Active substanceDiclofenacDiclofenac
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  • Dosage form: & nbsp
    solution for intramuscular injection
    Composition:3 ml of solution (1 ampoule) contain: active substance: diclofenac sodium 75 mg; Excipients: Mannitol - 18.0 mg, propylene glycol 600.0 mg, benzyl alcohol 120.0 mg, sodium disulfite 2.0 mg, sodium hydroxide to pH 7.8-8.0, water for injection up to 3, 0 ml.
    Description:
    From a colorless to light yellow solution.
    Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug
    ATX: & nbsp

    S.01.B.C.03   Diclofenac

    M.01.A.B.05   Diclofenac

    Pharmacodynamics:Voltaren® contains diclofenac sodium, the substance of the nonsteroidal structure, which has a pronounced anti-inflammatory, analgesic and antipyretic effect. The main mechanism of action of diclofenac, established under experimental conditions, is inhibition of the biosynthesis of prostaglandins. Prostaglandins play an important role in the pathogenesis of inflammation, pain and fever. In vitro diclofenac sodium, in concentrations equivalent to those achieved in the treatment of patients, does not inhibit the biosynthesis of proteoglycans of cartilaginous tissue. In rheumatic diseases, the anti-inflammatory and analgesic effects of Voltaren® provide a clinical effect characterized by a significant reduction in the severity of such manifestations of diseases as pain at rest and during movement, morning stiffness and swelling of the joints, as well as an improvement in the functional state. A pronounced analgesic effect of Voltaren® was noted with moderate and severe pain of non-rheumatic origin.
    Pain relief comes in 15-30 minutes.
    When posttraumatic and post-operative inflammatory phenomena Voltaren® quickly reduces pain, reduces inflammatory edema and swelling of the postoperative wound. When used in combination with opioids in patients with postoperative pain, Voltaren® significantly reduces the need for opioid analgesics. In addition, Voltaren® facilitates migraine attacks.
    Pharmacokinetics:
    Suction
    After intramuscular administration of 75 mg of diclofenac, its absorption begins immediately.The maximum concentration in plasma (Cmax), the average value of which is about 2.5 μg / ml (8 μmol / L), is reached after about 20 minutes. The amount of absorbing active substance is in linear dependence on the amount of the drug. The area under the concentration-time curve (AUC) after intramuscular injection of the Voltaren® preparation is approximately 2 times greater than after its oral or rectal administration, since in the latter cases about half the amount of diclofenac is metabolized by the "first passage" through the liver. With subsequent administration of the drug, pharmacokinetic parameters do not change. Provided that the recommended intervals between injections of the drug cumulation is not noted.
    Distribution
    The connection with serum proteins is 99.7%, mainly with albumin (99.4%). The apparent volume of distribution is 0.12-0.17 l / kg. Diclofenac penetrates into the synovial fluid, where its maximum concentration is reached 2-4 hours later than in the blood plasma. The apparent half-life of the synovial fluid is 3-6 hours. Two hours after reaching the maximum concentration in plasma, the concentration of diclofenac in the synovial fluid is higher than in plasma,and its values ​​remain higher for a period of up to 12 hours.
    Diclofenac was detected in low concentrations (100 ng / ml) in breast milk of one of the nursing mothers. The estimated amount of the drug that enters the baby's breast through the breast is equivalent to 0.03 mg / kg / day.
    Biotransformation / Metabolism
    Metabolism of diclofenac is carried out in part by glucuronization of unchanged molecules, but, mainly, by single and multiple hydroxylation and methoxylation, which leads to the formation of several phenolic metabolites (3'-hydroxy-, 4'-hydroxy-, 5'-hydroxy-, 4 ', 5-dihydroxy- and 3'-hydroxy-4'- methoxydiclofenac), most of which are converted to glucuronic conjugates. Two phenolic metabolites are biologically active, but to a much lesser extent than diclofenac.
    Excretion
    The total systemic plasma clearance of diclofenac is 263 ± 56 ml / min. The final half-life is 1-2 hours. The half-life of 4 metabolites, including two pharmacologically active metabolites, is also short-lived and is 1-3 hours. One of the metabolites, 3'-hydroxy-4'-methoxy-diclofenac, has a longer half-life, but this metabolite is completely inactive.
    About 60% of the drug dose is excreted in the urine in the form of glucuronic conjugates of unchanged active substance, as well as in the form of metabolites, most of which are also glucuronic conjugates. Unchanged, less than 1% of diclofenac is excreted. The rest of the dose is excreted as metabolites with bile.
    The concentration of diclofenac in the blood plasma depends linearly on the value of the dose taken.
    Pharmacokinetics in selected groups of patients
    Absorption, metabolism and excretion of the drug do not depend on age. However, in some elderly patients, a 15-minute intravenous infusion of diclofenac led to an increase in plasma concentration of the drug by 50% compared with that expected in adult patients. In patients with impaired renal function, cumulation of the unchanged active substance is not observed when the recommended dosage regimen is observed. When creatinine clearance (CK) is less than 10 ml / min, the calculated equilibrium concentrations of diclofenac hydroxy metabolites are approximately 4 times higher than in healthy volunteers, with the metabolites being excreted exclusively with bile. In patients with chronic hepatitis or
    compensated cirrhosis of the liver, the pharmacokinetics of diclofenac are similar to those in patients without liver disease.
    Indications:
    • Inflammatory and degenerative diseases of the musculoskeletal system including:
    - rheumatoid arthritis,
    - Ankylosing spondylitis and other spondyloarthropathies,
    - osteoarthritis,
    - gouty arthritis,
    bursitis, tendovaginitis.
    - Pain syndromes from the side of the spine (lumbago, sciatica, ossalgia, neuralgia, myalgia, arthralgia, sciatica);
    • Renal and biliary colic.
    • Post-traumatic and postoperative pain syndrome, accompanied by inflammation.
    • Severe attacks of migraine.
    Contraindications:
    - Stomach or intestinal ulcer.
    -Increased sensitivity to diclofenac and any other ingredients of the drug, including sodium metabisulfite.
    -Voltaren® is contraindicated in patients with asthma attacks, urticaria or acute rhinitis caused by acetylsalicylic acid or other NSAIDs, as well as by any drugs that inhibit the production of prostaglandins.
    -Voltaren® injection is not prescribed for children and adolescents under the age of 18 years.
    -Voltaren® solution for injection is not prescribed during pregnancy.
    Carefully:In applying the drug Voltaren® and other NSAIDs, careful medical supervision of patients with ulcerative lesions of the stomach or bowel, infection of Helicobacter pylori, ulcerative colitis, Crohn's disease, impaired liver function or a history of patients complained, pointing to the gastro-intestinal tract . The risk of developing gastrointestinal bleeding increases with an increase in the dose of NSAIDs or in the presence of ulcerative anamnesis, especially bleeding and perforation of the ulcer and in elderly patients. Special care should be taken when using Voltaren® in patients receiving drugs that increase the risk of gastrointestinal hemorrhage: systemic glucocorticosteroids (incl. prednisolone), anticoagulants (incl. warfarin), antiplatelet agents (including clopidogrel, acetylsalicylic acid) or selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline).
    Caution is necessary for the appointment of Voltaren® in patients with mild and moderate impairment of liver function, as well as in patients with hepatic porphyria,since the drug can provoke attacks of porphyria.
    It should be used with caution in patients with bronchial asthma, seasonal allergic rhinitis, edema of the nasal mucosa (including with nasal polyps), chronic obstructive pulmonary disease, chronic infectious diseases of the respiratory tract (especially associated with allergic rhinitis-like symptoms).
    Particular care is required in the treatment of patients with cardiovascular diseases (including coronary heart disease, cerebrovascular disease, compensated heart failure, diseases
    peripheral vessels), impaired renal function, including chronic renal failure (CK 30-60 ml / min),
    dyslipidemia / hyperlipidemia, diabetes mellitus, hypertensive disease, treatment of smokers or alcohol abusers in the treatment of elderly patients receiving diuretics or other drugs that affect the function of the kidneys, as well as patients with a significant decrease in the volume of extracellular fluid of any etiology, for example,in the periods before and after massive surgical interventions.
    It is necessary to use with caution the preparation Voltaren® in patients with defects of the hemostasis system. Caution should be exercised when using Voltaren® in patients at risk of developing cardiovascular thrombosis (including myocardial infarction and stroke). Caution should be exercised when using Voltaren® in elderly patients. This is especially true in weakened or low-weight elderly people; they are recommended to prescribe the drug at the lowest effective dose.
    Particular care should be taken when intramuscular introduction of the drug Voltaren® to patients with bronchial asthma due to the risk of exacerbation of the disease, since sodium bisulfite contained in the drug is capable of causing severe hypersensitivity reactions.
    Pregnancy and lactation:
    There is insufficient data on the safety of diclofenac in pregnant women. Prescribe Voltaren® in the I and II trimesters of pregnancy should be used only when the expected benefit to the mother exceeds the potential risk to the fetus.Voltaren®, like other inhibitors of prostaglandin synthesis, is contraindicated in the last 3 months of pregnancy (possibly suppressing the contractility of the uterus and premature closure of the arterial duct in the fetus).
    Despite the fact that the preparation Voltaren®, like other NSAIDs, penetrates into breast milk in small quantities, the drug should not be prescribed to lactating women to prevent undesirable effects on the baby. If it is necessary to use Voltaren® in a lactating woman Breastfeeding is discontinued.
    Since Voltaren®, like other NSAIDs, can have a negative effect on fertility, women who plan pregnancy are not recommended to take the drug.
    Patients undergoing examination and treatment for infertility, the drug should be canceled.
    Dosing and Administration:
    The use of Voltaren®, a solution for intramuscular injection, should be carried out individually, and in order to reduce the risk of side effects, it is recommended to apply the minimum effective dose, if possible, with the shortest treatment period, in accordance with the purpose of treatment and the patient's condition.Voltaren® in ampoules is particularly suitable for the initial treatment of inflammatory and degenerative Rheumatic diseases, as well as pain due to inflammation of non-rheumatic origin.
    Voltaren® is administered by deep injection into the gluteus muscle. Do not inject Voltaren® for more than 2 consecutive days. If necessary, treatment can be continued with Voltaren® in tablets or rectal suppositories. When carrying out intramuscular (IM) injection in order to avoid damage to the nerve or other tissues, it is recommended adhere to the following rules.
    The drug should be injected deep in the / m in the upper outer quadrant of the gluteal region.
    The dose is usually 75 mg (the contents of 1 ampoule) once a day. In severe cases (for example, with colic) as an exception, 2 75 mg injections can be given, with an interval of several hours (the second injection should be performed in the opposite gluteal region). Alternatively, one injection per day (75 mg) can be combined with the administration of other dosage forms of the Voltaren® preparation (tablets, rectal suppositories), with a total daily dose not exceeding 150 mg.
    In migraine attacks, the best result is achieved if Voltaren® is administered as early as possible after the onset of an attack, IM at a dose of 75 mg (1 ampoule), followed by the use of suppositories at a dose of up to 100 mg on the same day, if required. Total daily The dose should not exceed 175 mg on the first day.

    The drug solution should be clear. Do not use a solution with a crystalline or other precipitate.

    The ampoule of the drug should be used only once. The solution should be administered immediately after opening the ampoule. After a single use, unused remedies for the solution of Voltaren® are no longer used.

    Do not mix Voltaren® solution contained in ampoules with solutions of other drugs for injection.

    Children and teenagers under 18 years of age

    Voltaren®, an injection solution, should not be used in children and adolescents under 18 due to the difficulty of dosing the drug; If treatment is needed in this category of patients, Voltaren® can be use in tablets or suppositories.

    Elderly patients (65 years old)

    Correction of the initial dose in patients aged 65 years and older is not required. Weakened patients, patients with low body weight, are recommended to adhere to the minimum dose.

    Patients with diseases of the cardiovascular system or a high risk of diseases of the cardiovascular system

    It should be used with extreme caution in patients with cardiovascular disease (including uncontrolled hypertension) or a high risk of developing cardiovascular diseases. If you need long-term therapy (more than 4 weeks) in such patients should use the drug in a daily dose, not exceeding 100 mg.

    Patients with impaired renal function of mild to moderate severity

    There is no data on the need for dose adjustment in the use of the drug in patients with mild and moderate renal dysfunction due to the lack of safety studies for the use of the drug in this category of patients.

    Patients with impaired liver function of mild to moderate severity

    There is no data on the need for dose adjustment in the use of the drug in patients with impaired hepatic and mild liver function due to lack of safety research applications preparation in this category patients.

    Side effects:

    Below are the undesirable phenomena that have been identified in clinical trials, as well as the use of diclofenac in clinical practice.

    To assess the incidence of adverse events, the following criteria are used: "very often" (1/10), "often" (≥ 1/100, <1/10) "infrequently" ( 1/1000, <1/100), "rarely" ( 1/10 000, <1/1000), "very rarely" (<1/10 000). For each system of organs, undesirable phenomena are grouped in order of decreasing frequency of their occurrence. Within each group allocated according to frequency of occurrence, undesirable phenomena are distributed in order of decreasing importance.

    Infectious and parasitic diseases: very rarely - post-injection abscess.

    Violations from the blood and lymphatic system: very rarely - thrombocytopenia, leukopenia, hemolytic anemia, aplastic anemia, agranulocytosis.

    Disorders from the immune system system: rarely - hypersensitivity, anaphylactic / anaphylactoid reaction, including reduction blood pressure (BP) and shock; highly rarely - angioedema (including swelling of the face).

    Disorders of the psyche: rarely - disorientation, depression, insomnia, nightmarish dreams, irritability, mental violations.

    Violations from the nervous system: often a headache, dizziness; rarely - drowsiness; very rarely - violations sensitivity, including paresthesia, memory disorders, tremors, convulsions, sensation of anxiety, acute disorders cerebral circulation, aseptic meningitis.

    Disorders from the side of the organ of vision: very rarely - visual impairment (blurring of vision), diplopia.

    Violations from the organ of hearing and labyrinthine disorders: often - vertigo; very rarely - hearing impairment, noise in ears.

    Heart Disease: infrequently - myocardial infarction, cardiac insufficiency heart palpitations, chest pain.

    Vascular disorders: highly rarely - increased blood pressure, vasculitis.

    Disorders from the respiratory system, chest mediastinum: rarely - bronchial asthma (including dyspnea); very rarely - pneumonitis.

    Disturbances from the gastrointestinal tract: often abdominal pain, nausea, vomiting, diarrhea, dyspepsia, flatulence,decreased appetite; rarely - gastritis, gastrointestinal bleeding, vomiting of blood, melena, diarrhea with blood, ulcers of the stomach and intestines (with or without bleeding or perforation); very rarely - stomatitis, glossitis, damage to the esophagus, the appearance of diaphragm-like strictures in the intestine, colitis (nonspecific hemorrhagic colitis, exacerbation of ulcerative colitis or Crohn's disease), constipation, pancreatitis, dysgeusia.

    Disorders from the liver and bile ducts: often increased activity of aminotransferases in blood plasma; rarely - hepatitis, jaundice; impaired liver function; very rarely - fulminant hepatitis, liver necrosis, liver failure.

    Disturbances from the skin and subcutaneous tissues: often - skin rash; rarely - hives; very rarely - bullous dermatitis, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, Lyell syndrome (toxic epidermal necrolysis), exfoliative dermatitis, pruritus, alopecia, photosensitivity reactions; purple, purple Shenlaine-Henoch.

    Disorders from the kidneys and urinary tract: very rarely - acute renal failure, hematuria, proteinuria, tubulo-interstitial nephritis, nephrotic syndrome, papillary necrosis.

    General disorders and disorders at the site of administration: often - pain, compaction at the injection site; rarely - swelling, necrosis at the injection site.

    Clinical studies indicate a slight increase in the risk of developing cardiovascular thrombotic complications (eg, myocardial infarction), especially with prolonged use of diclofenac in high doses (daily dose of more than 150 mg).

    If any of the side effects indicated in the manual are aggravated, or you notice any other side effects not indicated at instructions, inform the doctor about it.

    Overdose:
    Symptoms: vomiting, gastrointestinal bleeding, diarrhea, dizziness, tinnitus, convulsions. In case of significant poisoning, it is possible to develop acute renal failure and liver damage.
    Treatment: supporting and symptomatic treatment is indicated in such complications as a decrease in blood pressure, renal failure, convulsions, gastrointestinal disturbances and respiratory depression. Forced diuresis, hemodialysis or hemoperfusion are ineffective for diclofenac, since the active substances of these preparations are largely bound to plasma proteins and are intensive metabolism.
    Interaction:

    Identified interactions

    Powerful inhibitors CYP2C9. Caution should be exercised when co-prescribing diclofenac and potent inhibitors CYP2C9 (such as voriconazole) because of the possible increase in concentration diclofenac in the serum and enhance the systemic action caused by inhibition of diclofenac metabolism.

    Lithium, digoxin. Diclofenac can increase the concentration of lithium and digoxin in the blood plasma. It is recommended to monitor the concentration of lithium, digoxin in the blood serum.

    Diuretic and antihypertensives. When used simultaneously with diuretics and antihypertensive drugs (for example, beta-blockers, angiotensin-converting enzyme-ACE inhibitors), diclofenac can reduce their hypotensive effect. Therefore, in patients, especially the elderly, with the simultaneous administration of diclofenac and diuretics or antihypertensive agents, blood pressure, kidney function and hydration should be regularly monitored (especially when combined with diuretics and ACE inhibitors due to increased risk of nephrotoxicity).

    Cyclosporine. The effect of diclofenac on the activity of prostaglandins in the kidneys can enhance the nephrotoxicity of cyclosporine. Therefore, diclofenac doses used should be lower than in patients not using ciclosporin.

    Drugs that can cause hyperkalemia: A joint the use of diclofenac with potassium-sparing diuretics, cyclosporine, tacrolimus and trimethoprim may lead to an increase in the level of potassium in the blood plasma, (in the case of such a combination, this indicator should often be monitored).

    Antibacterial agents derived from quinolone. There are separate reports on the development of seizures in patients who received concurrently derivatives of quinolone and diclofenac.

    Intended interactions

    NSAIDs and glucocorticosteroids. Simultaneous systemic use of diclofenac and other systemic NSAIDs or glucocorticosteroids can increase the frequency occurrence of undesirable phenomena (in particular, from the gastrointestinal tract).

    Anticoagulants and antiaggregants. It is necessary to combine with caution diclofenac with the drugs of these groups because of the risk of bleeding.Despite the fact that in clinical studies there was no effect of diclofenac on action anticoagulants, there are some reports of an increased risk of bleeding in patients taking this combination of drugs. Therefore, in the case of such a combination of drugs, careful monitoring of patients is recommended.

    Selective serotonin reuptake inhibitors. The simultaneous use of diclofenac with selective inhibitors of serotonin reuptake increases the risk of developing gastrointestinal bleeding.

    Hypoglycemic drugs. In clinical trials It is established that it is possible simultaneous application diclofenac and hypoglycemic drugs, while the effectiveness of the latter does not change. However, some reports of development in such cases as hypoglycemia and hyperglycemia are known, which necessitated a change in the dose of hypoglycemic drugs against diclofenac. Therefore, during the simultaneous use of diclofenac and hypoglycemic drugs, it is recommended to monitor the concentration of glucose in the blood.

    Methotrexate. Caution should be exercised when administering diclofenac less than 24 hours before or 24 hours after taking methotrexate, since in such cases, the concentration of methotrexate in the blood may increase and its toxic effect may increase.

    Phenytoin. With simultaneous use of phenytoin and diclofenac it is necessary to control the concentration of phenytoin in the blood plasma because of the possible increase in its systemic effect.

    Special instructions:
    Defeat gastrointestinal tract
    With the use of diclofenac, there have been phenomena such as bleeding or ulceration / perforation of the gastrointestinal tract, in some cases fatal. These phenomena can occur at any time with the use of drugs in patients with or absence of previous symptoms and serious gastrointestinal
    illnesses in the anamnesis or without them. In elderly patients, such complications can have serious consequences. With the development of patients receiving the drug Voltaren®, bleeding or ulceration of the gastrointestinal tract drug should be discarded.
    To reduce the risk of toxic effect on the gastrointestinal tract of patients with ulcerative lesions of the gastrointestinal tract, especially complicated by bleeding or perforation in history, as well as in elderly patients the drug should be used in the lowest effective dose.
    Patients with an increased risk of developing gastrointestinal complications, as well as patients receiving low-dose acetylsalicylic acid (aspirin), should be taken gastroprotectives (proton pump inhibitors or misoprostol) or other medications to reduce the risk of unwanted effects on the digestive tract. Patients with a history of gastrointestinal disease, especially the elderly, should be informed of all abdominal symptoms.
    Patients with bronchial asthma
    Exacerbation of asthma (intolerance to NSAID / asthma provoked by NSAID), angioneurotic edema, and urticaria most frequently reported in patients with bronchial asthma, seasonal allergic rhinitis, nasal polyps, chronic obstructive pulmonary disease or chronic infectious respiratory diseases (particularly related to allergic rhinitis-like symptoms).In this group of patients, as well as in patients with allergies to other drugs (rash, itching or urticaria) with Voltaren®, special care should be taken (readiness for resuscitation
    activities).
    Skin Reactions
    Serious dermatological reactions such as exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, in some cases fatal, have been very rare with diclofenac. The greatest risk and frequency of severe dermatological reactions were observed in the first month of treatment with diclofenac. When developing patients receiving the preparation Voltaren8, the first signs of skin rash, lesions of mucous membranes or other symptoms of hypersensitivity drug should be canceled. In rare cases, patients who are not allergic to diclofenac, with the use of the drug Voltaren® can develop
    anaphylactic / anaphylactoid reactions.
    Effects on the liver
    Since during the period of application of Voltaren1 'the activity of one or several hepatic enzymes may increase, prolonged therapy with the drug, as a precautionary measure, shows control of liver function.With the preservation and progression of violations of the hepatic function or the appearance of signs of liver disease, or other symptoms (eg, eosinophilia, rash, etc.), the drug should be withdrawn. It should be borne in mind that hepatitis against the background of the use of the drug Voltaren® can develop without prodromal phenomena.
    Effects on the kidneys
    On the background of therapy with Voltaren®, it is recommended to monitor renal function in patients with hypertension, cardiac or renal function disorders, the elderly, patients receiving diuretics or other drugs that affect renal function, as well as in patients with a significant decrease in the volume of circulating blood plasma, either etiology, for example, in the period before and after massive surgical interventions. After discontinuation of therapy with the drug, normalization of renal function to normal values ​​is usually noted.
    Effects on the cardiovascular system
    Therapy of NSAIDs, including diclofenac, at long-term therapy and high-dose therapy may be associated with a slight increase in the risk of developing serious cardiovascular thrombotic complications (including myocardial infarction and stroke).
    In patients with diseases of the cardiovascular system and a high risk of developing cardiovascular diseases (for example, with arterial hypertension, hyperlipidemia, diabetes, smokers), the drug should be used with extreme caution in the lowest effective dose with the minimum possible duration of treatment, since the risk of thrombotic complications increases with increasing the dose and duration of treatment. With prolonged therapy (more than 4 weeks), the daily dose of diclofenac in such patients should not exceed 100 mg. Evaluate the effectiveness of treatment and the patient's need for symptomatic therapy, especially cases, when its duration is more than 4 weeks. The patient should be instructed about the immediate application of medical care when the first symptoms of thrombotic disorders appear (for example, chest pain, feelings of lack of air, weakness, speech impairment).
    Effects on the hematopoietic system
    Voltaren® can temporarily inhibit platelet aggregation.Therefore, patients with hemostasis disorders should carefully monitor the relevant laboratory indicators. With prolonged use of the drug Voltaren, it is recommended to conduct regular clinical analysis of peripheral blood.
    Masking the signs of the infectious process
    Anti-inflammatory the effect of the Voltaren® preparation may make it difficult to diagnose infectious processes.
    Application simultaneously with other NSAIDs
    Do not use Voltaren® concomitantly with other NSAIDs, including selective COX-2 inhibitors, because of the risk of increased adverse events.
    Effect on the ability to drive transp. cf. and fur:
    Patients who experience visual impairment, dizziness, drowsiness, vertigo, or other abnormalities from the central nervous system against the background of the use of Voltaren® should not drive the vehicle and work with the mechanisms.
    Form release / dosage:Solution for intramuscular injection 25 mg / ml.
    Packaging:3 ml in a glass vial. For 5 ampoules with a break point or a ring of fracture together with instructions for use in a cardboard pack.
    Storage conditions:

    At a temperature of no higher than 30 ° C, in a place protected from light.

    The drug should be stored out of the reach of children.

    Shelf life:2 years. The drug should not be used after the expiry date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:П N011889 / 04
    Date of registration:12.03.2010
    Expiration Date:Unlimited
    The owner of the registration certificate:Novartis Pharma AGNovartis Pharma AG Switzerland
    Manufacturer: & nbsp
    Representation: & nbspNOVARTIS PHARMA LLCNOVARTIS PHARMA LLC
    Information update date: & nbsp06.03.2017
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