Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327)
Hevert Pharmaceuticals LLC
ARNICA MONTANA ROOT
ARNICA MONTANA ROOT 4 [hp_X] in 2 mL
INTRAVENOUS
PRESCRIPTION DRUG
1.1 Hevert® Arnica is a homeopathic drug indicated for the treatment of muscle pain and stiffness, bruising and swelling due to injuries and overexertion. Hevert® Arnica is contraindicated in patients with known hypersensitivity to Arnica montana or other plants from the daisy family (Compositae). Animal reproduction studies have not been performed with Hevert® Arnica or any of its ingredients. There are not adequate and well-controlled studies in pregnant women. Hevert® Arnica should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. No non-teratogenic effects are known. No recognized use in labor or delivery. It is not known whether Hevert® Arnica is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Hevert® Arnica is administered to a nursing woman. Safety and effectiveness in pediatric patients have not been established. However, traditional homeopathic use of the ingredients in Hevert® Arnica has n
unapproved homeopathic
HEVERT ARNICA- ARNICA MONTANA ROOT INJECTION HEVERT PHARMACEUTICALS LLC _Disclaimer: This homeopathic product has not been evaluated by the Food and Drug_ _Administration for safety or efficacy. FDA is not aware of scientific evidence to support_ _homeopathy as effective._ ---------- HEVERT ARNICA HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE HEVERT ARNICA SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR HEVERT ARNICA. HEVERT ARNICA SOLUTION FOR INJECTION, FOR INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, AND INTRACUTANEOUS ADMINISTRATION. RX USE ONLY ----------- INDICATIONS AND USAGE ---- ------- Hevert Arnica is a homeopathic drug indicated for the treatment of muscle pain and stiffness, bruising and swelling due to injuries and overexertion. (1) ------ DOSAGE AND ADMINISTRATION - ----- Standard Dosage: ADULTS AND CHILDREN 12 YEARS AND OLDER: 1 mL to 2 mL 1 to 3 times per 7 days. Acute Dosage: ADULTS AND CHILDREN 12 YEARS AND OLDER: 1 mL to 2 mL up to 3 times daily. Hevert Arnica may be administered intravenously, intramuscularly, subcutaneously, or intracutaneously. (2) ----- DOSAGE FORMS AND STRENGTHS ----- One ampule containing 2 mL solution for injection, containing the active ingredients in the strengths listed under Description. (3) ------------- CONTRAINDICATIONS ------- ------ Hevert Arnica is contraindicated in patients with known hypersensitivity to Arnica montana or other plants from the daisy family (Compositae). (4) ------ WARNINGS AND PRECAUTIONS -- ----- Keep out of reach of children. (5) -------------- ADVERSE REACTIONS ------ -------- No adverse events have been reported with causal relationship to Hevert Arnica (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT HEVERT PHARMACEUTICALS AT 1-855-387-6466 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. -------------- DRUG INTERACTIONS ------ ------- None known. (7) ------- USE IN SPECIFIC POPULATIONS ------ No studies have been conducted with Hevert Arnica on pregnant or lactati Olvassa el a teljes dokumentumot