PHARMA & LIFE SCIENCES
Patient leaflets in 24+ languages without breaking regulatory format
Ellon AI translates SmPCs, patient information leaflets, and clinical study reports across EMA language requirements while preserving section structure, bullet formatting, and medical terminology.
Regulatory translation has no room for formatting drift
EMA authorizations require patient-facing documentation in all 24 official EU languages. plus Norwegian and Icelandic. and each version has to pass QRD template compliance before approval. Patient information leaflets need readability thresholds met in every language. Summary of Product Characteristics (SmPC) sections have fixed numbering that can't drift. Clinical study reports can run 500+ pages with strict cross-reference integrity. Traditional translation workflows send each language pair to a specialist translator, wait two to four weeks per language, and then burn more time reformatting when the back-translation comes back with collapsed headings or mismatched section numbering. A submission that should close in a month takes three.
- Section numbering, QRD template structure, and bulleted instructions preserved
- Medical terminology handled with context awareness. consistent term renders across the document
- GDPR-aligned processing, no training on submitted documents
- Redact patient identifiers and investigator names before external review
Translate patient leaflets across EMA languages
Upload a Word or PDF patient information leaflet or SmPC. Ellon AI translates while preserving section numbering, bulleted dosing instructions, bold warnings, and table formatting. Output aligns with QRD template expectations, ready for regulatory affairs review before submission to EMA, MHRA, Swissmedic, or TGA.
Original · English
- 1.What Ellonex is and what it is used for
- 2.What you need to know before you take Ellonex
- 3.How to take Ellonex
- 4.Possible side effects
- 5.How to store Ellonex
- 6.Contents of the pack and other information
Ellonex contains the active substance ellonatumab, a selective inhibitor of the EL-2 signalling pathway. Ellonex is indicated in adults for the treatment of moderate to severe chronic inflammatory conditions where first-line therapy has not provided adequate control. Treatment should be initiated and supervised by a specialist experienced in the management of these conditions.
Do not take Ellonex if:
- you are allergic to ellonatumab or to any of the other ingredients of this medicine (listed in Section 6).
- you have an active severe infection, including active tuberculosis.
- you have moderate to severe heart failure (NYHA class III or IV).
Tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby. Women of child-bearing potential must use effective contraception during treatment and for at least twelve (12) weeks after the final dose. Breast-feeding is not recommended during treatment.
Ellonex may cause mild dizziness in a small proportion of patients. If you feel affected, do not drive or operate machinery until the effect has resolved.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, strong CYP3A4 inhibitors (such as ketoconazole, clarithromycin, or ritonavir) may increase ellonatumab exposure; a dose reduction may be required.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Take the tablet whole with a glass of water, with or without food, at the same time each day.
| Body weight | Daily dose | Number of tablets |
|---|---|---|
| < 60 kg | 5 mg once daily | 1 tablet |
| 60 – 90 kg | 7.5 mg once daily | 1½ tablets |
| > 90 kg | 10 mg once daily | 2 tablets |
Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor immediately if you notice any of the following:
| Frequency | System organ class | Side effect |
|---|---|---|
| Very common (≥ 1/10) | Infections and infestations | Upper respiratory tract infection |
| Very common (≥ 1/10) | Nervous system | Headache |
| Common (≥ 1/100 to < 1/10) | Gastrointestinal | Nausea, abdominal discomfort |
| Common (≥ 1/100 to < 1/10) | Hepatobiliary | Elevated transaminases (ALT / AST) |
| Common (≥ 1/100 to < 1/10) | Skin and subcutaneous | Rash, pruritus |
| Uncommon (≥ 1/1,000 to < 1/100) | Infections and infestations | Herpes zoster reactivation |
| Rare (≥ 1/10,000 to < 1/1,000) | Immune system | Severe allergic reaction (anaphylaxis) |
| Very rare (< 1/10,000) | Skin and subcutaneous | DRESS syndrome |
If you get any side effects, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via your national reporting system — in the United Kingdom the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects, you help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date shown on the carton and blister after EXP — the expiry date refers to the last day of the month indicated.
The active substance is ellonatumab. Each film-coated tablet contains 5 mg of ellonatumab.
Microcrystalline cellulose, lactose monohydrate (see Section 2), sodium starch glycolate, magnesium stearate. Film-coating: hypromellose, titanium dioxide (E171), iron oxide yellow (E172).
Translated · Español
- 1.Qué es Ellonex y para qué se utiliza
- 2.Qué necesita saber antes de empezar a tomar Ellonex
- 3.Cómo tomar Ellonex
- 4.Posibles efectos adversos
- 5.Conservación de Ellonex
- 6.Contenido del envase e información adicional
Ellonex contiene el principio activo ellonatumab, un inhibidor selectivo de la vía de señalización EL-2. Ellonex está indicado en adultos para el tratamiento de afecciones inflamatorias crónicas de moderadas a graves en las que el tratamiento de primera línea no ha proporcionado un control adecuado. El tratamiento debe ser iniciado y supervisado por un especialista con experiencia en el manejo de estas afecciones.
No tome Ellonex si:
- es alérgico al ellonatumab o a alguno de los demás componentes de este medicamento (incluidos en la Sección 6).
- tiene una infección grave activa, incluida tuberculosis activa.
- tiene insuficiencia cardíaca de moderada a grave (clase III o IV de la NYHA).
Informe a su médico si está embarazada, cree que podría estarlo o tiene intención de tener un hijo. Las mujeres en edad fértil deben utilizar un método anticonceptivo eficaz durante el tratamiento y durante al menos doce (12) semanas después de la última dosis. No se recomienda la lactancia durante el tratamiento.
Ellonex puede causar mareo leve en una pequeña proporción de pacientes. Si esto ocurre, no conduzca ni maneje maquinaria hasta que el efecto haya desaparecido.
Informe a su médico o farmacéutico si está tomando, ha tomado recientemente o pudiera tener que tomar cualquier otro medicamento. En particular, los inhibidores potentes del CYP3A4 (como ketoconazol, claritromicina o ritonavir) pueden aumentar la exposición a ellonatumab; puede ser necesaria una reducción de la dosis.
Siga exactamente las instrucciones de administración de este medicamento indicadas por su médico. En caso de duda, consulte de nuevo a su médico o farmacéutico. Tome el comprimido entero con un vaso de agua, con o sin alimentos, a la misma hora todos los días.
| Peso corporal | Dosis diaria | Número de comprimidos |
|---|---|---|
| < 60 kg | 5 mg una vez al día | 1 comprimido |
| 60 – 90 kg | 7,5 mg una vez al día | 1½ comprimidos |
| > 90 kg | 10 mg una vez al día | 2 comprimidos |
Al igual que todos los medicamentos, este medicamento puede producir efectos adversos, aunque no todas las personas los sufran. Informe a su médico de inmediato si nota alguno de los siguientes:
| Frecuencia | Clasificación por órganos | Efecto adverso |
|---|---|---|
| Muy frecuentes (≥ 1/10) | Infecciones e infestaciones | Infección de las vías respiratorias altas |
| Muy frecuentes (≥ 1/10) | Sistema nervioso | Cefalea |
| Frecuentes (≥ 1/100 a < 1/10) | Gastrointestinales | Náuseas, molestias abdominales |
| Frecuentes (≥ 1/100 a < 1/10) | Hepatobiliares | Elevación de transaminasas (ALT / AST) |
| Frecuentes (≥ 1/100 a < 1/10) | Piel y tejido subcutáneo | Erupción, prurito |
| Poco frecuentes (≥ 1/1.000 a < 1/100) | Infecciones e infestaciones | Reactivación de herpes zóster |
| Raros (≥ 1/10.000 a < 1/1.000) | Sistema inmunitario | Reacción alérgica grave (anafilaxia) |
| Muy raros (< 1/10.000) | Piel y tejido subcutáneo | Síndrome DRESS |
Si experimenta cualquier tipo de efecto adverso, consulte a su médico, farmacéutico o personal de enfermería. También puede notificar los efectos adversos directamente a través del sistema de notificación nacional — en España: www.notificaram.es. Al notificar los efectos adversos, usted contribuye a proporcionar más información sobre la seguridad de este medicamento.
Mantener este medicamento fuera de la vista y del alcance de los niños. No utilice este medicamento después de la fecha de caducidad que aparece en el envase y el blíster tras CAD — la fecha de caducidad es el último día del mes que se indica.
El principio activo es ellonatumab. Cada comprimido recubierto con película contiene 5 mg de ellonatumab.
Celulosa microcristalina, lactosa monohidrato (véase la Sección 2), glicolato sódico de almidón, estearato de magnesio. Recubrimiento: hipromelosa, dióxido de titanio (E171), óxido de hierro amarillo (E172).
Track labeling changes across PIL revisions
Upload two versions of a patient leaflet or SmPC (DOCX or PDF). Ellon AI produces a Word tracked-changes document with AI semantic categorization that separates meaning-altering edits (a new contraindication, an updated dosage) from formatting and terminology changes. Critical for post-market updates where labeling drift has to be caught before the next submission cycle.
Do not take Ellonex if you are allergic to ellonatumab or to any of the other ingredients of this medicine (listed in Section 6), if you have an active severe infection including active tuberculosis, or if you have moderate to severe heart failure (NYHA class III or IV). Do not take Ellonex if you are pregnant, think you may be pregnant, or are breast-feeding — ellonatumab crosses the placental barrier and has been detected in breast milk in non-clinical studies. Women of child-bearing potential must use effective contraception during treatment and for at least twelve (12) weeks after the final dose.
The recommended dose for adult patients with a body weight between 60 and 90 kg is 7.5 mg once daily 3.75 mg twice daily, taken morning and evening, taken with a glass of water, with or without food. Population pharmacokinetic modelling supports the revised dosing schedule to maintain steady-state plasma concentrations within the therapeutic window identified in pivotal trial ELO-301-A.
If you miss a dose and it is within eight (8) hours six (6) hours of the scheduled time, take the missed dose immediately. Otherwise, skip the missed dose and continue with your usual schedule. Do not double the next dose to make up for the one you missed.
Frequency of severe allergic reactions has been updated on the basis of post-marketing surveillance. In addition to the events already listed in Rev 1, severe skin reactions including drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) have been reported post-marketing at a frequency of < 1/10,000 (very rare). Patients must stop taking Ellonex immediately and seek medical attention if they develop a widespread rash, fever, facial swelling, or swollen lymph nodes.
The frequency of elevated liver enzymes has been reclassified from uncommon (≥ 1/1,000 to < 1/100) common (≥ 1/100 to < 1/10) based on cumulative data from post-marketing pharmacovigilance reports.
Ellonex is metabolised predominantly by CYP3A4. Concomitant administration with strong CYP3A4 inhibitors (such as ketoconazole, clarithromycin, or ritonavir) may increase ellonatumab exposure by up to 2.1-fold and is not recommended. Where co-administration is unavoidable, the daily dose of Ellonex should be reduced by 50 % and liver function monitored every four (4) weeks for the first three (3) months.
Store below 25 °C below 30 °C in the original packaging to protect from light and moisture. Shelf-life is extended from 24 months 36 months based on long-term stability data submitted under variation EMEA/H/C/005721/IB/0009. Do not refrigerate or freeze.
Revision 2 reflects the Type IB safety variation approved by the European Medicines Agency on 18 March 2026. Existing stock labelled under Rev 1 may remain in distribution until exhaustion subject to Member-State competent authority confirmation.
Redact patient identifiers and site-specific data
Upload a DOCX or PDF. clinical study reports, case report forms, site narratives. Ellon AI auto-detects nine PII categories including people (patients, investigators), dates of birth, reference numbers (site codes, patient IDs), and addresses. Review each detection, choose a redaction style (labels, black bars, or pseudonyms), and download the redacted document with an audit log for the submission file.
The subject, a 45-year-old Caucasian female, has a medical history of Type 2 diabetes mellitus (diagnosed 03 June 2019), essential hypertension controlled on ramipril 5 mg once daily, and moderate plaque psoriasis diagnosed 11 September 2022. She entered study ELO-301-A on 12 January 2026 following informed consent obtained by Dr. María Rodríguez-Ortega.
On 19 March 2026 (Day 67 of treatment), the subject reported Grade 2 nausea and elevated ALT of 142 U/L (upper limit of normal 55 U/L). The event was assessed as probably related to study medication by Dr. Rodríguez-Ortega. Per protocol ELO-301-A, the daily dose was held and ALT monitored weekly. The subject remained at home and was followed up by telephone by the study coordinator at Site 04 — Hospital Clínico San Carlos, Madrid.
ALT returned to within normal limits (38 U/L) by the scheduled visit on the date the subject returned to the site. Study medication was reintroduced at half-dose under the protocol rechallenge procedure; no recurrence of elevated transaminases or nausea was observed through the end-of-treatment visit. Patient Subject 04-017 completed the study per protocol. The case was reported to BioNorth Pharmaceuticals pharmacovigilance within 24 hours as required by ICH-E2A.
Two additional subjects at the same site — Subject 04-021 (J. Fernández-López) and Subject 04-034 (C. Vega-Moreno) — experienced transient ALT elevations under protocol ELO-301-A and were managed without dose discontinuation. None of the events met the criteria for serious adverse events per ICH-E2A.
This narrative is extracted from the Clinical Study Report submitted by BioNorth Pharmaceuticals under EudraCT 2025-004731-18. Redacted versions are generated for DSMB members and competent-authority reviewers not entitled to unredacted patient-level data.
Clause review on clinical trial and supply contracts
Clinical development runs on contracts. clinical trial agreements (CTAs), investigator agreements, master service agreements with CROs, supply and manufacturing contracts. Upload a contract (DOCX or PDF). Ellon AI assigns an overall risk score, flags each clause with a risk level and explanation, surfaces missing standard provisions, and suggests improved language for high-risk clauses.
- Subject-injury compensation inverts the ABPI no-fault standard
- 24-month publication veto conflicts with ICMJE authorship rules
- No Article 28 GDPR Data Processing Agreement attached
“Institution shall be responsible for medical treatment of any Study Subject who experiences an injury related to participation in the Study. Sponsor will reimburse Institution for documented costs following Sponsor's investigation and confirmation that the injury was caused by the investigational medicinal product administered in accordance with the Protocol.”
Under the ABPI Clinical Trial Compensation Guidelines and consistent with ICMRA-aligned practice, the sponsor should indemnify on a first-dollar, no-fault basis for trial-related injuries when the IMP is administered per protocol and per GCP. Requiring the Institution to front-fund treatment while the sponsor investigates causation exposes the Institution's operating budget and creates an unacceptable delay for the subject.
Sponsor shall indemnify the Institution and the Study Subject, on a no-fault basis, for all reasonable medical expenses arising from study-related injury where the investigational medicinal product was administered in accordance with the Protocol and ICH-GCP. Payment shall be made directly to the treating facility within thirty (30) days of submission of evidence of costs, without requiring prior confirmation of causation by Sponsor.
- GCP Compliance Representationshigh
No express representations by Sponsor and Institution that the Study shall be conducted in accordance with ICH-E6(R2) Good Clinical Practice. Regulators and ethics committees expect this to be explicit in any CTA.
- Sub-Investigator Flow-Downmedium
The Agreement binds the Principal Investigator, but confidentiality, GCP, and subject-injury obligations are not expressly flowed down to sub-investigators and site staff — common source of compliance gaps.
- Public-Health Emergency / Force Majeuremedium
No modernised force majeure covering pandemic, quarantine, or public-health emergency. Post-COVID market standard includes a specific carve-out for these events affecting subject enrolment, follow-up, and site access.
How life sciences teams use Ellon AI
Pharmaceutical translation sits at the intersection of patient safety, regulatory compliance, and commercial timing. A single labeling update that needs to propagate across 24 EU languages is a month-long project under traditional workflows. and every week of delay is a week the updated safety information isn't in patient hands.
Regulatory affairs
Translate SmPCs, patient information leaflets, and labeling for EMA, MHRA, Swissmedic, TGA, and Health Canada submissions. Ellon AI preserves the QRD template structure. fixed section numbering (4.1 Therapeutic indications, 4.2 Posology and method of administration, 4.8 Undesirable effects) stays in place across every translated version. Bulleted dosing instructions, warning callouts, and table structures survive the translation without manual reformatting.
Clinical development
Translate patient-facing materials, consent forms, and investigator brochures across the languages your trial sites operate in. The redact tool handles PII stripping from study documents for submissions that require de-identified data. auto-detecting patients, investigators, sites, and dates, then producing a redacted version with an audit log.
Contract workflows
Clinical trial agreements, CRO master service agreements, supply and manufacturing contracts, and investigator agreements move through the legal team in volume. The contract analyzer flags high-risk clauses, surfaces missing provisions, and suggests improvements. a first-pass review that focuses legal attention on the clauses that actually matter.
Pharmacovigilance and safety reporting
Translate periodic safety update reports (PSURs), risk management plans (RMPs), and individual case safety reports across the languages your global safety team operates in.
Medical affairs and scientific communication
Translate publications, conference abstracts, and advisory board materials for international medical affairs activities. Ellon AI handles the medical terminology with context awareness. 'acute myeloid leukemia' translates consistently across every occurrence, not swapped for a slightly different term in the middle of the paper.
Manufacturing and CMC
Translate chemistry, manufacturing, and controls documentation for global submissions. Batch records, analytical procedures, and validation protocols need to flow to CMOs and regulators in local languages without losing specification tables or step-by-step procedure numbering.
Post-market surveillance
When a labeling change is triggered by post-market safety data, translate the update across all affected language versions in parallel. The compare tool surfaces every change between the old and new label with AI semantic analysis so local regulatory affairs leads can sign off on the safety-relevant changes quickly.
Data handling
Clinical data is subject to GDPR in Europe, HIPAA in the US, and a growing list of local privacy regulations. Ellon AI processes documents in infrastructure you can audit, doesn't train on submitted content, and supports dedicated deployment for organizations with strict data residency requirements. For sponsors with audit trails tied to regulatory submissions, Ellon AI emits processing logs that can be captured for traceability.
Language coverage
Ellon AI supports 200+ language pairs, including all EU official languages, major Asian languages (Japanese, Korean, Mandarin, Cantonese), and emerging market languages (Portuguese Brazilian, Spanish Latin American, Arabic). Medical terminology consistency is maintained within each translated document; the translator automatically builds an internal glossary from the source to keep terms aligned across the output.
Medical devices and combination products
The same workflow handles instructions for use (IFUs), device labeling, and accompanying patient materials for medical device submissions under MDR, IVDR, and equivalent regulations globally.
Medical writing and trial master files
Medical writing teams translate investigator brochures, protocols, and regulatory submission modules; trial master file (TMF) management across global trials involves thousands of documents that need translation for sponsor review, ethics committee submissions, and regulatory inspections. Ellon AI handles the TMF translation backlog at per-page pricing that makes comprehensive TMF translation economically viable. not the multi-month agency project it has traditionally been.
The net effect: submission packages that used to take three months of translator coordination now close in three weeks, and post-market labeling updates that used to stall on translation bottlenecks now propagate across language versions in parallel.
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