Ibuprofen B. Braun 200 mg solution for infusion

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Ibuprofen

Dostupné s:

B. Braun Melsungen AG

ATC kód:

M01AE01

INN (Mezinárodní Name):

Ibuprofen

Dávkování:

200 milligram(s)

Léková forma:

Solution for infusion

Terapeutické oblasti:

ibuprofen

Stav Autorizace:

Not marketed

Datum autorizace:

2020-05-15

Informace pro uživatele

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IBUPROFEN B. BRAUN 200 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 adolescents and children from 20 kg
bodyweight and 6 years of age and above 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
(aspirin) or other similiar painkillers
(NSAIDs).
-
If you have a condition which increases your tendency or active
bleeding.
-
If you have active, or history of two or more episodes of 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 bleed

Charakteristika produktu

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 200 mg solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 4 mg of ibuprofen.
Each 50 ml bottle contains 200 mg of ibuprofen.
Excipient with known effect:
Each ml of solution contains 9.10 mg of sodium chloride (3.58 mg of
sodium).
Each 50 ml bottle contains 455 mg of sodium chloride (179 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 adolescents and children from 20 kg
bodyweight and 6 years of age and above 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
inappropriate. Patients must switch to oral treatment as soon
as this is possible.
This medicinal product is indicated for the shortest period needed.
Treatment should not exceed 3 days.
Adequate hydration of the patient should be maintained to minimize the
risk of possible adverse reactions at renal level.
The recommended ibuprofen dose in children and adolescents is based on
the bodyweight or age. As a general rule, the
recommended daily dose is 20 to 30 mg/ kg of bodyweight divided into
three to four single doses (5-10 mg/kg):
Children weighing 20 kg – 29 kg (6-9 years old): 200 mg of ibuprofen
up to 3 times a day not exceeding a maximum d