Data from FDA - Curated by EPG Health - Last updated 05 July 2018

Indication(s)

INDICATION AND USAGE Spascupreel® Injection Solution is a homeopathic drug product indicated for the relief of spasms of the smooth musculature of the gastrointestinal and the urogenital tract as well as general muscle spasms.

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Advisory information

contraindications
CONTRAINDICATIONS Spascupreel® Injection Solution is contraindicated in patients with known hypersensitivity to Spascupreel® or any of its ingredients.
Adverse reactions
ADVERSE REACTIONS Post-marketing Experience No adverse events have been reported with a causal relationship to Spascupreel® injection solution. To report SUSPECTED ADVERSE REACTIONS, contact MediNatura. at 1.844.633.4628 or [email protected] or FDA at1-800-FDA-1088 or www.fda.gov/medwatch.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION General Considerations The dosage schedules listed below can be used as a general guide for the administration of Spascupreel® Injection Solution. Spascupreel® Injection Solution may be administered s.c., i.d., i.m., or i.v. If co-administration with a local anesthetic is desired, Spascupreel®Injection Solution may be mixed with lidocaine or similar agents at the discretion of the physician. The interval between injections is left to the discretion of the HCP, but should not exceed 1 ampule in 24 hours. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard any unused ampule contents. Draw up required dose into syringe. Discard any unused ampule contents. Do not reuse ampule. Only licensed practitioners with sufficient expertise in injecting drugs, including the respective route of administration, should administer the product. Standard Dosage: Adults and children 12 years and older: 1 ml 1 to 3 times per 7 days. Children 6 to 11 years: 0.7 ml 1 to 3 times per 7 days. Children 2 to 5 years: 0.5 ml 1 to 3 times per 7 days. Acute Dosage: Adults and children 12 years and older: 1 ml daily, and then continue with standard dosage. Children 6 to 11 years: 0.7 ml daily, and then continue with standard dosage. Children 2 to 5 years: 0.5 ml daily, and then continue with standard dosage.

More information

Category Value
Agency product number 23H32AOH17
Orphan designation No
Product NDC 50114-7040
Date Last Revised 20-06-2018
Type HUMAN PRESCRIPTION DRUG
Marketing authorisation holder MediNatura Inc