{"adverse_reactions":["6 Adverse Reactions 6.1 Post-marketing Experience No adverse reactions have been reported with a causal relationship to Hevert ® Calmvalera™ comp."],"contraindications":["4 Contraindications Hevert ® Calmvalera™ comp. is contraindicated in patients with known hypersensitivity to lady's slipper or orchids, 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 Cimicifuga racemosa 4X 5 % 5.5X Cocculus indicus 4X 5 % 5.5X Cypripedium pubescens 4X 5 % 5.5X Ignatia amara 6X 5 % 7.5X Passiflora incarnata 4X 5 % 5.5X Platinum metallicum 10X 5 % 11.5X Valeriana officinalis 4X 5 % 5.5X Zincum valerianicum 8X 5 % 9.5X Inactive ingredients: Sodium chloride 0.015 g 11.2 Pharmaceutical Form Sterile solution for injection 11.3 Route of Administration Parenteral: IV, IM, or SC"],"description_table":["
Active Ingredients:
Ingredient namePotencyQuantityFinal dilution
Cimicifuga racemosa 4X 5 % 5.5X
Cocculus indicus 4X 5 % 5.5X
Cypripedium pubescens 4X 5 % 5.5X
Ignatia amara 6X 5 % 7.5X
Passiflora incarnata 4X 5 % 5.5X
Platinum metallicum10X 5 %11.5X
Valeriana officinalis 4X 5 % 5.5X
Zincum valerianicum 8X 5 % 9.5X
"],"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 ® Calmvalera™ comp. may be administered intravenously, intramuscularly or subcutaneously. 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® Calmvalera™ comp. may be administered intravenously, intramuscularly or subcutaneously.
"],"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":"20211022","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 ® Calmvalera™ 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 ® Calmvalera™ comp. ampules are supplied as 1 ampule of 2 mL solution for injection in packs of 10 ampules NDC 54532-0036-4 16.2 Storage Store at 68 to 77 °F. Protect from light. Keep out of reach of children"],"id":"db8a9bb1-6223-4ba0-bf2a-7fbf5df642bf","indications_and_usage":["1 Indications and Usage 1.1 Hevert ® Calmvalera™ comp. is a homeopathic drug indicated for the treatment of nervous disorders, such as restlessness and sleep disorders, mild depressive states, and mental exhaustion."],"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 ® Calmvalera™ comp. is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Hevert ® Calmvalera™ 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 54532-0036-4 HEVERT ® CALMVALERA™ COMP. Homeopathic Solution for Injection Rx only IV IM SC 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 ® Calmvalera™ 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 ® Calmvalera™ comp. or any of its ingredients. There are not adequate and well-controlled studies in pregnant women. Hevert ® Calmvalera™ 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":"d8b13f26-ed02-4c88-b661-b028d2273b6f","spl_product_data_elements":["Hevert Calmvalera comp. black cohosh, anamirta cocculus seed, cypripedium parvifolum root, strychnos ignatii seed, passiflora incarnata flowering top, platinum, valerian, and zinc valerate dihydrate BLACK COHOSH BLACK COHOSH ANAMIRTA COCCULUS SEED ANAMIRTA COCCULUS SEED CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT STRYCHNOS IGNATII SEED STRYCHNOS IGNATII SEED PASSIFLORA INCARNATA FLOWERING TOP PASSIFLORA INCARNATA FLOWERING TOP PLATINUM PLATINUM VALERIAN VALERIAN ZINC VALERATE DIHYDRATE VALERIC ACID SODIUM CHLORIDE"],"spl_unclassified_section":["HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Hevert ® Calmvalera™ comp. safely and effectively. See full prescribing information for Hevert ® Calmvalera™ comp. Hevert ® Calmvalera™ comp. solution for injection, for intravenous, intramuscular and subcutaneous administration. Rx Use Only ------------- INDICATIONS AND USAGE ------------- Hevert ® Calmvalera™ comp. is a homeopathic drug indicated for the treatment of nervous disorders such as restlessness and sleep disorders, mild depressive states, and mental exhaustion. ( 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 ® Calmvalera™ comp. may be administered intravenously, intramuscularly or subcutaneously. ( 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 ® Calmvalera™ comp. is contraindicated in patients with known hypersensitivity to lady's slipper or orchids, 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 ® Calmvalera™ 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 ® Calmvalera™ comp. on pregnant or lactating women, in patients under 18 years of age, or elderly. ( 8 ) Revised: 04/2018 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 529/1812"],"spl_unclassified_section_table":["
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Hevert® Calmvalera™ comp. safely and effectively. See full prescribing information for Hevert® Calmvalera™ comp. Hevert® Calmvalera™ comp. solution for injection, for intravenous, intramuscular and subcutaneous administration. Rx Use Only ------------- INDICATIONS AND USAGE ------------- Hevert® Calmvalera™ comp. is a homeopathic drug indicated for the treatment of nervous disorders such as restlessness and sleep disorders, mild depressive states, and mental exhaustion. (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® Calmvalera™ comp. may be administered intravenously, intramuscularly or subcutaneously. (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® Calmvalera™ comp. is contraindicated in patients with known hypersensitivity to lady's slipper or orchids, 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® Calmvalera™ 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® Calmvalera™ comp. on pregnant or lactating women, in patients under 18 years of age, or elderly. (8)Revised: 04/2018
","
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 ® Calmvalera™ comp. or any of its ingredients. There are not adequate and well-controlled studies in pregnant women. Hevert ® Calmvalera™ 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 ® Calmvalera™ comp. or any of its ingredients. There are not adequate and well-controlled studies in pregnant women. Hevert ® Calmvalera™ 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 ® Calmvalera™ comp. is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Hevert ® Calmvalera™ 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 ® Calmvalera™ 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 ® Calmvalera™ 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."]}