HEVERT ARNICA- arnica montana root injection

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Vedd Meg Most

Letöltés Termékjellemzők (SPC)
21-10-2021

Aktív összetevők:

ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327)

Beszerezhető a:

Hevert Pharmaceuticals LLC

INN (nemzetközi neve):

ARNICA MONTANA ROOT

Összetétel:

ARNICA MONTANA ROOT 4 [hp_X] in 2 mL

Az alkalmazás módja:

INTRAVENOUS

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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

Engedélyezési státusz:

unapproved homeopathic

Termékjellemzők

                                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
                                
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