Kenacort-A (triamcinolone acetonate) %0.1 40 Mg 1 Ampoule

INSTRUCTIONS FOR USE

• Active substance: 40 mg triamcinolone acetonide in 1 ml of suspension

• Excipients: Benzyl alcohol, polysorbate 80, sodium carboxy methyl cellulose, sodium chloride, water for injection

Please read this INSTRUCTIONS carefully before using this medicine, as it contains important information for you.

• Keep these operating instructions. You can need to read again.

• If you have other questions, please talk your doctor or pharmacist.

• This medicine has been prescribed for you personally, not to others.

• Tell your doctor that you are taking this medicine when you go to a doctor or hospital.

• Do not use high or low doses other than the recommended dose for the drug.

In these Instructions for Use: 1. What is KENACORT-A and what is it used for? 2. Cautions before using KENACORT-A 3. How to use KENACORT-A? 4. What are the possible side effects? 5. KENACORT-A storage headers are included.

1. What is KENACORT-A and what is it used for? KENACORT-A is a white to whitish, odorless or mild benzyl alcohol scented, fluid suspension and is a group of drugs called corticosteroids. KENACORT-A is available in 1 ml ampoule, 2 ampoules and 5 ampoules. KENACORT-A, endocrine diseases, rheumatic diseases, collagen tissue diseases, gastrointestinal tract and lung problems are used in the treatment of various serious inflammatory and / or allergic diseases such as skin diseases, eye diseases, blood diseases, neoplastic diseases and edema.

2. Cautions before using KENACORT-A DO NOT use KENACORT-A in the following cases:If you

•are allergic to triamcinolone acetonide or components of KENACORT-A

infection

• If you have an• If you have an idiopathic thrombocytopenic purpura ( If you have bleeding)

KENACORT to intravenous (intravenous), intrathecal, epidural (back of the spine) or should not be applied into the eye.

KENACORT-A

's

USE CAREFULLY in the following cases: if

you are pregnant or breastfeeding your

baby,even if these alerts at any time in the past, is true for you, please consult your doctor. Avoid straining your joints even if KENACORT-A relieves the symptoms of your disease. The inflammation that causes the symptoms may not be fully healed. As KENACORT-A may cause an increase in your blood pressure, water and salt retention, and potassium and calcium excretion, salt restriction and potassium may be required in your diet. If you are on high-dose corticosteroid therapy, do not be vaccinated.

Using KENACORT-A with food and drink KENACORT-A has no interaction with food and drink: however, dietary salt restriction and potassium supplementation may be required.

Pregnancy Consult your doctor or pharmacist before using the medicine. If you are pregnant; however, you can use KENACORT-A if your doctor determines that there is a need. If you discover that you are pregnant during your treatment, consult your doctor or pharmacist immediately.

Breastfeeding Consult your doctor or pharmacist before using the medicine. If you are breastfeeding: if your doctor decides that you have a definite requirement you can use KENACORT-A If yousoon If you

have any infectionhave ahave

blood clotting problem If you

a disease (osteoporosis) in your bones If you

have a disease such as thyroid dysfunction or cirrhosis If you have a

mental disorder

Kidney failure, peptic ulcers, diabetes, tuberculosis, intestinal diseases, cancer, epilepsy (epilepsy), myasthenia gravis (a disease characterized by excessive fatigue in the muscles) or glaucoma (increase of pressure inside the eye) If you have had

your blood pressure if you have high or heart failure

if you are having chicken pox or measles

Vehicle and machine use It is not known whether KENACORT-A affects the ability to drive and use machines; but be careful when using the vehicle and the machine as KENACORT-A may cause eye problems and dizziness.

Important information on certain excipients in the content of KENACORT-A It should not be applied to premature babies and newborns due to the presence of benzyl alcohol contained in it. Infants and children up to 3 years of age may cause toxic reactions and allergic reactions. Each 1 ml suspension contains less than 23 mg (6.6 mg sodium chloride) sodium; ie essentially 'does not contain sodium.

"Otherdrugs with use: If you use any of KENACORT-in using the following drugs, please inform your doctor:

Drugs used in thyroid problems.

Before an intervention require any surgery or anesthesia, KENACORT-treatment see you necessarily Tell your doctor or dentist if you are

vaccinated or if you are vaccinated during the treatment of KENACORT-A, the corticosteroid group, including KENACORT-A, will reduce the response to skin tests, such as.

aspirin, ibuprofen or other non-steroidal anti-inflammatory drugs(NSAI) drugs (corticosteroids may increase the risk of bleeding, gastrointestinal found associated with such drugs),

muscle relaxant drugs,

antibiotics called macrolide (eg. you klaritorami, erythromycin, azithromycin),

antifungal drugs (ketoconazole, are amfetori)

is Varfu drugs used in the treatment of, such as blood-thinning drugs, such as

oral contraceptive pills or hormone replacement (replacement)

human growth hormone (eg. somatrem,

immunosuppressive cyclosporin, drugs used in

high blood pressure or irregular heartbeat (eg digoxin), drugs used in the treatment of

myasthenia gravis (a disease characterized by excessive fatigue in the muscles),

Sara (epilepsy) or other seizures the drugs used in disorders (eg. phenytoin),

tuberculosis (TB) drugs used in the treatment (eg. isoniazid, rifampin),

drugs used in diabetes,

high cholesterol, used to treat cholestyramine,

If you are using prescription or over the counter any drug currently or please inform your doctor or pharmacist if you have used them recently.

3. How to use KENACORT-A Instructions for proper use and dose / frequency of administration: DOSAGE REQUIREMENTS SHOULD BE CHANGED, ADJUSTED TO THE TREATED DISEASE, AND DUE TO THE PATIENT'S DUE TO THE PATIENT'S RESPONSE. Always use KENACORT-A as your doctor says. If you are unsure, you should consult your doctor or pharmacist. Systemic use (Treatment areas other than joint diseases) The recommended dose ranges from 40 to 80 mg. Your doctor will determine your dose according to your response to your disease and treatment.

In patients with hay fever or pollen asthma, a single injection at a dose of 40-100 mg can provide relief during the whole pollen season.

Local use (in joint diseases) The dose to be administered into joint or tendon sheaths varies depending on the size of the joint and the condition being treated. Your doctor will determine the appropriate dose for you. Doses of 2.5-10 mg in small joints and up to 40 mg in large joints can be given.

Method and method of administration: It should be applied to deep muscles by deep injection or joint. It should not be applied intravenously, intradermally, intraocularly, epidural, intrathecal.

Different age groups Use in children: KENACORT-A should not be administered to children under 6 years of age. Use in the elderly: When KENACORT-A is administered to patients over 65 years of age, patients should be closely monitored for the aggravation of side effects. Specific Use Conditions Kidney / Liver Failure: Caution should be exercised when applying KENACORT-A in patients with renal or hepatic impairment. Talk to your doctor or pharmacist if you have an impression that KENACORT-A is too strong or too weak.

If you used more KENACORT-A than you should use: If you have used more than you should use from KENACORT-A, talk to a doctor or pharmacist.

If you forget to use KENACORT-A: Your doctor will decide when the missed dose administered. It is important that you follow the instructions of your doctor for the new administration time of the following dose. Do not take double doses to compensate for forgotten doses.

Effects that may occur when treatment with KENACORT-A is terminated.

4. What are the possible side effects? Like all medicines, there may be side effects in people who are sensitive to the substances contained in KENACORT-A. Stop using KENACORT-A and IMMEDIATELY tell your doctor or contact the emergency department of the hospital nearest you:

- Itching, redness of the skin, hypersensitivitywith symptoms such as edema in the throat

reactions(allergic reactions) - Hypersensitivity reactions - Blood due to venous inflammation clot formation These are all very serious side effects. If you have one of these, you have a serious allergy to KENACORT-A. You may need urgent medical attention or hospitalization. All of these very serious side effects are very rare. If you notice any of the following, tell your doctor immediately or contact your nearest hospital emergency department:

- Irregularity in your heart, heart failure, cardiovascular problems - Elevation in your blood pressure - Salt and fluid retention - Bone fragility, Late recovery in fractures - Ulcer, pancreatitis - Menstrual irregularities - Suppression of growth in children - Increased need for drugs in diabetes - Eye problems - Inflammation or masking of infection -heartbeat and ECG (of electrical activity)

Loss of potassium in theloss- Hypokalemic alkalosis - Mass loss in muscles - Convulsions - Increased intracranial pressure with papilla edema, usually seen after treatment These are all serious side effects. Emergency medical intervention may be required. Serious side effects are very rare.

Tell your doctor if you notice any of the following:

- Muscle weakness, fatigue - the delay in wound healing - thinning of the skin, bruising easily - dizziness, headache, insomnia, mood swings (depression), mood - changes, personality changes - Applications - Fainting - Abdominal swelling - Inflammation of the ulcerative esophagus - Exacerbation of pre-existing psychiatric condition - Excessive feelings of joy, trust, strength - Psychotic symptoms - Development of Cushingoid condition - Reduced carbohydrate tolerance - Latent diabetes (diabetes) -to increased blood sugar levels, detection of sugar in urine and protein catabolism

Negative nitrogen balance dueThese are mild side effects of KENACORT-A. Please inform your doctor or pharmacist if you experience any side effects not mentioned in these instructions.

5. Storage of KENACORT-A Keep KENACORT-A out of reach of children and in its packaging. Store at room temperature below 25 ° C. Protect from light. Do not freeze. Use in accordance with expiration dates. Do not use KENACORT-A since the expiry date indicated on the label or packaging. "Expiration Date" is the last day of the specified month. Do not use KENACORT-A if you notice any defects in the product and / or its packaging.

THE FOLLOWING INFORMATION IS FOR HEALTH STAFF TO BE IMPLEMENTED THIS DRUG.

The application should be used in application. Before using the bulb, the particles should be shaken to obtain an evenly distributed suspension. Before pulling into the injector, it should be checked whether the suspension is agglomeration or granular appearance. There may be agglomeration in the drug that has remained in freezing degrees before and should not be used. Injection should be done without delay, to prevent precipitation in the injector after the injection. Injection should be done carefully to avoid the possibility of entering a blood vessel and transmitting infection.

Systemic In systemic treatment, the gluteal cavity should be made deep, making sure that the injection is done intramuscularly. If the intramuscular injection is not performed deep, local atrophy can be seen. Injection should be performed on the gluteal area unless it is a necessity. Injection into this area should be avoided as injection of the deltoid site is more common with local atrophy. For adults, the shortest needle length should be 3.8 cm. A longer needle may be required in obese patients. Different sites should be selected for consecutive injections.

The general intraarticular injection technique for the treatment of local joints should be done as specified in the basic books on the subject. If excess fluid is present in the joint, a portion of the synovial fluid, but not all, should be aspirated to help alleviate pain and prevent excessive dilution of the corticosteroid.

Intra-articular, intra-articular application and local anesthetic use is frequently applied when injecting into tendon sheaths. Because such injections (especially in the deltoid region) and the injections into the tendon sheaths may cause tissue atrophy, care must be taken to avoid injecting the suspension into surrounding tissues.

In the treatment of acute nonspecific tenosynovitis, care must be taken to ensure that the injection is done into the tendon sheath but not into the tendon. Epicondylitis (tennis elbow) can be treated by infiltrating the drug to the area of ​​highest sensitivity.

Unused products or waste materials must be disposed of in accordance with the 'Regulation on Control of Medical Wastes' and 'Regulation on Control of Packaging and Packaging Wastes'.