De-Span solution for injection 25 mg/ml ampoule 2 ml cassette No. 10

Instructions De-Span solution for injection 25 mg/ml ampoule 2 ml cassette No. 10

Composition

active ingredient: dexketoprofen;

1 ml of solution for injection contains 36.9 mg of dexketoprofen trometamol, equivalent to 25 mg of dexketoprofen;

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

Dosage form

Solution for injection.

Main physicochemical properties: clear colorless liquid.

Pharmacotherapeutic group

Nonsteroidal anti-inflammatory and antirheumatic drugs. Propionic acid derivatives. Dexketoprofen. ATX code M01A E17.

Pharmacological properties

Pharmacodynamics

Dexketoprofen trometamol is the tromethamine salt of (S)-(+)-2-(3-benzoylphenyl)propionic acid, which has analgesic, anti-inflammatory, and antipyretic effects and belongs to the class of nonsteroidal anti-inflammatory drugs (NSAIDs).

Mechanism of action.

The mechanism of action of NSAIDs is based on a decrease in prostaglandin synthesis by inhibiting cyclooxygenase activity. In particular, the conversion of arachidonic acid to cyclic endoperoxides PGG2 and PGH2 is inhibited, from which prostaglandins PGE1, PGE2, PGF2α, PGD2 are formed, as well as prostacyclin PGI2 and thromboxanes ThA2 and ThB2. In addition, inhibition of prostaglandin synthesis may affect other inflammatory mediators, such as kinins, which may also indirectly affect the main effect of the drug.

Pharmacodynamics.

Dexketoprofen trometamol has been shown to inhibit cyclooxygenase-1 and cyclooxygenase-2 activity in laboratory animals and humans.

Clinical efficacy and safety.

Clinical studies in various types of pain have demonstrated that dexketoprofen trometamol has a pronounced analgesic effect. The analgesic effect of dexketoprofen trometamol when administered intramuscularly and intravenously to patients with moderate to severe pain has been studied in various types of pain during surgical interventions (orthopedic and gynecological operations, abdominal operations), as well as in musculoskeletal pain (acute low back pain) and renal colic. During the studies, the analgesic effect of the drug began quickly and reached a maximum within the first 45 minutes. The duration of analgesic effect after the use of 50 mg of dexketoprofen trometamol is usually 8 hours. Clinical studies have demonstrated that the use of dexketoprofen trometamol allows for a significant reduction in the dose of opiates when they are used simultaneously for the purpose of relieving postoperative pain. When patients who were given morphine for postoperative pain relief using a patient-controlled analgesia device were also given dexketoprofen trometamol, they required significantly less morphine (by 30–45%) than patients who received placebo.

Pharmacokinetics

After intramuscular administration of dexketoprofen trometamol to humans, the maximum concentration (Cmax) is reached after approximately 20 minutes (10–45 minutes). It has been proven that with a single intramuscular or intravenous administration of 25–50 mg of the drug, the area under the AUC curve (“concentration - time”) is proportional to the dose. Pharmacokinetic studies of multiple use of the drug have shown that AUC and Cmax (mean maximum value) after the last intramuscular and intravenous administration do not differ from those after a single administration, which indicates the absence of drug accumulation.

Distribution.

Similar to other drugs with a high degree of binding to plasma proteins (99%), the volume of distribution of dexketoprofen is on average 0.25 l/kg. The half-life is approximately 0.35 hours, and the half-life is 1–2.7 hours.

Pharmacokinetic studies of multiple administration of the drug have demonstrated that Cmax and AUC after the last intramuscular or intravenous administration do not differ from those after a single administration, indicating the absence of drug accumulation.

Biotransformation and excretion.

Dexketoprofen is mainly metabolized by conjugation with glucuronic acid and subsequent renal excretion. After administration of dexketoprofen trometamol, only the S-(+) optical isomer is detected in the urine, indicating that there is no transformation of the drug into the R-(–) optical isomer in humans.

Elderly patients.

After single and multiple doses, the extent of exposure to the drug in healthy elderly volunteers (65 years and older) participating in the study was significantly higher (up to 55%) than in young volunteers, but there was no statistically significant difference in maximum concentration (Cmax) and time to reach it. The mean half-life increased (up to 48%), and the determined total clearance decreased.

Standard preclinical studies — pharmacological safety, genotoxicity and immunopharmacology studies — did not reveal any special hazard for humans. Chronic toxicity studies in animals have revealed a maximum dose of the drug that does not cause adverse reactions, which is 2 times higher than the dose recommended for humans. When higher doses of the drug were administered to monkeys, the main adverse reaction was blood in the stool, decreased body weight gain, and at the highest dose — pathologies of the gastrointestinal tract in the form of erosions. These reactions occurred at doses at which the exposure to the drug was 14–18 times higher than at the maximum dose recommended for humans. Carcinogenicity studies in animals have not been conducted.

Like all NSAIDs, dexketoprofen can cause embryo or fetal death in animals by directly affecting its development or indirectly by damaging the gastrointestinal tract of the mother.

Indication

Symptomatic treatment of acute pain of moderate to severe intensity in cases where oral administration of the drug is inappropriate, such as postoperative pain, renal colic and lumbago (back pain).

Contraindication

Hypersensitivity to dexketoprofen, any other non-steroidal anti-inflammatory drug (NSAID) or to any of the excipients of the drug;

It is contraindicated for use in patients in whom substances with similar effects, such as acetylsalicylic acid or other NSAIDs, provoke the development of attacks of bronchial asthma, bronchospasm, acute rhinitis or cause the development of nasal polyps, urticaria or angioedema;

contraindicated in patients who have experienced photoallergic or phototoxic reactions during treatment with ketoprofen or fibrates;

history of gastrointestinal bleeding or perforation related to previous NSAID therapy;

active peptic ulcer/gastrointestinal bleeding or history of gastrointestinal bleeding, ulcers or perforations;

chronic dyspepsia;

gastrointestinal bleeding, other bleeding in the active phase or increased bleeding;

Crohn's disease or nonspecific ulcerative colitis;

severe heart failure;

moderate or severe renal impairment (creatinine clearance < 59 ml/min);

severe liver dysfunction (10–15 points on the Child-Pugh scale);

hemorrhagic diathesis and other blood clotting disorders;

severe dehydration (due to vomiting, diarrhea, or insufficient fluid intake);

III trimester of pregnancy and breastfeeding period;

Do not use for neuraxial, intrathecal or epidural administration (due to ethanol content).

Interaction with other medicinal products and other types of interactions

The concomitant use of the following NSAIDs is not recommended:

other NSAIDs (including selective cyclooxygenase-2 inhibitors), including salicylates in high doses (≥ 3 g/day). The simultaneous use of several NSAIDs increases the risk of gastrointestinal ulcers and bleeding due to their mutual potentiation of action;

Anticoagulants: NSAIDs enhance the effect of anticoagulants, such as warfarin, due to the high degree of binding of dexketoprofen to blood plasma proteins, as well as inhibition of platelet function and damage to the gastric and duodenal mucosa. If concomitant use is necessary, it should be carried out under close medical supervision and appropriate laboratory parameters;

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 carried out under the supervision of a physician and with careful monitoring of relevant laboratory parameters;

Corticosteroids: increased risk of developing ulcers in the digestive tract and gastrointestinal bleeding;

Lithium (reported with several NSAIDs): NSAIDs increase the level of lithium in the blood, which can lead to intoxication (reduced renal excretion of lithium). Therefore, when starting dexketoprofen, when adjusting the dose or discontinuing the drug, it is necessary to monitor the level of lithium in the blood;

methotrexate in high doses (at least 15 mg per week). Due to the decrease in renal clearance of methotrexate against the background of the use of NSAIDs, its negative effect on the blood system is generally increased;

hydantoin derivatives and sulfonamides: possible increased toxicity of these substances.

diuretics, angiotensin-converting enzyme (ACE) inhibitors, antibacterial aminoglycosides and angiotensin II receptor antagonists. Dexketoprofen reduces the effectiveness of diuretics and other antihypertensive agents. In some patients with impaired renal function (e.g., in cases of dehydration or in the elderly), the use of cyclooxygenase inhibitors with ACE inhibitors, angiotensin II receptor antagonists or antibacterial aminoglycosides may worsen renal function, which is usually reversible. When using dexketoprofen with any diuretic, it is necessary to ensure that the patient is not dehydrated, and at the beginning of treatment it is necessary to monitor renal function;

methotrexate in low doses (less than 15 mg per week): due to the decrease in renal clearance of methotrexate against the background of the use of NSAIDs, its negative effect on the blood system in general is increased. In the first weeks of simultaneous use, it is necessary to conduct a blood test every week. Even with a slight impairment of renal function, as well as in elderly patients, treatment should be carried out under strict medical supervision;

Pentoxifylline: there is a risk of bleeding. It is necessary to increase monitoring and check the bleeding time more often;

zidovudine: there is a risk of increased toxicity to erythrocytes due to effects on reticulocytes, which leads to severe anemia after the first week of NSAID use. A blood test and reticulocyte count should be performed within 1–2 weeks of starting NSAID use;

Sulfonylureas: NSAIDs can enhance the hypoglycemic effect of these agents by displacing sulfonylureas from their plasma protein binding.

Possible interactions should be considered when using the following agents:

β-blockers: NSAIDs can weaken their antihypertensive effect by inhibiting prostaglandin synthesis;

Cyclosporine and tacrolimus: possible increase in nephrotoxicity due to the effect of NSAIDs on renal prostaglandins. Renal function should be monitored during combination therapy;

thrombolytic agents: increased risk of bleeding;

Antiplatelet agents and selective serotonin reuptake inhibitors: increased risk of gastrointestinal bleeding;

Probenecid: an increase in the concentration of dexketoprofen in the blood plasma is possible, which is probably due to inhibition of renal tubular secretion and conjugation of the drug with glucuronic acid and requires correction of the dose of dexketoprofen;

cardiac glycosides: NSAIDs can increase the concentration of glycosides in blood plasma;

Mifepristone: There is a theoretical risk that the efficacy of mifepristone may be altered by prostaglandin synthetase inhibitors. Limited data suggest that co-administration of NSAIDs on the same day as a prostaglandin does not adversely affect the efficacy of mifepristone or prostaglandin in cervical ripening or contractility, nor does it reduce the clinical efficacy of medical abortion.

Quinoline antibiotics: animal studies have shown that the use of quinolone derivatives in high doses in combination with NSAIDs increases the risk of seizures;

Tenofovir: when used together with NSAIDs, the concentration of urea nitrogen and creatinine in the blood plasma may increase, therefore, to assess the possible effect of the combined use of these drugs, it is necessary to monitor renal function;

Deferasirox: Concomitant use with NSAIDs may increase the risk of gastrointestinal toxicity. Careful patient monitoring is required when this medicinal product is used concomitantly with deferasirox;

Pemetrexed: Pemetrexed elimination may be reduced when co-administered with NSAIDs; therefore, caution should be exercised when high doses of NSAIDs are used. In patients with mild to moderate renal impairment (creatinine clearance 45 ml/min to 79 ml/min), concomitant use of pemetrexed and NSAIDs should be avoided for two days before and two days after pemetrexed administration.

Application features

The drug should be used with caution in patients with a history of allergic conditions. It is necessary to avoid using the drug in combination with other NSAIDs, including selective cyclooxygenase-2 inhibitors. Adverse reactions can be reduced by using the lowest effective dose for the shortest possible time necessary to improve the condition.

Gastrointestinal safety.

Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, sometimes fatal. Treatment of such patients should be started with the lowest possible dose. Before starting the use of dexketoprofen trometamol in patients with a history of esophagitis, gastritis and/or peptic ulcer disease, it should be ensured that these diseases are in remission. In patients with existing symptoms of gastrointestinal pathology and with a history of gastrointestinal diseases, the condition of the digestive tract should be monitored for possible disorders, especially gastrointestinal bleeding, during the use of the drug. NSAIDs should be prescribed with caution to patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease), since there is a risk of their exacerbation. For such patients and patients taking low-dose acetylsalicylic acid or other agents that increase the risk of gastrointestinal adverse reactions, combination therapy with protective agents, such as misoprostol or proton pump inhibitors, should be considered.

Patients, especially the elderly, who have a history of adverse reactions from the digestive tract should inform their doctor about all unusual symptoms related to the digestive system, in particular gastrointestinal bleeding, especially in the initial stages of treatment.

Caution should be exercised when prescribing the drug to patients who are concomitantly taking agents that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid.

Kidney safety.

Patients with impaired renal function should be prescribed the drug with caution, since against the background of the use of NSAIDs, deterioration of renal function, fluid retention in the body and edema are possible. Due to the increased risk of nephrotoxicity, the drug should be prescribed with caution in treatment with diuretics, as well as in those patients who may develop hypovolemia. During treatment, the body should receive a sufficient amount of fluid to avoid dehydration, which can lead to increased toxic effects on the kidneys. Like all NSAIDs, the drug may increase the concentration of urea nitrogen and creatinine in the blood plasma. Like other prostaglandin synthesis inhibitors, its use may be accompanied by adverse reactions from the kidneys, leading to glomerulonephritis, interstitial nephritis, papillary necrosis, nephrotic syndrome and acute renal failure. Most impaired renal function occurs in elderly patients.

Liver safety.

The drug should be used with caution in patients with impaired liver function. As with other NSAIDs, the drug may cause a temporary and slight increase in some liver function tests, as well as a pronounced increase in the activity of aspartate aminotransferase (AST) and alanine aminotransferase (ALT). If these values increase, therapy should be discontinued.

Most liver dysfunction occurs in elderly patients.

Safety regarding the cardiovascular system and cerebral circulation.

Patients with arterial hypertension and/or mild to moderate heart failure should be under close medical supervision. Particular caution should be exercised when treating patients with a history of heart disease, in particular with previous episodes of heart failure (the risk of developing heart failure increases with the use of the drug), since fluid retention in the tissues and the formation of edema have been observed during treatment with NSAIDs. Clinical studies and epidemiological data suggest that the risk of arterial thrombosis (for example, myocardial infarction or stroke) is slightly increased with the use of some NSAIDs (especially in high doses and for a long time). There is insufficient data to exclude such a risk with the use of dexketoprofen. Therefore, in case of uncontrolled arterial hypertension, congestive heart failure, ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease, dexketoprofen should be prescribed only after a careful assessment of the patient's condition. Equally careful assessment should be performed before initiating long-term treatment in patients with risk factors for cardiovascular disease (e.g., hypertension, hyperlipidemia, diabetes mellitus, smoking).

Non-selective NSAIDs can reduce platelet aggregation and increase bleeding time by inhibiting prostaglandin synthesis. The simultaneous use of dexketoprofen trometamol and low molecular weight heparin in prophylactic doses in the postoperative period was studied in clinical studies and no effect on coagulation parameters was found. However, patients who use dexketoprofen trometamol simultaneously with drugs that affect hemostasis (e.g. warfarin, other coumarins or heparins) should be under close medical supervision. The greatest impairment of cardiovascular function occurs in elderly patients.

There have been very rare reports of serious skin reactions (some fatal) with NSAIDs, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis. Patients are at greatest risk at the start of treatment; in most patients they occur within the first month of therapy. If skin rash, signs of mucosal involvement or other symptoms of hypersensitivity occur, DE-SPAN® should be discontinued.

Masking the symptoms of underlying infections

DE-SPAN® can mask the symptoms of infections, which can prevent diagnosis and timely treatment and, thereby, worsen the consequences of the infection. Such cases have been observed with bacterial pneumonia and bacterial complications of chickenpox. When DE-SPAN® is administered to relieve pain associated with an infectious process, monitoring of the infectious process is recommended. In outpatient settings, the patient should consult a doctor if symptoms persist or worsen.

Other information.

Particular caution should be exercised when prescribing the drug to patients with:

hereditary disorders of porphyrin metabolism (for example, in acute intermittent porphyria);

dehydration;

immediately after major surgical interventions.

If the doctor considers that long-term use of dexketoprofen is necessary, liver and kidney function should be monitored regularly.

In very rare cases, severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed. At the first signs of severe hypersensitivity reactions after taking DE-SPAN®, treatment should be discontinued. Depending on the symptoms, any treatment necessary in such cases should be carried out under the supervision of a doctor.

Patients with asthma in combination with chronic rhinitis, chronic sinusitis and/or nasal polyps are at higher risk of allergy to acetylsalicylic acid and/or NSAIDs than other patients. The administration of this drug may cause asthma attacks or bronchospasm, especially in patients with allergy to acetylsalicylic acid or NSAIDs.

Severe infectious complications of the skin and soft tissues may develop in the setting of chickenpox. To date, no data have been obtained that would rule out the role of NSAIDs in aggravating this infectious process. Therefore, DE-SPAN® is not recommended for use in chickenpox.

DE-SPAN® should be prescribed with caution to patients with hematopoietic disorders, systemic lupus erythematosus, and mixed connective tissue diseases.

As with other NSAIDs, dexketoprofen trometamol may mask the symptoms of infectious diseases during its use. In isolated cases, there have been reports of activation of infectious processes localized in soft tissues during the use of NSAIDs. Therefore, if symptoms of a bacterial infection appear or worsen during use, patients are advised to consult a doctor immediately.

Each ampoule of the drug DE-SPAN® contains 200 mg of ethanol, which corresponds to 5 ml of beer or 2.08 ml of wine per dose. The drug may have a negative effect on people suffering from alcoholism. The ethanol content should be taken into account when used in pregnant and breastfeeding women, children and patients at risk, for example, with liver disease, as well as patients with epilepsy.

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

Use during pregnancy or breastfeeding

The use of the drug DE-SPAN® is contraindicated in the third trimester of pregnancy and during breastfeeding.

Pregnancy.

Starting from the 20th week of pregnancy, the use of DE-SPAN® may cause oligohydramnios due to fetal renal dysfunction. This may occur shortly after the start of treatment and is usually reversible after discontinuation of treatment. In addition, there are reports of narrowing of the ductus arteriosus after treatment in the second trimester of pregnancy, which in most cases disappeared after discontinuation of treatment. Therefore, the appointment of dexketoprofen trometamol in the I and II trimesters of pregnancy is possible only in case of extreme necessity. When prescribing dexketoprofen trometamol to women planning a pregnancy or in the I and II trimesters of pregnancy, the lowest possible effective dose should be used for the shortest possible duration of treatment.

After exposure to DE-SPAN® for several days, starting from the 20th week of gestation, oligohydramnios and narrowing of the ductus arteriosus should be considered in prenatal monitoring. If oligohydramnios or narrowing of the ductus arteriosus is detected, the use of DE-SPAN® should be discontinued.

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

risks to the fetus:

cardiopulmonary toxic syndrome (premature narrowing/closure of the ductus arteriosus and pulmonary hypertension);

renal dysfunction (see above), which may progress to renal failure with the development of oligohydramnios;

Risks at the end of pregnancy for mother and child:

prolongation of bleeding time (effect of inhibiting platelet aggregation), which is possible even when using low doses;

Delayed uterine contractions with corresponding delayed labor and prolonged labor.

Breast-feeding.

There is no data on the penetration of dexketoprofen into breast milk. The drug DE-SPAN® is contraindicated during breastfeeding.

Fertility.

As with all NSAIDs, dexketoprofen trometamol may impair female fertility and is therefore not recommended in women attempting to conceive. If a woman has difficulty conceiving or is undergoing investigation for infertility, discontinuation of the drug should be considered.

Ability to influence reaction speed when driving vehicles or other mechanisms

While using DE-SPAN®, dizziness, visual disturbances or drowsiness may occur. In such cases, the ability to react quickly, navigate the road situation and drive vehicles or other mechanisms may deteriorate.

Method of administration and doses

To minimize adverse reactions, the lowest effective dose should be used for the shortest period of time (see section "Special warnings and precautions for use").

Adults.

The recommended dose is 50 mg every 8–12 hours. If necessary, a second dose should be administered after 6 hours. The maximum daily dose should not exceed 150 mg. The drug is intended for short-term use, therefore it should be used only during acute pain (no longer 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 to severe postoperative pain, the drug can be used according to indications in the same recommended doses in combination with opioid analgesics.

Elderly patients.

Dose adjustment is usually not necessary. However, due to physiological decline in renal function, a lower dose is recommended, with a maximum daily dose of 50 mg in mild renal impairment.

Liver disorders.

For patients with mild to moderate liver disease (Child-Pugh score 5-9), the maximum daily dose should be reduced to 50 mg and liver function should be closely monitored. In severe liver disease (Child-Pugh score 10-15), the drug is contraindicated.

Kidney disorders.

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

Children (including teenagers).

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

Method of application.

Intramuscular injection.

The contents of one ampoule (2 ml) should be slowly injected deep into the muscle.

Intravenous infusion.

For intravenous infusion, the contents of the 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, avoiding exposure to natural daylight. The finished solution should be transparent. The infusion should be carried out within 10–30 minutes.

DE-SPAN®, diluted in 100 ml of 0.9% sodium chloride solution or glucose solution, can be mixed with dopamine, heparin, hydroxyzine, lidocaine, morphine, pethidine and theophylline.

Intravenous injection (bolus administration).

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

DE-SPAN® should not be mixed in small volumes (e.g. in a syringe) with solutions of dopamine, promethazine, pentazocine, pethidine and hydroxyzine, as a precipitate forms.

Diluted infusion solutions should not be mixed with promethazine or pentazocine.

The medicine can only be mixed with the drugs listed above.

For intramuscular or intravenous bolus administration, the drug should be administered immediately after it has been withdrawn from the ampoule.

When storing diluted drug solutions in polyethylene bags or in products made of ethyl vinyl acetate, cellulose propionate, low-density polyethylene, and polyvinyl chloride designed for administration, no changes in the content of the active substance due to sorption were observed.

The drug DE-SPAN® is intended for single use, therefore the remains of the finished solution should be disposed of. Before administering the drug, it is necessary to make sure that the solution is clear and colorless. A solution containing solid particles should not be used.

Children

The medicine should not be used in children (including adolescents) due to a lack of data on its efficacy and safety.

Overdose

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.

Side effects

The table below lists adverse reactions classified by organ system and frequency, the relationship of which to dexketoprofen trometamol, according to clinical studies, is considered at least possible, as well as adverse reactions reported after the drug was put on the market.

MedDRA System Organ Class	Often (≥ 1/100, < 1/10)	Infrequently (≥ 1/1000, <1/100)	Rarely (≥ 1/10000, < 1/1000	Very rare (< 1/10000)
Blood and lymphatic system disorders	–	Anemia	–	Neutropenia, thrombocytopenia
On the part of the immune system	–	–	Swelling of the larynx	Anaphylactic reactions, including anaphylactic shock
Metabolism and metabolic disorders	–	–	Hyperglycemia, hypoglycemia, hypertriglyceridemia, anorexia, lack of appetite	–
From the psyche	–	Insomnia, anxiety	–	–
From the nervous system	–	Headache, dizziness, drowsiness	Paresthesia, fainting	–
From the organs of vision	–	Blurred vision	–	–
From the hearing organs	–	Vertigo	Tingle	–
From the heart	–	Palpitation	Extrasystole, tachycardia	–
From the vascular system	–	Arterial hypotension, hot flashes	Arterial hypertension, superficial vein thrombophlebitis	–
Respiratory, thoracic and mediastinal disorders	–	–	Bradypnoea	Bronchospasm, shortness of breath
Gastrointestinal tract	Nausea, vomiting	Abdominal pain, dyspepsia, diarrhea, constipation, vomiting with blood, dry mouth	Peptic ulcer disease, bleeding or perforation	Pancreatitis
Hepatobiliary system	–	–	Hepatocellular pathology	–
Skin and subcutaneous tissue disorders	–	Dermatitis, itching, rash, increased sweating	Hives, acne	Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), angioedema, facial edema, photosensitivity
Musculoskeletal and connective tissue disorders	–	–	Muscle stiffness, joint stiffness, muscle cramps, back pain	–
Renal and urinary disorders	–	–	Acute renal failure, polyuria, renal pain, ketonuria, proteinuria	Nephritis, nephrotic syndrome
Reproductive system and breast disorders	–	–	Menstrual disorders, prostate dysfunction	–
General disorders	Injection site pain, injection site reactions including inflammation, hematoma, bleeding	Fever, p Specifications Characteristics Active ingredient Dexketoprofen Adults Can ATC code M MEDICINES AFFECTING THE MUSCULOSKOLE SYSTEM; M01 ANTI-INFLAMMATORY AND ANTIRHEUMATIC MEDICINES; M01A NON-STEROIDAL ANTI-INFLAMMATORY AND ANTIRHEUMATIC MEDICINES; M01A E Propionic acid derivatives; M01A E17 Dexketoprofen Country of manufacture Ukraine Diabetics With caution Dosage 25 mg/ml Drivers With caution For allergies With caution For children It is impossible. Form Ampoules Method of application Injections Nursing It is impossible. Pregnant In case of emergency in the 1st and 2nd trimesters of pregnancy Primary packaging ampoule Producer Mikrohim LLC NVF Quantity per package 10 ampoules Trade name De-span Vacation conditions By prescription Reviews There are no reviews for this product. + Add review Write a review De-Span solution for injection 25 mg/ml ampoule 2 ml cassette No. 10 My mark: Continue There are no reviews for this product, be the first to leave your review. Answers & questions Add your question and we will answer as soon as possible. + Ask a question Ask a question Add your question and we will answer as soon as possible. * Your question Continue No questions about this product, be the first and ask your question. You are watched new Hit Bupivacaine-ZN solution for injection 5 mg/ml ampoule 5 ml No. 10 In stock 0 588.25 грн. Add to Cart new Hit Movixikam solution for injection 15 mg/1.5 ml ampoule No. 5 In stock 0 450.81 грн. Add to Cart new Hit Dermazol shampoo 20 mg/ml sachet 8 ml No. 20 In stock 0 800.93 грн. Add to Cart new Hit Marcaine solution for injection 5 mg/ml bottle 20 ml No. 5 In stock 0 625.00 грн. Add to Cart new Hit Keiver solution for injection 50 mg/2 ml ampoule 2 ml No. 5 In stock 0 445.92 грн. Add to Cart new Hit Inoseda syrup 250mg/5ml 120 ml In stock 0 498.70 грн. Add to Cart