Dicloberl N 75 solution for injection 75 mg/3 ml, 3ml x 5 ampoules — Made in Germany — Free Delivery

(Dicloberl N 75)
Dicloberl N 75 solution for injection 75 mg/3 ml, 3ml x 5 ampoules — Made in Germany — Free Delivery
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Description Dicloberl N 75 solution for injection 75 mg/3 ml, 3ml x 5 ampoules — Made in Germany — Free Delivery

Pharmacological properties

Pharmacodynamics. Dicloberl N 75 is a non-steroidal preparation with pronounced analgesic and anti-inflammatory properties, an inhibitor of prostaglandin synthetase (cog).
Pharmacokinetics. Absorption. After the introduction of 75 mg of diclofenac by intramuscular injection, absorption begins immediately, and the average Cmax in blood plasma is reached after 20 minutes. The volume of absorption is linearly proportional to the dose.
Bioavailability. AUC after i / m administration is approximately twice that after oral administration or rectal administration, since this pathway avoids first pass metabolism through the liver.
Distribution. The degree of binding to blood plasma proteins is about 99%. Diclofenac enters the synovial fluid, where Cmax is determined 2–4 hours after reaching the peak value in blood plasma. The expected T1 / 2 from the synovial fluid is 3-6 hours. 2 hours after reaching the peak plasma level, the concentration of diclofenac in the synovial fluid exceeds that in the blood plasma and remains higher up to 12 hours.
Diclofenac was detected at a low concentration (100 ng / ml) in breast milk in one breastfeeding woman. The estimated amount of the preparation entering the infant's body through breast milk is equivalent to 0.03 mg / kg / day.
Metabolism. Diclofenac metabolism occurs partly by glucuronidation of an intact molecule, but mainly by single and multiple hydroxylation and methoxylation, which leads to the formation of several phenolic metabolites, most of which are converted to glucuronide conjugates. Two of these phenolic metabolites are biologically active, but their effect is much less pronounced than the effect of diclofenac.
Excretion. T½ from plasma is about 2 hours.
Special patient groups
Patients with impaired renal function. Based on the kinetics of the preparation after a single use, in patients with impaired renal function, if the usual dosage regimen is observed, the accumulation of unchanged active substance can not be expected. With a creatinine clearance of 10 ml / min, the levels of hydroxymetabolites in the blood plasma are approximately 4 times higher than in healthy volunteers. However, the metabolites are finally excreted in the bile.
Patients with liver disease. In patients with chronic hepatitis or compensated liver cirrhosis, the kinetics and metabolism of diclofenac are the same as in patients with a healthy liver.

Indications

The preparation when administered intramuscularly is intended for the treatment of: inflammatory and degenerative forms of rheumatism, rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, spondyloarthritis, vertebral pain syndrome, non-articular rheumatism; acute attacks of gout; renal and biliary colic; pain and swelling after injuries and surgeries; severe migraine attacks.

Application

Side effects can be minimized by administering the lowest effective dose for the shortest time possible, sufficient to control symptoms.
Adults. The preparation Dikloberl N 75, injection solution, is not used for more than 2 days. If necessary, treatment can be continued with Dicloberl tablets or suppositories.
In order to prevent damage to nerve or other tissues at the injection site, the following rules must be followed.
IM injection. The dose is usually 75 mg (1 ampoule) per day, which is injected by deep injection into the upper outer quadrant of the gluteus maximus muscle. In severe cases (for example, colic), the daily dose can be increased to two injections of 75 mg, between which an interval of several hours is kept (1 injection in each buttock). Alternatively, 75 mg of injection solution can be combined with other dosage forms of Dicloberl (for example, tablets or suppositories) up to a maximum total daily dose of 150 mg of diclofenac sodium.
With a migraine attack, clinical experience is limited to cases with the initial use of 75 mg of diclofenac, the dose is administered as soon as possible after the use of suppositories of 100 mg on the same day (if necessary). The total daily dose should not exceed 175 mg on the first day. There is no data available on the use of the preparation Dicloberl for the treatment of migraine attacks longer than 1 day. If necessary, on the following days, treatment can be continued with the use of suppositories.
The maximum daily dose is 150 mg.
Elderly patients. Although in elderly patients the pharmacokinetics of the preparation Dikloberl N 75 does not significantly deteriorate, in patients, as a rule, more prone to the development of adverse reactions, NSAIDs should be used with caution. In particular, for debilitated elderly patients or patients with low body weight, it is recommended to use the lowest effective dose (see SPECIAL INSTRUCTIONS); patients should also be examined for gastrointestinal bleeding.
Application for impaired renal or liver function. In case of impaired renal or liver function of a mild to moderate degree, dose adjustment is not required.
The recommended maximum daily dose of Dicloberl N 75 is 150 mg.
The preparation should be used in the lowest effective doses for a short period of time, taking into account the purpose of treatment for each individual patient.

Contraindications

A history of bleeding or perforation of the gastrointestinal tract associated with previous NSAID treatment. a history of active peptic ulcer / bleeding or a history of recurrent peptic ulcer / bleeding (two or more separate episodes of established ulcer or bleeding). iii trimester of pregnancy. patients in whom the use of ibuprofen, acetylsalicylic acid or other NSAIDs provokes attacks of BA, angioedema, urticaria or acute rhinitis. inflammatory bowel disease (such as Crohn's disease or ulcerative colitis). hepatic and renal failure. peripheral arterial disease; cerebrovascular diseases in patients who have suffered a stroke or have episodes of transient ischemic attacks; ischemic heart disease in patients with angina pectoris or myocardial infarction. congestive heart failure (nyha ii – iv). high risk of postoperative bleeding, blood clotting, hemostasis disorders, hematopoietic disorders or cerebrovascular bleeding. treatment of perioperative pain with coronary artery bypass grafting (or the use of a heart-lung machine).

Side effects

When assessing side effects, the following criteria for the frequency of their occurrence are used: very often (≥1 / 10); often (≥1 / 100, 1/10); sometimes (≥1 / 1000, 1/100); rarely (≥1 / 10,000, 1/1000); very rare (1 / 10,000), frequency not established (frequency cannot be estimated based on available data). the following side effects include those associated with the administration of the preparation dicloberl n 75 in conditions of short-term and long-term use.
On the part of the blood and lymphatic system: very rarely - a violation of hematopoiesis (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis), hemolytic anemia. The first signs may be fever, sore throat, superficial sores in the mouth, flu-like symptoms, severe weakness, nosebleeds, and bleeding from the skin.
From the immune system: often - hypersensitivity reactions (skin rash and itching); sometimes - urticaria; very rarely - severe general hypersensitivity reactions (anaphylactic), such as swelling of the face, tongue and throat with narrowing of the airways, shortness of breath, tachycardia, a decrease in blood pressure up to the development of life-threatening anaphylactic shock, allergic vasculitis and pneumonia, aplastic anemia, anaphylactic and anaphylactoid reactions.
Mental disorders: very rarely - disorientation, depression, insomnia, nightmares, irritability and other mental disorders.
From the nervous system: often - headache, dizziness; rarely - drowsiness, fatigue; very rarely - paresthesia, memory impairment, convulsions, anxiety, tremor, aseptic meningitis, taste disorder, stroke, confusion, hallucinations, impaired sensitivity, general malaise.
From the side of the organ of vision: very rarely - visual disturbance, blurred vision, diplopia; optic neuritis.
On the part of the organ of hearing and the labyrinth: often - vertigo; very rarely - ringing in the ears, hearing impairment.
From the side of the cardiovascular system: very rarely - palpitations, chest pain, heart failure, myocardial infarction; Hypertension, arterial hypotension, vasculitis.
Respiratory, thoracic and mediastinal disorders: rarely - asthma (including dyspnea); very rarely - pneumonitis.
From the digestive system: very rarely - nausea, vomiting, diarrhea, bleeding in the gastrointestinal tract; often - dyspepsia, abdominal pain, flatulence, anorexia, gastrointestinal ulcer with or without bleeding, perforation (sometimes fatal, especially in the elderly); rarely - gastritis, gastrointestinal bleeding; very rarely - colitis (including hemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease), intestinal membrane strictures, pancreatitis.
From the hepatobiliary system: often - an increase in the level of transaminases; sometimes - hepatitis, jaundice; rarely - liver dysfunction; very rarely - instantaneous hepatitis, hepatonecrosis, liver failure.
On the part of the skin and subcutaneous tissues: often - rashes; rarely - urticaria; very rarely, bullous rash, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis, hair loss, photosensitivity reaction, purpura, allergic purpura, pruritus.
On the part of the kidneys and urinary tract: sometimes - the formation of edema, especially in patients with hypertension or with renal failure; very rarely - acute renal failure, hematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.
General disorders and disorders at the injection site: often - reaction at the injection site, pain, hardening; rarely - edema, necrosis at the injection site; very rarely - an abscess at the injection site.
On the part of the reproductive system and mammary glands: impotence.
Clinical research data and epidemiological data indicate an increased risk of thrombotic complications (for example, myocardial infarction or stroke) associated with the use of diclofenac, in particular in high therapeutic doses (150 mg / day) and with prolonged use.

Special instructions

Patients with risk factors for the development of cardiovascular diseases (such as ag, hyperlipidemia, diabetes mellitus or smoking) should be prescribed diclofenac only after a thorough analysis of their condition. side effects can be minimized by using the lowest effective dose for the shortest time necessary to control symptoms. the preparation dicloberl n 75 is used when it is necessary to have a particularly rapid onset of action, as well as when the use of other dosage forms of diclofenac sodium is impossible, while, as a rule, treatment is recommended as a single injection to start therapy. the use of the preparation in combination with other NSAIDs, including selective inhibitors of Tsog-2, should be avoided due to the lack of any synergistic benefits and the likelihood of additional side effects.
The preparation should be used with caution in elderly patients. For patients with poor health and patients with a low body mass index, the lowest effective dose is recommended.
Allergic reactions, including anaphylactic / anaphylactoid reactions, may also occur without prior exposure to diclofenac. Diclofenac may mask the signs and symptoms of infection. If, during treatment, the symptoms of infection reappear or intensify, the patient is advised to immediately consult a doctor who will determine whether there is an indication for the appointment of anti-infective therapy or antibiotic therapy.
Effect on the gastrointestinal tract. With the use of all NSAIDs, including diclofenac, cases of gastrointestinal bleeding (vomiting of blood, melena), ulceration or perforation, sometimes fatal, occurring at any time during treatment have been reported, regardless of the presence of symptoms or a history of serious events with sides of the digestive tract. These phenomena usually have more serious consequences in elderly patients (including possible death). If patients receiving diclofenac develop gastrointestinal bleeding or ulcers, the preparation should be discontinued.
Particular care should be taken when prescribing diclofenac to patients with symptoms suggestive of gastrointestinal disorders, or with a history of gastric or intestinal ulcers, bleeding and perforation. The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing doses of NSAIDs, including diclofenac, as well as in patients with a history of ulcers, especially with complications such as bleeding or perforation. Patients with ulcerative colitis or Crohn's disease should seek medical attention and use caution as these conditions may worsen (see CONTRAINDICATIONS). Elderly patients are more likely to experience adverse reactions when using NSAIDs, especially such as gastrointestinal bleeding and perforation, which can be fatal. To reduce the risk of gastrointestinal toxicity in patients with a history of ulcers, especially those with complications such as bleeding or perforation, and in elderly patients, treatment is started and maintained with low effective doses.
For such patients, as well as patients who require the combined use of preparations containing low doses of acetylsalicylic acid or other preparations that increase the risk of adverse effects on the gastrointestinal tract, you should consider combination therapy with the use of protective preparations (for example, proton pump inhibitors or misoprostol ).
Patients with a history of gastrointestinal toxicity, especially the elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding). Caution should also be given to patients receiving concomitant medications that increase the risk of ulcers or bleeding, such as systemic corticosteroids, anticoagulants (eg warfarin), antithrombotics (eg acetylsalicylic acid), or selective serotonin reuptake inhibitors.
Effects on the liver. Careful medical supervision is required if Dikloberl N 75 is prescribed to patients with impaired liver function, since their condition may worsen. One or more liver enzymes may be elevated. With long-term treatment with the preparation, regular monitoring of liver function is prescribed as a precautionary measure. With persisting or increasing liver dysfunction, if clinical symptoms may be associated with progressive liver disease or other manifestations (eg eosinophilia, rash) are observed, the preparation should be discontinued. Diseases such as hepatitis may progress without prodromal symptoms. Caution is necessary if the preparation is used in patients with hepatic porphyria, due to the likelihood of provoking an attack.
Effects on the kidneys. Since fluid retention and edema have been reported in the treatment of NSAIDs, including diclofenac, special attention should be paid to patients with impaired cardiac or renal function, a history of hypertension, the elderly, patients receiving diuretic therapy or preparations that significantly affect renal function. and patients with a significant decrease in extracellular fluid volume for any reason, such as before or after major surgery. In such cases, monitoring of renal function is recommended as a precautionary measure. Discontinuation of therapy usually results in the return of the condition that preceded treatment.
Effects on the skin. In connection with the use of NSAIDs, including the preparation Dicloberl N 75, serious skin reactions (some of them fatal) were very rarely recorded, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis. The highest risk of developing these reactions exists at the beginning of the course of therapy, in most cases during the first month of treatment. The use of the preparation should be discontinued at the first appearance of skin rashes, mucosal lesions or any other signs of hypersensitivity.
Systemic lupus erythematosus and mixed connective tissue diseases. Patients with systemic lupus erythematosus and mixed connective tissue diseases have an increased risk of developing aseptic meningitis.
Cardiovascular and cerebrovascular effects. For patients with a history of hypertension and / or congestive heart failure of mild to moderate severity, appropriate monitoring and recommendations are necessary, since in connection with the use of NSAIDs, including diclofenac, cases of fluid retention and edema have been reported.
Clinical studies and epidemiological data indicate that the use of diclofenac, especially in high doses (150 mg / day) for a long time, increases the risk of arterial thrombotic events (for example, myocardial infarction or stroke). Diclofenac is not recommended for patients with uncontrolled hypertension, congestive heart failure, persistent coronary artery disease, peripheral arterial disease and / or cerebrovascular disease; if necessary, use is possible only after a thorough risk / benefit assessment only at a dose of ≤100 mg / day. Such an assessment should be performed before starting long-term treatment of patients with risk factors for the development of cardiovascular disorders (for example, hypertension, hyperlipidemia, diabetes mellitus and smoking). Patients should be informed about the possibility of severe antithrombotic symptoms (chest pain, shortness of breath, weakness, speech impairment). In such cases, you should immediately consult a doctor.
Influence on hematological parameters. With prolonged use of pain relievers, headache may occur, which cannot be treated with higher doses of the preparation. Habitual use of pain relievers, especially when several pain relievers are combined, can lead to permanent kidney damage, with the risk of kidney failure (analgesic nephropathy). The simultaneous use of alcohol can increase the side effects of diclofenac sodium, especially those concerning the digestive tract and the central nervous system. With prolonged use of the preparation, like other NSAIDs, monitoring of the blood test is recommended. Like other NSAIDs, the preparation can temporarily suppress platelet aggregation. Patients with hemostasis disorders, hemorrhagic diathesis or hematological disorders should be closely monitored.
History of asthma. Patients with asthma, seasonal allergic rhinitis, patients with swelling of the nasal mucosa (nasal polyps), chronic obstructive pulmonary disease or chronic respiratory tract infections (especially those associated with allergic symptoms like rhinitis) are more likely than others to have reactions to NSAIDs, similar to exacerbation of asthma (the so-called intolerance to analgesics / analgesic asthma), Quincke's edema, urticaria. In this regard, such patients are recommended special measures (readiness to provide emergency care). This also applies to patients with allergies to other substances, manifested by skin reactions, itching or hives. Like other preparations that suppress the activity of prostaglandin synthetase, diclofenac sodium and other NSAIDs can provoke the development of bronchospasm in patients with asthma or in patients with a history of asthma.
Fertility in women. The use of the preparation can lead to impaired fertility in women and is not recommended for women who seek to become pregnant. If a woman has difficulty conceiving or is being tested for infertility, discontinuation of the preparation should be considered.
Prescribing diclofenac to patients with significant risk factors for cardiovascular events (eg, hypertension, hyperlipidemia, diabetes mellitus, smoking) can only be after a thorough clinical assessment. Since the cardiovascular risks of diclofenac can increase with increasing dose and duration of treatment, it should be used for the shortest possible period and at the lowest effective dose.
Patient needs and response to therapy should be monitored periodically. Use with caution in persons over the age of 65 years.
Use during pregnancy and lactation. In the I and II trimester of pregnancy, the preparation can be prescribed only if the expected benefit to the mother outweighs the potential risk to the fetus, only in the minimum effective dose, the duration of treatment should be as short as possible. The preparation is contraindicated in the third trimester of pregnancy (suppression of uterine contractility and premature closure of the ductus arteriosus in the fetus are possible).
Inhibition of prostaglandin synthesis can adversely affect pregnancy and / or embryo / fetal development. Epidemiological data indicate an increased risk of miscarriages and / or the risk of developing heart defects and gastroschisis after using an inhibitor of prostaglandin synthesis in early pregnancy. The absolute risk of cardiovascular disease increased from less than 1% to about 1.5%. It is possible that the risk increased with increasing dose and duration of treatment. In animals, the administration of an inhibitor of prostaglandin synthesis leads to an increase in pre- and post-implantation losses and death for the embryo / fetus. In addition, in animals that received an inhibitor of prostaglandin synthesis during the period of organogenesis, an increased frequency of various malformations, including those of the cardiovascular system, was recorded. If the preparation is used in women who seek to become pregnant, or in the first trimester of pregnancy, the dose of the preparation should be as low as possible, and the duration of treatment should be as short as possible.
In the third trimester of pregnancy, all inhibitors of prostaglandin synthesis can affect the fetus, causing cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); impaired renal function, which can progress to renal failure with oligohydramnios; effect on mother and newborn - possible lengthening of bleeding time, antiplatelet effect, which can be observed even at very low doses; inhibition of uterine contractions, which leads to a delay or lengthening of labor. So, the preparation is contraindicated in the third trimester of pregnancy.
Breastfeeding period. Like other NSAIDs, diclofenac passes into breast milk in small amounts. Thus, in order to avoid unwanted effects on the infant, the preparation should not be used during breastfeeding.
Fertility Like other NSAIDs, Dicloberl N 75 can affect a woman's fertility. The preparation is not recommended for women planning pregnancy. A woman who has complications with fertilization, or those who have been examined for infertility, must stop using the preparation Dikloberl N 75.
Children. Diclofenac in a dosage form for injection is contraindicated in children.
The ability to influence the reaction rate when driving or operating machinery. Patients who, during treatment, experience visual impairment, dizziness, vertigo, drowsiness or other disorders of the central nervous system, lethargy or fatigue, should refrain from driving and operating machinery.
This is especially true for the simultaneous use with alcohol. Propylene glycol, which is part of the preparation, can cause symptoms similar to those after drinking alcohol.

Interactions

Below are the interactions that were observed when using the preparation dicloberl n 75, injection solution and / or other dosage forms of diclofenac.
Lithium. Digoxin. Phenytoin. Provided the simultaneous use of diclofenac can increase the concentration of digoxin, phenidione and lithium in the blood plasma. Monitoring of serum digoxin, phenidione and lithium levels is recommended.
Diuretics, ACE inhibitors (ACE inhibitors) and angiotensin II receptor antagonists. Preparations of the NSAID group can weaken the effect of diuretics and antihypertensive preparations. In patients with impaired renal function (dehydrated patients or elderly people in whom renal function is reduced), the simultaneous use of an ACE inhibitor or angiotensin II receptor antagonists with a preparation that suppresses cyclooxygenase can lead to further deterioration of renal function, including the development of acute renal failure (this the process is reversible). Such patients should be provided with a sufficient intake of fluid into the body, and also from the beginning of combination therapy, regularly monitor their renal function. The simultaneous use of diclofenac sodium and potassium-sparing diuretics can lead to hyperkalemia.
Preparations known to cause hyperkalemia. Concomitant treatment with potassium-sparing diuretics, cyclosporine, tacrolimus or trimethoprim may be associated with an increase in plasma potassium levels, so patients should be monitored more frequently.
Anticoagulants and antithrombotic agents. Concomitant use can increase the risk of bleeding, so it is recommended to take precautions. Although clinical studies do not indicate the effect of diclofenac on the activity of anticoagulants, there are some data on an increased risk of bleeding in patients using simultaneously diclofenac and anticoagulants. Therefore, to ensure that no changes in the dosage of anticoagulants are required, careful monitoring of such patients is recommended. Like other NSAIDs, high doses of diclofenac can temporarily suppress platelet aggregation.
Other NSAIDs, including selective COX-2 inhibitors, and corticosteroids. Concomitant use of diclofenac and other NSAIDs or corticosteroids may increase the risk of gastrointestinal bleeding or ulcers. The simultaneous use of two or more NSAIDs should be avoided.
Selective serotonin reuptake inhibitors. The simultaneous use of NSAIDs and selective serotonin reuptake inhibitors may increase the risk of gastrointestinal bleeding.
Antidiabetic preparations. Clinical studies have shown that diclofenac can be used in combination with oral hypoglycemic agents, which does not affect their therapeutic effect. However, there are some reports of the development in such cases of both hypoglycemia and hyperglycemia, which necessitated a change in the dose of antidiabetic agents during the use of diclofenac. For this reason, it is recommended to monitor blood glucose levels during combination therapy as a precautionary measure.
Probenecid and sulfinpyrazone. Medicines containing probenecid and sulfinpyrazone can slow down the elimination of diclofenac sodium from the body.
Methotrexate. Diclofenac can suppress the renal tubular clearance of methotrexate, resulting in increased methotrexate levels. Care should be taken when prescribing NSAIDs, including diclofenac, less than 24 hours before using methotrexate, since in such cases the concentration of methotrexate in the blood may increase and its toxic effect may increase. Cases of serious toxicity have been reported when the interval between the use of methotrexate and NSAIDs, including diclofenac, was within 24 hours. This interaction is mediated through the accumulation of methotrexate as a result of impaired renal excretion in the presence of NSAIDs.
Cyclosporine. The effect of diclofenac, like other NSAIDs, on the synthesis of prostaglandins in the kidneys may increase the nephrotoxicity of cyclosporin, therefore, diclofenac should be used in lower doses than in patients not using cyclosporin.
Tacrolimus. When using NSAIDs with tacrolimus, an increased risk of nephrotoxicity is possible, which may be mediated through the renal antiprostaglandin effects of NSAIDs and a calcineurin inhibitor.
Antibacterial quinolones. It is possible that seizures develop in patients taking quinolone derivatives and NSAIDs at the same time. This can occur in patients with or without a history of epilepsy and seizures. Thus, caution should be exercised when deciding whether to use quinolones in patients already receiving NSAIDs.
Colestipol and colestyramine. These preparations may delay or decrease the absorption of diclofenac. Therefore, it is recommended to prescribe diclofenac at least 1 hour before or 4–6 hours after the use of colestipol / colestyramine.
Cardiac glycosides. The simultaneous use of cardiac glycosides and NSAIDs can increase heart failure, reduce the glomerular filtration rate and increase the level of glycosides in the blood plasma.
Mifepristone. NSAIDs should not be used within 8-12 days after taking mifepristone, as NSAIDs may reduce its effect.
Potent inhibitors of CYP 2C9. It is recommended to be careful when prescribing diclofenac with potent inhibitors of CYP 2C9 (for example voriconazole), which can lead to a significant increase in plasma Cmax and exposure to diclofenac due to inhibition of the metabolism of diclofenac.

Overdose

Symptoms there is no typical clinical picture characteristic of diclofenac overdose. overdose can cause symptoms such as headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, diarrhea, dizziness, disorientation, agitation, coma, drowsiness, ringing in the ears, loss of consciousness or seizures, hypotension, shortness of breath, and cyanosis ... in case of severe poisoning, opn and liver damage are possible.
Treatment. Within 1 hour after accidental use of a potentially toxic amount of the preparation, it may be advisable to use activated carbon. Alternatively, for adults, gastric lavage may be required for 1 hour after taking a potentially toxic amount of the preparation.
For frequent or prolonged convulsions, diazepam should be administered intravenously. Other measures may be indicated depending on the patient's clinical condition. Treatment is symptomatic.

Storage conditions

Store ampoules in their original packaging at a temperature not exceeding 30 ° C to protect them from light.

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