Dekenor

Package Leaflet: Information for the User

Dekenor 50 mg/2 mL Solution for Injection/Infusion

Dexketoprofen

Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, as you may need to read it again.
• In case of any further questions, consult a doctor, pharmacist, or nurse.
• If the patient experiences any side effects, including any not listed in this package leaflet, inform a doctor or pharmacist. See section 4.

Package Leaflet Contents

• 1. What is Dekenor and What is it Used For
• 2. Important Information Before Using Dekenor
• 3. How to Use Dekenor
• 4. Possible Side Effects
• 5. How to Store Dekenor
• 6. Package Contents and Other Information

1. What is the Medication and What is it Used For

Dekenor is a Pain Relief Medication Belonging to a Group of Medications Called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). It is Used to Treat Moderate to Severe Acute Pain, When Oral Administration is Not Appropriate, Such as Post-Operative Pain, Renal Colic Pain (Severe Kidney Pain), and Lower Back Pain.

2. Important Information Before Using Dekenor

When Not to Use Dekenor:

• If the Patient is Allergic to Dexketoprofen or Any of the Other Ingredients of this Medication (Listed in Section 6);
• If the Patient has a Hypersensitivity to Acetylsalicylic Acid or Other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs);
• If the Patient has Asthma or has Had Asthma Attacks in the Past, Acute Allergic Rhinitis (Short Period of Nasal Mucosa Inflammation), Nasal Polyps (Growths Inside the Nose Caused by Allergy), Urticaria (Skin Rash), Angioedema (Face, Eye, Lip, or Respiratory Tract Swelling), or Wheezing After Taking Acetylsalicylic Acid or Other NSAIDs; If the Patient has Had Hypersensitivity Reactions to Sunlight in the Past: Photoallergic or Phototoxic Reactions (Particularly in the Form of Redness and/or Blisters on the Skin Exposed to the Sun) When Taking Ketoprofen (Non-Steroidal Anti-Inflammatory Drug) or Fibrates (Drugs Used to Lower Blood Lipid Levels);
• If the Patient has Stomach or Duodenal Ulcer Disease or Gastrointestinal Bleeding, or if They Have Had Gastrointestinal Bleeding, Ulcer, or Perforation in the Past;
• If the Patient has Chronic Gastrointestinal Problems (e.g., Indigestion, Heartburn);
• If the Patient has Had Gastrointestinal Bleeding or Perforation Due to the Use of NSAIDs;

and/or

• If the Patient has Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis);
• If the Patient has Severe Heart Failure, Moderate or Severe Renal Impairment, or Severe Hepatic Impairment;
• If the Patient has a Tendency to Bleed or Coagulation Disorders;
• If the Patient is Severely Dehydrated (Excessive Fluid Loss from the Body) Due to Vomiting, Diarrhea, or Inadequate Fluid Intake;
• If the Patient is in the Third Trimester of Pregnancy or Breastfeeding.

Warnings and Precautions

Before Starting to Use Dekenor, Discuss it with a Doctor, Pharmacist, or Nurse:

• If the Patient has Had Chronic Inflammatory Bowel Disease (Ulcerative Colitis, Crohn's Disease) in the Past;
• If the Patient has or has Had Other Stomach or Intestinal Diseases;
• If the Patient is Taking Other Medications that Increase the Risk of Stomach Ulcer or Duodenal Ulcer or Gastrointestinal Bleeding, Such as Oral Steroids, Certain Antidepressants (SSRI Group, e.g., Serotonin Reuptake Inhibitors), Anticoagulants, Such as Acetylsalicylic Acid or Anticoagulants, Such as Warfarin. In Such Cases, Before Taking Dekenor, Consult a Doctor Who May Decide to Administer an Additional Protective Medication (e.g., Misoprostol or Medications that Inhibit Gastric Juice Production);
• If the Patient has Heart Disease, Has Had a Stroke, or is at Risk of These Conditions (e.g., Due to High Blood Pressure, Diabetes, High Cholesterol, or Smoking). In Such Cases, Before Using the Medication, Consult a Doctor. Taking Such Medications as Dekenor May be Associated with a Slightly Increased Risk of Heart Attack (Myocardial Infarction) or Stroke. This Risk Increases with Long-Term Use of High Doses of the Medication. Do Not Exceed the Recommended Dose and Duration of Treatment;
• If the Patient is Elderly: There is an Increased Risk of Side Effects (See Section 4). In Such a Case, Consult a Doctor Immediately;
• If the Patient has Allergies or Has Had Allergic Symptoms in the Past;
• If the Patient has Kidney, Liver, or Heart Function Disorders (Hypertension and/or Heart Failure), as Well as Fluid Retention or if Any of These Problems Have Occurred in the Patient in the Past;
• In Patients Receiving Diuretics or in Patients with Decreased Hydration and Reduced Blood Volume Due to Excessive Fluid Loss (e.g., Frequent Urination, Diarrhea, or Vomiting);
• In Women with Fertility Problems (Dekenor May Affect Female Fertility and is Not Recommended for Women Planning Pregnancy or Undergoing Infertility Treatment);
• In Women in the First and Second Trimester of Pregnancy;
• If the Patient has Blood Cell or Blood Clotting Disorders;
• If the Patient has Systemic Lupus Erythematosus or Mixed Connective Tissue Disease (Immune System Disorders Affecting Connective Tissue);
• If the Patient has Infections, See "Infections" Below;
• If the Patient has Asthma and Chronic Rhinitis, Chronic Sinusitis, and/or Nasal Polyps, the Risk of Allergy to Acetylsalicylic Acid and/or NSAIDs is Higher Than in the Rest of the Population. Administration of this Medication May Cause Asthma Attacks or Bronchospasm, Especially in Patients Allergic to Acetylsalicylic Acid and/or NSAIDs.

Infections

Dekenor May Mask the Symptoms of Infections, Such as Fever and Pain. For this Reason, it is Possible to Delay Appropriate Treatment of the Infection, Which May Lead to an Increased Risk of Complications. This Has Been Observed in Bacterial Pneumonia and Bacterial Skin Infections Associated with Chickenpox. If the Patient is Taking this Medication During an Infection, and the Symptoms of the Infection Persist or Worsen, Consult a Doctor Immediately.
It is Recommended to Avoid Using this Medication During Chickenpox.

Children and Adolescents

Dekenor Has Not Been Studied in Children and Adolescents. The Safety and Efficacy of this Medication Have Not Been Established, and Therefore, it Should Not be Used in Children and Adolescents.

Dekenor and Other Medications

Tell the Doctor About All Medications the Patient is Currently Taking or Has Recently Taken, Including Those Available Without a Prescription.
Certain Medications Should Not be Used at the Same Time as Dekenor, and in the Case of Other Medications, the Dose May Need to be Changed Due to Concurrent Use of Dekenor.
Always Inform the Doctor, Dentist, or Pharmacist if the Patient is Taking Any of the Following Medications with Dekenor:
Concomitant Use is Not Recommended:

• Acetylsalicylic Acid (Aspirin), Corticosteroids, or Other Anti-Inflammatory Medications
• Warfarin, Heparin, or Other Anticoagulant Medications
• Lithium Used to Treat Certain Mood Disorders
• Methotrexate (Anticancer or Immunosuppressive Medication) Used in High Doses of 15 mg per Week
• Hydantoin Derivatives and Phenytoin Used to Treat Epilepsy
• Sulfamethoxazole Used to Treat Bacterial Infections

Concomitant Use Requiring Caution:

• ACE Inhibitors, Diuretics, and Angiotensin II Antagonists Used to Treat High Blood Pressure and Heart Disease
• Pentoxifylline and Oxpentifylline Used to Treat Ulcers in Chronic Venous Insufficiency
• Zidovudine Used to Treat Viral Infections
• Aminoglycoside Antibiotics Used to Treat Bacterial Infections
• Sulfonylurea Derivatives (e.g., Chlorpropamide and Glibenclamide) Used to Treat Diabetes;
• Methotrexate Used in Low Doses, Below 15 mg per Week.

Concomitant Use Requiring Special Consideration:

• Quinolone Antibiotics (e.g., Ciprofloxacin, Levofloxacin) Used to Treat Bacterial Infections
• Cyclosporine and Tacrolimus Used to Treat Immune System Diseases and in Transplants
• Streptokinase and Other Thrombolytic or Fibrinolytic Medications, i.e., Medications Used to Dissolve Blood Clots
• Probenecid Used to Treat Gout
• Digoxin Used to Treat Chronic Heart Failure
• Mifepristone Used as an Abortion Medication (to Terminate Pregnancy)
• Antidepressant Medications from the SSRI Group
• Antiplatelet Medications Used to Reduce Platelet Aggregation and Blood Clot Formation
• Beta-Adrenergic Blockers Used to Treat High Blood Pressure and Heart Disease
• Tenofovir, Deferasirox, Pemetrexed.

In Case of Any Doubts Related to the Use of Dekenor, Consult a Doctor or Pharmacist.

Pregnancy, Breastfeeding, and Fertility

Do Not Use Dekenor in the Last Three Months of Pregnancy or During Breastfeeding.
Consult a Doctor.
Dekenor May Cause Kidney and Heart Problems in the Unborn Child, as Well as Increase the Risk of Bleeding in the Mother and Child, and May Delay or Prolong Labor.
If the Patient is Pregnant, Suspects She May be Pregnant, or is Planning to Have a Child, She Should Consult a Doctor or Pharmacist, as the Use of Dekenor May be Inappropriate in this Situation.
Pregnant Women or Those Planning to Become Pregnant Should Avoid Using this Medication.
The Use of the Medication During Pregnancy Should Only be Done Under the Recommendation of a Doctor.
From the 20th Week of Pregnancy, Dekenor May Cause Kidney Function Disorders in the Unborn Child if Used for More Than a Few Days. This May Lead to a Decrease in the Amount of Amniotic Fluid Surrounding the Child (Oligohydramnios) or Narrowing of the Arterial Duct (Ductal Constriction) in the Child's Heart. If Treatment for a Longer Period is Necessary, the Doctor May Recommend Additional Monitoring.
Dekenor is Not Recommended for Women Planning Pregnancy or Undergoing Infertility Treatment.
Information on the Potential Impact on Fertility can be Found in Section 2. "Warnings and Precautions".

Driving and Operating Machinery

Dekenor May Cause Dizziness and Fatigue, and Therefore, May Slightly Affect the Ability to Drive Vehicles and Operate Machinery. If Such Symptoms are Observed, Do Not Drive Vehicles or Operate Moving Machinery Until the Symptoms Have Resolved. In Case of Doubts, Consult a Doctor.

Dekenor Contains Ethanol

The Medication Contains 12% v/v Ethanol (Alcohol), i.e., Up to 200 mg per Dose, Which Corresponds to 5 ml of Beer or 2.08 ml of Wine per Dose. This May Have a Harmful Effect on Individuals with Alcoholism.
Consider this in Pregnant Women, Breastfeeding Women, Children, and High-Risk Groups, Such as Patients with Liver Disease or Epilepsy.
The Medication Contains Less Than 1 mmol of Sodium (23 mg) per Dose, Which Means it Can be Considered "Sodium-Free".

3. How to Use Dekenor

This Medication Should Always be Used as Directed by a Doctor. In Case of Doubts, Consult a Doctor or Pharmacist.
The Smallest Effective Dose Should be Used for the Shortest Time Necessary to Relieve Symptoms. In Case of Infections, Consult a Doctor Immediately if Symptoms (Such as Fever and Pain) Persist or Worsen (See Section 2).
The Doctor Will Inform the Patient About the Dose of Dekenor, Which Will Depend on the Type, Severity, and Duration of the Symptoms. The Recommended Dose is 1 Ampoule (50 mg) of Dekenor at Intervals of 8 to 12 Hours. If Necessary, the Dose Can be Repeated After 6 Hours. Do Not Exceed the Maximum Daily Dose, Which is 150 mg of Dekenor (3 Ampoules).
The Use of Injections is Intended for Short-Term Use and Should Only be Used in the Acute Pain Phase (Not Longer Than 2 Days). The Doctor Will Switch to Oral Pain Relief Medications as Soon as Possible.
In Elderly Patients with Renal Impairment and in Patients with Kidney or Liver Disorders, Do Not Exceed the Dose of 50 mg of Dekenor per Day (Corresponding to 1 Ampoule of the Medication).

Method of Administration:

Dekenor Can be Administered Intramuscularly or Intravenously. A Detailed Description of Intravenous Administration can be Found in the Section "Information Intended for Healthcare Professionals Only":.
When Administering Dekenor Intramuscularly, the Solution Should be Injected Immediately After Opening the Ampoule, by Slow Injection Deep into the Muscle.
Only Use Clear and Colorless Solutions.

Children and Adolescents

Do Not Use this Medication in Children and Adolescents (Under 18 Years of Age).

Overdose of Dekenor

In Case of Suspected Overdose of Dekenor, Inform a Doctor or Nurse Immediately.

Missed Dose of Dekenor

The Medication is Administered Under the Close Supervision of a Doctor, So Missing a Dose is Unlikely.
However, Inform a Doctor or Nurse if a Dose is Missed.

In Case of Any Further Doubts Related to the Use of this Medication, Consult a Doctor or Pharmacist.

4. Possible Side Effects

Like All Medications, Dekenor Can Cause Side Effects, Although Not Everybody Gets Them.
Possible Side Effects are Listed Below and Ranked According to Their Frequency of Occurrence.

Frequent Side Effects (May Occur in Up to 1 in 10 People):

Nausea and/or Vomiting, Pain at the Injection Site, Reactions at the Injection Site, e.g., Inflammation, Bruising, or Bleeding.

Uncommon Side Effects (May Occur in Up to 1 in 100 People):

Vomiting Blood, Low Blood Pressure, Fever, Blurred Vision, Dizziness, Drowsiness, Sleep Disorders, Headache, Anemia, Abdominal Pain, Constipation, Indigestion, Diarrhea, Dryness of the Mouth Mucosa, Redness of the Face, Rash, Skin Inflammation, Itching, Increased Sweating, Fatigue, Pain, Feeling of Cold.

Rare Side Effects (May Occur in Up to 1 in 1,000 People):

Stomach Ulcer Disease, Gastrointestinal Bleeding, or Perforation of the Stomach Ulcer, High Blood Pressure, Fainting, Slow Breathing Rate, Superficial Vein Inflammation Due to Blood Clots (Thrombophlebitis), Abnormal Heart Rhythm (Extrasystoles), Rapid Heart Rate, Swelling of the Extremities, Throat Swelling, Abnormal Sensations, Feeling of Increased Body Temperature, and Shivering, Ringing in the Ears (Tinnitus), Itchy Rash, Jaundice, Acne, Back Pain, Kidney Area Pain, Increased Urination, Menstrual Disorders, Benign Prostatic Hyperplasia, Muscle Stiffness, Joint Stiffness, Muscle Cramps, Abnormal Liver Function Test Results (Blood Tests), High Blood Sugar Levels (Hyperglycemia), Low Blood Sugar Levels (Hypoglycemia), High Blood Levels of Certain Fats (Hypertriglyceridemia), Increased Excretion of Ketone Bodies (Ketonuria) or Protein (Proteinuria) in the Urine, Liver Cell Damage (Hepatitis), Acute Kidney Failure.

Very Rare Side Effects (May Occur in Up to 1 in 10,000 People):

Anaphylactic Reactions (Severe Allergic Reactions that Can Lead to Anaphylactic Shock), Skin, Lip, Eye, or Genital Ulceration (Stevens-Johnson Syndrome and Lyell's Syndrome), Face or Lip and Throat Swelling (Angioedema), Shortness of Breath Caused by Bronchospasm (Bronchospasm), Shortness of Breath, Pancreatitis, Allergic Skin Reactions and Photosensitivity, Kidney Damage, Decreased White Blood Cell Count (Neutropenia), Decreased Platelet Count (Thrombocytopenia).
Inform a Doctor if the Patient Observes Any Side Effects at the Beginning of Treatment Related to the Stomach or Intestines (e.g., Stomach Pain, Heartburn, or Bleeding), if the Patient Has Had Similar Side Effects in the Past Due to Long-Term Use of Anti-Inflammatory Medications, Especially in Elderly Patients.
If a Skin Rash or Any Mucosal Ulceration (e.g., in the Mouth) or Any Allergic Symptoms Occur, Stop Using Dekenor Immediately.
When Using Non-Steroidal Anti-Inflammatory Medications, Fluid Retention and Swelling (Especially of the Ankles and Feet) May Occur, as Well as Increased Blood Pressure and Heart Failure.
Taking Such Medications as Dekenor May be Associated with a Slightly Increased Risk of Heart Attack (Myocardial Infarction) or Cerebrovascular Events (Stroke).
In Patients with Systemic Lupus Erythematosus or Mixed Connective Tissue Disease (Immune System Disorders Affecting Connective Tissue), the Administration of Anti-Inflammatory Medications May Rarely Cause Fever, Headache, and Neck Stiffness.
The Most Commonly Observed Side Effects Were Related to Stomach and Intestinal Disorders. Especially in Elderly Patients, Stomach Ulcer Disease, Perforation, or Gastrointestinal Bleeding May Occur, in Some Cases with Fatal Consequences.
After Using the Medication, the Following Were Observed: Nausea, Vomiting, Diarrhea, Bloating, Constipation, Indigestion, Abdominal Pain, Black Stools, Bloody Vomiting, Ulcerative Stomatitis, Exacerbation of Ulcerative Colitis, and Crohn's Disease. Less Commonly, Gastritis was Observed.
Immediately Inform a Doctor if Infection Symptoms or Worsening of the Patient's Condition Occur While Taking Dekenor.

Reporting Side Effects

If Any Side Effects Occur, Including Those Not Listed in this Package Leaflet, Inform a Doctor or Pharmacist. Side Effects can be Reported Directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C,
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side Effects can Also be Reported to the Marketing Authorization Holder.
By Reporting Side Effects, More Information on the Safety of the Medication can be Collected.

5. How to Store Dekenor

Keep the Medication Out of Sight and Reach of Children.
Do Not Use this Medication After the Expiration Date Stated on the Packaging After the Abbreviation EXP. The Expiration Date Refers to the Last Day of the Specified Month.
Store in the Original Packaging to Protect from Light.
There are No Special Recommendations for the Storage Temperature of the Medicinal Product.
It Has Been Shown that After Dilution as Recommended in the Section "Information Intended for Healthcare Professionals Only", the Diluted Solution, Stored at a Temperature of 25°C, Maintains Chemical Stability for 24 Hours, Provided it is Protected from Daylight.
From a Microbiological Point of View, Unless the Dilution Method Excludes the Risk of Microbiological Contamination, the Product Should be Used Immediately. If the Product is Not Used Immediately, the User is Responsible for the Storage Time and Conditions.
Medications Should Not be Disposed of in Sewers or Household Waste Containers. Ask a Pharmacist How to Dispose of Unused Medications. This Will Help Protect the Environment.

6. Package Contents and Other Information

What Dekenor Contains

• The Active Substance of the Medication is Dexketoprofen. Each 2 mL Ampoule of the Solution for Injection/Infusion Contains 50 mg of Dexketoprofen (in the Form of Dexketoprofen Trometamol).
• The Other Ingredients of the Medication are Sodium Chloride, Ethanol (96%), Sodium Hydroxide (to Adjust pH), and Water for Injections. See Section 2 "Dekenor Contains Ethanol and Sodium".

What Dekenor Looks Like and What the Package Contains

Dekenor Solution for Injection/Infusion is a Clear, Virtually Particle-Free Solution (pH: 7.0-8.0; Osmolality: 270-328 mOsmol/l).
Dekenor is Available in Boxes Containing 1, 5, or 10 Ampoules of the Solution for Injection/Infusion.
Not All Package Sizes May be Marketed.

Marketing Authorization Holder and Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
To Obtain More Detailed Information on the Names of Medicinal Products in Other Member States of the European Economic Area, Contact the Local Representative of the Marketing Authorization Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500
Date of Last Revision of the Package Leaflet: 18.01.2023
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Information Intended for Healthcare Professionals Only:

Dekenor 50 mg/2 mL Solution for Injection/Infusion

Dexketoprofenum

Intravenous Administration:

Intravenous Infusion: Dilute the Contents of 1 Ampoule (2 mL) of Dekenor in a Volume of 30 mL to 100 mL of Physiological Saline Solution, 5% Glucose Solution, or Ringer's Solution. The Diluted Solution Should be Administered as a Slow Intravenous Infusion Over a Period of 10 Minutes to 30 Minutes. The Solution Should Always be Protected from Daylight.
Intravenous Bolus:if Necessary, the Contents of 1 Ampoule (2 mL) of Dekenor Can be Administered as a Slow Intravenous Bolus Over a Period of Not Less Than 15 Seconds.

Due to the Ethanol Content, Dekenor Should Not be Used Undiluted for Spinal (Intrathecal or Epidural) Administration.

Instructions for Handling the Medicinal Product:

When Administering the Medicinal Product Dekenor as an Intravenous Bolus, the Solution Should be Injected Immediately After Withdrawal from the Colored Ampoule.
In the Case of Intravenous Infusion, the Solution Should be Diluted Under Aseptic Conditions and Protected from Daylight.
Only Use Clear and Colorless Solutions.

Compatibility Information:

It Has Been Shown that Dekenor is Compatible When Mixed in Small Volumes(e.g., in a Syringe) with Solutions for Injection of Heparin, Lidocaine, Morphine, and Theophylline.
The Solution for Injection Diluted as Described is a Clear Solution. Dekenor Diluted in a Volume of 100 mLof Normal Physiological Saline Solution or Glucose Solution is Compatible with the Following Medications in the Form of Solutions for Injection: Dopamine, Heparin, Hydroxyzine, Lidocaine, Morphine, Pethidine, and Theophylline.
No Absorption of the Active Substance was Observed When the Diluted Solutions of the Medicinal Product Dekenor Were Stored in Plastic Bags or Administration Devices Made of Ethylene-Vinyl Acetate (EVA), Cellulose Propionate (CP), Low-Density Polyethylene (LDPE), and Polyvinyl Chloride (PVC).