Descrizione Clinica
AMBROXOL TECNIGEN
active ingredients
AMBROXOL TecniGen 15 mg/2 ml nebulizing solution A 2 ml vial contains: Active ingredient: ambroxol hydrochloride 15 mg. AMBROXOL TecniGen 30 mg/10 ml bottle syrup 200 ml 100 ml contain: Active ingredient: ambroxol hydrochloride 300 mg. AMBROXOL TecniGen 30 mg/10 ml syrup monodose containers 10 ml Each single-dose container contains: Active ingredient: ambroxol hydrochloride 30 mg. Excipient(s) with known effects: glycerol, sorbitol, benzoic acid For the complete list of excipients, see paragraph 6.1.Excellent
AMBROXOL TecniGen 15 mg/2 ml nebulizing solution Sodium phosphate monobasic bihydrate; sodium phosphate bibasic bihydrate; water for injectable preparations. AMBROXOL TecniGen 30 mg/10 ml bottle syrup 200 ml Hydroxyethylcellulose; 70% sorbitol; glycerol; benzoic acid; bitter aroma; propylene glycol; tartaric acid; purified water. AMBROXOL TecniGen 30 mg/10 ml syrup monodose containers 10 ml Hydroxyethylcellulose; 70% sorbitol; glycerol; benzoic acid; bitter aroma; propylene glycol; tartaric acid; purified water.Therapeutic indications
Treatment of secretion turbs in acute and chronic bronchopulmonary affections.Contraindications
Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1 Severe liver and/or kidney alterations. The drug is contraindicated in children under 2 years of age (for oral forms).Population
Population Nebulizing solution Adults: 2–3 vials per day. Children up to 5 years: 1–2 vials per day. Children over 5 years: 2–3 vials per day. How to administer As in the deep breathing of aerosol can subtract cough, you must try to breathe normally during inhalation. It is recommended to heat the solution up to the body temperature before inhalation. In patients with bronchial asthma it is recommended to administer the usual bronchospasmolytic before inhalation. The nebulizing solution can be administered using normal aerosol therapy devices. It can also be diluted in distilled water in ratio 1:1. Syroppo Adults: 10 ml (30 mg) 3 times a day. Children from 2 to 5 years: 2.5 ml (7,5 mg) 3 times a day.Children over 5 years: 5 ml (15 mg) 3 times a day. How to administration It is recommended to take syrup after meals. Do not use ambroxol for protracted treatments.Conservation
None.Warnings
Ambroxol should be given with caution in patients with peptic ulcer. Mucolitics may induce bronchial obstruction in children under 2 years of age. In fact the drainage capacity of the bronchial mucus is limited in this age range, due to the physiological characteristics of the respiratory tract. They must therefore not be used in children under 2 years (for oral forms) (see paragraph 4.3). Serious skin reactions such as multiform erythema, Stevens–Johnson syndrome (SJS)/ Toxic epidermal necrolysis (TEN) and generalized acute acute edema (AGEP) were reported. If there are symptoms or signs of progressive skin rash (sometimes associated with bladders or mucosa lesions), treatment with ambroxol must be stopped immediately and a doctor must be consulted. AMBROXOL TecniGen 30mg/10ml syrup contains: • sorbitol: patients with rare hereditary problems of fructose intolerance should not take this medicine. It can have a slight laxative effect. • glycerol: dangerous at high doses. It can cause migraine, gastric disorders and diarrhea. • benzoic acid: slightly irritating for skin, eyes and mucous membranes. It can increase the risk of jaundice in newborns.Interactions
AMBROXOL TecniGen generally does not interfere with other drugs.Effects
Rarely: tiredness, dry mouth, rhorrhea, dysuria, headache, gastrointestinal pathologies Rari: (pyrosis, dyspepsia, constipation, nausea and vomiting), respiratory pathologies, thoracic and mediastinics No Note: bronchial obstruction Immune system disorders Rare: hypersensitivity reactions, contact dermatitis or other allergic reactions (especially skin rashes) Notable: anaphylactic reactions, including anaphylactic shock, angioedema and itching Pathologies of the skin and subcutaneous tissue Rare: rash, hives Notable: severe skin adverse reactions (including multiform erythema, Stevens–Johnson syndrome/toxic epidermal necrolysis and generalized acute exantematic pustolosis). Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at:http://www.agenziafarmaco.gov.it/it/responsabili.Overdosing
Ambroxol overdose data is limited. Syntomatology corresponds to the undesirable effects described. In case of need to implement suitable symptomatic and support therapy.Pregnancy Clinical data relating to exposed pregnancy are not available for ambroxol. Animal studies indicate no direct or indirect harmful effects on pregnancy, embryo/fetal development, birth or post-natal development (see 5.3). It is necessary to be prudent in prescribing the medicine to pregnant women. In pregnancy drugs should only be prescribed if the expected benefit for the mother is considered greater than the risk for the fetus. All drugs should be avoided, if possible, during the first trimester of pregnancy. Food The drug is secreted in breast milk. The use of ambroxol by the mother can cause side effects; therefore it is necessary to decide whether to stop breastfeeding or treatment with the medicinal product, taking into account the importance of the drug for the mother.
Source: Farmadati
