Essentiale Forte 50 capsules Liver Detox Cleanse Regeneration Health Support - contains Soy Essential Phospholipids Non-GMO

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One hundred eleven children (2 were enrolled twice and counted as separate patients), age 16 years and under, of whom 11 were less than 1 year, have been treated with Essentiale Forte® (amphotericin b) at 5 mg/kg/day in two open-label studies and one small, prospective, single-arm study. In one single-center study, 5 children with hepatosplenic candidiasis were effectively treated with 2.5 mg/kg/day of Essentiale Forte® (amphotericin b). No serious unexpected adverse events have been reported. Geriatric Use The metabolic pathways of amphotericin B after administration of Essentiale Forte are not known. Excretion

tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue,There are no reports of pregnant women having been treated with Essentiale Forte® (amphotericin b). Teratogenic Effects. Pregnancy Category B: Reproductive studies in rats and rabbits at doses of Essentiale Forte® (amphotericin b) up to 0.64 times the human dose revealed no harm to the fetus. Because animal reproductive studies are not always predictive of human response, and adequate and well-controlled studies have not been conducted in pregnant women, Essentiale Forte® (amphotericin b) should be used during pregnancy only after taking into account the importance of the drug to the mother. Nursing Mothers The undesirable effects listed with frequency “not known” (encephalopathy, bronchospasm, dermatitis exfoliative, hyposthenuria, renal tubular acidosis) have been observed during post-marketing use.

Pharmacokinetic Parameters of Amphotericin B in Whole Blood in Patients Administered Multiple Doses of Essentiale Forte® or Amphotericin B DesoxycholateAdverse reactions are listed below as MedDRA preferred term by system organ class and frequency. Frequencies are defined as: very common (>1/10), common (>1/100 and <1/10), uncommon (>1/1000 and <1/100), not known (cannot be estimated from the available data). As with any amphotericin B-containing product, during the initial dosing of Essentiale Forte® (amphotericin b) , the drug should be administered under close clinical observation by medically trained personnel. Anaphylaxis has been reported with amphotericin B deoxycholate and other amphotericin B-containing drugs, including Essentiale Forte. If a severe anaphylactic reaction occurs, the infusion should be immediately discontinued and the patient should not receive further infusions of Essentiale Forte. PRECAUTIONS General The incidence of infusion related reactions on Day 1 in pediatric and adult patients is summarized in the following table:

Witaminy-Zioła-Leki-Kosmetyki-to wszystko znajdziesz w naszej aptece. Dostarczamy również produkty na specjalne indywidualne zamówienie.The following infrequent adverse experiences have been reported in post-marketing surveillance, in addition to those mentioned above: angioedema, erythema, urticaria, bronchospasm, cyanosis/hypoventilation, pulmonary edema, agranulocytosis, hemorrhagic cystitis, and rhabdomyolysis. Clinical Laboratory Values Cardiorespiratory events, except for vasodilatation (flushing), during all study drug infusions were more frequent in amphotericin B-treated patients as summarized in the following table:

Segment II studies in both rats and rabbits have concluded that Essentiale Forte had no teratogenic potential in these species. In rats, the maternal non-toxic dose of Essentiale Forte was estimated to be 5 mg/kg (equivalent to 0.16 to 0.8 times the recommended human clinical dose range of 1 to 5 mg/kg) and in rabbits, 3 mg/kg (equivalent to 0.2 to 1 times the recommended human clinical dose range), based on body surface area correction. Rabbits receiving the higher doses, (equivalent to 0.5 to 2 times the recommended human dose) of Essentiale Forte experienced a higher rate of spontaneous abortions than did the control groups. Essentiale Forte should only be used during pregnancy if the possible benefits to be derived outweigh the potential risks involved. Nursing Mothers The following adverse events are based on the experience of 244 patients (202 adult and 42 pediatric patients) of whom 85 patients were treated with Essentiale Forte 3 mg/kg, 81 patients were treated with Essentiale Forte 5 mg/kg and 78 patients treated with amphotericin B lipid complex 5 mg/kg in Study 97-0-034, a randomized double-blind, multi-center study in febrile, neutropenic patients. Essentiale Forte and amphotericin B lipid complex were infused over two hours. The incidence of adverse events occurring in more than 10% of subjects in one or more arms regardless of relationship to study drug are summarized in the following table: DO NOT DILUTE WITH SALINE SOLUTIONS OR MIX WITH OTHER DRUGS OR ELECTROLYTES as the compatibility of Essentiale Forte® (amphotericin b) with these materials has not been established. An existing intravenous line should be flushed with 5% Dextrose Injection before infusion of Essentiale Forte® (amphotericin b) , or a separate infusion line should be used. DO NOT USE AN IN-LINE FILTER. Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing;Dacă aveţi orice întrebări suplimentare cu privire la acest medicament, adresaţi-vă medicului dumneavoastră, farmacistului sau asistentei medicale.