For hospitals, pharmacies and universities

The evidence-based clinical assistant

Ask about a medicine, a dose, an interaction or a clinical guideline and get an answer in seconds, cited to the SmPC, the guideline or the regulation.

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Wardside University Hospital, Cardiology
What does the ESC recommend for anticoagulation in atrial fibrillation, and what is the rivaroxaban dose?

The 2020 ESC guideline recommends oral anticoagulation with a CHA₂DS₂-VASc score ≥ 2 in men and ≥ 3 in women and prefers the newer oral anticoagulants to vitamin K antagonists. [1] For rivaroxaban (Xarelto) in non-valvular atrial fibrillation, the SmPC states 20 mg once daily, and 15 mg once daily at a creatinine clearance of 15–49 mL/min. [2]

Dosing: Xarelto, non-valvular atrial fibrillation
SmPC section 4.2, prevention of stroke and systemic embolism
Recommended dose

20 mg once daily; this is also the recommended maximum dose.

CrCl 15–49 mL/minmoderate and severe impairment

15 mg once daily; use with caution at 15–29 mL/min.

CrCl < 15 mL/min

Not recommended.

Administration

The 15 mg and 20 mg tablets are taken with food.

Xarelto 15 mg and 20 mg, SmPC section 4.2. Source: EMA
Sources2
[1]ESC 2020: Atrial fibrillation, recommendations for stroke prevention
[2]Xarelto SmPC section 4.2 Posology and method of administration (EMA)

Not a treatment recommendation.

Medicines/Xarelto
Xarelto 20 mg Equivalents (78)Ask a question
Rivaroxaban, film-coated tablets
ATCB01AF01 Groupantithrombotic agents MAHBayer AGGermany
SmPC (PDF)Package leaflet (PDF)
UseSafetyInteractionsPharmacologyPrices and reimbursementRegistersSmPC
Therapeutic indicationsSmPC §4.1

Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.

Route of administration

Oral, film-coated tablets

Posology and method of administrationSmPC §4.2
Renal impairmentDosing by GFR

SmPC section 4.2 contains a separate dosing schedule in renal impairment; the source states creatinine clearance as the determining parameter.

ContraindicationsSmPC §4.3

Active clinically significant bleeding. Pregnancy and breast-feeding (see section 4.6).

Special warnings and precautions for useSmPC §4.4

In adult patients with severe renal impairment (creatinine clearance < 30 ml/min) rivaroxaban plasma levels may be significantly increased (1.6 fold on average).

Fertility, pregnancy and lactationSmPC §4.6
Pregnancy and lactationContraindicated

Due to the potential reproductive toxicity, the intrinsic risk of bleeding and the evidence that rivaroxaban passes the placenta, Xarelto is contraindicated during pregnancy.

Effects on ability to drive and use machinesSmPC §4.7
Undesirable effectsSmPC §4.8
OverdoseSmPC §4.9
Interactions
Active substance or medicinal product
Rivaroxaban1 Amiodarone1
2 of 20 productsClear all
ListMatrix 1 interaction
Food and alcohol1
Moderate clinical significance1
Rivaroxaban×Amiodarone Increased plasma exposure to rivaroxaban
EffectANSM

Increased plasma exposure to rivaroxaban; the clinical significance increases in renal impairment.

MechanismCerner Multum

Amiodarone inhibits CYP3A4 and P-glycoprotein, the two main elimination pathways of rivaroxaban.

Severity per: ANSM, Cerner Multum
eGFR (CKD-EPI 2021)
CKD-EPI 2021 Creatinine Equation
Save
Serum creatinine
118µmol/L
Age
74
Sex
MaleFemale
eGFR
42mL/min/1.73 m²
CKD stage G3bModerately to severely decreased
CKD stages
G1 ≥ 90G2 60–89G3a 45–59G3b 30–44G4 15–29G5 < 15
Source: KDIGO 2021 Clinical Practice Guideline
Related to the case

Xarelto SmPC section 4.2 states creatinine clearance (mL/min), not eGFR, as the parameter on which the dosing schedule is built. By Cockcroft-Gault, at 68 kg, the clearance is about 40 mL/min. The source contains a separate regimen for a clearance of 15–49 mL/min.

Xarelto SmPC section 4.2. Source: EMA
Wardside
Anticoagulation in atrial fibrillation: ESC and rivaroxaban dose?

ESC 2020 recommends oral anticoagulation with CHA₂DS₂-VASc ≥ 2 in men and ≥ 3 in women and prefers the newer oral anticoagulants.[1] For rivaroxaban the SmPC states 20 mg once daily, and 15 mg at CrCl 15–⁠49 mL/min.[2]

Dosing: Xarelto, atrial fibrillation SmPC section 4.2
Sources [1]ESC 2020: Atrial fibrillation [2]Xarelto SmPC section 4.2 (EMA)
Xarelto 20 mg
Rivaroxaban, film-coated tablets
ATCB01AF01 MAHBayer AG
UseSafetyInteractions
Fertility, pregnancy and lactationSmPC sections 4.3, 4.6
Pregnancy and lactationContraindicated
Rivaroxaban Amiodarone
2 of 20 products
Moderate clinical significance
Rivaroxaban × Amiodarone

Amiodarone inhibits CYP3A4 and P-glycoprotein, the two main elimination pathways of rivaroxaban.

Severity per: ANSM, Cerner Multum
eGFR (CKD-EPI 2021)
Serum creatinine118 µmol/L Age74 SexFemale
eGFR 42mL/min/1.73 m² CKD stage G3bModerately to severely decreased
Source: KDIGO 2021 Clinical Practice Guideline

Ask. The ESC guideline and the SmPC in one answer, with citations.

Answers from the official sources

EMATGAWHO AWaReANSMCerner MultumESCEASDEASLEAUEANEHAERSESCMIDESHESICMESMOEULARKDIGONICEProfessional societies

Why Wardside

The answer is somewhere in thousands of pages. Wardside finds it in seconds.

Summaries of product characteristics (SmPCs), national medicine registers, reimbursement lists, interactions and guidelines sit in different systems. Wardside brings them together in one place, with a citation to the exact section of the source.

Every statement points to its source

The answer cites the section of the SmPC, the page of the guideline or the row in the register. The citation is checked against the text before you see it.

One question instead of ten sections

Clinical guidelines, regulations, medicines, interactions and calculators in one search. On the computer in the consulting room and on the phone at the bedside.

Risks are visible in time

Interaction checks for up to 20 medicines, contraindications, pregnancy and breast-feeding, dose adjustment in renal impairment and the antibiotic’s WHO AWaRe group.

The whole team works from one source

Physicians, pharmacists and residents see the same verified answer. The team is on the same page, and attention stays with the patient.

Section-level citation

Guidelines, standards and regulations

The answer also comes from the guidelines, not only from the SmPC

Wardside searches European and international clinical guidelines, national pharmacotherapeutic standards, the consensus documents of professional societies and national legislation. The answer cites the document and the place within it.

  • ESC, ESMO, EASL, KDIGO, GOLD, GINA, ADA, EAU, IDSA and others
  • National pharmacotherapeutic standards and the consensus documents of professional societies
  • National regulations: prescribing and dispensing of medicines, immunisation schedules, good pharmacy practice
  • Your institution’s protocols, visible only to your staff
The guidelines library

In numbers

171,659 interactions with a stated severity

From a curated database with three severity levels and sources such as ANSM and Cerner Multum. When the sources disagree, Wardside shows the more severe grade.

7,600+

summaries of product characteristics, split into sections

Medicines
164

guidelines, standards and regulations in 18 areas

Guidelines
89

clinical calculators and scores in 14 specialties, each with its formula and source

Tools
693

renal dosing monographs, with the verbatim rows by GFR

Renal dosing

For institutions

One platform for the whole institution with your rules and your formulary

Wardside is deployed across the whole organisation. Staff sign in through single sign-on with their work account and use your formulary and your protocols. Access is managed centrally, by role and department.

Hospitals

One reference for every department, from the same source.

  • The hospital formulary in every search
  • Internal protocols, cited on a par with the SmPC
  • Computers on the hospital network without a personal account
For hospitals

Pharmacy chains

The same answer at every counter, in every branch.

  • SmPC, reimbursement and prices by package
  • Interactions across up to 20 medicines at dispensing
  • Watched products: an alert when the price, the status or the export ban changes
For pharmacy chains

Medical universities

Students learn to check the source from their first year.

  • Group invitations for a cohort and its lecturers
  • A separate profile for students
  • A section-level citation in every answer
For universities

Pharmaceutical companies

The registers, the SmPCs and the changes to them, in one place.

  • Status, reimbursement and prices from the registers
  • SmPC changes over the last 12 months
  • Watched products with an alert on any change
For pharmaceutical companies

Professional societies

Your guidelines and consensus documents, in one version for all members.

  • The organisation’s documents, cited in the answers
  • Visible only to members
  • Group invitations, with administrators you appoint
For professional societies

Administration

Centralised access and content management

Sign-in and roles

Single sign-on with the institution’s account

SSO (SAML or OIDC) or a work email domain. Users, roles and departments are managed from the administration console.

Formulary

Your formulary, in every search

You upload it as CSV or XLSX. Its products are marked in the register and on every product page.

Protocols and audit

Your protocols, cited on a par with the SmPC

Internal documents are visible only to your staff. Answers are kept in an audit log, with a monthly usage report.

Rollout

How we start

  1. 1

    A demo with your questions

    We show the platform with questions from your departments and work out what you need.

  2. 2

    The organisation is set up

    We set up the organisation, the first administrator and sign-in: a work domain or SSO.

  3. 3

    The team signs in

    The administrator invites staff, assigns roles and departments and uploads the formulary.

  4. 4

    You follow usage

    An audit log, a weekly formulary notification and a monthly report.

Roles by professionPhysician, nurse, pharmacist, by department.
Invitations by emailAn invitation is valid for 30 days; invitations can go out in batches, to a whole team or cohort.

Safety

It cites the sources. It does not recommend treatment.

Wardside is not a clinical decision support system and does not replace the physician’s judgement. It shows what the official sources state, and when there is no source, it declines to answer.

Servers in the EUThe servers and databases are in Belgium. The language model runs at an external sub-processor.
Masking of personal dataPersonal ID numbers, phone numbers and names in a question are masked.
Audit logEvery answer is kept with its sources.
SSO and rolesSign-in through the institution’s account.
A refusal instead of a guess

Citations are checked against the source text. In the safety sections an unconfirmed sentence is removed, and if nothing confirmed remains, Wardside does not answer.

In brief

Questions and answers about Wardside

More on sources, security and deployment: All questions

What is Wardside?

Wardside is an AI clinical assistant for hospitals, pharmacy chains, medical universities, pharmaceutical companies and professional societies. It answers from European and international clinical guidelines, standards, regulations and SmPCs, citing the exact section of the source.

Where do the answers come from?

From official and published sources: European and international clinical guidelines (ESC, ESMO, EASL, KDIGO, GOLD, GINA, ADA and others), national pharmacotherapeutic standards and legislation, summaries of product characteristics (SmPCs) from the European Medicines Agency (EMA) and national regulators, and national medicine registers. Every sentence in the answer carries a citation, and text without a citation is not shown. If there is no source, Wardside says that it found no material and does not answer.

How does an institution get access?

Wardside is offered to institutions. Staff sign in with their work account, through single sign-on (SSO) or by work email domain, and access is managed centrally, by role and department. The first step is a demo, in which we show you the platform with questions from your own practice.

Is Wardside a medical device?

No. Wardside is not a medical device within the meaning of Regulation (EU) 2017/745 and is not a clinical decision support system. It shows what the sources state and does not recommend treatment.

See Wardside with questions from your own practice

We will show you the platform and plan the set-up for your institution together.

Request a demo