natgillin/translations-raw huggingface dataset:
Your doctor will reduce your starting dose to 50 microgram if you have severe kidney problems.
Če imate hude težave z ledvicami, bo zdravnik vaš začetni odmerek zmanjšal na 50 mikrogramov.
Besremi contains sodium
Zdravilo Besremi vsebuje natrij
Serious eye disorders have been reported with interferon alfa such as retinopathy, retinal haemorrhage, retinal exudates, retinal detachment and retinal artery or vein occlusion (see section 4.4).
Pri interferonu alfa so poročali o resnih boleznih oči, kot so retinopatija, mrežnična krvavitev, mrežnični eksudati, odstop mrežnice in zapora mrežnične arterije ali vene (glejte poglavje 4.4).
Besremi 250 micrograms/0.5 mL solution for injection in pre-filled pen Besremi 500 micrograms/0.5 mL solution for injection in pre-filled pen
Besremi 250 mikrogramov/0,5 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku Besremi 500 mikrogramov/0,5 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku
It delivers doses of 50 μg, 100 μg, 150 μg, 200 μg,
Možni odmerki so 50 μg, 100 μg, 150 μg,
Once opened, the pre-filled pen may be stored for a maximum of 30 days in the refrigerator (2 °C8 °C) when stored with the pen cap on and kept in the outer carton in order to protect from light.
Po odprtju lahko napolnjen injekcijski peresnik shranjujete v hladilniku (2 °C - 8 °C) največ 30 dni, če je shranjen z nameščenim pokrovčkom peresnika in v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
Each cartridge contains 0.5 mL of solution.
En peresnik vsebuje 0,5 ml raztopine.
An abortifacient effect was reported in primates receiving other interferon alfa medicinal products.
Pri primatih, ki so prejemali druga zdravila z interferonom alfa, so poročali o abortivnem učinku.
Dental and periodontal disorders, which may lead to loss of teeth, have been reported with other interferon alfa medicinal products (see section 4.8).
Pri drugih zdravilih z interferonom alfa so poročali o boleznih zobnih in obzobnih tkiv, ki lahko vodijo do izgube zob (glejte poglavje 4.8).
Adjustments in the recommended dose for ropeginterferon alfa-2b are not necessary when starting therapy in elderly patients (see section 5.2).
Pri uvajanju zdravljenja pri starejših bolnikih prilagajanje priporočenega odmerka ropeginterferona alfa-2b ni potrebno (glejte poglavje 5.2).
Besremi 250 micrograms/0.5 mL solution for injection in pre-filled pen The pre-filled pen is made of white polypropylene, with a grey push button and the strength “250 mcg/0.5 mL” highlighted in grey on the label.
Besremi 250 mikrogramov/0,5 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku Napolnjen injekcijski peresnik je izdelan iz belega polipropilena in ima siv potisni gumb, na nalepki pa ima s sivo označeno jakost “250 mcg/0,5 ml”.
Store the pen in the outer carton in the refrigerator.
Peresnik shranjujte v zunanji ovojnini in ga hranite v hladilniku.
Ropeginterferon alfa-2b is contraindicated in patients with decompensated cirrhosis of the liver (see section 4.3).
Ropeginterferon alfa-2b je kontraindiciran pri bolnikih z dekompenzirano cirozo jeter (glejte poglavje 4.3).
If renal function decreases during treatment, ropeginterferon alfa-2b therapy should be discontinued.
Če se delovanje ledvic med zdravljenjem poslabša, je treba zdravljenje z ropeginterferonom alfa-2b prekiniti.
Common side effects (may affect up to 1 in 10 people): - changes in your heart beat (when the heart beats very fast and uneven)
- spremembe srčnega ritma (kadar srce bije zelo hitro ali neenakomerno).
Since Besremi is a solution, it does not require resuspension before use.
Ker je zdravilo Besremi raztopina, resuspendiranje pred injiciranjem ni potrebno.
Gastrointestinal disorders common diarrhoea, nausea, abdominal pain, constipation, abdominal distension, dry mouth uncommon gastritis, abdominal wall disorder, flatulence, frequent bowel movements, odynophagia, gingival bleeding not known tooth disorder#, periodontal disease#
suha usta občasni gastritis, bolezen trebušne stene, flatulenca, pogosto odvajanje blata, odinofagija, krvavitev iz dlesni neznana bolezni zob#, bolezen obzobnega tkiva#
- diarrhoea, nausea, abdominal pain or stomach discomfort, constipation, dry mouth - liver disorder, increase in certain liver enzymes (shown in blood tests) - itching, hair loss, rash, redness of skin, psoriasis, dry and scaly skin, acne, thickening of the outer layer of the skin, increased sweating - a disorder called Sjogren's syndrome where the body's immune system attacks glands that produce fluid (such as the tear and saliva glands), arthritis, pain in arms and legs, bone pain, painful sudden tightening of a muscle - fever, weakness, chills, general health problems, irritation or redness at the site of injection - in blood tests: antibodies which are produced by the body´s immune system, increase of an enzyme called lactate dehydrogenase
zadebelitev zunanjega sloja kože, povečano znojenje, - bolezen, imenovana Sjögrenov sindrom, pri kateri telesni imunski sistem napade žleze, v katerih nastaja tekočina (kot so solzne žleze in žleze slinavke), artritis, bolečina v rokah in nogah, bolečina v kosteh, nenadno boleče krčenje mišice, - vročina, šibkost, mrzlica, splošne zdravstvene težave, razdražena ali pordela koža na mestu injiciranja,
Administration of 180 micrograms of pegylated interferon alfa-2a once weekly for 4 weeks in healthy male subjects did not show any effect on mephenytoin, dapsone, debrisoquine and tolbutamide pharmacokinetics profiles, suggesting that pegylated interferon alfa-2a has no effect on in vivo metabolic activity of cytochrome P450 (CYP) 3A4, 2C9, 2C19 and 2D6 isozymes.
Dajanje 180 mikrogramov pegiliranega interferona alfa-2a enkrat na teden 4 tedne pri zdravih moških preskušancih ni vplivalo na farmakokinetični profil mefenitoina, dapsona, debrisokina in tolbutamida.
It delivers doses of 50 μg, 100 μg, 150 μg, 200 μg and 250 μg.
Možni odmerki so 50 μg, 100 μg, 150 μg, 200 μg in
• Do not inject into skin that is irritated, reddened, bruised, infected or scarred in any way.
• Nikakor ne injicirajte v kožo, ki je razdražena, pordela, podpluta, okužena ali brazgotinasta.
• Set the dose your doctor told you by turning the dose knob.
• Z vrtenjem odmernega gumba nastavite odmerek, ki vam ga je določil zdravnik.
Investigations common antithyroid antibody positive, blood thyroid stimulating hormone increased, body temperature increased, antinuclear antibody positive, blood lactate dehydrogenase increased uncommon platelet count increased, blood uric acid increased,
Preiskave pogosti prisotnost protiteles proti ščitnici, zvečana vrednost tirotropina v krvi, zvišana telesna temperatura, prisotnost antinuklearnih protiteles, zvečana vrednost laktatdehidrogenaze v krvi občasni zvečano število trombocitov, zvečana vrednost sečne kisline v krvi, pozitiven Coombsov test, zmanjšanje telesne mase
Hepatic failure in hepatitis C virus infected patients was reported with other interferon alfa medicinal products (see section 4.8).
Pri drugih zdravilih z interferonom alfa so pri bolnikih z okužbo z virusom hepatitisa C poročali o odpovedi jeter (glejte poglavje 4.8).
Besremi 500 micrograms/0.5 mL solution for injection in pre-filled pen 1.5 years.
Besremi 500 mikrogramov/0,5 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku 1,5 leta
No interaction studies have been performed with ropeginterferon alfa-2b.
Študij medsebojnega delovanja z ropeginterferonom alfa-2b niso opravili.
Only limited pharmacokinetic data are available from the use of ropeginterferon alfa-2b in the elderly.
Iz uporabe ropeginterferona alfa-2b pri starejših so na voljo le omejeni farmakokinetični podatki.
Tell your doctor especially if you are taking any of the following medicines: - theophylline (a medicine used to treat respiratory diseases such as asthma) - methadone (a medicine used to treat pain or opioid dependence) - vortioxetine or risperidone (medicines used to treat mental disorders) - anti-cancer medicines such as those stopping or slowing the growth of blood-forming cells in the bone marrow (e.g. hydroxycarbamide) - medicines that work on the central nervous system to relieve pain, help you sleep, or have a calming effect (e.g. morphine, midazolam)
- zdravila proti raku, kot so tista, ki ustavijo ali upočasnijo rast krvotvornih celic v kostnem mozgu (npr. hidroksikarbamid), - zdravila, ki delujejo na centralni živčni sistem in lajšajo bolečino, delujejo uspavalno ali imajo pomirjujoč učinek (npr. morfin, midazolam).
Cardiac events including cardiomyopathy, myocardial infarction, atrial fibrillation and ischaemic coronary artery disorders have been associated with interferon alfa treatment (see section 4.8).
V povezavi z zdravljenjem z interferonom alfa so poročali o srčnih dogodkih, vključno s kardiomiopatijo, miokardnim infarktom, atrijsko fibrilacijo in ishemičnimi boleznimi koronarnih arterij (glejte poglavje 4.8).
Respiratory disorders such as lung infiltration, pneumonitis, pneumonia or pulmonary arterial hypertension have been observed rarely in patients treated with interferon alfa (see section 4.8).
Pri bolnikih, zdravljenih z interferonom alfa, so redko poročali o boleznih dihal, kot so infiltracija pljuč, pnevmonitis, pljučnica ali pljučna arterijska hipertenzija (glejte poglavje 4.8).
Most common adverse reactions during ropeginterferon alfa-2b treatment.
Najpogostejši neželeni učinki med zdravljenjem z ropeginterferonom alfa-2b
Based on the results from the PROUD-PV and CONTINUATION-PV Study on drug exposure, pharmacodynamic response and tolerability, a dose adjustment for ropeginterferon alfa-2b is not considered necessary in the elderly population.
PROUD-PV in CONTINUATION-PV, prilagajanje odmerka ropeginterferona alfa-2b pri starejših ni potrebno.
The pre-filled pen may be stored for a maximum of 30 days in the refrigerator (2 °C - 8 °C) when stored with the pen cap on and kept in the outer carton in order to protect from light.
Po prvi uporabi Napolnjen injekcijski peresnik lahko shranjujete v hladilniku (2 °C - 8 °C) največ 30 dni, če je shranjen z nameščenim pokrovčkom peresnika in v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
Patients with 24 months of ropeginterferon alfa-2b treatment1
Bolniki s 24 meseci zdravljenja z ropeginterferonom alfa-2b1
Besremi 500 micrograms/0.5 mL solution for injection in pre-filled pen The pre-filled pen is made of white polypropylene, with a blue push button and the strength “500 mcg/0.5 mL” highlighted in blue on the label.
Besremi 500 mikrogramov/0,5 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku Napolnjen injekcijski peresnik je izdelan iz belega polipropilena in ima moder potisni gumb, na nalepki pa ima z modro označeno jakost “500 mcg/0,5 ml”.
In patients who develop evidence of hepatic decompensation during treatment, ropeginterferon alfa-2b should be discontinued.
Pri bolnikih, pri katerih med zdravljenjem pride do dokazane dekompenzacije jeter, je treba zdravljenje z ropeginterferonom alfa-2b prekiniti.
- if you have liver problems − you will have blood tests regularly to check how your liver is working if you are on a long-term Besremi therapy.
- če imate sladkorno bolezen ali visok krvni tlak - zdravnik vam bo morda naročil, da greste na očesni pregled; - če imate težave z jetri - če ste na dolgotrajnem zdravljenju z zdravilom Besremi, vam bodo redno opravljali preiskave krvi za preverjanje delovanja vaših jeter; - če imate težave z ledvicami;
The dose was gradually increased depending on disease response and tolerability (for ropeginterferon alfa-2b, from 50 to
Odmerek so postopoma zvečevali glede na odziv na zdravljenje in prenašanje (pri ropeginterferonu alfa-2b so dajali od 50 do 500 mikrogramov subkutano vsaka dva tedna).
Patients with 36 months of ropeginterferon alfa-2b treatment2
Bolniki s 36 meseci zdravljenja z ropeginterferonom alfa-2b2
Side effects with frequency not known (cannot be estimated from the available data): - Vogt-Koyanagi-Harada disease (a rare disease that can lead to loss of vision, hearing and skin pigmentation), severe allergic reaction - discolouration of the skin
- Vogt-Koyanagi-Haradova bolezen (redka bolezen, ki lahko povzroči izgubo vida, sluha in obarvanosti kože), huda alergijska reakcija, - obarvanje kože, - bolezni zob in obzobnih tkiv (prizadenejo dlesni), sprememba barve jezika.
Sodium chloride Sodium acetate, anhydrous Acetic acid, glacial Benzyl alcohol Polysorbate 80
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi natrijev klorid brezvodni natrijev acetat koncentrirana ocetna kislina benzilalkohol polisorbat 80 voda za injekcije
Disease response after 24 and 36 months of ropeginterferon alfa-2b.
Odziv bolezni po 24 in 36 mesecih zdravljenja z ropeginterferonom alfa-2b Skupina, zdravljenja z ropeginterferonom alfa-2b
The 500 micrograms/0.5 mL pre-filled pen has a blue push button.
Napolnjen injekcijski peresnik s 500 mikrogrami/0,5 ml ima moder potisni gumb.
The 250 micrograms/0.5 mL pre-filled pen has a grey push button.
Napolnjen injekcijski peresnik z 250 mikrogrami/0,5 ml ima siv potisni gumb.
Patients who develop this condition during treatment and cannot be controlled by medicinal products should discontinue ropeginterferon alfa-2b therapy.
Bolniki, ki se jim med zdravljenjem pojavi sladkorna bolezen, ki je ni mogoče nadzorovati z zdravili, morajo zdravljenje z ropeginterferonom alfa-2b prekiniti.
Renal and urinary disorders uncommon cystitis haemorrhagic, dysuria, micturition urgency, urinary retention
Bolezni sečil občasni hemoragični cistitis, disurija, urgentna mikcija,
Besremi 250 mcg/0.5 mL injection ropeginterferon alfa-2b SC
Besremi 250 mcg/0,5 ml injekcija ropeginterferon alfa-2b s.c.
LIST OF EXCIPIENTS
NALEPKA PERESNIKA
Besremi 500 mcg/0.5 mL injection ropeginterferon alfa-2b SC
Besremi 500 mcg/0,5 ml injekcija ropeginterferon alfa-2b s.c.
The same elimination route is considered for ropeginterferon alfa-2b.
Menijo, da je pot izločanja ropeginterferona alfa-2b enaka.
Skin and subcutaneous tissue disorders common pruritus, alopecia, rash, erythema, psoriasis, xeroderma, dermatitis acneiform, hyperkeratosis, hyperhidrosis, dry skin uncommon photosensitivity reaction, skin exfoliation, nail dystrophy not known skin depigmentation#
akneiformni dermatitis, hiperkeratoza, hiperhidroza, suha koža občasni fotosenzitivna reakcija, deskvamacija kože, distrofija nohtov neznana depigmentacija kože#
- if you have or had an autoimmune disease (such as rheumatoid arthritis, psoriasis or inflammatory bowel disease).
- če imate ali ste imeli hude težave s srcem (kot je srčni infarkt ali kap); - če imate ali ste imeli avtoimuno bolezen (kot je revmatoidni artritis, luskavica ali vnetna črevesna bolezen);
Common side effects (may affect up to 1 in 10 people): - infection of the respiratory tract, runny or stuffy nose, fungal infections - decrease in the number or size of red blood cells - increase or decrease in the thyroid gland activity, increase of thyroid stimulating hormone, inflammation of the thyroid gland - increase of triglycerides (a type of lipid) in the blood, decreased appetite - aggressive behaviour, feeling depressed, feeling anxious, problems with falling asleep or staying asleep, mood changes, lacking bodily energy or motivation - headache, feeling dizzy, reduced sense of touch or sensation, feeling sleepy, sensation of tingling and ‘pins and needles' - dry eyes - damage of the capillaries (very small blood vessels) in the body - breathing problems
- zvečanje ali zmanjšanje aktivnosti žleze ščitnice, zvečanje vrednosti tirotropina, vnetje žleze ščitnice, - zvečana raven trigliceridov (vrste lipidov) v krvi, zmanjšan apetit, - agresivno vedenje, občutek depresije, občutek tesnobnosti, težave s spanjem ali začetkom spanja, spremembe razpoloženja, pomanjkanje telesne energije ali motivacije,
Do not inject into skin that is irritated, reddened, bruised, infected or scarred in any way.
Nikakor ne injicirajte v kožo, ki je razdražena, pordela, podpluta, okužena ali brazgotinasta.
Besremi 250 micrograms/0.5 mL solution for injection in pre-filled pen 3 years.
Besremi 250 mikrogramov/0,5 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku 3 leta
Each pre-filled pen contains 0.5 mL of solution.
En napolnjen injekcijski peresnik vsebuje 0,5 ml raztopine.
No dose adaptions for ropeginterferon alfa-2b should be necessary when concomitantly administered with medicinal products metabolised via CYP2C9/19, CYP3A4 or by N-acetyltransferase.
Ob sočasni uporabi z zdravili, ki se presnavljajo preko CYP2C9/19, CYP3A4 ali N-acetiltransferaze, prilagajanje odmerka ropeginterferona alfa-2b ni potrebno.
Name and address of the manufacturer(s) of the biological active substance(s) PharmaEssentia Corp.
Ime in naslov izdelovalca (izdelovalcev) biološke učinkovine (učinkovin)
The Besremi pre-filled pen comes with two needles.
Pakiranje napolnjenega injekcijskega peresnika zdravila Besremi vsebuje dve igli.
Package leaflet: Information for the user Besremi 500 micrograms/0.5 mL solution for injection in pre-filled pen ropeginterferon alfa-2b This medicine is subject to additional monitoring.
Navodilo za uporabo Besremi 500 mikrogramov/0,5 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku ropeginterferon alfa-2b Za to zdravilo se izvaja dodatno spremljanje varnosti.
Infections and infestations common respiratory tract infection, rhinitis, fungal skin infection uncommon oral herpes, herpes zoster, oral candidiasis, sinusitis, oesophageal candidiasis, vulvovaginal mycotic infection, hordeolum, onychomycosis
Infekcijske in parazitske bolezni pogosti okužba zgornjih dihal, rinitis, glivična okužba kože občasni ustni herpes, herpes zoster, ustna kandidoza, sinuzitis,
PT
PI
The metabolism of ropeginterferon alfa-2b is not fully characterised.
Presnova ropeginterferona alfa-2b ni popolnoma opredeljena.
Coombs test positive, weight decreased #Reported as adverse reactions during treatment with other interferon alfa medicinal products.
#V poročilih kot neželeni učinki med zdravljenjem z drugimi zdravili z interferonom alfa.
Uncommon side effects (may affect up to 1 in 100 people): - attempted suicide, thoughts about killing yourself - loss of vision which may be caused by bleeding in the retina (the retina is the light-sensitive layer in the eye), or by build-up of fat in or under the retina
- izguba vida, ki jo lahko povzroči mrežnična krvavitev (mrežnica je na svetlobo občutljiv sloj v očesu) ali kopičenje maščobe pod ali v mrežnici.
Serious, acute hypersensitivity reactions (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis) have been rarely observed with other interferon alfa medicinal products.
Pri bolnikih, zdravljenih z drugimi zdravili z interferonom alfa, so redko poročali o resnih, akutnih preobčutljivostnih reakcijah (npr. koprivnica, angioedem, bronhokonstrikcija, anafilaksija).
GGT (≥3 times the upper limit of normal) and bilirubin (>2 times the upper limit of normal) levels have been observed in patients treated with ropeginterferon alfa-2b.
Pri bolnikih, zdravljenih z ropeginterferonom alfa-2b, so opazili zvišanja ravni ALT (≥ 3-krat nad zgornjo mejo normale), AST (≥ 3-krat nad zgornjo mejo normale), GGT (≥ 3-krat nad zgornjo mejo normale) in bilirubina (>2-krat nad zgornjo mejo normale).
Package leaflet: Information for the user Besremi 250 micrograms/0.5 mL solution for injection in pre-filled pen ropeginterferon alfa-2b This medicine is subject to additional monitoring.
Navodilo za uporabo Besremi 250 mikrogramov/0,5 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku ropeginterferon alfa-2b Za to zdravilo se izvaja dodatno spremljanje varnosti.
Immune system disorders uncommon
Bolezni imunskega sistema občasni
Severe eye disorders such as retinopathy, retinal haemorrhage, retinal exudates, retinal detachment and retinal artery or vein occlusion which may result in blindness have been observed rarely in patients treated with interferon alfa (see section 4.8).
Vid Pri bolnikih, zdravljenih z interferonom alfa, so redko poročali o hudih boleznih oči, kot so retinopatija, mrežnična krvavitev, mrežnični eksudati, odstop mrežnice in zapora mrežnične arterije ali vene, ki lahko povzročijo slepoto (glejte poglavje 4.8).
Besremi 500 micrograms/0.5 mL solution for injection in pre-filled pen Each pre-filled pen of 0.5 mL solution contains 500 micrograms of ropeginterferon alfa-2b as measured on a protein basis, corresponding to 1,000 micrograms/mL.
Besremi 500 mikrogramov/0,5 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku En napolnjen injekcijski peresnik z 0,5 ml raztopine vsebuje 500 mikrogramov ropeginterferona alfa2b, merjeno glede na beljakovine, kar ustreza 1.000 mikrogramom/ml.
Besremi 250 micrograms/0.5 mL solution for injection in pre-filled pen Each pre-filled pen of 0.5 mL solution contains 250 micrograms of ropeginterferon alfa-2b as measured on a protein basis, corresponding to 500 micrograms/mL.
Besremi 250 mikrogramov/0,5 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku En napolnjen injekcijski peresnik z 0,5 ml raztopine vsebuje 250 mikrogramov ropeginterferona alfa2b, merjeno glede na beljakovine, kar ustreza 500 mikrogramom/ml.
Ropeginterferon alfa-2b is contraindicated in patients with end stage renal disease (see section 4.3).
Ropeginterferon alfa-2b je kontraindiciran pri bolnikih s končno ledvično odpovedjo (glejte poglavje
Treatment with ropeginterferon alfa-2b should be discontinued when, despite dose reduction, the increase in liver enzyme levels is progressive and clinically significant.
Kadar je zvišanje jetrnih encimov napredujoče in klinično pomembno kljub zmanjšanju odmerka, je treba zdravljenje z ropeginterferonom alfa-2b prekiniti.
Very rare side effects (may affect up to 1 in 10,000 people): - idiopathic or thrombotic thrombocytopenic purpura (increased bruising, bleeding, decreased platelets, anaemia and extreme weakness) - myocardial ischemia (reduced blood flow to your heart muscle)
Zelo redki neželeni učinki (pojavijo se lahko pri največ 1 od 10.000 bolnikov): - idiopatska ali trombotična trombocitopenična purpura (zvečano pojavljanje podplutb, krvavitev,
including suicidal ideation, attempted suicide, aggression, bipolar disorder, mania and confusion have been observed with other interferon alfa medicinal products.
Pri drugih zdravilih z interferonom alfa so opazili druge učinke na CŽS, vključno s samomorilnimi mislimi, poskusom samomora, agresijo, bipolarno motnjo, manijo in zmedenostjo.
Dose reduced
SPROŠČANJE SERIJ
Please read this leaflet carefully before using the Besremi 500 micrograms pre-filled pen.
Navodila za uporabo Pred uporabo zdravila Besremi 500 mikrogramov napolnjen injekcijski peresnik natančno preberite to navodilo.
Besremi 500 micrograms/0.5 mL solution for injection in pre-filled pen ropeginterferon alfa-2b
Besremi 500 mikrogramov/0,5 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku ropeginterferon alfa-2b
Eye disorders common dry eye uncommon retinal haemorrhage#, retinal exudates#, visual impairment, visual acuity reduced, vision blurred, ocular discomfort, eczema eyelids rare retinopathy#, optic neuropathy#, retinal artery occlusion#, retinal vein occlusion#,
zmanjšana ostrina vida, zamegljen vid, nelagodje v očesu, ekcem na vekah redki retinopatija#, nevropatija vidnega živca#, zapora mrežnične arterije#, zapora mrežnične vene#
Name and address of the manufacturer(s) responsible for batch release AOP Orphan Pharmaceuticals AG
Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij
Vascular disorders common microangiopathy uncommon
Žilne bolezni pogosti mikroangiopatija občasni
Description Besremi 500 micrograms pre-filled pen
Opis napolnjenega injekcijskega peresnika zdravila Besremi 500 mikrogramov
Ear and labyrinth disorders uncommon deafness, tinnitus, vertigo
vključno z motnjami labirinta občasni gluhost, tinitus, vrtoglavica