{"adverse_reactions":["6 Adverse Reactions 6.1 Post-marketing Experience No adverse reactions have been reported with a causal relationship to Hevert ® Gelsemium comp."],"contraindications":["4 Contraindications Hevert ® Gelsemium comp. is contraindicated in patients with known hypersensitivity to Rhus toxicodendron or other plants from the cashew family, 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 Aconitum napellus 4X 5 % 5.5X Cocculus indicus 4X 5 % 5.5X Colocynthis 4X 5 % 5.5X Gelsemium sempervirens 4X 5 % 5.5X Lachesis mutus 12X 5 % 13.5X Mezereum 6X 5 % 7.5X Nux vomica 6X 5 % 7.5X Plumbum aceticum 6X 5 % 7.5X Rhus toxicodendron 6X 5 % 7.5X Inactive ingredients: Sodium chloride 0.014 g 11.2 Pharmaceutical Form Sterile solution for injection 11.3 Route of Administration Parenteral: IM, SC or IC"],"description_table":["
Active Ingredients:
Ingredient namePotencyQuantityFinal dilution
Aconitum napellus4X5 %5.5X
Cocculus indicus4X5 %5.5X
Colocynthis4X5 %5.5X
Gelsemium sempervirens4X5 %5.5X
Lachesis mutus12X5 %13.5X
Mezereum6X5 %7.5X
Nux vomica6X5 %7.5X
Plumbum aceticum6X5 %7.5X
Rhus toxicodendron6X5 %7.5X
"],"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 1 mL to 2 mL 1 to 3 times per 7 days. 2.3 Acute Dosage Adults: 1 mL to 2 mL up to 3 times daily. Hevert ® Gelsemium comp. may be administered 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: 1 mL to 2 mL up to 3 times daily. Hevert® Gelsemium comp. may be administered 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":["8.4 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 ® Gelsemium 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 ® Gelsemium comp. ampules are supplied as 1 ampule of 2 mL solution for injection in packs of 10 ampules NDC 54532-0027-4 16.2 Storage Store at 68 to 77 °F. Protect from light. Keep out of reach of children"],"id":"ddd6316e-3775-4858-9e7f-fbb4b0a6f261","indications_and_usage":["1 Indications and Usage 1.1 Hevert ® Gelsemium comp. is a homeopathic drug indicated for the improvement of painful nerve conditions, such as postherpetic neuralgia, trigeminal neuralgia, or sciatic nerve pain."],"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 ® Gelsemium comp. is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Hevert ® Gelsemium 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 54532-0027-4 HEVERT ® GELSEMIUM COMP. Homeopathic Solution for Injection Rx only IM SC IC 10 sterile 2.0 mL ampules hEVERT PRINCIPAL DISPLAY PANEL - 2.0 mL Ampule Carton"],"pregnancy":["8.1 Pregnancy 8.1.1 Teratogenic effects Pregnancy Category C Animal reproduction studies have not been performed with Hevert ® Gelsemium comp. or any of its ingredients. There are not adequate and well-controlled studies in pregnant women. Hevert ® Gelsemium 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":"5856840b-9012-4613-8de4-3ad0f4ed110e","spl_product_data_elements":["Hevert Gelsemium comp aconitum napellus, anamirta cocculus seed, citrullus colocynthis fruit, gelsemium sempervirens root, lachesis muta venom, daphne mezereum bark, strychnos nux-vomica seed, lead acetate anhydrous, and toxicodendron pubescens shoot ACONITUM NAPELLUS WHOLE ACONITUM NAPELLUS WHOLE ANAMIRTA COCCULUS SEED ANAMIRTA COCCULUS SEED CITRULLUS COLOCYNTHIS FRUIT CITRULLUS COLOCYNTHIS FRUIT GELSEMIUM SEMPERVIRENS ROOT GELSEMIUM SEMPERVIRENS ROOT LACHESIS MUTA VENOM LACHESIS MUTA VENOM DAPHNE MEZEREUM BARK DAPHNE MEZEREUM BARK STRYCHNOS NUX-VOMICA SEED STRYCHNOS NUX-VOMICA SEED LEAD ACETATE ANHYDROUS LEAD Cation PB4+ TOXICODENDRON PUBESCENS SHOOT TOXICODENDRON PUBESCENS SHOOT SODIUM CHLORIDE"],"spl_unclassified_section":["HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Hevert ® Gelsemium comp. safely and effectively. See full prescribing information for Hevert ® Gelsemium comp. Hevert ® Gelsemium comp. solution for injection, for intramuscular, subcutaneous, and intracutaneous administration. Rx Use Only ------------- INDICATIONS AND USAGE ------------- Hevert ® Gelsemium comp. is a homeopathic drug indicated for the improvement of painful nerve conditions, such as postherpetic neuralgia, trigeminal neuralgia, or sciatic nerve pain. ( 1 ) --------- DOSAGE AND ADMINISTRATION --------- Standard Dosage: Adults: 1 mL to 2 mL 1 to 3 times per 7 days. Acute Dosage: Adults: 1 mL to 2 mL up to 3 times daily. Hevert ® Gelsemium comp. may be administered 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 ® Gelsemium comp. is contraindicated in patients with known hypersensitivity to Rhus toxicodendron or other plants from the cashew family, 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 ® Gelsemium 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 ® Gelsemium comp. on pregnant or lactating women, 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 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 530/1812"],"spl_unclassified_section_table":["
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Hevert® Gelsemium comp. safely and effectively. See full prescribing information for Hevert® Gelsemium comp. Hevert® Gelsemium comp. solution for injection, for intramuscular, subcutaneous, and intracutaneous administration. Rx Use Only ------------- INDICATIONS AND USAGE ------------- Hevert® Gelsemium comp. is a homeopathic drug indicated for the improvement of painful nerve conditions, such as postherpetic neuralgia, trigeminal neuralgia, or sciatic nerve pain. (1) --------- DOSAGE AND ADMINISTRATION --------- Standard Dosage: Adults: 1 mL to 2 mL 1 to 3 times per 7 days.Acute Dosage: Adults: 1 mL to 2 mL up to 3 times daily.Hevert® Gelsemium comp. may be administered 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® Gelsemium comp. is contraindicated in patients with known hypersensitivity to Rhus toxicodendron or other plants from the cashew family, 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® Gelsemium 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® Gelsemium comp. on pregnant or lactating women, 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 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 ® Gelsemium comp. or any of its ingredients. There are not adequate and well-controlled studies in pregnant women. Hevert ® Gelsemium 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 ® Gelsemium comp. or any of its ingredients. There are not adequate and well-controlled studies in pregnant women. Hevert ® Gelsemium 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 ® Gelsemium comp. is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Hevert ® Gelsemium comp. is administered to a nursing woman. 8.4 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 ® Gelsemium comp. has not identified differences in responses between adults and geriatric patients."],"version":"5","warnings_and_cautions":["5 Warnings and Precautions Keep out of reach of children."]}