Store in a cool (50° to 68° F; 10° to 20° C) and dry place. Keep out of direct sunlight and heat. Discard 10 days after first puncture or sooner if signs of contamination are present. Refrigerate between 36° to 46° F / 2° to 8° C after first use. Always use aseptic measures. Do not use if tamper-evident seal is broken or removed. Discard the vial if the product has eclipsed the expiry date.
10ml Rx Sterile multi-dose injectable homeopathic vial Isotonic saline with 1% Benzyl alcohol as a preservative. For IV, IM, SC, Parenteral Use Osmolarity around 0.3mOsmol/ml.
Description
DESCRIPTION SECTION
Viatrexx-Adipose is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These nano particles are designed to nourish the system.
Indications and Use
INDICATIONS & USAGE SECTION
Viatrexx-Adipose a sterile, injectable, biodegradable, clear isotonic liquid that is injected into the various layers of the skin, muscles, ligaments, joints, other body tissues or added to an IV, either as a push or into the bag.
Contraindications
CONTRAINDICATIONS SECTION
This product should not be used in patients with a known hypersensitivity to any ingredient found in the formula, porcine products, isotonic saline or benzyl alcohol, or patients with a history of severe allergies. As with all injections, epinephrine injection (1:1,000) must be immediately available should an acute anaphylactoid reaction occur due to any component of the injection.
Warnings
WARNINGS SECTION
Homeopathic injections are quite safe, but all medical procedures carry some risk. The most common risk is an allergic reaction to the injection of any ingredient found in the formula, porcine, benzyl alcohol &/or saline. Do not use if allergic to any of these substances. Side effects include some risk of bruising and temporary redness at the site of the injection. Use appropriate emergency protocol if signs of allergic reaction or infection appear, during or shortly after the injection.
Use in Obstetrics
USE IN SPECIFIC POPULATIONS SECTION
This product contains 1% Benzyl Alcohol. Benzyl Alcohol has been reported to be associated with a fatal "Gasping Syndrome" in premature infants. Due to the benzyl alcohol content, this product should not be given to a pregnant woman.
Nursing Mothers
NURSING MOTHERS SECTION
It is not known whether the benzyl alcohol or any of the ingredients is excreted in human milk. Caution should be exercised when products with benzyl alcohol are administered to nursing woman.
Use in Children
USE IN SPECIFIC POPULATIONS SECTION
This product should not be used in patients with a known hypersensitivity to any ingredient in this formula, porcine products, isotonic saline or benzyl alcohol, or patients with a history of severe allergies. As with all injections, epinephrine injection (1:1,000) must be immediately available should an acute anaphylactoid reaction occur due to any component of the injection.
Techniques
SPL UNCLASSIFIED SECTION
May use any injection technique appropriate to the condition being addressed.
Dosage
DOSAGE & ADMINISTRATION SECTION
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Viatrexx-Adipose is a clear, colorless solution. The product may be used directly as supplied. No dilution or reconstitution is necessary. 1% benzyl alcohol is included as a preservative. The quantity injected can vary between 0.1 ml through 10 ml, depending on the opinion of the practitioner and technique used. 0.2 ml per injection site is common. It is important to use a separate sterile needle and syringe free of preservatives, antiseptics and detergents, for each operation with the product and for each individual patient. Always use aseptic measures. Never introduce any foreign substance into the vial, if so then discard the ampoule. Never use expired product.
Use with other injectables
SPL UNCLASSIFIED SECTION
No adverse effects have been reported when combining with other Viatrexx injectables, stem cells, PRP, procaine or dextrose.
Over dosage
OVERDOSAGE SECTION
No over dosage has been reported with this product.
Storage
STORAGE AND HANDLING SECTION
Store in a cool (50° to 68° F; 10° to 20° C) and dry place. Keep out of direct sunlight and heat. Discard 10 days after first puncture or sooner if signs of contamination are present. Refrigerate between 36° to 46° F / 2° to 8° C after first use. Always use aseptic measures. Do not use if tamper-evident seal is broken or removed. Discard the vial if the product has eclipsed the expiry date.
Product availability
SPL UNCLASSIFIED SECTION
Product may be acquired in 10 ml multi-dose ampoules in boxes of 1, 3, 6 or 12 vials.
References upon request
To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Distributed by Viatrexx Bio Incorporated Newark, DE, USA, 19713
Manufactured by 8046255 Canada Inc Beloeil, Qc, J3G 6S3
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.