natgillin/translations-raw huggingface dataset:
In view of the concerns raised by France, to indicate and to substantiate where necessary any differences between Equibactin vet. (333 mg/g + 67 mg/g) Oral Paste for Horses and the reference product Tribrissen Oral Paste (authorised in the Netherlands) that could justify different conclusions on the safety or efficacy for the two products.
Glede na zadržke, ki jih je imela Francija, prikaz in po potrebi utemeljitev morebitnih razlik med zdravilom Equibactin vet. (333 mg/g + 67 mg/g) peroralna pasta za konje in referenčnim zdravilom Tribrissen peroralna pasta (odobreno na Nizozemskem), s katerimi bi lahko utemeljili različne zaključke glede varnosti ali učinkovitosti obeh zdravil.
A copy of the dossier of Equibactin vet. (333 mg/g + 67 mg/g) Oral Paste for Horses and any supplementary data added to it, up to day 60 of the referral procedure in CM(v).
Kopijo dosjeja zdravila Equibactin vet. (333 mg/g + 67 mg/g) peroralna pasta za konje in vse dodatne podatke, do 60. dne napotitvenega postopka v CM(v).
Equibactin vet Oral Paste proved to be essentially similar to the reference product, Tribrissen Oral Paste.
Zdravilo Equibactin vet. peroralna pasta se je izkazalo za bistveno podobno referenčnemu zdravilu Tribrissen peroralna pasta.
Oral Paste for Horses proved to be bioequivalent to the reference products Tribrissen (REG NL 5055 in the Netherlands) and Tribissen (Vm 0201/4064 in the UK).
V študiji GLP biološke enakovrednosti enkratnega odmerka pri konjih, ki je bila izvedena skladno z ustreznimi smernicami, so dokazali, da je zdravilo Equibactin vet. peroralna pasta za konje biološko enakovredna referenčnemu zdravilu Tribrissen (REG NL 5055 na Nizozemskem) in zdravilu Tribissen (Vm 0201/4064 v Združenem kraljestvu).
Oral Paste in accordance with the outcome of referral procedure EMEA/V/023 under Article 35 of Directive 2001/82/EC as amended, for the reference medicinal product Tribrissen Oral Paste authorised in The Netherlands.
Priporoča se uporaba zdravila Equibactin vet. peroralna pasta, v skladu z rezultatom napotitvenega postopka EMEA/V/023 iz člena 35 Direktive 2001/82/ES, kakor je bila spremenjena, kot različice referenčnega zdravila Tribrissen peroralna pasta, odobrenega na Nizozemskem.
Product invented name
Izmišljeno ime zdravila Farmacevtska oblika
Oral Paste for Horses with the reference product Tribrissen Oral Paste (authorised in the Netherlands under REG NL 5055).
Še več, obstajajo le podobnosti, ki dokazujejo enako varnost in učinkovitost zdravila Equibactin vet. peroralna pasta za konje in referenčnega zdravila Tribrissen peroralna pasta (odobreno na Nizozemskem pod REG NL 5055).
Based on the identical composition with respect to active ingredients, Trimethoprim and Sulfadiazine, the same pharmaceutical form, and proven bioequivalence between Equibactin vet.
Glede na enako sestavo, kar zadeva zdravilni učinkovini trimetoprim in sulfadiazin, enako farmacevtsko obliko in dokazano biološko enakovrednost med zdravilom Equibactin vet. peroralna pasta in zdravilom Tribrissen peroralna pasta za učinkovini trimetoprim in sulfadiazin, se zdravili obravnavata za bistveno podobni.
Treatment should always be started during the first week of the menstrual period.
Zdravljenje je treba vedno začeti v prvem tednu menstruacijskega ciklusa.
Further information on Esmya can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Nadaljnje informacije za zdravilo Esmya so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
1 See outcome of safety review carried out in 2018 here.
Izid varnostnega pregleda, opravljenega v letu 2018, si lahko ogledate tukaj.
Esmya (ulipristal acetate)
Esmya (ulipristalacetat)
The recommended dose is one tablet a day for up to three months (one treatment course).
Priporočeni odmerek je ena tableta na dan največ tri mesece (en ciklus zdravljenja).
Esmya received a marketing authorisation valid throughout the European Union on 23 February 2012.
Za zdravilo Esmya je bilo 23. februarja 2012 izdano dovoljenje za promet, veljavno po vsej EU.
It is available as tablets (5 mg) to be taken by mouth.
Na voljo je v obliki tablet (5 mg), ki se jemljejo peroralno.
What measures are being taken to ensure the safe and effective use of Esmya?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Esmya?
A reduction in fibroid size was also observed.
Opaziti je bilo mogoče tudi zmanjšanje velikosti leiomiomov.
The European Medicines Agency decided that the benefits of Esmya outweigh its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da koristi zdravila Esmya odtehtajo njegova tveganja in da se lahko odobri za uporabo v EU.
An overview of Esmya and why it is authorised in the EU
Pregled zdravila Esmya in zakaj je odobreno v EU
As for all medicines, data on the use of Esmya are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Esmya stalno spremljajo.
Esmya can be given:
Zdravilo Esmya se lahko daje:
The three-month treatment course can be repeated in women in whom surgery is not suitable.
Trimesečni ciklus zdravljenja se lahko pri ženskah, za katere kirurški poseg ni primeren, ponovi.
What benefits of Esmya have been shown in studies?
Kakšne koristi zdravila Esmya so se pokazale v študijah?
Other information about Esmya
Druge informacije o zdravilu Esmya
The company that markets Esmya will ensure that doctors who are expected to prescribe this medicine receive educational material with information about the safety of Esmya, including recommendations for monitoring liver function and endometrial changes during treatment.
Podjetje, ki trži zdravilo Esmya, bo zagotovilo, da bodo zdravniki, ki naj bi predpisovali to zdravilo, prejeli izobraževalno gradivo z informacijami o njegovi varnosti, vključno s priporočili za spremljanje delovanja jeter in sprememb endometrija med zdravljenjem.
Side effects reported with Esmya are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Esmya, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
The size of the fibroids was also smaller in women treated with Esmya than in those who received placebo.
Prav tako je bila velikost leiomiomov manjša pri ženskah, ki so se zdravile z zdravilom Esmya, kot pri tistih, ki so prejemale placebo.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Esmya 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 Esmya upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Long-term treatment with Esmya has been investigated in a main study involving 451 women who were given 4 three-month courses of 5 or 10 mg of Esmya.
Dolgotrajno zdravljenje z zdravilom Esmya so proučevali v eni glavni študiji, v katero je bilo vključenih 451 žensk, ki so prejele štiri trimesečne cikluse zdravljenja s 5- ali 10-miligramskim odmerkom zdravila Esmya.
What is Esmya and what is it used for?
Kaj je zdravilo Esmya in za kaj se uporablja?
Esmya must not be used in women who are pregnant or breastfeeding, have bleeding from the genital region of unknown cause or for reasons other than uterine fibroids, have cancer of the womb, cervix (the neck of the womb), ovary or breast, or have liver problems.
Zdravila Esmya ne smejo uporabljati ženske, ki so noseče ali dojijo, krvavijo iz spolovil iz neznanega razloga ali razloga, ki ni povezan z materničnimi leiomiomi, oziroma imajo raka maternice, cerviksa (materničnega vratu), jajčnikov ali dojke, ali imajo težave z jetri.
The most common side effects with Esmya (which may affect more than 1 in 10 patients) are amenorrhea (absence of menstrual period) and endometrial thickening (thickening of the lining of the womb).
Najpogostejša neželena učinka zdravila Esmya (ki se lahko pojavita pri več kot 1 od 10 bolnic) sta amenoreja (izostanek menstruacije) in odebelitev endometrija (odebelitev maternične sluznice).
In some women, progesterone may promote the growth of fibroids, which can cause symptoms such as heavy uterine bleeding (bleeding from the womb during or outside the menstrual period), anaemia (low red blood cell counts, due to bleeding) and abdominal pain (such as period pain).
Pri nekaterih ženskah lahko progesteron spodbuja rast leiomiomov, kar lahko povzroči simptome, kot so močne krvavitve iz maternice (krvavitve iz maternice med menstruacijskim ciklusom ali zunaj njega), anemija (nizko število rdečih krvnih celic zaradi krvavitev) in bolečine v trebuhu (kot so bolečine med menstruacijo).
For more information about using Esmya, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Esmya glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
What are the risks associated with Esmya?
Kakšna tveganja so povezana z zdravilom Esmya?
49% of women receiving 5 mg Esmya (95 out of the 195 women who were assessed) had no more than one day of spotting (minimal uterine bleeding) within a 35-day interval after each treatment course, and 70% had no more than one day of spotting within a 35-day interval at the end of the fourth treatment course.
Pri 49 % žensk, ki so prejemale 5-miligramski odmerek zdravila Esmya (95 od ocenjenih 195 žensk), se je v 35 dneh po vsakem ciklusu zdravljenja krvavitev (minimalna krvavitev iz maternice) pojavila v največ enem dnevu, na koncu četrtega ciklusa pa se pri 70 % žensk v 35 dneh krvavitev ni pojavila.
Why is Esmya authorised?
Zakaj je bilo zdravilo Esmya odobreno?
• as intermittent treatment for women in whom surgery is not suitable.
• v okviru zdravljenja s prekinitvami pri ženskah, za katere kirurški poseg ni primeren.
The active substance in Esmya, ulipristal acetate, blocks the activity of progesterone, a hormone in the body involved in controlling the growth of the lining of the womb.
Učinkovina v zdravilu Esmya, ulipristalacetat, zavira delovanje progesterona, hormona, ki v telesu sodeluje pri nadzorovanju rasti maternične sluznice.
Esmya is a medicine used to treat moderate to severe symptoms of uterine fibroids in adult women who have not yet reached the menopause.
Zdravilo Esmya se uporablja za zdravljenje zmernih do hudih simptomov materničnih leiomiomov pri odraslih ženskah, ki še niso v menopavzi.
Esmya improved the symptoms of uterine fibroids in two main studies involving 549 women who were to have surgery to remove the fibroids.
Zdravilo Esmya je izboljšalo simptome materničnih leiomiomov v dveh glavnih študijah, v kateri je bilo vključenih 549 žensk, pri katerih naj bi opravili kirurški poseg za odstranitev leiomiomov.
In the first study, uterine bleeding was reduced in 92% of women taking Esmya for three months (one treatment course) compared with 19% of women taking placebo (a dummy treatment).
V prvi študiji so se krvavitve iz maternice zmanjšale pri 92 % žensk, ki so zdravilo Esmya jemale tri mesece (en ciklus zdravljenja), in pri 19 % žensk, ki so jemale placebo (zdravilo brez učinkovine).
In the second study, Esmya taken for three months was as effective as leuprorelin (another medicine for fibroids) in reducing heavy uterine bleeding, with bleeding reduced in 90% of women treated with Esmya compared with 89% of women treated with leuprorelin.
V drugi študiji je bil trimesečni ciklus zdravljenja z zdravilom Esmya enako učinkovit kot levprorelin (drugo zdravilo za leiomiome) pri zmanjševanju močnih krvavitev iz maternice, saj so se krvavitve zmanjšale pri 90 % žensk, ki so se zdravile z zdravilom Esmya, in pri 89 % tistih, ki so prejemale levprorelin.
• as a single treatment course in women before they have surgery for their fibroids;
• v okviru enega ciklusa zdravljenja pri ženskah pred kirurškim posegom zaradi leiomiomov;
Uterine fibroids are non-cancerous (benign) tumours of the womb (uterus).
Maternični leiomiomi so nerakavi (benigni) tumorji maternice (uterusa).
Esmya has been shown to be effective in reducing symptoms as well as the size of the fibroids in women who were to have surgery for their fibroids and when used intermittently for longer periods (up to 4 treatment courses).
Pokazalo se je, da zdravilo Esmya učinkovito zmanjšuje simptome in velikost leiomiomov pri ženskah, pri katerih naj bi opravili kirurški poseg zaradi leiomiomov, in je učinkovito pri dolgotrajni uporabi s prekinitvami (v največ štirih ciklusih zdravljenja).
Esmya can only be obtained with a prescription, and treatment should be started and supervised by a doctor experienced in the diagnosis and treatment of uterine fibroids.
Predpisovanje in izdaja zdravila Esmya je le na recept, zdravljenje pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem materničnih leiomiomov.
For the full list of all side effects reported with Esmya, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Esmya, glejte navodilo za uporabo.
The medicine contains the active substance ulipristal acetate.
Vsebuje učinkovino ulipristalacetat.
When progesterone activity is blocked, fibroid cells stop dividing and eventually die, which reduces the size of the fibroids and the symptoms caused by them.
Ko je dejavnost progesterona zavrta, se celice leiomioma nehajo deliti in sčasoma odmrejo.
How does Esmya work?
Kako zdravilo Esmya deluje?
Rare but serious cases of liver injury have been reported with the medicine and measures have been put in place to minimise this risk.1 Although endometrial thickening was seen in some patients, it normally disappeared after stopping treatment.
Pri uporabi zdravila so poročali o redkih, a resnih primerih okvare jeter, zato so bili vzpostavljeni ukrepi za zmanjšanje tega tveganja
How is Esmya used?
Kako se zdravilo Esmya uporablja?
A card will also be given to patients to inform them about the need for liver monitoring and to contact their doctor if they develop symptoms of liver injury (such as tiredness, yellowing of the skin, darkening of the urine, nausea and vomiting).
zdravnikom, če se pri njih pojavijo simptomi okvare jeter (kot so utrujenost, porumenela koža, temen urin, siljenje na bruhanje in bruhanje).
MA (EU) Number (Invented) name Strength Pharmaceutical form Route of administration Immediate Packaging Pack size blister (PVC/alu)
Farmacevtska oblika Pot uporabe Stična ovojnina Velikost pakiranja
Medicinal product no longer authorised
Zdravilo nim a več dovoljenja za prom et
In some Member States, these medicines were available without prescription.
V nekaterih državah članicah so bila ta zdravila na voljo brez recepta.
The review of fusafungine-containing medicines was initiated on 11 September 2015 at the request of Italy, under Article 31 of Directive 2001/83/EC.
Pregled zdravil, ki vsebujejo fuzafungin, se je začel 11. septembra 2015 na zahtevo Italije v skladu s členom 31 Direktive 2001/83/ES.
They were authorised through national approval procedures under various trade names (Bioparox, Fusaloyos, Locabiotal and Locabiosol) in the following countries: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Portugal, Romania, Slovakia and Spain.
Odobrena so bila z nacionalnimi postopki odobritve pod različnimi tržnimi imeni (Bioparox, Fusaloyos, Locabiotal and Locabiosol) v naslednjih državah: Avstrija, Belgija, Bolgarija, Ciper, Češka republika, Estonija, Nemčija, Grčija, Madžarska, Irska, Italija, Latvija, Litva, Luksemburg, Malta, Portugalska, Romunija, Slovaška in Španija.
Fusafungine-containing medicines have been available in several EU countries for over 50 years.
Zdravila, ki vsebujejo fuzafungin, so bila na voljo v različnih državah EU več kot 50 let.
• Healthcare professionals should advise patients on alternative treatments, if needed.
• Zdravstveni delavci bi morali bolnikom po potrebi svetovati nadomestno zdravljenje.
The CMDh is a regulatory body representing EU Member States as well as Iceland, Liechtenstein and Norway.
Skupina CMDh je regulativni organ, ki zastopa države članice EU ter Islandijo, Lihtenštajn in Norveško.
As fusafungine-containing medicines are all authorised nationally, the PRAC recommendations were forwarded to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position on 31 March 2016.
Ker so vsa zdravila, ki vsebujejo fuzafungin, odobrena na nacionalni ravni, so bila priporočila odbora PRAC posredovana Usklajevalni skupini za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh), ki je sprejela dokončno stališče 31. marca 2016.
• These sprays are being taken off the market in the EU because of rare cases of serious allergic reactions and the lack of strong evidence that these medicines work.
• Ta pršila se jemljejo s trga v EU zaradi redkih primerov resnih alergijskih reakcij in pomanjkanja trdnih dokazov, da so ta zdravila učinkovita.
In addition, there were concerns about the potential for fusafungine to promote antibiotic resistance (the ability of bacteria to grow in the presence of an antibiotic that would normally kill them or limit their growth).
Poleg tega se je pojavila zaskrbljenost, da ima fuzafungin potencial za spodbujanje antibiotične odpornosti (sposobnosti bakterij, da rastejo v prisotnosti antibiotika, ki bi jih navadno ubil ali omejil njihovo rast).
During its review the PRAC consulted EMA's paediatric scientific committee as well as experts in the field of anti-infective medicines.
Med pregledom se je odbor PRAC posvetoval z znanstvenim odborom za pediatrijo agencije EMA in s strokovnjaki za zdravila proti okužbam.
Although the review found that serious allergic reactions are rare, they can be life-threatening and no measures have been identified to sufficiently reduce or manage this risk.
Čeprav je bilo med pregledom ugotovljeno, da so resne alergijske reakcije redke, so lahko smrtno nevarne, poleg tega ni opredeljenih ukrepov, ki bi zadostno zmanjšali ali obvladali to tveganje.
Medicines to be withdrawn due to serious allergic reactions and limited evidence of benefit
Zdravila, ki jih je treba umakniti zaradi resnih alergijskih reakcij in omejenih dokazov o koristih.
The benefit-risk balance for fusafungine-containing medicines is therefore negative for all currently authorised uses.
Razmerje med tveganji in koristmi zdravil, ki vsebujejo fuzafungin, je zato negativno za vse trenutno odobrene uporabe.
With regard to the benefits, the evidence for beneficial effects of fusafungine is weak.
Kar zadeva koristi, so dokazi za koristne učinke fuzafungina šibki.
This follows a review by EMA's Pharmacovigilance Risk Assessment Committee (PRAC) which concluded that the benefits of fusafungine do not outweigh its risks, particularly the risk of serious allergic reactions.
To izhaja iz pregleda Odbora za oceno tveganja na področju farmakovigilance (PRAC) agencije EMA, ki je sklenil, da koristi fuzafungina ne odtehtajo njegovih tveganj, zlasti tveganja za resne alergijske reakcije.
Although there is insufficient evidence to establish that fusafungine can increase the risk of resistance, this risk could not be ruled out.
Čeprav ni dovolj dokazov za utemeljitev, da lahko fuzafungin poveča tveganje za razvoj odpornosti, tega tveganja ni mogoče izključiti.
The CMDh1 has endorsed by consensus the revocation of marketing authorisations for fusafungine sprays in the EU.
Skupina CMDh1 je soglasno podprla razveljavitev dovoljenj za promet s pršili s fuzafunginom v EU.
Serious allergic reactions have occurred soon after the use of these sprays and involved bronchospasm (excessive and prolonged contractions of the airway muscles leading to difficulty breathing).
Kmalu po uporabi teh pršil so se pojavile resne alergijske reakcije, med drugim bronhospazem (čezmerno in podaljšano krčenje mišic dihal, ki povzroči oteženo dihanje).
• Upper airway infections are usually mild and self-limiting.
• Okužbe zgornjih dihal so navadno blage in izzvenijo same.
Following the CMDh consensus position, EU Member States will start revoking the marketing authorisations of these medicines in their territories, according to an agreed timetable.
V skladu s soglasnim stališčem skupine CMDh bodo države članice EU začele z razveljavitvijo dovoljenj za promet s temi zdravili na svojih ozemljih po dogovorjeni časovnici.
Fusafungine is an antibiotic and anti-inflammatory medicine used in the form of a nasal and oromucosal (to be applied to the mouth) spray for the treatment of the following infections of the upper airways: sinusitis (sinus infection), rhinitis (stuffy and runny nose), rhinopharyngitis (common cold), tonsillitis (inflammation of the tonsils caused by an infection) and laryngitis (inflammation of the voice box).
Fuzafungin je antibiotično in protivnetno zdravilo, ki se uporablja v obliki nazalnega in oromukoznega (za uporabo v ustih) pršila za zdravljenje teh okužb zgornjih dihal: sinuzitis (okužba sinusov), rinitis (zamašen nos ali izcedek iz nosu), rinofaringitis (običajen prehlad), tonzilitis (vnetje mandljev zaradi okužbe) in laringitis (vnetje glasilk).
Taking into account the mild and self-limiting nature of upper airway infections such as rhinopharyngitis, the benefits of fusafungine were not considered to outweigh the risks.
Ob upoštevanju blage narave okužb zgornjih dihal, kot je rinofaringitis, in dejstva, da izzvenijo same, koristi fuzafungina ne odtehtajo tveganj.
• Fusafungine nose and mouth sprays have been used to treat upper airway infections.
• Pršila s fuzafunginom za nos in usta so se uporabljala za zdravljenje okužb zgornjih dihal.
As the CMDh adopted its position by consensus, the measures recommended by the PRAC will be implemented directly by the Member States where the medicines are authorised, according to an agreed timetable.
Skupina CMDh je soglasno sprejela svoje stališče, zato bodo države članice, v katerih so zdravila odobrena, morale izvajati ukrepe odbora PRAC v skladu z dogovorjeno časovnico.
Fusafungine is an antibiotic and anti-inflammatory nose and mouth spray used to treat upper airway infections such as rhinopharyngitis (common cold).
Fuzafungin je antibiotično in protivnetno pršilo za nos in usta, ki se uporablja za zdravljenje okužb zgornjih dihal, kot je rinofaringitis (običajni prehlad).
• Symptomatic treatment of veno-lymphatic insufficiency All references to the above mentioned indications should be deleted from the remaining relevant sections of the summaries of product characteristics.
• simptomatsko zdravljenje veno-limfatične insuficience Vse reference, ki se nanašajo na zgoraj omenjene indikacije je treba izbrisati iz preostalih ustreznih poglavij povzetkov glavnih značilnosti zdravila.
• Prophylaxis of migraine headache
• profilaksa migrenskih glavobolov
[the below currently approved indications should be deleted (specific wording of the indication may vary from product to product)]
4.1 Terapevtske indikacije [trenutno odobrene spodaj naštete indikacije je treba izbrisati (specifično besedilo za indikacije lahko varira od zdravila do zdravila)]
A. Summary of Product Characteristics
A. POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
All references to the above mentioned indications should be deleted from the relevant sections of the package leaflets.
Vse reference, ki se nanašajo na zgoraj omenjene indikacije je treba izbrisati iz ustreznih poglavij navodil za uporabo.
Annex III Amendments to relevant sections of the summaries of product characteristics and package leaflets
Priloga III Popravki ustreznih poglavij v povzetku glavnih značilnosti zdravila in navodilu za uporabo
B. Package Leaflet
B. NAVODILO ZA UPORABO