natgillin/translations-raw huggingface dataset:
The majority of patients with reflux symptoms can be controlled at the self-care level or a primary care level.
Bolniki z dolgoročnimi ponavljajočimi se simptomi prebavnih motenj ali zgage morajo redno obiskovati svojega zdravnika.
Patients in this study were at least 18 years old and had heartburn of at least moderate intensity for at least the previous 3 months.
• So starejši od 55 let in so se jim pojavili novi simptomi ali pa so se ti nedavno spremenili.
1 FENDRICK AM et al., Self-Selection and Use Patterns of Over-the-Counter Omeprazole for Frequent Heartburn, Clinical Gastroenterology and Hepatology 2004;2:17-21
Bolezni kože in podkožja izbruh izpuščaja/ eksantema; srbenje urtikarija; angioedem
Based on the review of data on quality, safety and efficacy the benefits of CONTROLOC Control outweigh the risks for the short-term treatment of reflux symptoms under the classification as medicinal product not subject to medical prescription.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih in genotoksičnosti ne kažejo posebnega tveganja za človeka.
Gastro-oesophageal reflux disease (GORD) is defined as a condition which develops when the reflux of stomach contents causes troublesome symptoms and/or complications.
Refluks je vračanje kisline iz želodca v požiralnik (»prebavna cev«), ki lahko postane pekoče in boleče.
It has been proven that the drug substance can be reproducibly manufactured.
Študije na živalih so pokazale vpliv na sposobnost razmnoževanja.
The drug substance specification includes tests for identification (IR and sodium), appearance of solution, optical rotation, water content (Karl Fisher), heavy metals, related substances (HPLC), assay (titration), particle size (laser diffraction) and residual solvents (GC).
Lahko pa jemljete zdravilo CONTROLOC Control z antacidi (npr. magaldrat, alginska kislina, natrijev hidrogenkarbonat, aluminijev hidroksid, magnezijev karbonat ali kombinacije naštetih), če je potrebno.
The manufacturing process has been applied unchanged over the recent years.
V nekaj primerih je bil čas izločanja podaljšan.
Detailed description of the Pharmacovigilance system
KAKO JEMATI ZDRAVILO CONTROLOC CONTROL
Furthermore bulk stability for the gastro-resistant tablets were submitted to guarantee stability prior to further processing.
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago.
Although spontaneous abortions and premature births did not occur with higher frequency, because animal studies have shown reproductive toxicity (signs of slight fetotoxicity were observed at doses above 5 mg/kg), patients are advised not to use pantoprazole during pregnancy.
V 2 letnih raziskavah na glodalcih so pri podganah (samo v 1 študiji) in pri mišjih samicah opazili povečano število jetrnih tumorjev, ki naj bi nastali zaradi močno povečanega presnavljanja pantoprazola v jetrih.
The differences between pantoprazole and placebo in the relief from heartburn (table 2) were statistically significant at 1 and 2 weeks in both the intent-to-treat and per protocol populations (p<0.001, Fisher's Exact Test).
Po uporabi pantoprazola pri bolnikih z okvarjenimi jetri (Child-Pugh razredi A, B in C) se razpolovni čas podaljša na 3 do 7 ur in vrednosti AUC narastejo s faktorjem 3-6, medtem ko poraste Cmax komaj opazno, s faktorjem 1,3 v primerjavi z zdravimi osebami.
The product specification is standard for tablets (modified release) and contains tests with suitable limits for appearance, mean mass, disintegration time, loss on drying, identification, dissolution (UV determination), content uniformity, assay (HPLC), purity - impurities and degradation products (HPLC), microbial limits.
- Redki neželeni učinki: motnje vida kot je zamegljen vid, bolečine v sklepih, bolečine v mišicah, nihanje telesne mase, povišana telesna temperatura, otekanje okončin, alergijske reakcije, depresija, povečane vrednosti bilirubina in maščob v krvi (razvidno iz krvnih testov).
• Serious adverse event/deaths/other significant events
• Imajo katerokoli drugo resno bolezen, ki vpliva na splošno dobro počutje.
Participant flow
Okvara jeter
All analytical methods, except for particle size and residual solvents, are compendial and validation of these methods was not deemed necessary.
V primeru prevelikega odmerjanja s kliničnimi znaki zastrupitve ni razen simptomatskega in podpornega zdravljenja nobenih posebnih priporočil za zdravljenje.
60.1% to 69.8% Placebo
Po 14 in 28 dneh je popolno izboljšanje zgage navajalo 62,9% do 88,6% oz. 68,1% do 92,3% bolnikov.
The per-protocol set included all patients of the full analysis set except those who fulfilled at least one of the major protocol violations.
Predlagateljeva utemeljitev je temeljila na 6 „neobjavljenih” študijah, med katerimi jih je 5 bilo objavljenih v celoti, ena pa le v obliki povzetka.
Serious adverse drug reactions have therefore been rare.
- Zelo redki neželeni učinki:
Unlike other proton pump inhibitors, pantoprazole has linear pharmacokinetics in a dose range of 10 - 80mg.
V razponu odmerkov od 10 do 80 mg je plazemska kinetika pantoprazola linearna, tako za peroralni kot tudi za intravenski vnos.
Since in patients with liver cirrhosis the elimination half-life, the AUC and the maximum serum concentration is increased compared to healthy subjects, patients with liver disease should not be supplied with non-prescription pantoprazole without consulting a doctor.
Če je pri bolniku predvidena endoskopija ali dihalni test s sečnino, se mora pred jemanjem tega zdravila posvetovati s svojim zdravnikom.
Tablet cores are produced by wet granulation.
SEZNAM POMOŽNIH SNOVI Vsebuje sojin lecitin.
It was noted by the CHMP that the maximum effect of proton pump inhibitors is experienced following a few days treatment, while antacids and histamine receptor antagonists exert their effect without delay.
Zmanjšanje znakov kislega refluksa in zgage utegnete opaziti že po 1 dnevu zdravljenja z zdravilom CONTROLOC Control, vendar to zdravilo ni namenjeno takojšnjemu olajšanju.
During extensive post-marketing experience, no safety concerns have been identified.
6.6 Posebni varnostni ukrepi za odstranjevanje Ni posebnih zahtev.
Mild symptoms occurring 2 or more days per week or moderate to severe symptoms occurring more than 1 day per week are often considered troublesome for patients.
Mogoče bo za dosego zmanjšanja simptomov potrebno jemati tablete 2-3 dni zaporedoma.
It should be noted that the following overview of marketing authorizations concerns the prescriptiononly medicine with the exception of the approval in Sweden where pack sizes with 7 and 14 tablets of the 20 mg gastro-resistant tablets are approved for non-prescription use since 24-Feb-2000.
Alu/Alu pretisni omoti, ki vsebujejo 7 ali 14 gastrorezistentnih tablet ali Alu/Alu pretisni omoti s kartonsko oporo, ki vsebujejo 7 ali 14 gastrorezistentnih tablet.
Table 9 Overview of adverse drug reactions
PODATKI NA VMESNI OVOJNINI KARTONSKA OPORA
The study was a double-blind comparison of pantoprazole 20 mg and ranitidine 300 mg once daily in patients with reflux-related symptoms (heartburn, acid regurgitation or pain on swallowing) of at least ‘rather severe' intensity on a 7-point Likert Scale.
Dokazano je bilo, da sočasen vnos atazanavirja 300 mg/ritonavirja 100 mg z omeprazolom (40 mg enkrat na dan) ali atazanavirja 400 mg z lanzoprazolom (60 mg v enkratnem odmerku) pri zdravih prostovoljcih povzroči znatno zmanjšanje biološke razpoložljivosti atazanavirja.
No difference has been found in the in-vitro or in-vivo activity of the two enantiomers.
Farmakokinetika po enkratnem ali večkratnem vnosu se ne razlikuje.
The results of clinical studies where symptomatic relief of GORD was investigated show that pantoprazole provides relief of heartburn and acid regurgitation during a short-term treatment course (2-4 weeks).
Čeprav v kliničnih farmakokinetičnih raziskavah niso opazili nobenega medsebojnega delovanja pri sočasni uporabi fenprokumona ali varfarina, so v post-marketinškem obdobju zabeležili nekaj posameznih primerov spremenjenih vrednosti INR (International Normalised Ratio) ob sočasnem zdravljenju.
Patients with new symptoms will be referred to a doctor.
Bolnikom je treba naročiti, da se posvetujejo z zdravnikom, če:
Follow-up
Trajanje
2.3 Non-clinical aspects
4.8 Neželeni učinki
62.9% to 83.0% H2RA (Ranitidine 300mg, Ranitidine 2x150 mg, Nizatidine 2x150 mg)
V povprečju se približno 2,0 h - 2,5 h po vnosu (tmax) enkratnega peroralnega odmerka 20 mg doseže maksimalna serumska koncentracija (Cmax) približno 1-1,5 µg/ml, in te vrednosti po večkratnem vnosu ostanejo konstantne.
The printed tablets are put into the container closure systems.
Tablete morate pogoltniti cele.
Day 7 PP (N=158) Day 14 PP (N=158)
D-78467 Konstanz Nemčija tel. +49-(0)7531-84-0 fax: +49-(0)7531-84-2474
The secondary outcome was to assess the effects of pantoprazole and ranitidine in the following variables: - absence of heartburn during the 3 days prior to the second visit (after 28 days ±3 days of treatment) - safety and tolerability - influence of H.pylori status on efficacy - symptomatic improvement after 2 and 4 weeks of treatment, judged by a symptom score
Bodite posebno pozorni pri zdravilu CONTROLOC Control Najprej se posvetujte s svojim zdravnikom, če: - ste se zaradi zgage ali prebavnih motenj neprekinjeno zdravili 4 tedne ali več - ste starejši od 55 let in zaradi prebavnih motenj dnevno jemljete zdravila brez recepta - ste starejši od 55 let in imate nove simptome ali pa so se ti nedavno spremenili - ste že imeli razjedo želodca ali operacijo želodca
Reflux of gastric acid into the oesophagus is mediated by different mechanisms such as transient lower oesophageal sphincter relaxations or reduced pressure, impaired oesophageal clearance and hiatus hernia.
Ker se pantoprazol veže na encim distalno od celičnega receptorja, lahko zavira izločanje klorovodikove kisline neodvisno od stimulacije z drugimi snovmi (acetilholin, histamin, gastrin).
Active Substance
peroralna uporaba
Since the manufacturing of the product is identical to the reference product, there is no requirement to specifically address the impurity profile of the new product from a nonclinical perspective.
Ker so terapevtski odmerki pri človeku nizki, na ščitnici ni pričakovati neželenih učinkov.
The efficacy and safety of the 20 mg dose subject to medical prescription in the treatment of mild reflux disease and its symptoms is acknowledged.
Zaradi nezadostnih podatkov o varnosti in učinkovitosti uporaba CONTROLOC Control 20 mg gastrorezistentnih tablet pri otrocih in mladostnikih pod 18 let ni priporočljiva.
In addition, the applicant proposed the classification for supply of CONTROLOC Control to “medicinal product not subject to medical prescription”.
SHRANJEVANJE ZDRAVILA CONTROLOC CONTROL Zdravilo shranjujte nedosegljivo otrokom!
It is noted that specific aspects of the national implementation of a nonprescription status vary amongst Member States.
Znaki prevelikega odmerjanja pri človeku niso znani.
Day 7
Tabela 1.
All results are with specifications and show batch-to-batch and site-to-site consistency.
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
Safety
Nosečnost
The multiple level of significance was set to 5%, and an appropriate sample size was chosen to achieve a power of 90%.
Porazdelitev Porazdelitveni volumen je približno 0,15 l/kg, vezava na serumske beljakovine pa je približno 98%.
Other GI symptoms (epigastric pain, retrosternal tightness, nausea, vomiting etc.) showed a considerable decrease.
- Druge resne reakcije (pogostnost neznana): porumenitev kože in oči (zaradi resne okvare jeter), ali težave z ledvicami, kot so boleče uriniranje in bolečine v spodnjem delu hrbta z vročino.
Is freely soluble in water and in ethanol (96%), practically insoluble in hexane.
Glavna pot izločanja njegovih presnovkov je preko ledvic (približno 80%), preostanek se izloča z blatom.
Licensing status:
NAVODILO ZA UPORABO
Call your doctor immediately.
Takoj pokličite zdravnika.
For safety reasons:
Iz varnostnih razlogov:
Let your skin dry.
Pustite, da se koža osuši.
Your injection could take about 10 seconds.
Injiciranje lahko traja približno 10 sekund.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 March 2017
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 22. marec 2017
Median time to failure (months)
Srednji čas do neuspeha (meseci)
Wash your hands thoroughly with soap and water.
Dobro si umijte roke z milom in vodo.
Always take the outer carton of this medicine with you, even if it is empty.
Vedno vzemite s seboj zunanjo ovojnino zdravila, tudi če je prazna.
Tell your healthcare provider if you are allergic to latex.
Povejte zdravstvenemu delavcu, če ste alergični na lateks.
This is part of the syringe.
To je del brizge.
Most side effects are mild to moderate.
Večina stranskih učinkov je blagih do zmernih.
Particular attention regarding the risk for infection should be paid when treating the elderly.
Posebna pozornost glede tveganja okužb je potrebana pri zdravljenju starejših.
You will also need these additional items, as they are not included in the carton:
Potrebovali boste tudi ta dodaten material, ki pa ni vključen v škatli:
if you have moderate or severe heart failure.
• če imate zmerno ali hudo srčno popuščanje.
Keep pushing down on your skin.
Še naprej pritiskajte ob kožo.
CI 95% for HRa
IZ 95 % za RTa
Blue start button
Modri sprožilni gumb
- Any part appears cracked or broken.
- Se kateri koli del zdi zdrobljen ali zlomljen.
You and your doctor should pay special attention to signs of infection while you are being treated with AMGEVITA.
Vi sami in vaš zdravnik morata biti posebej pozorna na znake okužbe, medtem ko ste zdravljeni z zdravilom AMGEVITA.
● If you want to use the same injection site, make sure it is not the same spot on the injection site you used for a previous injection.
● Če želite uporabiti isto mesto za injiciranje, se prepričajte, da ne boste injicirali na isti točki kot ste pri predhodnem injiciranju.
When you are ready to inject, press the blue start button.
I. Ko ste pripravljeni na injiciranje, pritisnite modri sprožilni gumb.
OTHER SPECIAL WARNING(S), IF NECESSARY Contains latex, read the package leaflet before use.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Vsebuje lateks, pred uporabo preberite priloženo navodilo.
Important: Do not touch the blue start button yet.
Pomembno: Ne dotikajte se še modrega sprožilnega gumba.
Disease flares at the end of 32 weeksa (n/N)
Zagon bolezni na koncu 32-tedenskega obdobjaa (n/N)
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Kot vsa zdravila lahko tudi to zdravilo povzroči neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
This leaflet was last revised in
To navodilo je bilo nazadnje revidirano dne
Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli za “EXP”.
≥30% Reduction in Skin Painb
≥ 30 % zmanjšanje bolečine na koži b
Apply a plaster if needed.
Če je treba, namestite obliž.
Concomitant stable doses of aminosalicylates, corticosteroids, and/or immunomodulatory agents were permitted and 80% of patients continued to receive at least one of these medications.
Dovoljena je bila sočasna uporaba stabilnih odmerkov aminosalicilatov, kortikosteroidov in/ali imunomodulacijskih zdravil; 80 % bolnikov je še naprej prejemalo vsaj eno od takšnih zdravil.
● Talk with your doctor or pharmacist about proper disposal.
● Z zdravnikom ali farmacevtom se posvetujte o pravilnem odlaganju.
It is normal to see a drop of liquid at the end of the needle.
Normalno je, da se na koncu igle pokaže kapljica tekočine.
After 32 weeks or at disease flare, patients were eligible to enrol into the open-label extension phase.
Po 32 tednih ali v primeru zagona bolezni so bili bolniki primerni za vključitev v odprto podaljšano fazo.
if you have a severe infection, including active tuberculosis (see “Warnings and precautions”).
• če imate hudo okužbo, vključno z aktivno tuberkulozo (glejte "Opozorila in previdnostni ukrepi").
TNF-antagonists, such as AMGEVITA affect the immune system and their use may affect the body's defence against infection and cancer.
TNF-antagonisti, kot je zdravilo AMGEVITA, prizadanejo imunski sistem in njihova uporaba lahko vpliva na obrambo telesa proti okužbi in raku.
The interpretation of data may be impacted due to methodological limitations of the study, including small sample size and non-randomised design.
Na interpretacijo podatkov lahko vplivajo metodološke omejitve raziskave, vključno z majhno velikostjo vzorca in nerandomizirano zasnovo raziskave.
The expiry date refers to the last day of that month.
Rok uporabe zdravila se izteče na zadnji dan navedenega meseca.
Dry natural rubber
Suha naravna guma
• According to a pregnancy study, there was no higher risk of birth defects when the mother had received AMGEVITA during pregnancy compared with mothers with the same disease who did not receive AMGEVITA.
• Glede na študije v nosečnosti ni bilo večjega tveganja za defekte ob rojstvu, če je mati jemala zdravilo AMGEVITA med nosečnostjo, v primerjavi z materami z enako boleznijo, ki zdravila AMGEVITA niso jemale.
Important: You must push all the way down but do not touch the blue start button until you are ready to inject.
Pomembno: Potisniti morate do konca dol, vendar se ne dotikajte modrega sprožilnega gumba, dokler niste pripravljeni na injiciranje.
73% of patients enrolled in psoriasis studies I and II had received prior systemic therapy or phototherapy.
73 % bolnikov, vključenih v študiji pri psoriazi I in II, je predhodno dobivalo sistemsko zdravljenje ali fototerapijo.
The primary endpoint of the study was clinical remission at week 26, defined as PCDAI score ≤ 10.
Primarni cilj študije je bila klinična remisija v 26.tednu, definirana kot vrednost PCDAI ≤ 10.
Maintenance regimen
Vzdrževalni režim
● Do not use any medicine that is left in the used syringe.
● Ne uporabite zdravila, ki je ostalo v uporabljeni brizgi.
Worsening or new onset of psoriasis (including palmoplantar pustular psoriasis)1),
pogosti poslabšanje ali pojav psoriaze (vključno s palmplantarno pustularno psoriazo)1),
HS study II
Študija HS II
H. Using slow and constant pressure, push the plunger rod all the way down until it stops moving.
H. S počasnim in enakomernim pritiskom potisnite bat brizge do konca dol, dokler se ne preneha premikati.
Grab Here
Primite tukaj
Limited information from the published literature indicates that adalimumab is excreted in breast milk at very low concentrations with the presence of adalimumab in human milk at concentrations of 0.1% to 1% of the maternal serum level.
Omejeni podatki iz objavljene literature kažejo, da se adalimumab izloča v materino mleko v zelo nizkih koncentracijah, s prisotnostjo adalimumaba v človeškem mleku v koncentraciji 0,1 % do 1 % glede na materin serum.
Clean your injection site with an alcohol wipe.
Očistite mesto injiciranja z alkoholnim zložencem.
Appropriate screening tests (i.e. tuberculin skin test and chest x-ray) should be performed in all patients (local recommendations may apply).
Pri vseh bolnikih je treba narediti ustrezne presejalne preiskave (tj. tuberkulinski kožni test in rentgensko slikanje prsnih organov) (veljajo lahko lokalna priporočila).
If you forget to give yourself an injection, you should inject the next dose of AMGEVITA as soon as you remember.
Če si pozabite dati injekcijo, si jo morate naslednji odmerek zdravila AMGEVITA injicirati, čim se spomnite.
Efficacy results at 12 weeks, HS studies I and II
Rezultati učinkovitosti v 12. tednu, HS študiji I in II Študija HS I
- if you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na adalimumab ali katerokoli sestavino tega zdravila, navedeno v poglavju 6.
• opportunistic infections (which include tuberculosis and other infections that occur when resistance to disease is lowered);
• oportunistične okužbe (ki vključujejo tuberkulozo in druge okužbe, ki se pojavijo ob slabši telesni odpornosti na bolezen);
C. Gather all materials needed for your injection.
C. Pripravite ves material, potreben za injiciranje.
This will include a thorough medical evaluation including your medical history and appropriate screening tests (for example chest x-ray and a tuberculin test).
To bo vključevalo natančno zdravniško oceno vključno s poizvedbo o vašem zdravju v preteklosti in ustrezne preiskave (npr. rentgensko slikanje prsnih organov in tuberkulinski test).
One hundred patients (n = 100) from the Paediatric CD Study continued in an open-label long-term extension study.
Sto bolnikov (n = 100) iz študije Chronove bolezni pri pediatričnih bolnikih je nadaljevalo v odprti dolgoročni podaljšani študiji.
The decision to stop using AMGEVITA should be discussed with your doctor.
O odločitvi, da bi prenehali uporabljati zdravilo AMGEVITA, se morate posvetovati s svojim zdravnikom.
a HR of adalimumab versus placebo from proportional hazards regression with treatment as factor.
a RT adalimumaba v primerjavi s placebom iz regresije proporcionalnih tveganj z zdravljenjem kot faktorjem.
PGA-F clear/minimal and ≥ 2-grade improvement
PGA-F čisto/minimalno in ≥ izboljšanje za dva razreda (%)
* further information is found elsewhere in sections 4.3, 4.4 and 4.8 ** including open-label extension studies
* Nadaljnje informacije v zvezi s tem najdete v poglavjih 4.3, 4.4 in 4.8 ** Vključno pri podaljšanih študijah brez placeba 1)Vključno s podatki iz spontanega poročanja
6.6 Special precautions for disposal and other handling Detailed instructions for use are provided in the package leaflet.
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Podrobna navodila za uporabo so na voljo v Navodilu za uporabo.
In some rare cases, especially if you are taking other medicines that suppress the immune system, reactivation of HBV can be life-threatening.
V redkih primerih, zlasti če uporabljate druga zdravila, ki zavirajo imunski sistem, je reaktivacija HBV lahko smrtno nevarna.
Advise your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV or if you think you might be at risk of contracting HBV.
• Zdravniku morate povedati, če ste nosilec virusa hepatitisa B (HBV), če imate aktiven HBV ali če mislite, da bi se lahko nalezli HBV.
Ps study IV efficacy results at 16, 26 and 52 weeks
Študija pri psoriazi IV Rezultati učinkovitosti po 16, 26 in 52 tednih Končna točka
If you received AMGEVITA while you were pregnant, your baby may be at higher risk for getting such an infection for up to approximately five months after the last dose you received during pregnancy.
Če ste prejemali zdravilo AMGEVITA med nosečnostjo, obstaja večje tveganje, da bo vaš otrok dobil takšno okužbo do približno pet mesecev po zadnjem odmerku, ki ste ga prejeli med nosečnostjo.
Your doctor may recommend temporary discontinuation of AMGEVITA.
Vaš zdravnik bo morda priporočil začasno prenehanje uporabe zdravila AMGEVITA.
Urticaria,
urtikarija,
Carefully lift the pre-filled pen straight up out of the box.
Previdno dvignite napolnjeni injekcijski peresnik naravnost iz škatle.
Clinical response is usually achieved within 2-8 weeks of treatment.
Klinični odziv je po navadi dosežen v 2-8 tednih zdravljenja.
> 32 weeks
> 32 tednov
Regarding combination with disease-modifying anti-rheumatic drugs other than methotrexate see sections 4.4 and 5.1.
Za kombinirano uporabo z drugimi imunomodulirajočimi antirevmatičnimi zdravili razen metotreksata glejte poglavji 4.4 in 5.1.
AMGEVITA in combination with methotrexate, is indicated for:
Zdravilo AMGEVITA je v kombinaciji z metotreksatom indicirano za:
If you are over 65 years you may be more susceptible to infections while taking AMGEVITA.
• Če ste starejši od 65 let, ste morda dovzetnejši za okužbe, če jemljete zdravilo AMGEVITA.
Bruising (including purpura),
modrice (vključno s purpuro),