Active substanceDiclofenacDiclofenac
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  • Dosage form: & nbspSolution for intramuscular injection.
    Composition:
    Active substance:

    diclofenac sodium - 25 mg

    Excipients:

    propylene glycol 200 mg, mannitol (mannitol) 6 mg, benzyl alcohol 40 mg, sodium disulfite (sodium pyrosulfite) 3 mg, 1 M sodium hydroxide solution to pH 8.4, water for injection up to 1 ml.
    Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug (NSAID).
    ATX: & nbsp

    S.01.B.C.03   Diclofenac

    M.01.A.B.05   Diclofenac

    Contraindications:
    Hypersensitivity to diclofenac (including other NSAIDs) and to other components of the drug. Exacerbation of peptic ulcer of the stomach and duodenum, ulcerous bleeding and perforation of the gastrointestinal tract.
    Complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (including in the anamnesis).
    Severe hepatic insufficiency or any active liver disease, severe renal failure (QC less than
    30 ml / min), decompensated heart failure.
    Conditions accompanied by a risk of bleeding, such as hemophilia and other bleeding disorders (including cerebrovascular hemorrhages).
    Confirmed hyperkalemia.
    Aortocoronary bypass surgery (perioperative period).
    Inflammatory bowel disease (Crohn's disease, ulcerative colitis) in the phase of exacerbation.
    Pregnancy.
    Children's age (up to 18 years).
    The drug is not recommended for use during breastfeeding.
    Carefully:
    When using the drug diclofenac and other NSAIDs, careful medical observation of patients with gastric or intestinal ulcer, Helicobacter pylori infection, ulcerative colitis, Crohn's disease, history of liver function disorder, or patients presenting with complaints, indicating the diseases of the gastrointestinal 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 the drug diclofenac in patients receiving drugs that increase the risk of gastrointestinal bleeding: systemic glucocorticosteroids (incl. prednisolone), anticoagulants (incl. warfarin), antiplatelet agents (including clopidogrel, acetylsalicylic acid) or selective inhibitors of the inverse
    seizure of serotonin (including citalopram, fluoxetine, paroxetine, sertraline).
    Caution is necessary when prescribing the drug diclofenac in patients with mild and moderate impairment of liver function, as well as in patients with hepatic porphyria, since the drug can provoke porphyria attacks.
    It should be used with caution in patients with bronchial asthma, seasonal allergic rhinitis, edema of the nasal mucosa (including nasal polyps), chronic obstructive pulmonary disease, chronic respiratory infections (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, peripheral vascular disease), impaired renal function, including chronic renal failure (clearance
    creatinine 30-60 ml / min), in patients with dyslipidemia / hyperlipidemia, diabetes mellitus, hypertension, in the 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 circulating blood of any etiology, for example, before and after massive surgical
    interventions.
    Use with caution the drug diclofenac in patients with defects in the hemostasis system.
    Caution should be exercised in patients at risk of developing cardiovascular thrombosis (including myocardial infarction and stroke).
    Care should be taken when using the drug diclofenac 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 with intramuscular injection of the drug diclofenac patients with bronchial asthma because of the risk of exacerbation of the disease, since the sodium disulfite contained in the preparation is capable of causing severe undesirable reactions.
    Pregnancy and lactation:
    The drug is contraindicated in pregnancy. If you need to use the drug during lactation, breastfeeding should be discontinued.
    Special instructions:
    Lesion of the gastrointestinal tract.
    When using diclofenac, such phenomena as bleeding or ulceration / perforation of the gastrointestinal tract, in some cases with a fatal outcome, were noted. These phenomena can occur at any time with the use of drugs in patients with the presence or absence of previous symptoms and serious gastrointestinal diseases in or without anamnesis. In elderly patients, such complications can have serious consequences. When developing in patients receiving the drug diclofenac, bleeding or ulceration of the gastrointestinal tract, the drug should be discarded.To reduce the risk of toxic effects on the gastrointestinal tract to patients with gastrointestinal ulcer, especially complicated bleeding or perforation in the anamnesis, as well as
    In elderly patients, the drug should be administered at the lowest effective dose at the lowest possible short course.
    Patients with an increased risk of developing gastrointestinal complications, as well as patients receiving low-dose acetylsalicylic acid (aspirin), or other drugs that can increase the risk of GI loss, should take gastroprotectors (for example, proton pump inhibitors or
    misoprostol). Patients with a history of gastrointestinal disease, especially the elderly, should be informed of all symptoms
    from the digestive system.
    Skin Reactions
    Serious dermatological reactions such as exfoliative dermatitis, Stevens-Jones syndrome, toxic epidermal necrolysis, in some cases fatal, against diclofenac were noted
    rarely. When developing in patients receiving the drug diclofenac, the first signs of skin rash, lesions of mucous membranes or other symptoms of hypersensitivity, the drug should be canceled.
    Masking the signs of the infectious process
    Anti-inflammatory effect of the drug diclofenac can make it difficult to diagnose infectious processes.
    Use with other NSAIDs
    Do not prescribe a drug diclofenac together with other NSAIDs, including selective inhibitors of COX-2 because of the risk of increased adverse events.
    Effects on the liver
    Since during the period of drug use diclofenac there may be an increase in activity of one or more
    "hepatic" enzymes, with 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 discontinued. It should be borne in mind that hepatitis against the background of the drug diclofenac can develop without prodromal phenomena.
    Effects on the kidneys
    Against the background of drug therapy diclofenac it is recommended to monitor renal function in patients with hypertensive
    heart disease, kidney disease, elderly patients, 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 of any etiology, for example, 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 hematopoietic system
    A drug diclofenac may temporarily inhibit platelet aggregation. Therefore, patients with hemostasis disorders should carefully monitor the relevant laboratory indicators.
    Patients with bronchial asthma
    Exacerbation of bronchial asthma (NSAID intolerance / bronchial asthma induced by NSAID intake), Quincke's edema and urticaria are most often noted in patients with bronchial asthma, seasonal allergic rhinitis, nasal
    polyps, chronic obstructive pulmonary disease or chronic infectious respiratory diseases (especially associated with allergic rhinitis-like symptoms).In this group of patients, as well as in patients with allergies to other drugs (rash, itching or urticaria) with the appointment of diclofenac
    special care must be taken (readiness for resuscitation).
    Impact on fertility
    Because the diclofenac, like other NSAIDs, can have a negative effect on fertility, women,
    planning pregnancy, it is not recommended to take the drug.
    Patients, undergoing examination and treatment for infertility, the drug should be discarded.
    Effect on the ability to drive transp. cf. and fur:
    Patients who, against the background of the drug diclofenac there are visual disturbances, dizziness, drowsiness, vertigo or other disorders from the central nervous system should not drive vehicles and engage in other potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions.
    Form release / dosage:
    Solution for intramuscular injection 25 mg / ml.
    Packaging:
    For 3 ml with a capacity of 3 ml or 5 ml in neutral glass ampoules.

    For 10 ampoules with instruction for use and a knife for opening ampoules or a scarifier ampullum is placed in a box of cardboard. By 5 or 10 ampoules per contour cell packaging of polyvinyl chloride film or polyethylene terephthalate and aluminum foil or paper with polyethylene coating or without foil, or without paper. For 1 or 2 contour squares with instructions for use and a knife for opening ampoules or a scarifier ampullum is placed in a pack of cardboard. When you pack the ampoules with a break ring or break point, the ampoule opener or ampoule scapper is not put in.
    Storage conditions:Store in a dark place at a temperature of 15 to 25 ° C. Keep out of the reach of children.
    Shelf life:2 years.
    Terms of leave from pharmacies:On prescription
    Registration number:P N001279 / 01
    Date of registration:23.04.2007
    The owner of the registration certificate:NOVOSIBHIMFARM, OJSC NOVOSIBHIMFARM, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp11.03.2016
    Illustrated instructions
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