Instructions Kenalog 40 suspension for injection 40 mg/ml ampoule 1 ml No. 5
Composition
active ingredient: triamcinolone acetonide;
1 ml of suspension for injection contains triamcinolone acetonide 40 mg;
Excipients: sodium carboxymethylcellulose, sodium chloride, benzyl alcohol, polysorbate 80, water for injections.
Dosage form
Suspension for injection.
Main physicochemical properties: white suspension, practically free of visible mechanical inclusions and lumps, with a slight odor of benzyl alcohol.
Pharmacotherapeutic group
Corticosteroids for systemic use. Glucocorticoids.
Pharmacological properties
Pharmacodynamics.
Triamcinolone acetonide is a derivative of triamcinolone intended for general use. Although triamcinolone itself is almost twice as potent as prednisone, as shown in animal models of inflammation, triamcinolone acetonide is almost 8 times more potent than prednisone.
The main effects of triamcinolone in humans are related to its glucocorticoid action and suppression of the inflammatory response. Glucocorticoid activity leads to increased gluconeogenesis and decreased glucose utilization in tissues. Protein catabolism is accelerated and synthesis from dietary protein is reduced, although the overall effect on nitrogen balance depends on other factors, including diet, dose, and duration of treatment. At doses of 12–24 mg per day, a negative nitrogen balance may occur. Fats are metabolized, and fat deposits on the shoulders, face, and abdomen increase. Triamcinolone has little mineralocorticoid activity. During corticosteroid treatment, the number of erythrocytes and neutrophils increases; the number of eosinophils and basophils decreases. The mass of lymphoid tissue also decreases.
Corticosteroids prevent or suppress the first signs of the inflammatory process, i.e. redness, soreness, local increase in body temperature, sweating, as well as later complications, including fibroblast proliferation or collagen deposition.
Pharmacokinetics.
Absorption and distribution
When 120 mg of triamcinolone acetonide is administered intramuscularly, the maximum concentration of the drug in blood plasma is 44–54 μg/100 ml after 8–10 hours; this level decreases to 8.9 μg/100 ml 72 hours after administration.
Three days after intra-articular injection, 58% to 67% of triamcinolone acetonide is absorbed. Comparison of the area under the plasma concentration-time curve (AUC) for intra-articular and intramuscular injections indicates complete absorption of the drug for both routes of administration.
Metabolism
Like prednisone, triamcinolone is likely metabolized in the liver. Less than 15% of the drug is excreted unchanged in the urine. After absorption through the skin, topical corticosteroids behave in the same way as systemic corticosteroids: metabolism occurs primarily in the liver.
Three metabolites of triamcinolone have been identified, and the metabolic pattern is similar for all three routes of administration. The metabolites of triamcinolone include 6-beta-hydroxytriamcinolone acetonide, 21-carboxy-6-beta-hydroxytriamcinolone acetonide, and 21-carboxytriamcinolone acetonide.
Breeding
Pharmacokinetic clinical studies have not shown sufficient systemic absorption of topical corticosteroids to result in significant amounts of the drug being present in breast milk. Systemically administered corticosteroids pass into breast milk in amounts unlikely to have adverse effects on the infant.
After an intramuscular dose of 40 mg of triamcinolone acetonide, the radioactivity recovered in the urine was 12.5% of the administered dose. After an oral dose of 32 mg of triamcinolone, the drug was present in the urine for four days in one patient and for five days in another. After a single intramuscular dose of 80 mg of triamcinolone acetonide, the drug was present in the urine for 7 days in 2 patients and 11 days in 1 patient.
Topical corticosteroids and their inactive metabolites enter the bile in small amounts after systemic absorption.
The plasma half-life of oral triamcinolone ranges from 2 to more than 5 hours.
Pharmacokinetics are dose-dependent. In studies with 5 mg/kg, the mean elimination half-life was 85 minutes; 10 mg/kg, 88 minutes. Total body clearance was 61.6 L/h in the 5 mg/kg group and 48.2 L/h in the 10 mg/kg group; the difference was statistically significant. The pharmacokinetics of triamcinolone and its phosphate ester were studied after intravenous injection of 5 mg/kg and 10 mg/kg. One group received 80 mg of triamcinolone acetonide.
Indication
Triamcinolone acetonide is recommended for the treatment of:
allergic conditions, including seasonal and perennial allergic rhinitis, atopic and contact dermatitis, drug reactions, serum sickness, and acute noninfectious laryngeal edema. In anaphylactic reactions, corticosteroids are not useful for treating the acute event, but they are useful for preventing the onset of the final phase of the allergic reaction;
Corticosteroids should be used for patients with severe rheumatoid arthritis who are awaiting the beneficial effects of long-acting antirheumatic drugs. They are indicated for the short-term treatment of acute gout, acute nonspecific ankylosing spondylitis, bursitis, epicondylitis, post-traumatic osteoarthritis, psoriatic arthritis, and synovitis in osteoarthritis;
dermatological diseases:
Corticosteroids are recommended for dermatitis herpetiformis, exfoliative dermatitis, severe erythema multiforme, severe psoriasis, severe seborrheic dermatitis, eczema, atopic dermatitis, discoid lupus, contact dermatitis, alopecia areata, pemphigus, and various acute and chronic dermatoses;
eye diseases:
Corticosteroids are recommended for severe acute and chronic allergic and inflammatory conditions, including allergic conjunctivitis, allergic marginal corneal ulcers, anterior segment inflammation, chorioretinitis, diffuse posterior uveitis and choroiditis, herpes zoster ophthalmicus, iritis and iridocyclitis, keratitis, optic neuritis, and sympathetic ophthalmia;
endocrine diseases:
Corticosteroids are recommended for the treatment of primary and secondary adrenocortical insufficiency, congenital hyperplasia, hypercalcemia associated with malignancy, De Quervain's disease, and Addison's disease;
respiratory diseases:
corticosteroids should be used to treat aspiration pneumonitis, berylliosis, and Leffler syndrome;
other diseases:
tuberculous meningitis, polymorphic sclerosis (corticosteroids should be used to treat exacerbations of polymorphic sclerosis; they reduce the duration of exacerbations, but they do not stop the progression of the disease).
Contraindication
Hypersensitivity to the active substance or to any of the excipients.
Systemic infections, except in cases of specific antibacterial therapy.
Chronic primary hemorrhagic diathesis caused by insufficiency of the platelet component of hemostasis, with subcutaneous hemorrhages and hemorrhages from mucous membranes into natural cavities (Vergolf's disease).
Intravenous, intrathecal, and epidural or intraocular administration.
History of corticosteroid-induced proximal myopathy.
Interaction with other medicinal products and other types of interactions
When used simultaneously with amphotericin B and potassium-sparing agents, the patient should be monitored for the possible development of hypokalemia.
Anticholinesterase agents have an antagonistic effect on corticosteroids.
Corticosteroids antagonize antihypertensives and diuretics. The hypokalemic effect of diuretics, including acetazolamide, is more pronounced.
Anti-tuberculosis drugs: serum concentrations of isoniazid may increase.
Cyclosporine: Careful monitoring for signs of increased cyclosporine toxicity is required when co-administered with corticosteroids.
Digitalis glycosides: Concomitant use increases the likelihood of digitalis toxicity.
Estrogens, including oral contraceptives: Corticosteroid half-life and concentration may be increased and clearance may be decreased.
Hepatic enzyme inducers (including barbiturates, phenytoin, carbamazepine, rifampicin, primidone, aminoglutethimide): may increase the metabolic clearance of Kenalog 40. The patient requires close monitoring for possible reduction in steroid effects and dosage adjustment as appropriate.
Human growth hormone: the growth-promoting effect may be inhibited.
Thyroid drugs: Metabolic clearance of adrenocorticoids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in the patient's thyroid status may require adjustment of adrenocorticoid doses.
The combination of a corticosteroid with nonsteroidal anti-inflammatory drugs increases the risk of peptic ulcers and gastrointestinal bleeding.
Medicines containing acetylsalicylic acid should be taken with caution with corticosteroids in hypothrombinemia.
Steady-state serum salicylate concentrations are reduced by intra-articular injection of corticosteroids, including triamcinolone.
Concomitant administration of corticosteroids and muscle relaxants has been reported to counteract neuromuscular blockade.
Clinical studies have shown that corticosteroids accelerate and reduce the activity of oral anticoagulants when used concomitantly. Therefore, patients receiving oral anticoagulants and corticosteroids should be carefully monitored.
Phenytoin has been shown to increase the hepatic metabolism of corticosteroids and reduce the effectiveness of triamcinolone.
Concomitant influenza vaccination and immunosuppressive therapy (corticosteroids) was associated with a worsening of the immune response to the vaccine.
Corticosteroids may increase blood glucose levels, so diabetes should be monitored, especially when corticosteroid treatment is started, stopped, or the dosage is changed.
Corticosteroid preparations for injection into the affected area can be diluted with water for injection or 0.9% sodium chloride solution for injection.
After 7 days, any unused diluted suspension should be discarded.
Corticosteroids may be mixed with local anesthetics before administration to the affected area. Reconstituted preparations should be used immediately; unused portions should be discarded. Suitable anesthetics include 1% or 2% lidocaine hydrochloride solution or 1% procaine hydrochloride solution.
CYP 3A4 inhibitors: Triamcinolone acetonide is a CYP3A4 substrate. Concomitant use of strong CYP3A4 inhibitors (e.g. ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with triamcinolone is not recommended as it may increase systemic corticosteroid side effects (see section 4.8).
Concomitant use of triamcinolone and protease inhibitors (ritonavir, lopinavir) may increase systemic concentrations of triamcinolone, so caution is recommended.
Non-depolarizing muscle relaxants: corticosteroids may reduce or enhance the neuromuscular blocking effect.
In addition, corticosteroids may reduce serum salicylate levels and therefore reduce their effectiveness. Conversely, discontinuation of corticosteroids during high-dose salicylate therapy may result in salicylate toxicity.
Concomitant treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic adverse effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid adverse effects. Systemic corticosteroid effects should be monitored if this combination is used. During post-marketing use, clinically significant drug interactions have been reported in patients receiving triamcinolone acetonide and ritonavir, resulting in systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression. Therefore, concomitant use of triamcinolone acetonide and ritonavir is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects (see section 4.4).
Application features
Kenalog 40 should not be administered intravenously.
Since complications of glucocorticoid treatment (including triamcinolone) depend on the dose and duration of treatment, a risk/benefit assessment of the dose and duration of treatment should be performed in each individual case and it should be determined whether daily or short-term therapy should be used.
Adequate and comprehensive studies demonstrating the safety of Kenalog 40 for intranasal, subconjunctival, subtenon, retrobulbar, and intraocular (intravitreal) injections have not been conducted. Endophthalmitis, eye inflammation, increased intraocular pressure, and visual disturbances (including vision loss) have been reported with intraocular (intravitreal) injections. There have been isolated reports of blindness following intranasal corticosteroid suspension injections and intrafocal head injections.
Isolated cases of serious anaphylactic reactions and anaphylactic shock, including fatal outcomes, have been reported, regardless of the route of administration.
During long-term therapy, the administration of free proteins is important to prevent progressive weight loss, which is sometimes associated with negative nitrogen balance and skeletal muscle atrophy.
Patients or caregivers should be aware of the possibility of serious psychiatric disorders associated with systemic steroid therapy. Typical symptoms appear within days or weeks of initiation of therapy. The risk may increase with increasing dose or systemic exposure, although the dose level does not predict the onset, type, severity, or duration of the reaction. Most reactions resolve after dose reduction or discontinuation, but specific treatment may be necessary. Patients or caregivers should seek medical attention if they experience any psychiatric symptoms that concern them, especially if they develop depressive mood or suicidal thoughts. Patients or caregivers should be aware of the possibility of psychiatric disorders that may occur immediately after or during a period of dose reduction and/or discontinuation of systemic steroids, although reports of such adverse reactions have been extremely rare.
The drug should be used with extreme caution: in fresh intestinal anastomosis, diverticulitis, thrombophlebitis, a history of severe affective disorder (especially in previous steroid psychosis), exanthematous diseases, chronic nephritis or renal failure, metastatic carcinoma, osteoporosis (in postmenopausal women); in patients with peptic ulcer in the acute stage (or peptic ulcer in history); in myasthenia gravis; in latent or inactive form of tuberculosis; in the presence of local or systemic viral infection, systemic fungal infection or active infection not controlled by antibiotics; in acute psychosis, acute glomerulonephritis; in arterial hypertension; congestive heart failure; glaucoma (or glaucoma in a family history), previous steroid myopathy or epilepsy; in hepatic failure.
The effects of corticosteroids may be more pronounced in patients with hypothyroidism or cirrhosis and less pronounced in patients with hyperthyroidism.
All corticosteroids increase calcium excretion.
Patients on corticosteroid therapy who are exposed to severe stress should receive rapid-acting corticosteroid support, and the dose should be increased before, during, and after the stressful situation.
Adrenal suppression may persist for several months after discontinuation of treatment; therefore, replacement therapy may be required during periods of stress.
Corticosteroids can mask signs of infection and reduce resistance to infection.
Corticosteroid therapy may increase the risk of tuberculosis in patients with latent tuberculosis or with a positive Mantoux test. The use of corticosteroids in active tuberculosis should be limited to hyperacute or disseminated disease, in which the corticosteroid is used in conjunction with an appropriate antituberculosis regimen.
Corticosteroids may increase the risk of serious or fatal infection in people who have a viral infection such as chickenpox or measles.
Patients taking corticosteroid therapy should not be vaccinated.
Corticosteroids should be used with caution in patients with ocular herpes simplex due to the possibility of corneal perforation.
Corticosteroids can cause psychiatric disorders ranging from euphoria, insomnia, mood swings, personality changes to severe depression and overt psychosis. Corticosteroids may also exacerbate existing emotional instability or psychotic tendencies.
Corticosteroids should be used with caution in patients with nonspecific ulcerative colitis, diverticulitis, fresh anastomosis, active or latent peptic ulcers, renal failure, hypertension, osteoporosis, and myasthenia gravis.
Patients on corticosteroid therapy who have not previously had this viral disease are at increased risk of developing varicella. Such patients should avoid contact with infectious patients. If they have had contact with them, passive immunization is recommended.
The growth and development of a child on long-term corticosteroid therapy should be carefully monitored.
The effects of corticosteroids may be enhanced in patients with hypothyroidism or cirrhosis and reduced in patients with hyperthyroidism.
Intra-articular use of corticosteroids may cause systemic side effects in addition to local side effects.
Intra-articular administration of corticosteroids into previously inflamed or unstable joints should be avoided.
When intra-articular injection is used, synovial fluid should be examined to rule out septic conditions. Significant increase in pain, accompanied by local swelling, subsequent limitation of joint mobility, fever, and general malaise, indicate the presence of septic arthritis. If this complication occurs and sepsis is confirmed, appropriate antibiotic therapy should be initiated.
Drug-induced secondary adrenocortical insufficiency can be minimized by gradual dose reduction. This type of insufficiency may persist for months after discontinuation of therapy.
The following laboratory parameters may increase during corticosteroid treatment: white blood cell count (greater than 20,000/mm3) without signs of inflammation or neoplasm, blood glucose, cholesterol, triglycerides, and low-density lipoproteins.
Triamcinolone may increase blood glucose levels, which may lead to glycosuria or diabetes mellitus.
Decreased urinary 17-ketosteroid and 17-hydroxysteroid levels may occur secondary to adrenal suppression during triamcinolone therapy.
Menstrual irregularities may occur, and vaginal bleeding has been observed in postmenopausal women. Women should be informed of this possibility, but this should not prevent appropriate investigations as indicated.
Visual disturbances have been reported with systemic and topical corticosteroids. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be referred to an ophthalmologist for evaluation of possible causes of the disturbances, which may include cataracts, glaucoma, or rare conditions such as central serous chorioretinopathy (CSCR), which have been reported with systemic and topical corticosteroids.
Excipients of the drug Kenalog 40
1 ml of Kenalog 40 (1 ampoule) contains 9.9 mg of benzyl alcohol. It should not be administered to premature or newborn infants. It may cause toxic and anaphylactoid reactions in infants and children under 3 years of age.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially sodium-free.
Use during pregnancy or breastfeeding
The likelihood of corticosteroids crossing the placental barrier varies between different drugs and their forms.
Administration of corticosteroids to pregnant animals may cause fetal abnormalities, including cleft palate; intrauterine growth retardation, and impaired growth and brain development. Prolonged or repeated administration of corticosteroids during pregnancy may increase the risk of intrauterine growth retardation. Hypoadrenalism is theoretically possible when the fetus is exposed to corticosteroids during the prenatal or neonatal periods.
Corticosteroids should only be prescribed if the benefits to the mother and child outweigh the potential risks.
Breastfeeding
Corticosteroids may pass into breast milk, although there are no data for triamcinolone. Infants whose mothers have taken high doses of systemic corticosteroids for a long time may have some degree of adrenal suppression.
Ability to influence reaction speed when driving vehicles or other mechanisms
Treatment with Kenalog 40 has a minor or moderate effect on the patient's ability to drive and use machines.
The following adverse reactions from the central nervous system may occur during the first or second week of treatment: sedation, depression, headache, insomnia, personality changes, mania, hallucinations and psychosis. If such symptoms occur, you should refrain from driving or operating other machinery until they disappear.
Method of administration and doses
It should be noted that dosing requirements for triamcinolone vary and should be individualized based on the disease and patient response. The lowest possible dose of corticosteroids should be used to control the condition being treated, and if dose reduction is possible, it should be gradual.
Dosage should be determined according to the size of the joint and the severity of the symptoms and the patient's response.
Therapeutic results should be observed after 2–3 weeks. However, in some cases, it may take even more than 6 weeks before certain positive results begin to be observed.
Kenalog should not be administered intravenously!
Intramuscular injection
Kenalog 40 can be administered intramuscularly in doses ranging from 40 to 80 mg.
The recommended starting dose for adults and children aged 12 years and over is 60 mg.
If necessary, a dose of 100–120 mg can be administered immediately.
The recommended initial dose for children aged 6–12 years is 0.03–0.2 mg/kg intramuscularly at intervals of 1–7 days.
Intramuscular administration of Kenalog 40 can often replace initial oral therapy.
The dose should be injected deep into the gluteal muscle.
A single parenteral dose can generally be expected to be sufficient for 4–7 days and up to 3–4 weeks of disease control. A single dose of 40–60 mg may induce seasonal remission of symptoms in patients with allergic rhinitis or pollen-induced asthma.
This route of administration may provide beneficial effects, for example in asthma, but it may be associated with side effects such as fever, which is typical of chronic corticosteroid use.
Intra-articular injection
Triamcinolone acetonide is currently rarely used for the symptomatic treatment of rheumatoid arthritis; it can be administered intra-articularly to relieve pain and inflammation in rheumatoid arthritis, gouty arthritis (gout), psoriatic arthritis, and osteoarthritis. Patients should not overload their joints after symptomatic improvement has been achieved. Repeated intra-articular injections over a prolonged period of time may cause severe joint destruction and bone necrosis.
The usual intra-articular dose of triamcinolone acetonide for adults is 5–10 mg for smaller joints and 20–60 mg for larger joints. However, doses of 6–10 mg per injection for smaller joints and 40 mg per injection for larger joints have been used successfully. For injections into multiple joints, up to 80 mg of triamcinolone acetonide has been administered.
Triamcinolone acetonide can be administered topically for the relief of bursitis and tendosynovitis. Care should be taken to inject into the space between the tendon sheath and the tendon rather than into the tendon itself, as this may cause rupture. The dose depends on the size of the joint or synovial space and the degree of inflammation.
Introduction to the lesion site
The dose for intralesional injection of triamcinolone acetonide is usually in the range of 5 to 10 mg. This dose is divided into portions according to the affected area.
The recommended initial dose for children aged 12–18 years is 2.5–40 mg. Subsequent doses may be increased based on clinical response.
Large areas generally require multiple injections and smaller doses per injection site. Typically, 2–3 injections are required every 2–3 weeks. Intralesional administration is appropriate for the treatment of large lesions, such as psoriasis and alopecia areata.
Kidney dysfunction
No dose adjustment is required.
Liver dysfunction
In severe hepatic impairment, treatment should be initiated at half the dose, as the effect of corticosteroids may be enhanced in such patients.
Triamcinolone acetonide can be diluted or mixed with certain local anesthetics (see section “Interaction with other medicinal products and other types of interactions”).
Children.
Triamcinolone acetonide by intramuscular injection is not recommended for children under 6 years of age. Intra-articular or intralesional injection is not recommended for children under 12 years of age unless clearly indicated. The child's growth and development should be closely monitored during treatment.
Overdose
There have been isolated reports of fatal outcome due to acute overdose.
As a rule, it is only after a few weeks of using very high doses that most of the undesirable effects may occur, primarily Cushing's syndrome, as well as restlessness, agitation, depression, gastrointestinal colic or bleeding, ecchymoses, arterial hypertension, hyperglycemia.
There is no specific antidote. Use supportive and symptomatic treatment.
Hemodialysis is not an effective method for accelerating the removal of triamcinolone from the body.
Side effects
Side effects that may occur during the use of triamcinolone acetonide are divided into groups by frequency:
very common (≥ 1/10);
common (≥ 1/100 to < 1/10);
uncommon (≥ 1/1000 to < 1/100);
rare (≥ 1/10,000 to < 1/1,000);
very rare (< 1/10,000);
frequency unknown (cannot be estimated from the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
| Often | Infrequently | Rarely | Very rare | Frequency unknown |
| Infections and infestations | Infection | Injection site abscess sterile, masked infection, tuberculosis, candidal infection, viral eye infection, fungal eye infection, rhinitis, conjunctivitis | | Septic necrosis (especially in patients with systemic lupus erythematosus or rheumatoid arthritis) | |
| Blood and lymphatic system disorders | | | Granulocytosis, lymphopenia, monocytopenia | | |
| Immune system disorders | | Anaphylactoid reaction, anaphylactic reaction, anaphylactoid shock | | | |
| Endocrine disorders | | Cushingoid, adrenal suppression, secondary adrenocortical insufficiency, hypopituitarism | | | |
| Metabolic and nutritional disorders | | Sodium retention, fluid retention, alkalosis, hypokalemia, hyperglycemia, inadequate control of diabetes mellitus, calcium deficiency, increased appetite | Porphyria | | |
| Mental disorders | | Psychiatric symptoms, depression, sedation, euphoric mood, mood swings, psychotic disorder, personality change, insomnia, drug dependence, mental disorder, irritability, suicidal ideation, anxiety, cognitive disorder, mania | Hallucinations | | |
| Nervous system disorders | Headache | Convulsions, epilepsy, syncope, benign intracranial hypertension neuritis, paresthesia, increased intracranial pressure, dizziness | | | |
| Vision impairment | | Blindness, cataract, glaucoma, exophthalmos, corneal perforation, papillary edema | | | Blurred vision (see "Special warnings and precautions for use") |
| Hearing and labyrinth disorders | | Vertigo | | | |
| Heart disorders | | Congestive heart failure, arrhythmia | | | |
| Vascular disorders | | Hypertension, embolism, thrombophlebitis, necrotizing vasculitis, hypotension, hot flashes | | | |
| Gastrointestinal disorders | Dry mouth | Ulcer perforation, hemorrhagic peptic ulcer, pancreatitis, abdominal distension, ulcerative esophagitis, dyspepsia | | | Hiccup |
| Skin and subcutaneous tissue disorders | Urticaria, rash, skin hyperpigmentation, skin hypopigmentation, skin atrophy, skin fragility, petechiae, ecchymosis, erythema, hyperhidrosis, purpura, skin striae, hirsutism, dermatitis acneiform, cutaneous lupus erythematosus, angioedema, pruritus | | | |
| Musculoskeletal and connective tissue disorders | Arthralgia | Osteoporosis, osteonecrosis, pathological fracture, delayed fracture union, musculoskeletal discomfort, muscular weakness, myopathy, muscle atrophy, growth retardation, neuropathic arthropathy, myalgia | | | |
| Kidney and urinary tract disorders | | Glucosuria | | | |
| Reproductive system and mammary gland disorders | | Menstrual irregularities, amenorrhea and postmenopausal vaginal bleeding | | | |
| General disorders and administration site conditions | Injection site reaction | Synovitis, pain, injection site irritation, injection site discomfort, fatigue, impaired healing, hyperthermia | | | |
| Research | Infection | Decreased blood potassium levels, electrocardiogram changes, decreased carbohydrate tolerance, negative nitrogen balance, increased intraocular pressure, weight loss, changes in blood calcium levels, changes in total protein levels | | | |
| Injury, poisoning and procedural complications | | Spinal compression fracture | | | |
Expiration date
3 years.
Storage conditions
Store at a temperature of 8 to 25 °C. Do not freeze. Store upright. Keep out of the reach of children.
Packaging
1 ml of suspension for injection in an ampoule; 5 ampoules in a blister in a cardboard box.
Vacation category
According to the recipe.
Producer
KRKA, dd, Novo mesto, Slovenia.
Location of the manufacturer and address of its place of business
Smarjeska cesta 6, 8501 Novo mesto, Slovenia.
