natgillin/translations-raw huggingface dataset:
In addition, other relevant changes have been implemented in the product information of strontium ranelate, strengthening the contraindications and warnings as well as restricting the indication for strontium ranelate to patients at high risk of fracture for whom treatment with other medicinal products is not possible due to, for example, contraindications or intolerance.
Evropska agencija za zdravila je zaključila pregled zdravila Protelos/Osseor ter priporočila dodatno omejitev uporabe zdravila, in sicer na bolnike, ki jih ni mogoče zdraviti z drugimi zdravili, odobrenimi za osteoporozo.
The CHMP considered the PRAC recommendation and the additional information provided by the MAH both in writing and at an oral explanation.
Odbor CHMP je priporočila predložil Evropski komisiji, ki jih je potrdila in izdala končni pravno zavezujoči sklep, ki velja za celotno EU.
Study CLE-12911-021, for example, was an observational international prospective cohort survey (non-interventional) performed in seven EU countries with the main objective to follow-up during 3 years a cohort of post-menopausal women treated with strontium ranelate with a special focus on all potential safety concerns.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom velikim tveganjem, zaključil, da mora zdravilo Protelos/Osseor ostati dostopno bolnikom, ki v anamnezi nimajo srčno-žilnih bolezni in ne morejo uporabljati drugih zdravil.
The medicine can only be obtained with a prescription and treatment should only be started and given under the supervision of a doctor who has experience in the use of cancer medicines.
Predpisovanje in izdaja zdravila je le na recept, zdravljenje z njim pa se sme uvesti in izvajati samo pod nadzorom zdravnika, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
The recommended starting dose depends on the patient's height and weight.
Priporočeni odmerek je odvisen od bolnikove telesne mase in višine.
For more information on generic medicines, see the question-andanswer document here.
Za več informacij o generičnih zdravilih si oglejte dokument z vprašanji in odgovori, ki je na voljo tukaj.
Patients with moderately or severely impaired liver function should be treated with lower doses.
Bolnike z zmernimi ali hudimi okvarami delovanja jeter je treba zdraviti z manjšimi odmerki.
Further information on Bortezomib Fresenius Kabi can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/bortezomib-fresenius-kabi.
Nadaljnje informacije o zdravilu Bortezomib Fresenius Kabi so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/bortezomib-fresenius-kabi.
Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Velcade, and do not need to be repeated for Bortezomib Fresenius Kabi.
Študije o koristih in tveganjih učinkovine pri odobrenem načinu uporabe so že bile izvedene z referenčnim zdravilom Velcade, zato jih ni treba ponoviti za zdravilo Bortezomib Fresenius Kabi.
When injected under the skin, it is given in the thigh or abdomen (belly).
Pri injiciranju v podkožje se zdravilo daje v stegno ali abdomen (trebuh).
Because Bortezomib Fresenius Kabi is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Bortezomib Fresenius Kabi generično zdravilo, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
Bortezomib Fresenius Kabi is available in vials (3.5 mg) as a powder to be made up into a solution for injection.
Zdravilo Bortezomib Fresenius Kabi je na voljo v vialah (3,5 mg) v obliki praška za pripravo raztopine za injiciranje.
The European Medicines Agency concluded that, in accordance with EU requirements, Bortezomib Fresenius Kabi has been shown to be comparable to Velcade.
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Bortezomib Fresenius Kabi primerljivo z zdravilom Velcade.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Bortezomib Fresenius Kabi 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 Bortezomib Fresenius Kabi upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
What measures are being taken to ensure the safe and effective use of Bortezomib Fresenius Kabi?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Bortezomib Fresenius Kabi?
Bortezomib Fresenius Kabi is a medicine used to treat multiple myeloma, a blood cancer, in the following groups of patients:
Bortezomib Fresenius Kabi je zdravilo proti raku, ki se uporablja za zdravljenje multiplega mieloma, tj. krvnega raka, pri naslednjih skupinah bolnikov:
As for every medicine, the company provided studies on the quality of Bortezomib Fresenius Kabi.
Tako kot za vsako zdravilo je podjetje predložilo študije o kakovosti zdravila Bortezomib Fresenius Kabi.
Side effects reported with Bortezomib Fresenius Kabi are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Bortezomib Fresenius Kabi, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
For more information about using Bortezomib Fresenius Kabi, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Bortezomib Fresenius Kabi glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
When given into a vein, the solution is given as a three- to five-second injection through a catheter (a thin sterile tube).
Pri injiciranju v veno se raztopina tri do pet minut vbrizgava skozi kateter (ozko sterilno cevko).
There was no need for ‘bioequivalence' studies to investigate whether Bortezomib Fresenius Kabi is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Izvedba študije „bioekvivalence“, s katero bi raziskali, ali se zdravilo Bortezomib Fresenius Kabi absorbira podobno kot referenčno zdravilo in tako doseže enako raven učinkovine v krvi, ni bila potrebna.
Doses of Bortezomib Fresenius Kabi are given intermittently, with rest periods in between doses, in treatment cycles of three to six weeks depending on whether Bortezomib Fresenius Kabi is given alone or in combination with other medicines.
Odmerki zdravila Bortezomib Fresenius Kabi se dajejo v časovnih razmikih, pri čemer mora biti med dvema zaporednima odmerkoma premor, cikli zdravljenja pa trajajo od tri od šest tednov, kar je odvisno od tega, ali se zdravilo daje samostojno ali v kombinaciji z drugimi zdravili.
This means that Bortezomib Fresenius Kabi contains the same active substance, bortezomib, and works in the same way as a ‘reference medicine' already authorised in the EU called Velcade.
To pomeni, da vsebuje enako učinkovino, bortezomib, in deluje na enak način kot „referenčno zdravilo“, ki je že odobreno v EU in se imenuje Velcade.
The company that markets Bortezomib Fresenius Kabi will ensure that healthcare professionals receive educational material explaining how to calculate the dose and how to prepare and administer the medicine.
Podjetje, ki trži zdravilo Velcade, bo zagotovilo, da bodo zdravstveni delavci prejeli izobraževalno gradivo, ki vsebuje pojasnila o izračunavanju ustreznega odmerka ter pripravi in dajanju zdravila.
An overview of Bortezomib Fresenius Kabi and why it is authorised in the EU
Pregled zdravila Bortezomib Fresenius Kabi in zakaj je odobreno v EU
Additionally, when Bortezomib Fresenius Kabi is given under the skin, the active substance in both products, which have the same composition, is expected to be absorbed in the same way.
Kadar se zdravilo Bortezomib Fresenius Kabi injicira v podkožje, se pričakuje, da se bo učinkovina, ki ima v obeh primerih enako sestavo, absorbirala na enak način.
Bortezomib Fresenius Kabi is also used to treat mantle cell lymphoma, another blood cancer, in untreated adults who cannot have blood stem-cell transplantation.
Zdravilo Bortezomib Fresenius Kabi se uporablja tudi za zdravljenje limfoma plaščnih celic, tj. še ene vrste krvnega raka, pri predhodno nezdravljenih odraslih, pri katerih presaditev krvotvornih matičnih celic ni mogoča.
What are the benefits and risks of Bortezomib Fresenius Kabi?
Kakšne so koristi in tveganja, povezani z zdravilom Bortezomib Fresenius Kabi?
The active substance in Bortezomib Fresenius Kabi, bortezomib, is a proteasome inhibitor.
Učinkovina v zdravilu Bortezomib Fresenius Kabi, bortezomib, je zaviralec proteasoma.
Other information about Bortezomib Fresenius Kabi
Druge informacije o zdravilu Bortezomib Fresenius Kabi
Why is Bortezomib Fresenius Kabi authorised in the EU?
Zakaj je bilo zdravilo Bortezomib Fresenius Kabi odobreno v EU?
Bortezomib Fresenius Kabi is a ‘generic medicine'.
Zdravilo Bortezomib Fresenius Kabi je generično zdravilo.
What is Bortezomib Fresenius Kabi and what is it used for?
Kaj je zdravilo Bortezomib Fresenius Kabi in za kaj se uporablja?
In these patients, Bortezomib Fresenius Kabi is used in combination with melphalan and prednisone;
Pri teh bolnikih se zdravilo Bortezomib Fresenius Kabi uporablja v kombinaciji z melfalanom in prednizonom;
As for all medicines, data on the use of Bortezomib Fresenius Kabi are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Bortezomib Fresenius Kabi stalno spremljajo.
Fresenius Kabi is only given by injection into a vein or under the skin.
Bortezomib Fresenius Kabi se lahko dajo samo z injiciranjem v veno ali podkožje.
Therefore, the Agency's view was that, as for Velcade, the benefits of Bortezomib Fresenius Kabi outweigh the identified risks and it can be authorised for use in the EU.
Zato je menila, da koristi zdravila Bortezomib Fresenius Kabi enako kot pri zdravilu Velcade odtehtajo znana tveganja in se zdravilo lahko odobri v EU.
Bortezomib Fresenius Kabi is either used on its own in these patients or in combination with pegylated liposomal doxorubicin or dexamethasone.
Zdravilo Bortezomib Fresenius Kabi se pri teh bolnikih uporablja samostojno ali v kombinaciji s pegiliranim liposomalnim doksorubicinom ali deksametazonom;
This is because when Bortezomib Fresenius Kabi is given by injection into a vein the active substance is delivered straight into the bloodstream.
Zdravilo Bortezomib Fresenius Kabi se namreč daje z injiciranjem v veno, tako da učinkovina vstopa neposredno v krvni obtok.
For mantle cell lymphoma, Bortezomib Fresenius Kabi is used in combination with rituximab, cyclophosphamide, doxorubicin and prednisone.
Za zdravljenje limfoma plaščnih celic se zdravilo Bortezomib Fresenius Kabi uporablja v kombinaciji z rituksimabom, ciklofosfamidom, doksorubicinom in prednizonom.
In this group of patients, Bortezomib Fresenius Kabi is used in combination with dexamethasone, or with dexamethasone plus thalidomide;
Pri tej skupini bolnikov se zdravilo Bortezomib Fresenius Kabi uporablja v kombinaciji z deksametazonom ali pa z deksametazonom in talidomidom;
How has Bortezomib Fresenius Kabi been studied?
Kako je bilo zdravilo Bortezomib Fresenius Kabi raziskano?
How does Bortezomib Fresenius Kabi work?
Kako zdravilo Bortezomib Fresenius Kabi deluje?
Bortezomib
Zdravilo
How is Bortezomib Fresenius Kabi used?
Kako se zdravilo Bortezomib Fresenius Kabi uporablja?
Don't drive or use machines unless you're feeling well.
Ne vozite in ne upravljajte strojev, če se ne počutite dobro.
A risk to the breastfeeding child cannot be excluded.
Tveganja za dojenega otroka ni mogoče izključiti.
The safety and efficacy of epoprostenol in children younger than 18 years have not yet been established.
Varnost in učinkovitost epoprostenola pri otrocih, mlajših od 18 let, še nista ugotovljeni .
They will also advise you how to stop treatment if necessary.
Pojasnila vam bosta tudi, kako prenehati z zdravljenjem, če je to potrebno.
The procedure given below should be closely followed.
Natančno je treba upoštevati spodaj navedeni postopek.
This procedure should be conducted in a hospital with adequate resuscitation equipment.
Ta postopek je treba opraviti v bolnišnici in z dosegljivo ustrezno reanimacijsko opremo.
It is very important that you follow all of their instructions carefully.
Zelo pomembno je, da natančno upoštevate vsa njuna navodila.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 4.2.
Zdravila se ne sme mešati z drugimi zdravili razen s tistimi, ki so omenjena v poglavju 4.2.
• You have more frequent, or longer periods of bleeding.
• Imate pogostejše ali dolgotrajnejše krvavitve.
If it does, the skin could be damaged.
Če se to zgodi, lahko pride do poškodbe kože.
• digoxin (used to treat heart disease).
• digoksin (uporablja se za zdravljenje bolezni srca).
The amount you are given is based on your body weight, and your type of illness.
Količina, ki jo boste dobili, bo odvisna od vaše telesne mase in vrste vaše bolezni.
It is not known how many people are affected:
Ni znano, pri kolikšnem številu ljudi se pojavijo naslednji neželeni učinki:
• for up to 12 hours at 25oC, if it has just been made up
• do 12 ur pri temperaturi 25 oC, če je bila pravkar pripravljena,
N=4/25).
s 5/24).
• You feel dizzy or feel faint, especially on standing.
• Občutite omotico ali omedlevico, zlasti ko vstanete.
Also your blood pressure can become too low.
Tudi krvni tlak se lahko preveč zniža.
Your first treatment will be given to you in a hospital.
Zdravljenje se bo začelo v bolnišnici.
Bleeding risk was defined as: • Very high risk - presence of active bleeding at the time of dialysis initiation
Tveganje za krvavitev je bilo opredeljeno kot: • Zelo veliko tveganje - prisotnost aktivne krvavitve v času začetka dialize
• increase in sugar (glucose) in the blood
• zvišanje sladkorja (glukoze) v krvi.
Reconstitution and dilution should be carried out immediately prior to use (see section 4.2, section 6.3 and Section 6.6).
Pripravo in razredčenje je treba opraviti tik pred uporabo (glejte poglavja 4.2, 6.3 in 6.6).
Improvements were apparent in some patients at the end of the first week of therapy.
Izboljšanja so bila pri nekaterih bolnikih opazna že ob koncu prvega tedna zdravljenja.
However, 9 of 27 epoprostenol dialyses were unsuccessful following multiple attempts.
Toda 9 od 27 dializ z epoprostenolom ni bilo uspešnih niti po več poskusih.
This is because your doctor needs to monitor you and find the best dose for you.
Zdravnik vas mora namreč kontrolirati in vam določiti najprimernejši odmerek.
Tell your doctor or nurse immediately, as these may be signs of infection of the blood or low blood pressure or serious bleeding:
Svojemu zdravniku ali medicinski sestri morate nemudoma povedati za naslednje težave, kajti te težave so lahko znaki okužbe krvi, nizkega krvnega tlaka ali resne krvavitve:
• if you are allergic to Flolan or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na zdravilo Flolan ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
Given the absence of alternative medicines, epoprostenol can be used in those women who choose to continue their pregnancy, despite the known risk of pulmonary arterial hypertension during pregnancy.
Glede na to, da alternativnih zdravil ni, se epoprostenol lahko uporablja pri tistih ženskah, ki želijo nosečnost nadaljevati kljub znanim tveganjem pljučne arterijske hipertenzije med nosečnostjo.
Extreme caution is advised in patients with coronary artery disease.
Skrajna previdnost je potrebna pri bolnikih z boleznijo koronarnih arterij.
Your doctor or nurse will show you how to clean your ‘line' and the area around it.
Zdravnik ali medicinska sestra vam bosta pokazala, kako očistiti kateter in predel okrog njega.
Your doctor will decide how much Flolan is right for you.
Zdravnik bo odločil, kolikšna količina zdravila Flolan je primerna za vas.
Frequencies are defined as follows: very common ≥1/10 (≥10%); common ≥1/100 and <1/10 (≥1% and <10%); uncommon ≥1/1000 and <1/100 (≥0.1% and <1%); rare ≥1/10,000 and <1/1000 ( ≥0.01% and <0.1%); very rare <1/10,000 (< 0.01%) and not known (cannot be estimated from the available data).
Opredelitev pogostnosti je: zelo pogosti ≥1/10 (≥10 %), pogosti ≥1/100 in < 1/10 (≥1 % in < 10 %), občasni ≥ 1/1000 in <1/100 ( ≥ 0,1 % in < 1 %), redki ≥ 1/10.000 in < 1/1000 ( ≥0,01 % in < 0,1 %), zelo redki < 1/10.000 (< 0,01 %) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
It is also a potent vasodilator.
Je tudi močan vazodilatator.
4.6 Fertility, pregnancy,and lactation
4.6 Plodnost, nosečnost in dojenje
Local infection*
Redki lokalna okužba*
It is important that the medicine does not leak out of the vein into the surrounding tissue.
Pomembno je, da zdravilo ne pronica iz vene v okoliško tkivo.
• if you have any problems with bleeding.
• če imate kakšne težave s strjevanjem krvi (krvavitvami).
These haemodynamic improvements appeared to persist when epoprostenol was administered for at least 36 months in an open, nonrandomized study.
Ta hemodinamska izboljšanja so se ohranila, ko je bil epoprostenol vsaj 36 mesecev uporabljan v odprti, nerandomizirani študiji.
Following the administration of radiolabelled epoprostenol to humans, at least 16 metabolites were found, 10 of which were structurally identified.
Po uporabi radioaktivno označenega epoprostenola pri človeku so ugotovili vsaj 16 presnovkov; 10 od teh je strukturno opredeljenih.
INFORMATION FOR HEALTHCARE PROFESSIONALS
INFORMACIJE ZA ZDRAVSTVENO OSEBJE
The infusion should be stopped at the end of dialysis.
Infundiranje je treba končati ob koncu dialize.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine as your symptoms could worsen during pregnancy.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte s svojim zdravnikom, preden vzamete to zdravilo, kajti simptomi se vam lahko med nosečnostjo poslabšajo.
Most epoprostenol dialyses (67%) that required replacement of artificial kidney were completed subsequently with epoprostenol without clotting.
Večino dializ z epoprostenolom (67 %), ki so zahtevale zamenjavo umetne ledvice, so nato dokončali z epoprostenolom brez strjevanja.
• if you start to develop a build-up of fluid in your lungs causing breathlessness after starting this treatment.
• če se vam začne v pljučih kopičiti tekočina; to povzroči težko dihanje po začetku tega zdravljenja.
Using Flolan at home (only for treatment of Pulmonary Arterial Hypertension) If you are treating yourself at home, your doctor or nurse will show you how to prepare and use Flolan.
Uporaba zdravila Flolan doma (samo za zdravljenje pljučne arterijske hipertenzije) Če se zdravite sami doma, vam bosta zdravnik ali medicinska sestra pokazala, kako pripraviti in uporabiti zdravilo Flolan.
• for a maximum of 8 hours if it was made previously and has been stored at 2-8oC.
• največ 8 ur, če je bila pripravljena že prej in je bila shranjena pri temperaturi od 2 do 8 oC.
Those patients who continued to bleed were evaluated for changes in bleeding severity.
Bolnike, ki so krvaveli še naprej, so ocenili glede sprememb v resnosti krvavitev.
Tachycardia2, bradycardia3,
Srčne bolezni Pogosti tahikardija2, bradikardija3
• infection of the blood (septicaemia)
• okužba krvi (septikemija),
This should be carried out according to the instructions given for renal dialysis.
Opraviti jo je treba v skladu z navodili, navedenimi za ledvično dializo.
The cardiovascular effects during infusion disappear within 30 min of the end of administration.
Kardiovaskularni učinki, ki se pojavijo med infundiranjem, izginejo v 30 minutah po koncu dajanja zdravila.
Long-term continuous infusion:
Dolgotrajno stalno infundiranje:
This may be followed by blistering and shedding of the skin.
Sledi lahko nastanek mehurjev in lupljenje kože.
Reconstitution and dilution of Flolan must be carried out under aseptic conditions, immediately prior to clinical use.
Pripravo in razredčenje zdravila Flolan je treba opraviti v aseptičnih pogojih, tik pred klinično uporabo.
If you think any of these apply to you, don't take Flolan until you have checked with your doctor.
Če menite, da kaj od tega velja za vas, ne jemljite zdravila Flolan, dokler se ne posvetujete s svojim zdravnikom.
The powder is white or off-white and the solution is clear and colourless.
Prašek je bele ali skoraj bele barve, raztopina pa je bistra in brezbarvna.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo; to velja tudi za zdravila, ki ste jih dobili brez recepta.
When Flolan is used alone, measurements such as activated whole blood clotting time may not be reliable.
Če je zdravilo Flolan uporabljeno samo, so meritve, kakršna je aktivirani čas strjevanja polne krvi, lahko nezanesljive.
Epoprostenol potentiates the anticoagulant activity of heparin by approximately 50%, possibly reducing the release of heparin neutralising factor.
Epoprostenol poveča antikoagulantno delovanje heparina za približno 50 % in morda zmanjša sproščanje faktorja, ki nevtralizira heparin.
Improvements were apparent as early as the first week of therapy.
Izboljšanja so bila opazna že po prvem tednu zdravljenja.
Dosage adjustments:
Prilagoditve odmerjanja:
The infusion rate may be calculated from the following formula:
Hitrost infundiranja je mogoče izračunati po naslednji formuli:
If you have any of the liquid left over, it must be thrown away.
Če kaj te tekočine ostane, jo morate zavreči.
Pharmacotherapeutic group: Antithrombotic Agents; Platelet aggregation inhibitors excl. heparin, ATC code: B01AC09
Farmakoterapevtska skupina: antitrombotiki, zaviralci agregacije trombocitov brez heparina, oznaka ATC: B01AC09
Short-term (acute) dose ranging:
Kratkotrajno (akutno) ugotavljanje odmerka:
The symptoms of low blood pressure include dizziness and fainting.
Med simptomi nizkega krvnega tlaka sta omotica in omedlevica.
Flow rates in mL/h b. Diluted: A commonly used dilution is:
Hitrost pretoka v ml/h b. Razredčeno: Pogosto uporabljeno razredčenje je:
If you forget to take Flolan Do not take a double dose to make up for a forgotten dose.
Če ste pozabili vzeti zdravilo Flolan Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
The effects of epoprostenol on mean pulmonary artery pressure (PAPm) in patients with PPH were variable and minor.
Učinki epoprostenola na srednji pljučni arterijski tlak (PAPm - mean pulmonary artery pressure) pri bolnikih s PPH so bili spremenljivi in majhni.
The liquid does not contain a preservative.
Ta tekočina ne vsebuje konzervansa.
What Flolan is and what it is used for
Kaj je zdravilo Flolan in za kaj ga uporabljamo
Sodium Chloride
Natrijev klorid
Before you are given Flolan your doctor needs to know:
Preden dobite zdravilo Flolan, morate zdravniku povedati:
There is a limited amount of data from the use of epoprostenol in pregnant women.
Podatkov o uporabi epoprostenola pri nosečnicah je malo.
Animal studies did not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Študije na živalih niso pokazale neposrednih ali posrednih škodljivih učinkov glede reproduktivne toksičnosti (glejte poglavje 5.3).
Talk to your doctor or pharmacist or nurse about any other side effects, including those not listed in this leaflet.
S svojim zdravnikom, farmacevtom ali medicinsko sestro se posvetujte tudi o vseh drugih neželenih učinkih, vključno s tistimi, ki niso omenjeni v tem navodilu.