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Phosphor-Homaccord® Summary of Product Characteristics

Drops Injection solution Compositions: Drops: 100g contains: Active ingredients: Argentum nitricum D10 0.3 g, Argentum nitricum D30 0.3 g, Argentum nitricum D200 0.3 g, Paris quadrifolia D6 0.3 g, Paris quadrifolia D10 0.3 g, Paris quadrifolia D30 0.3 g, Paris quadrifolia D200 0.3 g, Phosphorus D10 0.4 g, Phosphorus D30 0.4 g, Phosphorus D200 0.4 g. Excipients: Ethanol (96 per cent) 29.1 g, Water, purified 67.6 g. Contains 35 vol.-% alcohol. Injection solution: 1 ampoule = 1.1 g contains: Active ingredients: Argentum nitricum D10 3.3 mg, Argentum nitricum D30 3.3 mg, Argentum nitricum D200 3.3 mg, Paris quadrifolia D6 3.3 mg, Paris quadrifolia D10 3.3 mg, Paris quadri- folia D30 3.3 mg, Paris quadrifolia D200 3.3 mg, Phosphorus D10 4.4 mg, Phosphorus D30 4.4 mg, Phosphorus D200 4.4 mg. Excipients: Sodium chloride 10.3 mg, Water for injections 1063.7 mg. Indications: Drops, injection solution: Hoarseness especially due to respiratory tract infections, e.g. laryngitis. Contraindications: Drops, injection solution: Known allergy (hypersensitivity) to one or more of the ingredients. Special warnings and special precautions for use: Drops: This medicinal product contains 35 vol.-% ethanol (alcohol). Injection solution: None. Side effects: Drops, injection solution: Like all medicinal products, this homeopathic medicinal product can cause side effects, although not everybody gets them. Interactions with other medication: Drops, injection solution: No interactions have been reported, and none are expected due to the homeopathic dilutions. Pregnancy and lactation: Drops, injection solution: For this product no clinical data on pregnancy and lactation are available. Homeopathic dilutions of the substances present in this medicament are not known to be toxic during pregnancy and lactation. No adverse effects have so far been reported. Effects on ability to drive and use machines: Drops, injection solution: No effects on the ability to drive and use machines have been reported, and none are expected due to the homeopathic dilutions. Dosage: Drops: Standard Dosage: Adults (and children 12 yrs. and older): 10 drops 3x daily. Pediatric: Below 2 yrs.: 3 drops 3x daily. 2 5 yrs.: 5 drops 3x daily. 6 11 yrs.: 7 drops 3x daily. Acute or Initial Dosage: Adults (and children 12 yrs. and older): 10 drops every ½ to 1 hr., up to 12x daily, and then continue with standard dosage. Pediatric: Below 2 yrs.: 3 drops every ½ to 1 hr., up to 12x daily, and then continue with standard dosage. 2 5 yrs.: 5 drops every ½ to 1 hr., up to 12x daily, and then continue with standard dosage. 6 11 yrs.: 7 drops every ½ to 1 hr., up to 12x daily, and then continue with standard dosage. Method of administration: This medicine should be taken away from meals. For children, add drops to a small amount of water. Injection solution: Standard Dosage: Adults (and child- ren 12 yrs. and older): 1 ampoule 1 to 3x weekly. Pediatric: 2 5 yrs.: ½ ampoule 1 to 3x weekly. 6 11 yrs.: ⅔ of an ampoule 1 to 3x weekly. Acute or Initial Dosage: Adults (and children 12 yrs. and older): 1 ampoule daily, and then continue with standard dosage. Pediatric: 2 5 yrs.: ½ ampoule daily, and then continue with standard dosage. 6 11 yrs.: ⅔ of an ampoule daily, and then continue with standard dosage. Method of administration: Phosphor-Homaccord, Solution for injection may be administered by the s.c., i.d., i.m., or i.v. route. Overdose: Drops, injection solution: No cases of overdose have been reported, and none are expected due to the homeopathic dilutions. Package sizes: Drops (9787): Drop bottles containing 30 and 100 ml. Injection solution (8588): Packs containing 5, 10, 50 and 100 ampoules of 1.1 ml.