DECLOPHEN 3AMP; diclofenac sodium, anti inflammatory agents .
ACTIVE-INGREDIENT OF DECLOPHEN 3AMP
each ampoule (3 ml ) contains : diclofenac sodium 75 mg .
INDICATION OF DECLOPHEN 3AMP
intramuscular injection initial treatment of : exacerbations of inflammatory , and degerative forms of rheumatism : rheumatoid arthritis, osteoarthritis, ankylosing spondylitis,spondylarthritis , painful syndromes of the vertebral column , non-articular rheumatism . acute attacks of gout . renal colic and biliary colic . post-traumatic and post -operative pain , inflammation , and swelling . intravenous infusion : treatment of prevention of postoperative pain in a hospital setting . – Acute musclo-skeletal disorders such as periarthritis (for example frozen shoulder ), tendinitis, tenosynovitis, bursitis. – Other painful conditions resulting from trauma, including fracture, low back pain, sprains dislocations, orthropaedic, dental and other minor surgery. – Children (aged 1-12 years) juvenile chronic arthritis (25 mg tablet only).
DOSAGE OF DECLOPHEN 3AMP
Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet
Ask your pharmacist or doctor for help if you do not understand the instructions on the box .
The recommended dose is : –
adults : declophen ampoules should not be given for more than 2 days ; if necessary , treatment can be continued with declophen tablets or suppositories . Intramuscular injection : the following directions for intramuscular injection must be followed in order to avoid damage to a nerve or other tissue at the injection site . the dosage is generally one 75 mg ampoule daily , given by deep intragluteal injection into the upper outer quaderant . in severe cases (e.g. colic ) the daily dose can exceptionally be increased to two injections of 75 mg , separated by an interval of a few hours ( one into each buttock ) alternatively , one ampoule of 75 mg can be combined with other dosage forms of declphen ( tablets, suppositories ) up to a maximum daily dosage of 150 mg , in migraine attacks , clinical experiences is limited to initial use of 1 ampoule of 75 mg administered as soon as possible , followed by suppositories up to 100 mg on the same day if required . the total dosage should not exceed 175 mg on the first day . no data are available on the use of declophen to treat migraine for more than one day . should it be necessary to continue treatment on the following days , the maximum daily dose is to be limited to 150 mg ( given in divided doses in the form of suppositories ) . intravenous injection : declophen must not be given as an intravenous bolus injection . immediately before starting an intravenous infusion , declophen must be diluted with salin 0.9 % or glucose 5% infusion solution buffered with sodium bicarbonate . two alternative dosage regimens of declophen are recommended . for the treatment of moderate to severe postoperative pain , 75 mg should be infused continuosly over a period of 30 minutes to 2 hours . if necessary , treatment may be repeated after a few hours , but the dosage should not exceed 150 mg within any period of 24 hours . for the prevention of post-operative pain , a loading dose of 25 – 50 mg should be infused after surgery over 15 minutes to 1 hour , followed by a continuous infusion of about 5 mg per hour up to a maximum daily dosage of 150 mg . children : declophen ampoules are contraindicated in children .
OVER-DOSAGE OF DECLOPHEN 3AMP
CONTRA-INDICATION OF DECLOPHEN 3AMP
gastric or intestinal ulcer . Known hypersensitivity to the active substance or any of the excipients . Like other non-steroidal anti-inflammatory drugs ( NSAIDS ) . Declophen is also contraindicated in patients in whom attacks of asthma , urticaria , or acute rhinitis are precipitated by acetysalicylic acid or other drugs with prostaglandin synthesase inhibiting activity . nasal polyps , angioedema , bronchospasm , or asthma , liver & kidney diseases , hypovolaemia , or dehydration . patients at high risk for postoperative bleeding or incomplete haemostasis , haematopoietic disorders , or cerebrovascular bleeding . declophen must not be used together with high doses of anticoagulants or with anti-inflammatory agents . declophen ampoules must not be used in children , since there is no experience of such use . pregnancy , nursing mothers & pediatric use : do not adminiester injections preserved with benzyl alcohol to neonates , infants , pregnant women or nursing mothers . benzyl alcohol has been associated with serious adverse events 7death , particularily in pediatric patients . injections presevative free should be used in these populations .
STORAGE OF DECLOPHEN 3AMP
store at temperature not exceeding 30 C .keep out of reach of children .
PACK OF DECLOPHEN 3AMP
a carton box containing 3 or 6 printed transparent glass type (1) ampoules 3 ml each and an inner pamphlet .
DECLOPHEN 3AMP MANUFACTURED BY
PHARCO B Iternational for PHARCO pharnmaceuticals .