Spascupreel

Spascupreel 1.1ml Injection

Spascupreel Description

Injection Solution Ingredient Information: Each 1.1 ml ampule contains: Aconitum napellus 6X 2.2 mcl; Ammonium bromatum 4X 1.1 mcl; Colocynthis 4X 1.1 mcl; Atropinum sulphuricum 6X 1.1 mcl; Gelsemium sempervirens 6X 1.1 mcl; Magnesia phosphorica 6X 1.1 mcl; Veratrum album 6X 1.1 mcl; Passiflora incarnata 2X 0.55 mcl; Chamomilla 3X 0.55 mcl; Agaricus muscarius 4X 0.55 mcl; Cuprum sulphuricum 6X 0.55 mcl. Inactive Ingredients: Sterile isotonic sodium chloride solution.

INDICATION AND USAGE

              

Spascupreel® Injection Solution is indicated for the temporary relief of muscle spasms, anywhere in the body including abdominal cramps, menstrual cramps, spasmodic cough, intestinal colic, and smooth musculature spasms.

Spascupreel® Injection Solutionis classified as a homeopathic combination drug.


Botanical ingredients:

Aconitum napellus (Monk's hood, Wolfsbane)

Colocynthis (Bitter cucumber)

Veratrum album (White hellebore)

Passiflora incarnata (Passion flower)

Chamomilla (German chamomile)

Agaricus muscarius (Fly agaria)

Gelsemium sempervirens (Yellow jasmine)


Mineral ingredients:

Ammonium bromatum (Ammonium bromide)

Atropinum sulphuricum (Atropine sulfate)

Magnesia phosphorica (Magnesium phosphate)

Cuprum sulphuricum (Copper sulfate)

Warnings and Precautions

If new syptoms occur, or if redness, pain or swelling at the puncture site persists, the patient should be carefully re-evaluated because these could be signs of a more serious condition.

Pregnancy Category C. Animal reproduction studies have not been conducted with this drug. It is also not known whether this drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This drug should be given to a pregnant woman only if clearly needed.

Adverse Reactions

To report SUSPECTED ADVERSE REACTIONS, contact Heel Inc. at 1.800.920.9203 or info@heelusa.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Overdosage

Due to the low concentration of active ingredients in homeopathic preparations such as Spascupreel® Injection Solution, adverse reactions following overdosage are extremely unlikely. However care must be taken not to exceed the recommended dosage.

Spascupreel - Clinical Pharmacology

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

DOSAGE

Injections: 1.1 ml ampule

Spascupreel_injectable box_09.jpg

Spascupreel  aconitum napellus and ammonium bromide and citrullus colocynthis fruit pulp and atropine sulfate and gelsemium sempervirens root and magnesium phosphate, dibasic trihydrate and veratrum album root and passiflora incarnata flower and chamomile and amanita muscaria var. muscaria and cupric sulfate and   injection

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 52919-141 Route of Administration INTRADERMAL, INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACONITUM NAPELLUS (ACONITUM NAPELLUS) ACONITUM NAPELLUS 6 [hp_X]  in 1.1 mL AMMONIUM BROMIDE (AMMONIUM BROMIDE) AMMONIUM BROMIDE 4 [hp_X]  in 1.1 mL CITRULLUS COLOCYNTHIS FRUIT PULP (CITRULLUS COLOCYNTHIS FRUIT PULP) CITRULLUS COLOCYNTHIS FRUIT PULP 4 [hp_X]  in 1.1 mL ATROPINE SULFATE (SULFATE ION) ATROPINE SULFATE 6 [hp_X]  in 1.1 mL GELSEMIUM SEMPERVIRENS ROOT (GELSEMIUM SEMPERVIRENS ROOT) GELSEMIUM SEMPERVIRENS ROOT 6 [hp_X]  in 1.1 mL MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (PHOSPHATE ION) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 6 [hp_X]  in 1.1 mL VERATRUM ALBUM ROOT (VERATRUM ALBUM ROOT) VERATRUM ALBUM ROOT 6 [hp_X]  in 1.1 mL PASSIFLORA INCARNATA FLOWER (PASSIFLORA INCARNATA FLOWER) PASSIFLORA INCARNATA FLOWER 2 [hp_X]  in 1.1 mL CHAMOMILE (CHAMOMILE) CHAMOMILE 3 [hp_X]  in 1.1 mL AMANITA MUSCARIA VAR. MUSCARIA (AMANITA MUSCARIA VAR. MUSCARIA) AMANITA MUSCARIA VAR. MUSCARIA 4 [hp_X]  in 1.1 mL CUPRIC SULFATE (SULFATE ION) CUPRIC SULFATE 6 [hp_X]  in 1.1 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 52919-141-10 1.1 mL In 1 AMPULE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/20/2011

Labeler - Hameln Pharma GmbH (315869123)

Revised: 01/2011Hameln Pharma GmbH