Dexalgin Inject solution for injection 50 mg/2 ml in 2 ml ampoules 5 pcs.

1 ml of solution for injection contains (active substance) dexketoprofen trometamol 36.9 mg, equivalent to dexketoprofen 25 mg (one 2 ml ampoule contains dexketoprofen trometamol 73.8 mg, equivalent to dexketoprofen 50 mg).

Excipients: ethanol 96%, sodium chloride, sodium hydroxide, water for injections.

• hypersensitivity to dexketoprofen, any other non-steroidal anti-inflammatory drugs (NSAIDs) or to the excipients of the drug;
• if substances with a similar effect, for example, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs provoke the development of attacks of bronchial asthma, bronchospasm, acute rhinitis or cause the development of nasal polyps, the appearance of urticaria or angioedema;
• if photoallergic or phototoxic reactions occurred during treatment with ketoprofen or fibrates;
• with a history of gastrointestinal bleeding or perforation associated with previous NSAID therapy;
• patients with active peptic ulcer disease/gastrointestinal bleeding, or a history of gastrointestinal bleeding, ulcers or perforation;
• patients with chronic dyspepsia;
• with gastrointestinal bleeding, other bleeding in the active phase or with increased bleeding;
• with Crohn’s disease or nonspecific ulcerative colitis;
• with severe heart failure;
• with moderate or severe renal impairment (creatinine clearance ≤ 59 ml / minute);
• with severe liver dysfunction (10-15 points on the Child-Pugh scale);
• with hemorrhagic diathesis and other blood clotting disorders;
• with severe dehydration (due to vomiting, diarrhea or insufficient fluid intake);
• in the third trimester of pregnancy and during breastfeeding;
• Due to the ethanol content in the drug, Dexalgin Inject is contraindicated for neuraxial (intrathecal or epidural) administration.

The recommended dose for adults is 50 mg at intervals of 8-12 hours. If necessary, a second dose should be administered after 6 hours. The maximum daily dose should not exceed 150 mg. Dexalgin Inject is intended for short-term use, therefore it should be used only during the period of acute pain (no more than 2 days). Patients should be transferred to oral analgesics, if possible. Adverse reactions can be reduced by using the lowest effective dose for the shortest possible time necessary to improve the condition. For moderate or severe postoperative pain, the drug can be used according to indications in the same recommended doses in combination with opioid analgesics.

Pregnant women

The use of dexketoprofen trometamol in the first and second trimesters of pregnancy is possible only if absolutely necessary. When prescribing dexketoprofen trometamol to women planning a pregnancy or in the first and second trimesters of pregnancy, the lowest possible effective dose should be used for the shortest possible duration of treatment.

As with all NSAIDs, dexketoprofen trometamol may impair female fertility and is therefore not recommended in women attempting to conceive. Women who have difficulty conceiving or are undergoing investigation of infertility should consider discontinuing the drug.

Children

The drug should not be used in children and adolescents due to the lack of data on its efficacy and safety.

Drivers

While using the drug Dexalgin Inject dizziness, visual disturbances or drowsiness may occur. In such cases, the ability to react quickly, navigate in a traffic situation and drive vehicles or other mechanisms may deteriorate.

Symptoms of overdose are unknown. Similar drugs cause disorders of the digestive tract (vomiting, anorexia, abdominal pain) and the nervous system (drowsiness, dizziness, disorientation, headache). In case of accidental overdose, symptomatic treatment should be immediately initiated according to the patient’s condition. Dexketoprofen trometamol is removed from the body by dialysis.

The most common were digestive tract disorders.

Dexalgin Inject cannot be mixed in small volumes (for example, in a syringe) with solutions of dopamine, promethazine pentazocine, pethidine and hydrocortisone, as a white precipitate is formed.

Store in the original packaging, protected from light. After dilution, the solution is stored for 24 hours at a temperature of 2 °C to 8 °C. Keep out of the reach of children.

Shelf life – 5 years.