QUALITATIVE AND QUANTITATIVE COMPOSITION
For 100 g:
Calendula officinalis tinctura ............................. 0,1 g
Phytolacca decandra tinctura ............................. 0,3 g
Bryonia dioica tinctura ....................................... 0,1 g
Benzoe tinctura ............................................... 0 1 g
Acidum boricum ............................................... 4 0 g
3. PHARMACEUTICAL FORM
Ointment tube 40 g
4. CLINICAL DATA
4.1. Indications
Maintenance therapy in irritant dermatitis.
4.2. Dosage and administration
Superficial skin lesions
A thin layer of ointment is applied 1 to 3 times daily.
4.3. Contraindications
- Children under 30 months of age
- Known hypersensitivity to any component (or group sensitization)
- Svrahinfektirani and secreting areas.
4.4. Special warnings and precautions for use
Associated with the presence of boric acid: application to the mucosa or the injured region of the skin increases the penetration of boric acid, which in children may result in a general toxic effect. These effects are more likely when the ointment is used in more frequent repetition of the applications of the recommended or long time in very large surfaces under waterproof occlusive dressing on highly damaged skin (particularly burned), when applied to mucous membranes and in young children.
If after using the product symptoms persist or the condition worsens, to reassess treatment.
4.5. Interactions
No data
4.6. Pregnancy and lactation
Do not apply on the breast during lactation.
4.7. Effects on ability to drive and use machines
No data.
4.8. Undesirable effects
- Risk of adverse reactions (see "Special warnings and precautions for use '')
- In infants and children, boric acid was expressed reason for intoxication. The appearance of skin symptoms (highly pronounced and diffuse erythroderma followed by desquamation with initials erythema, appearing often in the buttock or mouth) is a signal of damage.
4.9. Overdose
Related to the presence of boric acid
Manifestations of acute toxicity in accidental oral intake include: vomiting and diarrhea, abdominal pain, erythematous rash on skin and mucous membranes, followed by desquamation stimulation or depression of the central nervous system, convulsions and hyperthermia. Rarely can be observed kidney and liver damage.
The slow excretion of boric acid can lead to accumulation with prolonged use and in the induction of chronic poisoning in which can be observed anorexia, gastrointestinal damage, dermatitis, anemia, alopecia, convulsions and other. See "Special warnings and precautions for use"
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Epitelotonichno and anti-inflammatory
(Dermatology) ATC code: D08AD
6. PHARMACEUTICAL PARTICULARS
6.1 .List of excipients
Soft paraffin
6.2. Incompatibilities
No data
6.3. Shelf life
5 years
6.4. Special storage conditions
Do not store above 25 ° C.
6.5. Packaging Data and Content
Aluminum tube 40 g, sealed, lined by epoksifenolov varnish, closed with a cap of polypropylene.
6.6. Directions, recommendations for use
Apply carefully a thin layer of ointment to the affected area.