Χώρα: Μάλτα
Γλώσσα: Αγγλικά
Πηγή: Medicines Authority
BENZALKONIUM CHLORIDE, XYLOMETAZOLINE HYDROCHLORIDE
Dolorgiet GmbH & Co. KG Otto-von-Guericke-Str. 1, 53757 Sankt Augustin / Bonn, Germany
R01AA07
BENZALKONIUM CHLORIDE 5 mg/ml XYLOMETAZOLINE HYDROCHLORIDE 0.05 % (W/V)
NASAL DROPS, SOLUTION
BENZALKONIUM CHLORIDE 5 mg/ml XYLOMETAZOLINE HYDROCHLORIDE 0.05 % (W/V)
OTC
NASAL PREPARATIONS
Withdrawn
2006-11-24
PACKAGE INSERT LOCAL VASOCONSTRICTOR BALKIS® 0.05 % NASAL DROPS Active Ingredient: Xylometazoline COMPOSITION: 1 ml (30 drops approx.) contains: _Active ingredient :_ xylometazoline hydrochloride 0.5 mg, benzalkonium chloride 0.2 mg. _Excipients :_ sodium monohydrogen phosphate, potassium dihydrogen phosphate, sodium chloride, water. PHARMACOTHERAPEUTIC GROUP : Xylometazoline has vasoconstrictive properties and thus exerts a detumescent effect on the mucosa. INDICATIONS: For the relief of nasal congestion caused by common cold, for the relief of nasal congestion in case of paroxysmal vasomotor rhinitis (rhinitis vasomotorica), for the decongestion of the mucosa in case of rhinitis allergica. Balkis 0.05 % Nasal Drops are intended for the use in children from 2 to 6 years. CONTRAINDICATIONS: Hypersensitivity to the active ingredient, dry inflammation of the nasal mucosa (rhinitis sicca), babies and infants under 2 years of age, a careful consideration of the benefit-risk ratio is required in case of glaucoma, particularly narrow-angle glaucoma. A careful consideration of the benefit-risk ratio is indicated in case of severe cardiovascular diseases (e. g. coronary heart disease, hypertension), phaeochromocytoma and metabolic disturbances (e. g. hyperthyroidism, diabetes). The same is valid for patients treated with monamine oxidase inhibitors and other potentially hypertensive drugs. Due to the content of the preservative benzalkonium chloride Balkis 0.05 % Nasal Drops must no be administered in case of hypersensitivity to this substance. Pregnancy and lactation: Balkis 0.05 % are not recommended for the use in pregnant women, as there are no adequate and well-controlled studies concerning the effect on the human fetus. It is not known whether the active ingredient xylometazoline is excreted in human milk. Therefore, the drug Διαβάστε το πλήρες έγγραφο
Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Balkis 0.1 % Nasal Drops Balkis 0.05 % Nasal Drops 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Balkis® 0.1 % Nasal Drops 1 ml of nasal Nasal Drops, solution (^ about 30 drops) contains 1.0 mg of xylometazoline hydrochloride; 0.2 mg of benzalkonium chloride Balkis® 0.05 % Nasal Drops 1 ml of Nasal Drops, solution(^ about 30 drops) contains 0.5 mg of xylometazoline hydrochloride; 0.2 mg of benzalkonium chloride For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Nasal drops, solution 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the relief of nasal congestion caused by common cold, paroxysmal vasomotor rhinitis (rhinitis varomotorica) and rhinitis allergica. Balkis® 0.1 % Nasal Drops are intended for the use in adults and school children above 6 years of age. Balkis® 0.05 % Nasal Drops are intended for children from 2 to 6 years of age. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Balkis® 0.1 % Nasal Drops Unless otherwise prescribed, adults and school children above 6 years of age, give, if necessary, 1 – 2 drops of Balkis® 0.1 % Nasal Drops into each nostril up to 3 times daily. The dosage depends on the individual sensitivity and the clinical effect. Balkis® 0.05 % Nasal Drops Unless otherwise prescribed, give, if necessary, in children from the age of 2 – 6 years of age, 1 – 2 Nasal Drops of Balkis® 0.05 % Nasal Drops into each nostril up to 3 times daily. The use of xylometazoline 0.1 % Nasal Drops and 0.05 % Nasal Drops should be restricted to 5 days, unless otherwise prescribed. Page 2 of 6 Renewed application only after an interruption of several days. As a general principle, the physician should be consulted concerning the duration Διαβάστε το πλήρες έγγραφο