DESCRIPTION

Inactive Ingredients:

Water for injection 1,089.0 μl

Sodium Chloride 10.4 μl

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.

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.

CONTRAINDICATIONS

Spascupreel® Injection Solution is contraindicated in patients with known hypersensitivity to Spascupreel® or any of its ingredients.

WARNINGS AND PRECAUTIONS

Keep out of reach of children.

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 info@medinatura.com or FDA at1-800-FDA-1088

  or www.fda.gov/medwatch.

CLINICAL PHARMACOLOGY

Mechanism of Action

The exact mechanism of Spascupreel® Injection Solution is not fully understood.

Pharmacodynamics

Not applicable for homeopathic medicinal products.

DOSAGE

1 ampule containing 1.1 ml solution for injection.