Betaphos suspension for injection 5 mg/ml + 2 mg/ml 1 ml No. 5

Instructions Betafos suspension for injection 5 mg/ml + 2 mg/ml 1 ml No. 5

Composition

active ingredient: betamethasone;

1 ml of suspension contains 6.43 mg of betamethasone dipropionate (equivalent to 5 mg of betamethasone) and 2.63 mg of betamethasone sodium phosphate (equivalent to 2 mg of betamethasone);

Excipients: methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), benzyl alcohol, polyethylene glycol (macrogol) 4000, carmellose sodium, disodium phosphate dodecahydrate, disodium edetate, sodium chloride, polysorbate 80, 1 M hydrochloric acid solution, water for injections.

Dosage form

Suspension for injection.

Main physicochemical properties: suspension containing white to off-white particles that easily resuspend upon shaking to form a suspension free from foreign particles, white or slightly yellowish in color without agglomerates.

Pharmacotherapeutic group

Corticosteroids for systemic use. Glucocorticoids. ATX code H02A B01.

Pharmacological properties

Pharmacodynamics.

Betamethasone is a synthetic glucocorticoid (9 alpha-fluoro-16 beta-methylprednisolone). Betamethasone has strong anti-inflammatory, anti-allergic and immunosuppressive effects.

Betamethasone does not have clinically significant mineralocorticoid activity.

Glucocorticosteroids diffuse across cell membranes and form complexes with specific cytoplasmic receptors. These complexes then enter the cell nucleus, bind to DNA (chromatin) and stimulate the transcription of messenger RNA and the subsequent protein synthesis of various enzymes. The latter will ultimately be responsible for the actions observed with the systematic use of glucocorticoids. In addition to their significant effects on inflammatory and immune processes, glucocorticoids also affect the metabolism of carbohydrates, proteins and lipids. They also have effects on the cardiovascular system, skeletal muscles and the central nervous system.

Effect on inflammatory and immune processes

It is the anti-inflammatory, immunosuppressive and anti-allergic properties of glucocorticoids that underlie their use in therapeutic practice. The main aspects of these properties are a decrease in the number of immunoactive cells at the level of the inflammatory focus, a decrease in vasodilation, stabilization of lysosomal membranes, inhibition of phagocytosis, and a decrease in the production of prostaglandins and related compounds.

The anti-inflammatory effect is approximately 25 times greater than that of hydrocortisone and 8–10 times greater than that of prednisolone (in weight ratio).

Effect on carbohydrate and protein metabolism

Glucocorticoids stimulate protein catabolism. In the liver, the released amino acids are converted to glucose and glycogen through the process of gluconeogenesis. Glucose absorption into peripheral tissues is reduced, leading to hyperglycemia and glycosuria, particularly in patients with a predisposition to diabetes.

Effect on lipid metabolism

Glucocorticoids have a lipolytic effect. This lipolysis is more pronounced at the level of the extremities. In addition, the lipolytic effect is manifested, in particular, at the level of the trunk, neck and head. The complex of actions is expressed through the redistribution of fat deposits.

The maximum pharmacological effect of corticosteroids appears later than the peak in serum, indicating that the effectiveness of these drugs lies primarily not in direct pharmacological action, but in the modification of enzyme activity.

Pharmacokinetics.

Betamethasone sodium phosphate and betamethasone dipropionate are absorbed from the site of administration and exert therapeutic and other pharmacological effects, both local and systemic.

Betamethasone sodium phosphate is highly soluble in water and is metabolized in the body to form betamethasone, a biologically active steroid. 2.63 mg of betamethasone sodium phosphate is equivalent to 2 mg of betamethasone.

The presence of betamethasone dipropionate ensures prolonged activity of the drug. This component is a practically insoluble compound and forms a depot at the injection site, so it is absorbed more slowly and provides relief of symptoms for a longer period.

Betamethasone is metabolized in the liver. Betamethasone is primarily bound to albumin. In patients with impaired liver function, clearance of betamethasone is slower or delayed.

Indication

Corticosteroid therapy is an adjunct to, not an alternative to, traditional treatment.

Dermatological diseases

Rheumatic diseases

Rheumatoid arthritis, osteoarthritis, bursitis, tendosynovitis, tendonitis, peritendinitis, ankylosing spondylitis, epicondylitis, radiculitis, coccydynia, sciatica, lumbago, torticollis, ganglion cyst, exostosis, fasciitis, acute gouty arthritis, synovial cysts, Morton's disease, cuboid inflammation, foot diseases, bursitis on the background of a hard callus, spurs, stiffness of the big toe.

Allergic conditions

Bronchial asthma, asthmatic status, hay fever, severe allergic bronchitis, seasonal and aperiodic allergic rhinitis, angioedema, contact dermatitis, atopic dermatitis, serum sickness, hypersensitivity reactions to drugs or insect bites.

Collagen diseases

Systemic lupus erythematosus, scleroderma, dermatomyositis, periarteritis nodosa.

Oncological diseases

Palliative therapy of leukemia and lymphoma in adults, acute leukemia in children.

Other diseases

Adrenogenital syndrome, ulcerative colitis, Crohn's disease, sprue, pathological changes in the blood that require corticosteroid therapy, nephritis, nephrotic syndrome.

Primary and secondary adrenal insufficiency (with mandatory simultaneous administration of mineralocorticoids).

Contraindication

Hypersensitivity to the active substances or to any of the excipients included in the preparation.

Hypersensitivity to corticosteroids.

Systemic fungal infections.

Intramuscular administration to patients with idiopathic thrombocytopenic purpura.

Interaction with other medicinal products and other types of interactions

Interaction with other drugs

Concomitant use of phenobarbital, rifampicin, phenytoin, or ephedrine may increase the metabolism of corticosteroids, thereby reducing their therapeutic activity.

Patients receiving corticosteroid therapy cannot receive the following treatments:

vaccination against smallpox;

other methods of immunization (especially when using high doses) due to the risk of neurological complications and inadequate antibody response.

However, patients receiving corticosteroids as replacement therapy may be immunized (e.g., for Addison's disease).

Combination with diuretics such as thiazides may increase the risk of glucose intolerance.

Patients receiving concomitant corticosteroids and estrogens should be monitored for possible excessive corticosteroid effects.

Concomitant use of corticosteroids and cardiac glycosides may increase the risk of arrhythmias or signs of digitalis toxicity associated with hypokalemia. Patients taking cardiac glycosides are often also taking potassium-sparing diuretics, in which case it is important to determine potassium levels.

Corticosteroids may enhance the potassium excretion caused by amphotericin B. Serum electrolyte levels, especially serum potassium, should be closely monitored in all patients receiving one of these drug combinations.

Concomitant use of corticosteroids and coumarin anticoagulants may result in increased or decreased anticoagulant effects, which may require dose adjustment. In patients receiving anticoagulants in combination with glucocorticoids, the possibility of corticosteroid-induced gastrointestinal ulceration or an increased risk of internal bleeding should be considered.

When used simultaneously, corticosteroids may reduce the plasma concentration of salicylates. Acetylsalicylic acid should be used with caution in combination with corticosteroids in hypoprothrombinemia. When reducing the dosage of corticosteroids or discontinuing treatment, patients should be observed for possible salicylic acid poisoning. The combination of corticosteroids with salicylates may increase the frequency and severity of gastrointestinal ulcers.

The combined use of glucocorticosteroids with nonsteroidal anti-inflammatory drugs or with alcohol may increase the risk of developing gastrointestinal ulcers or worsening of existing ulcers. For patients with diabetes, it is sometimes necessary to adapt the dosage of oral antidiabetic drugs or insulin, given the property of corticosteroids to cause hyperglycemia.

The simultaneous administration of glucocorticosteroids and somatotropin may lead to a slowdown in the absorption of the latter. When taking somatotropin, doses of betamethasone exceeding 300-450 mcg (0.3-0.45 mg) per 1 m2 of body surface area per day should be avoided.

Concomitant therapy with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic adverse reactions. Concomitant use should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid adverse reactions; in such cases, patients should be monitored for systemic corticosteroid adverse reactions.

Other types of interactions

Impact on laboratory tests

Corticosteroid treatment should also be considered when interpreting biological parameters and tests (skin tests, thyroid hormone levels) in patients.

Application features

Betaphos suspension is not intended for intravenous or subcutaneous administration.

Serious neurological events, including fatalities, have been reported following epidural corticosteroid injections. Other events reported include spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke. These serious neurological events have occurred with and without fluoroscopy. Because the safety and efficacy of epidural administration have not been established, corticosteroids are not recommended for epidural use.

Anaphylactoid/anaphylactic reactions with the possibility of shock have been observed rarely in patients treated with parenteral corticosteroids. Appropriate precautions should be observed in patients with a history of allergic reactions to corticosteroids.

Strict adherence to asepsis rules is mandatory when using the drug.

Betaphos contains two betamethasone esters, one of which, betamethasone sodium phosphate, is rapidly absorbed from the injection site. Therefore, it should be noted that this soluble component of Betaphos may have systemic effects.

Abrupt withdrawal or reduction of the dose during continuous use (in the case of very high doses, after a short period of use) or when the need for corticosteroids increases (due to stress: infection, trauma, surgery) may increase the adrenal insufficiency. In this case, it is necessary to gradually reduce the dosage. In the case of stress, it is sometimes necessary to resume taking corticosteroids or increase the dosage.

Dosage reduction should be done under strict medical supervision; sometimes it is necessary to monitor the patient's condition for a period of up to one year after discontinuation of long-term treatment or use of increased doses.

Symptoms of adrenal insufficiency include discomfort, muscle weakness, mental disorders, drowsiness, muscle and bone pain, peeling skin, shortness of breath, anorexia, nausea, vomiting, fever, hypoglycemia, hypotension, dehydration, and even death after abrupt discontinuation of treatment. Treatment of adrenal insufficiency consists of the use of corticosteroids, mineralocorticoids, water, sodium chloride, and glucose.

Rapid intravenous administration of high-dose corticosteroids can lead to cardiovascular failure, so the injection should be given over a 10-minute period.

With prolonged corticosteroid therapy, a switch from parenteral to oral administration should be considered after assessing the potential benefits and risks.

When performing intra-articular injections, it is important to know that:

such administration can have local and systemic effects;

To rule out the possibility of a septic process, it is very important to examine any fluid that may be in the joint;

Local injection should not be given into a previously infected joint;

A marked increase in pain and local swelling, further limitation of joint mobility, fever and discomfort may indicate septic arthritis; if the diagnosis of this infection is confirmed, appropriate antibacterial treatment should be initiated;

Corticosteroids should not be injected into unstable joints, infected areas, or the intervertebral space;

repeated injections into joints affected by osteoarthritis may lead to increased joint destruction;

after successful intra-articular therapy, the patient should avoid overloading the joint;

Corticosteroids should not be injected directly into the tendon because this may lead to tendon rupture in the future.

Intramuscular corticosteroid injections must be administered deep into the muscle to prevent local tissue atrophy.

Administration of a corticosteroid into soft tissue or into a lesion and into a joint may cause systemic and local effects.

Special groups of patients at risk

Betamethasone can only be used for a short period under strict medical supervision in patients with diabetes, given its glucocorticoid properties (transformation of proteins into glucose).

An increased effect of glucocorticoids has been observed in patients with hypothyroidism or cirrhosis of the liver.

Betafos should be avoided in patients with herpetic ocular lesions (due to the possibility of corneal perforation).

Precautions are necessary in the following cases: nonspecific ulcerative colitis, threat of perforation, abscess or other pyogenic infections; diverticulitis; intestinal anastomoses; gastric and duodenal ulcers; renal failure; arterial hypertension; osteoporosis; myasthenia gravis; glaucoma; acute psychoses; viral and bacterial infections; growth retardation; tuberculosis; Cushing's syndrome; diabetes; heart failure; in the case of difficult-to-treat epilepsy; predisposition to thromboembolism or thrombophlebitis; during pregnancy.

Since complications of corticosteroid treatment depend on the dose and duration of treatment, the risk-benefit ratio must be considered for each patient when choosing the dose and duration of treatment.

The use of corticosteroids may mask some signs of infection or make it more difficult to detect infection. New infections may occur during such treatment due to decreased resistance.

Prolonged treatment may lead to the development of posterior subcapsular cataracts (especially in children) or glaucoma, which can cause damage to the optic nerves and aggravate secondary eye infections caused by fungi or viruses. In case of prolonged treatment (more than 6 weeks), regular ophthalmological examinations are necessary.

Moderate to high doses of corticosteroids may cause elevations in blood pressure, fluid and sodium retention in tissues, and increased potassium excretion. These effects are less likely with synthetic derivatives unless used in high doses. A low-salt diet and potassium supplements may be considered. All corticosteroids increase calcium excretion.

Patients receiving corticosteroid therapy cannot receive the following treatments:

vaccination against smallpox;

other methods of immunization (especially when using high doses) due to the risk of neurological complications and inadequate antibody response.

However, patients receiving corticosteroids as replacement therapy may be immunized (e.g., for Addison's disease).

Patients, particularly children, receiving immunosuppressive doses of corticosteroids should avoid contact with people with chickenpox and measles.

The drug should only be used in active tuberculosis in cases of rapid or disseminated tuberculosis in combination with adequate anti-tuberculosis therapy. If corticosteroids are prescribed to patients with latent tuberculosis or those who respond to tuberculin, strict monitoring is necessary, since relapse of the disease is possible. With prolonged therapy with corticosteroids, patients should also receive chemoprophylaxis. If rifampicin is used in a chemoprophylaxis program, it is necessary to monitor the increase in metabolic clearance in the liver by corticosteroids; corticosteroid dosage adjustment may be necessary.

Since corticosteroids can retard growth in children, including infants, and suppress endogenous corticosteroid production, it is important to carefully monitor the growth and development of children during long-term treatment.

When using glucocorticosteroids, changes in sperm motility and count are possible in some patients.

Betafos contains benzyl alcohol, which may cause toxic reactions and anaphylactoid reactions in infants and children under 3 years of age. This medicine should not be used in premature infants or full-term newborns.

Betaphos contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216), which may cause allergic reactions (possibly delayed), and in exceptional cases, difficulty breathing.

This medicinal product contains less than 1 mmol (23 mg) sodium/dose, i.e. essentially 'sodium-free'.

Vision impairment

Visual disturbances are possible with systemic and topical corticosteroids (including intranasal, inhaled, and intraocular administration). If symptoms such as blurred vision or other visual disturbances occur, the patient should be evaluated by an ophthalmologist to evaluate possible causes of visual disturbances, which may include cataracts, glaucoma, or rare conditions such as central serous chorioretinopathy, which have been reported following the use of systemic and topical corticosteroids.

Pheochromocytoma crisis, including fatal cases, has been reported. Corticosteroids should be administered to patients with known or suspected pheochromocytoma only after appropriate benefit-risk assessment.

Use during pregnancy or breastfeeding

Due to the lack of controlled studies on the safety of the drug in humans, glucocorticoids should be prescribed to pregnant women, breastfeeding women, and women of reproductive age after careful assessment of the benefit to the woman and the potential risk to the embryo/fetus.

Studies have shown an increased risk of neonatal hypoglycemia after a short antenatal course of betamethasone in women at risk of late preterm birth.

When prescribing corticosteroids in the prenatal period, the benefits and drawbacks of such treatment and the clinical effect should be weighed against the side effects (including growth retardation and increased risk of infections).

In some cases, it is necessary to continue corticosteroid treatment during pregnancy or even increase the dosage (for example, in the case of corticosteroid replacement therapy).

Intramuscular administration of betamethasone leads to a significant reduction in the incidence of dyspnea in the fetus if the drug is administered more than 24 hours before delivery (before the 32nd week of pregnancy).

Published data indicate that the issue of prophylactic use of corticosteroids after 32 weeks of gestation is still controversial. Therefore, when prescribing corticosteroids after 32 weeks of gestation, the physician should weigh all the benefits of such treatment against the potential risks to the woman and fetus.

Corticosteroids are not prescribed to treat hyaline membrane disease in newborns.

In the case of prophylactic treatment of hyaline membrane disease in premature infants, corticosteroids should not be administered to pregnant women with preeclampsia and eclampsia or those with placental involvement.

Children whose mothers received significant doses of corticosteroids during pregnancy should be monitored for signs of adrenal insufficiency.

When betamethasone was administered to pregnant women before delivery, transient inhibition of fetal growth hormone and possibly pituitary hormones that regulate steroid production was observed in the infants, both in the definitive and fetal zones of the adrenal glands in the fetus. However, inhibition of fetal hydrocortisone production did not affect the pituitary-adrenal stress response after delivery.

Because corticosteroids cross the placenta, newborns and infants whose mothers received corticosteroids during most or part of pregnancy should be carefully examined for the rare possibility of congenital cataracts.

Women who have received corticosteroids during pregnancy should be monitored during and after labor and delivery for early detection of adrenal insufficiency due to the stress of childbirth.

Breast-feeding

Corticosteroids cross the placental barrier and are excreted in breast milk.

Because Betafos can cause undesirable effects in breast-fed infants, a decision should be made whether to discontinue breast-feeding or discontinue therapy, taking into account the importance of therapy to the mother.

Ability to influence reaction speed when driving vehicles or other mechanisms

Caution should be exercised, taking into account the central nervous system effects at high doses (euphoria, insomnia) and in connection with visual disturbances that may occur with prolonged treatment (for detailed information, see section "Adverse reactions").

Method of administration and doses

Shake before use.

The dosage regimen is set individually, depending on the indications, severity of the disease and the patient's clinical response to treatment.

Dosage

The dose should be kept as low as possible and the duration of treatment as short as possible. The initial dose should be adjusted to achieve a satisfactory clinical effect. If a satisfactory clinical effect is not achieved within a certain period of time, treatment with the drug should be discontinued by progressive dose reduction and other appropriate therapy should be instituted.

In the event of a favorable response, an appropriate dose should be determined and maintained, gradually reducing the initial dose at appropriate intervals until the lowest dose with an adequate clinical response is reached.

Method of application

Betaphos suspension is not intended for intravenous or subcutaneous administration.

Systemic application

For systemic use, in most cases, treatment is started with 1–2 ml of the drug and repeated if necessary. The dosage and frequency of administration depend on the severity of the patient's condition and the response to treatment. The drug is administered deep intramuscularly into the buttock:

in severe conditions (systemic lupus erythematosus and asthmatic status) that require emergency measures, the initial dose of the drug may be 2 ml;

for various dermatological diseases, 1 ml of the drug administered intramuscularly is usually sufficient; the administration of the drug can be repeated, depending on the response to treatment;

in diseases of the respiratory system, symptom relief is achieved within a few hours after intramuscular injection of Betafos. In bronchial asthma, hay fever, allergic bronchitis and allergic rhinitis, a significant improvement in the condition is achieved after the administration of 1–2 ml of the drug;

For acute and chronic bursitis, the dose for intramuscular administration is

1–2 ml of the drug. If necessary, several repeated injections are performed.

The simultaneous use of a local anesthetic is only necessary in rare cases (the injection is practically painless). If simultaneous administration of an anesthetic is desired, Betafos can be mixed (in a syringe, not in a vial) with 1% or 2% lidocaine hydrochloride or procaine hydrochloride solution, or similar local anesthetics, using dosage forms that do not contain parabens. Anesthetics containing methylparaben, propylparaben, phenol and other similar substances are not allowed. When using an anesthetic in combination with Betafos, first draw the required dose of the drug from the vial into the syringe, then draw the required amount of local anesthetic into the same syringe and shake the syringe for a short period of time.

In acute bursitis (subdeltoid, subscapular, ulnar, and anteropopliteal), injecting 1–2 ml of Betafos into the synovial bursa relieves pain and fully restores mobility within a few hours.

Chronic bursitis is treated with lower doses of the drug after the acute symptoms of the disease have subsided.

In acute tendosynovitis, tendinitis, and peritendinitis, a single injection of Betafos may alleviate the patient's condition; in chronic cases, repeated administration of the drug may be necessary, depending on the patient's condition.

In rheumatoid arthritis and osteoarthritis, intra-articular administration of the drug in a dose of 0.5–2 ml can reduce pain, tenderness and stiffness of the joints within 2–4 hours after administration. The duration of the therapeutic effect of the drug varies significantly and can be 4 weeks or more. Intra-articular administration of Betafos is well tolerated by the joint and periarticular tissues.

Recommended doses of the drug when administered into large joints (e.g., knee, hip) are 1–2 ml; into medium joints (e.g., elbow) are 0.5–1 ml; into small joints (e.g., wrist) are 0.25–0.5 ml.

In the case of dermatological diseases, intradermal administration of the drug directly into the lesion is effective. The reaction of some lesions that are not treated directly may be due to a small systemic effect of the drug. 0.2 ml/cm2 of Betafos is injected into the skin (not under the skin) using a tuberculin syringe and a 26 G needle. The total amount of drug injected into the injection site should not exceed 1 ml.

Corticosteroid-responsive foot conditions. Bursitis under the corn can be treated with two consecutive injections of 0.25 ml each. In conditions such as hallux valgus (flexion contracture of the big toe), hallux varus (inward deviation of the fifth toe) and acute gouty arthritis, relief can occur very quickly. A tuberculin syringe with a 25 G needle, 1.9 cm long, is suitable for most foot injections.

Recommended doses of Betafos (with an interval of approximately 1 week between injections): for bursitis under the corn – 0.25–0.5 ml; for heel spur – 0.5 ml; for stiffness of the big toe – 0.5 ml; for varus little toe – 0.5 ml; for synovial cyst – 0.25–0.5 ml; for Morton's metatarsalgia – 0.25–0.5 ml; for tendosynovitis – 0.5 ml; for inflammation of the cuboid bone – 0.5 ml; for acute gouty arthritis – 0.5–1 ml.

Children

There is insufficient clinical data on the use of the drug in children, therefore it is undesirable to use it in patients of this age category (possible growth retardation and development of secondary adrenal insufficiency).

Overdose

Symptoms. Acute overdose of glucocorticoids, including betamethasone, does not create life-threatening situations. The administration of high doses of glucocorticosteroids for several days does not lead to undesirable consequences (except in cases of very high doses or in the case of use in diabetes mellitus, glaucoma, exacerbation of erosive-ulcerative lesions of the gastrointestinal tract, or in the case of use in patients who are simultaneously receiving therapy with cardiac glycosides, coumarin anticoagulants or potassium-sparing diuretics).

Treatment. In case of complications arising from the metabolic effects of corticosteroids or from the harmful effects of the underlying or concomitant diseases, as well as in case of complications resulting from interactions with other drugs, appropriate treatment should be carried out. It is necessary to maintain optimal fluid intake and monitor the content of electrolytes in plasma and urine (especially the balance of sodium and potassium in the body). If an imbalance of these ions is detected, appropriate therapy should be carried out.

Side effects

Adverse events observed during the use of Betafos, as with the use of other corticosteroids, are due to the dose and duration of use of the drug.

Among the adverse reactions to corticosteroids in general, the following effects should be particularly noted.

Musculoskeletal system: muscle weakness, loss of muscle mass, worsening of myasthenic symptoms in myasthenia gravis, osteoporosis, sometimes with severe bone pain and spontaneous fractures (spinal compression fractures), aseptic necrosis of the femoral or humeral heads, tendon ruptures, steroid myopathy, pathological fractures, joint instability.

Skin: skin atrophy, impaired wound healing, thinning and weakening of the skin, petechiae, bruising, skin reactions such as allergic dermatitis, angioedema, facial erythema, increased sweating, urticaria.

On the part of the digestive system: gastric ulcer with possible perforation and bleeding, pancreatitis, bloating, intestinal perforation, esophageal ulcers, nausea, vomiting, hiccups.

Neurological disorders: seizures, dizziness, headache, migraine, increased intracranial pressure (pseudotumor cerebri).

Psychiatric disorders: euphoria, mood swings, personality changes and severe depression, increased irritability, insomnia, psychotic reactions, particularly in patients with a history of mental disorders, depression.

On the part of the organs of vision: increased intraocular pressure (pseudotumor cerebri: see Neurological and disorders), glaucoma, posterior subcapsular cataract, exophthalmos, blurred vision (see also section "Special instructions").

On the part of the endocrine system: clinical symptomatology of Cushing's syndrome, menstrual cycle disorders, increased need for insulin injections or oral antidiabetic agents in patients with diabetes, fetal or child growth retardation, impaired carbohydrate tolerance, manifestations of latent diabetes mellitus, secondary suppression of the pituitary gland and adrenal cortex is especially harmful in case of stress (injury, surgery or illness).

Metabolic disorders: negative nitrogen balance due to protein catabolism, lipomatosis, weight gain.

Immune system: Corticosteroids may cause suppression of skin tests, mask symptoms of infection and activate latent infections, and reduce resistance to infections, including mycobacteria, tuberculosis, Candida albicans and viruses.

Other disorders: anaphylactic or allergic reactions, hypotensive reactions or reactions associated with shock.

The following adverse reactions may occur with parenteral administration of corticosteroids.

Isolated cases of blindness associated with injection into the lesion in the head, particularly the face, hyper- or hypopigmentation, subcutaneous and cutaneous atrophy, aseptic abscesses, post-injection exacerbation (intra-articular injection) and Charcot arthropathy.

After repeated intra-articular injection, joint damage is possible. There is a risk of infection.

Reporting of suspected adverse reactions

It is important to report suspected adverse reactions after a medicinal product has been authorised. This allows for continued monitoring of the benefit/risk balance of the medicinal product. Qualified healthcare professionals are asked to report all suspected adverse reactions.

Expiration date

2 years.

Storage conditions

Store in the original packaging to protect from light at a temperature not exceeding 25 °C.

Incompatibility

Concomitant administration of a local anesthetic is rarely necessary. If Betafos is administered concomitantly with a local anesthetic, Betafos may be mixed (in a syringe, not in a vial) with 1% or 2% lidocaine hydrochloride or procaine hydrochloride using paraben-free preparations. Similar local anesthetics may also be used. However, anesthetics containing methylparaben, propylparaben, or phenol should be avoided.

Packaging

1 ml in an ampoule, 5 ampoules in a cardboard pack.

Vacation category

According to the recipe.

Producer

K.T. Rompharm Company SRL/SC Rompharm Company SRL

Location of the manufacturer and address of its place of business

Eroilor St. No. 1A, Otopeni, 075100, Il district