{"adverse_reactions":["6 Adverse Reactions 6.1 Post-marketing Experience No adverse reactions have been reported with a causal relationship to Hevert ® Hepar comp."],"contraindications":["4 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."],"description":["11 Description 11.1 Ingredients Each 2 mL solution for injection ampule contains: Active Ingredients: Ingredient name Potency Quantity Final dilution Carduus marianus 4X 10 % 5X Chelidonium majus, radix 6X 10 % 7X Quassia 4X 10 % 5X Taraxacum officinale 4X 10 % 5X Inactive ingredients: Sodium chloride 0.014 g 11.2 Pharmaceutical Form Sterile solution for injection 11.3 Route of Administration Parenteral: IV, IM, SC or IC"],"description_table":["
Active Ingredients:
Ingredient namePotencyQuantityFinal dilution
Carduus marianus4X10 %5X
Chelidonium majus, radix6X10 %7X
Quassia4X10 %5X
Taraxacum officinale4X10 %5X
"],"dosage_and_administration":["2 Dosage and Administration 2.1 General Instructions Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Draw up required dose into syringe. Discard any unused ampule contents. Do not reuse ampule. 2.2 Standard Dosage Adults and children 12 years and older: 1 mL to 2 mL 1 to 3 times per 7 days. 2.3 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. image 2.4 Instruction for Opening Glass Ampule Cutting open the glass ampule is not necessary. Hold the ampule head up at an angle, and tap/shake down the solution contained in the ampule head. Then break off the ampule head by applying pressure away from the color dot. Discard unused solution."],"dosage_and_administration_table":["
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.
"],"dosage_forms_and_strengths":["3 Dosage Forms and Strengths One ampule containing 2 mL solution for injection, containing the active ingredients in the strengths listed under Description."],"drug_interactions":["7 Drug Interactions No interactions have been reported, and none are expected due to the homeopathic dilutions."],"effective_time":"20211021","geriatric_use":["8.5 Geriatric Use Safety and effectiveness in elderly patients (≥65 years of age) have not been established. However, traditional homeopathic use of the ingredients in Hevert ® Hepar comp. has not identified differences in responses between adults and geriatric patients."],"how_supplied":["16 How Supplied/Storage and Handling 16.1 Dosage Forms and Package Sizes Hevert ® Hepar comp. ampules are supplied as 1 ampule of 2 mL solution for injection in packs of 10 ampules NDC 54532-0028-4 16.2 Storage Store at 68 to 77 °F. Protect from light. Keep out of reach of children"],"id":"987cef22-d540-4a72-adf6-f498311fd282","indications_and_usage":["1 Indications and Usage 1.1 Hevert ® Hepar comp. is a homeopathic drug indicated for the treatment of liver and biliary system disorders."],"labor_and_delivery":["8.2 Labor and Delivery No recognized use in labor or delivery."],"nonteratogenic_effects":["8.1.2 Non-teratogenic effects No non-teratogenic effects are known."],"nursing_mothers":["8.3 Nursing Mothers 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."],"openfda":{},"overdosage":["10 Overdosage No negative effects of an overdose have been reported and none are expected due to the homeopathic dilutions."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 2.0 mL Ampule Carton NDC 54532-0028-4 HEVERT ® HEPAR COMP. Homeopathic Solution for Injection Rx only IV IM SC IC 10 sterile 2.0 mL ampules hEVERT PRINCIPAL DISPLAY PANEL - 2.0 mL Ampule Carton"],"pediatric_use":["8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. However, traditional homeopathic use of the ingredients in Hevert ® Hepar comp. has not identified differences in responses between adults and pediatric patients."],"pregnancy":["8.1 Pregnancy 8.1.1 Teratogenic effects Pregnancy Category C 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. 8.1.2 Non-teratogenic effects No non-teratogenic effects are known."],"references":["15 References German Homeopathic Pharmacopeia, Clarke"],"set_id":"6850fd73-f915-49e3-ad16-6e11899246a1","spl_product_data_elements":["Hevert Hepar comp. MILK THISTLE, CHELIDONIUM MAJUS ROOT, QUASSIA AMARA WOOD, and TARAXACUM OFFICINALE MILK THISTLE MILK THISTLE CHELIDONIUM MAJUS ROOT CHELIDONIUM MAJUS ROOT QUASSIA AMARA WOOD QUASSIA AMARA WOOD TARAXACUM OFFICINALE TARAXACUM OFFICINALE SODIUM CHLORIDE"],"spl_unclassified_section":["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 INTERACTIONS ---------------- None known. ( 7 ) ---------- USE IN SPECIFIC POPULATIONS ---------- No studies have been conducted with Hevert ® Hepar comp. on pregnant or lactating women, in patients under 18 years of age, or elderly. ( 8 ) Revised: 4/2018 FULL PRESCRIBING INFORMATION: CONTENTS * 1 Indications and Usage 2 Dosage and Administration 2.1 General Instructions 2.2 Standard Dosage 2.3 Acute Dosage 2.4 Instruction for Opening Glass Ampule 3 Dosage Forms and Strength 4 Contraindications 5 Warnings and Precautions 6 Adverse Reactions 6.1 Post-marketing Experience 7 Drug Interactions 8 Use in specific Populations 8.1 Pregnancy 8.2 Labor and Delivery 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 10 Overdosage 11 Description 11.1 Ingredients 11.2 Pharmaceutical Form 11.3 Route of Administration 15 References 16 How Supplied / Storage and Handling 16.1 Dosage Forms and Package Sizes 16.2 Storage * Sections or subsections omitted from the full prescribing information are not listed.","Distributed by: Hevert Pharmaceuticals, LLC, Boulder, CO 80303, www.hevertusa.com Made in Germany US 487/1812"],"spl_unclassified_section_table":["
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 INTERACTIONS ----------------None known. (7)---------- USE IN SPECIFIC POPULATIONS ----------No studies have been conducted with Hevert® Hepar comp. on pregnant or lactating women, in patients under 18 years of age, or elderly. (8)Revised: 4/2018
","
FULL PRESCRIBING INFORMATION: CONTENTS* 1 Indications and Usage 2 Dosage and Administration 2.1 General Instructions 2.2 Standard Dosage 2.3 Acute Dosage 2.4 Instruction for Opening Glass Ampule 3 Dosage Forms and Strength 4 Contraindications 5 Warnings and Precautions 6 Adverse Reactions 6.1 Post-marketing Experience 7 Drug Interactions 8 Use in specific Populations 8.1 Pregnancy 8.2 Labor and Delivery 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 10 Overdosage 11 Description 11.1 Ingredients 11.2 Pharmaceutical Form 11.3 Route of Administration 15 References 16 How Supplied / Storage and Handling 16.1 Dosage Forms and Package Sizes 16.2 Storage * Sections or subsections omitted from the full prescribing information are not listed.
"],"storage_and_handling":["16.2 Storage Store at 68 to 77 °F. Protect from light. Keep out of reach of children"],"teratogenic_effects":["8.1.1 Teratogenic effects Pregnancy Category C 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."],"use_in_specific_populations":["8 Use in specific Populations 8.1 Pregnancy 8.1.1 Teratogenic effects Pregnancy Category C 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. 8.1.2 Non-teratogenic effects No non-teratogenic effects are known. 8.2 Labor and Delivery No recognized use in labor or delivery. 8.3 Nursing Mothers 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. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. However, traditional homeopathic use of the ingredients in Hevert ® Hepar comp. has not identified differences in responses between adults and pediatric patients. 8.5 Geriatric Use Safety and effectiveness in elderly patients (≥65 years of age) have not been established. However, traditional homeopathic use of the ingredients in Hevert ® Hepar comp. has not identified differences in responses between adults and geriatric patients."],"version":"4","warnings_and_cautions":["5 Warnings and Precautions Keep out of reach of children."]}