Ibuprofen B. Braun 600 mg solution for infusion

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Ibuprofen

Dostupno od:

B. Braun Melsungen AG

ATC koda:

M01AE; M01AE01

INN (International ime):

Ibuprofen

Doziranje:

600 milligram(s)

Farmaceutski oblik:

Solution for infusion

Tip recepta:

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

Područje terapije:

Propionic acid derivatives; ibuprofen

Status autorizacije:

Not marketed

Datum autorizacije:

2017-10-06

Uputa o lijeku

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IBUPROFEN B. BRAUN 600 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 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.
-
If you are suffering from severe dehydration (caused

Svojstava lijeka

Health Products Regulatory Authority
25 April 2023
CRN00D6DT
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ibuprofen B. Braun 600 mg solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 6 mg of ibuprofen.
Each 100 ml bottle contains 600 mg of ibuprofen.
Excipient with known effect:
Each ml of solution contains 9.15 mg of sodium chloride (3.60 mg of
sodium).
Each 100 ml bottle contains 915 mg of sodium chloride (360 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 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
One dose of 600 mg. If clinically justified, another 600 mg dose can
be administered after 6 to 8 hours depending on the
intensity of the condition and response to treatment. The maximum
total daily dose is 1200 mg.
ELDERLY PATIENTS
Like with all non-steroidal anti-inflammatory drugs (NSAIDs),
precautions should be takenwhen treating elderly patients as
they, are generally more prone to adverse effects (see section 4.4 and
4.8), and are more l