Desket

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT DEXKET (DESKET)

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, 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. Dexketoprofen trometamol has been shown to inhibit the activity of both cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). Clinical studies in various types of pain have demonstrated 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 procedures (orthopedic and gynecological surgeries, abdominal surgeries), as well as 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 significantly lower morphine requirements (by 30–45%) compared to patients receiving placebo.

Pharmacokinetics.

After intramuscular administration of dexketoprofen trometamol, maximum plasma concentration (Cmax) is reached approximately within 20 minutes (10–45 minutes). It has been demonstrated that following single intramuscular or intravenous administration of 25–50 mg of the drug, the area under the concentration–time curve (AUC) is dose-proportional. Pharmacokinetic studies of repeated dosing 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 averages 0.25 L/kg. The distribution half-life is approximately 0.35 hours, while the elimination half-life ranges from 1 to 2.7 hours. 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. Following administration of single and multiple doses, the extent of drug exposure in elderly 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 were observed in maximum concentration or time to reach it. 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 in cases where oral administration of the drug is inappropriate, e.g., postoperative pain, renal colic, and low back pain (back pain).

Contraindications.

• Hypersensitivity to dexketoprofen, to any other non-steroidal anti-inflammatory drug (NSAID), or to excipients of the drug;
• if substances with similar action, e.g., acetylsalicylic acid or other NSAIDs, provoke attacks of bronchial asthma, bronchospasm, acute rhinitis, or cause nasal polyps, urticaria, or angioedema;
• in the active phase of peptic ulcer disease or bleeding, suspected thereof, or in recurrent peptic ulcer or bleeding history (no fewer than two confirmed episodes of ulcer or bleeding), or chronic dyspepsia;
• if photoallergic or phototoxic reactions occurred during treatment with ketoprofen or fibrates;
• in gastrointestinal bleeding, other active bleeding, or increased bleeding tendency;
• history of gastrointestinal bleeding or perforation associated with previous NSAID therapy;
• Crohn’s disease or ulcerative colitis;
• history of bronchial asthma;
• severe heart failure;
• moderate or severe renal impairment (creatinine clearance < 59 mL/min);
• severe hepatic impairment (Child-Pugh score 10–15 points);
• hemorrhagic diathesis and other disorders of blood coagulation;
• pronounced dehydration (due to vomiting, diarrhea, or insufficient fluid intake);
• third trimester of pregnancy and during breastfeeding;
• for neuroaxial administration (intrathecal or epidural injection) (due to ethanol content).

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). Concurrent use of multiple NSAIDs increases the risk of gastrointestinal ulceration and gastrointestinal bleeding due to their mutually enhancing effects.
• Anticoagulants: NSAIDs enhance the effect of anticoagulants, e.g., warfarin, due to high plasma protein binding of dexketoprofen, as well as platelet function inhibition and damage to gastric and duodenal mucosa. If concomitant use is necessary, it should be performed under strict medical supervision and appropriate laboratory monitoring.
• Heparin: increased risk of bleeding (due to platelet function inhibition and damage to 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, or upon discontinuation.
• High-dose methotrexate (≥ 15 mg weekly): NSAIDs in general may enhance the negative hematological effects of methotrexate due to reduced renal clearance.
• Hydantoin derivatives and sulfonamides: possible increase in 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 effectiveness of diuretics and other antihypertensive agents. In some patients with impaired renal function (e.g., dehydration or elderly patients), concomitant use of drugs that inhibit cyclooxygenase with ACE inhibitors, angiotensin II receptor antagonists, or aminoglycoside antibiotics may worsen renal function, which 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): due to reduced renal clearance of methotrexate under NSAID therapy, its overall negative hematological effects may be enhanced. During the first weeks of concomitant use, weekly blood tests are required. Treatment should be closely supervised by a physician, especially in elderly patients or those with even mild renal impairment.
• Pentoxifylline: risk of bleeding. Monitoring should be intensified, and bleeding time should be checked more frequently.
• Zidovudine: risk of increased toxic effects on erythrocytes due to effects on reticulocytes, leading to severe anemia after the first week of NSAID use. Blood tests and reticulocyte count should be performed 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:

• Beta-blockers: NSAIDs may reduce their antihypertensive effect by inhibiting prostaglandin synthesis.
• Cyclosporine and tacrolimus: possible increase in 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 increase in dexketoprofen plasma concentration, 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 under the influence of prostaglandin synthetase inhibitors. Limited data suggest that co-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.
• Quinolones: animal studies indicate that high-dose quinolone derivatives in combination with NSAIDs may increase the risk of seizures.
• Tenofovir: concomitant use with NSAIDs may increase plasma concentrations of blood urea nitrogen and creatinine; therefore, renal function should be monitored to assess potential effects of combined use.
• Deferasirox: concomitant use with NSAIDs may increase the risk of gastrointestinal toxicity. Close 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 for use.

Use with caution in patients with a history of allergic conditions. Avoid using Desket, 25 mg/ml injection solution, concomitantly 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 control symptoms.

Gastrointestinal safety

Gastrointestinal bleeding, ulceration, and perforation, sometimes fatal, have been reported with all NSAIDs at various stages of treatment, regardless of the presence of preceding 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, particularly in patients with a history of peptic ulcer, especially 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 begin with the lowest possible dose. NSAIDs should be prescribed with caution in patients with a history of gastrointestinal disorders due to the risk of exacerbation. NSAID use may provoke relapses of non-specific ulcerative colitis or Crohn’s disease in patients in remission. Before initiating treatment with dexketoprofen trometamol, patients with a history of esophagitis, gastritis, and/or peptic ulcer should be confirmed to be in remission. Patients with existing gastrointestinal symptoms or a history of gastrointestinal disorders should be monitored during treatment for possible complications, particularly gastrointestinal bleeding.

For such patients and those taking low-dose acetylsalicylic acid or other drugs increasing the risk of gastrointestinal adverse reactions, consider combination therapy with protective agents, such as misoprostol or proton pump inhibitors.

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

The drug should be prescribed with caution in patients concurrently using medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants (e.g., warfarin), SSRIs, or antiplatelet agents like acetylsalicylic acid.

Cardiovascular and cerebrovascular safety

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 previous episodes of heart failure (due to an increased risk of heart failure development during treatment), as NSAIDs may cause fluid retention and edema.

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 slight increase in the risk of arterial thrombotic events, such as myocardial infarction or stroke. Data to exclude dexketoprofen trometamol from this risk are insufficient.

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 prophylactic doses of low-molecular-weight heparin in the postoperative period has been studied in clinical trials, with no effect on coagulation parameters observed. However, patients receiving dexketoprofen trometamol together with drugs affecting hemostasis, such as warfarin, other coumarins, or heparins, require close medical supervision. Most cardiovascular adverse events occur in elderly patients.

Skin reactions

There have been reports of very rare cases of serious skin reactions (some fatal) associated with NSAID use, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis. The risk is likely highest during the initial stages of treatment, with most cases occurring within the first month of therapy. If skin rashes, signs of mucosal involvement, or other symptoms of hypersensitivity occur, Desket, 25 mg/ml injection solution, should be discontinued.

Renal function impairment

The drug should be used with caution in patients with impaired renal function, as NSAIDs may cause renal dysfunction, fluid retention, and edema. Due to the increased risk of nephrotoxicity, the drug should be used cautiously in patients receiving diuretics or those at risk of hypovolemia. Adequate fluid intake should be maintained during treatment to prevent dehydration, which may exacerbate renal toxicity. Like other NSAIDs, the drug may increase plasma urea and creatinine concentrations. 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. Most renal adverse events occur in elderly patients.

Hepatic function impairment

The drug should be used with caution in patients with impaired liver function. Like other NSAIDs, it may cause transient and minor elevations in certain liver function tests, as well as significant increases in AST and ALT levels. Treatment should be discontinued if such increases occur.

Most hepatic adverse events occur in elderly patients.

Masking symptoms of underlying infections

Like other NSAIDs, dexketoprofen trometamol may mask symptoms of infectious diseases during treatment, potentially delaying diagnosis and timely treatment, thereby worsening infection outcomes. Such cases have been observed in bacterial pneumonia and bacterial complications of varicella. When the drug 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

Desket, 25 mg/ml injection solution, should be administered with caution in patients with coagulation disorders, systemic lupus erythematosus, and mixed connective tissue diseases.

Each ampoule of Desket, 25 mg/ml injection solution, contains 200 mg of ethanol, equivalent to 5 ml of beer or 2.08 ml of wine per dose. The drug may have a negative effect on individuals suffering from alcoholism. The ethanol content should be considered when using the drug in pregnant women, breastfeeding women, children, and patients at risk, such as those with liver disease or epilepsy. The drug contains less than 1 mmol of sodium (23 mg) per dose and is therefore practically sodium-free.

Particular caution should be exercised when prescribing the drug 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 early signs of severe hypersensitivity reactions occur after administration of Desket, treatment should be discontinued. Depending on symptoms, any necessary treatment should be administered under medical supervision.

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

Severe infectious complications of the skin and soft tissues may occur during varicella. Data to exclude the role of NSAIDs in exacerbating this infection are lacking. Therefore, the use of Desket is not recommended during varicella.

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

Use during pregnancy or breastfeeding.

The use of Desket, 25 mg/ml injection solution, 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 in early pregnancy increases the risk of miscarriage, congenital heart defects, and abdominal wall defects. The absolute risk of cardiovascular abnormalities increases from <1% to approximately 1.5%. The risk is considered 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, a higher incidence of fetal developmental abnormalities, including cardiovascular anomalies, was observed. However, animal studies with dexketoprofen trometamol did not reveal reproductive organ toxicity. From the 20th week of pregnancy, the use of Desket, 25 mg/ml injection solution, may cause oligohydramnios due to fetal renal dysfunction. This may occur soon after starting treatment and is usually reversible upon discontinuation. Dexketoprofen trometamol may be used during the first and second trimesters of pregnancy 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. Prenatal monitoring for oligohydramnios should be considered after exposure to Desket, 25 mg/ml injection solution, for several days starting from the 20th week of pregnancy. The drug should be discontinued if oligohydramnios is detected.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may cause:

Risks to the fetus:

• cardiopulmonary toxic syndrome (with closure of the arterial duct and pulmonary hypertension);
• renal dysfunction, which may progress to renal failure with oliguria.

Risks to the mother and child near the end of pregnancy:

• prolonged bleeding time (due to platelet aggregation inhibition), which may occur even with low drug doses;
• delayed uterine contractions, leading to prolonged labor.

Breastfeeding period

There are no data on the passage of dexketoprofen into breast milk. Desket, 25 mg/ml injection solution, 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.

Dizziness, visual disturbances, or drowsiness may occur during treatment with Desket, 25 mg/ml injection solution. In such cases, the ability to react quickly, orient in traffic situations, and drive or operate machinery may be impaired.

Dosage and Administration

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 be used only during episodes of acute pain (no longer than 2 days). Patients should be switched to oral analgesics as soon as possible, if feasible. Adverse reactions can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms. In 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 (Child-Pugh score 5–9), the maximum daily dose should be reduced to 50 mg, and liver function should be closely monitored. The drug is contraindicated in severe hepatic impairment (Child-Pugh score 10–15).

Renal impairment. In patients with mild renal impairment (creatinine clearance 50–80 mL/min), the maximum daily dose should be reduced to 50 mg. The drug is contraindicated in moderate to severe renal impairment (creatinine clearance < 50 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 injection solution should be administered slowly and deeply into the muscle.

Intravenous infusion.

To prepare 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 must be prepared under aseptic conditions, avoiding exposure to natural daylight. The prepared solution should be clear. The infusion should be administered over 10–30 minutes. Avoid exposure of the prepared solution to natural daylight.

Dexket, injection solution 25 mg/mL, 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.

Dexket, injection solution 25 mg/mL, must not be mixed in the infusion solution with promethazine or pentazocine.

Intravenous bolus injection.

If necessary, the contents of one ampoule (2 mL of injection solution) may 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.

Dexket, injection solution 25 mg/mL, must not be mixed in small volumes (e.g., in a syringe) with dopamine, promethazine, pentazocine, pethidine, or hydrocortisone solutions, as a white precipitate may form.

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

When administered intramuscularly or intravenously by injection, the drug should be administered immediately after being drawn from the ampoule. The solution for intravenous infusion should be used immediately after preparation.

No changes in active substance content due to adsorption were 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.

Dexket, injection solution 25 mg/mL, 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. Do not use solutions containing particulate matter.

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 disturbances (nausea, 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 adverse reactions classified by organs and organ systems and frequency of occurrence, whose relationship with dexketoprofen trometamol is considered at least possible.

Gastrointestinal disorders were observed most frequently.

The development of peptic ulcer, perforation, or gastrointestinal bleeding, sometimes with fatal outcome, is possible, especially in elderly patients. 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 occur 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 disorders (purpura, aplastic and hemolytic anemia, rarely agranulocytosis and bone marrow hypoplasia). Bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rare), may also occur.

According to clinical studies 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 arterial thrombotic events, such as myocardial infarction and stroke.

Reporting of adverse reactions.

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

Shelf life.

2 years.

Storage conditions.

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

Incompatibilities.

Desket, solution for injection 25 mg/mL, must not be mixed in small volumes (e.g., in a syringe) with dopamine, promethazine, pentazocine, meperidine, or hydrocortisone solutions, as a white precipitate forms.

Diluted infusion solutions prepared as described in the section "Intravenous infusions" must not be mixed with promethazine or pentazocine.

Packaging.

2 mL in an ampoule, 5 ampoules in a blister pack, 1 or 2 blister packs in a carton.

Prescription status.

Prescription only.

Manufacturer.

Private Joint-Stock Company "Lekhim-Kharkiv".

Manufacturer's address and location of its business activities.

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