Ketonal amp. 100 mg. 2 ml. 10 amp
Ketonal amp. 100 mg. 2 ml. 10 amp
What Ketonal ?
Ketoprofen belongs to the group of NSAIDs. Ketonal relieves pain and has anti-inflammatory and antipyretic (high temperature) effect.
What used Ketonal ?
For short-term symptomatic treatment of acute rheumatic inflammatory diseases and radikulitni lumbar pain, pain of tumor origin postoperative pain in adults and children over 15 years.
When you need to apply Ketonal ?
If you are hypersensitive to ketoprofen or any of the excipients in Ketonal ®, aspirin and other nonsteroidal anti-inflammatory drugs
If you have an active gastric or duodenal ulcer
If you have had gastric or duodenal ulcers or bleeding from the gastrointestinal tract
If you have had chronic dyspepsia (discomfort or pain in the upper stomach)
If you suffer from severe liver and kidney disease
If you tend to bleed
When should observe precautions for use Ketonal
If you have had gastrointestinal problems
If you have a bleeding disorder
If you are taking anti-clotting medications (anticoagulants)
If impaired hepatic or renal function
If you have high blood pressure (hypertension) and heart failure with edema
If you have an infectious disease
If you consume large amounts of alcohol or are a smoker
If you are elderly
Tell your doctor if any of these conditions apply to you.
If you are going to have surgery to stop the implementation of
In women of childbearing potential application of this product may cause reversible inhibition of fertility.
What food and drink can influence the effect of Ketonal ?
It is advisable to avoid alcohol during treatment with Ketonal .
What special precautions should be taken during pregnancy and lactation?
Ask your doctor or pharmacist before taking any medicine.
You should not apply Ketonal during the third trimester of pregnancy, as NSAIDs can cause delayed birth process, premature closure of the Strait of Botallo and pulmonary hypertension in the newborn. In the first and second trimesters Ketonal ® should be used only if the potential benefit outweighs the potential risk. Ketonal should not be used if you are breastfeeding.
What you must consider when driving or operating machinery?
In some sensitive individuals NSAIDs can cause lightheadedness, dizziness and drowsiness. If you experience these effects, do not drive or operate machinery during treatment.
Information on excipients in the formulation of Ketonal
The product contains 12.3 vol% (V / v) ethanol. Each 2 ml ampoule contains 0.2 g of ethanol. The ethanol can be dangerous for patients with liver disease who suffer from alcoholism, epilepsy, brain injury or brain disease, pregnant and lactating women and children. It is also possible to modify or increase the effect of other medicines.
What other drugs affect Ketonal effect or may be affected by it?
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Do not take Ketonal concomitantly with other NSAIDs or aspirin, for example. acetylsalicylic acid. The effect of drugs to treat high blood pressure and diuretics may be reduced by concurrent use with Ketonal . The effect of drugs for epilepsy and diabetes may increase during concomitant use with Ketonal .
The risk of renal impairment is greater in patients taking diuretics and ACE inhibitors concomitantly with Ketonal .
The risk of bleeding increases with concomitant use of Ketonal and anticoagulants (blood clotting drugs) or corticosteroids. Adverse effects of drugs such as cardiac glycosides, lithium, methotrexate, or cyclosporine are enhanced by concomitant use of Ketonal ®, due to reduced removal.
The effect of mifepristone may be reduced during concomitant use with NSAIDs. Therefore, they should not be taken 8-12 days after using mifepristone.
Dosage, method and duration of administration:
Follow the doctor's instructions carefully. Do not change the dosage and do not stop treatment without consulting your doctor.
Will be given one ampoule intramuscularly (100 mg) once or twice daily. If necessary Ketonal ®injections can be combined with the intake of capsules.
The infusion should be administered only in a hospital setting. The infusion should be continued for a period of 1/2 - \ h to a maximum of 48 hours. The maximum dosage is 300 mg per 24 hours.
How long can you take Ketonal ?
Your doctor will tell you how long treatment.
If you feel that the effect of the drug is too strong or too weak, talk to your doctor or pharmacist.
What should I do if Ketonal ® was administered in very large quantities (intentional or unintentional overdose)?
If you apply more than the prescribed dose Ketonal , talk to your doctor.
High doses of the drug can cause nausea, vomiting, epigastric pain, vomiting of blood, black stools, impaired consciousness, respiratory depression, convulsions, decreased kidney function and kidney failure.
What should I do if omitted pursuant to Ketonal
The dose should not be administered as soon as you remember. If it is time for your next dose, wait until the next dose you receive at the appointed time.
You should not apply a double dose to compensate for the missed dose. What side effects can cause the application of Ketonal ?
As with any drug Ketonal can cause side effects.
The most common one that occurs in 11% of patients had poor or painful indigestion (dyspepsia), which is manifested by early sense of satiation, bloating, belching after eating, nausea, flatulence, abdominal pain and heartburn in the upper stomach.
Common side effects (occurring in 3-9% of patients) were nausea, diarrhea, constipation, flatulence and abdominal pain and weakness, dizziness or vertigo A.
In Z 1-3% of patients (often) can occur refusal of food (anorexia)
vomiting or inflammation of the mouth, tinnitus, depression or nervousness, nightmares, drowsiness, visual disturbances, skin rash or swelling (in 2% of patients).
Less than 1% of patients (infrequently) may occur changes in blood counts, anemia, pinpoint bleeding, destruction of red blood cells (hemolysis), psychiatric disorders with visual and auditory hallucinations, disorientation and speech (delirium), high blood pressure, heart failure, bloody sputum (hemoptysis), shortness of breath (dyspnea), inflammation of the throat or nose, narrowing of the airways, swelling of the throat (a symptom of an anaphylactic reaction), hair loss, eczema, sweating, urticaria, skin reactions including scaling (exfoliative dermatitis), or bleeding outside the menstrual cycle in women. It is possible to display and headache.
A Isolated cases of colitis, intestinal perforation (including polyps, and complications of diverticulitis), worsening bowel disease (ulcerative colitis and Crohn's disease), disease of the small intestine with mild bleeding and loss of proteins with the characteristics of the ulcer, blockage or perforation, jaundice, liver disease, one case of severe skin disease, inflammation and renal failure have been reported. It is possible to trigger an attack of asthma.
It is possible to seal up and pain at the injection site.
What measures should be taken in relation to side effects?
Stop taking Ketonal immediately and tell your doctor or go to the nearest emergency room if you notice the following effects:
Swelling of hands, feet, ankles, face, lips, mouth or throat which may cause zatrtrudneno swallowing or breathing
Jaundice (yellow skin and eyes)
These are very serious but rare side effects. If you notice any of them means that you're very serious allergic reaction to Ketonal and need urgent medical attention.
Tell your doctor if you notice any of the following:
Pain in upper stomach after eating
Vomiting of blood
These effects are severe, but rare, require immediate medical attention.
If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Keep out of reach of children.
Store at temperatures below 25 ° C in the original package.
Do not use after the expiry date stated on the packaging.
Additional Information for Healthcare Professionals
Dosage and method of administration
Intramuscular: the recommended intramuscular dose is one ampoule (100 mg) once or twice daily.
If necessary, treatment may be accompanied by oral, rectal or transdermal therapy.
Daily dose of Ketonal ® can be increased to 300 mg or decreased to 100 mg, depending on the disease and the patient.
Intravenous infusion: infusion should be administered only in hospital for a period of ½ -1 hours to a maximum of 48 hours. The maximum dosage is 300 mg per 24 hours.
Intermittent intravenous infusion: 100-200 mg ketoprofen, diluted in 100 ml 0.9% sodium chloride is applied to ½ -1 hours, infusion repeated every 8 hours. The maximum dosage is 300 mg per 24 hours.
Continuous infusion: 100-200 mg ketoprofen, diluted in 500 ml infusion solution (0.9% sodium chloride, Renger pact glucose) is applied for 8 hours, the infusion can be repeated every 8 hours. The maximum dosage is 300 mg per 24 hours.
Ketoprofen can be combined with centrally acting analgesics can be combined with morphine in the same bank: 10-20 mg morphine and 100 to 200 mg
ketoprofen diluted in 500 ml 0.9% sodium chloride or Ringer lactate and applied in 8:00. The maximum dosage is 300 mg per 24 hours.
Do not mix tramadol and ketoprofen in the same bank as it forms a precipitate.
Banks infusion should be wrapped in black paper or aluminum foil as ketoprofen is sensitive to light.
Dosage in renal failure
In patients with creatinine clearance less than 0.33 ml / sec (20 ml / min) required dose adjustment.
What is the active ingredient?
Each ampoule of 2 ml contains 100 mg of ketoprofen.
What else contains Ketonal ®?
Propylene glycol, ethanol (12.3 voI%), Benzyl alcohol, sodium hydroxide (for pH adjustment) and water for injections.
Formulation and packaging:
Injection. Packs of 10 or 50 ampoules.