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Instruction for use: Flamadex

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Active substance Dexketoprofen

ATX code M01AE17 Dexketoprofen

Pharmacological group

Non-steroidal anti-inflammatory drugs (NSAIDs) [NSAIDs - Propionic acid derivatives]

Nosological classification (ICD-10)

C79.5 Secondary malignant neoplasm of bone and bone marrow

Bone metastasis, Metastatic bones tumors Metastases in the bone, Metastatic bone damage

K08.8.0 * Painful toothache

Dentinal pain, Dentinal pains, Pain pulpitis, Anesthesia in dentistry, Pain syndromes in dental practice, Pain after removal of tartar, Pain when extracting a tooth, Toothache, Pain after dental interventions

M02 Reactive arthropathy

Reactive arthritis

M06.9 Other specified rheumatoid arthritis

Rheumatoid arthritis,Pain syndrome in rheumatic diseases, Pain in rheumatoid arthritis, Inflammation in rheumatoid arthritis, Degenerative forms of rheumatoid arthritis, Children's rheumatoid arthritis, Exacerbation of rheumatoid arthritis, Acute articular rheumatism, Rheumatic arthritis, Rheumatic polyarthritis, Rheumatoid arthritis, Rheumatic polyarthritis, Rheumatoid arthritis, Rheumatoid arthritis of active course, Rheumatoid arthritis, Rheumatoid polyarthritis, Acute rheumatoid arthritis, Acute rheumatism

M07.3 Other psoriatic arthropathies (L40.5 +)

Arthritis psoriatic, The generalized form of psoriatic arthritis, Psoriatic arthritis

M10.9 Gout, unspecified

Arthritis Gouty, Acute gouty arthritis, Acute attack of gout, Gouty Arthritis, Articular syndrome with exacerbation of gout, Articular syndrome with gout, Urarturia, Chronic arthritic arthritis, Acute gout, Salt diathesis

M13.9 Arthritis, unspecified

Arthritis,Purulent arthritis (non-infectious), acute Arthritis,Pain in acute inflammatory diseases of the musculoskeletal system,Pain in chronic inflammatory diseases of the musculoskeletal system,The pain in osteoarthritis, Inflammation in osteoarthritis, Inflammatory arthropathy, Inflammatory and degenerative joint diseases, Inflammatory disease of the musculoskeletal system, Inflammatory joint disease, Inflammatory diseases of the musculoskeletal system, destructive arthritis, The disease of the musculoskeletal system, Diseases of the musculoskeletal system, Diseases of the musculoskeletal system and connective tissue, Infections musculoskeletal system, monoartrit, Non-infectious arthritis, rheumatic arthritis, Osteoarthritis, Acute inflammation of the musculoskeletal tissue, Acute inflammatory diseases of the musculoskeletal system, Acute inflammatory condition of the musculoskeletal system, Acute arthritis, Acute osteoarthritis, Post-traumatic osteoarthritis, Reactive arthritis, Chronic inflammatory diseases of the joints, Chronic arthritis, Chronic inflammatory arthritis, Chronic inflammation of the inner layer of the joint capsule, Chronic inflammation of the joint capsule,Chronic inflammatory disease of the joints, Exudative arthritis

M19.9 Arthrosis, unspecified

Change in brush with osteoarthritis, Osteoarthritis, Osteoarthrosis, Arthrosis of large joints, Pain syndrome in osteoarthritis, Pain syndrome in acute inflammatory diseases of the musculoskeletal system, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Deforming arthrosis, Deforming osteoarthritis, Deforming osteoarthritis of joints, Osteoarthritis in the acute stage, Osteoarthritis of large joints, Acute pain syndrome with osteoarthritis, Post-traumatic osteoarthritis, Rheumatic osteoarthritis, Spondylarthrosis, Chronic osteoarthritis

M25.5 Pain in the joint

Arthralgia, Pain syndrome in musculo-articular diseases, Pain syndrome in osteoarthritis, Pain syndrome in osteoarthritis, Pain syndrome in acute inflammatory diseases of the musculoskeletal system, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Pain in the joints, Soreness of the joints, Soreness of joints in severe physical exertion, Painful inflammatory joint damage, Painful conditions of the musculoskeletal system, Painful joint conditions, Painful traumatic affection of joints, Pain in the musculoskeletal system, Pain in Shoulder Joints, Pain in the joints, Joint pain, Joint pain with injuries, Musculoskeletal pain, Pain with osteoarthritis, Pain in the pathology of the joints, Pain in rheumatoid arthritis, Pain in chronic degenerative bone diseases, Pain in chronic degenerative joint diseases, Bone-joint pain, Joint pain, Arthritic pain of rheumatic origin, Articular pain syndrome, Joint pain, Rheumatic pain, Rheumatic pains

M45 Ankylosing spondylitis

Ankylosing spondylarthrosis, Marie-Strumpel disease, Ankylosing spondylitis, Pain syndrome in acute inflammatory diseases of the musculoskeletal system, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Bechterew's disease, Ankylosing spondylitis, Diseases of the spinal column, Rheumatic spondylitis, Bechterew-Marie-Strumpel disease

M47.9 Spondylosis, unspecified

Deforming spondylosis, Diseases of the spine, Spondyloarthritis, Seronegative spondylitis, Spondylarthrosis

M54.9 Dorsalgia, unspecified

Pain syndrome with radiculitis, Pain syndrome in the back,Pain with radiculitis, Degenerative changes in the spine, Degenerative and dystrophic disease of the spine and joints, Degenerative disease of the spine, Osteoarthrosis of the spine, Painful lesions of the spine

M79.2 Neurology and neuritis, unspecified

Pain syndrome with neuralgia, Brachialgia, Occipital and intercostal neuralgia, Neuralgia, Neuralgic pain, Neuralgia, Neuralgia of intercostal nerves,Neuralgia of the posterior tibial nerve, Neuritis, Neuritis traumatic, Neuritis, Neurological Pain Syndromes, Neurological contractures with spasms, Acute neuritis, Peripheral neuritis,Post-traumatic neuralgia,Severe pain of a neurogenic nature, Chronic neuritis, Essential neuralgia

N23 Renal colic unspecified

Pain in renal colic, Pain smooth muscle spasm, Pain spasm of smooth muscles (renal and biliary colic, intestinal spasms, dysmenorrhea), Pain spasm of smooth muscles of internal organs, Pain spasm of smooth muscles of internal organs (kidney and biliary colic, intestinal spasms, dysmenorrhea), renal Colic, ureteral colic, Renal colic, Renal colic with urolithiasis, Kidney disease, Spasm of smooth muscle in diseases of the urinary system, The spasm of the urinary tract, The spasm of the ureter, The spasm of the ureters, Spasms of the urinary tract, Spasms of the urinary tract

N94.6 Dysmenorrhea Unspecified

Pain during menstruation, Functional disorders of the menstrual cycle, Menstrual cramps, Emmeniopathy, Pain during menstruation, Painful menstrual irregularities, algomenorrhea, algomenoreya, Pain smooth muscle spasm, Pain spasm of smooth muscles (renal and biliary colic, intestinal spasms, dysmenorrhea), Pain spasm of smooth muscles of internal organs (kidney and biliary colic, intestinal spasms, dysmenorrhea), Disalgomenoreya, dysmenorrhea, Dysmenorrhea (essential) (Exfoliative), menstrual disorder, menstruation painful, metrorrhagia, Violation of the menstrual cycle, Menstrual irregularities, Prolaktinzavisimoe menstrual disorders, Prolaktinzavisimoe menstrual dysfunction, Pain spasm of smooth muscles of internal organs, Spasmodic dysmenorrhea, Primary disalgomenoreya

R52.0 Acute pain

Acute pain syndrome, Acute pain syndrome with osteoarthritis, Acute pain syndrome of traumatic origin, Severe pain of a neurogenic nature, Severe pain, Pain syndrome at delivery

R52.1 Constant unrestrained pain

Pain syndrome in oncology practice, Pain syndrome pronounced, Pain syndrome in malignant neoplasms, Pain syndrome in cancer, Pain syndrome with tumors, Pain syndrome in cancer patients, Pain in malignant neoplasms, Pain in malignant tumors, Pain in tumors, Pain in cancer patients, Pain in bone metastases, Pain in cancer, Malignant pain syndrome, Intensive chronic pain, Intensive pain syndrome, Intensive non-curable pain syndrome, Intensive chronic pain syndrome, Unrestrained pain, Unrestrained pain, Tumor pain, Post-traumatic pain syndrome, Severe pain, Chronic pain, Chronic Pain Syndrome

R52.2 Other constant pain

Pain syndrome, rheumatic origin, Pain at vertebral lesions, Pain in the chamber, Pain for burns, Pain syndrome weak or moderate, Perioperative pain,Moderate to severe pain, Moderately or weakly expressed pain syndrome, Moderate to severe pain, Ear pain of otitis, Neuropathic pain, neuropathic pain

R68.8.0 * Inflammatory syndrome

Painful syndrome of inflammatory genesis, Pain syndrome with inflammation of non-rheumatic nature, Pain syndrome with inflammatory lesions of the peripheral nervous system, Painful inflammation of the shoulder joint, Painful inflammation after trauma or surgery, Painful inflammation after surgery, Painful hemorrhoids, Inflammation of the tympanic membrane, Inflammation of the larynx, Inflammation of the gums, Inflammation of cellulose, Inflammation of lymph nodes, Tonsillitis, Inflammation of muscles, Inflammation of soft tissues, Inflammation of the mouth, Inflammation after surgery and trauma, Inflammation after orthopedic surgery, Inflammation after trauma, Inflammation in rheumatoid arthritis, Inflammation of the middle ear, Inflammatory gum disease, Inflammatory diseases of the eyelids, Inflammatory eye diseases, Inflammatory swelling of soft tissues, Inflammatory processes, Inflammatory processes after surgical interventions, Inflammatory process, Inflammatory Syndrome, Inflammatory syndrome of non-rheumatic origin, Inflammatory syndrome after surgery, Purulent infections, Infringements of function of a liver of an inflammatory etiology, Acute inflammation of the musculoskeletal tissue, Pre-inflammatory soft tissue inflammation

T14.9 Injury unspecified

Pain syndrome after trauma, Pain syndrome with injuries, Pain syndrome with trauma and after surgery, Pain in case of injury, Pain of a traumatic nature, Joint pain with injuries, Postoperative and post-traumatic pain, Pain in case of injury, Pain of a traumatic origin, Severe pain syndrome of traumatic origin, Deep tissue damage, Deep scratches on the trunk, Closed injury, Minor Household Injuries, Minor skin damage, Violations of the integrity of soft tissues, Uncomplicated trauma, Extensive traumatic injury, Acute pain syndrome of traumatic origin, Edema with trauma, Postponed sports injuries, Post-traumatic pain, Soft tissue injuries, Joint wounds, Sports injuries, Injury, Traumatic pain, Traumatic pains, Traumatic infiltrate,Injuries to sports

T88.9 Complication of surgical and medical care, unspecified

Pain in the postoperative period, Pain in the postoperative period after orthopedic surgery, Pain syndrome after diagnostic procedures, Pain after surgery Diagnostic, Pain after surgery, Pain after orthopedic surgery, Pain after the removal of hemorrhoids, Pain in the application of excimer laser, Pain with injuries and after surgical interventions, Pain syndromes in the dental practice, Painful diagnostic intervention, Painful diagnostic manipulations, Painful instrumental diagnostic procedures, Painful instrumental manipulation, Painful treatments, Painful manipulations, Painful dressings, Painful therapeutic interventions, Pain in the area of the surgical wound, Pain in the postoperative period, Pain after diagnostic procedures, Pain after orthopedic surgery, Pain during diagnostic procedures, Pain during therapeutic procedures, Pain in orthopedics, The pain in the postoperative period, Pain after diagnostic procedures, The pain after sclerotherapy, The pain after dental surgery, postoperative Pain, Pain postoperative and posttraumatic, The pain of tooth extraction, Inflammation after surgery or injury, Inflammation after orthopedic surgery, Inflammation after surgery, The inflammatory syndrome after surgery, Festering postoperative fistula, Operating wound, Complications after tooth extraction

Composition

Solution for intravenous and intramuscular injection 1 amp. (2 ml)

active substance:

dexketoprofen trometamol (in terms of dexketoprofen) 50 mg

auxiliary substances: ethanol (ethyl alcohol 95% in terms of 100% substance) - 200.0 mg; sodium chloride - 8 mg; sodium disulfite - 2 mg; sodium hydroxide - up to pH 6.5-8.5; water for injection - up to 2 ml

Description of dosage form

A clear, colorless solution.

pharmachologic effect

Pharmacological action - anti-inflammatory, analgesic.

Pharmacodynamics

NSAIDs (non-steroidal anti-inflammatory drugs), a derivative of propionic acid. Has analgesic, anti-inflammatory and antipyretic effect. The mechanism of action is associated with inhibition of PG synthesis at the level of COX-1 and COX-2.

The analgesic effect occurs 30 minutes after parenteral administration.

The duration of analgesic effect after the administration of a dose of 50 mg is about 4-8 hours.

With combined therapy with opioid analgesics, dexketoprofen significantly (up to 30-45%) reduces the need for opioids.

Pharmacokinetics

Suction. After the / m administration of dexketoprofen Cmax in the blood serum is achieved on average after 20 min (10-45 min). AUC after a single injection in a dose of 25-50 mg is proportional to the dose, both with / m and with iv introduction. The corresponding pharmacokinetic parameters are similar after a single and repeated IM or IV injection, which indicates the absence of cumulation of the drug.

Distribution. Dexketoprofen is characterized by a high level of binding to plasma proteins (99%). The average value of Vd is less than 0.25 l / kg, half-distribution time is about 0.35 h.

Excretion. The metabolism of dexketoprofen mainly occurs by conjugation with glucuronic acid, followed by excretion by the kidneys. T1 / 2 dexketoprofen trometamol is about 1-2 hours.

Pharmacokinetics in special clinical cases

In the elderly, there is an increase in the duration of T1 / 2 (either after a single dose, or after repeated IM or IV injection) on average to 48% and a decrease in the overall clearance of the drug.

Indications

The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use in the following diseases and conditions:

relief of pain syndrome of various genesis (including postoperative pain, bone metastases, posttraumatic pain, pain in renal colic, algodismenorea, sciatica, radiculitis, neuralgia, toothache);

symptomatic treatment of acute and chronic inflammatory, inflammatory-degenerative and metabolic diseases of the musculoskeletal system (including rheumatoid arthritis, osteoarthritis, spondyloarthritis: ankylosing spondylitis, reactive arthritis, psoriatic arthritis).

On the progression of the disease is not affected.

Contraindications

hypersensitivity to dexketoprofen or other NSAIDs, or any of the excipients that make up the drug (including sulfites);

complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including in the anamnesis);

erosive and ulcerative lesions of the gastrointestinal tract and duodenum;

gastrointestinal hemorrhages in anamnesis, other active bleeding (including suspicion of intracranial bleeding), anticoagulant therapy;

inflammatory bowel disease (ulcerative colitis, Crohn's disease) in the stage of exacerbation;

severe violations of the liver (10-15 points on the scale Child-Pugh);

progressive kidney disease, severe renal dysfunction (Cl creatinine less than 30 mL / min);

confirmed hyperkalemia;

Decompensated heart failure;

period after aortocoronary shunting;

hemophilia and other disorders of blood clotting;

Neuroaxial (epidural or intrathecal) administration (presence of ethanol in the formulation);

pregnancy;

the period of breastfeeding;

children and adolescence up to 18 years.

With caution: peptic ulcer of the stomach and duodenum; ulcerative colitis; Crohn's disease; liver disease in history; hepatic porphyria; chronic renal failure (Cl creatinine 30-60 ml / min); chronic heart failure; arterial hypertension; a significant decrease in BCC (including after surgery); elderly patients (including those receiving diuretics, weakened patients and with low body weight); bronchial asthma; simultaneous reception of GCS (including prednisolone), anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), SSRIs (including citalopram, fluoxetine, paroxetine, sertraline) , cardiac ischemia; cerebrovascular diseases; dyslipidemia / hyperlipidemia; diabetes; diseases of peripheral arteries; smoking; presence of Helicobacter pylori infection; systemic connective tissue diseases; long-term use of NSAIDs; tuberculosis; severe osteoporosis; alcoholism, severe physical illness.

pregnancy and lactation

The use of Flamadex® during pregnancy and during lactation is contraindicated.

Side effects

Frequency of development of side effects: often (1-10%); infrequently (0.1-1%); rarely (0.01-0.1%); very rarely (less than 0.01%, including individual reports).

From the hemopoietic system: rarely - anemia; very rarely - neutropenia, thrombocytopenia.

From the side of the central nervous system: infrequently - headache, dizziness, insomnia, drowsiness; rarely - paresthesia.

From the senses: infrequently - blurred vision; rarely - noise in the ears.

From the CCC: infrequently - arterial hypotension, a feeling of heat, hyperemia of the skin; rarely - extrasystole, tachycardia, arterial hypertension, peripheral edema, superficial thrombophlebitis.

From the respiratory system: rarely - bradypnoe; very rarely - bronchospasm, dyspnoea.

On the part of the digestive system: often - nausea, vomiting; infrequently - abdominal pain, dyspepsia, diarrhea, constipation, hematemesis, dry mouth; rarely - erosive and ulcerative lesions of the digestive tract, including bleeding and perforation, anorexia, increased activity of hepatic enzymes, jaundice; very rarely - the defeat of the pancreas, liver damage.

From the urinary system: rarely - polyuria, renal colic; very rarely - nephritis or nephrotic syndrome.

On the part of the reproductive system: rarely - a menstrual cycle (in women), a violation of the function of the prostate (in men).

From the musculoskeletal system: rarely - muscle spasm, difficulty in movement in the joints.

Dermatological reactions: sometimes - dermatitis, rash, sweating; rarely - acne; very rarely photosensitization.

Allergic reactions: rarely - hives; very rarely - severe skin reactions (Stevens-Johnson syndrome, Lyell's syndrome), angioedema, allergic dermatitis.

From the side of metabolism: rarely - hyperglycemia, hypoglycemia, hypertriglyceridemia.

On the part of laboratory indicators: rarely - ketonuria, proteinuria.

Local and general reactions: often - pain at the injection site; infrequently - inflammatory reaction, hematoma, hemorrhages at the injection site, a feeling of heat, chills, fatigue; rarely - back pain, fainting, fever; very rarely - anaphylactic shock, swelling of the face.

Other: Aseptic meningitis, which occurs mainly in patients with systemic lupus erythematosus or mixed connective tissue diseases, hematologic disorders (purpura, aplastic and hemolytic anemia, rarely - agranulocytosis and bone marrow hypoplasia).

Interaction

Common types of interaction characteristic of all NSAIDs, including dexketoprofen.

Unwanted combinations

- with other NSAIDs, including salicylates in high doses (> 3 g / day): simultaneous application of several NSAIDs increases the risk of gastrointestinal bleeding and ulcers;

- oral anticoagulants, heparin in doses exceeding the preventive;

- ticlopidine (increased risk of bleeding due to inhibition of platelet aggregation and lesions of the mucous membrane of the digestive tract);

- Lithium preparations - NSAIDs increase the concentration of lithium in the blood plasma (decrease in renal lithium excretion), which can reach toxic levels, so the level of lithium in the blood should be monitored in the appointment, changing the dose or canceling dexketoprofen;

- Methotrexate in high (at least 15 mg / week) doses - the toxicity of methotrexate is increased due to a decrease in its renal clearance when using NSAIDs;

- SCS: increased risk of ulcers and gastrointestinal bleeding;

- derivatives of hydantoin and sulfonamides: the severity of their toxic manifestations may increase.

Combinations that require caution

- with diuretics, ACE inhibitors, antibacterial drugs from the group of aminoglycosides and ARA II. Dexketoprofen weakens the action of diuretics and other antihypertensive agents. Treatment with NSAIDs is associated with a risk of developing acute renal failure in patients with dehydration (decreased glomerular filtration due to reduced GH synthesis). With the combined use of dexketoprofen and diuretics, you should ensure adequate hydration of the patient and control the function of the kidneys before the appointment;

- Methotrexate in low (less than 15 mg / week) doses - the hematologic toxicity of methotrexate is increased due to a decrease in its renal clearance when using NSAIDs. Weekly monitoring of the blood picture in the first weeks of combined treatment should be performed. In the presence of even minor violations of kidney function, as well as in the elderly, careful monitoring is necessary;

- pentoxifylline - the risk of bleeding increases. It requires active clinical monitoring and frequent monitoring of bleeding time or clotting time;

- zidovudine - there may be a toxic effect of zidovudine on reticulocytes, which after the first week of NSAID use may lead to the development of severe anemia. It is necessary to count blood cells and reticulocytes 1-2 weeks after the beginning of the combined treatment;

- oral hypoglycemic drugs - in view of the possible increase in hypoglycemic effects in connection with the ability of NSAIDs to displace them from the binding sites with plasma proteins.

Combinations that need to be considered

- with β-adrenoblockers - it is possible to reduce their antihypertensive effect in connection with the suppression of NSAIDs in the synthesis of PG;

- cyclosporin and tacrolimus: it is possible to enhance their nephrotoxicity, due to the effect of NSAIDs on renal PG. When performing combined therapy, it is necessary to monitor kidney function;

- thrombolytic drugs - increased risk of bleeding;

- probenecid: an increase in the concentration of dexketoprofen in the blood plasma is possible, which may be due to the inhibitory effect on tubular secretion and / or conjugation with glucuronic acid and requires correction of the dose of dexketoprofen;

- cardiac glycosides - NSAIDs can lead to an increase in their concentration in the blood plasma;

- mifepristone - in connection with the theoretical risk of changing the effectiveness of mifepristone under the influence of inhibitors of the synthesis of PG, NSAIDs should be administered 8-12 days after taking mifepristone;

- antibiotics of the quinolone series: a high risk of seizures when using NSAIDs in combination with high doses of quinolones.

Pharmaceutical interaction

Flamadex® should not be mixed in a single syringe with a solution of dopamine, promethazine, pentazocine, pethidine or hydroxyzine (a precipitate is formed).

Flamadex® can be mixed in one syringe with a solution of heparin, lidocaine, morphine and theophylline.

A prepared solution of the preparation Flamadex® for IV administration of drip administration can not be mixed with prometazine or pentazocine.

The prepared Flamadex® solution is compatible with the following injectable solutions: dopamine, heparin, hydroxyzine, lidocaine, morphine, pethidine and theophylline.

Dosing and Administration

Intramuscularly (intramuscularly) (deep, slow), intravenously (intravenously) in jet (slow, not less than 15 s) or drip (10-30 min).

The recommended adult dose is 50 mg every 8-12 hours. If necessary, repeated administration of the drug with a 6-hour interval is possible. The daily dose should not exceed 150 mg. Flamadex® is indicated for short-term use, and treatment should be limited to a period of acute symptoms (no more than 2 days).

Violation of the function of the liver. In patients with mild to moderate liver function impairment (5-9 points on the Child-Pugh scale), the total daily dose should be reduced to 50 mg and frequent monitoring of liver functional parameters. Flamadex® should not be administered to patients with severe liver dysfunction.

Impaired renal function. For patients with mild renal impairment (Cl creatinine 30-60 ml / min), the daily dose is reduced to 50 mg.

Flamadex® should not be given to patients with moderate or severe renal failure (Cl creatinine less than 30 mL / min).

Patients of advanced age. Dose adjustment for elderly patients is usually not required, but in connection with the physiological decline in kidney function, it is recommended to reduce the dose of the drug: a total daily dose of 50 mg for mild renal impairment in elderly patients.

Rules for the preparation of solutions.

To prepare a solution of Flamadex ® for intravenous infusion, the contents of 1 amp. (2 ml) is diluted in 30-100 ml of 0.9% solution of sodium chloride, glucose solution or Ringer's solution. The solution should be prepared in aseptic conditions, protecting from exposure to daylight. The prepared solution must be clear and colorless.

Overdose

Symptoms: cases of overdose are not described. Possible development of vomiting, anorexia, abdominal pain, dizziness, disorientation, headache, drowsiness.

Treatment: symptomatic therapy; if necessary, hemodialysis.

special instructions

Flamadex® should be used with caution in patients with an allergy in history. In persons with symptoms of gastrointestinal disorders or with gastrointestinal diseases in the anamnesis, a doctor's supervision is required, especially with gastrointestinal bleeding. In cases of gastrointestinal bleeding in patients taking dexketoprofen, the drug is immediately withdrawn.

Caution is advised to prescribe the drug to patients taking drugs at the same time that may increase the risk of ulcers or bleeding: corticosteroids, anticoagulants (eg warfarin), SSRIs or antiplatelet agents (including acetylsalicylic acid).

Dexketoprofen can cause reversible inhibition of platelet aggregation and increase bleeding time.

Flamadex® should be used with caution in patients with CHF I-II functional classes according to NYHA.

Similarly to other NSAIDs, Flamadex® can cause an increase in the level of creatinine and nitrogen in the blood plasma, have a negative effect on the urinary system, leading to the development of glomerulonephritis, interstitial nephritis, papillary necrosis, nephrotic syndrome and acute renal failure. As with other NSAIDs, there may be a slight transient increase in some liver samples, a significant increase in the activity of ACT and ALT in the serum. At the same time, control of liver and kidney functions is necessary in elderly patients. In the case of a significant increase in the relevant indicators, Flamadex® should be discontinued.

Flamadex® should be used with caution in patients with impaired hematopoiesis, in patients with systemic lupus erythematosus or other connective tissue diseases.

Like other NSAIDs, Flamadex® can mask the symptoms of infectious diseases. Single cases of exacerbation of infectious processes localized in soft tissues during the application of NSAIDs have been reported. Therefore, medical supervision of patients with signs of bacterial infection or deterioration during treatment with dexketoprofen is required.

Care should be taken when prescribing the drug to patients with impaired liver, kidney, heart, or with conditions that can cause fluid retention in the body. In these patients, the use of NSAIDs may lead to impairment and fluid retention in the body. Care should also be taken when prescribing dexketoprofen to patients who use diuretics or are prone to hypovolemia, because they have a greater risk of developing nephrotoxicity.

Caution is necessary when prescribing the drug to the elderly, because they are more likely to detect violations of the kidneys, liver or CCC, as well as the occurrence of unwanted reactions, such as gastrointestinal bleeding or intestinal perforation. Each ampoule of Flamadex® contains 200 mg of ethanol.

Impact on the ability to drive vehicles and other mechanisms that require increased concentration of attention. In connection with the possible dizziness and drowsiness against the background of treatment with Flamadex®, a decrease in the ability to concentrate attention and speed of psychomotor reactions is possible.

Form of issue

Solution for intravenous and intramuscular administration, 25 mg / ml. 2 ml per ampoule of light-protective glass with a color fracture ring or with a colored dot and a notch.

Ampoules are additionally applied with 1, 2 or 3 color rings and / or a two-dimensional barcode, and / or alphanumeric coding or without additional color rings, a two-dimensional barcode, alphanumeric coding. At 5 amp. in a planar cell box made of PVC film and aluminum foil or polymer film or without foil and film.

1 or 2 contour squares are placed in a pack of cardboard.

Conditions of leave from pharmacies

On prescription.

Storage conditions

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life

solution for intravenous and intramuscular administration of 25 mg / ml - 2 years.

Do not use after the expiry date printed on the package.

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