What is Ketavel and What is it Used For? Side Effects and Prospectus

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What is KETAVEL and what is it used for?

KETAVEL is a pain reliever from the group of drugs called non-steroidal anti-inflammatory drugs (NSAITER).

It is used for the symptomatic treatment of moderate to severe postoperative pain, renal colic (severe kidney pain) and back pain in patients who cannot take medication in the form of tablets.

KETAVEL contains 50 mg of dexketoprofen (trometamol) and is available in 2 ampoules of packaging, each containing 6 ml of clear and colorless solution.

What are the Side Effects?

Like all drugs, there may be side effects in people who are sensitive to substances contained in KETAVELin.

Possible side effects are listed below based on how often they occur. This table shows how many patients these side effects can occur:

Common:

More than 100 patients and less than 10 patients Eden

Uncommon:

More than 1,000 patients Eden and less than 100 ’ in 1 patient

Sparse:

More than 10,000 patients and less than 1,000 patients

Very rare:

less than Eden in 10,000 patients including isolated reports

Common Side Effects

  • Nausea and/or vomiting
  • Pain at the injection site.
  • Reaction at the injection site, including inflammation, bruising and redness (bleeding)

    • Uncommon side effects

  • Bloody vomiting,
  • Low blood pressure,
  • Fever
  • Blurred vision, the,
  • Dizziness
  • Sleepiness
  • Sleep disorders, and,
  • Headache
  • Nonsensitivity,
  • Abdominal pain
  • Constipation
  • Digestive disorders, the,
  • Diarrhea
  • Dry mouth
  • Al bass
  • Rash
  • Dermatitis,
  • Itch
  • Excessive sweating
  • Fatigue
  • Pain,
  • Chilling

    • Rare Side Effects

  • Peptic ulcer, peptic ulcer bleeding or perforation of the stomach or intestine due to peptic ulcer, etc,
  • High blood pressure
  • Fainting
  • Do not breathe too slowly,
  • Inflammation of superficial balls vessels due to blood clots (surfaceal thrombophlebitis)
  • Isolated heart rhythm disorder (extrasystole)
  • Fast heartbeat
  • Peripheral edema (swelling in the legs and arms),
  • Abnormality in the senses
  • Feeling the fire rising and trembling, the,
  • Ringing in the ears (tinnitus)
  • Itchy rash,
  • Jaundice,
  • Acne
  • Back pain
  • Kidney pain, the,
  • Frequent urination
  • Menstrual irregularities,
  • Prostate problems
  • Muscle stiffness, the,
  • Joint rigidity, the,
  • Muscle cramp
  • Abnormal liver tests (blood tests), elevated blood sugar levels (hyperglycemia), decreased blood sugar level (hypoglycemia), increased concentration of triglyceride fats in the blood (hypertriglyceridemia), ketone bodies in urine (ketonuria), etc, protein in urine (proteinuria).

    • Very rare:

  • Anaphylactic reaction (hypersensitivity reaction that can lead to collapse)
  • Ulcer formation in the skin, mouth, eyes and genital areas (Stevens Johnson and Lyell syndromes), and,
  • Percent swelling or swelling of the lips and throat (angioneurotic edema),
  • Breathlessness due to contraction of muscles around the airways (broncospasm)
  • - stenosis of the feet,
  • Pancreatitis,
  • Liver cell poppy (hepatitis),
  • Skin sensitivity reactions and hypersensitivity to light, the,
  • Kidney damage,
  • Decrease in the number of white blood cells (neutropenia),
  • Decrease in the number of blood plows (thrombocytopenia),

    • If you notice any stomach/gut side effects at the beginning of treatment (e.g., stomach pain, heartburn, or bleeding), you may, if any side effects have occurred in advance due to long-term use of anti-inflammatory drugs, and especially if you are old, tell your doctor immediately.

    Stop the use of KETAVEL as soon as you notice any lesions appear on the skin rash or mucous surfaces (for example, in the mouth) or any signs of allergies.

    During treatment with non-steroidal anti-inflammatory drugs, increased blood pressure and heart failure were reported in fluid retention and swelling (especially in the wrists and legs).

    Medications such as KETAVEL may be associated with a slight increase in the risk of heart attack (“myocardial infarction”) or stroke.

    Anti-inflammatory drugs in patients with systemic lupus erythematosus (a disease manifested by extensive flaking in the skin) or mixed connective tissue disease (immune system disorders affecting connective tissue), rarely fever, they can lead to headaches and stiffness in the neck.

    If signs of infection occur or symptoms worsen while using KETAVEL, tell your doctor immediately.

    If side effects worsen or if you notice side effects that are not listed in this instructions for use, please contact your doctor or pharmacist.

    how is KETAVEL Used?

    If you have any further questions about the use of this product, ask your doctor or pharmacist.

    things to consider before using KETAVEL

    who Shouldn't KETAVEL be Used by?

    If,

    • if you are allergic (hypersensitive) to dilexketoprofen trometamole or any of the excipients in KETAVELin;

  • if you are allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;

    • • asthma attack, acute allergic rhinitis (short-term inflammation of the nose due to allergy), if you have asthma or have used acetylsalicylic acid or other non-steroidal anti-inflammatory drugs in the past, nasal polyps (lumps formed in the nose depending on the allergy), urticaria (skin rash), swelling of the face and throat as a result of allergies (face, eyes, eyes, swelling or difficulty breathing in the lips or tongue) or wheezing (vvheezing) have occurred;

  • if you have peptic ulcer or have previously complained;
  • if stomach or intestinal bleeding or perforation has occurred due to previous use of non-steroidal anti-inflammatory drugs (NSAIDs), or if you have had such a complaint in the past
  • if you have ongoing digestive problems (such as indigestion, burning in the chest) or an ongoing inflammatory bowel disease (Crohn's disease or ulcerative colitis);

    • • if you have severe heart failure, moderate or severe kidney problems, or severe liver problems; or;

  • if you have a bleeding disorder or blood clotting disorder;
  • if you are in your third trimester of pregnancy or breastfeeding.

    • What Should KETAVEL Users Pay Attention to?

    If,

  • if you have had an ongoing inflammatory bowel disease in the past (ulcerative colitis, Crohn's disease);
  • if you have stomach and bowel problems or have had complaints in the past;

    • • other drugs that increase the risk of peptic ulcers or bleeding, eg. oral steroids, some antidepressants (SSRI-type drugs, for example Selective Serotonin Reuptake inhibitors), if you are taking anticoagulants such as warfarin or agents that prevent blood clotting such as acetylsalicylic acid, in such cases, consult your doctor before taking KETAVEL. Your doctor may ask you to take an additional medication to protect your stomach (e.g., misoprostol or drugs that block stomach acid production).

  • if you have heart problems, have had a stroke before, or think you are at risk (for example, if you have high blood pressure, diabetes, or high cholesterol, or smoke), consult your doctor or pharmacist about your treatment. Medications such as KETAVEL may be associated with a slightly increased risk of heart attack (“myocardial infarction”) or stroke. With high doses and long-term treatment, all kinds of risks are more likely. Do not exceed the recommended dose or duration of treatment.
  • if you are older: you are more likely to experience side effects, especially bleeding and perforation of peptic ulcers can be life-threatening (see. Of Section 4). If any of these occur, contact your doctor immediately;
  • if you have allergy complaints or have had allergic problems in the past;
  • if, besides fluid retention, you have had kidney, liver or heart problems (high blood pressure and/or heart failure) or any of these problems in the past;
  • if you are taking diuretic (uridizing) medications or you are experiencing water loss and decreased blood volume due to excessive fluid loss (e.g., excessive urination, diarrhea or vomiting);
  • if you have fertility problems (KETAVEL can negatively affect fertility, so do not use this drug if you plan to get pregnant or have a fertility test);
  • if you are in the first or second trimester of your pregnancy;
  • if you have a complaint of irregularity in the production of blood or blood cells;
  • if you have systemic lupus erythematosus (a disease that manifests itself in widespread skin flaking) or mixed connective tissue disease (immune system disorders that can affect connective tissue);
  • If you are under 18 years old.
  • if you experience any of the following during your treatment, stop taking the drug and urgently seek medical attention: if blood comes from the stool, tarry stool of black color, blood vomiting or dark parts similar to coffee grounds; if there are any;
  • if you suffer from indigestion or heartburn, pain in the abdominal area (pain in the stomach) or other abnormal stomach symptoms, stop taking the medication and consult your doctor.

    • If these warnings apply to you, even at any time in the past, please consult your doctor.

    Food and Beverage Consumption Together With KETAVEL

    What are the foods and drinks that are inconvenient to be consumed with the specified medication? What should we eat or not eat?

    No warning is required due to the route of application.

    Is it Used During Pregnancy (Pregnancy) Period?

    Consult your doctor or pharmacist before using the medicine.

    Do not use KETAVELi during the third trimester of pregnancy.

    Unless very necessary, not taking KETAVELari during the first or second trimester of pregnancy will be the best choice.

    Tell your doctor if you are pregnant. If you are planning to get pregnant, using KETAVEL may not be right for you.

    If you notice that you are pregnant during treatment, consult your doctor or pharmacist immediately.

    Can it be Used During Breastfeeding?

    Consult your doctor or pharmacist before using the medicine.

    Do not use KETAVEL if you are breastfeeding.

    Vehicle and machinery use

    KETAVEL, due to the possibility of dizziness or drowsiness as a side effect of treatment, may affect your ability to drive vehicles and machines. If you notice these effects, do not use the tool or machine until the symptoms have passed. Consult your doctor for advice.

    What is KETAVEL Active Ingredient?

    Each KETAVEL ampoule contains 5 mg of ethanol equivalent to 2.08 ml of beer or 200 ml of wine per dose. Alcohol can be harmful to those with addiction. It should be considered for pregnant or lactating women, children and patients in high-risk groups such as liver disease or epilepsy.

    This drug product contains less than 1 mmol (23 mg) of sodium per dose; no side effects due to sodium at this dose are expected.

    Is It Used With Other Drugs?

    If you are taking any of the following medications besides KETAVELin, be sure to inform your doctor, dentist or pharmacist. Some medications may not be used together or their doses may need to be adjusted if used.

    Unrecommended combinations:

  • Acetylsalicylic acid (aspirin), corticosteroids or other anti-inflammatory drugs
  • Warfarin, heparin or other drugs used to prevent blood clots
  • Lithium used in the treatment of specific mood disorders
  • Methotrexate used for rheumatoid arthritis (a persistent disease that causes pain and disfigurement in joints) and cancer treatment
  • Hidantoins and phenytoin used for epilepsy (sara)
  • Sulfamethoxazole used for bacterial infections (inflammatory microbial disease)

    • Combinations requiring precautions:

  • ADE inhibitors, diuretics, beta-blockers and angiestensin II antagonists used in high blood pressure and heart problems
  • Pentoxifylline and oxpentifillin used in the treatment of persistent venous ulcers
  • Zidovudin used in the treatment of viral infection
  • Chlorpropamide and glibenclamide used for diabetes

    • Combinations that need attention:

  • Antibiotics of quinolone used for bacterial infections (e.g., ciprofloxacin, levofloxacin)
  • Cyclosporine or tacrolimus used in the treatment of immune system diseases and organ transplantation
  • Streptokinase and other thrombolytic or fibrinolytic drugs, namely drugs used to dissolve blood clots
  • Probenecid used in the treatment of gout
  • Digoxin used in the treatment of ongoing heart failure
  • Mifepristone used to end pregnancy
  • Antidepressants in the type of selective serotonin reuptake inhibitors (SSRITer)

    • • anti-thrombocyte agents used for thrombocyte aggregation (clumping of blood plows) and reducing blood clot formation

    If you are currently taking any prescription or over-the-counter medications or have recently used them, please tell your doctor or pharmacist about them.

    To download the KETAVEL prospectus as a PDF file here
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