Oligostim Manganese-Cuivre-Cobalt

Copper (Copper Gluconate Dihydrate):

• Indications:
• General directions:
• Active ingredient:
• Inactive ingredients:
• Caution:
• Storage:
• Net contents:
• Oligostim Manganese-Cuivre-Cobalt (Copper (Copper Gluconate Dihydrate)) reviews

Water-Resistant Protection Without Bandaging

Recommended as an Aid in Treating Horses and Ponies With Thrush Due to Organisms Susceptible to Oligostim Manganese-Cuivre-Cobalt (Copper (Copper Gluconate Dihydrate)) Naphthenate.

For Animal Use Only.

INDICATIONS:

ThrushTox® is indicated in the treatment of thrush in horses and ponies.

GENERAL DIRECTIONS:

Clean the hoof thoroughly, removing debris and necrotic material prior to application of Oligostim Manganese-Cuivre-Cobalt (Copper (Copper Gluconate Dihydrate))^®. Apply daily to affected hoofs with a narrow paint brush (about 1”) until fully healed. Caution: Do not allow runoff of excess Oligostim Manganese-Cuivre-Cobalt (Copper (Copper Gluconate Dihydrate))^® onto hair since contact with Oligostim Manganese-Cuivre-Cobalt (Copper (Copper Gluconate Dihydrate))^® may cause some hair loss. Do not contaminate feed.

NOTE: Oligostim Manganese-Cuivre-Cobalt (Copper (Copper Gluconate Dihydrate))^® is easily removed from hands, clothing and surfaces with light grade fuel oil or any type of lighter fluid.

CONTAINS FOIL SEAL – REMOVE BEFORE USE.

SHAKE WELL BEFORE USE.

To report suspected adverse reactions or to obtain technical assistance, call 1-800-650-4899.

ACTIVE INGREDIENT:

Oligostim Manganese-Cuivre-Cobalt (Copper (Copper Gluconate Dihydrate)) Naphthenate...37.5% w/w

INACTIVE INGREDIENTS:

Inert Ingredients...62.5% w/w

Total... 100.0%

CAUTION:

Do not use in horses intended for human consumption.

CAUTION: COMBUSTIBLE MIXTURE.

Use in a well-ventilated place. Avoid fire, flame, sparks or heaters.

If swallowed, do not induce vomiting, call physician immediately. Avoid breathing vapor. Avoid contact with skin and eyes.

KEEP OUT OF REACH OF CHILDREN AND PETS.

STORAGE:

Store at controlled room temperature 15º to 30ºC (59º to 86ºF). Keep container tightly closed when not in use.

Manufactured for:

Aspen Veterinary Resources,^® Ltd.

Liberty, MO 64068, USA

FC163FP 11/13

Manufactured by:

First Priority, Inc.

Elgin, IL 60123-1146, USA

NET CONTENTS:

16 OZ (473 mL)

ANADA 200-304, Approved by FDA

Image of 473 mL bottle/case label

Manganese (Manganese Gluconate Dihydrate):

• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Drug abuse and dependence
• Overdosage
• Dosage and administration
• How supplied
• Rl-0104
• Oligostim Manganese-Cuivre-Cobalt (Manganese (Manganese Gluconate Dihydrate)) reviews

INDICATIONS AND USAGE

Oligostim Manganese-Cuivre-Cobalt (Manganese (Manganese Gluconate Dihydrate)) 0.1 mg/mL (Manganese Chloride Injection, USP) is indicated for use as a supplement to intravenous solutions given for total parenteral nutrition (TPN).

Administration helps to maintain Oligostim Manganese-Cuivre-Cobalt (Manganese (Manganese Gluconate Dihydrate)) serum levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.

CONTRAINDICATIONS

None known.

WARNINGS

Direct intramuscular or intravenous injection of Oligostim Manganese-Cuivre-Cobalt (Manganese (Manganese Gluconate Dihydrate)) 0.1 mg/mL (Manganese Chloride Injection, USP) is contraindicated as the acidic pH of the solution (pH 2.0) may cause considerable tissue irritation.

Liver and/or biliary tract dysfunction may require omission or reduction of copper and Oligostim Manganese-Cuivre-Cobalt (Manganese (Manganese Gluconate Dihydrate)) doses because these elements are primarily eliminated in the bile.

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

PRECAUTIONS

General

Do not use unless solution is clear and seal is intact.

Oligostim Manganese-Cuivre-Cobalt ) 0.1 mg/mL (Manganese Chloride Injection, USP) should only be used in conjunction with a pharmacy directed admixture program using aseptic technique in a laminar flow environment; it should be used promptly and in a single operation without any repeated penetrations. Solution contains no preservatives; discard unused portion immediately after admixture procedure is completed.

Laboratory Tests

Serum Oligostim Manganese-Cuivre-Cobalt (Manganese (Manganese Gluconate Dihydrate)) levels can be measured periodically at the discretion of the investigator. Because of the low serum concentration normally present, samples will usually be analyzed by a reference laboratory.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term animal studies to evaluate the carcinogenic potential of Oligostim Manganese-Cuivre-Cobalt ) 0.1 mg/mL (Manganese Chloride Injection, USP) have not been performed, nor have studies been done to assess mutagenesis or impairment of fertility.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Oligostim Manganese-Cuivre-Cobalt (Manganese (Manganese Gluconate Dihydrate)) 0.1 mg/mL (Manganese Chloride Injection, USP) additive is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Pregnancy Category C.

Animal reproduction studies have not been conducted with Oligostim Manganese-Cuivre-Cobalt (Manganese (Manganese Gluconate Dihydrate)) chloride. It is also not known whether Oligostim Manganese-Cuivre-Cobalt (Manganese (Manganese Gluconate Dihydrate)) chloride can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Oligostim Manganese-Cuivre-Cobalt (Manganese (Manganese Gluconate Dihydrate)) chloride should be given to a pregnant woman only if clearly indicated.

Geriatric Use

An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

ADVERSE REACTIONS

None known.

DRUG ABUSE AND DEPENDENCE

None known.

OVERDOSAGE

Oligostim Manganese-Cuivre-Cobalt (Manganese (Manganese Gluconate Dihydrate)) toxicity in TPN patients has not been reported.

DOSAGE AND ADMINISTRATION

Oligostim Manganese-Cuivre-Cobalt (Manganese (Manganese Gluconate Dihydrate)) 0.1 mg/mL (Manganese Chloride Injection, USP) contains 0.1 mg manganese/mL and is administered intravenously only after dilution. The additive should be administered in a volume of fluid not less than 100 mL. For the adult receiving TPN, the suggested additive dosage for Oligostim Manganese-Cuivre-Cobalt (Manganese (Manganese Gluconate Dihydrate)) is 0.15 to 0.8 mg/day (1.5 to 8 mL/day). For pediatric patients, a dosage of 2 to 10 mcg manganese/kg/day (0.02 to 0.1 mL/kg/day) is recommended.

Periodic monitoring of Oligostim Manganese-Cuivre-Cobalt (Manganese (Manganese Gluconate Dihydrate)) plasma levels is suggested as a guideline for subsequent administration.

Parenteral products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (See PRECAUTIONS .)

HOW SUPPLIED

Oligostim Manganese-Cuivre-Cobalt (Manganese (Manganese Gluconate Dihydrate)) 0.1 mg/mL (Manganese Chloride Injection, USP) is supplied in 10 mL Plastic Vials (NDC No. 0409-4091-01).

Store at 20 to 25°C (68 to 77°F)

Revised: November, 2009

Printed in USA EN-2320

Hospira, Inc., Lake Forest, IL 60045 USA

RL-0104