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What KetoFLEX 50 mg / ml solution for injection is and what it is used for
How does KetoFLEX 50 mg / ml solution for injection work?
Ketoprofen belongs to the group of non-steroidal anti-inflammatory drugs. KetoFLEX 50 mg / ml solution for injection relieves pain and has anti-inflammatory and antipyretic (antipyretic) effect.
What is KetoFLEX 50 mg / m used for? solution for injection?
To relieve pain (after surgery or after trauma, menstrual pain, as well as pain from bone metastases in patients with tumors);
For the treatment of various rheumatic diseases (rheumatoid arthritis, various types of seronegative spondyloarthritis such as ankylosing spondylitis, psoriatic arthritis and reactive arthritis following infection; gout, pseudogout, osteoarthritis and extraarticular rheumatism, including burntitis and tendinitis and tendinitis).
2. What you need to know before you use KetoFLEX 50 mg / ml solution for injection
Do not use KetoFLEX 50 mg / ml solution for injection
If you are allergic to ketoprofen or any of the other ingredients of this medicine (listed in section 6), to salicylates and other non-steroidal anti-inflammatory drugs.
If you have had difficulty breathing, asthma, worsening pre-existing asthma and nasal congestion or rhinitis while taking ketoprofen, acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs;
If you have an active stomach or duodenal ulcer;
If you have had a stomach or duodenal ulcer in the past, or bleeding from the gastrointestinal tract;
If you suffer from severe liver or kidney disease;
If you suffer from severe heart failure;
If you have a tendency to bleed;
If you currently have active gastrointestinal, cerebrovascular or other bleeding;
If you suffer from a blood clotting disorder or are being treated with anti-coagulants;
If you are pregnant.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using KetoFLEX 50 mg / ml solution for injection.
If you have had gastrointestinal problems in the past. You should be aware that when using non-steroidal anti-inflammatory drugs (NSAIDs), bleeding or perforation of the stomach and intestines may occur suddenly, without previous symptoms or a history of serious gastrointestinal reactions. The risk of gastrointestinal bleeding, perforation or perforation is increased with increasing NSAID doses, in patients with a history of ulceration, especially if it has been complicated by haemorrhage or perforation, and in the elderly. Such patients should start treatment with the lowest possible doses. Patients who have had gastrointestinal problems with such medicines in the past, and especially in the elderly, should report any unusual symptoms in the abdomen (especially gastrointestinal bleeding) and especially in the early stages of the gastrointestinal tract. treatment. If gastrointestinal bleeding or ulceration occurs in patients receiving KetoFLEX 50 mg / ml solution for injection, treatment should be discontinued immediately.
If you are taking medicines that increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, certain antidepressants (SSRIs - selective serotonin reuptake inhibitors) or platelet antiplatelet agents such as acetylsalicylic acid.
NSAIDs should be used with caution in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) due to possible exacerbations.
If you suffer from asthma, chronic rhinitis (nasal congestion and / or nasal discharge), chronic sinusitis, nasal polyps.
If you have impaired liver or kidney function. Renal function and urinary excretion should be monitored in patients with renal and hepatic impairment, in patients on diuretic therapy (drainage therapy), after major surgery, in dehydration and especially in the elderly.
If you have high blood pressure (hypertension) and heart failure with swelling. Regular follow-up is required in patients with hypertension and / or mild to moderate congestive heart failure, as fluid retention and edema have been reported during NSAID therapy. Clinical studies and epidemiological data suggest that the use of some NSAIDs (especially at high doses and long-term treatment) may lead to an increased risk of arterial thrombosis (eg myocardial infarction or stroke). There are insufficient data to rule out such a risk with KetoFLEX 50 mg / ml solution for injection.
KetoFLEX 50 mg / ml solution for injection should be discontinued at the first sign of skin rash, mucosal disorders or other signs of hypersensitivity.
If you have an infectious disease.
In women of childbearing potential, administration of the product may cause reversible suppression of fertility. In women who cannot conceive
Medicinal products whose concomitant use with KetoFLEX 50 mg / ml solution for injection requires precautions to be taken:
Diuretics (medicines to drain). You should be rehydrated before starting concomitant use and your kidney function should be monitored when starting treatment. KetoFLEX 50 mg / ml solution for injection reduces the effects of diuretics.
ACE inhibitors and angiotensin II antagonists (medicines used to treat high blood pressure): in patients with impaired renal function (eg dehydrated or elderly patients), concomitant use with an ACE inhibitor or angiotensin II antagonist may lead to more further deterioration of renal function, including to acute renal failure.
Methotrexate at doses lower than 15 mg per week: complete blood counts should be monitored weekly during the first weeks of co-administration. If there is a change in kidney function or if you are elderly, monitoring should be done more often.
Corticosteroids: due to an increased risk of gastrointestinal ulceration or bleeding.
Medicinal products whose concomitant use with KetoFLEX 50 mg / ml solution for injection requires caution:
Medicines to treat high blood pressure such as beta-blockers, angiotensin converting enzyme inhibitors, diuretics: KetoFLEX 50 mg / ml solution for injection reduces the effects of antihypertensive agents.
Thrombolytics: due to the increased risk of bleeding.
Selective serotonin reuptake inhibitors (medicines used to treat depression): due to an increased risk of gastrointestinal bleeding.
Cyclosporine and tacrolimus (used to suppress the immune response): due to an increased risk of nephrotoxicity, especially in the elderly.
Potassium salts, potassium-sparing diuretics due to the risk of increased potassium levels in the blood when co-administered with KetoFLEX 50 mg / ml solution for injection.
Antiplatelet agents due to increased risk of bleeding.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
KetoFLEX 50 mg / ml solution for injection should not be prescribed during the first and second trimesters of pregnancy unless clearly necessary. If KetoFLEX 50 mg / ml solution for injection is given to a woman trying to become pregnant, or during the first and second trimesters of her pregnancy, the dose should be as low as possible and the duration of administration as short as possible.
KetoFLEX 50 mg / ml solution for injection is contraindicated in the third trimester of pregnancy.
KetoFLEX 50 mg / ml solution for injection is not recommended if you are breast-feeding.
Driving and using machines
In some more sensitive individuals, non-steroidal anti-inflammatory drugs may cause dizziness, vertigo and drowsiness. Visual disturbances are also possible. If you experience such reactions, do not drive or use machines during treatment.
Important information about some of the ingredients of KetoFLEX 50 mg / ml solution for injection
KetoFLEX 50 mg / ml solution for injection contains 12.3 v / v. % ethanol. Each 2 ml dose contains 0.2 g of ethanol. This should be taken into account in patients suffering from alcoholism, patients with brain damage, pregnant or lactating women and children.
3. How to use KetoFLEX 50 mg / ml solution for injection
Always use KetoFLEX 50 mg / ml solution for injection exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.
You will be given one ampoule (100 mg) intramuscularly once or twice a day.
If needed, KetoFLEX 50 mg / ml solution for injection can be combined with capsules.
The infusion should only be used in a hospital setting. The infusion should be continued for a period of Vi - 1 hour to a maximum of 48 hours. The maximum dose is 200 mg in 24 hours.
Your doctor will tell you how long the treatment will last.
If you have the impression that the effect of this medicine is too strong or too weak, talk to your doctor or pharmacist.
If you use more KetoFLEX 50 mg / ml solution for injection than you should
If you are given more KetoFLEX 50 mg / ml solution for injection than you should, talk to a doctor straight away.
In elderly patients, the main signs of overdose are headache, dizziness, drowsiness, nausea, vomiting, diarrhea and abdominal pain. In severe intoxication, hypotension, respiratory depression and bleeding from the gastrointestinal tract have been observed.
An overdose patient should be transferred immediately to a specialist hospital, where symptomatic treatment may be initiated. There is no specific antidote.
If you forget to use KetoFLEX 50 mg / ml solution for injection
The dose should be given as soon as you remember. If it is time for your next dose, wait for the next dose to come at the right time.
A double dose should not be used to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, KetoFLEX 50 mg / ml solution for injection can cause side effects, although not everybody gets them.
In case of serious side effects, treatment should be discontinued.
The classification of adverse reactions is by organ specificity and frequency:
Very common (affects 1 or more in every 10 patients);
Common (affects 1 or more in 100 but less than 1 in 10 patients);
Uncommon (affects 1 or more in every 1000 but less than 1 in every 100 patients);
Rare (affects 1 or more in every 10,000 but less than 1 in every 1,000 patients);
Very rare (affects less than 1 user in 10,000);
Not known (frequency cannot be estimated from the available data).
Disorders of the blood and lymphatic system
Uncommon: thrombocytopenia (decreased number of platelets in the blood), agranulocytosis (severe reduction to complete absence of granulocytes, which are part of white blood cells). Rare: haemorrhagic anemia (decreased number of red blood cells due to bleeding), leukopenia (decreased number of white blood cells).
Immune system disorders
Very rare: anaphylactic reactions (including shock).
Not known: mood swings.
Nervous system disorders
Common: headache, dizziness.
Not known: convulsions.
Rare: blurred vision.
Disorders of the ear and labyrinth
Not known: heart failure.
Not known: hypertension.
Respiratory, thoracic and mediastinal disorders
Uncommon: rhinitis, bronchospasm (especially in patients with hypersensitivity to acetylsalicylic acid or other NSAIDs).
The most common side effects are from the gastrointestinal tract. Ulcers, perforations or bleeding from the gastrointestinal tract may occur, sometimes fatal, especially in the elderly. Nausea, vomiting, diarrhea, gas, constipation, indigestion, abdominal pain, blood in the stool, vomiting of blood, vomiting of ulcers on the oral mucosa, exacerbation of colitis and Crohn's disease have been reported after ingestion. Gastritis is less common.
Common: nausea, abdominal pain, diarrhea, constipation, vomiting and inflammation of the oral cavity.
Uncommon: gastritis. Rare: peptic ulcer.
Very rare: colitis, intestinal perforation and haemorrhage.
Not known: gastrointestinal discomfort, stomach pain and rare cases of colitis.
Rare: hepatitis, elevated transaminases, elevated bilirubin levels due to hepatic impairment.
Disorders of the skin and underlying tissue
Common: skin rash
Uncommon: pruritus, hair loss, urticaria.
Very rare: Large bladder rash, including toxic epidermal necrolysis and Stevens-Johnson syndrome.
Not known: exacerbation of chronic urticaria, angioedema.
Kidney and urinary tract disorders
Water / salt retention may occur with possible swelling, increased potassium levels in the blood.
Renal impairment is possible, which may lead to acute renal failure: isolated cases of tubular necrosis and renal papillary necrosis have been reported. Very rare: acute renal failure, nephritis, nephrotic syndrome.
General disorders and administration site conditions
Injection site reactions, including redness, warmth and pain, may occur.
Clinical studies and epidemiological data suggest that the use of some NSAIDs (especially in high doses and prolonged use) may be associated with an increased risk of arterial thrombosis.
How to store KetoFLEX 50 mg / ml solution for injection
At a temperature below 25 ° C, in the original cardboard box.
Keep out of reach of children!
Do not use this medicine after the expiry date which is stated on the pack.
The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the package and additional information
What KetoFLEX 50 mg / ml solution for injection contains
The active substance is ketoprofen. One ampoule contains 100 mg of ketoprofen.
The other ingredients are: propylene glycol, ethanol (12.3% v / v), benzyl alcohol, sodium hydroxide (for pH adjustment), water for injections.
What KetoFLEX 50 mg / ml solution for injection looks like and contents of the pack
KetoFLEX 50 mg / ml solution for injection is a clear, colorless to pale yellow liquid in brown glass ampoules with a color dot mark.
Ampoules of 2 ml, self-breaking, made of dark neutral glass, type I.
5 or 10 ampoules are placed in a blister of PVC foil.
A single blister, together with a patient leaflet, is placed in a cardboard box.
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