Dexamethasone Kalceks

Isolated cases of anaphylactic reactions with circulatory failure, cardiac arrest, cardiac arrhythmia, bronchospasm, and/or decrease or increase in blood pressure have been observed following administration of DEXAMED. Treatment with DEXAMED may, due to immunosuppression, increase the risk of bacterial, viral, parasitic, opportunistic, and fungal infections. Signs of existing or developing infection may be masked, making diagnosis more difficult. Latent infections such as tuberculosis or hepatitis B may be reactivated. If certain stressful situations occur during treatment with DEXAMED (accident, surgery, childbirth, etc.), a temporary dose increase may be necessary. In patients with COVID-19 who are already being treated with systemic (oral) corticosteroids for other reasons (e.g. patients with COPD (chronic obstructive pulmonary disease)) but who do not require supplemental oxygen therapy, systemic corticosteroids should not be discontinued. In the following conditions, treatment with DEXAMED should be administered only when strictly indicated and, where necessary, in conjunction with anti-infective therapy: acute viral infections (hepatitis B, herpes zoster, herpes simplex, varicella, herpetic keratitis) HBsAg-positive chronic active hepatitis approximately 8 weeks before and up to 2 weeks after vaccination with live vaccines systemic mycoses and parasitoses (e.g. nematodes) in patients with confirmed strongyloidiasis or suspected strongyloidiasis (infection caused by the parasitic nematode of the genus Strongyloides), glucocorticoids may lead to activation and massive proliferation of the parasites poliomyelitis lymphadenitis following BCG vaccination acute and chronic bacterial infections in cases of tuberculosis in the patient's history, use this medicinal product only with concomitant administration of antituberculotics Treatment with DEXAMED should be administered only when strictly indicated and, where appropriate, in conjunction with other specific therapy in the following conditions: gastrointestinal ulcers osteoporosis severe heart failure hypertension that is difficult to control diabetes mellitus that is difficult to control psychiatric disorders (including those in the patient's history), including suicidal tendencies. In this case, neurological or psychiatric evaluation is recommended. narrow-angle and wide-angle glaucoma. Ophthalmological monitoring and concomitant therapy are recommended. corneal ulceration and damage. Ophthalmological monitoring and concomitant therapy are recommended. Owing to the risk of intestinal wall perforation, DEXAMED should be used only when strictly indicated and under appropriate supervision in the following conditions: severe ulcerative colitis with impending perforation, even without peritoneal irritation diverticulitis entero-anastomoses (immediately after surgery) In patients receiving high doses of glucocorticoids, signs of peritoneal irritation following gastrointestinal perforation may be undetectable. When using DEXAMED in diabetic patients, the possibility of an increased dose of insulin or oral antidiabetic agents should be considered. During treatment with DEXAMED, regular blood pressure monitoring is required, particularly in hypertensive patients on high doses that are difficult to control. Patients with severe heart failure should be closely monitored, as there is a risk of deterioration of their condition. Bradycardia may occur with high doses of dexamethasone. Severe anaphylactic reactions may occur. When glucocorticoids are co-administered with fluoroquinolones, the risk of tendon damage, inflammation, and rupture is increased. Symptoms of myasthenia gravis may worsen at the beginning of treatment with DEXAMED. In principle, vaccination with inactivated vaccines is possible. However, it should be noted that the immune response, and hence the success of vaccination, may be impaired by higher doses of corticoids. When high doses are administered, adequate potassium intake and sodium restriction should be ensured, and serum potassium levels should be monitored. Abrupt discontinuation of treatment after more than 10 days may lead to exacerbation or recurrence of the underlying disease, as well as to acute adrenal insufficiency / corticoid withdrawal syndrome. Therefore, if the medicinal product needs to be discontinued, the dose should be tapered slowly. Viral infections (chickenpox, measles) may have a particularly severe course in patients treated with glucocorticoids. Special caution is recommended in immunocompromised patients, in patients who have not had measles or chickenpox, or who are in contact with persons with any of these diseases. Tumour lysis syndrome (TLS) has been reported in the post-marketing setting in patients with haematological malignancies following the use of dexamethasone alone or in combination with other chemotherapeutic agents. Patients at high risk of TLS, such as those with a high proliferation rate, high tumour burden, and high sensitivity to cytostatic agents, should be closely monitored, and appropriate preventive measures should be instituted. Visual disturbance Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes, which may include cataract, glaucoma, or rare diseases such as central serous chorioretinopathy (CSCR), which has been reported following the use of systemic and topical corticosteroids. For intravenous administration, the injection should be given slowly (over 2–3 minutes), as overly rapid administration may cause short-term, harmless side effects in the form of unpleasant tingling or paraesthesia lasting up to 3 minutes. DEXAMED is a medicinal product intended for short-term use. In the event of off-label use over a longer period, the additional instructions and precautions applicable to glucocorticoid medicinal products for long-term use must be observed. With local use, possible systemic side effects and interactions should be taken into account. Intra-articular administration of glucocorticoids increases the risk of joint infections. Long-term repeated use of glucocorticoids in weight-bearing joints may exacerbate changes associated with joint wear. This may be caused by excessive use of the affected joint after pain or other symptoms have subsided. Local administration in ophthalmology Cushing's syndrome and adrenal insufficiency may be associated with the systemic absorption of ophthalmic dexamethasone after intensive or long-term treatment in predisposed patients, including children and patients treated with CYP3A4 inhibitors (including ritonavir and cobicistat). In such cases, treatment should be discontinued gradually. Phaeochromocytoma crisis Phaeochromocytoma crisis, which can be fatal, has been reported following administration of systemic corticosteroids. Corticosteroids should be administered to patients with suspected or identified phaeochromocytoma only after appropriate evaluation of the benefit-risk balance. Hypertrophic cardiomyopathy Hypertrophic cardiomyopathy has been reported following systemic administration of corticosteroids, including dexamethasone, in premature infants. In most reported cases, it was reversible after discontinuation of treatment. In premature infants treated with systemically administered dexamethasone, diagnostic evaluation should be performed and cardiac function and structures should be monitored (section 4.8). Paediatric population Premature infants Following early treatment (<96 hours after birth) in premature infants with chronic lung disease, with initial doses of 0.25 mg/kg twice daily, the available data suggest negative long-term effects on neuronal development. In children in the growth phase, the benefit-risk balance of treatment with DEXAMED should be carefully considered. Elderly patients Owing to the increased risk of osteoporosis, an individual benefit-risk assessment should be carried out in elderly patients. Use of DEXAMED may lead to positive results in doping controls. Excipients This medicinal product contains less than 1 mmol (23 mg) of sodium per ampoule, that is to say, essentially "sodium-free".