natgillin/translations-raw huggingface dataset:
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JIH MORAJO IZPOLNITI DRŽAVE ČLANICE POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JIH MORAJO IZPOLNITI DRŽAVE ČLANICE
The Member States shall agree the details of a controlled distribution system with the MAH according to national regulations and healthcare systems and ensure that it is implemented nationally so that prior to prescribing (and at the discretion of the Member State, dispensing) all health care professionals who intend to prescribe (and where appropriate, dispense) Volibris have been provided with the following:
podatke o zdravilu (Povzetek glavnih značilnosti zdravila (SmPC) in Navodilo za uporabo) podatke o zdravilu Volibris za zdravstvene delavce kontrolni seznam dejstev/ preiskav, ki jih morajo poznati/ izvesti zdravniki pred začetkom zdravljenja
• • • • • • • • •
• • • • • •
Product information (Summary of Product Characteristics (SPC) and Package Leaflet) Healthcare professional information regarding Volibris Pre-prescription checklist for physicians Information about the post marketing surveillance study Information booklets for patients Information booklets for male partners of female patients with childbearing potential Patient reminder cards Pregnancy reporting forms Adverse drug reaction reporting forms
podatke o študiji spremljanja zdravila po pridobitvi dovoljenja za promet informacijske brošure za bolnike informacijske brošure za moške partnerje bolnic v rodni dobi opozorilne kartončke za bolnika obrazce za poročanje o nosečnosti obrazce za poročanje o neželenih učinkih zdravila
Health care Professional information The healthcare professional information regarding Volibris should contain the following key elements:
Podatki za zdravstvene delavce Podatki o zdravilu Volibris za zdravstvene delavce morajo vključevati naslednje bistvene elemente:
Obligations of health care professionals in relation to the prescribing of Volibris: o That patients should be capable of complying with the requirements for the safe use of Volibris. o The need to provide comprehensive advice and counselling to patients. o The need to provide patients with the appropriate information booklet(s) and patient reminder card. o Should consider monthly prescription of 30 day supply to ensure that patients and key test results are reviewed prior to further prescription. o That the safety database of Volibris is limited and physicians are encouraged to enrol patients in a post marketing surveillance study. o To report suspected adverse reactions and pregnancy.
Obveznosti zdravstvenih delavcev pri predpisovanju zdravila Volibris: o presoditi morajo, da so bolniki sposobni izpolnejvati zahteve glede varne uporabe zdravila Volibris. o bolnikom morajo zagotoviti razumljiv nasvet in svetovanje. o bolnikom morajo zagotoviti ustrezno informacijsko brošuro (brošure) in opozorilni kartonček za bolnika. o presoditi morajo o mesečnem predpisovanju zdravila za 30- dnevno zalogo, da lahko pred nadaljnjim predpisovanjem pregledajo tako bolnika kot rezultate ključnih testov. o seznaniti se morajo s celotno podatkovno bazo o varnosti zdravila Volibris in možnostjo vključitve bolnikov v študijo spremljanja zdravila po pridobitvi dovoljenja za promet. o poročati morajo o sumu na neželene učinke in o primerih nosečnosti.
That Volibris is teratogenic o Volibris is contraindicated in pregnancy and in women of child bearing potential who are not using reliable contraception. o That women receiving Volibris should be advised of the risk of foetal harm. o Guidance for identifying women of child bearing potential and the actions the physician should take if unsure.
Da je zdravilo Volibris teratogeno o Uporaba zdravila Volibris je kontraindicirana med nosečnostjo in pri ženskah v rodni dobi, ki ne uporabljajo zanesljive metode kontracepcije. o Ženske, ki se zdravijo z zdravilom Volibris, je treba seznaniti s tveganjem za okvaro plodu. o Smernice za ugotovitev rodne dobe pri ženskah in ukrepe, ki jih morajo v primeru negotovosti izvesti zdravniki.
Exclusi on of pregnancy prior to treatment initiation and monthly pregnancy testing during treatment.
2/ 4 Za ženske v rodni dobi Izključitev nosečnosti pred začetkom zdravljenja in mesečno izvajanje testov za o ugotavljanje nosečnosti med zdravljenjem.
The need t o advise women (even if a woman has amenorrhoea) on the use of reliable contraception during treatment and for one month following permanent discontinuation of treatment.
Ženskam (tudi ženskam z amenorejo) je treba svetovati, da morajo med zdravljenjem o in še en mesec po trajni ukinitvi zdravljenja uporabljati zanesljivo metodo kontracepcije.
Definiti on of reliable contraception and the need to seek expert advice if unsure what is suitable for an individual patient.
Opredeliti je treba zanesljivo metodo kontracepcije in v primeru negotovosti, kaj je o primerno za posamezno bolnico, pridobiti mnenje specialista.
That if a w omen of childbearing potential needs to change or stop her method of contraception she should inform: − The physician prescribing her contraception that she is taking Volibris − The physician prescribing Volibris that she has changed or stopped her method of contraception.
Da mora ženska v rodni dobi, ki mora spremeniti ali prenehati uporabljati dosedanjo o metodo kontracepcije obvestiti: − zdravnika, ki ji je predpisal kontracepcijo o tem, da jemlje zdravilo Volibris − zdravnika, ki ji je predpisal zdravilo Volibris o tem, da je spremenila ali prenehala uporabljati dosedanjo metodo kontracepcije.
That the patient sh ould contact her doctor immediately if pregnancy is suspected and that alternative therapy should be initiated if pregnancy confirmed.
Da mora bolnica, ki misli da je zanosila, o tem nemudoma obvestiti svojega o zdravnika, in da je v primeru potrjene nosečnosti treba uvesti alternativno obliko zdravljenja.
The need to refer patients who become pregnant to a physician specialised or experienced in teratology and its diagnosis for evaluation and advice.
Da je bolnico, ki je zanosila, treba napotiti k specialistu ali zdravniku z izkušnjami v o teratologiji, ki mora izvesti diagnostične preiskave in podati svoje mnenje.
To report all cases of pregnancy occurring during therapy.
Poročati o vseh primerih nosečnosti, do katerih je prišlo med zdravljenjem. o
• That Volibris is potentially hepatotoxic o Contraindication in patients with severe hepatic impairment (with or without cirrhosis) and in patients with baseline values of hepatic aminotransferases (AST and/or ALT) > 3X ULN. o Hepatic aminotransferases (ALT and/or AST) should be evaluated prior to initiation of ambrisentan. o During therapy, monthly monitoring of ALT and AST is recommended. o Discontinuation of ambrisentan therapy if patients develop sustained, unexplained clinically significant ALT and/or AST elevation or if ALT and/or AST elevation is accompanied by signs or symptoms of hepatic injury (e.g. jaundice). o In subjects without clinical symptoms of hepatic injury or jaundice, reinitiation of ambrisentan may be considered following resolution of hepatic enzyme abnormalities.
• Da je zdravilo Volibris lahko hepatotoksično o Kontraindikacija pri bolnikih s hudo okvaro jeter (s cirozo ali brez) in pri bolnikih z izhodiščnimi vrednostmi jetrnih aminotransferaz (AST in/ ali ALT) > 3X ZNM (“ zgornje normalne meje ”). o Pred uvedbo zdravljenja z ambrisentanom je treba ovrednotiti vrednost jetrnih aminotransferaz (ALT in/ ali AST). o Med zdravljenjem je priporočljivo mesečno nadzirati vrednosti ALT in AST. o Če se pri bolniku pojavi trdovratno, nepojasnjeno klinično pomembno zvišanje vrednosti ALT in/ ali AST, ali če zvišanje vrednosti ALT in/ ali AST spremljajo znaki ali simptomi okvare jeter (npr. zlatenica), je treba zdravljenje z ambrisentanom prekiniti. o Pri osebah brez kliničnih simptomov okvare jeter ali zlatenice se o ponovni uvedbi zdravljenja z ambrisentanom lahko razmisli, ko nenormalnosti jetrnih encimov minejo.
• That treatment with Volibris often causes a decrease in haemoglobin and haematocrit o Initiation of Volibris is not recommended for patients with clinically significant anaemia. o Patients taking Volibris should have their haemoglobin and/or haematocrit levels measured regularly. o If tests show a clinically significant decrease in haemoglobin or haematocrit, and other causes have been excluded, consider reducing the dose of Volibris, or stopping treatment.
• Zdravljenje z zdravilom Volibris je pogosto povezano z znižanjem vrednosti hemoglobina in hematokrita o Pri bolnikih s klinično pomembno anemijo uvedba zdravljenja z zdravilom Volibris ni priporočljiva. o Pri bolnikih, ki jemljejo zdravilo Volibris, je treba redno nadzirati vrednosti hemoglobina in/ ali hematokrita. o Če preiskave pokažejo klinično pomembno znižanje vrednosti hemoglobina ali hematokrita in so drugi vzroki izključeni, je treba razmisliti o zmanjšanju odmerka zdravila Volibris ali o prekinitvi zdravljenja.
• That Volibris should be initiated with caution in patients with severe renal impairment.
3/ 4 • Da je pri bolnikih s hudo okvaro ledvic treba zdravljenje z zdravilom Volibris uvesti previdno.
3/4 Physician checklist The physician pre-prescription checklist will highlight the contraindications to the use of ambrisentan and important pre-prescription assessments including: • Liver function tests. • Determination of child bearing potential in female patients. • Pregnancy test if female patient with childbearing potential. • That women of child bearing potential are on reliable contraception.
Kontrolni seznam za zdravnike V kontrolnem seznamu za zdravnike morajo biti posebej poudarjene kontraindikacije za uporabo ambrisentana in pomembna dejstva/ preiskave, ki jih je treba poznati/ izvesti pred začetkom zdravljenja, vključno s/ z: • preiskavami delovanja jeter. • določitvijo rodne dobe pri bolnicah. • testom za ugotavljanje nosečnosti pri bolnicah v rodni dobi. • preverjanjem, če ženska v rodni dobi uporablja zanesljivo metodo kontracepcije.
Patient information The information for patients should include the following information: • That Volibris may cause serious birth defects in unborn babies conceived before, during, or within a month after stopping treatment. • That Volibris cannot be initiated if patient is pregnant. • Women with childbearing potential must have a pregnancy test immediately prior to the first prescription and at monthly intervals whilst taking Volibris. • The need to ensure that women of child bearing potential are using reliable contraception and that patients should inform their doctors of any possibility of pregnancy before a new prescription is issued. • That if a women of childbearing potential needs to change or stop her method of contraception she should inform: o The physician prescribing her contraception that she is taking Volibris o The physician prescribing Volibris that she has changed or stopped her method of contraception • The need for female patients to contact their treating doctor immediately if they suspect that they might be pregnant. • The need for the patient to discuss with her doctor if she is planning to become pregnant. • That Volibris may cause liver injury. • That because of the potential for liver injury and anaemia, patients should have regular blood tests and also tell their doctor if experiencing any symptoms of liver injury. • That the patient should not give Volibris to any other person. • That the patient should tell their doctor about any adverse event.
Podatki za bolnike Podatki za bolnike morajo vključevati naslednje podatke: • da lahko zdravilo Volibris povzroči resne okvare ploda, če ženska zanosi pred, med ali v enem mesecu po prekinitvi zdravljenja. • da se zdravljenje z zdravilom Volibris ne sme uvesti, če je bolnica noseča. • da morajo ženske v rodni dobi neposredno pred začetkom zdravljenja z zdravilom Volibris opraviti test za ugotavljanje nosečnosti in ga nato med zdravljenjem opravljati v mesečnih intervalih. • da morajo ženske v rodni dobi uporabljati zanesljivo metodo kontracepcije in da morajo bolnice pred izdajo novega recepta svojega zdravnika obvestiti o vsaki možnosti zanositve. • da mora ženska v rodni dobi, ki mora spremeniti ali prenehati uporabljati dosedanjo metodo kontracepcije obvestiti: o zdravnika, ki ji je predpisal kontracepcijo o tem, da jemlje zdravilo Volibris o zdravnika, ki ji je predpisal zdravilo Volibris o tem, da je spremenila ali prenehala uporabljati dosedanjo metodo kontracepcije • da mora bolnica o vsaki možnosti zanositve nemudoma obvestiti svojega lečečega zdravnika. • da se mora bolnica posvetovati s svojim zdravnikom, če namerava zanositi. • da lahko zdravilo Volibris povzroči okvaro jeter. • da je zaradi možne okvare jeter in anemije treba redno izvajati krvne preiskave in da mora bolnik obvestiti svojega zdravnika, če se pojavi kakršenkoli simptom okvare jeter. • da bolnik zdravila Volibris ne sme dajati drugi osebi. • da mora bolnik svojega zdravnika obvestiti o vsakem neželenem učinku.
Booklet for male partners of women with childbearing potential The information for male partners of women with childbearing potential should include the following information: • That Volibris may cause serious birth defects in unborn babies conceived before, during, or within a month after stopping treatment. • The need to ensure that women of child bearing potential are using reliable contraception. • That Volibris cannot be taken if a woman is or might become pregnant.
Brošura za moške partnerje žensk v rodni dobi Podatki za moške partnerje žensk v rodni dobi morajo vključevati naslednje podatke: • da lahko zdravilo Volibris povzroči resne okvare ploda, če ženska zanosi pred, med ali v enem mesecu po prekinitvi zdravljenja. • da morajo ženske v rodni dobi uporabljati zanesljivo metodo kontracepcije. • da ženska, ki je ali bi lahko bila noseča, ne sme jemati zdravila Volibris.
Patient reminder card • This should include key messages regarding the need for regular blood and pregnancy tests and provide spaces for the dates of appointments and the results of tests.
Opozorilni kartonček za bolnika • Vključevati mora bistvene podatke o potrebnosti rednega izvajanja krvnih preiskav in testov za ugotavljanje nosečnosti ter imeti predviden prostor za vpisovanje terminov in rezultatov opravljenih preiskav.
Volibris is a medicine containing the active substance ambrisentan.
Volibris je zdravilo, ki vsebuje zdravilno učinkovino ambrisentan.
It is available as tablets (pale pink, square:
Na voljo je v obliki tablet (svetlorožnate, kvadratne:
5 mg; deep pink, oval:
5 mg; temnorožnate, ovalne:
Volibris is used for the treatment of patients with pulmonary arterial hypertension (PAH) to improve exercise capacity (the ability to carry out physical activity).
Zdravilo Volibris se uporablja za zdravljenje bolnikov s pljučno arterijsko hipertenzijo (PAH) z namenom izboljšanja telesne zmogljivosti (zmožnosti izvajanja fizičnih aktivnosti).
PAH is abnormally high blood pressure in the arteries of the lungs.
PAH je nenormalno visok krvni tlak v pljučnih arterijah.
Volibris is used in patients with class II or III disease.
Zdravilo Volibris se uporablja pri bolnikih z boleznijo razreda II ali III.
The ‘ class ’ reflects the seriousness of the disease: ‘ class II ’ involves slight limitation of physical activity and ‘ class III’ involves marked limitation of physical activity.
„ razred II “ vključuje majhne omejitve z vidika fizičnih aktivnosti, „ razred III “ pa izrazite omejitve z vidika fizičnih aktivnosti.
The effectiveness of Volibris has been shown in PAH with no identified cause and in PAH caused by connective tissue disease.
Učinkovitost zdravila Volibris je bila dokazana pri PAH brez znanega vzroka in pri PAH, povezani z boleznijo vezivnega tkiva.
Because the number of patients with PAH is low, the disease is considered ‘ rare’, and Volibris was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 11 April 2005.
Ker je število bolnikov s PAH majhno, velja ta bolezen za redko, zato je bilo zdravilo Volibris dne 11. aprila 2005 določeno kot „ zdravilo sirota “ (zdravilo, ki se uporablja pri redkih boleznih).
Treatment with Volibris must be initiated by a doctor who has experience in the treatment of PAH.
Zdravljenje z zdravilom Volibris mora uvesti zdravnik z izkušnjami z zdravljenjem PAH.
The standard dose of Volibris is 5 mg once a day.
Standardni odmerek zdravila Volibris je 5 mg enkrat dnevno.
The tablets should be swallowed whole, with or without food.
Tablete je treba pogoltniti cele, s hrano ali brez.
A 10 mg dose may have a greater effect in patients with class III disease but this is associated with an increased risk of fluid retention and swelling.
Pri bolnikih z boleznijo razreda III utegne imeti večji učinek 10- miligramski odmerek, vendar pa je ta povezan s povečanim tveganjem za zastajanje tekočin in otekanje.
Patients with PAH caused by connective tissue disease may also need to take 10 mg to get the best benefit from Volibris.
Bolniki s PAH, ki je posledica bolezni vezivnega tkiva, utegnejo za doseganje optimalnega učinka zdravila Volibris prav tako potrebovati 10- miligramski odmerek.
The dose should only be increased if the 5 mg dose is well tolerated.
Odmerek je dopustno povečati le, če bolnik 5- miligramski odmerek dobro prenaša.
Volibris is not recommended for use in patients below 18 years of age because of a lack of information on safety and effectiveness in this group.
Uporaba zdravila Volibris pri bolnikih, mlajših od 18 let, zaradi pomanjkanja podatkov o varnosti in učinkovitosti v tej skupini ni priporočljiva.
In patients who have severe problems with their kidneys, treatment with Volibris should be started with caution, and a dose increase should be carried out with particular care.
Pri bolnikih s hudimi težavami z ledvicami je treba zdravljenje z zdravilom Volibris uvesti previdno, pri povečanju odmerka pa je potrebna še posebna previdnost.
Volibris should not be used in patients who have severe liver problems as it has not been studied in this group.
Zdravila Volibris ne smejo uporabljati bolniki s hudimi težavami z jetri, saj njegove uporabe v tej skupini niso preučevali.
Reproduction is authorised provided the source is acknowledged. pressure reduces the amount of oxygen that can get into the blood in the lungs, making physical activity more difficult.
PAH je onesposabljajoča bolezen, pri kateri pride do hude konstrikcije (zoženja) žilja v pljučih.
The active substance in Volibris, ambrisentan, blocks the receptors for a hormone called endothelin, which causes blood vessels to constrict.
Zdravilna učinkovina ambrisentan, ki jo vsebuje zdravilo Volibris, blokira receptorje za hormon, imenovan endotelin, ki povzroča krčenje žil.
By blocking the effect of endothelin, Volibris allows the vessels to dilate (expand), helping to lower the blood pressure and improving symptoms.
S preprečevanjem učinka endotelina omogoči zdravilo Volibris širjenje žil, kar prispeva k znižanju krvnega tlaka in izboljšanju simptomov.
The effects of Volibris were first tested in experimental models before being studied in humans.
Učinki zdravila Volibris so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
The effectiveness of Volibris was studied in two main studies involving a total of 394 patients with PAH, most of whom had class II or III disease (slight or marked limitation of physical activity).
Učinkovitost zdravila Volibris so preučevali v dveh glavnih študijah s skupno 394 bolniki s PAH, pri čemer je večina imela bolezen razreda II ali III (majhna ali izrazita omejitev fizične aktivnosti).
The studies compared various doses of Volibris (2.5, 5 and 10 mg) with placebo (a dummy treatment).
V študijah so primerjali različne odmerke zdravila Volibris (2, 5, 5 in 10 mg) s placebom (zdravilom brez zdravilne učinkovine).
The main measure of effectiveness was the change in the distance the patients could walk in six minutes after 12 weeks of treatment.
Glavno merilo učinkovitosti je bila sprememba razdalje, ki jo je bolnik zmogel prehoditi v šestih minutah po 12 tednih zdravljenja.
This is a way of measuring the change in exercise capacity.
To je način merjenja spremembe telesne zmogljivosti.
Volibris was more effective than placebo at improving exercise capacity in patients with class II or III disease.
Zdravilo Volibris je bilo pri izboljševanju telesne zmogljivosti bolnikov z boleznijo razreda II ali III učinkovitejše od placeba.
Overall, in the two studies taken together, patients taking Volibris at a dose of 5 mg once a day could walk an average of 44.6 m further after 12 weeks of treatment, from a baseline of around 345 m at the start of the study.
Na podlagi rezultatov obeh študij skupaj je mogoče ugotoviti, da so bolniki, ki so prejemali zdravilo Volibris v odmerku 5 mg enkrat dnevno, zmogli po 12 tednih zdravljenja hoditi v povprečju 44, 6 m dlje v primerjavi z izhodiščno vrednostjo približno 345 m na začetku študije.
Patients taking placebo showed a reduction of 9.0 m after 12 weeks.
Bolniki, ki so prejemali placebo, so po 12 tednih izkazali skrajšanje prehojene razdalje za 9, 0 m.
Patients with class III disease and those with PAH caused by connective tissue disease gained a greater benefit from the 10 mg dose than from the 5 mg dose.
Bolniki z boleznijo razreda III in bolniki s PAH, ki je posledica bolezni vezivnega tkiva, so bili deležni večje koristi pri uporabi 10- miligramskega kot 5- miligramskega odmerka.
The most common side effects with Volibris (seen in more than 1 patient in 10) are headache (including sinus headache and migraine), peripheral oedema (swelling, especially of the ankles and feet) and fluid retention.
Najpogostejši neželeni učinki zdravila Volibris (opaženi pri več kot 1 bolniku izmed 10) so glavobol (vključno s sinusnim glavobolom in migreno), periferni edem (otekanje, še posebej gležnjev in stopal) ter zastajanje tekočin.
For the full list of all side effects reported with Volibris, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Volibris, glejte navodilo za uporabo.
Volibris should not be used in people who may be hypersensitive (allergic) to soya, ambrisentan or any of the other ingredients.
Zdravila Volibris ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) sojo, ambrisentan ali katero koli drugo sestavino.
Because it might be able to cause birth defects, Volibris should not be used in pregnant women or in women who could become pregnant unless they are using reliable contraception.
Ker utegne povzročati okvare ploda, se zdravilo Volibris ne sme uporabljati pri nosečnicah ali ženskah v rodni dobi, razen če uporabljajo zanesljive kontracepcijske metode.
It should not be used in patients who are breast feeding, who have severe liver problems or who have high levels of liver enzymes in the blood.
Ne sme se uporabljati pri osebah, ki dojijo, imajo hude težave z jetri ali imajo visoke vrednosti jetrnih encimov v krvi.
The Committee for Medicinal Products for Human Use (CHMP) decided that Volibris’ s benefits are greater than its risks for the treatment of patients with PAH classified as WHO functional class II and III, to improve exercise capacity.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Volibris pri zdravljenju bolnikov s PAH, razvrščenih v funkcijski razred II in III po klasifikaciji SZO, z namenom izboljšanja telesne zmogljivosti večje od z njim povezanih tveganj.
The Committee recommended that Volibris be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Volibris odobri dovoljenje za promet.
Which measures are being taken to ensure the safe use of Volibris?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Volibris?