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What is Dekenor injectable / infusion solution and what it is used for
Dekenor injection / infusion solution is a painkiller of the group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It is used to treat acute moderate to severe pain when taking tablets is inappropriate, such as post-operative pain, kidney colic (severe kidney pain) and lower back pain.
2. What you need to know before using Dekenor injection / infusion solution
Do not use Dekenor injection / infusion solution:
if you are allergic to dexketoprofen or any of the other ingredients of this medicine (listed in section 6);
if you are allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
if you have asthma or have suffered from asthma attacks, acute allergic rhinitis (short period of inflammation of the nasal mucosa), nasal polyps (nose lumps due to allergy), urticaria (skin rash), angioedema (swelling of the face, eyes, tongue or respiratory distress) or chest wheals after administration of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
if you have stomach or intestinal bleeding or if you have previously suffered from stomach or intestinal bleeding, ulceration (ulceration) or perforation (mucosal lesion);
if you have or have suffered from gastrointestinal or intestinal bleeding or perforation in the past due to previous use of non-steroidal anti-inflammatory drugs (NSAIDs);
if you have chronic digestive problems (eg indigestion, heartburn) or have chronic bowel disease (Crohn's disease or ulcerative colitis);
if you have severe heart failure, moderate or severe kidney problems or serious liver problems;
if you have bleeding disorder or bleeding disorder;
if you have or have suffered in the past from asthma;
if you are in the third trimester of pregnancy or are breast-feeding.
Warnings and precautions
Talk to your doctor before using Dekenor injectable / infusion solution:
if you have previously suffered from chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
if you have or have suffered in the past from other stomach or intestinal problems;
if you are taking other medicines that increase the risk of peptic ulceration or bleeding, for example, oral steroids, some antidepressants (those of the selective serotonin reuptake inhibitor type), blood-clotting agents such as acetylsalicylic acid or anticoagulants such as warfarin. In such cases, talk to your doctor before using Dechenor injectable / infusion solution: he / she may want to take an additional gastro-resistant medicine (for example, misoprostol or medicines that block gastric acid production);
if you have heart problems, a pre-existing heart attack or think you may be at risk from these conditions (for example, if you have high blood pressure, diabetes or high cholesterol or are a smoker), you should discuss your treatment with your doctor or pharmacist . Medicines such as Dekenor injection / infusion solution may be associated with a slightly increased risk of a heart attack ("myocardial infarction") or stroke. The risk is more likely at high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment;
if you are elderly: you may be more likely to suffer from side effects (see section 4). If any of these reactions occur, talk to your doctor immediately.
if you have an allergy or if you have had allergy problems in the past;
if you have kidney, liver or heart problems (hypertension and / or heart failure) as well as fluid retention or have suffered from any of these problems in the past;
if you are taking diuretics or suffer from very poor hydration (dehydration) and reduced blood volume due to excessive fluid loss (eg excessive urination, diarrhea or vomiting);
if you are a woman with fertility problems (Deennor injection / infusion solution may damage your fertility, so you should not use it if you are planning to become pregnant or do fertility tests);
if you are in the first or second trimester of pregnancy;
if you suffer from a disorder in the formation of blood and blood cells;
if you have systemic lupus erythematosus or mixed connective tissue disease (disorders of the immune system that affect the connective tissue);
if you are under 18 years of age.
Children and adolescents
Deconin injection / infusion solution has not been studied in children and adolescents. Therefore, safety and efficacy have not been established and the medicine should not be used in children and adolescents.
Other medicines and Dekenor injection / infusion solution
Tell your doctor or pharmacist if you have recently used either
Combinations that are not recommended:
acetylsalicylic acid (aspirin), corticosteroids or other anti-inflammatory agents;
warfarin, heparin or other medicines used to prevent the formation of blood clots;
lithium used to treat some mood disorders;
methotrexate used for rheumatoid arthritis and cancer;
hydantoins and phenytoin used for epilepsy;
sulfamethoxazole used for bacterial infections.
Combinations that require precautions:
ACE inhibitors, diuretics, beta-blockers and angiotensin II antagonists used for high blood pressure and heart disease;
pentoxifylline and oxpentifylline, used to treat chronic venous ulcers;
zidovudine, used to treat viral infections;
aminoglycoside antibiotics used to treat bacterial infections;
chlorpropamide and glibenclamide used for diabetes;
Combinations that require careful consideration:
quinolone antibiotics (e.g., ciprofloxacin, levofloxacin) used for bacterial infections;
cyclosporine or tacrolimus, used to treat immune system disorders and organ transplantation;
streptokinase and other thrombolytic or fibrinolytic drugs, i. e. medicines used to break down blood clots;
probenecid used in gout;
digoxin used to treat chronic heart failure;
mifepristone used to induce abortion (to stop pregnancy);
antidepressants such as selective serotonin reuptake inhibitors;
antiplatelet agents used to reduce platelet aggregation (clotting) and the formation of blood clots.
If you have any doubts about taking other medicines with Decenor 50 mg / 2 ml solution for injection / infusion, talk to your doctor or pharmacist.
Pregnancy, breastfeeding and fertility
Do not use Decenor injection / infusion solution during the last three months of pregnancy or when breast-feeding. Ask your doctor for advice.
If you are pregnant, think you may be pregnant or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine as Decenor injection / infusion solution may not be suitable for you.
The use of Decenor injection / infusion solution should be avoided by women who are planning pregnancy or are pregnant. Treatment at any time during pregnancy should only be made as directed by your doctor.
It is not recommended to use Dekenor injection / infusion solution while attempting to become pregnant or during infertility testing.
Driving and using machines
Deconin injection / infusion solution may slightly affect your ability to drive and use machines due to the possibility of dizziness or drowsiness as undesirable effects of treatment. If you notice such effects, do not drive or operate machinery until the symptoms disappear. Ask your doctor for advice.
Deconin injection / infusion solution contains ethanol and sodium
Each ampoule of Dekenor injection / infusion solution contains 200 mg of ethanol equivalent to 5 ml of beer or 2.08 ml of wine per dose. Harmful to those who suffer from alcoholism.
To be taken into consideration in pregnant or breastfeeding women, children and high-risk groups such as patients with liver disease or epilepsy.
This medicine contains less than 1 mmol sodium (23 mg) per dose, ie. essentially "does not contain sodium".
3. How to use Dekenor 50 mg / 2 ml solution for injection / infusion
Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.
Your doctor will tell you what the dose of Decenor injection / infusion solution you need, depending on the type, severity and duration of symptoms.
The recommended dose is usually 1 ampoule (50 mg) of Decenor injection / infusion solution every 8-12 hours. If necessary, the injection may be repeated after only 6 hours. In any case, do not exceed the total daily dose of 150 mg Dekenorer 50 mg / 2 ml solution for injection / infusion (3 ampoules).
Use injection treatment only during the acute period (ie no longer than two days). Switch to oral painkiller whenever possible.
Elderly patients with impaired renal function and patients with renal or hepatic impairment should not exceed a total daily dose of 50 mg Decenor Solution for Injection / Infusion (1 ampoule).
Dekenor injection / infusion solution can be administered intramuscularly or intravenously (details of the intravenous injection technique are given in section 7). When a solution for injection / infusion solution is given intramuscularly, the solution should be injected immediately after removal from the colored ampoule by slowly injecting deep into the muscle.
Only clear and colorless solution should be used.
Use in children and adolescents
This medicine should not be used in children and adolescents (under 18 years of age).
If you use more than the required dose of Decenor injection / infusion solution
If you use too much of this medicine, tell your doctor or pharmacist immediately or go to the emergency room of the nearest hospital. Please do not forget to take this medicine or this leaflet with you.
If you forget to use a solution for injection / infusion solution
Do not use a double dose to make up for the missed dose. When it is time, use the next regular dose (according to section 3 "How to use a solution for injection / infusion solution").
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Possible side effects are listed below depending on how likely they are.
Common side effects: may affect up to 1 in 10 people:
Nausea and / or vomiting, injection site pain, injection site reactions, such as inflammation, bruising or bleeding.
Uncommon side effects: may affect up to 1 in 100 people:
Vomiting blood, low blood pressure, fever, blurred vision, dizziness, sleepiness, sleep disturbances, headache, anemia, abdominal pain, constipation, digestive problems, diarrhea, dry mouth, redness, rash, dermatitis, itching, sweating, fatigue, pain, feeling cold.
Rare side effects: may affect up to 1 in 1,000 people:
Peptic ulcer, peptic ulcer hemorrhage or peptic ulcer perforation, high blood pressure, fainting, too slow breathing, inflammation of the surface vein due to blood clot (surface thrombophlebitis), single heart rate (extrasystoles), accelerated heartbeat, peripheral edema, larynx edema, abnormal sensation, fever and shaking, tinnitus, itchy rash, jaundice, acne, back pain, kidney pain, frequent urination, menstrual disorders, prostate problems, muscle stiffness, stiffness (hyperglycaemia), low blood sugar (hypoglycaemia), increased triglyceride fat in the blood (hypertriglyceridemia), ketone bodies in the urine (ketonuria ), urinary proteins (proteinuria), hepatic cell damage (hepatitis), acute renal failure.
Very rare: may affect up to 1 in 10,000 people:
Anaphylactic reaction (hypersensitivity reaction that can lead to collapse), skin, mouth, eye and genital area ulcers (Stevens-Johnson and Lyal syndromes), swelling of the face or swelling of the lips and throat (angioedema), shortness of breath (bronchospasm), dyspnoea, pancreatitis, skin sensitization and skin hypersensitivity to light, renal impairment, low white blood cell count (neutropenia), decreased platelet count (thrombocytopenia).
Tell your doctor immediately if you notice any stomach / intestinal side effects at the beginning of treatment (for example, stomach ache, stomach acid or bleeding) if you have previously suffered from such side effects due to prolonged use of anti-inflammatory drugs, especially if you are in the elderly.
Stop using Decenor 50 mg / 2 ml solution for injection / infusion as soon as you notice a skin rash or some damage to mucosal surfaces (for example, the inner part of the mouth) or any sign of allergy.
During treatment with non-steroidal anti-inflammatory drugs, fluid retention and swelling (especially ankles and feet), increased blood pressure and heart failure have been reported.
Medicines such as Decenor injection / infusion solution may be associated with a slightly increased risk of a heart attack ("myocardial infarction") or stroke.
In patients with systemic lupus erythematosus or mixed connective tissue disease (disorders of the immune system that affect connective tissue), anti-inflammatory drugs can rarely cause fever, headache and backache.
How to store Dekenor injection / infusion solution
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Store in the original package in order to protect from light.
This medicine does not require special storage conditions.
After dilution according to the instructions given in section 6.6, the chemical and physical stability of the diluted solution during use is demonstrated for 24 hours at 25 ° C if adequately shielded from natural daylight.
From a microbiological point of view, unless the dilution method excludes the risk of microbial contamination, the product should be used immediately. If not used immediately, storage times and conditions during use are the responsibility of the user.
Do not dispose of medicines in the sewage system or in the household waste container.
Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Package Contents and Additional Information
What Dekenor contains Injection / infusion solution
The active substance is dexketoprofen. Each ampoule of 2 ml solution for injection / infusion contains 50 mg dexketoprofen (as dexketoprofen trometamol).
The other ingredients (excipients) are: sodium chloride, ethanol (96%), sodium hydroxide (for pH adjustment) and water for injections. See section 2 "Decenor 50 mg / 2 ml solution for injection / infusion contains ethanol and sodium".
What Decenor looks like and what the package contains
Injection / infusion solution (injection / infusion) solution is a clear, colorless solution virtually free of visible particles (pH: 7.0 - 8.0, osmolarity: 270 - 328 mOsmol / l).
Injection / infusion solution dispenser is provided in cartons of 1, 5 or 10 ampoules of 2 ml injection / infusion solution.
Not all pack sizes may be marketed.
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