Ambrovix syrup with pineapple flavor 30mg/5ml in 100ml vial №1

Name:
Ambrovix. Release form Pineapple syrup. Dosage 30 mg / 5 ml 100 ml Pack quantity: 1 pc. ProducerFarmtekhnologiya ltd. MNNAMbroxol. FTGMucolytic agent.
Description:
of the dosage form Ambrovix, syrup with pineapple flavor: clear, colorless or yellowish, slightly viscous liquid with a specific smell of pineapple; Ambrovix banana flavored syrup: clear, colorless or yellowish, slightly viscous liquid with a specific banana odor. Ingredients: 5 ml of syrup contains (15 mg) or (30 mg) ambroxol hydrochloride as an active ingredient. Excipients: methyl parahydroxybenzoate, propyl parahydroxybenzoate, non-crystallizing sorbitol solution, propylene glycol, ethyl alcohol 96%, concentrated hydrochloric acid, flavor additive “Aromatic” Pineapple AE 111 or flavor additive “Aromatic” Banana AE 210, purified water. The medicinal product contains 2.0% (w/v) ethyl alcohol 96%. Pharmacotherapeutic groupMeans used for coughs and colds. mucolytic agent. ATC code: R05CB06 Indications for use Secretolytic therapy in acute and chronic diseases of the respiratory tract, accompanied by impaired formation and excretion of bronchial secretions (sputum). Dosing and Administration The drug can be taken with or without food, with a glass of water after each dose. You should also take plenty of fluids throughout the day. Ambroxol 15 mg/5 ml: Adults and adolescents over 12 years of age: 10 ml (30 mg ambroxol hydrochloride) 3 times a day (every 8 hours), which means a maximum of 90 mg ambroxol hydrochloride daily. Children 6-12 years: 5 ml (15 mg ambroxol hydrochloride) 2-3 times a day, which means a maximum of 45 mg ambroxol hydrochloride daily. After 2-3 days, when the patient’s condition improves, the dose regimen can be reduced to 2 times a day every 12 hours. Children aged 2-5 years: 2.5 ml (7.5 mg ambroxol hydrochloride) 3 times a day (every 8 hours), which means a daily maximum of 22.5 mg ambroxol hydrochloride. 2-3 days after the patient’s condition improves, you can reduce the dosage regimen of the drug to 2 times a day every 12 hours. In this population, the use of the drug should be only after consulting a doctor. Ambroxol 30mg/5ml: Adults: 5 ml (30 mg ambroxol hydrochloride) 3 times a day (every 8 hours), which means a maximum of 90 mg ambroxol hydrochloride daily, or 10 ml (60 mg ambroxol hydrochloride) 2 times a day (every 12 hours), which means a maximum of 120 mg of ambroxol hydrochloride daily. After the patient gets better, the dose can be halved. Adolescents over 12 years: 5 ml to 7.5 ml, as needed (30 mg to 45 mg ambroxol hydrochloride), 2 times a day (every 12 hours a day), which means a daily maximum of 60-90 mg ambroxol hydrochloride. Children 6-12 years: 2.5 ml (15 mg ambroxol hydrochloride) 2-3 times a day, which means a maximum of 45 mg ambroxol hydrochloride daily. After 2-3 days, when the patient’s condition improves, the dosing regimen can be reduced to 2 times a day every 12 hours. Children 2-5 years: 1.25 ml (7.5 mg ambroxol hydrochloride) 3 times a day (every 8 hours), which means a daily maximum of 22.5 mg ambroxol hydrochloride. After 2-3 days, when the patient’s condition improves, you can reduce the dosage regimen of the drug to 2 times a day every 12 hours. In this population, the use of the drug should be only after consulting a doctor. Special patient populations Children under 2 years of age: This drug is contraindicated in children under 2 years of age. Patients with renal and hepatic insufficiency: in patients with impaired renal function or severe hepatic insufficiency, the drug should be taken only as prescribed by a physician and under medical supervision; it is necessary to reduce the dose or increase the interval between doses. Since ambroxol is metabolized in the liver and excreted by the kidneys, in severe renal failure, accumulation of ambroxol metabolites formed in the liver should be expected. If the patient’s condition does not improve or worsens after 5 days of treatment, reassess the clinical situation. In acute illnesses, a doctor should be consulted if symptoms persist and/or worsen despite taking Ambrovix syrup. The syrup can be dosed with a measuring cup attached to the drug. Side effect The evaluation of undesirable effects is based on the following data on the frequency of occurrence: very often (≥ / 10), often (≥ / 100 to <1/10), infrequently (≥ / 1000 to <1/100), rarely (≥ / 10,000 up to <1/1000), very rarely (<1/10,000), the frequency is unknown (cannot be estimated from the available data). On the part of the immune system Rarely: hypersensitivity reactions. Frequency unknown: angioedema, itching, anaphylactic reactions, including anaphylactic shock. On the part of the skin and subcutaneous tissues Rarely: rash, urticaria. Frequency unknown: severe skin lesions (including erythema multiforme, Stevens-Johnson syndrome / toxic epidermal necrolysis and acute generalized eczematous pustulosis). From the nervous system Often: dysgeusia. From the gastrointestinal tract Often: nausea, numbness of the mouth. Uncommon: Vomiting, diarrhea, dyspepsia, abdominal pain, dry mouth. Very rare: constipation, salivation. Frequency unknown: dry throat. On the part of the respiratory system, chest and mediastinum Often: numbness in the throat. Very rare: rhinorrhea. Frequency unknown: shortness of breath (as a symptom of a hypersensitivity reaction). From the side of the kidneys and urinary tract Very rarely: dysuria. Other Frequency unknown: fever. Reporting Adverse Reactions If you experience any adverse reactions, talk to your doctor. This recommendation applies to any possible adverse reactions, including those not listed in the package insert. You can also report adverse reactions to the adverse drug reactions (actions) information database, including reports of drug failures. By reporting adverse reactions, you help to get more information about the safety of the drug. Contraindications hypersensitivity to the components of the drug; children under 2 years old; pregnancy (I trimester); lactation period; taking the syrup is contraindicated in the presence of congenital fructose intolerance (due to the presence of sorbitol in the composition; see also "Special Instructions and Precautions"). Overdose There is no information on specific symptoms of overdose. In cases of accidental overdose and/or cases of medical error, symptoms were consistent with known adverse reactions to ambroxol at the usual recommended doses. Treatment; symptomatic. Interaction with other drugs Ambrovix is not prescribed simultaneously with antitussive drugs (for example, those containing codeine), as this makes it difficult for the discharge of liquefied sputum from the bronchi against the background of suppression of the cough reflex. Ambroxol promotes the penetration of antibiotics (amoxicillin, cefuroxime, oxytetracycline, doxycycline, erythromycin) into the bronchial secretion. Special instructions and precautions In extremely debilitated patients, patients with anatomical narrowing of the bronchi and increased secretion of mucus when using ambroxol, it may be difficult to evacuate bronchial secretions. In these cases, measures should be taken to suction the secret. The drug should be taken with caution in gastric and duodenal ulcers. In children aged 2 to 6 years, before using the drug, you should consult a doctor to assess the balance between the benefits and risks of using the drug. Ambrovix 15 mg/5 ml: 5 ml of syrup contains sorbitol. Ambrovix 30 mg/5 ml: 5 ml of syrup contains sorbitol. Sorbitol is a source of fructose. If a patient has intolerance to some sugars or is known to have hereditary fructose intolerance, a rare genetic condition in which a person cannot metabolize fructose, they should talk to their doctor before taking this drug. Sorbitol may cause gastrointestinal discomfort and a mild laxative effect. If you miss a dose, do not double the dose to make up for the missed dose. In severe renal and hepatic impairment, lower concentrations should be used or the interval between doses should be increased. There have been reports of the development of severe skin reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis in patients taking ambroxol. It is necessary to immediately stop taking the drug if symptoms of a progressive skin reaction (sometimes associated with the development of blisters and lesions of the mucous membranes) appear. The preparation contains parabens (methyl parahydroxybenzoate and propyl parahydroxybenzoate), which may cause allergic reactions (possibly delayed). The preparation contains 96% ethanol. 5 ml of syrup contains 114 mg of 96% ethanol, which is equivalent to about 2.3 ml of beer and 0.96 ml of wine. This must be taken into account for patients who abuse alcohol, children, pregnant and lactating mothers, as well as patients from a high-risk group, incl. with liver disease and epilepsy. Pregnancy and lactation May be used in the II and III trimester of pregnancy, if the expected effect of therapy outweighs the potential risk to the fetus. At the time of treatment should stop breastfeeding. Influence on the ability to drive a car or other moving mechanisms There are no known cases of the effect of the drug on the ability to drive a car and mechanisms. Relevant studies have not been conducted. Upakovkapo 100 ml and 150 ml of syrup in bottles, placed together with a dosing cup and leaflet in cardboard packs. Storage conditionsStore at a temperature not exceeding 30°C. Keep out of the reach of children. Shelf life 3 years. The expiration date is indicated on the packaging. This medicine must not be used after the date indicated on the package. Shelf life after opening the vial is 6 months. Terms of dispensing from pharmaciesThe drug is dispensed without a doctor's prescription. Buy Ambrovix pineapple flavor syrup 30mg/5ml in 100ml bottle No. one