natgillin/translations-raw huggingface dataset:
• If you have used your Besremi 500 microgram pre-filled pen once before, continue directly with step 7.
500 mikrograma napunjenu brizgalicu, nastavite izravno s korakom 7.
Patients with this condition who cannot be effectively controlled by medicinal products should not begin ropeginterferon alfa-2b therapy.
Bolesnici s dijabetes melitusom, koji se ne mogu učinkovito kontrolirati lijekovima, ne smiju započinjati terapiju ropeginterferonom alfa-2b.
Reproductive and developmental studies were not performed with ropeginterferon alfa-2b.
Nisu provedena ispitivanja reproduktivne i razvojne toksičnosti s ropeginterferonom alfa-2b.
Disposal of the pen:
Zbrinjavanje brizgalice:
CNS effects including suicide attempt, suicidal ideation, aggression, bipolar disorder, mania and confusion have been reported with interferon alfa (see section 4.4).
uključujući pokušaj samoubojstva, suicidalnu ideaciju, agresiju, bipolarni poremećaj, maniju i konfuziju, zabilježeni su kod interferona alfa (vidjeti dio 4.4).
Ropeginterferon alfa-2b is a recombinant interferon alfa-2b conjugated with a two-arm methoxypolyethylene glycol (mPEG) at a degree of substitution of 1 mole of polymer/mole of protein.
Ropeginterferon alfa-2b je rekombinantni interferon alfa-2b, konjugiran s metoksipolietilenglikolom (mPEG) s dva kraka, uz stupanj supstitucije od 1 mola polimera/mol proteina.
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).
Ozbiljni poremećaji oka zabilježeni su kod primjene interferona alfa,poput retinopatije, krvarenja u mrežnicu, eksudata u mrežnici, ablacije mrežnice i okluzije mrežnične arterije ili vene (vidjeti dio 4.4).
No ropeginterferon alfa-2b dose adjustment is required for adult patients with mild liver impairment.
Nije potrebna prilagodba doze ropeginterferona alfa-2b u odraslih bolesnika s blagim oštećenjem jetre.
During the clinical study program, one accidental case of overdose has been reported with ropeginterferon alfa-2b.
Tijekom programa kliničkog ispitivanja, zabilježen je jedan slučaj nehotičnog predoziranja s ropeginterferonom alfa-2b.
Reproductive system and breast disorders uncommon erectile dysfunction, haematospermia
Poremećaji reproduktivnog sustava i dojki manje često erektilna disfunkcija, hematospermija
Patients with pre-existing or a history of cardiovascular disorders should be closely monitored during ropeginterferon alfa-2b therapy.
Bolesnike s postojećim kardiovaskularnim poremećajima ili njihovom anamnezom treba pomno nadzirati tijekom terapije ropeginterferonom alfa-2b.
Ropeginterferon alfa-2b is contraindicated in patients with end stage renal disease (GFR <15 mL/min) (see section 4.3).
Ropeginterferon alfa-2b je kontraindiciran u bolesnika sa završnim stadijem bolesti bubrega (GFR <15 ml/min) (vidjeti dio 4.3).
The elimination of ropeginterferon alfa-2b is not fully characterised.
Eliminacija ropeginterferona alfa-2b nije u potpunosti određena.
Hepatic failure in hepatitis C virus infected patients was reported with other interferon alfa medicinal products (see section 4.8).
Zatajenje jetre u bolesnika zaraženih virusom hepatitisa C zabilježeno je kod primjene drugih lijekova koji sadrže interferon alfa (vidjeti dio 4.8).
Liver disorders have been reported in patients after long-term ropeginterferon alfa-2b therapy (see section 4.8).
Poremećaji jetre uočeni su u bolesnika nakon dugotrajne terapije ropeginterferonom alfa-2b (vidjeti dio 4.8).
Complete haematological responsea Complete haematological responsea and improvement in disease burdenb a defined as haematocrit <45% without phlebotomy (at least 3 months since last phlebotomy), platelets <400 x 109/L and leukocytes <10 x 109/L.
a definirano kao hematokrit <45% bez flebotomije (najmanje 3 mjeseca od posljednje flebotomije), trombociti <400 x 109/l i leukociti <10 x 109/l.
It delivers doses of 50 μg, 100 μg, 150 μg, 200 μg and 250 μg.
50 μg, 100 μg, 150 μg, 200 μg i 250 μg.
• Besremi pre-filled pen
• Besremi napunjenu brizgalicu
White n (%)
Bijelci n (%)
JAK2V617F allele burden JAK2V617F changes from baseline
Opterećenje alelom JAK2V617F
Shelf life after first use: 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.
Rok valjanosti nakon prve uporabe: Može se čuvati najdulje 30 dana u hladnjaku (2°C - 8°C) kada se čuva s kapicom na brizgalici i u vanjskoj kutiji radi zaštite od svjetlosti.
• If you have used your Besremi 250 microgram pre filled pen once before, continue directly with step 7.
250 mikrograma napunjenu brizgalicu, nastavite izravno s korakom 7.
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-Harada bolest (rijetka bolest koja može dovesti do gubitka vida, sluha te pigmentacije kože), teška alergijska reakcija
Clear, colourless to pale yellow solution.
Bistra, bezbojna do blijedožuta otopina.
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.
Nakon otvaranja, napunjena brizgalica može se čuvati najdulje 30 dana u hladnjaku (2°C - 8°C) kada se čuva s kapicom na brizgalici i u vanjskoj kutiji radi zaštite od svjetlosti.
Almost 50% of patients showed a complete haematological response with an improvement in disease burden after 36 months of treatment.
Gotovo 50% bolesnika liječenih ropeginterferonom alfa-2b pokazalo je potpuni hematološki odgovor s poboljšanjem u opterećenju bolesšću nakon 36 mjeseci liječenja.
JAK2V617F allele burden and changes from baseline in the CONTINUATION-PV extension study.
Tablica 4. Opterećenje alelom JAK2V617F i promjene od početne vrijednosti u produljenom ispitivanju CONTINUATION-PV
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.
Napunjena brizgalica može se čuvati najdulje 30 dana u hladnjaku (2°C - 8°C) kada se čuva s kapicom na brizgalici i u vanjskoj kutiji radi zaštite od svjetlosti.
Liver enzymes and hepatic function should be regularly controlled in patients with longterm ropeginterferon alfa-2b therapy.
Potrebno je redovito nadzirati jetrene enzime i funkciju jetre u bolesnika s dugotrajnom terapijom ropeginterferonom alfa-2b.
Most common adverse reactions
Najčešće nuspojave
The dose was gradually increased depending on disease response and tolerability (for ropeginterferon alfa-2b, from 50 to
Doza se postupno povećavala ovisno o odgovoru na bolest te podnošljivosti (za ropeginterferon alfa-2b od 50 do 500 mikrograma primijenjeno supkutano svaka 2 tjedna).
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,
Pretrage često pozitivna antitiroidna protutijela, povišena vrijednost TSH u krvi, povišena tjelesna temperatura, pozitivan nalaz na anti-nuklearna protutijela, povišena laktat dehidrogenaza u krvi manje često smanjen broj trombocita, povišena mokraćna kiselina u krvi, pozitivan Coombsov test, smanjena tjelesna težina
If renal function decreases during treatment, ropeginterferon alfa-2b therapy should be discontinued.
Ako se bubrežna funkcija smanji tijekom liječenja, potrebno je prekinuti terapiju ropeginterferonom 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#,
Poremećaji oka često suhe oči manje često krvarenje u mrežnicu#, eksudat u mrežnici#, poremećaj vida, smanjena oštrina vida, zamućeni vid, neugoda u oku, ekcemi na očnim kapcima rijetko retinopatija#, optička neuropatija#, okluzija mrežnične arterije#, okluzija mrežnične vene#
Cardiac disorders common atrial fibrillation uncommon myocardial infarction#, atrioventricular block, intracardiac thrombus, aortic valve incompetence, cardiovascular disorder rare cardiomyopathy#, angina pectoris#
Srčani poremećaji često fibrilacija atrija manje često infarkt miokarda#, atrioventrikularni blok, intrakardijalni tromb, inkompetencija aortalnog zalistka,
Increased liver enzyme levels have been observed in patients treated with ropeginterferon alfa-2b.
Povišene razine jetrenih enzima uočene su u bolesnika liječenih ropeginterferonom alfa-2b.
Co-administration of pegylated interferon alfa-2b showed no significant interaction with tolbutamide (CYP2C9 substrate), midazolam (CYP3A4 substrate), dapsone (N-acetyltransferase substrate) and modestly increased the exposure of caffeine (CYP1A2 substrate) and desipramine (CYP2D6 substrate).
(supstrat CYP2C9), midazolamom (supstrat CYP3A4), dapsonom (supstratom N-acetiltransferaze) te je umjereno povećala izloženost kofeinu (supstrat CYP1A2) i dezipraminu (supstrat CYP2D6).
Excipient with known effect Each pre-filled pen contains 10 mg benzyl alcohol per mL.
Jedna napunjena brizgalica sadrži 10 mg benzilnog alkohola po ml.
• Before you begin, check that the product has not expired.
• Prije početka provjerite rok valjanosti lijeka.
The 250 micrograms/0.5 mL pre-filled pen has a grey push button.
Napunjena brizgalica 250 mikrograma/0,5 ml ima sivi potisni gumb.
No interaction studies have been performed with ropeginterferon alfa-2b.
Nisu provedena ispitivanja interakcija s ropeginterferonom alfa-2b.
Comparable exposure and pharmacokinetic profile was reported for another interferon alfa medicinal product (pegylated interferon alfa-2a) in cirrhotic (Child-Pugh A) and non-cirrhotic patients.
Oštećenje jetre Usporediva izloženost i farmakokinetički profil zabilježen je za druge lijekove koji sadrže interferon alfa (pegilirani interferon alfa-2a) u bolesnika s cirozom (Child-Pugh stadij A) te u bolesnika bez ciroze.
The most common gastrointestinal disorders reported in these studies were diarrhoea (5.1%; incidence rate: 2.8 [events/100 patients per year]) and nausea (4.5%; incidence rate: 1.6 events/100 patients per year]).
događaja/100 bolesnika po godini) i mučnina (4,5%; stopa incidencije: 1,6 [događaja/100 bolesnika po godini]).
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).
Teški poremećaji oka kao što su retinopatija, krvarenje u mrežnici, eksudati u mrežnici, ablacija mrežnice i okluzija mrežnične arterije ili vene koja može rezultirati gubitkom vida, rijetko su prijavljeni u bolesnika liječenih interferonom alfa (vidjeti dio 4.8).
It is unknown if the active substance of the medicinal product is excreted into experimental animal or human milk (see section 4.6).
Nije poznato izlučuje li se djelatna tvar lijeka u majčino mlijeko eksperimentalnih životinja ili ljudi
Patients who develop respiratory symptoms should be monitored closely and if necessary, ropeginterferon alfa-2b therapy should be discontinued.
Bolesnike koji razviju respiratorne simptome treba pomno nadzirati te ako je potrebno prekinuti primjenu ropeginterferona alfa-2b.
Description Besremi 500 micrograms pre-filled pen
Opis lijeka Besremi 500 mikrograma napunjene brizgalice
The same elimination route is considered for ropeginterferon alfa-2b.
Smatra se da je put eliminacije za ropeginterferon alfa-2b isti.
Diabetes mellitus have been observed with other interferon alfa medicinal products (see section 4.8).
Dijabetes melitus je uočen kod terapije drugim lijekovima koji sadrže interferon alfa (vidjeti dio 4.8).
Very rare side effects (may affect up to 1 in 10,000 people): - blindness - breathing problems including shortness of breath, cough and chest pain which may be caused by lung infiltration, pneumonia (lung infection), pulmonary arterial hypertension (high blood pressure in the blood vessels bringing blood from the heart to the lungs) and pulmonary fibrosis (a lung disease where scars are formed in the lung tissue)
- poteškoće s disanjem uključujući nedostatak zraka, kašalj i bol u prsima, što može biti uzrokovano plućnim infiltratom, pneumonijom (plućnom infekcijom), hipertenzijom plućne arterije (visoki krvni tlak u krvnim žilama koje vode krv iz srca u pluća) te plućnom fibrozom
Hepatobiliary very common gamma-glutamyltransferase increased disorders common liver disorder, alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased uncommon hepatotoxicity, hepatitis toxic, hepatomegaly rare hepatic failure#
povišena aspartat aminotransferaza, povišena alkalna fosfataza u krvi manje često hepatotoksičnost, toksični hepatitis, hepatomegalija rijetko zatajenje jetre#
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 mikrograma/0,5 ml otopina za injekciju u napunjenoj brizgalici Besremi 500 mikrograma/0,5 ml otopina za injekciju u napunjenoj brizgalici
Description Besremi 250 micrograms pre-filled pen
Opis lijeka Besremi 250 mikrograma napunjene brizgalice
Ear and labyrinth disorders uncommon deafness, tinnitus, vertigo
Poremećaji uha i labirinta manje često gluhoća, tinitus, vrtoglavica
The cartridge is sealed in a pen injector.
Uložak je učvršćen u brizgalici.
Musculoskeletal and connective tissue disorders very common arthralgia, myalgia common
Poremećaji mišićno koštanog sustava i vezivnog tkiva vrlo često artralgija, mialgija često
Visual system
Sustav vida
General disorders and administration site conditions very common influenza like illness, fatigue common pyrexia, injection site reaction, asthenia, chills, general physical health deterioration, injection site erythema uncommon injection site pain, injection site pruritus, sensitivity to weather change not known:
Opći poremećaji i reakcije na mjestu primjene vrlo često bolest nalik influenci, umor često pireksija, reakcija na mjestu primjene injekcije, astenija, zimica, pogoršanje općeg tjelesnog zdravstvenog stanja, eritem na mjestu primjene injekcije manje često bol na mjestu primjene injekcije, pruritus na mjestu primjene injekcije, osjetljivost na promjenu vremena nepoznato hiperpigmentacija jezika#
Respiratory, thoracic and mediastinal disorders common dyspnoea uncommon pneumonitis, cough, epistaxis, throat irritation very rare lung infiltration#
Dispneja manje često pneumonitis, kašalj, epistaksa, iritacija grla vrlo rijetko infiltracija pluća#
Psychiatric disorders common depression, aggression#, insomnia, anxiety, mood altered, mood swings, listless uncommon suicide attempt#, suicidal ideation#, confusional state#, acute stress disorder, hallucination, emotional distress, nervousness, apathy, nightmare, irritability rare bipolar disorder#, mania#
Psihijatrijski poremećaji često depresija, agresija#, nesanica, tjeskoba, promijenjeno raspoloženje, promjene raspoloženja, bezvoljnost manje često pokušaj suicida#, suicidalna ideacija#, konfuzno stanje #,
Also contains sodium chloride, polysorbate 80, anhydrous sodium acetate, glacial acetic acid, water for injections, and benzyl alcohol.
POPIS POMOĆNIH TVARI Također sadrži natrijev klorid, polisorbat 80, bezvodni natrijev acetat, ledenu acetatnu kiselinu, vodu za injekcije te benzilni alkohol.
Besremi 500 micrograms/0.5 mL solution for injection in pre-filled pen 1.5 years.
Besremi 500 mikrograma/0,5 ml otopina za injekciju u napunjenoj brizgalici 1,5 godina.
Ropeginterferon alfa-2b is contraindicated in patients with decompensated cirrhosis of the liver (see section 4.3).
Ropeginterferon alfa-2b je kontraindiciran u bolesnika s dekompenziranom cirozom jetre (vidjeti dio 4.3).
It is not known if Besremi is present in breast milk.
Nije poznato izlučuje li se Besremi u majčino mlijeko.
- if you are allergic to ropeginterferon alfa-2b or any of the other ingredients of this medicine
- ako ste alergični na ropeginterferon alfa-2b ili neki drugi sastojak ovog lijeka (naveden u dijelu - ako imate bolest štitnjače koja se ne kontrolira lijekovima.
Nervous system disorders common headache, dizziness, hypoesthesia, somnolence, paraesthesia uncommon polyneuropathy, peripheral motor neuropathy, radiculopathy, migraine, mental impairment, tremor, aura
Poremećaji živčanog sustava često glavobolja, omaglica, hipoestezija, somnolencija, parestezija manje često polineuropatija, periferna motorička neuropatija,
Besremi contains sodium
Besremi sadrži natrij
Patients who develop this condition during treatment and cannot be controlled by medicinal products should discontinue ropeginterferon alfa-2b therapy.
Bolesnici u kojih se dijabetes melitus javi tijekom liječenja i koji se ne mogu kontrolirati lijekovima trebaju prekinuti terapiju ropeginterferonom alfa-2b.
Each pre-filled pen contains 0.5 mL of solution.
Jedna napunjena brizgalica sadrži 0,5 ml otopine.
Ropeginterferon alfa-2b is contraindicated in patients with end stage renal disease (see section 4.3).
Ropeginterferon alfa-2b je kontraindiciran u bolesnika sa završnim stadijem bolesti bubrega (vidjeti dio 4.3).
Patients with 36 months of ropeginterferon alfa-2b treatment2
Bolesnici s 36-mjesečnim liječenjem ropeginterferonom alfa-2b2
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.
farmakodinamičkom odgovoru te podnošljivosti, prilagodba doze ropeginterferona alfa-2b ne smatra se potrebnom kod starije populacije.
Serious, acute hypersensitivity reactions (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis) have been rarely observed with other interferon alfa medicinal products.
Akutna preosjetljivost Ozbiljne, akutne reakcije preosjetljivosti (npr. urtikarija, angioedem, bronhokonstrikcija, anafilaksija)
Side effects with frequency not known (cannot be estimated from the available data): - detachment of the retina (you may experience eye problems including changes in vision)
- odvajanje mrežnice (mogu Vam se javiti problemi s očima uključujući promjene vida)
• Severe pre-existing cardiovascular disease, (i.e. uncontrolled hypertension, congestive heart failure (≥ NYHA class 2), serious cardiac arrhythmia, significant coronary artery stenosis,
• Postojanje ili anamneza teških psihijatrijskih poremećaja, posebice teške depresije, suicidalne ideacije ili pokušaja samoubojstva • Teška postojeća kardiovaskularna bolest (tj. nekontrolirana hipertenzija, kongestivno zatajenje srca (≥ NYHA klase 2), ozbiljna srčana aritmija, značajna stenoza koronarne arterije, nestabilna angina) ili nedavni moždani udar ili infarkt miokarda
Liver function
Bubrežna funkcija
Disease response after 24 and 36 months of ropeginterferon alfa-2b.
Tablica 3. Odgovor na liječenje ropeginterferonom alfa-2b nakon 24 i 36 mjeseci Skupina koja je primala ropeginterferon alfa-2b
In patients who develop evidence of hepatic decompensation during treatment, ropeginterferon alfa-2b should be discontinued.
U bolesnika u kojih se javi dokaz dekompenzacije jetre tijekom liječenja potrebno je prekinuti terapiju ropeginterferonom alfa-2b.
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
Infekcije i infestacije često infekcija respiratornog sustava, rinitis, gljivična infekcija kože manje često oralni herpes, herpes zoster, oralna kandidijaza, sinusitis,
112-month treatment duration in the PROUD-PV Study and 12-month treatment duration in the extension study 212-month treatment duration in the PROUD-PV Study and 24-month treatment duration in the extension study
2 Bolesnici s 12-mjesečnim trajanjem liječenja u ispitivanju PROUD-PV i 24-mjesečnim trajanjem liječenja u produžetku ispitivanja).
Very common side effects (may affect more than 1 in 10 people): - decrease in the number of a type of white blood cells (called leucocytes) and in blood clotting cells (called platelets) - joint or muscle pain - flu-like symptoms, feeling tired - in blood tests: increase of an enzyme called gamma-glutamyltransferase
Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba): - smanjenje broja bijelih krvnih stanica (zvanih leukociti) i broja stanica koje zgrušavaju krv (zvanih trombociti)
The metabolism of ropeginterferon alfa-2b is not fully characterised.
Metabolizam ropeginterferona alfa-2b nije do kraja određen.
• Pre-existing thyroid disease unless it can be controlled with conventional treatment
• Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1 • Prethodna bolest štitne žlijezde, osim ako se može kontrolirati standardnim liječenjem
Control treatment arm (n=127)
(n=127)
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.
Napunjena brizgalica je načinjena od bijelog polipropilena sa sivim potisnim gumbom i jačinom „250 µg/0,5 ml“ naznačenom sivom bojom na naljepnici.
Renal and urinary disorders uncommon cystitis haemorrhagic, dysuria, micturition urgency, urinary retention
Poremećaji bubrega i mokraćnog sustava manje često hemoragični cistitis, dizurija, urgencija mokrenja, urinarna retencija
Do not inject into an area where the skin is irritated, reddened, bruised, infected or scarred.
Nemojte primjenjivati injekciju u područje u kojem je koža nadražena, crvena, s modricama, inficirana ili s ožiljcima.
• Put the cap back on the pen securely.
• Vratite kapicu natrag na brizgalicu i učvrstite je.
Besremi 250 micrograms/0.5 mL solution for injection in pre-filled pen 3 years.
Besremi 250 mikrograma/0,5 ml otopina za injekciju u napunjenoj brizgalici 3 godine.
• Remove the cap from the pen.
• Skinite kapicu s brizgalice.
No n (%)
Ne br (%)
- if you develop signs of a severe allergic reaction (such as difficulty in breathing, wheezing or hives) while using Besremi - if this is the case you will need to seek medical help immediately.
dok upotrebljavate lijek Besremi - u tom slučaju morate odmah potražiti liječničku pomoć.
CNS
SŽS
Name and address of the manufacturer(s) of the biological active substance(s) PharmaEssentia Corp.
Naziv(i) i adresa(e) proizvođača biološke(ih) djelatne(ih) tvari
Besremi 500 mcg/0.5 mL injection ropeginterferon alfa-2b SC
Besremi 500 μg/0,5 ml injekcija ropeginterferon alfa-2b s.c.
• Do not inject into skin that is irritated, reddened, bruised, infected or scarred in any way.
• Nemojte injicirati u kožu koja je nadražena, crvena, s modricama, inficirana ili ima bilo kakve ožiljke.
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#
Poremećaji kože i potkožnog tkiva često pruritus, alopecija, osip, eritem, psorijaza, kseroderma, akneiformni dermatitis, hiperkeratoza, hiperhidroza,
Do not inject into skin that is irritated, reddened, bruised, infected or scarred in any way.
Nemojte injicirati u kožu koja je nadražena, crvena, s modricama, inficirana ili ima bilo kakve ožiljke.
Regardless of the starting dose or degree of renal impairment, patients should be monitored.
Bolesnike treba nadzirati neovisno o početnoj dozi ili stupnju oštećenja bubrega.