FrancophonIA/ELRC3.0 huggingface dataset:
English: ● Risk Management Plan (RMP)
Slovenian: • Načrt za obvladovanje tveganj (RMP) Imetnik dovoljenja za promet z zdravilom bo izvedel farmakovigilančne aktivnosti in ukrepe,
English: Elevations in ALT and AST >3 × upper limit of normal (ULN) have been reported in patients receiving therapy with Esbriet.
Slovenian: Pri bolnikih, ki so se zdravili z zdravilom Esbriet, so poročali o zvišanju vrednosti ALT in AST na vrednost, večjo od trikratne zgornje meje normalnih vrednosti (Upper Limit of Normal, ULN).
English: Angioedema1
Slovenian: Bolezni imunskega sistema Občasni angioedem1
English: Dose adjustments or temporary treatment discontinuation may be necessary in mild to severe cases of photosensitivity reaction or rash (see section 4.2).
Slovenian: V primerih blage do hude reakcije preobčutljivosti na svetlobo ali izpuščaja bo morda treba prilagoditi odmerek ali pa začasno prekiniti zdravljenje (glejte poglavje 4.2).
English: 60 (p<0.001).
Slovenian: 39. tednu (p = 0,000002) glede na izhodiščno vrednost.
English: Film-coated tablet Multipack containing 252 (3 packs each containing 4 blisters of 21) film-coated Tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA filmsko obložena tableta skupno pakiranje, ki vsebuje 252 (3 pakiranja, od katerih vsako vsebuje 4 pretisne omote po 21)
English: The primary endpoint was the change from Baseline to Week 52 in percent predicted FVC.
Slovenian: Primarni cilj je bila sprememba v 52. tednu glede na izhodiščno vrednost v odstotkih predvidene forsirane vitalne kapacitete.
English: Esbriet is contraindicated in patients with concomitant use of fluvoxamine (see section 4.3).
Slovenian: Zdravilo Esbriet je kontraindicirano pri bolnikih, ki sočasno uporabljajo fluvoksamin (glejte poglavje 4.3); jemanje fluvoksamina je treba opustiti pred začetkom zdravljenja z zdravilom Esbriet,
English: The film coat consists of: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide yellow (E172)
Slovenian: Filmsko oblogo sestavljajo: polivinilalkohol, titanov dioksid (E171), makrogol 3350, smukec in rumeni železov oksid (E172).
English: Tel: +44 (0) 1707 366000
Slovenian: Roche Products Ltd. Tel: +44 (0) 1707 366000
English: If any of the above affects you, do not take Esbriet.
Slovenian: Če kaj od naštetega velja za vas, ne vzemite zdravila Esbriet.
English: Dyspnoea; cough; productive cough Gastrointestinal disorders Very Common Dyspepsia; nausea; diarrhoea Common
Slovenian: Bolezni prebavil Zelo pogosti dispepsija, navzea, driska
English: ● muscle pain, aching joints/joint pains
Slovenian: • bolečine v mišicah, trganje/bolečine v sklepih,
English: ● Days 8 to 14: two capsules, three times a day (1602 mg/day)
Slovenian: • 8.-14. dan: dve kapsuli trikrat na dan (1602 mg/dan) • Od 15. dne dalje: tri kapsule trikrat na dan (2403 mg/dan)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/020
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/667/020
English: ● You should tell your doctor if you suffer from mild to moderate liver problems.
Slovenian: • Če imate blage do zmerne težave z jetri, to povejte zdravniku.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/017 252 tablets (3 x 84)
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/667/017 252 tablet (3 × 84)
English: Package leaflet: Information for the user Esbriet 267 mg hard capsules Pirfenidone
Slovenian: Navodilo za uporabo Esbriet 267 mg trde kapsule pirfenidon
English: Esbriet therapy should not be used in patients with severe renal impairment (CrCl <30 ml/min) or end stage renal disease requiring dialysis (see sections 4.3 and 5.2).
Slovenian: Pri bolnikih s hudo okvaro ledvic (očistek kreatinina < 30 ml/min) ali končno odpovedjo ledvic, pri kateri je potrebna dializa, se zdravljenje z zdravilom Esbriet ne sme izvajati (glejte poglavji 4.3 in 5.2).
English: ● shortness of breath
Slovenian: • bolečine v prsnem košu,
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/019 252 tablets (3 x 84)
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/667/019 252 tablet (3 × 84)
English: Dizziness
Slovenian: Esbriet
English: No dose adjustment is necessary in patients with mild renal impairment.
Slovenian: Pri bolnikih z blago okvaro ledvic odmerka ni treba prilagajati.
English: ● sunburn.
Slovenian: • omotica,
English: INFORMATION IN BRAILLE esbriet 534 mg tablets
Slovenian: esbriet 534 mg tablete
English: Continuation pack: multipack containing 252 (3 packs each containing 4 blisters of 21) film-coated tablets
Slovenian: Nadaljevalno pakiranje: skupno pakiranje, ki vsebuje 252 (3 pakiranja, od katerih vsako vsebuje
English: ● Patient information (PIL)
Slovenian: • informacije o zdravilu (povzetek glavnih značilnosti zdravila)
English: 250 ml white HDPE bottle with child-resistant closure containing 270 capsules.
Slovenian: 250 ml plastenka bele barve iz polietilena visoke gostote z za otroke varno zaporko; vsebuje
English: Esbriet 801 mg film-coated tablets are brown, oval, approximately 2 x 0.9 cm biconvex film-coated tablets, debossed with “PFD”.
Slovenian: Esbriet 801 mg filmsko obložene tablete so rjave, ovalne, velike približno 2 x 0,9 cm, bikonveksne,
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: PROIZVAJALEC (PROIZVAJALCI), ODGOVOREN
English: 4 years for bottles.
Slovenian: 6.3 Rok uporabnosti 4 leta za pretisne omote.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/016 63 tablets (21 + 42)
Slovenian: EU/1/11/667/016 63 tablet (21 + 42)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/021
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/667/021
English: Myalgia; arthralgia
Slovenian: Tor. Sre.
English: The studies were nearly identical in design, with few exceptions including an intermediate dose group (1,197 mg/day) in PIPF-004.
Slovenian: 004 dobivala srednje velik odmerek (1197 mg/dan), po zasnovi skoraj identični.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/011
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/667/011
English: ● feeling sick (nausea)
Slovenian: • utrujenost, • driska,
English: High-Density Polyethylene (HDPE) bottle with a child-resistant and tamper-evident screw cap Pack sizes
Slovenian: 6.5 Vrsta ovojnine in vsebina Plastenka iz polietilena visoke gostote (HDPE) z za otroke varno zaporko, ki je ni mogoče odpreti brez vidnih znakov odpiranja
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/018 84 tablets (4x21)
Slovenian: EU/1/11/667/018 84 tablet (4 × 21)
English: Respiratory, thoracic and mediastinal disorders Common
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora Pogosti dispneja, kašelj, produktivni kašelj
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/005
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/667/005
English: Pruritus; erythema; dry skin; rash erythematous; rash macular; rash pruritic Musculoskeletal and connective tissue disorders Common
Slovenian: Pogosti srbečica, eritem, suha koža, eritematozni izpuščaj, makularni izpuščaj, srbeči izpuščaj
English: 2 bottles each containing 21 film-coated tablets (42 film-coated tablets in total) 1 bottle containing 42 film-coated tablets 1 bottle containing 90 film-coated tablets 2 bottles each containing 90 film-coated tablets (180 film-coated tablets in total) 1 bottle containing 180 film-coated tablets
Slovenian: 2 plastenki, od katerih vsaka vsebuje 90 filmsko obloženih tablet (skupno 180 filmsko obloženih tablet) 1 plastenka s 180 filmsko obloženimi tabletami
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/002
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/667/002
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/009
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/667/009
English: Film-coated tablet 21 film-coated tablets.
Slovenian: 21 filmsko obloženih tablet
English: Talk to your doctor or pharmacist before taking Esbriet
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Esbriet Ne jemljite zdravila Esbriet
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/667/001
English: Roche Registration GmbH Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany
Slovenian: D-79639 Grenzach-Whylen Nemčija
English: Printing Inks
Slovenian: PODATKI NA ZUNANJI OVOJNINI
English: Do not store this medicine above 30ºC.
Slovenian: Shranjujte pri temperaturi do 30 °C
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/007
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/667/007
English: Multipack containing 252 (3 packs each containing 4 blisters of 21) film-coated tablets
Slovenian: 2 plastenki, od katerih vsaka vsebuje 21 filmsko obloženih tablet (skupno 42 filmsko obloženih tablet)
English: ● loss of appetite
Slovenian: • izguba telesne mase,
English: Skin and subcutaneous tissue disorders Very Common Photosensitivity reaction; rash Common
Slovenian: Zelo pogosti reakcija preobčutljivosti na svetlobo, izpuščaj
English: The decline in distance walked during a 6MWT from Baseline to Week 52 was significantly reduced in patients receiving Esbriet compared with patients receiving placebo in PIPF-016 (p=0.036, rank
Slovenian: V študiji PIPF-016 se je razdalja, prehojena v šestminutnem testu hoje v 52. tednu, glede na izhodiščno vrednost značilno manj zmanjšala pri bolnikih, ki so dobivali zdravilo Esbriet, v primerjavi z bolniki, ki so dobivali placebo (p = 0,036, rang ANCOVA); pri 26 % bolnikov, ki so dobivali zdravilo Esbriet, se je razdalja v šestminutnem testu hoje zmanjšala za ≥ 50 m v primerjavi s 36 %
English: Patients should drink plenty of water throughout the day.
Slovenian: Bolniki morajo čez dan popiti veliko vode.
English: The recommended dose is one tablet once daily, in the morning.
Slovenian: Priporočeni odmerek je ena tableta enkrat na dan zjutraj.
English: Further information on Duzallo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Nadaljnje informacije za zdravilo Duzallo so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Duzallo (allopurinol / lesinurad)
Slovenian: Duzallo (alopurinol/lesinurad)
English: Allopurinol has been marketed in the EU since the 1960s.
Slovenian: Alopurinol se v EU trži od šestdesetih let prejšnjega stoletja.
English: What measures are being taken to ensure the safe and effective use of Duzallo?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Duzallo?
English: Other information about Duzallo
Slovenian: Druge informacije o zdravilu Duzallo
English: The European Medicines Agency decided that Duzallo's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Duzallo večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: Combining the active substances in a single tablet has the advantage of simplifying treatment.
Slovenian: Prednost kombinacije učinkovin v eni tableti je poenostavitev zdravljenja.
English: Duzallo is available as tablets containing either 200 or 300 mg of allopurinol in combination with 200 mg of lesinurad.
Slovenian: Zdravilo Duzallo je na voljo v obliki tablet, ki vsebujejo 200 ali 300 mg alopurinola v kombinaciji z 200 mg lesinurada.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Duzallo have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Duzallo upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Lesinurad has been authorized in the EU as Zurampic since 2016.
Slovenian: Lesinurad je v EU odobren od leta 2016 kot zdravilo Zurampic.
English: What benefits of Duzallo have been shown in studies?
Slovenian: Kakšne koristi zdravila Duzallo so se pokazale v študijah?
English: It must also not be taken in patients with tumour lysis syndrome (a complication due to the rapid breakdown of cancer cells during cancer treatment) or Lesch-Nyhan syndrome (a rare genetic disease).
Slovenian: Ne smejo ga jemati bolniki s sindromom lize tumorja (zapletom zaradi hitre razgradnje rakavih celic med zdravljenjem raka) ali Lesch-Nyhanovim sindromom (redko dedno boleznijo).
English: As for all medicines, data on the use of Duzallo are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Duzallo stalno spremljajo.
English: Side effects reported with Duzallo are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Duzallo, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Why is Duzallo authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Duzallo odobreno v EU?
English: The most common side effects with Duzallo (which may affect up to 1 in 10 people) are flu, gastrooesophageal reflux disease (stomach acid coming back to the mouth), headache and blood tests showing increased blood creatinine levels (a marker of kidney function).
Slovenian: Najpogostejši neželeni učinki zdravila Duzallo (ki se lahko pojavijo pri največ 1 od 10 bolnikov) so gripa, gastroezofagealna refluksna bolezen (vračanje želodčne kisline nazaj v usta), glavobol ter izvidi krvnih preiskav, ki kažejo na zvišano koncentracijo kreatinina v krvi (označevalca delovanja ledvic).
English: What are the risks associated with Duzallo?
Slovenian: Kakšna tveganja so povezana z zdravilom Duzallo?
English: For more information about using Duzallo, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Duzallo glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: The safety profile of Duzallo is similar to the individual components.
Slovenian: Varnostni profil zdravila Duzallo je podoben kot pri posameznih učinkovinah.
English: Gout results from a build-up of uric acid crystals in and around the joints, especially in the toes, which causes pain and swelling.
Slovenian: Protin nastane zaradi kopičenja kristalov sečne kisline v sklepih in okoli njih, zlasti v prstih na nogi, kar povzroča bolečino in otekanje.
English: An overview of Duzallo and why it is authorised in the EU
Slovenian: Pregled zdravila Duzallo in zakaj je odobreno v EU
English: What is Duzallo and what is it used for?
Slovenian: Kaj je zdravilo Duzallo in za kaj se uporablja?
English: The active substances in Duzallo have already been shown to be effective when used as separate tablets.
Slovenian: Učinkovini zdravila Duzallo sta se že izkazali za učinkoviti, kadar se uporabljata v obliki ločenih tablet.
English: The most serious adverse reactions were kidney failure, reduced kidney function, and kidney stones, which affected less than 1 patient in 100.
Slovenian: Najresnejši neželeni učinki so bili ledvična odpoved, okvarjeno delovanje ledvic in ledvični kamni; ti učinki so se pojavili pri manj kot 1 od 100 bolnikov.
English: Duzallo must not be taken by patients with severely reduced kidney function, including those who have severely impaired kidney function, who are on dialysis or have received a kidney transplant.
Slovenian: Zdravila Duzallo ne smejo jemati bolniki z hudo okvaro delovanja ledvic, vključno s tistimi, ki imajo močno oslabljeno delovanje ledvic, se zdravijo z dializo ali so imeli presaditev ledvice.
English: It is used when allopurinol on its own is not able to control uric acid levels sufficiently.
Slovenian: Uporablja se, kadar samo z alopurinolom ni mogoče zadostno nadzorovati ravni sečne kisline.
English: The two active substances in Duzallo work in different ways to prevent the build-up of uric acid:
Slovenian: Učinkovini zdravila Duzallo delujeta na različne načine pri preprečevanju kopičenja sečne kisline:
English: • Lesinurad helps to remove uric acid from the body by blocking a protein called ‘uric acid transporter-1' (URAT1) in the kidneys.
Slovenian: • lesinurad pomaga pri izločanju sečne kisline iz telesa, tako da zavira beljakovino, imenovano prenašalec sečne kisline 1 (URAT1), v ledvicah.
English: By reducing the production of uric acid, allopurinol can reduce levels of uric acid in the blood and keep them low, stopping crystals from building up.
Slovenian: Z zmanjševanjem tvorbe sečne kisline lahko alopurinol zniža njeno koncentracijo v krvi in jo vzdržuje na nizki ravni ter tako ustavi kopičenje kristalov.
English: • Allopurinol reduces the production of uric acid in the body by blocking an enzyme called xanthine oxidase, which is needed to make uric acid in the body.
Slovenian: • alopurinol zmanjšuje tvorbo sečne kisline v telesu, tako da zavira encim, imenovan ksantinoksidaza, ki je potreben za tvorbo sečne kisline v telesu.
English: Two main studies showed that the combination of allopurinol and lesinurad can help lower uric acid levels when allopurinol on its own is not working well enough.
Slovenian: Dve glavni študiji sta pokazali, da lahko kombinacija alopurinola in lesinurada pomaga pri zniževanju ravni sečne kisline, kadar alopurinol, ki se daje samostojno, ne deluje dovolj dobro.
English: The two studies involved over 800 adults with gout whose blood level of uric acid was high (above 65 mg/litre) despite allopurinol treatment.
Slovenian: V obeh študijah je sodelovalo več kot 800 odraslih s protinom, ki so imeli kljub zdravljenju z alopurinolom visoko raven sečne kisline v krvi (več kot 65 mg/l).
English: By blocking URAT1, more uric acid is passed out in the urine and less remains in the blood.
Slovenian: Z zaviranjem beljakovine URAT1 se več sečne kisline izloča z urinom in je manj ostaja v krvi;
English: The strength of Duzallo tablet is chosen to match the dose of allopurinol the patient has been taking.
Slovenian: Jakost tablete Duzallo se določi na podlagi odmerka alopurinola, ki ga jemlje bolnik.
English: Two main studies showed that lesinurad in combination with allopurinol reduced the blood levels of uric acid in gout patients in whom allopurinol alone was not sufficient.
Slovenian: Dve glavni študiji sta pokazali, da je lesinurad v kombinaciji z alopurinolom zmanjšal ravni sečne kisline v krvi pri bolnikih s protinom, pri katerih samostojno zdravljenje z alopurinolom ni zadoščalo.
English: In addition two studies were carried out to show that Duzallo produced similar levels of active substances in the blood to the active substances given separately.
Slovenian: Dodatno so izvedli dve študiji, v katerih so pokazali, da je zdravilo Duzallo ustvarilo podobne ravni učinkovin v krvi, kot če se učinkovini dajeta samostojno.
English: For the full list of side effects reported with Duzallo, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Duzallo, glejte navodilo za uporabo.
English: Adding lesinurad 200 mg once daily to the treatment led to 55% patients having levels below 60 mg/litre after 6 months.
Slovenian: Dodajanje 200 mg lesinurada enkrat dnevno k zdravljenju je povzročilo, da je imelo 55 % bolnikov po šestih mesecih raven sečne kisline v krvi pod 60 mg/l, v primerjavi s 26 % bolnikov, ki so poleg alopurinola prejemali placebo (zdravilo brez učinkovine).
English: Duzallo contains the active substances allopurinol and lesinurad.
Slovenian: Zdravilo Duzallo vsebuje učinkovini alopurinol in lesinurad.
English: How does Duzallo work?
Slovenian: Kako zdravilo Duzallo deluje?
English: Duzallo is a medicine used in adults with gout to reduce high levels of uric acid in the blood.
Slovenian: Duzallo je zdravilo za zniževanje visoke koncentracije sečne kisline v krvi pri odraslih s protinom.
English: How is Duzallo used?
Slovenian: Kako se zdravilo Duzallo uporablja?
English: URAT1 allows uric acid to return to the blood after the kidneys have filtered it out.
Slovenian: Ko ledvice izločijo sečno kislino iz krvi, beljakovina URAT1 omogoča, da se sečna kislina vrne v kri.
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Slovenian: Države članice morajo zagotoviti, da so vsi pogoji ali omejitve v zvezi z varno in učinkovito uporabo zdravila, opisani spodaj, izvedeni:
English: • Key signs and symptoms of serious adverse events
Slovenian: • ključne znake in simptome resnih neželenih dogodkov,
English: The physician educational material should contain the following key elements:
Slovenian: Izobraževalni material za zdravnika mora vsebovati naslednje ključne sestavine:
English: The Member States shall ensure that the Marketing Authorisation Holder (MAH) will provide all physicians who are expected to prescribe/use Aclasta in the authorised indications of treatment of osteoporosis in post-menopausal women and in men at increased risk of fracture, including those with a recent low-trauma hip fracture, and treatment of osteoporosis associated with long-term systemic glucocorticoid therapy in post-menopausal women and in men at increased risk of fracture with an updated physician information pack containing the following:
Slovenian: Države članice morajo zagotoviti, da bo imetnik dovoljenja za promet (MAH) pripravil za vse zdravnike, ki bi lahko predpisovali/uporabljali zdravilo Aclasta za odobrene indikacije zdravljenja osteoporoze pri postmenopavzalnih ženskah in pri moških s povečanim tveganjem za zlome, vključno s tistimi z nedavnim zlomom kolka po lažji poškodbi, in zdravljenja osteoporoze zaradi dolgotrajnega zdravljenja s sistemskimi glukokortikoidi pri postmenopavzalnih ženskah in pri moških, pri katerih obstaja povečano tveganje za zlom, posodobljen izobraževalni material, ki vsebuje naslednje:
English: • Reminder card with the following key messages: o Need to measure serum creatinine before treatment with Aclasta o Contraindication in patients with creatinine clearance < 35 ml/min o Contraindication in pregnancy and in breast-feeding women due to potential teratogenicity o Need to ensure appropriate hydration of the patient o Need to infuse Aclasta slowly over a period of no less than 15 minutes o One-yearly dosing regime o Adequate calcium and vitamin D intake are recommended in association with Aclasta administration.
Slovenian: • Opomnik z naslednjimi ključnimi sporočili: o potrebnost meritve kreatinina v serumu pred zdravljenjem z zdravilom Aclasta, o kontraindikacija pri bolnikih z očistkom kreatinina < 35 ml/min, o kontraindikacije med nosečnostjo in dojenjem zaradi možne teratogenosti, o potrebo po zagotovitvi primerne hidriranosti bolnika, o potrebnost počasnega infundiranja zdravila Aclasta v času, ki ni krajši od 15 minut, o shemo odmerjanja enkrat letno, o priporočilo o zadostnem vnosu kalcija in vitamina D v zvezi z uporabo zdravila
English: The patient information pack should be provided and contain the following key messages:
Slovenian: Pripraviti je treba Komplet podatkov o zdravilu za bolnika, ki mora vsebovati naslednja ključna sporočila:
English: • Contraindication in pregnancy and in breast-feeding women
Slovenian: • kontraindikacije med nosečnostjo in dojenjem,
English: • Contraindication in patients with severe kidney problems
Slovenian: • kontraindikacijo za bolnike s hudimi težavami z ledvicami,
English: • Physician educational material • Patient information pack
Slovenian: • Izobraževalni material za zdravnika • Komplet podatkov o zdravilu za bolnika
English: • When to seek attention from the health care provider
Slovenian: • navodila o tem, kdaj je treba poiskati zdravniško pomoč.
English: • The Summary of Product Characteristics
Slovenian: • Povzetek glavnih značilnosti zdravila;
English: • Need for adequate calcium & vitamin D supplementation, appropriate physical activity, non smoking and healthy diet
Slovenian: • potrebnost zadostnega nadomeščanja kalcija in vitamina D, ustrezne telesne dejavnosti in zdrave prehrane ter odsotnosti kajenja,