Evinopon solution for injections 25 mg/ml. 3 ml. (75 mg.) №5 ampoules

$22.10

Manufacturer: Greece

The drug is intended for the treatment of intramuscular injection: inflammatory and degenerative forms of rheumatism, rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, spondyloarthritis, vertebral pain syndrome, non-articular rheumatism; acute gout; renal and biliary colic; pain and swelling after injuries and operations; severe migraine attacks. The drug, when administered as intravenous infusions, is intended for the treatment or prevention of postoperative pain.

Category:

Description

Evinopon Storage
active substance: diclofenac sodium;

3 ml of solution contain: 75 mg of diclofenac sodium (25 mg / ml);

Excipients: sodium metabisulphite (E 223), mannitol (E 421), benzyl alcohol, sodium hydroxide, propylene glycol, water for injections.

Evinopon Dosage form
Solution for injection.

Basic physical and chemical properties: transparent, almost colorless solution.

Pharmacotherapeutic group
Nonsteroidal anti-inflammatory and anti-rheumatic drugs. Acetic acid derivatives and related compounds. ATX code M01A B05.

Pharmacological properties

Pharmacodynamics.

Evinopon is a non-steroidal drug with pronounced analgesic / anti-inflammatory properties. It is a prostaglandin synthetase (cyclooxygenase) inhibitor. Diclofenac sodium in vitro at concentrations equivalent to those achieved in humans does not inhibit the biosynthesis of proteoglycans in cartilage. If the drug is used concomitantly with opioids to relieve postoperative pain, Evinopon significantly reduces the need for opioids.

Evinopon Pharmacokinetics.

Absorption.

After administration of 75 mg of diclofenac by intramuscular injection, absorption begins immediately, and the mean maximum concentration (Cmax) in blood plasma, which is approximately 2,558 ± 0,968 μg / ml (2.5 μg / ml ≡ 8 μmol / l), achieved in about 20 minutes. The amount of absorption is linearly proportional to the dose.

If 75 mg of diclofenac is administered by intravenous infusion over 2 hours, the mean maximum plasma concentration is approximately 1.875 ± 0.436 mg / ml (1.9 μg / ml ≡ 5.9 μmol / l). Shorter infusion times result in higher peak plasma concentrations, whereas longer infusions result in a plateau concentration proportional to the infusion rate after 3–4 hours. In contrast to the corresponding results of oral administration, in the case of the drug in the form of suppositories or intramuscular administration, the concentration in blood plasma decreases rapidly immediately after reaching maximum levels.

Indication
The drug for intramuscular administration is intended for the treatment of:

– inflammatory and degenerative forms of rheumatism, rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, spondyloarthritis, vertebral pain, non-articular rheumatism;

– acute gout attacks;

– renal and biliary colic;

– pain and swelling after injuries and operations;

– severe migraine attacks.

The drug when administered as an intravenous infusion is intended for the treatment or prevention of postoperative pain.

Contraindication
– Hypersensitivity to the active substance, sodium metabisulfite or to any other components of the drug.

– Bleeding or perforation of the gastrointestinal tract in the anamnesis associated with previous treatment with nonsteroidal anti-inflammatory drugs (NSAIDs).

– Active form of peptic ulcer / bleeding or recurrent peptic ulcer / bleeding in the anamnesis (two or more separate episodes of established ulcer or bleeding).

– Active form of gastric and / or duodenal ulcer, gastrointestinal bleeding or perforation.

– III trimester of pregnancy.

– Like other NSAIDs, diclofenac is contraindicated in patients in whom ibuprofen, acetylsalicylic acid or other NSAIDs provoke asthma attacks, bronchospasm, angioneurotic edema, urticaria, acute rhinitis or nasal rhinitis / nasal symptoms.

– Inflammatory bowel disease (such as Crohn’s disease or ulcerative colitis).

– Hepatic failure (Child-Pew class C), liver cirrhosis and ascites.

– Heart failure (functional class II-IV according to NYHA – New York Cardiac Association).

– Renal insufficiency (glomerular filtration rate (GFR) <15 ml / min / 1.73 m2).

– High risk of postoperative bleeding, non-coagulation, haemostasis, haematopoietic disorders or cerebrovascular haemorrhage.

– Do not use for the treatment of postoperative pain during coronary artery bypass grafting (or when using an artificial circulation device).

– Ischemic heart disease in patients with angina or myocardial infarction.

– Cerebrovascular disease in patients who have suffered a stroke or have episodes of transient ischemic attacks.

– Diseases of peripheral arteries.

– In this dosage form, the drug is contraindicated in children.