FrancophonIA/ELRC3.0 huggingface dataset:
English: SQUIRE, a global, multicenter, two-arm, randomized study of Portrazza, was conducted in 1,093 patients with stage IV (American Joint Committee on Cancer Version 7) squamous NSCLC, including patients with ECOG PS2, who had received no prior anticancer therapy for metastatic disease.
Croatian: Ispitivanje SQUIRE - globalno, multicentrično, randomizirano ispitivanje lijeka Portrazza s dvije skupine - provedeno je u 1093 bolesnika s planocelularnim NSCLC-om stadija IV (American Joint
English: Eyelash trichomegaly Isolated cases of Grade 1 trichomegaly have been reported in patients treated with necitumumab.
Croatian: U bolesnika liječenih necitumumabom prijavljeni su izolirani slučajevi trihomegalije 1. stupnja.
English: Pre-emptive skin treatment including skin moisturiser, sun screen, topical steroid cream (1 % hydrocortisone) and an oral antibiotic (e.g. doxycycline) may be useful in the management of dermatologic reactions as clinically appropriate.
Croatian: topikalne steroidne kreme (hidrokortizon u koncentraciji od 1%) i oralnog antibiotika (npr. doksiciklina).
English: Do not freeze or shake the infusion solution.
Croatian: Otopina za infuziju ne smije se zamrzavati ni tresti.
English: DO NOT FREEZE OR SHAKE the infusion solution.
Croatian: Otopina za infuziju NE SMIJE SE ZAMRZAVATI NI TRESTI.
English: Arterial thromboembolic events (ATEs) were reported in approximately 4 % of patients treated with necitumumab in combination with pemetrexed and cisplatin (versus 6 % in the pemetrexed and cisplatin alone arm) and mainly present as stroke and myocardial infarction.
Croatian: Arterijski tromboembolijski (AT) događaji prijavljeni su u približno 4% bolesnika liječenih necitumumabom u kombinaciji s pemetreksedom i cisplatinom (naspram 6% onih u skupini liječenoj samo pemetreksedom i cisplatinom), a manifestirali su se uglavnom kao moždani udar i infarkt miokarda.
English: No formal studies have been conducted to evaluate the effect of hepatic impairment on the PK of necitumumab.
Croatian: Nisu provedena formalna ispitivanja kojima bi se ocijenio učinak oštećenja bubrežne funkcije na farmakokinetiku necitumumaba.
English: Common Headache Common Dysgeusia
Croatian: Poremećaji živčanog sustava često glavobolja često disgeuzija
English: Stomatitis
Croatian: Nuspojavaa
English: An increased frequency of cardiorespiratory arrest or sudden death was observed with necitumumab.
Croatian: Kod liječenja necitumumabom primijećena je povećana učestalost kardiorespiratornog zastoja ili iznenadne smrti.
English: Portrazza must not be administered as an intravenous bolus or push.
Croatian: Portrazza se ne smije primijeniti bolusnom ni brzom intravenskom injekcijom.
English: Sodium citrate dihydrate (E331) Citric acid anhydrous (E330) Sodium chloride Glycine (E640)
Croatian: 6.1 Popis pomoćnih tvari natrijev citrat, dihidrat (E331) citratna kiselina, bezvodna (E330) natrijev klorid glicin (E640) manitol (E421) polisorbat 80 (E433) voda za injekcije
English: Excipient with known effect Each 50 mL vial contains approximately 76 mg sodium.
Croatian: Jedna bočica od 50 ml sadrži približno 76 mg natrija.
English: Infusion-related reactions may occur during treatment with Portrazza.
Croatian: Tijekom liječenja lijekom Portrazza mogu se javiti reakcije na infuziju.
English: Hypersensitivity/infusion-related reactions (IRRs) were reported with necitumumab.
Croatian: Reakcije preosjetljivost/reakcije na infuziju Kod primjene necitumumaba prijavljene su reakcije preosjetljivost/reakcije na infuziju.
English: Musculoskeletal and connective tissue disorders
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva često mišićni grčevi
English: The addition of necitumumab did not improve the efficacy outcome over pemetrexed and cisplatin alone in advanced non-squamous NSCLC.
Croatian: U bolesnika s uznapredovalim neplanocelularnim NSCLC-om, dodavanje necitumumaba nije poboljšalo ishod za djelotvornost u odnosu na liječenje samo pemetreksedom i cisplatinom.
English: In case of previous hypersensitivity or infusion-related reaction, recommendations for management of hypersensitivity/infusion-related reactions should be followed, as for Table 1.
Croatian: treba se pridržavati preporuka za zbrinjavanje reakcija preosjetljivosti/reakcija na infuziju navedenih u Tablici 1.
English: Toxicity in the elderly or in patients with ECOG PS 2
Croatian: Toksičnost u starijih osoba ili u bolesnika s funkcionalnim ECOG statusom 2 Klinički značajne toksičnosti u starijih osoba i bolesnika s rezultatom za funkcionalni ECOG (engl.
English: Necitumumab hinders other proteins from binding to the EGFR and thus prevents the cancer cell from growth and division.
Croatian: Necitumumab onemogućuje vezivanje drugih proteina na EGFR
English: Handling instructions Portrazza 800 mg concentrate for solution for infusion necitumumab
Croatian: Upute za rukovanje Portrazza 800 mg koncentrat za otopinu za infuziju necitumumab
English: GC Arm N=548
Croatian: N=548
English: Prepare the infusion solution using aseptic technique to ensure the sterility of the prepared solution.
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Pripremite otopinu za infuziju aseptičnom tehnikom kako biste osigurali sterilnost pripremljene otopine.
English: Portrazza 800 mg concentrate for solution for infusion necitumumab
Croatian: Portrazza 800 mg koncentrat za otopinu za infuziju necitumumab
English: Severe ATEs were reported in approximately 3 % of patients treated with necitumumab in combination with pemetrexed and cisplatin (versus 4 % in the pemetrexed and cisplatin alone arm).
Croatian: Teški AT događaji prijavljeni su u približno 3% bolesnika liječenih necitumumabom u kombinaciji s pemetreksedom i cisplatinom (naspram 4% onih u skupini liječenoj samo pemetreksedom i cisplatinom).
English: Severe VTEs were reported in approximately 6 % of patients treated with necitumumab in combination with pemetrexed and cisplatin (versus 4 % in the pemetrexed and cisplatin alone arm).
Croatian: Teški VT događaji prijavljeni su u približno 6% bolesnika liječenih necitumumabom u kombinaciji s pemetreksedom i cisplatinom (naspram 4% onih u skupini liječenoj samo pemetreksedom i cisplatinom).
English: Thromboprophylaxis should be considered after careful assessment of a patient's risk factors (including the increased risk of serious bleeding in patients with tumour cavitation or tumour involvement of large central blood vessels).
Croatian: (uključujući povećan rizik od ozbiljnog krvarenja u bolesnika s kavitacijom tumora ili u kojih je tumor zahvatio velike središnje krvne žile).
English: To administer using empty intravenous infusion containers Aseptically transfer 50 mL of necitumumab medicine into an empty intravenous container and add 200 mL of sterile sodium chloride 9 mg/mL (0.9%) solution for injection to the container to bring the total volume to 250 mL.
Croatian: Aseptičnom metodom prebacite 50 ml necitumumaba u prazan spremnik za intravensku infuziju i dodajte 200 ml sterilne otopine natrijeva klorida za injekciju od 9 mg/ml (0,9%) u spremnik da biste dobili ukupan volumen od 250 ml.
English: Infections and infestations
Croatian: Infekcije i infestacije često infekcija mokraćnih putova
English: There are no data regarding necitumumab administration in patients with severe renal impairment.
Croatian: Nema podataka o primjeni necitumumaba u bolesnika s teškim oštećenjem bubrežne funkcije.
English: To administer using empty intravenous infusion containers Aseptically transfer 50 mL of necitumumab medicinal product into an empty intravenous container and add 200 mL of sodium chloride 9 mg/mL (0.9 %) solution for injection to the container to bring the total volume to 250 mL.
Croatian: Aseptičnom metodom prebacite 50 ml necitumumaba u prazan spremnik za intravensku infuziju i dodajte 200 ml otopine natrijeva klorida za injekciju od 9 mg/ml (0,9%) u spremnik da biste dobili ukupan volumen od 250 ml.
English: Cases of cardiorespiratory disorders and unexplained death were observed in patients treated with Portrazza in combination with gemcitabine and cisplatin and in patients treated with gemcitabine and cisplatin alone.
Croatian: U bolesnika liječenih lijekom Portrazza u kombinaciji s gemcitabinom i cisplatinom te u bolesnika koji su primali samo gemcitabin i cisplatin prijavljeni su slučajevi srčanih i dišnih poremećaja te neobjašnjive smrti.
English: Only sodium chloride 9 mg/mL (0.9 %) solution for injection should be used as a diluent.
Croatian: Kao sredstvo za razrjeđivanje smije se koristiti samo otopina natrijeva klorida za injekciju od 9 mg/ml (0,9%).
English: Animal reproduction studies have not been conducted with necitumumab.
Croatian: Nisu provedena ispitivanja učinaka necitumumaba na reprodukciju u životinja.
English: To administer using pre-filled intravenous infusion containers Aseptically remove 50 mL of sodium chloride 9 mg/mL (0.9%) solution for injection from the prefilled 250 mL container and transfer 50 mL of necitumumab medicine into the container to bring the final volume in the container back to 250 mL.
Croatian: Aseptičnom tehnikom izvadite 50 ml otopine natrijeva klorida za injekcijeuod 9 mg/ml (0,9%) iz napunjenog spremnika volumena 250 ml i zatim prebacite 50 ml necitumumaba u spremnik kako biste konačan volumen u njemu vratili na 250 ml.
English: An improvement was observed in subgroups for OS and PFS including the pre-specified stratification factors [ECOG PS score (0-1 vs. 2) and geographic region (North America, Europe, and Australia vs. South America, South Africa, and India vs. Eastern Asia)]; in patients age 70 and over, the hazard ratio for overall survival was 1.03 (0.75, 1.42) (see Figure 2).
Croatian: Primijećeno je poboljšanje u podskupinama za OS i PFS, uključujući unaprijed specificirane stratifikacijske faktore (rezultat za funkcionalni ECOG status [0 - 1 naspram 2] i geografska regija
English: In patients who have experienced a previous Grade 1-2 hypersensitivity or infusion-related reaction to Portrazza, premedication with a corticosteroid and an antipyretic in addition to an antihistamine is recommended.
Croatian: 1. ili 2. stupnja, preporučuje se premedikacija kortikosteroidom i antipiretikom te antihistaminikom.
English: Inspect the contents of the vials for particulate matter and discolouration.
Croatian: Pregledajte sadržaj bočica kako biste se uvjerili da ne sadrži čestice i da nije promijenio boju.
English: Grade ≥ 3
Croatian: 3. stupanj
English: Electrolyte abnormalities
Croatian: Trihomegalija trepavica
English: There was no premedication for Portrazza mandated by the study.
Croatian: Protokol ispitivanja nije zahtijevao premedikaciju uz lijek Portrazza.
English: Hepatic impairment
Croatian: Preživljenje bez progresije bolesti
English: Respiratory, thoracic and mediastinal disorders
Croatian: - Srčani i dišni poremećaji
English: The overall survival hazard ratio [HR] was 0.83 [0.55, 1.52].
Croatian: Azije]); omjer hazarda za ukupno preživljenje u bolesnika u dobi od 70 ili više godina iznosio je 1,03 (0,75; 1,42) (vidjeti Sliku 2).
English: a Grade per NCI-CTCAE, Version 3.0 b Once the infusion rate has been reduced for a Grade 1 or 2 hypersensitivity/infusion-related reaction, it is recommended that the lower infusion rate be utilized for all subsequent infusions.
Croatian: National Cancer Institute Common Terminology Criteria for Adverse Events, NCI-CTCAE) b Kada se brzina infuzije smanji zbog reakcije preosjetljivosti/reakcije na infuziju
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji bubrega i mokraćnog sustava često dizurija
English: NAME OF THE MEDICINAL PRODUCT Portrazza 800 mg concentrate for solution for infusion necitumumab
Croatian: Uputa o lijeku: Informacije za korisnika Portrazza 800 mg koncentrat za otopinu za infuziju necitumumab
English: How you are given Portrazza
Croatian: Ne smijete primiti lijek Portrazza
English: The incidence of fatal VTEs was similar between arms (0.2%).
Croatian: Incidencija VT događaja sa smrtnim ishodom bila je slična u obje skupine
English: Common Muscle spasms
Croatian: - grčevi u mišićima
English: Only patients with baseline and at least one post-baseline result are included.
Croatian: Uključeni su samo bolesnici za koje su postojali nalazi dobiveni na početku ispitivanja i još najmanje jednom nakon početka ispitivanja.
English: Patients should be monitored during infusion for signs of infusion-related reactions (see section 4.4).
Croatian: Bolesnike je potrebno nadzirati tijekom infuzije zbog moguće pojave znakova reakcija na infuziju
English: Very rare (<1/10,000)
Croatian: Vrlo često (mogu se javiti u više od 1 na 10 osoba)
English: 11 January 2019
Croatian: 11. siječnja 2019.
English: The European Commission issued an EU-wide legally binding decision on 11 January 2019.
Croatian: Europska komisija objavila je pravno obvezujuću odluku na razini EU-a dana 11. siječnja 2019.
English: The review of Paclitaxel Hetero was initiated at the request of Portugal under Article 29 of Directive 2001/83/EC.
Croatian: Pregled lijeka Paclitaxel Hetero započeo je na zahtjev Portugala u skladu s člankom 29. Direktive 2001/83/EZ.
English: However, the Member States were not able to reach an agreement and the Portuguese agency referred the matter to EMA for arbitration on 2 November 2017.
Croatian: Međutim, države članice nisu mogle postići dogovor, pa je agencija za lijekove u Portugalu uputila predmet EMA-i na arbitražni postupak 2. studenoga 2017.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance Portugal) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States where the company has applied for a marketing authorisation (the ‘concerned Member States', in this instance Germany, the Netherlands and the UK).
Croatian: To je postupak u kojemu jedna država članica („referentna država članica”, u ovom slučaju Portugal) ocjenjuje lijek radi izdavanja odobrenja za njegovo stavljanje u promet koje će biti valjano u toj državi i u drugim državama članicama u kojima je tvrtka podnijela zahtjev za odobrenje za stavljanje u promet („predmetne države članice”, u ovom slučaju Nizozemska, Njemačka i Ujedinjena Kraljevina).
English: It was to be available as a concentrate for solution for infusion (6 mg/ml) for the treatment of breast cancer, cancer of the ovaries, non-small cell lung cancer and Kaposi's sarcoma (a cancer of the blood vessels) in patients with acquired immune deficiency syndrome (AIDS).
Croatian: Trebao je biti dostupan kao koncentrat za otopinu za infuziju (6 mg/ml) za liječenje raka dojke, raka jajnika, raka pluća nemalih stanica te Kaposijevog sarkoma (raka krvnih žila) kod pacijenata sa sindromom stečene imunodeficijencije (SIDA).
English: In particular, the company did not provide direct comparative data with the reference medicine, which is normally required for medicines formulated in micelles.
Croatian: Tvrtka posebno nije pružila izravne usporedive podatke s referentnim lijekom, što je obično potrebno za lijekove u obliku micela.
English: On 18 October 2018, the European Medicines Agency (EMA) completed a review of Paclitaxel Hetero following a disagreement among EU Member States regarding its authorisation.
Croatian: Europska agencija za lijekove je 18. listopada 2018. okončala pregled lijeka Paclitaxel Hetero nakon neslaganja među državama članicama EU-a u pogledu izdavanja odobrenja za dotični lijek.
English: It blocks the ability of cancer cells to break down their internal ‘skeleton' that allows them to divide and multiply.
Croatian: Lijek inhibira sposobnost stanica raka da razgrađuju svoj unutarnji „kostur”, što im omogućuje diobu i razmnožavanje.
English: Paclitaxel Hetero was developed as a generic medicine.
Croatian: Paclitaxel Hetero razvijen je kao generički lijek.
English: What is Paclitaxel Hetero?
Croatian: Što je Paclitaxel Hetero?
English: Paclitaxel belongs to the group of cancer medicines known as the ‘taxanes'.
Croatian: Paklitaksel pripada skupini lijekova za liječenje raka pod nazivom „taksani”.
English: The Agency therefore concluded that the benefits of Paclitaxel Hetero do not outweigh its risks and recommended that the marketing authorisation should not be granted in the concerned Member States.
Croatian: Agencija je stoga zaključila da koristi od lijeka Paclitaxel Hetero ne nadmašuju s njim povezane rizike te je preporučila da se ne izda odobrenje za stavljanje u promet u dotičnim državama članicama.
English: The Agency concluded that the benefits of Paclitaxel Hetero do not outweigh its risks, and the marketing authorisation cannot be granted in Portugal or in other Member States of the EU (Germany, the Netherlands and the UK).
Croatian: Agencija je zaključila da prednosti lijeka Paclitaxel Hetero ne nadmašuju rizike povezane s tim lijekom te da se ne može izdati odobrenje za njegovo stavljanje u promet u Portugalu i drugim državama članicama EU-a (Nizozemska, Njemačka i Ujedinjena Kraljevina).
English: Instead, it submitted indirect comparative data and a study which compared blood levels of paclitaxel in Paclitaxel Hetero with those of another generic paclitaxel medicine, which was not considered sufficient by the Netherlands.
Croatian: Umjesto toga, podnijela je neizravne usporedive podatke i istraživanje u kojem je uspoređena razina paklitaksela u krvi nakon uzimanja lijeka Paclitaxel Hetero s razinama drugog generičkog lijeka koji sadržava paklitaksel, što Nizozemska smatra nedostatnim.
English: The grounds for the referral were concerns raised by the Netherlands that the data submitted to support the application were not sufficient to show that Paclitaxel Hetero is ‘bioequivalent' to Taxol.
Croatian: Temelj za arbitražni postupak bila je zabrinutost Nizozemske o tome da podatci koji su podneseni uz zahtjev nisu dostatni da bi se moglo dokazati da je Paclitaxel Hetero bioekvivalent lijeka Taxol.
English: The paclitaxel in Paclitaxel Hetero and in Taxol is contained in tiny particles called micelles, to help it dissolve in the solution.
Croatian: Paklitaksel u lijeku Paclitaxel Hetero i u lijeku Taxol nalazi se u obliku sitnih čestica zvanih micele kako bi se pospješilo njegovo otapanje u otopini.
English: This means that Paclitaxel Hetero was developed to contain the same active substance and work in the same way as a ‘reference medicine' already authorised in EU called Taxol.
Croatian: To znači da sadržava istu djelatnu tvar i djeluje na jednak način kao i referentni lijek koji je već odobren u EU-u pod nazivom Taxol.
English: Based on the evaluation of the currently available data, the Agency concluded that they were not sufficient to show that Paclitaxel Hetero is ‘bioequivalent' to Taxol and that their active substances behave in the same way in the body.
Croatian: Na temelju procjene trenutačno dostupnih podataka Agencija je zaključila da ti podatci nisu dostatni da bi se moglo dokazati da je lijek Paclitaxel Hetero bioekvivalent lijeka Taxol te da se njihove djelatne tvari ponašaju na isti način u tijelu.
English: Viladecans (Barcelona) submitted Paclitaxel Hetero to the Portuguese medicines agency for a decentralised procedure.
Croatian: Hetero Europe S.L. Tvrtka Viladecans (Barcelona) pokrenula je decentralizirani postupak za lijek Paclitaxel Hetero agenciji za lijekove u Portugalu.
English: Paclitaxel Hetero is a medicine that contains the active substance paclitaxel.
Croatian: Paclitaxel Hetero je lijek koji sadržava djelatnu tvar paklitaksel.
English: Why was Paclitaxel Hetero reviewed?
Croatian: Zašto je Paclitaxel Hetero podvrgnut pregledu?
English: This may take between 30 to 60 minutes.
Croatian: To može potrajati 30 do 60 minuta.
English: • water for injections or,
Croatian: • vode za injekcije ili,
English: The use of gloves is recommended.
Croatian: Preporuča se nošenje rukavica.
English: Detailed information on this medicinal product is available on the website of [name of MS Agency link].
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici [naziv poveznice MS Agencije].
English: Blood pressure usually normalizes within a few hours after cessation of the infusion.
Croatian: Krvni tlak obično se normalizira u roku od nekoliko sati nakon prekida davanja infuzije.
English: However, if this does occur your doctor will treat any symptoms that follow.
Croatian: Međutim, ako dođe do toga, Vaš liječnik će liječiti sve nastale simptome.
English: <Date of first authorisation: {DD month YYYY}> <Date of latest renewal: {DD month YYYY}>
Croatian: <Datum prvog odobrenja: <{DD mjesec GGGG}> <Datum zadnje obnove: <{DD mjesec GGGG}>
English: • high blood pressure • low blood pressure
Croatian: • visok krvni tlak • nizak krvni tlak
English: All steps of preparation must be carried out under Laminar Air Flow conditions.
Croatian: Svi koraci pripreme moraju se provoditi u uvjetima laminarnog protoka zraka.
English: The treatment regimen should be chosen according to the local standard of care.
Croatian: Režim liječenja potrebno je odabrati sukladno lokalnom standardu liječenja.
English: Care should be taken to avoid extravasation.
Croatian: Potreban je oprez da se izbjegne ekstravazacija.
English: • 5% glucose solution or,
Croatian: • 5%-tne otopine glukoze ili,
English: Bleeding has been reported.
Croatian: Prijavljeno je krvarenje.
English: The safety and efficacy of ETOPOPHOS and associated names below 18 years of age have not been established.
Croatian: Sigurnost i djelotvornost primjene ETOPOPHOSA i pridruženih imena u djece mlađe od 18 godina nije ustanovljena.
English: No delayed hypotension has been noted.
Croatian: Nije zabilježena odgođena pojava hipotenzije.
English: Tell your doctor or nurse immediately if you get any of the following symptoms: swelling of your tongue or throat, breathing difficulties, fast heartbeat, flushing of the skin or a rash.
Croatian: Odmah obavijestite liječnika ili medicinsku sestru ako dobijete bilo koji od sljedećih simptoma: oticanje jezika ili grla, problemi s disanjem, ubrzano kucanje srca, crvenilo kože ili osip.
English: • damage to the liver (hepatotoxicity)
Croatian: • oštećenje jetre (hepatotoksičnost)
English: The stock solution should be used as soon as possible (see section 6.3).
Croatian: Rekonstituirana otopina treba se upotrijebiti što je prije moguće (vidjeti dio 6.3).
English: Given its mechanism of action, etoposide phosphate should be considered a possible carcinogen in humans.
Croatian: S obzirom na mehanizam djelovanja, etopozidfosfat treba smatrati potencijalno kancerogenim za ljude.
English: Exact measuring must be ensured for withdrawal.
Croatian: Za izvlačenje je nužno osigurati točno mjerenje.
English: Talk to your doctor, pharmacist or nurse before receiving ETOPOPHOS and associated names
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primite ETOPOPHOS i pridružena imena
English: Given the possibility of extravasation, it is recommended to closely monitor the infusion site for possible infiltration during drug administration.
Croatian: S obzirom na mogućnost ekstravazacije, preporuča se pomno praćenje mjesta infuzije zbog moguće infiltracije tijekom primjene lijeka.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Cytotoxic.
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), UKOLIKO JE POTREBNO Citotoksično.
English: The safety profile between paediatric patients and adults is expected to be similar.
Croatian: Očekuje se sličan sigurnosni profil kod pedijatrijskih i odraslih bolesnika.
English: • changes in skin colour (pigmentation)
Croatian: • promjene boje kože (pigmentacija) • zatvor
English: Infections and infestations common infection
Croatian: Infekcije i infestacije često infekcija
English: The stock solution should be used as soon as possible.
Croatian: Rekonstituirana otopina treba se upotrijebiti što je prije moguće.
English: Reversible alopecia, sometimes progressing to total baldness, was observed in up to 44% of patients treated with etoposide phosphate.
Croatian: Reverzibilna alopecija, ponekad uznapredovala do potpune ćelavosti, zabilježena je kod do 44% bolesnika liječenih etopozidfosfatom.