Medicinal product name Paracetamol/Ibuprofen Vale 1000 mg/300 mg/100 ml solution for infusion
Pharmaceutical form Solution for infusion
Strength 1000 mg/300 mg/100 ml 
Information from the MAH on shortages Not notified
Legal status Rx Prescription (Pr.)
Package leaflet MS Word document 13-08-2020
Summary of product characteristics MS Word document 13-08-2020
ATC code N02BE51 Analgesics

Important notice

Additional information regarding the use for persons aged 75+

If used as "ANALGESICS"
SubstanceClassComment
ParacetamolumASuitable for older persons. Maximum dose in regular use 2-3 g/day. Note paracetamol in OTC drugs and combination products. Overdose is hepatotoxic. Concurrent use with warfarin is possible if INR values are monitored.
IbuprofenumCSuitable for older persons, with specific cautions. For short-term use only. May decrease renal function. Avoid use in severe renal insufficiency. May increase blood pressure, worsen cardiac insuffiency and cause cardiovascular events. Increases risk of gastrointestinal bleeding. Take interactions into account, especially with anticoagulants. Remember that anti-inflammatory analgesics are commonly used in self-care.

Medicinal products (1)

Availability of medicinal product Wholesalers Package size, content Primary packaging Maximum admissible pharmacy price (€ incl. VAT) Product No. Labelling
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N10
(100 ml)
Glass vial    20-0103-01 Labelling text Labelling text Aug 13, 2020

Registration information

Marketing authorisation No. 20-0103
Date of authorisation Aug 17, 2020
MA valid until Aug 16, 2025
Marketing authorisation holder, country Vale Pharmaceuticals Limited, Ireland