Ketoprofen-LF solution for intravenous and intramuscular administration 100mg/2ml in ampoules No. 5×2

Name:
Ketoprofen-LF solution for i.v. and i.m. in unitary enterprise No. 5х2
Description:
Transparent colorless or yellowish solution. The main active ingredient Ketoprofen Release form Solution for injection Dosage 50 mg / ml Indications for use Symptomatic treatment of pain in inflammatory diseases of the musculoskeletal system. Dosage and administration For parenteral use. The maximum daily dose is 200 mg per day. It is not recommended to prescribe injections for longer than 3 days. If necessary, treatment is continued with other dosage forms of ketoprofen. Intramuscular administration One ampoule (100 mg) 1-2 times a day. Can be combined with ketoprofen for oral, rectal or transdermal use. Intravenous administration Infusion must be carried out in a hospital, the duration of the infusion is 0.5-1 hour. Infusion can be carried out no more than 2 days in a row. Short-term intravenous infusion: 100-200 mg of ketoprofen, diluted in 100 ml of 0.9% sodium chloride solution, is administered over 0.5-1 hour. Long-term intravenous infusion: 100-200 mg of ketoprofen diluted in 500 ml of solution for infusion (0.9% sodium chloride solution, Ringer’s lactate, glucose) is administered over 8 hours. Ketoprofen can be combined with centrally acting analgesics. It can be mixed in one vial with morphine: 10-20 mg of morphine and 100 mg (up to 200 mg) of ketoprofen are diluted with 500 ml of 0.9% sodium chloride solution or Ringer’s lactate solution. To reduce the risk of adverse reactions, it is recommended to use the minimum therapeutically effective dose for the shortest possible time. The maximum daily dose of ketoprofen (regardless of dosage form) is 200 mg. Before starting treatment at a dose of 200 mg of ketoprofen per day, the benefits and possible risks should be carefully weighed. The use of higher doses is not recommended. Elderly patients are advised to start treatment with the lowest effective dose in order to reduce the incidence of side effects, since in these patients adverse reactions can more often have severe consequences. Patients with impaired renal function In patients with mild renal impairment (CC < 20 ml / min = 0.33 ml / s), the dose of ketoprofen is reduced. Ketoprofen is contraindicated in patients with severe renal impairment. Patients with impaired liver function In patients with chronic liver disease with reduced serum albumin, the dose of ketoprofen should be reduced. Ketoprofen is contraindicated in patients with severe hepatic impairment. Children The safety and efficacy of ketoprofen in children has not been studied. Caution: do not mix tramadol and ketoprofen in the same infusion fluid due to sedimentation. Infusion vials should be wrapped in black paper or aluminum foil to protect from light. Use during pregnancy and lactation Inhibition of prostaglandin synthesis may have a negative effect on pregnancy and / or development of the embryo / fetus. The use of prostaglandin synthesis inhibitors in early pregnancy is associated with an increased risk of miscarriage, the development of heart defects and gastroschisis. The absolute risk of developing congenital malformations of the cardiovascular system increases from < 1% to 1.5%. Presumably the risk increases with increasing dose and duration of treatment. In the first or second trimester of pregnancy, ketoprofen should not be prescribed unless absolutely necessary. If ketoprofen is used by a woman trying to conceive either in the first or second trimester of pregnancy, the dose should be as low as possible and the duration of treatment as short as possible. In the third trimester of pregnancy, all inhibitors of prostaglandin synthesis can have the following effects on the fetus: cardiopulmonary toxicity (with premature fusion of the Botalla duct and the development of pulmonary hypertension); impaired renal function, up to the development of renal failure with oligohydramnios. At the end of pregnancy, prostaglandin synthesis inhibitors can affect the mother and the newborn as follows: the likelihood of prolonged bleeding time - an antiplatelet effect that can be observed even with very low doses of the drug; inhibition of the contractile activity of the uterus, leading to a delay in the onset of labor and their lengthening. The use of ketoprofen in the third trimester of pregnancy is contraindicated. If it is necessary to use Ketoprofen-LF during lactation, it is recommended to stop breastfeeding, since there are no data on the penetration of Ketoprofen into milk. Not recommended for nursing mothers. Precautions Avoid the use of the drug in combination with other NSAIDs, including selective COX-2 inhibitors. The severity of side effects can be reduced by using the minimum effective dose for the minimum time necessary to improve the condition. Elderly patients are more likely to experience adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal. Bleeding, ulcers and perforation of the gastrointestinal tract Gastrointestinal bleeding, formation or perforation of an ulcer, in some cases with a fatal outcome, were noted for all NSAIDs at different stages of treatment, regardless of the presence of precursor symptoms or a history of serious pathology from the gastrointestinal tract. According to epidemiological data, the use of ketoprofen may be associated with a high risk of severe gastrointestinal toxicity, which is typical for some other NSAIDs, especially when taking high doses. The risk of gastrointestinal bleeding, ulcer formation or perforation increases with increasing dose of NSAIDs in patients with a history of ulcer, especially complicated by bleeding or perforation, as well as in elderly patients. In this case, treatment begins with a minimum dose. For these patients, as well as for patients taking low doses of acetylsalicylic acid or other drugs that increase the risk of complications from the gastrointestinal tract, combination therapy with protective drugs, such as misoprostol or proton pump inhibitors, should be considered. Patients with a history of gastrointestinal toxicity, especially elderly patients, should report all unusual symptoms to the doctor, especially in the initial stages of treatment. With extreme caution, the drug is prescribed to patients who simultaneously use drugs that may increase the risk of ulcers or bleeding: oral corticosteroids, anticoagulants (for example, warfarin), selective serotonin reuptake inhibitors, or antiplatelet agents such as aspirin. With the development of gastrointestinal bleeding, the use of the drug should be discontinued. NSAIDs are prescribed with caution to patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease), as exacerbations of these diseases may occur. The relative risk of developing gastrointestinal bleeding increases in patients with low weight, with the development of bleeding, treatment should be discontinued immediately. Cardiovascular and cerebrovascular effects Patients with arterial hypertension and / or congestive heart failure of mild to moderate severity require appropriate monitoring and consultation, since fluid retention and edema have been reported with the use of NSAIDs. According to the results of clinical studies and epidemiological data, the use of some NSAIDs, especially at high doses and for a long time, may be accompanied by an increased risk of arterial thrombosis, such as myocardial infarction or stroke. There are not enough data to exclude such a danger when using ketoprofen. Patients with asthma associated with chronic allergic rhinitis, chronic allergic sinusitis and/or nasal polyps are at high risk of allergy to aspirin and/or NSAIDs. The use of ketoprofen may cause asthma attacks or bronchospasm, especially in patients allergic to aspirin or NSAIDs. It is necessary to monitor renal function at the beginning of treatment in patients with heart failure, liver cirrhosis and impaired liver function, especially in patients taking diuretics, patients with chronic renal failure, especially in elderly patients. In these patients, ketoprofen may cause a decrease in renal blood flow due to inhibition of prostaglandins and lead to renal failure. In patients with impaired liver function, it is necessary to regularly evaluate the level of transaminases, especially with prolonged therapy. Treatment should be discontinued if visual disturbances such as blurred vision occur. Be wary appoint persons suffering from alcohol dependence. Extremely rare cases of serious skin reactions (some fatal) have been reported with NSAIDs, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis. Patients are most at risk during the first month of treatment. If a skin rash, signs of mucosal damage or other symptoms of hypersensitivity appear, the drug should be discontinued. With prolonged treatment, it is necessary to control the number of blood cells, as well as the function of the liver and kidneys. Like other NSAIDs, ketoprofen, due to its anti-inflammatory, antipyretic or analgesic effect, may mask symptoms of infection progression, such as fever. Before extensive surgery, the drug must be discontinued. With hyperkalemia due to diabetes or concomitant therapy with potassium-sparing drugs, it is necessary to regularly monitor the level of potassium. For severe pain, ketoprofen can be used in combination with morphine. The use of NSAIDs may impair female fertility and the use of NSAIDs in women who are planning to become pregnant is not recommended. In women who have difficulty becoming pregnant or who are being investigated for infertility, discontinuation of ketoprofen should be considered. Excipients The solution contains about 8% ethanol by volume, i.e. up to 197.2 mg / ampoule of ethanol, which corresponds to 4 ml of beer or 1.6 ml of wine. The drug may adversely affect persons suffering from alcoholism. The ethanol content should be taken into account when prescribing the drug during pregnancy and lactation, children and patients at risk, for example, with liver diseases, as well as those suffering from epilepsy. Due to the content of benzyl alcohol, the drug should not be prescribed to premature babies or newborns, benzyl alcohol can cause toxic and anaphylactoid reactions in children under the age of three years. Propylene glycol at doses of 400 mg/kg in adults and 200 mg/kg in children can cause symptoms similar to those caused by alcohol consumption. The preparation contains sodium in an amount of less than 1 mmol/ampoule and is therefore considered to be sodium-free. Therapy with the injectable form of ketoprofen should be carried out under close medical supervision. When eliminating acute pain, it is advisable to switch to other dosage forms that are less likely to cause serious adverse reactions. Intramuscular administration for long periods is recommended in a hospital under medical supervision. Interaction with other drugs Undesirable combinations With other NSAIDs, including salicylates in high doses, selective COX-2 inhibitors: risk of gastrointestinal bleeding and ulcers. Anticoagulants (heparin, warfarin) and inhibitors of platelet aggregation (ticlopidine, clopidogrel, etc.): increased risk of bleeding. If necessary, joint use requires close medical supervision. Lithium: the risk of an increase in the level of lithium in plasma, up to toxic due to a decrease in the excretion of lithium by the kidneys, and therefore this indicator must be monitored when prescribing, changing the dose and after discontinuing NSAIDs. Methotrexate at doses greater than 15 mg/week: increased hematological toxicity of methotrexate due to a decrease in its renal clearance during NSAID therapy. Between the end or start of treatment with ketoprofen and treatment with methotrexate, at least 12 hours should elapse. Combinations requiring caution Corticosteroids: increased risk of gastrointestinal ulcers or bleeding. Diuretics: In patients taking diuretics, there is an increased risk of renal failure due to a decrease in renal blood flow due to inhibition of prostaglandin synthesis. Such patients should be adequately hydrated prior to co-administration of such drugs, and renal function should be monitored at the start of treatment. ACE inhibitors and angiotensin II receptor antagonists: In patients with impaired renal function, the concomitant use of an ACE inhibitor or an angiotensin II receptor antagonist and drugs that inhibit COX may cause additional deterioration of renal function, including possible acute renal failure. Methotrexate at doses less than 15 mg / week: in the first weeks, it is necessary to monitor the detailed blood picture weekly. In case of impaired renal function, as well as in elderly patients, monitoring should be carried out more often. Pentoxifylline: increased risk of bleeding. Intensive clinical monitoring and frequent monitoring of bleeding time is required. Combinations to be taken into account Antihypertensive drugs (beta-blockers, ACE inhibitors, diuretics): ketoprofen reduces the effect of antihypertensive drugs (inhibition of vasodilatory prostaglandins). Thrombolytics: increased risk of bleeding. Selective serotonin reuptake inhibitors: risk of gastrointestinal bleeding. Probenecid: Co-administration of probenecid may significantly reduce plasma clearance of ketoprofen Cyclosporine and tacrolimus: Risk of additive nephrotoxicity, especially in elderly patients. Risks associated with hyperkalemia: some drugs can cause hyperkalemia (potassium salts, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor blockers, NSAIDs, heparins (low molecular weight or unfractionated), cyclosporine, tacrolimus, trimethoprim. The risk of developing hyperkalemia may depend on the presence of additional factors, the risk is increased if the drugs are used simultaneously Antiplatelet risk: interactions may occur with the simultaneous use of certain drugs that prevent aggregation: tirofiban, eptifibaride, abciximab, iloprost Simultaneous use of several antiplatelet agents increases the risk of bleeding Contraindications Hypersensitivity to ketoprofen or any of excipients.A history of bronchial asthma, allergic rhinitis, urticaria, bronchospasm or other allergic-type reactions after the use of ketoprofen or substances similar in action (NSAIDs, salicylates ). Severe heart failure, management of perioperative pain during coronary artery bypass grafting, active peptic ulcer, and history of gastrointestinal bleeding, ulcer, or perforation. Cerebrovascular or other active bleeding (including gastrointestinal bleeding), history of chronic dyspepsia, severe renal or hepatic impairment, predisposition to bleeding, last trimester of pregnancy, children, bleeding disorder, or current anticoagulant treatment. Composition One ampoule (2 ml) contains: Active substance: ketoprofen 100.0 mg. Excipients: ethyl alcohol 96%, propylene glycol, benzyl alcohol, sodium hydroxide, 2.5M sodium hydroxide solution or 2.5M hydrochloric acid solution, water for injection. OverdoseSymptoms: In adults, the main signs of overdose are headache, dizziness, drowsiness, nausea, vomiting, diarrhea and abdominal pain. In severe overdose, hypotension, respiratory depression and gastrointestinal bleeding have been observed. Treatment: the patient is hospitalized and symptomatic treatment is carried out, the specific antidote is unknown. Adverse reactions are classified according to the frequency of occurrence as follows: often (≥ 1/100 to < 1/10), infrequently (≥ 1/1,000 to < 1/100), rarely (≥ 1/10,000 to < 1/100) 1,000), very rare (<1/10,000), frequency not known (cannot be determined from the available data). When using ketoprofen, the following undesirable effects have been reported in adults. On the part of the blood and lymphatic system: rarely: posthemorrhagic anemia; frequency not known: thrombocytopenia, agranulocytosis, rare cases of leukopenia. From the immune system: the frequency is not known: anaphylactic reactions (including shock). Mental disorders: frequency not known: mood changes. From the nervous system: infrequently: headache, dizziness, drowsiness; frequency not known: convulsions. From the senses: rarely: blurred vision, ringing in the ears (tinnitus). From the side of the heart and blood vessels: the frequency is not known: heart failure, arterial hypertension. From the respiratory system and mediastinal organs: rarely: bronchial asthma; frequency not known: bronchospasm (especially in patients with known hypersensitivity to aspirin and other NSAIDs), rhinitis. From the gastrointestinal tract: often: nausea, vomiting; infrequently: constipation, diarrhea, gastritis; rarely: stomatitis, peptic ulcer; frequency not known: perforation or gastrointestinal bleeding, gastrointestinal discomfort, stomach pain and rare cases of colitis, melena and hematemesis. The most undesirable reactions are reactions from the gastrointestinal tract, the development of peptic ulcers, perforations and bleeding in the gastrointestinal tract is possible, which in rare cases, especially in elderly patients, can be fatal. On the part of the hepatobiliary system: rarely: an increase in the level of transaminases, hepatitis, an increase in serum bilirubin due to liver disease. On the part of the skin and subcutaneous tissues: infrequently: itching, rash; frequency not known: photosensitivity reaction, alopecia, urticaria, angioedema, bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, exacerbation of chronic urticaria. From the side of the kidneys and urinary tract: the frequency is not known: acute renal failure, tubulointerstitial nephritis, nephritic syndrome, water / sodium retention with the possible development of edema, hyperkalemia, organic kidney damage that can cause acute renal failure (there have been reports of isolated cases of acute tubular and papillary necrosis). General disorders and disorders at the injection site: infrequently: edema; frequency not known: pain and burning at the injection site. Clinical studies and epidemiological data suggest that the use of certain non-selective NSAIDs (especially at high doses and in long-term treatment) may be associated with an increased risk of arterial thrombosis (myocardial infarction, stroke). Edema, high blood pressure and heart failure have been reported in connection with treatment with non-selective NSAIDs. Storage conditions In a place protected from light at a temperature not exceeding 25 ° C. Keep out of the reach of children. Buy Ketoprofen-LF solution for intravenous and intramuscular injection 100mg/2ml in ampoules No. 5x2 instructions for use for Ketoprofen-LF solution for intravenous and intramuscular administration 100mg/2ml in ampoules No. 5x2