READY-TO-USE
Paediatrics , ≥ 20 kg and ≥ 6 years
Ibuprofen B . Braun 200 mg solution for infusion
4 mg / ml in Ecoflac plus ® filled with 50 ml Make mixing a thing of the past
Ibuprofen is indicated in adolescents and children from ≥ 20 kg body weight and ≥ 6 years for :
Short-term symptomatic treatment of acute moderate pain and fever when administration by intravenous route is clinically justified or when other routes of administration are not possible .
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Ibuprofen B . Braun 200 mg solution for infusion
COMPOSITION Ibuprofen B . Braun 200 mg solution for infusion 1 ml of solution contains 4 mg of ibuprofen . Each 50 ml bottle contains 200 mg of ibuprofen . Excipient with known effect : 1 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 ). Excipients L-arginine , sodium chloride , hydrochloric acid ( for pH adjustment ), sodium hydroxide ( for pH adjustment ), water for injection .
THERAPEUTIC INDICATIONS Ibuprofen B . Braun 200 mg solution for infusion 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 .
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 active bleeding such as thrombocytopenia ; active , or history of recurrent peptic ulcer / haemorrhage ( 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 ) Common ( ≥ 1 / 100 to < 1 / 10 ) Uncommon ( ≥ 1 / 1000 to < 1 / 100 ) : Rare (> 1 / 10 000 , < 1 / 1000 ) : Very rare (< 1 / 10000 ) Not known : cannot be estimated from the available data )
The most commonly observed adverse events are gastrointestinal in nature . Peptic ulcers , perforation or GI bleeding , sometimes fatal . Nausea , vomiting , diarrhoea , flatulence , constipation , dyspepsia , abdominal pain , melaena , haematemesis , ulcerative stomatitis , exacerbation of colitis and Crohn ’ s disease have been reported following administration . Less frequently , gastritis has been observed . Particularly the risk of gastrointestinal bleeding occurring is dependent on the dose range and the duration of use .
Very rarely have been reported severe hypersensitivity reactions ( including infusion site reactions , anaphylactic shock ) and serious cutaneous adverse reactions such as bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis ( Lyell ’ s syndrome ), erythema multiforme and alopecia . Exacerbation of infection-related inflammations ( e . g . development of necrotising fasciitis ) coinciding with the use of nonsteroidal anti-inflammatory drugs has been described . This is possibly associated with the mechanism of action of the non-steroidal anti-inflammatory drugs . Photosensitivity , allergic vasculitis and in exceptional cases , severe skin infections and soft-tissue complications may occur during a varicella infection .
Oedema , hypertension and cardiac failure have been reported in association with NSAID treatment .
Clinical studies suggest that use of ibuprofen , particularly at a high dose ( 2400 mg / day ) may be associated with a small increased risk of arterial thrombotic events ( for example myocardial infarction or stroke ).
System organ class Infections and infestations Very rare : Exacerbation of infection-related inflammations ( e . g . development of 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 antiinflammatory drugs . Blood and lymphatic system disorders Very rare : Disturbances to blood formation ( anaemia , agranulocytosis , leukopenia , thrombocytopenia , and pancytopenia ). First symptoms are : fever , sore throat , superficial mouth wounds , influenza-like complaints , severe lassitude , nosebleeds and skin bleeding . Immune system disorders Uncommon : Hypersensitivity reactions with skin rashes and itching , as well as asthma attacks ( possibly with drop in blood pressure ). Very rare : 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 ). Psychiatric disorders Uncommon : Anxiety , restlessness . Rare : Psychotic reactions , nervousness , irritability , confusion or disorientation and depression . Nervous System disorders Very common : Fatigue or sleeplessness , headache , dizziness . Uncommon : Insomnia , agitation , irritability or tiredness . Very rare : Aseptic meningitis ( stiff neck , headache , nausea , vomiting , fever or confusion ). Patients with autoimmune disorders ( SLE , mixed connective-tissue disease ) appear to be predisposed . Eye disorders Uncommon : Visual disturbances . Rare : Reversible toxic amblyopia . Ear and labyrinth disorders Common : Vertigo . Uncommon : Tinnitus . Rare : Hearing disorders . Cardiac disorders Very rare : Palpitations , heart failure , myocardial infarction . Vascular disorders Very rare : Arterial hypertension . Respiratory , thoracic and mediastinal disorders s Very rare : Asthma , bronchospasm , dyspnoea and wheezing . Gastrointestinal disorders Very common : Pyrosis , abdominal pain , nausea , vomiting , flatulence , diarrhoea , constipation and slight gastrointestinal blood losses that may cause anaemia in exceptional cases . Common : Gastrointestinal ulcers , potentially with bleeding and perforation . Ulcerative stomatitis , exacerbation of colitis and Crohn ´ s disease . Uncommon : Gastritis . Rare : Oesophageal stenosis , exacerbation of diverticular disease , unspecific haemorrhagic colitis . If gastrointestinal bleeding occurs could cause anaemia and haematemesis . Very rare : Oesophagitis , pancreatitis , formation of intestinal , diaphragm-like strictures . Hepatobiliary disorders Rare : Jaundice , hepatic dysfunction , hepatic damage , particularly in long-term therapy , acute hepatitis . Not known : Hepatic insufficiency .
Skin and subcutaneous tissue disorders Common : Skin eruption . Uncommon : Urticaria , pruritus , purpura ( including allergic purpura ), skin rash . Very rare : 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 ”). Not known : Drug reaction with eosinophilia and systemic symptoms ( DRESS syndrome ), Acute generalised exanthematous pustulosis ( AGEP ).
Musculoskeletal and connective tissue disorders Rare : Stiff neck Renal and urinary disorders Uncommon : Reduced urinary excretion and formation of oedemas , particularly in patients with arterial hypertension or renal insufficiency , nephrotic syndrome , interstitial nephritis that may be accompanied by acute renal insufficiency . Rare : Renal tissue damage ( papillary necrosis ), particularly in long-term therapy , increased serum uric acid concentration in the blood . General disorders and administration site conditions Common : Pain and burning sensation in the administration site . Not known : Injection site reaction such as swelling , haematoma or bleeding .
WARNINGS Keep out of sight and reach of children .
NOTE Prescription only
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MARKETING AUTHORIZATION HOLDER B . Braun Melsungen AG 34209 Melsungen , Germany
Last revision : 01 / 2020 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 representative for product availability and information .