READY-TO-USE
Ibuprofen B. Braun
4 mg / ml and 6 mg / ml in Ecoflac® plus
Make mixing a thing of the past
Ibuprofen is recommended for the following indications in adults: 1
Ibuprofen B. Braun 400 mg
Short-term symptomatic treatment of actue moderate pain
Short-term symptomatic treatment of fever
Ibuprofen B. Braun 600 mg
Short-term symptomatic treatment of actue moderate pain
1. SmPC Ibuprofen, B. Braun.
B. Braun Melsungen AG | www.bbraun.com
Ibuprofen B. Braun 400 mg Solution
for Infusion /
Ibuprofen B. Braun 600 mg Solution
for Infusion
COMPOSITION
Ibuprofen B.Braun 400 mg Solution for Infusion
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).
Ibuprofen B.Braun 600 mg Solution for Infusion
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).
Excipients
L-arginine, Sodium chloride, Hydrochloric acid, Sodi-
um hydroxide, Water for injections
THERAPEUTIC INDICATIONS
- Ibuprofen B. Braun 400 mg is indicated in adults
for the short-term symptomatic treatment of acute
moderate pain, and for the short-term symptomatic
treatment of fever,
- Ibuprofen B. Braun 600 mg 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.
CONTRAINDICATIONS
- Hypersensitivity to the active substance, to other
NSAIDs or to any of the excipients
- A history of bronchospasm, asthma, rhinitis,
angioedema or urticaria associated with taking
acetylsalicylic acid (ASA) or other non-steroidal
anti-inflammatory drugs (NSAIDs);
- Conditions involving an increased tendency or ac-
tive bleeding such as thrombocytopenia;
- Active, or history of recurrent peptic ulcer / haem-
orrhage (two or more distinct episodes of proven
ulceration or bleeding);
- History of gastrointestinal bleeding or perforation,
related to previous NSAIDs therapy;
- Cerebrovascular or other active bleeding;
- Severe hepatic or renal insufficiency;
- Severe heart failure (NYHA Class IV);
- Severe dehydration (caused by vomiting, diarrhoea
or insufficient fluid intake);
- Pregnancy, in the last trimester.
UNDESIRABLE EFFECTS
Very common (≥ 1 / 10) :
Fatigue or sleeplessness, headache, dizziness, pyrosis,
abdominal pain, nausea, vomiting, flatulence, diar-
rhoea, constipation and slight gastro-intestinal blood
losses that may cause anaemia in exceptional cases.
Common (≥ 1 / 100 to < 1 / 10) :
Vertigo, gastrointestinal ulcers, potentially with bleed-
ing and perforation. Ulcerative stomatitis, exacerbation
of colitis and Crohn´s disease, skin eruption, pain and
burning sensation in the administration site.
Uncommon (≥ 1 / 1000 to < 1 / 100) :
Hypersensitivity reactions with skin rashes and itch-
ing, as well as asthma attacks (possibly with drop in
blood pressure), anxiety, restlessness, insomnia, ag-
itation, irritability or tiredness, visual disturbances,
tinnitus, gastritis, urticaria, pruritus, purpura (in-
cluding allergic purpura), skin rash, reduced urinary
excretion and formation of oedemas, particularly in
patients with arterial hypertension or renal insufficien-
cy, nephrotic syndrome, interstitial nephritis that may
be accompanied by acute renal insufficiency.
Rare (>1 / 10 000, <1 / 1000) :
Psychotic reactions, nervousness, irritability, con-
fusion or disorientation and depression, reversible
toxic amblyopia, hearing disorders, esophageal ste-
nosis, exacerbation of diverticular disease, unspecific
haemorrhagic colitis, if gastrointestinal bleeding
occurs could cause anemia and haematemesis, stiff
neck, renal tissue damage (papillary necrosis), partic-
ularly in long-term therapy, increased serum uric acid
concentration in the blood.
Very rare (<1/10000):
Exacerbation of infection-related inflammations (e. g.
development necrotising fasciitis) coinciding with the
use of non-steroidal anti-inflammatory drugs has
been described. This is possibly associated with the
mechanism of action of the non-steroidal anti-in-
flammatory drugs. Disturbances to blood formation
(anaemia, agranulocytosis, leucopenia, thrombocyto-
penia, and pancytopenia,). First symtomps are: fever,
sore throat, superficial mouth wounds, influen-
za-like complaints, severe lassitude, nosebleeds and
skin bleeding, systemic lupus erythematosus, severe
hypersensitivity reactions, face oedema, swelling
of the tongue, swelling of the internal larynx with
constriction of the airways, difficulty breathing,
palpitations, hypotension and life threatening shock),
Aseptic meningitis (stiff neck, headache, nausea,
vomiting, fever or confusion). Patients with auto-
immune disorders (SLE, mixed connective-tissue
disease) appear to be predisposed. Palpitations, heart
failure, myocardial infarction, arterial hypertension,
asthma, bronchospasm, dyspnoea and wheezing,
oesophagitis, pancreatitis, formation of intestinal,
diaphragm-like strictures, jaundice, hepatic dys-
function, hepatic damage, particularly in long-term
therapy, acute hepatitis, hepatic insufficiency. Bullous
reactions including Stevens-Johnson syndrome and
toxic epidermal necrolysis (Lyell’s syndrome), erythema
multiforme alopecia. Photosensitivity reactions and
allergic vasculitis. In exceptional cases, severe skin
infections and soft-tissue complications in varicella
infection (see also “Infections and infestations”). Site
of injection reactions such as swelling, haematoma
or bleeding.
WARNINGS
Keep out of the sight and reach of children.
For single use in one patient only.
MARKETING AUTHORIZATION HOLDER
B. Braun Melsungen AG, 34209 Melsungen, Germany
Last revision: 06 / 2017
Prescription only
Not all products are registered and approved for sale in all
countries or regions. Indications of use may also vary by
country and region. Please contact your country repre-
sentative for product availability and information.