KENACORT 40 mg /Ml Инъекционная Суспензия

Содержание инструкции

1. KENACORT 40 mg/ml injectable suspension
   1. What is KENACORT and what is it used for
   2. What you need to know before using/giving KENACORT to the child
   3. How to use/give KENACORT to the child
   4. Possible side effects
   5. How to store KENACORT
   6. Contents of the pack and other information

KENACORT 40 mg/ml injectable suspension

Triamcinolone Acetonide
Read this leaflet carefully before you use/give this medicine to the child because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, because it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What KENACORT is and what it is used for
• 2. What you need to know before you use/give KENACORT to the child
• 3. How to use/give KENACORT to the child
• 4. Possible side effects
• 5. How to store KENACORT
• 6. Contents of the pack and other information

1. What is KENACORT and what is it used for

KENACORT contains the active ingredient triamcinolone acetonide and belongs to a group of medicines
called systemic corticosteroids that act against inflammation.
KENACORT is used in adults and children over 6 years of age, and is administered
➢ intramuscularly (injection directly into the muscles), when oral therapy
is not possible, to treat:

• allergies, particularly in cases of severe or debilitating conditions that cannot be treated with conventional therapies
• dermatoses, skin diseases characterized by the appearance of pale pink patches that tend to scale
• generalized rheumatoid arthritis, a disease that affects the joints causing pain, swelling and stiffness
• other connective tissue diseases (the tissue that connects parts of our body). ➢ intra-articularly (injection directly into the joint) or intra-bursal (injection directly into the fluid sacs located where a tendon or ligament rubs against another tissue inside the joints, the bursae) for short-term treatment of:
• pain, swelling and stiffness that manifest locally at the level of the joints due to certain inflammatory diseases (e.g. traumatic arthritis, rheumatoid arthritis, osteoarthritis, synovitis, bursitis). In the case of generalized arthritic diseases, KENACORT is used as a support to treatment with other medicines, especially through injection into a joint.

2. What you need to know before using/giving KENACORT to the child

Do not use/give KENACORT to the child

• if they are allergic to triamcinolone acetonide or to any of the other ingredients of this medicine (listed in section 6)
• if they have an ongoing infection that is spreading from the site of infection throughout the body (systemic infection)
• if the child is less than two years old (see also section Children and adolescents)
• in the case of intramuscular administration, if they suffer from a blood clotting disorder that can lead to easy bruising and excessive bleeding (idiopathic thrombocytopenic purpura).

Warnings and precautions
Consult your doctor or pharmacist before using KENACORT if you/the child:

• have thyroid problems (a gland in the neck) that produce less hormone than they should (hypothyroidism) or if they suffer from a liver disease (hepatic cirrhosis). In these cases, the response to the medicine may be increased
• suffer from an eye infection caused by the herpes simplex virus, as in this case corneal perforation (the transparent membrane located in the front part of the eye) is possible. Prolonged use can lead to serious eye problems (posterior subcapsular cataract or glaucoma) and increase the likelihood of eye infections
• suffer from depression or a mental illness. Use of this medicine may worsen pre-existing unstable conditions. The use of antidepressant drugs does not relieve these disorders and can worsen mental disorders induced by the use of the medicine, which may include euphoria, insomnia, mood and personality changes, severe depression, or symptoms of real mental illnesses
• suffer from an inflammation of the intestine (ulcerative colitis) with a risk of perforation
• have collections of pus that form inside a tissue (abscesses) and infections caused by pyogens (germs that penetrate tissues and produce pus)
• suffer from inflammation of one or more diverticula (pouches that form in the intestine at the level of the colon)
• have recently undergone surgery to connect two sections of the intestine (intestinal anastomoses)
• suffer from a lesion of the stomach or intestinal mucosa (peptic ulcer) in an active or latent form (i.e. without manifestation of symptoms); in case of prolonged therapy, an antacid may be prescribed
• suffer from a kidney disease (renal insufficiency, acute glomerulonephritis and chronic nephritis), as fluid retention (edema) may occur
• suffer from high blood pressure (hypertension). Your doctor may prescribe a low-salt diet and potassium-containing supplements
• their heart is not pumping enough blood to meet the needs of the body (congestive heart failure)
• suffer from inflammation of the veins (thrombophlebitis)
• suffer from the formation of blood clots inside the veins (thromboembolic events)
• suffer from a reduction in bone mass (osteoporosis)
• have skin rashes (exanthema)
• suffer from a disease characterized by weight gain, fluid retention, stretch marks and abnormal hair growth due to excess corticosteroids (Cushing's syndrome)
• suffer from diabetes mellitus
• suffer from convulsive disorders
• suffer from a malignant tumor with the presence of metastases (cells that detach from the original tumor and spread to other organs)
• suffer from a disease that affects the muscles causing progressive loss of tone and strength (myasthenia gravis)
• are elderly. Your doctor will monitor you during treatment with KENACORT as some side effects, including osteoporosis (reduction in bone mass) or hypertension (high blood pressure), common in corticosteroid therapy, may have more serious consequences for you if you are elderly
• have a history of allergic reactions to drugs, as this medicine, in rare cases, can cause serious allergic reactions
• are in a condition of particular stress (such as trauma, surgery, or serious illness); in such cases, your doctor may prescribe appropriate additional therapy. During prolonged therapy, good protein intake is essential to avoid excessive weight loss and weakness.

Contact your doctor if you experience blurred vision or other visual disturbances.
Female patients should be informed that menstrual irregularities may occur and
in postmenopausal women, vaginal bleeding may occur. If your doctor deems it
appropriate, you will be advised to undergo appropriate investigations.

In case of intra-articular administration
In case of intra-articular administration, you/the child must pay particular attention:

• to not excessively strain the treated joints for which an improvement of symptoms has been obtained as these could further deteriorate
• if you experience an increase in pain associated with local swelling, increased difficulty in moving the joint, fever and malaise. These may be signs of an ongoing infection in the joint (see section 4. Possible side effects). In such cases, consult your doctor immediately, who will decide whether to discontinue treatment with KENACORT and establish a suitable therapy.

KENACORT and other diseases
Corticosteroid drugs can mask the symptoms of infection and infections may occur during their use.
If you are undergoing therapy with corticosteroids, your body's defenses may be reduced and it may be difficult to locate
the possible site of infection. Furthermore, if you are taking medicines that lower your body's defenses,
including corticosteroids, you are more susceptible to infections than those who
do not use these drugs.
Therefore, inform your doctor if you/the child:

• have chickenpox or measles going on. These infectious diseases can worsen or even lead to death. Avoid contact for yourself and the child during treatment with corticosteroids if you have not had these diseases. If contact occurs, inform your doctor as appropriate therapy must be implemented;
• have an ongoing pinworm infestation (disease caused by a very small worm that is able to penetrate through intact skin). You may develop inflammation of the intestine and serious infections that could even lead to death;
• are about to undergo a vaccine, as due to the lowering of the body's defenses you may be more prone to complications;
• suffer from active tuberculosis (an infectious disease caused by the bacterium Mycobacterium tuberculosis, which generally develops in the lungs). Your doctor may prescribe appropriate antitubercular therapy in association with KENACORT;
• suffer from latent tuberculosis or have a positive response to tuberculin (extracts of tuberculosis bacteria used for the diagnosis of the disease). Your doctor will prescribe therapy with drugs that prevent possible infection (chemoprophylaxis).

For those who play sports
The use of the drug without therapeutic necessity constitutes doping and may still
result in a positive doping test.

Children and adolescents
KENACORT contains 9.9 mg/ml of benzyl alcohol, therefore this medicine should not be given
to premature babies or newborns. KENACORT is contraindicated in children under two
years of ageand may cause toxic and allergic reactions in children up to 3 years of age.
Benzyl alcohol, if taken in excessive quantities, may cause a syndrome called
“agonal breathing syndrome”, characterized by effects such as:

• depression of the nervous system
• gasping respiration
• uncontrolled body movements (convulsions)
• bleeding in the head
• low blood pressure (hypotension), especially in newborns
• metabolic acidosis (increased amount of acid in the blood), especially in newborns
• slow heartbeat (bradycardia) Furthermore, due to the presence of benzyl alcohol, the child may experience:
• an increased risk of kernicterus (yellowing of the skin, sclera and mucous membranes caused by excessive levels of bilirubin in the blood), especially in premature babies
• rare cases of death, especially in premature babies.

KENACORT is not recommended in children under 6 years of age.
If the child is undergoing long-term corticosteroid therapy, the doctor will need to
carefully monitor their development as corticosteroids can slow down their growth (see
section 4. Additional side effects in children).
Children should also not be vaccinated or immunized during corticosteroid therapy
as these substances can affect the production of steroids by the body.

Other medicines and KENACORT
Tell your doctor or pharmacist if you/the child are taking, have recently taken or might
take any other medicines.
In particular, tell your doctor if you/the child are taking any of the following medicines:

• amphotericin B (drug for the treatment of fungal infections) or other substances that cause a decrease in potassium in the blood
• anticholinesterases (medicines that inhibit the elimination of acetylcholine, indicated for some gastrointestinal and respiratory disorders, post-operative vomiting, vomiting during pregnancy, etc.)
• oral anticoagulants (medicines to make the blood more fluid)
• antidiabetics (medicines for the treatment of diabetes, characterized by the presence of high levels of glucose in the blood)
• antituberculars (medicines used to treat tuberculosis, a disease caused by a bacterium, Mycobacterium tuberculosis, which generally develops in the lungs)
• cyclosporine (a medicine that depresses the activity of the body's defense system, used to prevent rejection reactions from organ transplantation)
• digitalis glycosides (drugs used to increase the force of heart contraction)
• estrogens (female sex hormones), including oral contraceptives (the pill)
• liver enzyme inducers (e.g. barbiturates, phenytoin, carbamazepine, rifampicin), medicines that affect how the liver works
• human growth hormone (e.g. somatrem), hormone that promotes height growth
• muscle relaxants (drugs capable of reducing muscle tone)
• NSAIDs, non-steroidal anti-inflammatory drugs (drugs used for the treatment of inflammation, pain and fever)
• thyroid drugs (drugs used for the treatment of thyroid disorders)
• vaccines (products that stimulate the immune system of patients to build a specific resistance to infections)
• acetylsalicylic acid (drug to make the blood more fluid or for the treatment of inflammation, pain and fever), as if you suffer from low levels of prothrombin (a protein involved in blood clotting processes) in the blood, your doctor will carefully assess whether to prescribe KENACORT
• drugs that inhibit an enzyme present in the organism (cytochrome P450 3A4) such as ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin ).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding
ask your doctor or pharmacist for advice before using this medicine.
The doctor will assess the benefit-risk ratio for you and/or the fetus, the newborn
in breastfeeding or the child.
If you have used high doses of KENACORT during pregnancy, your baby should be carefully
monitored as they may experience altered adrenal gland function (glands located
above the kidneys) with reduced production of one or more hormones (hypoadrenalism).

Driving and operating machinery
During the intake of KENACORT you may experience side effects such as dizziness.
If you experience these symptoms, do not drive vehicles and do not use machinery.

KENACORT contains benzyl alcohol and sodium
KENACORT contains 9.9 mg/ml of benzyl alcohol. Benzyl alcohol can cause allergic reactions.
Benzyl alcohol has been associated with the risk of serious side effects including breathing problems
(agonal breathing syndrome) in young children.
Do not administer to newborns up to 4 weeks of age unless otherwise recommended by the doctor.
Do not use for more than one week in young children (under 3 years of age) unless otherwise
recommended by your doctor or pharmacist.
Ask your doctor or pharmacist if you are pregnant or breastfeeding or if you have a liver or
kidney condition. This is because large amounts of benzyl alcohol can accumulate in the body and
cause side effects (such as metabolic acidosis).

KENACORT contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially "sodium-free".

3. How to use/give KENACORT to the child

Use/give this medicine to the child always following exactly the instructions of the doctor or the
pharmacist. If you have doubts consult the doctor or the pharmacist.
The doctor will establish the most suitable dose for you based on the disorder to be treated, the route of
administration and the age and response.
The recommended initial dose may vary from 2.5 to 60 mg per day, depending on the specific disorder
that needs to be treated.

Intramuscular administration

Adults and children over 12 years
The recommended initial dose is 60 mg.
The maintenance dose is generally between 40 and 80 mg, depending on the response to treatment and the
time it takes for symptoms to improve. In some cases, lower dosages of 20 mg or less may be sufficient.
If you/the child suffers from hay fever (allergic reaction of the mucous membranes of the eyes, nose and
respiratory tract to seasonal pollen) or pollen asthma (generally reversible obstruction of the
lower airways caused by exposure to pollen) a single injection of
40-100 mg of KENACORT may be sufficient to achieve remission of symptoms lasting throughout the pollen season.

Children from 6 to 12 years
The recommended initial dose is 40 mg.
The doctor will establish the most suitable dose for the child based on age, the disorder to be treated, the
route of administration and the response to treatment.

Intra-articular or intra-bursal administration
The doctor will establish the most suitable dose for you based on the disorder to be treated, the route of
administration and the age and response. See the information reported at the end of this leaflet.

Method of administration

• Use the product under absolutely sterile conditions
• Shake the bottle well before use, to ensure the uniformity of the preparation and the absence of agglomerates. Do not expose the product to low temperatures as they cause agglomerates and in this case do not use the product
• Withdraw the suspension from the bottle with the syringe
• Administer the injection immediately after withdrawal to prevent deposits from forming in the syringe. Use all precautions to avoid the risk of infection or the needle penetrating a blood vessel.

In case of intramuscular administration
In case of intramuscular administration, administer the injection deeply into the muscles of the
buttocks. Otherwise, more or less marked thinning of the subcutaneous fat may occur.
The gluteal region is preferred over the deltoid (shoulder muscle) as a higher incidence of local atrophy (reduction of muscle mass) occurs in this
area. For adults, it is recommended to use a needle with a minimum length of 4 cm or longer in the case of
obese subjects and to change the site with each subsequent injection.

In case of intra-articular or intra-bursal administration
The medicine will be administered by an experienced doctor. See the information reported at the end of
this leaflet.

Use in children
KENACORT should not be administered to children under 2 years of age(see paragraph 2
“Children and adolescents”) and its administration is not recommended in children under 6 years of age.
If you use/give the child more KENACORT than you should
If you use/give the child too much KENACORT contact the doctor or go to hospital immediately.
In the case of taking high doses of the medicine for a prolonged period, you may experience
symptoms such as:

• confusion
• anxiety
• depression
• cramps (sudden and violent muscle pains)
• bleeding from the stomach and/or intestines
• bruising
• moon-shaped face
• increased blood pressure

If you forget to use/give KENACORT to the child
Do not use a double dose to make up for a missed dose.

If you stop using KENACORT
If you stop taking the medicine after a long period of therapy, gradual and not abrupt discontinuation is recommended. In case of abrupt discontinuation, you may experience
inability of the adrenal glands to produce a sufficient amount of cortisol, an essential hormone
for the body (acute adrenal insufficiency), which also occurs in stressful conditions.
After stopping therapy with KENACORT, a sudden reappearance of the symptoms of the disease for which you have been treated may occur, so the doctor will monitor you carefully even
after stopping treatment. If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you/the child experience any of the following side effects STOPtreatment with
this medicine and contact your doctor immediately, who will advise you on the most appropriate therapy to
follow:

• rapid onset allergic reactions (severe anaphylactic reactions) or a severe allergic reaction that can be life-threatening (anaphylactic shock)
• an increase in pain associated with local swelling, increased difficulty in moving the joint, fever and malaise. These may be signs of an ongoing infection in the joint. The following side effects may occur during treatment with KENACORT, listed below according to the frequency of occurrence: common (may affect up to 1 in 10 people)
• infection
• headache
• opacification of the crystalline lens, the lens of the eye used to focus images (cataract)
• reactions at the injection site uncommon (may affect up to 1 in 100 people)
• pus accumulations that form at the injection site (sterile abscess), masking of infections
• reactions that manifest with symptoms similar to those of allergic reactions, but do not involve the immune system, the body's defense system (anaphylactoid reaction)
• a condition similar to that caused by Cushing's syndrome characterized by: moon face, buffalo hump, trunk obesity, increased amount of hair, irritability (Cushingoid appearance); suppression of adrenal gland function, glands located above the kidneys
• retention of fluids or sodium, reduction of blood acidity caused by a potassium deficiency (hypokalemic alkalosis), elevated blood sugar levels (hyperglycemia, diabetes mellitus), which may not respond to therapies (inadequate control of diabetes mellitus)
• mental illnesses, depression, euphoric mood, mood swings, personality changes, insomnia
• uncontrolled body movements (convulsions), transient fainting (syncope), increased pressure in the head in the absence of disease (benign intracranial hypertension), inflammation of a nerve (neuritis), tingling (paresthesia)
• blindness, a disease characterized by increased pressure of the fluid contained in the eye (glaucoma), protruding eye (exophthalmos), perforation of the transparent membrane of the eye (cornea)
• dizziness
• weakening of the heart, which does not pump enough blood to meet the body's needs (congestive heart failure), heart rhythm disturbance (arrhythmia)
• high blood pressure (hypertension), blockage of a blood vessel (embolism), inflammation of the veins, associated with the formation of blood clots (thrombophlebitis), chronic inflammation of blood vessels (necrotizing vasculitis)
• lesion of the mucosa of the stomach or intestine (peptic ulcer), possibly associated with perforation and blood loss, inflammation of the pancreas (pancreatitis), an organ involved in digestive processes, swollen abdomen, inflammation of the mucosa of the esophagus (tube connecting the mouth to the stomach) associated with the appearance of lesions (ulcerative esophagitis)
• urticaria, skin rash, dark and light spots on the skin, thinned skin, skin fragility, small hemorrhages caused by the leakage of blood from small blood vessels (petechiae), bruises (ecchymoses), skin redness (erythema), increased sweating (hyperhidrosis), appearance of patches on the skin of various sizes with a color ranging from bright red to purple to dark reddish-brown (purpura), stretch marks (striae of the skin), presence, in women, of hard and coarse hairs in typical male areas (hirsutism), skin rashes similar to boils (acneiform dermatitis), red, raised lesions, often located on the face (cutaneous lupus erythematosus)
• loss of bone mass (osteoporosis), death of bone (osteonecrosis), fracture of bones weakened by another disease (pathological fracture), delayed fracture healing, musculoskeletal discomfort, muscle weakness, muscle disease (myopathy), muscle mass loss (muscle atrophy), growth retardation, an inflammatory disease characterized by resorption of the bones of the joints of the foot (neuropathic arthropathy)
• elevated sugar levels in the urine (glycosuria)
• irregular or absent menstruation (amenorrhea), vaginal bleeding after menopause (postmenopausal hemorrhage)
• inflammation of the tissue lining the inside of the joints (synovitis), pain, irritation at the injection site, discomfort at the injection site, fatigue, incomplete healing
• decreased potassium levels in the blood, changes in the electrocardiogram (graphic representation of the electrical activity of the heart during its operation), decreased sugar tolerance, negative nitrogen balance (more nitrogen is lost than is taken in), increased pressure of the fluid inside the eye, interference in laboratory tests
• fractures of one or more vertebrae of the spine caused by compression (vertebral compression fracture)

frequency not known (frequency cannot be estimated from available data)

• hiccups
• blurred vision
• visual disturbances

Reporting of side effects
If you/the child experience any side effects, including those not listed in this
leaflet, please inform your doctor or pharmacist. You can also report side effects directly
through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse. By reporting side effects you can help provide more information
on the safety of this medicine.

5. How to store KENACORT

Do not store at a temperature above 25°C. Do not freeze.
Store the vials in an upright position.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the package after EXP. The
expiry date refers to the last day of that month.
Do not use this medicine if you notice the presence of agglomerates.

6. Contents of the pack and other information

What KENACORT contains

• the active ingredient is: triamcinolone acetonide. Each vial contains 40 mg of triamcinolone acetonide.
• other ingredients are: sodiumcarboxymethylcellulose, sodiumchloride, polysorbate 80, benzylalcohol(see paragraph “KENACORT contains benzyl alcohol”), and water for injections, hydrochloric acid/ sodiumhydroxide (pH adjusters).

Description of the appearance of KENACORT and contents of the pack
KENACORT is presented as an injectable suspension for intramuscular and intra-articular use.
KENACORT is available in packs containing 3 vials of 1 ml injectable suspension.

Marketing Authorisation Holder
BRISTOL-MYERS SQUIBB S.r.l.
Piazzale dell’Industria 40/46
Rome - Italy

Manufacturer
CATALENT ANAGNI S.R.L.
Loc. Fontana del Ceraso snc
Strada Provinciale 12 Casilina N. 41
03012 ANAGNI (FR) - Italy
or
Swords Laboratories Unlimited Company T/A Bristol-Myers Squibb Pharmaceutical Operations,
External Manufacturing Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867, Ireland

The following information is intended for physicians and healthcare professionals:
Therapeutic indications
Intramuscular administration of KENACORT is indicated for systemic corticosteroid therapy in conditions such as allergic syndromes (to control severe or debilitating conditions not treatable by conventional means), dermatoses, generalized rheumatoid arthritis and other connective tissue diseases. The intramuscular route of administration is particularly useful in the aforementioned diseases when oral corticosteroid therapy is not feasible.
KENACORT can also be administered by intra-articular or intra-bursal route. These routes of administration allow for effective short-term local therapy of pain, swelling and joint stiffness resulting from traumatic or rheumatoid arthritis, osteoarthritis, synovitis, bursitis.
In the treatment of generalized arthritic diseases, intra-articular injection of triamcinolone acetonide should be considered as a supplement to other conventional therapeutic measures. Locally limited processes such as traumatic arthritis or bursitis may represent typical indications for therapy conducted exclusively by intra-articular route.

Precautions for use
Although KENACORT may improve the symptoms of inflammation, it is necessary to investigate and treat the cause.
Intra-articular administration of a corticosteroid can produce systemic as well as local effects. Accidental injection of the suspension into periarticular soft tissues can also cause systemic effects and is the most common cause of local therapeutic failure. Patients undergoing intra-articular treatment should not subject the joints to excessive stress, otherwise a worsening of joint deterioration may occur.
On the occasion of intra-articular administration, avoid overdistension of the joint capsule and leakage of the steroid along the needle path, as subcutaneous atrophy may occur.
Avoid injecting the preparation into unstable joints. In some cases, repeated intra-articular injections may themselves cause joint instability. In some particular cases, especially after repeated administrations, a radiographic examination is recommended. Intra-articular injection rarely causes discomfort in the joint. An increase in pain accompanied by local swelling, further impairment of joint mobility, fever, malaise should raise suspicion of a septic joint process. If confirmed, discontinue the corticosteroid and immediately initiate appropriate antibacterial therapy for 7 to 10 days after the disappearance of any evidence of infection.
Avoid intra-articular injection into joints that have been the site of infectious processes. Edema may occur in the presence of renal dysfunction with a reduced glomerular filtration rate.
During prolonged therapy, adequate protein intake is essential to counteract the tendency to gradual weight loss sometimes associated with a negative nitrogen balance, weight loss and skeletal muscle weakness.
In peptic ulcer, recurrence may remain asymptomatic until perforation or bleeding occurs.
Prolonged corticosteroid therapy can cause hyperacidity or peptic ulcer; therefore, the administration of an antacid is recommended.

Special warnings
KENACORT is a long-acting preparation and is not recommended in acute situations.
This product contains benzyl alcohol as a preservative. Benzyl alcohol has been associated with serious adverse events and death, especially in pediatric patients. “Respiratory distress syndrome” has been associated with benzyl alcohol. Although normal therapeutic dosages of this product release amounts of benzyl alcohol that are substantially lower than those reported in association with “respiratory distress syndrome”, the minimum dose of benzyl alcohol that can cause toxicity is unknown.
Premature and low birth weight infants, as well as patients receiving high dosages, may more easily develop toxicity.
Therefore, the product should not be administered to children under two years of age due to the presence of benzyl alcohol.
Do not inject intravenously, as it is a suspension.
No studies have been conducted to demonstrate the safety of KENACORT therapy administered by intranasal (turbinates), subconjunctival, subtendinous, retrobulbar and intraocular (intravitreal) routes.
Following intravitreal administration, endophthalmitis, eye inflammation, increased intraocular pressure, chororetinopathy, including maculopathy due to active ingredient crystal deposits, and viral chororetinitis/retinitis (mainly cytomegalovirus) and visual disturbances including vision loss have been reported. Numerous cases of blindness have been reported following injections of corticosteroid suspensions into the nasal turbinates and at the level of the head. The administration of KENACORT (Triamcinolone Acetonide Injectable Suspension) is not recommended, nor is it indicated for any of these routes of administration.
The administration of KENACORT by epidural or intrathecal route should not be used. Cases of serious adverse events have been associated with epidural or intrathecal administration.
Cases of severe anaphylactic reactions and anaphylactic shock, including death, have been reported in subjects who received an injection of triamcinolone acetonide, regardless of the route of administration.
To avoid drug-induced adrenal insufficiency, supportive dosage is indicated in stressful situations (trauma, surgery or serious illness), both during treatment with KENACORT and in the year following it.
Visual disturbances
Visual disturbances can be reported with the use of systemic and topical corticosteroids. If a patient presents symptoms such as blurred vision or other visual disturbances, referral to an ophthalmologist should be considered for evaluation of possible causes, which may include cataracts, glaucoma, or rare diseases such as central serous chorioretinopathy (CSCR), which have been reported after the use of systemic and topical corticosteroids, including triamcinolone acetonide.
Prolonged use of corticosteroids can lead to posterior subcapsular cataract or glaucoma with possible damage to the optic nerves and increase the likelihood of secondary eye infections. Moderate and high doses of cortisone or hydrocortisone can cause increased blood pressure, water and salt retention, and increased potassium excretion. These effects are less likely with synthetic derivatives, unless they are used at high doses. A low-salt diet may be necessary, and potassium supplements may be administered at the same time. All corticosteroids increase calcium excretion, which may then be associated with or exacerbate pre-existing osteoporosis.
Corticosteroids can mask some signs of infection and infections may occur during their use. The body's defenses may be reduced during corticosteroid therapy and it may be difficult to locate a possible site of infection. In addition, subjects undergoing immunosuppressive therapy, including corticosteroids, are more susceptible to infections than those who do not use these drugs. Varicella and measles may have a more severe or even fatal course in patients treated with corticosteroids. In children or adults treated with corticosteroids who have not had these diseases, particular care should be taken to avoid contagion. If this occurs, varicella-zoster immunoglobulin (VZIG) or intravenous immunoglobulin (IVIG) therapy may be indicated. If varicella or herpes zoster develops, antiviral agents may be considered.
Similarly, corticosteroid drugs should be used with extreme caution in subjects with Strongyloides (pinworm) infestation, as the immunosuppression induced by corticosteroids can cause a superinfection with Strongyloides with widespread dissemination and larval migration, often accompanied by severe enterocolitis and gram-negative sepsis.
Patients undergoing corticosteroid treatment, especially at high doses, should not be vaccinated or immunized because they are predisposed to clinical complications, especially neurological ones, due to loss of antibody response.
The use of triamcinolone acetonide in active tuberculosis should be limited to cases of fulminant or disseminated disease in which the corticosteroid is used to treat the infection together with adequate anti-tuberculosis therapy. If corticosteroids are administered to patients with latent tuberculosis or with a positive tuberculin reaction, chemoprophylaxis is necessary.
Since rare cases of anaphylactic reactions have occurred in patients undergoing parenteral corticosteroid therapy, appropriate precautions should be taken before administration, especially when the patient's history shows allergy to drugs.
It is recommended that the intramuscular injection be performed deeply as local atrophy may occur. The gluteal region is preferred to the deltoid, as a higher incidence of local atrophy occurs in this area.

Interactions

Non-steroidal anti-inflammatory agents (NSAIDs): corticosteroids can increase the incidence and/orseverity of bleeding and gastrointestinal ulceration caused by NSAIDs. In addition, corticosteroids can reduce serum salicylate levels with a consequent decrease in efficacy. Conversely, stopping corticosteroid administration during therapy with high doses of salicylate could cause salicylate toxicity.
In subjects with hypoprothrombinemia, the association between corticosteroids and aspirin should be administered with caution.

Dosage, method and duration of administration
General
The initial dose of KENACORT may vary from 2.5 to 60 mg/day depending on the specific pathology to be treated.
In less severe cases, lower dosages may be sufficient, while in other patients higher initial doses may be necessary. Generally, the amount of drug administered parenterally varies from one-third to one-half of the dose administered orally every 12 hours. In cases that may put the patient's life at risk, higher dosages may be justified. The initial dosage should be maintained or adjusted until a satisfactory clinical response is achieved. If this is not achieved after a reasonable period of time, KENACORT should be gradually discontinued and the patient should be treated with other therapy.
THE DOSAGE SCHEME IS VARIABLE AND MUST BE INDIVIDUALIZED BASED ON THE PATHOLOGY TO BE TREATED AND THE PATIENT'S RESPONSE.
It is recommended to use the minimum dose useful for the pathology in question.
Once a positive response to therapy has been achieved, the appropriate maintenance dose should be determined by gradually decreasing the initial dose until the minimum dose useful for maintaining the desired therapeutic response is reached. If the product is to be discontinued after long-term therapy, gradual and not abrupt discontinuation is recommended.

Dosage
Systemic Route

Adults and children over 12 years:the recommended initial dose is 60 mg. Administer the
injection deeply into the muscles of the gluteal region.
If the injection is not administered correctly, fat atrophy may occur.
The dosage is generally adjusted between 40 and 80 mg, depending on the patient's response and the duration
of remission. In some patients, however, symptoms may be well controlled with low
doses of 20 mg or less. Patients suffering from hay fever or pollen asthma who do not
respond to desensitization therapy and other conventional therapies may achieve a
lasting remission of symptoms throughout the entire pollen season with a single injection of 40-100 mg.

Children from 6 to 12 years:the recommended initial dose is 40 mg, although the dosage depends more
on the severity of the symptoms than on age or body weight.

Newborns or premature infants:this preparation contains benzyl alcohol. Do not use in newborns or in
premature infants (see also the sections PRECAUTIONS FOR USE, Use in childrenand SPECIAL WARNINGS
SPECIAL)

For Local Administration

Intra-articular or intra-bursal administration: a single injection of triamcinolone acetonide is
often sufficient, but several may be necessary to adequately relieve symptoms.
Initial dose: 2.5-5 mg for small joints, 5 to 15 mg for larger ones, depending on the
type of pathology to be treated. In adults, doses up to 10 mg for smaller areas and up to 40 mg for
larger ones are usually sufficient. Doses up to a
total of 80 mg have been administered without adverse effects by single injections.

Administration
General

Administration under absolute sterile conditions is necessary.Before use, shake the
vial well to ensure uniform suspension of the preparation and make sure that no
agglomerates have formed. Exposure to low temperatures causes agglomerates and in this case the product should not
be used. After withdrawal, administer the injection immediately to avoid deposits in the
syringe. Use all precautions to prevent the risk of infection or the needle penetrating a
blood vessel.

Systemic Route
The injection should be administered deeply into the muscles of the gluteal region. For adults, the use of
a needle with a minimum length of 4 cm is recommended; in obese subjects, a longer needle may be necessary.
Alternate the site with each subsequent injection.

Local Administration
In cases of significant intra-articular effusion, it is advisable to aspirate part of the
synovial fluid preventively, without however completely emptying the collection; this
precautions helps to facilitate the remission of symptoms, while avoiding
excessive dilution of the steroid injected in situ. Then proceed with the
intra-articular administration according to the prescribed technical rules for injections into the articular cavity.
With intra-articular or intra-bursal administration of KENACORT, the use of a local anesthetic may often be appropriate.
Maximum attention must be paid to this type of injection, especially if performed in the
deltoid region, to avoid injection of the suspension into the surrounding tissue, as this
can lead to tissue atrophy.
Do not use KENACORT for intravenous, intradermal, subtendinous, endonasal (turbinates),
subconjunctival, retrobulbar or intravitreal (intraocular), epidural or intrathecal injection. See the
SPECIAL WARNINGS section for details.

Overdosage

Chronic Overdosage: symptoms of glucocorticoid overdosage may include confusion,
anxiety, depression, gastrointestinal cramps or bleeding, bruising, moon face and
hypertension. Following prolonged therapy, abrupt discontinuation of treatment may cause
acute adrenal insufficiency. The latter can also occur in cases of stress. Prolonged therapy with high doses can result in Cushingoid changes.

Acute Overdosage: there is no specific treatment for acute corticosteroid overdosage,
therefore supportive therapy should be instituted, and in case of gastrointestinal bleeding, intervention should be
carried out as in the case of peptic ulcer.