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Zeel

Hameln Pharma GmbH

Zeel 2.0 ml Injection


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ZEEL DESCRIPTION


Injection Solution Ingredient Information: Each 2.0 ml ampule contains: Arnica Montana, radix 4X 200 mcl, Rhus toxicodendron 2X 10 mcl, Dulcamara 3X 10 mcl, Symphytum officinale 6X 10 mcl, Sulphur 6X 3.6 mcl, Sanguinaria Canadensis 4X 3 mcl, Cartilago suis 6X 2 mcl, Embryo suis 6X 2 mcl, Funiculus umbillicalis suis 6X 2 mcl, Placenta suis 6X 2 mcl, α-Lipoicum acidum 8X 2 mcl, Coenzyme A 8X 2 mcl, Nadidum 8X 2 mcl, Natrum oxalaceticum 8X 2 mcl. Inactive ingredient: Sterile isotonic sodium chloride solution.

ZEEL INDICATIONS AND USAGE

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Zeel® Injection Solution is indicated for the temporary relief of mild to moderate arthritic pain, osteoarthritis and joint stiffness.

ZEEL DOSAGE AND ADMINISTRATION

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Adults and children 7 years and older : 1 ampule daily for acute disorders, or 1 ampule 1 to 3 times per week. Children ages 2 to 6 receive: ½ the adult dosage.






WARNINGS AND PRECAUTIONS

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Zeel® Injection Solution should not be administered for pain for more than 10 days for adults or five days for children. If new symptoms 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. Zeel® Injection Solution should not be administered to children for the pain of arthritis unless directed by a physician.

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.


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

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CLINICAL PHARMACOLOGY

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PRINCIPAL DISPLAY PANEL

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Zeel

Zeel

ARNICA MONTANA and TOXICODENDRON PUBESCENS LEAF and SOLANUM DULCAMARA STEM and SYMPHYTUM TUBEROSUM ROOT and SULFUR and SANGUINARIA CANADENSIS ROOT and SUS SCROFA CARTILAGE and SUS SCROFA EMBRYO and SUS SCROFA UMBILICAL CORD and SUS SCROFA PLACENTA and ALPHA LIPOIC ACID and COENZYME A and NADIDE and SODIUM DIETHYL OXALACETATE INJECTION

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:52919-116
Route of Administration INTRADERMAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ARNICA MONTANA ARNICA MONTANA 4 [hp_X]
TOXICODENDRON PUBESCENS LEAF TOXICODENDRON PUBESCENS LEAF 2 [hp_X]
SOLANUM DULCAMARA STEM SOLANUM DULCAMARA STEM 3 [hp_X]
SYMPHYTUM TUBEROSUM ROOT SYMPHYTUM TUBEROSUM ROOT 6 [hp_X]
SULFUR SULFUR 6 [hp_X]
SANGUINARIA CANADENSIS ROOT SANGUINARIA CANADENSIS ROOT 4 [hp_X]
SUS SCROFA CARTILAGE Sus Scrofa Cartilage 6 [hp_X]
SUS SCROFA EMBRYO SUS SCROFA EMBRYO 6 [hp_X]
SUS SCROFA UMBILICAL CORD SUS SCROFA UMBILICAL CORD 6 [hp_X]
SUS SCROFA PLACENTA SUS SCROFA PLACENTA 6 [hp_X]
ALPHA LIPOIC ACID ALPHA LIPOIC ACID 8 [hp_X]
COENZYME A COENZYME A 8 [hp_X]
NADIDE NADIDE 8 [hp_X]
SODIUM DIETHYL OXALACETATE DIETHYL OXALACETATE 8 [hp_X]

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52919-116-10 2.0 in 1 AMPULE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-01-24


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