, suspended, varied or revoked with view to the grounds for referral.
Slovenian: Cilj vrednotenja je ugotoviti, ali naj se dovoljenja za promet z zdraviloma za uporabo v veterinarski medicini, ki sta vključena v napotitveni postopek, obdržijo, zadržijo, spremenijo ali prekličejo glede na vzrok za napotitev.
English: CVMP started the referral procedure on 11 December 2007 and agreed on a 37 day time frame.
Slovenian: CVMP je pričel z napotitvenim postopkom 11. decembra 2007 in soglasno sprejel 37-dnevni rok.
English: The Netherlands, reference member state in the decentralised procedure, notified the EMEA on 26 November 2007 that the Co-ordination Group for Mutual Recognition and Decentralised ProceduresVeterinary (CMD(v)) failed to reach an agreement for Solacyl 100% powder for oral solution.
Slovenian: Nizozemska, referenčna država članica v decentraliziranem postopku, je 26. novembra 2007 obvestila EMEA, da v Koordinacijski skupini za postopke medsebojnega priznavanja in decentralizirane postopke - zdravila za veterinarsko uporabo (CMD(v)) ni bilo doseženo soglasje o zdravilu Solacyl 100 % prašek za peroralno raztopino.
English: The valid Summary of Product Characteristics, labelling and package leaflet are the versions agreed by the Reference Member State and Concerned Member States (except Ireland) at day 210 of the decentralised procedure.
Slovenian: Veljavni Povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so različice, s katerimi se strinjajo referenčna država članica in zadevne države članice (z izjemo Irske) na 210. dan decentraliziranega postopka.
English: This solution is then added, whilst stirring, into an amount of drinking water that will be consumed within approximately 3-4 hours and administered twice daily.
Slovenian: To raztopino nato ob mešanju dodamo v količino pitne vode, ki se porabi v približno 3-4 urah, ter jo damo dvakrat dnevno.
English: Administration: orally in drinking water or milk(replacer).
Slovenian: Uporaba: peroralno v pitni vodi ali mleku (nadomestku).
English: The application dossier and any data added to it up to Day 60 of the referral procedure in CMD(v) to be provided to all CVMP Members and the EMEA.
Slovenian: 1. dokumentacija predlagatelja in vsi podatki, ki so bili vanjo dodani do 60. dne napotitvenega postopka v CMD(v), se pošljejo vsem članicam CVMP in EMEA;
English: Alternatively Solacyl can also be administered with the drinking water as pulse medication.
Slovenian: Zdravilo Solacyl se lahko daje tudi s pitno vodo kot pulzno zdravilo.
English: Administration: orally in drinking water.
Slovenian: Uporaba: peroralno v pitni vodi.
English: ANNEX I NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER
Slovenian: DODATEK I IME, FARMACEVTSKA OBLIKA, JAKOST ZDRAVILA, ŽIVALSKE VRSTE, POTI UPORABE ZDRAVILA IN IMETNIK DOVOLJENJA ZA PROMET
English: In response to question 1, the applicant provided a copy of the original dossier as submitted in support of the application of a decentralised procedure, and the supplementary data submitted during the decentralised procedure in response to the phase I and phase II assessment and the referral procedure in CMD(v) thereafter.
Slovenian: V zvezi s 1. vprašanjem je predlagatelj predložil kopijo izvirne dokumentacije, ki je bila predložena kot utemeljitev vloge za decentralizirani postopek, in dodatne podatke, ki so bili predloženi med decentraliziranim postopkom kot odgovor na vrednotenje I. in II.
English: The objections raised by Ireland should not prevent the granting of a marketing authorisation for Solacyl 100% powder for oral solution for calves and pigs.
Slovenian: Zadržki, ki jih je podala Irska, ne smejo preprečiti odobritve dovoljenja za promet z zdravilom Solacyl 100 % prašek za peroralno raztopino za teleta in prašiče.
English: Calves: 20 mg sodium salicylate per kg bodyweight twice daily, for 1 to 3 days.
Slovenian: Teleta: 20 mg natrijevega salicilata na kg telesne mase dvakrat dnevno 1 do 3 dni.
English: It is recommended that Solacyl 100% powder for oral solution for calves and pigs should follow the outcome of the Community Referral according to Article 35(2) for sodium salicylate-containing oral soluble powders.
Slovenian: Priporočljivo je, da se za zdravilo Solacyl 100 % prašek za peroralno raztopino za teleta in prašiče upošteva izid napotitvenega postopka Skupnosti v skladu s členom 35(2) za peroralne topne praške, ki vsebujejo natrijev salicilat.
English: CVMP noted that Solacyl 100% powder for oral solution is a generic of Natrium salicylaat (authorised in The Netherlands) and that the concerns raised by Ireland could only be addressed in the framework of this procedure, in case any differences between both products would justify different conclusions on the safety or efficacy.
Slovenian: CVMP je opozoril, da je Solacyl 100 % prašek za peroralno raztopino generična različica zdravila Natrium salicylaat (ki je odobreno na Nizozemskem) in da se lahko zadržki Irske obravnavajo le v okviru tega postopka, če bi se ugotovilo, da razlike med zdraviloma omogočajo različne zaključke o varnosti in učinkovitosti.
English: Pigs: 35 mg sodium salicylate per kg bodyweight per day, for 3 to 5 days.
Slovenian: Prašiči: 35 mg natrijevega salicilata na kg telesne mase enkrat dnevno 3 do 5 dni.
English: Solacyl 100% powder for oral solution proved to be essentially similar to the reference product, Natrium salicylaat 100%.
Slovenian: Zdravilo Solacyl 100 % prašek za peroralno raztopino je dokazano bistveno podobno referenčnemu zdravilu Natrium salicylaat 100 %.
English: Half of the calculated total daily amount of powder is mixed with 5-10 litres of clean water and stirred until evenly dispersed.
Slovenian: Zmešamo polovico izračunane celokupne dnevne količine praška in 5-10 litrov čiste vode.
English: In response to question 2, the applicant answered that Solacyl 100% powder for oral solution is identical to the reference product and that there is no reason to reach different conclusions on the efficacy of the two products.
Slovenian: V zvezi z 2. vprašanjem je predlagatelj odgovoril, da je zdravilo Solacyl 100 % prašek za peroralno raztopino identično referenčnemu zdravilu in da ni razloga za različne zaključke o učinkovitosti zdravil.