Voltaren (diclofenac sodium) solution for injection 75 mg. 3 ml ampoules №5

Description

Voltaren solution for injection 75 mg. 3 ml ampoules №5

Composition:

active substance: diclofenac sodium;

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

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

Voltaren solution Dosage form

Solution for injection.

Main physical and chemical properties: clear solution from colorless to slightly yellow.

Pharmacotherapeutic group

Non-steroidal anti-inflammatory and anti-rheumatic drugs. Acetic acid derivatives and related compounds. ATX code M01A B05.

Pharmacological properties

Voltaren solution is a non-steroidal drug with pronounced analgesic / anti-inflammatory properties. It is an inhibitor of prostaglandin synthetase (cyclooxygenase). Prostaglandins play a leading role in inflammation, pain and fever. 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, Voltaren® significantly reduces the need for opioids.

Voltaren 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.

Method of application and dosage

The general recommendation is individual dose determination. Adverse reactions can be minimized by using the lowest effective dose for the shortest time necessary to control symptoms.

Adults

Voltaren solution for injection should not be used for more than 2 days. If necessary, treatment can be continued with gastro-resistant tablets or suppositories Voltaren.

Intramuscular injection

The following instructions should be followed to prevent damage to nerve or other tissues at the site of intramuscular injection. Such injuries can lead to muscle weakness, muscle paralysis and hypostasis.

The dose is usually 75 mg (one ampoule) per day, which is given by deep injection into the upper outer sector of the gluteus maximus using aseptic technique. In severe cases (such as colic), the daily dose can be increased to two injections of 75 mg, with an interval of several hours (one injection in each buttock). Alternatively, 75 mg solution for injection can be combined with other Voltaren formulations (such as tablets or suppositories) up to a maximum total daily dose of 150 mg diclofenac sodium.

Intravenous infusions

Immediately before the start of the intravenous infusion, Voltaren should be diluted in 100-500 ml of 0.9% sodium chloride solution or 5% glucose solution. Both solutions must first be buffered with sodium bicarbonate solution (0.5 ml of 8.4% solution or 1 ml of 4.2%). Only clear solutions can be used. If there are crystals or precipitate in the solution, it should not be used.

Voltaren solution for injection should not be given as an intravenous bolus injection.

Contraindication:

• hypersensitivity to the active substance, sodium metabisulfite or to any other components of the drug is known;
• history of bleeding or perforation of the gastrointestinal tract associated with previous treatment with nonsteroidal anti-inflammatory drugs (NSAIDs);
• active form of peptic ulcer / bleeding or recurrent peptic ulcer / bleeding history (two or more separate episodes of established ulcer or bleeding);
• active form of gastric and / or duodenal ulcers, 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 attacks of bronchial asthma, bronchospasm, angioneurotic edema, urticaria or acute rhinitis, but rhinitis / nasal polyps or symptoms;
• inflammatory bowel disease (such as Crohn’s disease or ulcerative colitis);
• hepatic failure;
• renal insufficiency (glomerular filtration rate (GFR) <15 ml / min / 1.73 m2);
• heart failure (NYHA II – IV);
• high risk of postoperative bleeding, non-coagulation, haemostasis, haematopoietic disorders or cerebrovascular haemorrhage;
• treatment of postoperative pain during coronary artery bypass grafting (or use of an artificial circulation device);
• ischemic heart disease in patients with angina, 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.