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Spascupreel

Hameln Pharma GmbH

Spascupreel 1.1ml Injection


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

SPASCUPREEL DESCRIPTION



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.

® 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.



SPASCUPREEL 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.

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

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 label Item Code (Source) NDC:52919-141
Route of Administration INTRADERMAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACONITUM NAPELLUS ACONITUM NAPELLUS 6 [hp_X]
AMMONIUM BROMIDE AMMONIUM BROMIDE 4 [hp_X]
CITRULLUS COLOCYNTHIS FRUIT PULP CITRULLUS COLOCYNTHIS FRUIT PULP 4 [hp_X]
atropine sulfate ATROPINE 6 [hp_X]
GELSEMIUM SEMPERVIRENS ROOT GELSEMIUM SEMPERVIRENS ROOT 6 [hp_X]
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE MAGNESIUM CATION 6 [hp_X]
VERATRUM ALBUM ROOT VERATRUM ALBUM ROOT 6 [hp_X]
PASSIFLORA INCARNATA FLOWER PASSIFLORA INCARNATA FLOWER 2 [hp_X]
CHAMOMILE CHAMOMILE 3 [hp_X]
AMANITA MUSCARIA VAR. MUSCARIA AMANITA MUSCARIA VAR. MUSCARIA 4 [hp_X]
CUPRIC SULFATE CUPRIC CATION 6 [hp_X]

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52919-141-10 1.1 in 1 AMPULE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-01-20


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