Biotin, 0.5%, Vitamin H, I.M. injectable solution, 6 1ml vials, treatment for hair loss

1. NAME OF DRUG BIOTIN, BAYER, 0.5%, I.M. injectable solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Biotin (vitamin H) ............ 5.0 mg For a 1ml vial 3. PHARMACEUTICAL FORM: Injectable solution. 4. CLINICAL DATA 4.1. Therapeutic Indications Supplementary treatment for hair loss. 4.2. Dosage and how to use ONLY TO BE TAKEN BY ADULTS. Intramuscular injection. 1-2 injections, 3 times a week for 6 weeks. 4.3. Contraindications: Hypersensitivity to one of its components in particular paraben. 4.4. Special warnings and side effects This drug contains Methyl parahydoxybenzoate and propyl, and can cause delayed allergic reactions; sometimes immediate reactions such as urticaria and bronchospasm. 4.5. Interactions with other drugs Not applicable. 4.6. Pregnancy and breast feeding: Pregnancy: There is no clear evidence of malformations detected in animals. In clinical studies, there are no particular malformative or fetotoxic effects appeared to date. However monitoring pregnancies exposed to this drug is not enough to rule out any risk. For precaution measures, it is advisable not to take this drug during pregnancy. Breast feeding: Due to the lack of available information, it is not advisable to take this drug during breast feeding. 4.7. Effects on the ability to drive and operate machinery No effects on the ability to drive vehicles or use machinery have been found. 4.8. Side effects Signs of allergic-like hypersensitivity, principally skin allergies (urticaria, angioedema, breakout, itchiness) have been reported. 4.9. Overdose No risk of a biotin overdose has been traced. 5. PHARMACOLOGICAL PROPERTIES 5.1. Pharmaco-dynamic properties Vitamin H (D: Dermatology 5.2. Pharmacokinetics properties Not applicable 5.3. Preclinical safety data Lack of results into the study of toxicity for the animal. However, biotin tolerance is widely documented. 6. Pharmaceutical data 6.1. List of dilutants Sodium dihydrogen phosphate dihydrate, sodium bicarbonate, methylparaben (E218), propylparaben (E216), water for injections. 6.2. Incompatibilities 6.3. Shelf life 3 years. 6.4. Storage precautions Store in a place below 25°C. 6.5. Nature and contents of outside packaging Type I easy-open 1ml colourless glass vials. 6.6. Precautions for handling and disposal 7. THE MARKETING AUTHORISATION HOLDER BAYER HEALTHCARE SAS 220 AVENUE DE LA RECHERCHE 59120 LOOS 8. NUMBER OF THE MARKETING AUTHORSATION HOLDER · 369 090-4: 1Ml vial (colourless glass); box of 6 9. START/RENEWEL DATE OF AUTHORISATION [To be completed by holder] 10. DATE OF UPDATE OF TEXT [To be completed by holder] 11. DOSIMETRY 12. INSTRUCTIONS FOR RADIOPHARMACEUTICAL PREPARATION PRESCRIPTION AND DELIVERY CONDITIONS Drug not subjected to prescription.