SPASCUPREEL - aconitum napellus, ammonium bromide, citrullus colocynthis fruit pulp, atropine sulfate, gelsemium sempervirens root, magnesium phosphate, dibasic trihydrate, veratrum album root, passiflora incarnata flowering top, matricaria recutita, amanita muscaria fruiting body and cupric sulfate injection 
MediNatura Inc

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Spascupreel 1.1ml Injection

DESCRIPTION

 Each 1.1 ml solution for injection ampule contains:
 Active Ingredients:
 Ingredient name Potency Quantity Final dilution
 Aconitum napellus 6X 2.20 µl 8.69X
 Agaricus muscarius 4X 0.55 µl 7.30X
 Ammonium bromatum 4X 1.10 µl 7.00X
 Atropinum sulphuricum 6X 1.10 µl 8.99X
 Chamomilla 3X 0.55 µl 6.30X
 Colocynthis 4X 1.10 µl 7.00X
 Cuprum sulphuricum 6X 0.55 µl 9.30X
 Gelsemium sempervirens 6x 1.10 µl 8.99X
 Magnesia phosphorica 6X 1.10 µl 8.99X
 Passiflora incarnata 2X 0.55 µl 5.30X
 Veratrum album 6X 1.10 µl 8.99X

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.

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.

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.

Spascupreel Injection.jpg

SPASCUPREEL 
aconitum napellus, ammonium bromide, citrullus colocynthis fruit pulp, atropine sulfate, gelsemium sempervirens root, magnesium phosphate, dibasic trihydrate, veratrum album root, passiflora incarnata flowering top, matricaria recutita, amanita muscaria fruiting body and cupric sulfate injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:50114-7040
Route of AdministrationINTRADERMAL, INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACONITUM NAPELLUS (ACONITUM NAPELLUS) ACONITUM NAPELLUS6 [hp_X]  in 1.1 mL
AMMONIUM BROMIDE (BROMIDE ION) AMMONIUM BROMIDE4 [hp_X]  in 1.1 mL
CITRULLUS COLOCYNTHIS FRUIT PULP (CITRULLUS COLOCYNTHIS FRUIT PULP) CITRULLUS COLOCYNTHIS FRUIT PULP4 [hp_X]  in 1.1 mL
ATROPINE SULFATE (ATROPINE) ATROPINE SULFATE6 [hp_X]  in 1.1 mL
GELSEMIUM SEMPERVIRENS ROOT (GELSEMIUM SEMPERVIRENS ROOT) GELSEMIUM SEMPERVIRENS ROOT6 [hp_X]  in 1.1 mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (MAGNESIUM CATION) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE6 [hp_X]  in 1.1 mL
VERATRUM ALBUM ROOT (VERATRUM ALBUM ROOT) VERATRUM ALBUM ROOT6 [hp_X]  in 1.1 mL
PASSIFLORA INCARNATA FLOWERING TOP (PASSIFLORA INCARNATA FLOWERING TOP) PASSIFLORA INCARNATA FLOWERING TOP2 [hp_X]  in 1.1 mL
MATRICARIA RECUTITA (MATRICARIA RECUTITA) MATRICARIA RECUTITA3 [hp_X]  in 1.1 mL
AMANITA MUSCARIA FRUITING BODY (AMANITA MUSCARIA FRUITING BODY) AMANITA MUSCARIA FRUITING BODY4 [hp_X]  in 1.1 mL
CUPRIC SULFATE (CUPRIC CATION) CUPRIC CATION6 [hp_X]  in 1.1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50114-7040-110 in 1 CARTON
11.1 mL in 1 AMPULE
2NDC:50114-7040-21 in 1 CARTON
21.1 mL in 1 AMPULE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/20/2011
Labeler - MediNatura Inc (102783016)

Revised: 12/2014
 
MediNatura Inc