Azimil 15 mg / 2 ml nebulizer solution - for bronchopulmonary diseases 15 vials

Product Description

Nebulizing Solution

Composition:

AZIMIL 15 mg/2 ml solution for nebulization and oral administration. A single-dose container contains: Active ingredient: Ambroxol hydrochloride 15 mg. AZIMIL 15 mg/5 ml syrup in single-dose container. A single-dose container contains: Active ingredient: Ambroxol hydrochloride 15 mg. AZIMIL 15 mg/5 ml multi-dose syrup 200 ml. 5 ml of syrup contain: Active ingredient: Ambroxol hydrochloride 15 mg. For the full list of excipients, see section 4. 6.1

Excipients

Nebulizer and oral solution: Sodium chloride, Water for injections. Syrup in single-dose container: Maltisorb (Maltitol 75%), Glycerol 98%, Citric acid monohydrate, Water for injections. Syrup in multi-dose bottle: Maltisorb (Maltitol 75%), Glycerol 98%, Citric acid monohydrate, Methyl p-hydroxybenzoate, Propyl p-hydroxybenzoate, Water for injections.

Therapeutic indications

Treatment of secretion disorders in acute and chronic bronchopulmonary diseases.

Contraindications

Hypersensitivity to ambroxol hydrochloride or to any of the excipients. of the excipients. Severe liver and kidney disorders. The drug is contraindicated in case of rare hereditary diseases that may be incompatible with one of the excipients (see section 4.4).

Dosage

Nebulizing and oral solution Each single-dose container contains 2 ml and has a 1 ml (half dose) mark. Nebulizing solution Adults and children over five years of age: 2 ml (one container) twice a day. Children under five years of age: 1-2 ml (half container - one container) once or twice a day. The solution can be administered using standard aerosol therapy devices. It can also be diluted in distilled water in a 1:1 ratio. Oral solution Adults: 2-4 ml (1-2 containers) three times a day. Children over five years of age: 1-2 ml (half a container - one container), 2-3 times a day. Children under five years of age: 1 ml (half a container) 2-3 times a day. Dilute the solution in a little water, tea, milk, or fruit juice. The medicine should be taken with meals. Syrup: Multi-dose syrup bottle. Adults: At the beginning of treatment, 10 ml 3 times a day, then 5 ml 3 times a day. Children over five years of age: 5 ml 3 times a day. Children under five years of age: 2.5 ml 2-3 times a day. The measuring cup included in the bottle packaging has volume marks for 2.5 ml, 5 ml, and 10 ml. The medicine should be taken with meals. Syrup in single-dose container Each single-dose container of syrup contains 5 ml and is marked with a volume of 2.5 ml (half dose). Adults: at the start of treatment, 10 ml (two containers) 3 times a day, then 5 ml (one container) 3 times a day. Children over five years of age: 5 ml (one container) 3 times a day. Children under five years of age: 2.5 ml (half container) 2-3 times a day. The medicine should be taken with meals.

Warnings and precautions

Ambroxol should be administered with caution to patients with peptic ulcers. Very rarely, serious skin lesions such as Stevens-Johnson syndrome and Lyell's syndrome have been observed in conjunction with the administration of mucolytic substances such as ambroxol. Most of these could be explained by the severity of underlying diseases or other concomitant medications. If new skin or mucous membrane lesions occur, consult your doctor immediately and discontinue treatment with ambroxol as a precaution. When administering the nebulized solution, since excessively deep inhalation of the aerosol may cause an irritating cough, try to inhale and exhale normally during inhalation. In particularly sensitive patients, prewarming the inhaled solution to body temperature may be recommended. Patients with bronchial asthma should take a bronchial antispasmodic before inhalation. The single-dose and multi-dose syrup contains maltitol: use with caution in patients with rare hereditary problems of fructose intolerance. The syrup in the multi-dose bottle contains parahydroxybenzoates which may cause allergic reactions (even delayed).

Interactions

Following the administration of ambroxol, the concentrations of antibiotics (amoxicillin, cefuroxime, erythromycin) in bronchopulmonary secretions and saliva are increased. No interactions with other medicinal products have been reported.

Side effects

Episodes of diarrhea have been commonly observed. Nausea, vomiting, other mild gastrointestinal disorders, and allergic reactions have been reported uncommonly. In rare cases, heartburn, dyspepsia, rash, urticaria, and angioedema have been reported. Extremely rare cases of anaphylactic reactions (including anaphylactic shock) have been reported.

Pregnancy and breastfeeding

Ambroxol crosses the placental barrier. Animal studies have not shown any direct or indirect harmful effects on pregnancy, embryonic/fetal development, childbirth, or postnatal development. Although preclinical studies and extensive clinical experience have not shown any harmful effects on the fetus after the 28th week of gestation, it is advisable to take the usual precautions when taking medications during pregnancy. Taking Ambroxol is not recommended, especially during the first trimester. The drug is excreted in breast milk, therefore, its use is not recommended during breastfeeding. However, no adverse effects on the infant are expected. During pregnancy and breastfeeding, the drug should be administered only when strictly necessary and under the direct supervision of a physician.