Ibuprofen B. Braun 400 mg solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ibuprofen

Available from:

B. Braun Melsungen AG

ATC code:

M01AE; M01AE01

INN (International Name):

Ibuprofen

Dosage:

400 milligram(s)

Pharmaceutical form:

Solution for infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Propionic acid derivatives; ibuprofen

Authorization status:

Marketed

Authorization date:

2017-10-06

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IBUPROFEN B. BRAUN 400 MG SOLUTION FOR INFUSION
ibuprofen
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ibuprofen B. Braun
is and what it is used for
2.
What you need to know before you are given Ibuprofen B. Braun
3.
How Ibuprofen B. Braun
is given
4.
Possible side effects
5.
How to store Ibuprofen B. Braun
6.
Contents of the pack and other information
1.
WHAT IBUPROFEN B. BRAUN IS AND WHAT IT IS USED FOR
Ibuprofen belongs to the group of medicines called “nonsteroidal
anti-inflammatory drugs” or (NSAIDs).
This medicine is used in adults for the short-term symptomatic
treatment of acute moderate pain, and for the
short-term symptomatic treatment of fever, when administration by
intravenous route is clinically justified
when other routes of administration are not possible.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN IBUPROFEN B. BRAUN
IBUPROFEN B. BRAUN MUST NOT BE GIVEN:
-
If you are allergic to ibuprofen or any of the other ingredients of
this medicine (listed in section 6).
-
If you have ever suffered from shortness of breath, have had asthma,
skin rash, itchy runny nose or facial
swelling, when previously taking ibuprofen, acetylsalicylic acid or
other similiar painkiller (NSAIDs).
-
If you have a condition which increases your tendency or active
bleeding.
-
If you have active, or history of recurrent (two or more episodes)
stomach ulcer or bleeding.
-
If you have ever had bleeding or a tear in your stomach or gut when
taking NSAIDs.
-
If you are suffering from bleeding in the brain (cerebrovascular
bleeding) or other active bleeding.
-
If you suffer from severe kidney, liver or heart problems.
-
I

Summary of Product characteristics

Health Products Regulatory Authority
25 April 2023
CRN00D6DT
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ibuprofen B. Braun 400 mg solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 4 mg of ibuprofen.
Each 100 ml bottle contains 400 mg of ibuprofen.
Excipient with known effect:
Each ml of solution contains 9.10 mg of sodium chloride (3.58 mg of
sodium).
Each 100 ml bottle contains 910 mg of sodium chloride (358 mg of
sodium).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
Clear and colourless to pale yellow solution for infusion, without any
particulate matter.
pH: 6.8-7.8
Osmolarity: 310-360 mOsm/L
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ibuprofen B. Braun is indicated in adults for the short-term
symptomatic treatment of acute moderate pain, and for the
short-term symptomatic treatment of fever, when administration by
intravenous route is clinically justified when other routes of
administration are not possible.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration necessary to control
symptoms (see section 4.4).
Use should be limited to situations where oral administration is
inappropiate. Patients must switch to oral treatment as soon as
this is possible.
This medicinal product is indicated for short-term acute treatment
only and should not be used for more than 3 days.
Adequate hydration of the patient should be maintained to minimize the
risk of possible adverse reactions at renal level.
ADULTS
The recommended dose is 400 mg of ibuprofen, every 6 to 8 hours as
necessary. The recommended maximum daily dose is
1200 mg and should not be exceeded.
ELDERLY PATIENTS
Like with all non-steroidal anti-inflammatory drugs (NSAIDs),
precautions should be taken when treating elderly patients, as
they are generally more prone to adverse effects (see section 4.4 and
4.8), and are more likely t