Decamex

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT DECAMEX (DECAMEX)

Composition:

Active substance: dexketoprofen trometamol;

1 ml of injection solution contains dexketoprofen trometamol 36.9 mg, equivalent to dexketoprofen 25 mg (1 ampoule of 2 ml contains dexketoprofen trometamol 73.8 mg, equivalent to dexketoprofen 50 mg);

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

Pharmaceutical form. Injection solution.

Main physicochemical properties: clear, colorless solution.

Pharmacotherapeutic group. Non-steroidal anti-inflammatory and antirheumatic agents. Propionic acid derivatives. Dexketoprofen. ATC code M01A E17.

Pharmacological properties.

Pharmacodynamics.

Dexketoprofen trometamol is a propionic acid salt exerting analgesic, anti-inflammatory, and antipyretic effects and belonging to the class of nonsteroidal anti-inflammatory drugs (NSAIDs). Its mechanism of action is based on reducing the synthesis of prostaglandins by inhibiting cyclooxygenase. Specifically, it inhibits the conversion of arachidonic acid into cyclic endoperoxides PGG2 and PGH2, from which prostaglandins PGE1, PGE2, PGF2α, PGD2, as well as prostacyclin PGI2 and thromboxanes TxА2 and TxВ2 are formed. In addition, inhibition of prostaglandin synthesis may affect other mediators of inflammation such as kinins, which may also indirectly influence the primary action of the drug. Inhibitory effects of dexketoprofen trometamol on the activity of cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) have been demonstrated. Clinical studies in various types of pain have shown that dexketoprofen trometamol exerts a pronounced analgesic effect. The analgesic effect of dexketoprofen trometamol after intramuscular and intravenous administration in patients with moderate to severe pain has been studied in various pain conditions associated with surgical interventions (orthopedic and gynecological surgeries, abdominal surgeries), as well as in musculoskeletal pain (acute low back pain) and renal colic. The duration of analgesic effect after administration of 50 mg of dexketoprofen trometamol usually lasts 8 hours. In patients receiving morphine via a patient-controlled analgesia device for postoperative pain relief, co-administration of dexketoprofen trometamol resulted in a significantly lower morphine requirement (by 30–45%) compared to patients receiving placebo.

Pharmacokinetics.

Absorption. After intramuscular administration of dexketoprofen trometamol, maximum concentration (Cmax) is reached approximately within 20 minutes (10–45 minutes). It has been demonstrated that after single intramuscular or intravenous administration of 25–50 mg of the drug, the area under the concentration-time curve (AUC) is dose-proportional.

Distribution. Pharmacokinetic studies of repeated administration have shown that AUC and Cmax after the last intramuscular or intravenous dose do not differ from those after single administration, indicating absence of drug accumulation. Similar to other drugs with a high degree of plasma protein binding (99%), the volume of distribution of dexketoprofen is on average 0.25 L/kg. The distribution half-life is approximately 0.35 hours, and the elimination half-life is 1–2.7 hours.

Biotransformation and elimination. The metabolism of dexketoprofen occurs mainly via conjugation with glucuronic acid followed by renal excretion. After administration of dexketoprofen trometamol, only the S-(+) optical isomer is detected in urine, indicating absence of transformation of the drug into the R-(-) optical isomer.

Elderly patients. After administration of single and multiple doses, the extent of exposure in elderly healthy volunteers (aged 65 years and older) participating in the study was significantly higher (up to 55%) compared to younger volunteers; however, no statistically significant differences in maximum concentration (Cmax) or time to reach Cmax (tmax) were observed. The mean elimination half-life was prolonged (by up to 48%), and total clearance was reduced.

Clinical characteristics.

Indications.

Symptomatic treatment of moderate to severe acute pain when oral administration of the drug is inappropriate, such as postoperative pain, renal colic, and back pain.

Contraindications.

• Hypersensitivity to dexketoprofen, to any other nonsteroidal anti-inflammatory drug (NSAID), or to excipients of the drug;
• Patients in whom administration of substances with similar action, e.g., acetylsalicylic acid or other NSAIDs, induces attacks of bronchial asthma, bronchospasm, acute rhinitis, nasal polyps, urticaria, or angioedema;
• If photoallergic or phototoxic reactions occurred during treatment with ketoprofen or fibrates;
• Gastrointestinal bleeding or perforation in medical history associated with NSAID therapy;
• Active peptic ulcer/gastrointestinal bleeding or history of gastrointestinal bleeding, ulcers, or perforations;
• Chronic dyspepsia;
• Active bleeding or increased bleeding tendency;
• Crohn’s disease or ulcerative colitis;
• Severe heart failure;
• Moderate to severe renal impairment (creatinine clearance ≤ 59 mL/min);
• Severe hepatic impairment (Child-Pugh score 10–15 points);
• Hemorrhagic diathesis and other coagulation disorders;
• Severe dehydration (due to vomiting, diarrhea, or insufficient fluid intake);
• Third trimester of pregnancy and breastfeeding period.

Due to the ethanol content, the medicinal product is contraindicated for neuraxial (intrathecal or epidural) administration.

Interaction with other medicinal products and other forms of interaction.

Concomitant use of the following medicinal products with NSAIDs is not recommended:

• Other NSAIDs (including selective COX-2 inhibitors), including salicylates in high doses (≥ 3 g daily): concomitant use of multiple NSAIDs increases the risk of gastrointestinal ulceration and gastrointestinal bleeding due to their mutually potentiating effects.

• Anticoagulants: NSAIDs enhance the effect of anticoagulants, such as warfarin, due to high plasma protein binding of dexketoprofen, as well as inhibition of platelet function and damage to the gastric and duodenal mucosa. If concomitant use is necessary, it should be performed under strict medical supervision and appropriate laboratory monitoring.

• Heparins: increased risk of bleeding (due to inhibition of platelet function and damage to the gastric and duodenal mucosa). If concomitant use is necessary, it should be performed under strict medical supervision and appropriate laboratory monitoring.

• Corticosteroids: increased risk of gastrointestinal ulceration and gastrointestinal bleeding.

• Lithium (reports exist for several NSAIDs): NSAIDs increase lithium blood levels, potentially leading to toxicity (reduced renal excretion of lithium). Therefore, lithium blood levels should be monitored at the start of dexketoprofen therapy, during dose adjustments, and upon discontinuation.

• High-dose methotrexate (≥ 15 mg weekly): NSAIDs in general reduce renal clearance of methotrexate, thereby enhancing its adverse effects on the blood system.

• Hydantoin derivatives and sulfonamides: possible increased toxicity of these substances.

Concomitant use of the following medicinal products with NSAIDs requires caution:

• Diuretics, angiotensin-converting enzyme (ACE) inhibitors, aminoglycoside antibiotics, and angiotensin II receptor antagonists. Dexketoprofen reduces the efficacy of diuretics and other antihypertensive agents. In some patients with impaired renal function (e.g., dehydration or elderly patients), concomitant use of cyclooxygenase inhibitors with ACE inhibitors, angiotensin II receptor antagonists, or aminoglycoside antibiotics may worsen renal function, although this is usually reversible. When using dexketoprofen with any diuretic, ensure the patient is not dehydrated and monitor renal function at the beginning of treatment.
• Low-dose methotrexate (< 15 mg weekly): reduced renal clearance of methotrexate due to NSAID use generally enhances its adverse effects on the blood system. During the first weeks of concomitant use, weekly blood tests are required. Treatment should be closely supervised by a physician, even in cases of mild renal impairment or in elderly patients.
• Pentoxifylline: risk of bleeding. Monitoring should be intensified, and bleeding time should be checked more frequently.
• Zidovudine: risk of increased toxic effect on erythrocytes due to effects on reticulocytes, leading to severe anemia after the first week of NSAID use. A blood test and reticulocyte count should be performed within 1–2 weeks after starting NSAID therapy.
• Sulfonylurea agents: NSAIDs may enhance the hypoglycemic effect of these drugs by displacing sulfonylureas from plasma protein binding sites.

Potential interactions should be considered when using the following medicinal products:

• β-blockers: NSAIDs may reduce their antihypertensive effect by inhibiting prostaglandin synthesis.
• Cyclosporine and tacrolimus: possible increased nephrotoxicity due to NSAID effects on renal prostaglandins. Renal function should be monitored during combination therapy.
• Thrombolytic agents: increased risk of bleeding.
• Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding.
• Probenecid: possible increased plasma concentration of dexketoprofen, likely due to inhibition of renal tubular secretion and glucuronide conjugation of the drug, requiring dose adjustment of dexketoprofen.
• Cardiac glycosides: NSAIDs may increase glycoside plasma concentrations.
• Mifepristone: theoretically, there is a risk of altered mifepristone efficacy due to prostaglandin synthetase inhibitors. Limited data suggest that concomitant administration of NSAIDs on the same day as prostaglandin does not adversely affect mifepristone or prostaglandin efficacy regarding cervical ripening or contractility, nor does it reduce the clinical efficacy of drugs used for medical termination of pregnancy.
• Quinolone antibiotics: animal studies indicate that high-dose quinolone derivatives combined with NSAIDs increase the risk of seizures.
• Tenofovir: when used concomitantly with NSAIDs, plasma urea nitrogen and creatinine concentrations may increase; therefore, renal function should be monitored to assess potential effects of combined use.
• Deferasirox: increased risk of gastrointestinal toxicity when used concomitantly with NSAIDs. Careful patient monitoring is required when using this drug with deferasirox.
• Pemetrexed: concomitant use with NSAIDs may reduce pemetrexed elimination; therefore, particular caution is required when using NSAIDs at high doses. Patients with mild to moderate renal impairment (creatinine clearance 45–79 mL/min) should avoid NSAID use for two days before and two days after pemetrexed administration.

Special precautions.

Use with caution in patients with a history of allergic conditions. Avoid using the medicinal product in combination with other NSAIDs, including selective COX-2 inhibitors. Adverse reactions can be minimized by using the lowest effective dose for the shortest duration necessary to relieve symptoms.

Gastrointestinal safety. Gastrointestinal bleeding, ulceration, or perforation, sometimes fatal, have been reported with all NSAIDs at various stages of treatment, regardless of the presence of warning symptoms or a history of serious gastrointestinal disorders. If gastrointestinal bleeding or ulceration occurs, the drug should be discontinued. The risk of gastrointestinal bleeding, ulceration, or perforation increases with higher NSAID doses, in patients with a history of peptic ulcer, especially if complicated by bleeding or perforation, and in elderly patients.

Elderly patients. Elderly patients have an increased frequency of adverse reactions to NSAIDs, particularly gastrointestinal bleeding and perforation, sometimes fatal. Treatment in these patients should be initiated at the lowest possible dose. Before starting treatment with dexketoprofen trometamol, it should be ensured that patients with a history of esophagitis, gastritis, and/or peptic ulcer disease are in remission. Patients with existing gastrointestinal symptoms or a history of gastrointestinal disorders should be monitored during treatment for possible complications, particularly gastrointestinal bleeding. The medicinal product Dexamex should be used with caution in patients with a history of gastrointestinal disorders (ulcerative colitis, Crohn's disease), as there is a risk of exacerbation. For such patients and for those taking low-dose acetylsalicylic acid or other drugs that increase the risk of gastrointestinal adverse reactions, concomitant therapy with protective agents (e.g., misoprostol or proton pump inhibitors) should be considered.

Patients, especially elderly ones, with a history of gastrointestinal adverse reactions should inform their physician about any unusual gastrointestinal symptoms, particularly gastrointestinal bleeding, especially during the initial stages of treatment.

The medicinal product Dexamex should be used with caution in patients who are concurrently taking drugs that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants (e.g., warfarin), SSRIs, or antiplatelet agents such as acetylsalicylic acid.

Renal function impairment. The medicinal product should be used with caution in patients with impaired renal function, as NSAIDs may cause deterioration of renal function, fluid retention, and edema. Due to the increased risk of nephrotoxicity, Dexamex should be used with caution in patients receiving diuretics or those at risk of hypovolemia. During treatment, adequate fluid intake should be maintained to prevent dehydration, which may exacerbate renal toxicity. Like other NSAIDs, Dexamex may increase blood urea nitrogen and creatinine levels. Similar to other prostaglandin synthesis inhibitors, its use may be associated with renal adverse reactions, including glomerulonephritis, interstitial nephritis, papillary necrosis, nephrotic syndrome, and acute renal failure. Renal function disturbances occur most frequently in elderly patients.

Hepatic function impairment. The medicinal product should be used with caution in patients with impaired liver function. Like other NSAIDs, the drug may cause transient and minor elevations in liver function tests, as well as significant increases in AST and ALT levels. If such increases occur, treatment should be discontinued. Hepatic function disturbances occur most frequently in elderly patients.

Cardiovascular and cerebrovascular disorders. Patients with arterial hypertension and/or mild to moderate heart failure require monitoring and medical supervision. Particular caution is required when treating patients with a history of heart disease, especially those with previous episodes of heart failure (the risk of heart failure increases during treatment), as fluid retention and edema may occur during NSAID therapy.

According to available clinical and epidemiological data, the use of certain NSAIDs, especially at high doses and for prolonged periods, may be associated with a small increased risk of thrombotic events such as myocardial infarction or stroke. Data to exclude dexketoprofen trometamol from this risk are insufficient. Therefore, dexketoprofen trometamol should be used only after careful patient assessment in cases of uncontrolled arterial hypertension, congestive heart failure, confirmed ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease. The same applies before initiating long-term treatment in patients with cardiovascular risk factors, such as arterial hypertension, hyperlipidemia, diabetes mellitus, or smoking.

Non-selective NSAIDs can reduce platelet aggregation and prolong bleeding time by inhibiting prostaglandin synthesis. The concomitant use of dexketoprofen trometamol and low-molecular-weight heparin at prophylactic doses in the postoperative period has been studied in clinical trials, and no effect on coagulation parameters was observed. However, patients receiving dexketoprofen trometamol together with drugs affecting hemostasis (e.g., warfarin, other coumarins, or heparins) should be under close medical supervision. Cardiovascular function disturbances occur most frequently in elderly patients.

Skin reactions. Very rare cases of serious skin reactions (some fatal) have been reported during NSAID use, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis. The highest risk likely occurs early in treatment, with most cases appearing within the first month of therapy. If skin rashes, signs of mucosal involvement, or other signs of hypersensitivity occur, the drug should be discontinued.

Masking symptoms of underlying infections. Dexketoprofen trometamol may mask symptoms of infectious diseases during its use, potentially interfering with diagnosis and timely treatment, thereby worsening infection outcomes. Such cases have been observed in bacterial pneumonia and bacterial complications of varicella. When the medicinal product is administered to relieve pain associated with an infectious process, monitoring of the infection is recommended. In outpatient settings, patients should consult a physician if symptoms persist or worsen.

Other information.

Particular caution should be exercised when prescribing the medicinal product to patients:

• with inherited porphyrin metabolism disorders (e.g., acute intermittent porphyria);
• with dehydration;
• immediately after major surgical procedures.

If prolonged use of dexketoprofen is deemed necessary by the physician, liver and kidney function should be monitored regularly.

In very rare cases, severe acute hypersensitivity reactions (e.g., anaphylactic shock) have been observed. If signs of severe hypersensitivity reactions occur after administration, treatment should be discontinued. Depending on symptoms, any necessary treatment should be administered under medical supervision.

Patients suffering from asthma combined with chronic rhinitis, chronic sinusitis, and/or nasal polyps are at higher risk of allergy to acetylsalicylic acid and/or NSAIDs than other patients. Administration of this drug may trigger asthma attacks or bronchospasm, particularly in patients with known hypersensitivity to acetylsalicylic acid or NSAIDs.

Severe infectious complications of the skin and soft tissues may occur during varicella. Data confirming the role of NSAIDs in exacerbating this infectious process are lacking. Therefore, the use of this medicinal product is not recommended in cases of varicella.

The medicinal product Dexamex should be administered with caution in patients with coagulation disorders, systemic lupus erythematosus, or mixed connective tissue diseases.

Like other NSAIDs, dexketoprofen trometamol may mask symptoms of infectious diseases during its use. In some cases, NSAIDs have been associated with the activation of soft tissue infections. Therefore, if symptoms of bacterial infection appear or worsen during treatment with Dexamex, patients are advised to seek immediate medical attention.

Each ampoule of the medicinal product contains 200 mg of ethanol, equivalent to 5 mL of beer or 2.08 mL of wine per dose. The product may adversely affect individuals suffering from alcoholism. The ethanol content should be considered when using the medicinal product in pregnant women, breastfeeding women, children, and patients at risk (e.g., those with liver disease or epilepsy). The medicinal product Dexamex contains less than 1 mmol of sodium (23 mg) per dose and is practically sodium-free.

Use during pregnancy or breastfeeding.

The use of the drug is contraindicated during the third trimester of pregnancy and during breastfeeding.

Pregnancy. Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or fetal development. According to epidemiological studies, the use of drugs that inhibit prostaglandin synthesis during early pregnancy increases the risk of miscarriage and fetal malformations, including cardiac defects and abdominal wall defects. The absolute risk of cardiovascular abnormalities increases from less than 1% to approximately 1.5%. The risk is believed to increase with higher drug doses and longer treatment duration. Animal studies with prostaglandin synthesis inhibitors have shown increased pre- and post-implantation losses and higher embryofetal mortality. Furthermore, in animals treated with prostaglandin synthesis inhibitors during organogenesis, an increased incidence of fetal developmental abnormalities, including cardiovascular anomalies, was observed. However, animal studies with dexketoprofen trometamol did not reveal toxicity to reproductive organs. Starting from the 20th week of pregnancy, the use of the drug may cause oligohydramnios due to fetal renal dysfunction. This may occur soon after starting treatment and is usually reversible upon discontinuation. Additionally, cases of fetal ductus arteriosus constriction have been reported after maternal use of the drug during the second trimester, most of which resolved after treatment cessation. Therefore, the use of dexketoprofen trometamol during the first and second trimesters should be considered only if absolutely necessary. When prescribing dexketoprofen trometamol to women planning pregnancy or during the first and second trimesters, the lowest effective dose for the shortest possible duration should be used. Fetal monitoring for oligohydramnios and ductus arteriosus constriction should be considered after exposure to Dexamex injection solution 25 mg/mL for several days starting from the 20th gestational week. Treatment with Dexamex injection solution 25 mg/mL should be discontinued if oligohydramnios or ductus arteriosus constriction is detected.

During the third trimester, all prostaglandin synthesis inhibitors cause:

Risks for the fetus:

• cardiopulmonary toxic syndrome (narrowing/occlusion of the ductus arteriosus and pulmonary hypertension);
• renal dysfunction (see above);

Risks for the mother and child at the end of pregnancy:

• prolonged bleeding time (due to inhibition of platelet aggregation), which may occur even with low-dose administration;
• delayed uterine contractions, leading to delayed or prolonged labor.

Lactation period. There are no data on the passage of dexketoprofen into breast milk. The drug is contraindicated during breastfeeding.

Fertility. Like all other NSAIDs, dexketoprofen trometamol may reduce female fertility and is therefore not recommended for women planning pregnancy. Women experiencing fertility problems or undergoing infertility evaluation should consider discontinuing the drug.

Ability to affect reaction speed when driving or operating machinery.

During treatment with Dexamex injection solution 25 mg/mL, dizziness, visual disturbances, or somnolence may occur. In such cases, the ability to react quickly, orient in traffic situations, and drive or operate machinery may be impaired.

Method of Administration and Dosage

To minimize adverse reactions, the lowest effective dose for the shortest duration should be used (see section "Special Warnings and Precautions for Use").

Adults. The recommended dose is 50 mg every 8–12 hours. If necessary, the repeat dose may be administered after 6 hours. The maximum daily dose should not exceed 150 mg. The drug is intended for short-term use and should only be administered during episodes of acute pain (no longer than 2 days). Patients should be switched to oral analgesics as soon as possible. For moderate to severe postoperative pain, the drug may be used as indicated at the same recommended doses in combination with opioid analgesics.

Elderly patients. Dose adjustment is generally not required. However, due to physiological decline in renal function, a lower dose is recommended (maximum daily dose of 50 mg in patients with mild renal impairment).

Hepatic impairment. In patients with mild or moderate hepatic impairment (5–9 points on the Child–Pugh scale), the maximum daily dose should be reduced to 50 mg, and liver function should be closely monitored. The drug is contraindicated in patients with severe hepatic disease (10–15 points on the Child–Pugh scale).

Renal impairment. In patients with mild renal impairment (creatinine clearance 60–89 mL/min), the maximum daily dose should be reduced to 50 mg. The drug is contraindicated in patients with moderate or severe renal impairment (creatinine clearance < 59 mL/min).

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

Intramuscular administration. The contents of one ampoule (2 mL) should be administered slowly by deep intramuscular injection.

Intravenous infusion. For intravenous infusion, the contents of a 2 mL ampoule should be diluted in 30–100 mL of 0.9% sodium chloride solution, glucose solution, or Ringer’s lactate solution. The infusion solution should be prepared under aseptic conditions and protected from exposure to natural daylight. The prepared solution should be clear.

The infusion should be administered over 10–30 minutes.

Dekamex 25 mg/mL injection solution, diluted in 100 mL of 0.9% sodium chloride solution or glucose solution, may be mixed with dopamine, heparin, hydroxyzine, lidocaine, morphine, pethidine, and theophylline.

Intravenous bolus injection. If necessary, the contents of one ampoule (2 mL of injection solution) should be administered intravenously over at least 15 seconds.

The drug may be mixed in small volumes (e.g., in a syringe) with injection solutions of heparin, lidocaine, morphine, and theophylline.

Dekamex 25 mg/mL injection solution must not be mixed in small volumes (e.g., in a syringe) with solutions of dopamine, promethazine, pentazocine, pethidine, or hydroxyzine, as precipitation may occur.

The diluted infusion solution must not be mixed with promethazine or pentazocine.

The drug should only be mixed with medicinal products listed above.

After drawing the drug from the ampoule, it should be administered immediately when given by intramuscular or intravenous injection.

No changes in active ingredient content due to adsorption have been observed during storage of diluted solutions in polyethylene bags or in administration devices made of ethylene-vinyl acetate, cellulose propionate, low-density polyethylene, or polyvinyl chloride.

Dekamex 25 mg/mL injection solution is intended for single use only; any unused portion of the prepared solution must be discarded. Before administration, ensure that the solution is clear and colorless. Solutions containing particulate matter must not be used.

Children.

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

Overdose.

Symptoms of overdose are unknown. Similar medicinal products may cause gastrointestinal disorders (vomiting, anorexia, abdominal pain) and nervous system effects (drowsiness, dizziness, disorientation, headache). In case of accidental overdose, symptomatic treatment appropriate to the patient's condition should be initiated immediately. Dexketoprofen trometamol is eliminated from the body by dialysis.

Adverse reactions.

The table below lists the adverse reactions by organ systems and frequency of occurrence, for which the relationship to dexketoprofen trometamol is considered at least possible.

Gastrointestinal disorders were observed most frequently.

Peptic ulcer, perforation, or gastrointestinal bleeding, sometimes fatal, especially in elderly patients, may occur. According to available data, nausea, vomiting, diarrhea, flatulence, constipation, dyspeptic symptoms, abdominal pain, melena, vomiting with blood, ulcerative stomatitis, exacerbation of colitis, and Crohn's disease may develop during treatment with the drug. Gastritis is observed less frequently. Edema, arterial hypertension, and heart failure, which may be caused by NSAID use, have also been reported. As with other NSAIDs, the following adverse reactions are possible: aseptic meningitis, which generally occurs in patients with systemic lupus erythematosus or mixed connective tissue diseases, and blood-related reactions (purpura, aplastic and hemolytic anemia, rarely agranulocytosis and bone marrow hypoplasia). Bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rare), are possible.

According to results of clinical studies and epidemiological data, the use of certain NSAIDs, particularly at high doses and over prolonged periods, may be associated with a small increased risk of thrombotic events such as myocardial infarction and stroke.

Reporting of adverse reactions. Reporting of adverse reactions after drug registration is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical personnel, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life. 2 years.

Storage conditions. Store in the original packaging protected from light at a temperature not exceeding 25 °C. After reconstitution, the solution should be stored for 24 hours at a temperature of 2 °C to 8 °C. Keep out of reach of children.

Incompatibility.

Dekamex, solution for injection 25 mg/mL, must not be mixed in small volumes (e.g., in a syringe) with solutions of dopamine, promethazine, pentazocine, meperidine, or hydroxyzine, as precipitation may occur.

Diluted infusion solutions prepared as described in the section “Directions for use and dosage” must not be mixed with promethazine or pentazocine.

Packaging. 2 mL in a vial, 5 vials in a blister pack, 1 blister pack in a carton.

Prescription status. Prescription only.

Manufacturer. Private Joint-Stock Company "Lekhim-Kharkiv".

Manufacturer's address and location of its business operations.

36 Severina Pototskoho Street, Kharkiv, Kharkiv Oblast, 61115, Ukraine.