Evinopon when administered intravenously is intended for the treatment of inflammatory and degenerative forms of rheumatism, rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, spondyloarthritis, vertebral pain syndrome, non-articular rheumatism, acute attacks of gout, renal and biliary colic, pain and swelling after injuries and surgeries, severe migraine attacks.
The drug, when administered as an intravenous infusion, is intended for the treatment or prevention of postoperative pain.
Composition
Active ingredient: diclofenac sodium, 3 ml of solution contains 75 mg of diclofenac sodium 25 mg/ml.
Excipients: sodium metabisulfite (E 223), mannitol (E 421), benzyl alcohol, sodium hydroxide, propylene glycol, water for injections.
Contraindication
Hypersensitivity to the active substance, sodium metabisulphate or to any of the other ingredients of the product History of gastrointestinal bleeding or perforation associated with previous treatment with non-steroidal anti-inflammatory drugs (NSAIDs) Active peptic ulcer or bleeding or history of recurrent peptic ulcer or bleeding Third trimester of pregnancy Like other NSAIDs, diclofenac is also contraindicated in patients in whom the use of ibuprofen, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs provokes attacks of bronchial asthma, angioedema, urticaria or acute rhinitis Inflammatory bowel diseases such as Crohn's disease or ulcerative colitis Liver failure Renal failure Congestive heart failure High risk of postoperative bleeding, blood clotting, hemostasis disorders, hematopoietic disorders or cerebrovascular bleeding; Treatment of preoperative pain in coronary artery bypass grafting (or the use of a cardiopulmonary bypass machine); Coronary heart disease in patients with angina pectoris, previous myocardial infarction; Cerebrovascular disease in patients with a history of stroke or transient ischemic attacks; Peripheral arterial disease
In this dosage form, the drug is contraindicated in children.
For intravenous use only:
Concomitant use of NSAIDs or anticoagulants, including low-dose heparin History of hemorrhagic diathesis, confirmed or suspected cerebrovascular bleeding in history Operations associated with high risk of bleeding History of bronchial asthma Moderate or severe renal impairment Hypovolemia or dehydration from any cause
Method of application
The drug should be used in the most effective doses for the shortest period of time, taking into account the treatment objectives of each individual patient.
Solution for injection, do not use for more than 2 days.
If necessary, treatment can be continued with Evinopon tablets or suppositories.
injections
To prevent nerve or other tissue damage at the injection site, the following rules must be followed:
The usual dose is 75 mg per day, administered by deep injection into the upper outer sector of the gluteus maximus muscle.
In severe cases, the daily dose can be increased to 2 injections of 75 mg, with an interval of several hours between them.
Alternatively, 75 mg solution for injection can be combined with other dosage forms of diclofenac preparations up to a maximum total dose of 150 mg diclofenac sodium.
In the setting of a migraine attack, clinical experience is limited to cases with the initial use of one 75 mg ampoule, the dose should be administered if possible immediately after the use of 100 mg suppositories on the same day (if necessary). The total daily dose should not exceed 175 mg on the first day.
Intravenous infusions
Immediately before starting the infusion, Evinopon should be diluted in 100-500 ml of 0.9% sodium chloride solution or 5% glucose solution.
Both solutions require buffering with sodium bicarbonate solution.
Only clear solutions can be used.
Recommended alternative dosing regimens for Evinopon, solution for injection: for the treatment of moderate to severe postoperative pain, 75 mg should be administered continuously from 30 minutes to 2 hours; if necessary, treatment can be repeated after 4-6 hours, but the dose should not exceed 150 mg per day.
For the prevention of postoperative pain, a loading dose of 25-50 mg should be administered 15 minutes to 1 hour after surgery, followed by a continuous infusion of approximately 5 mg/h up to a maximum daily dose of 150 mg.
Application features
Pregnant women
In the first and second trimesters of pregnancy, the drug can be prescribed only if the expected benefit to the mother outweighs the potential risk to the fetus, only in the minimum effective dose, and the duration of treatment should be as short as possible.
Like other nonsteroidal anti-inflammatory drugs, the drug is contraindicated in the last trimester of pregnancy.
For the mother and newborn, as well as at the end of pregnancy:
Possible prolongation of bleeding time, antiplatelet effect, which can be observed even at very low doses Inhibition of uterine contractions, leading to delayed or prolonged labor
During breastfeeding, like other nonsteroidal anti-inflammatory drugs, diclofenac passes into breast milk in small amounts.
Therefore, to avoid undesirable effects on the infant, Evinopon should not be used during breastfeeding.
Drivers
Patients who experience visual disturbances, dizziness, drowsiness, or other central nervous system disorders during treatment with the drug should refrain from driving or operating complex machinery.
Children
Evinopon in the dosage form of a solution for injection is contraindicated in children.
Overdose
There is no typical clinical picture of the consequences of diclofenac overdose.
Overdose may cause symptoms such as headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, diarrhea, dizziness, disorientation, agitation, coma, drowsiness, ringing in the ears, loss of consciousness, or convulsions.
In case of severe poisoning, acute renal failure and liver damage are possible.
Side effects
From the blood and lymphatic system: thrombocytopenia, leukopenia, anemia, agranulocytosis From the immune system: hypersensitivity, anaphylactic and anaphylactoid reactions, angioedema Mental disorders: disorientation, depression, insomnia, nightmares, irritability and other mental disorders From the nervous system: headache, dizziness, drowsiness, fatigue, paresthesia, memory impairment, convulsions, anxiety, tremor, aseptic meningitis, taste disturbance, stroke, confusion, hallucinations, sensory disturbances, general malaise From the organs of vision: visual impairment, blurred vision, diplopia, optic neuritis From the organs of hearing and labyrinth: vertigo, tinnitus, hearing impairment From the heart: palpitations, chest pain, heart failure, myocardial infarction From the Vascular system: hypertension, hypotension, vasculitis Respiratory, thoracic and mediastinal disorders: asthma, pneumonitis Digestive system: nausea, vomiting, diarrhea, dyspepsia, abdominal pain, flatulence, anorexia, gastritis, intestinal bleeding, vomiting with blood, hemorrhagic diarrhea, melena, gastric or intestinal ulcer with or without bleeding or perforation, colitis, constipation, stomatitis, glossitis, disorders of the esophagus, intestinal membrane structures, pancreatitis Hepatobiliary system: increased transaminase levels, hepatitis, jaundice, liver function abnormalities, very rarely transient hepatitis, hepatonecrosis, hepatic failure Skin and subcutaneous tissue: rash, urticaria, bullous eruptions, eczema, erythema, erythema multiforme, syndrome Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, hair loss, photosensitivity reaction, purpura, allergic purpura, pruritus Renal and urinary disorders: acute renal failure, hematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis General disorders and administration site conditions: injection site reaction, pain, induration, swelling, injection site necrosis, injection site abscess Reproductive system and breast disorders: impotence
Storage conditions
Shelf life 5 years.
Store in the original packaging at a temperature not exceeding 25 °C, out of the reach of children.
