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Tonsilla compositum Summary of Product Characteristics
Oral drops Injection solution Compositions: Oral drops: 100 g contain: Active ingredients: Acidum ascorbicum D6 3,0 g, Acidum L(+)-lacticum D6 3,0 g, Aesculus hippocastanum D6 3,0 g, Barium carbonicum D28 3,0 g, Calcium phosphoricum D10 3,0 g, Conium maculatum D12 3,0 g, Cortisonum aceticum D13 3,0 g, Dactylopius coccus D6 3,0 g, Echinacea D4 3,0 g, Ferrum phosphoricum D10 3,0 g, Galium aparine D6 3,0 g, Gentiana lutea D6 3,0 g, Geranium robertianum D6 3,0 g, Kalium stibyltartaricum D6 3,0 g, Levothyroxinum D13 3,0 g, Mercurius solubilis Hahnemanni D13 3,0 g, Pulsatilla pratensis D6 3,0 g, Solanum dulcamara D4 3,0 g, Sulfur D8 3,0 g, Cortex glandulae suprarena- lis suis D13 3,0 g, Embryo totalis suis D13 3,0 g, Funiculus umbilicalis suis D10 3,0 g, Hepar suis D10 3,0 g, Hypothalamus suis D10 3,0 g, Medulla ossis suis D10 3,0 g, Nodus lymphaticus suis D8 3,0 g, Splen suis D10 3,0 g, Tonsilla suis D28 3,0 g Excipients: Ethanol (96 per cent) 0,3 g, Water, purified 15,7 g. Contains 35 vol.-% alcohol. Injection solution: 1 ampoule (2.2 g) contains: Active ingredients: Acidum ascorbicum D6 22.0 mg, Acidum L(+)-lacticum D6 22.0 mg, Aesculus hippocastanum D6 22.0 mg, Barium carbonicum D28 22.0 mg, Calcium phosphoricum D10 22.0 mg, Conium maculatum D4 22.0 mg, Cortex glandulae suprarenalis suis D13 22.0 mg, Cortisonum aceticum D13 22.0 mg, Dactylopius coccus D6 22.0 mg, Echinacea D4 22.0 mg, Embryo totalis suis D13 22.0 mg, Ferrum phosphoricum D10 22.0 mg, Funiculus umbilicalis suis D10 22.0 mg, Galium aparine D6 22.0 mg, Gentiana lutea D6 22.0 mg, Geranium robertianum D6 22.0 mg, Hepar suis D10 22.0 mg, Hypothalamus suis D10 22.0 mg, Kalium stibyltartaricum D6 22.0 mg, Levothyroxinum D13 22.0 mg, Medulla ossis suis D10 22.0 mg, Mercurius solubilis Hahnemanni D13 22.0 mg, Nodus lymphaticus suis D8 22.0 mg, Psorinum Nosode D 28 22,0 mg, Pulsatilla pratensis D6 22.0 mg, Pyrogenium-Nosode D 198 22,0 mg, Solanum dulcamara D4 22.0 mg, Splen suis D10 22.0 mg, Sulfur D8 22.0 mg, Tonsilla suis D28 22.0 mg. Excipients: Sodium chloride 19.2 mg, water for injections 1540 mg. Indications: Oral drops, injection solution: Stimulation of the body defenses including the lymphatic immune system in acute, recurrent and chronic disorders, e.g. tonsillitis, recurrent infections. Contraindications: Oral drops, injection solution: Known allergy (hypersensitivity) to one or more of the ingredients. Special warnings and special precautions for use: Oral drops: This medicinal product contains 35 vol.-% ethanol (alcohol). Injection solution: None. Side effects: Oral drops, injection solution: Like all medicinal products, this homeopathic medicinal product can cause side effects, although not everybody gets them. Interactions with other medication: Oral drops, injection solution: No interactions have been reported, and none are expected due to the homeopathic dilutions. Pregnancy and lactation: Oral 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: Oral drops: This medicine has no or negligible influence on the ability to drive and use machines. 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: Oral 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 children 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. Method of administration: Tonsilla comp., Solution for injection may be administered by the s.c., i.d., i.m. or i.v. route. Overdose: Oral drops, injection solution: No cases of overdose have been reported, and none are expected due to the homeopathic dilutions. Package sizes: Oral drops (65636): Packs containing 30 ml and 100 ml. Injection solution (8538): Packs containing 5, 10, 50 and 100 ampoules of 2.2 ml each.