HEVERT HEPAR COMP.- milk thistle, chelidonium majus root, quassia amara wood, and taraxacum officinale injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MILK THISTLE (UNII: U946SH95EE) (MILK THISTLE - UNII:U946SH95EE), CHELIDONIUM MAJUS ROOT (UNII: FLT36UCF0N) (CHELIDONIUM MAJUS ROOT - UNII:FLT36UCF0N), QUASSIA AMARA WOOD (UNII: S5249Q85HW) (QUASSIA AMARA WOOD - UNII:S5249Q85HW), TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375)

Available from:

Hevert Pharmaceuticals LLC

INN (International Name):

MILK THISTLE

Composition:

MILK THISTLE 4 [hp_X] in 2 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

1.1 Hevert® Hepar comp. is a homeopathic drug indicated for the treatment of liver and biliary system disorders. Hevert® Hepar comp. is contraindicated in patients with known hypersensitivity to Carduus marianus, Taraxacum officinale or other plants from the daisy family (Compositae), or to any of its ingredients. Animal reproduction studies have not been performed with Hevert® Hepar comp. or any of its ingredients. There are not adequate and well-controlled studies in pregnant women. Hevert® Hepar comp. 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® Hepar comp. is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Hevert® Hepar comp. is administered to a nursing woman. Safety and effectiveness in pediatric patients have not been established. However, traditional homeopathic use of the

Authorization status:

unapproved homeopathic

Summary of Product characteristics

HEVERT HEPAR COMP.- MILK THISTLE, CHELIDONIUM MAJUS ROOT, QUASSIA
AMARA
WOOD, AND TARAXACUM OFFICINALE 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 HEPAR COMP.
HIGHLIGHTS OF PRESCRIBING
INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE
INFORMATION
NEEDED TO USE HEVERT HEPAR COMP.
SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR
HEVERT HEPAR COMP.
Hevert
Hepar comp. solution for injection,
for intravenous, intramuscular,
subcutaneous, and intracutaneous
administration.
Rx Use Only
------------- INDICATIONS AND USAGE --
-----------
Hevert
Hepar comp. is a homeopathic
drug indicated for the improvement of liver
and biliary system disorders. (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
Hepar comp. 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
Hepar comp. is contraindicated
in patients with known hypersensitivity
to Carduus marianus, Taraxacum
officinale, or other plants from the daisy
family (Compositae), or to any of its
ingredients. (4)
--------- WARNINGS AND PRECAUTIONS
---------
Keep out of reach of children. (5)
---------------- ADVERSE REACTIONS ----
------------
No adverse events have been reported
with causal relationship to Hevert
Hepar comp. (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 INTERACTION