TRIAMVIRGI 40 мг/мл Инъекционная суспензия

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1. TRIAMVIRGI “40mg/ml Injectable Suspension” 3 Vials of 1 ml

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TRIAMVIRGI “40mg/ml Injectable Suspension” 3 Vials of 1 ml

TRIAMVIRGI “80mg/2ml Injectable Suspension” 3 Vials of 2 ml
TRIAMVIRGI “80mg/2ml Injectable Suspension” 5 Ampoules of 2 ml
Triamcinolone acetonide
PHARMACOTHERAPEUTIC CATEGORY
Systemic corticosteroid

THERAPEUTIC INDICATIONS
Intramuscular administration of TRIAMVIRGI(Triamcinolone Acetonide injectable suspension) is
indicated for systemic corticosteroid therapy in conditions such as allergic syndromes (to
control severe or debilitating conditions not treatable conventionally), dermatoses, generalized rheumatoid arthritis
and other connective tissue diseases. The intramuscular route of administration is
particularly useful in these diseases when oral corticosteroid therapy is not feasible.

TRIAMVIRGIcan also be administered by intra-articular or intra-bursal route and directly into
tendon sheaths and cystic tendon formations.
These routes of administration allow for effective short-term local therapy for pain,
swelling and joint stiffness resulting from traumatic or rheumatoid arthritis, osteoarthritis,
synovitis, bursitis and tenosynovitis.
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 disease processes such as
traumatic arthritis or bursitis may represent typical indications for therapy conducted
exclusively by intra-articular route.

CONTRAINDICATIONS
Hypersensitivity to the active ingredient (triamcinolone acetonide) or to any of the excipients. Corticosteroids
are contraindicated in patients with systemic infections and in children under two years of age. Intramuscular
administration of corticosteroids is contraindicated in the presence of idiopathic thrombocytopenic purpura.

PRECAUTIONS FOR USE
Secondary adrenal insufficiency may occur following treatment with corticosteroids and
may persist for months after discontinuation of therapy. Therefore, in any stressful condition (such as trauma,
surgery or serious illness) that occurs during this period, hormone therapy must be
resumed. Since the secretion of mineralocorticoids may be impaired, sodium chloride and/or mineralocorticoids should be administered concurrently.
In patients with hypothyroidism or liver cirrhosis, the response to corticosteroids may be increased.
Caution is advised in patients with herpes simplex ophthalmicus, as corneal perforation is possible.
During corticosteroid therapy, various psychiatric disorders may occur: euphoria, insomnia,
mood and personality changes, severe depression or symptoms of true psychosis. Pre-existing
emotional instability or psychotic tendencies may be aggravated by corticosteroids. The use of antidepressant drugs does not relieve these disorders and may exacerbate mental disorders induced by corticosteroid therapy.
Corticosteroids should be administered with caution in the following cases: nonspecific ulcerative colitis with risk of
perforation, abscesses and pyogenic infections in general, diverticulitis, recent intestinal anastomoses, active or latent peptic ulcer, renal insufficiency, acute glomerulonephritis, chronic nephritis, hypertension, congestive heart failure, thrombophlebitis, thromboembolic episodes, osteoporosis, rash, metastatic carcinoma,
myasthenia gravis.
Although TRIAMVIRGImay improve the symptoms of inflammation, the cause should be investigated and treated.
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
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should not subject the joints in which improvement has been obtained to excessive stress,
otherwise a worsening of joint deterioration may occur.
On the occasion of intra-articular administration, overdistension of the joint capsule and leakage of the steroid along the needle track should be avoided, as this may cause subcutaneous atrophy.
Avoid injecting the preparation into unstable joints. In some cases, repeated intra-articular injections may
cause joint instability themselves. 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 limitation of joint mobility, fever, malaise, should raise suspicion of a
septic joint process. If confirmed, discontinue the corticosteroid and initiate
appropriate antibacterial therapy immediately, continuing for 7 to 10 days after the disappearance of all
evidence of infection.
Avoid intra-articular injection into joints that have been the site of infectious processes.
Repeated injections into inflamed tendons have been followed by tendon rupture, and this practice should therefore also be avoided.
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.
Women undergoing corticosteroid treatment may experience menstrual irregularities.
In peptic ulcer, recurrence may remain asymptomatic until perforation or
bleeding.
Prolonged corticosurrenal therapy can cause hyperacidity or peptic ulcer; therefore, administration of an antacid is recommended.
It is essential to monitor patients even after discontinuation of triamcinolone acetonide therapy as
a sudden recurrence of the main symptoms of the disease for which the
patient was treated may occur.
Menstrual irregularities may occur and vaginal bleeding has been observed in postmenopausal women. Women should be informed of the risk but should still
be advised to undergo appropriate investigations.

Use in children
Exposure to excessive amounts of benzyl alcohol has been associated with toxicity (hypotension, metabolic acidosis), especially in neonates, and an increased incidence of kernicterus, particularly in premature infants. There have been rare reports of death, especially in premature infants, associated with exposure to an
excessive amount of benzyl alcohol (see also WARNINGS).

TRIAMVIRGIis not recommended in children under 6 years of age.
Children undergoing prolonged corticosteroid therapy should be carefully monitored for growth and development as corticosteroids can suppress growth.
Caution should be exercised in case of exposure to varicella, measles or other infectious diseases.
Children should not be vaccinated or immunized during corticosteroid therapy. These can in fact
affect the production of endogenous steroids.

Use in the elderly
Side effects such as osteoporosis or hypertension, common in systemic corticosteroid therapy,
may have more serious consequences in the elderly.
Therefore, close clinical monitoring is recommended.

INTERACTIONS

Amphotericin B injections and agents that cause potassium decrease:subjects taking these agents
should be monitored for possible hypokalaemia.
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Anticholinesterases:antagonistic reactions with this agent may occur.

Oral anticoagulants:corticosteroids can both increase and decrease anticoagulant action; it is
therefore necessary to closely monitor subjects taking both oral anticoagulants and
corticosteroids.

Antidiabetics:corticosteroids can increase blood sugar; close monitoring of diabetic subjects is necessary, especially when starting, stopping or changing the dosage of corticosteroid therapy.

Antituberculosis drugs:serum isoniazid concentrations may be decreased.

Cyclosporine:increased activity of both corticosteroid and cyclosporine drugs has been observed when
taken simultaneously.

Digitalis glycosides:a possible increase in digitalis toxicity may occur when administered
concurrently with corticosteroid drugs.

Estrogens, including oral contraceptives:both the half-life and concentration of corticosteroids may increase, while clearance may decrease.

Hepatic enzyme inducers(e.g. barbiturates, phenytoin, carbamazepine, rifampicin): increased
metabolic clearance of triamcinolone acetonide has been observed; subjects taking these therapies should be
closely monitored and the dosage of corticosteroids may need to be adjusted.

Human growth hormone(e.g. somatrem): the growth-stimulating effect may be inhibited.

Ketoconazole:a decrease in the clearance of corticosteroid drugs may occur with a consequent
increase in effects.

Non-depolarizing muscle relaxants:corticosteroids can decrease or increase the neuromuscular blocking action.

Non-steroidal anti-inflammatory drugs (NSAIDs):corticosteroids can increase the incidence and/orseverity of
gastrointestinal bleeding and 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
may cause salicylate toxicity.
In subjects with hypoprothrombinemia, the association between corticosteroids and aspirin should be
administered with caution.

Thyroid drugs:the metabolic clearance of corticosteroids is decreased in hypothyroid subjects and increased
in hyperthyroid subjects. The dosage of corticosteroids should be rebalanced in case of changes in thyroid status.

Vaccines:subjects undergoing corticosteroid therapy who are vaccinated may experience neurological complications and loss of antibody response.

SPECIAL WARNINGS
This product contains benzyl alcohol as a preservative. Benzyl alcohol has been associated with serious adverse events and death, especially in pediatric patients. Gasping 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 gasping syndrome, the minimum dose of
benzyl alcohol that can cause toxicity is not known. Premature and low-weight infants, as well as patients who
receive high dosages, may more easily develop toxicity.

Due to the presence of benzyl alcohol, the product should not be administered to children
under two years of age.
Do not inject intravenously, as it is a suspension.
Studies have not been conducted to demonstrate the safety of TRIAMVIRGIadministered by
intranasal (turbinates), subconjunctival, subtendinous, retrobulbar and intraocular (intravitreal) route.
Endophthalmitis, eye inflammation, increased intraocular pressure, visual disturbances including vision loss have been reported following intravitreal administration. Numerous cases of blindness following injections of corticosteroid suspensions into the nasal turbinates and head injuries have also been reported. The administration of TRIAMVIRGI(Triamcinolone Acetonide Injectable Suspension) is
not recommended, nor is it indicated for any of these routes of administration.

TRIAMVIRGIis a preparation with a prolonged action and is not recommended in acute situations.
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To avoid drug-induced adrenal insufficiency, a support dosage is indicated in situations of
stress (trauma, surgery or serious illness), both during treatment with TRIAMVIRGIand
in the following year.
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 ocular infections.
Medium and high doses of cortisone or hydrocortisone can cause increased blood pressure, fluid 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 and potassium supplementation may be necessary. All
corticosteroids increase calcium excretion, which may therefore be associated with or exacerbate pre-existing
osteoporosis.
Corticosteroids can mask some signs of infection and infections may occur during their use. In the event of
corticosteroid therapy, the body's defenses may be reduced and it may be difficult to locate a possible injection
site. Furthermore, subjects undergoing immunosuppressive therapy including corticosteroids, are more
susceptible to infections than those who do not use these drugs. Chickenpox and measles may have a more
severe or even fatal course in patients undergoing corticosteroid therapy. In children or adults treated with
corticosteroids who have not had these diseases, particular attention should be paid to avoiding contagion. If this
occurs, therapy with varicella-specific immunoglobulins (VZIG) or pooled intravenous immunoglobulins (IVIG)
may be indicated. If chickenpox or herpes zoster develops, antiviral therapy may be considered.
Similarly, corticosteroid drugs must be used with extreme caution in subjects with
Strongyloides infestation (pinworms) as immunosuppression induced by corticosteroids can cause
a superinfection with Strongyloides with widespread dissemination and larval migration, often accompanied by
severe enterocolitis and potentially fatal gram-negative septicemia.
Patients undergoing corticosteroid treatment, especially at high doses, should not be vaccinated or immunized
because of the loss of antibody response they are predisposed to clinical complications, especially
neurological ones.
The use of triamcinolone acetonide in active tuberculosis should be limited to cases of fulminant or
disseminated disease where the corticosteroid is used to treat the infection along with adequate
antitubercular therapy. If corticosteroids are administered to patients with latent tuberculosis or with a
positive tuberculin response, chemoprophylaxis is necessary.
Since rare cases of anaphylactic reactions have occurred in patients undergoing parenteral therapy with
corticosteroids, appropriate precautions should be taken before administration, particularly
when the patient's history reveals an allergy to drugs.
It is recommended that the intramuscular injection be performed deeply as local atrophy may occur. The gluteal
region is preferred over the deltoid, as a higher incidence of local atrophy occurs in this area.

Pregnancy and breastfeeding
Many corticosteroids used at low doses have shown teratogenic effects in laboratory animals.
Since adequate reproduction studies have not been conducted in humans, the use of corticosteroids in
pregnancy, during breastfeeding or in women of childbearing potential should be assessed in light of the
possible benefit compared to the potential risk to the mother, embryo, fetus or breastfeeding infant.
Newborns from mothers who have received substantial doses of corticosteroids during pregnancy should be
carefully monitored for signs of hypoadrenalism.

Effects on the ability to drive and operate machinery
Given the possible occurrence of adverse effects on the Central Nervous System (e.g. dizziness),
the patient who is about to drive or operate machinery should be aware of this possibility.
FOR THOSE WHO PRACTICE SPORTS: THE USE OF THE DRUG WITHOUT THERAPEUTIC
NECESSITY CONSTITUTES DOPING AND CAN IN ANY CASE RESULT IN POSITIVE ANTI-DOPING TESTS.

DOSAGE, METHOD AND DURATION OF ADMINISTRATION
General
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The initial dose of TRIAMVIRGImay vary from 2.5 to 60 mg/day depending on the specific condition to be
treated.
In less severe cases, lower doses may be sufficient, while other patients may require higher initial doses. 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 doses 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, TRIAMVIRGIshould be gradually discontinued and the patient should be treated with other therapy.
THE POSOLOGICAL SCHEME IS VARIABLE AND MUST BE INDIVIDUALIZED BASED ON
THE CONDITION TO BE TREATED AND THE PATIENT'S RESPONSE.
It is recommended to use the minimum dose useful for the condition being examined.
Once a positive response to therapy has been achieved, the appropriate maintenance dose should be
determined by gradually reducing 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
For systemic use

Adults and children over 12 years:the recommended initial dose is 60 mg. Inject

deeply into the muscles of the gluteal region.
If the injection is not performed correctly, atrophy of the subcutaneous fat 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, symptoms may be well controlled with low doses of the order
of 20 mg or less. Patients with hay fever or pollen asthma who do not respond to desensitization therapy
and other conventional therapies, may obtain a remission of symptoms lasting
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 premature infants
(see also PRECAUTIONS FOR USE, Use in childrenand SPECIAL WARNINGS)

For local administration

Intra-articular or intra-bursal administration and injection into tendon sheaths:a single injection of
triamcinolone acetonide is often sufficient, but several may be needed 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
condition to be treated. In adults, doses up to 10 mg for the most restricted areas and up to 40 mg for the most
extensive ones are usually sufficient. Doses up to a total of 80 mg have been administered without adverse effects
through single injections.

Administration
General

Strict aseptic conditions are required.Before use, shake the container 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. Take all precautions to avoid the risk of infection or the penetration of the needle into a
blood vessel.

For systemic use
The injection should be performed deeply into the muscles of the gluteal region. For adults, it is recommended to use
a needle with a minimum length of 4 cm, in obese subjects, a longer needle may be necessary. Alternate the
site with each subsequent injection.
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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 precaution helps to facilitate the remission of symptoms,
while avoiding excessive dilution of the steroid injected in situ. Then proceed with intra-articular administration
according to the prescribed technical rules for injections into joint cavities.
With intra-articular or intra-bursal administration, and with the injection of TRIAMVIRGIinto tendon
sheaths or cystic formations, 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 and in tendon sheaths, to avoid
injection of the suspension into the surrounding tissue, as this can lead to tissue atrophy. In nonspecific acute
tenosynovitis, it is important that the injection be performed inside the sheath and not into the tendon. In case of
epicondylitis, the treatment can be carried out by infiltrating the product into the softest point.

Do not use TRIAMVIRGI for intravenous, intradermal, sub-tendinous, endonasal (turbinates),
subconjunctival, retrobulbar or intravitreal (intraocular) injection. See the section
SPECIAL WARNINGS for details.
Overdosage

Chronic overdose:symptoms of glucocorticoid overdose 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 case of stress. Following prolonged therapy with high doses, changes of the Cushingoid
type may occur.

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

UNDESIRABLE EFFECTS
The list is presented according to the MedDRA systemic organ classification and frequency using the following
frequency categories: very common (≥1/10), common (≥1/100, < 1/10), uncommon (≥1/1.000, <1/100), rare
(≥1/10.000, <1/1.000), very rare (<1/10.000), and not known (frequency cannot be estimated from available
data).

Following administration by any route

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Following intramuscular administration

Following intra-articular administration

Reporting of adverse reactions
If you experience any side effects, including those not listed in this leaflet, please tell 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
medicinal product.
KEEP THIS MEDICINE OUT OF THE REACH AND SIGHT OF CHILDREN

EXPIRY DATE AND STORAGE
WARNING: DO NOT USE THE MEDICINE AFTER THE EXPIRY DATE INDICATED
ON THE PACKAGING
AVOID FREEZING
Do not store above 25°C.

COMPOSITION
Each 40 mg/ml suspension for injection vial contains: ACTIVE INGREDIENT: Triamcinolone acetonide
40.0 mg; EXCIPIENTS: Sodium carboxymethylcellulose; Sodium chloride; Polysorbate; Benzyl alcohol; Water for injections q.s. to 1.0
ml.
Each 80mg/2ml suspension for injection vial contains: ACTIVE INGREDIENT: Triamcinolone acetonide
80.0 mg; EXCIPIENTS: Sodium carboxymethylcellulose; Sodium chloride; Polysorbate; Benzyl alcohol;
Water for injections q.s. to 2.0 ml.
Each vial of 80 mg/2 ml suspension for injection contains: ACTIVE INGREDIENT: Triamcinolone acetonide
80.0 mg; EXCIPIENTS: Sodium carboxymethylcellulose; Sodium chloride; Polysorbate; Benzyl alcohol;
Water for injections q.s. to 2.0 ml.
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PHARMACEUTICAL FORM AND CONTENT
Suspension for injection for intramuscular and intra-articular use.
Pack of 40 mg/ml Suspension for injection 3 vials of 1 ml
Pack of 80 mg/2 ml Suspension for injection 3 vials of 2 ml
Pack of 80 mg/2 ml Suspension for injection 5 vials of 2 ml

AIC HOLDER
FISIOPHARMA S.R.L.
NUCLEO INDUSTRIALE
84020 PALOMONTE (SA)- ITALY

MANUFACTURER AND FINAL CONTROLLER
FISIOPHARMA S.R.L.
NUCLEO INDUSTRIALE
84020 PALOMONTE (SA)- ITALY

DRUG
01/07/2019