TUXIFLUD SCIR 15MG/5ML

AMBROXOL UNION HEALTH

active ingredients

AMBROXOL UNION HEALTH “3 mg/ml syrup” - 150 ml bottle 100 ml syrup contain Active ingredient: ambroxol hydrochloride mg 300 AMBROXOL UNION HEALTH “0.75 % Nebulizer Solution” - 1 40 ml bottle 100 ml solution contain: Active ingredient: ambroxol hydrochloride 750 mg. AMBROXOL UNION HEALTH “7,5 mg/ml Nebulizer Solution” - 15 single-dose containers of 2 ml 100 ml solution to 0.75% contain: Active ingredient: ambroxol hydrochloride mg 750. AMBROXOL UNION HEALTH “15 mg/2 ml Nebulizer Solution” - 6 vials of 2 ml A vial contains: Active ingredient: ambroxol hydrochloride mg 15

Excellent

AMBROXOL UNION HEALTH “3 mg/ml syrup” - 150 ml bottle 100 ml syrup contain: Excipients: sucrose; methyl p-hydroxybenzoate; p-hydroxybenzoate propile; cherry aroma; purified water. AMBROXOL UNION HEALTH “0.75 % Nebulizer Solution” - 1 40 ml bottle Excipient: monohydrate citric acid; sodium phosphate bishodic bihydrate; sodium chloride; benzalconio chloride; purified water. AMBROXOL UNION HEALTH “7,5 mg/ml Nebulizer Solution” - 15 single-dose containers of 2 ml 100 ml solution to 0.75% contain: Excipient: chloride sodium, p-hydroxybenzoate methyl, p-hydroxybenzoate propile, purified water. AMBROXOL UNION HEALTH “15 mg/2 ml Nebulizer Solution” - 6 vials of 2 ml Excipient: citric acid; bishodic phosphate; sodium chloride; water for injectable preparations.

Therapeutic indications

Treatment of secretion turbs in acute and chronic bronchopulmonary affections.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients. Severe liver and/or kidney alterations. AMBROXOL UNION HEALTH “3 mg/ml syrup” - 150 ml bottle: the drug is contraindicated in children under 2 years of age.

Population

Nebulizing solution Adults and children over 5 years: 2-3 ml solution 1-2 times a day. Children under 5 years: 2 ml solution 1-2 times a day. Because in the deep breathing of aerosol it 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. Instructions for use of monodose aloid To use the monodose aloid, do the following: 1) isolate a fialoid from the strip. 2) open the monodose fialoid by turning the fin. 3) by exerting a moderate pressure on the walls of the monodose fialoid to release the medicine in the prescribed quantity. 4) in case of half-dose use, the haloid can be folded by flipping and pressing the cap. The remaining amount should be used within 24 hours.Syrup 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. It is recommended to take syrup after meals. Inhalation Fial 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. Instructions for the use of pre-coating vials: no lime required. Do not use Ambroxol for protracted treatments.

Conservation

None.

Warnings

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 of age (see paragraph 4.3) (for oral forms). AMBROXOL UNION HEALTH 0.75% solution for 40 ml bottle nebulizer and 3 mg/ml syrup contain methyl parahydroxybenzoate and propile parahydroxybenzoate: irritating blandi for skin, eyes and mucous membranes. They can increase the risk of jaundice in newborns. Ambroxol should be given with caution in patients with peptic ulcer. AMBROXOL UNION HEALTH 7.5 mg/ml solution for nebulizer in monodose containers contains benzalconium chloride as preservative. As a result of inhalation, this preservative can cause bronchoconstriction in sensitive patients with airway hyperreactivity.

Interactions

AMBROXOL UNION HEALTH generally does not interfere with other drugs.

Effects

Rarely: fatigue, dry mouth, rhyrrhea, dysuria, headache, gastrointestinal disorders (pyrosis, dyspepsia, stipsi, nausea and vomiting), contact dermatitis or other allergic reactions (especially skin rashes). Bronchial obstruction: (unknown frequency).

Overdosing

Ambroxol overdose data is limited. Syntomatology corresponds to the undesirable effects described. In case of need to implement suitable symptomatic and support therapy.

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. 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