PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC: 73069-102-42 Item: VSPC0092 Viatrexx Bio Incorporated Viatrexx-Mesenchyme Rx Box of 3 X 10 ml vials Sterile multi-dose injectable For IV, IM, SC, Parenteral Use Preserved with Benzyl Alcohol Osmolarity around 0.3 mOsmol/ml. Expiry date: Lot #: Manufactured for: Viatrexx Bio Incorporated Newark, DE, USA, 19713 www.Viatrexx.com Ingredients, homeopathic See insert or www.viatrexx.com Inactives: Benzyl Alcohol 1%, Isotonic saline NDC: 73069-102-41 Item: VSPC0092 Rx Viatrexx-Mesenchyme Box of 1 X10 ml vial To support matrix / connective tissue health and drainage Sterile multi-dose injectable For IV, IM, SC, Parenteral Use Preserved with Benzyl Alcohol Osmolarity around 0.3 mOsmol/ml. Ingredients, homeopathic See insert or www.viatrexx.com Inactives: Benzyl Alcohol 1% Isotonic saline Lot # Exp date: Manufactured for Viatrexx Bio Incorporated Newark, DE, USA, 19713 www.Viatrexx.com Viatrexx Bio Incorporated NDC: 73069-102-43 Item: VSPC0092 Viatrexx Bio Incorporated Viatrexx-Mesenchyme Rx Box of 5 X 10 ml vials Sterile multi-dose injectable For IV, IM, SC, Parenteral Use Preserved with Benzyl Alcohol Osmolarity around 0.3 mOsmol/ml. Expiry date: Lot #: Manufactured for: Viatrexx Bio Incorporated Newark, DE, USA, 19713 www.Viatrexx.com Ingredients, homeopathic See insert or www.viatrexx.com Inactives: Benzyl Alcohol 1%, Isotonic saline NDC: 73069-102-44 Item: VSPC0092 Viatrexx Bio Incorporated Viatrexx-Mesenchyme Rx Box of 6 X 10 ml vials Sterile multi-dose injectable For IV, IM, SC, Parenteral Use Preserved with Benzyl Alcohol Osmolarity around 0.3 mOsmol/ml. Expiry date: Lot #: Manufactured for: Viatrexx Bio Incorporated Newark, DE, USA, 19713 www.Viatrexx.com Ingredients, homeopathic See insert or www.viatrexx.com Inactives: Benzyl Alcohol 1%, Isotonic saline NDC: 73069-102-45 Item: VSPC0092 Viatrexx Bio Incorporated Viatrexx-Mesenchyme Rx Box of 10 X 10 ml vials Sterile multi-dose injectable For IV, IM, SC, Parenteral Use Preserved with Benzyl Alcohol Osmolarity around 0.3 mOsmol/ml. Expiry date: Lot #: Manufactured for: Viatrexx Bio Incorporated Newark, DE, USA, 19713 www.Viatrexx.com Ingredients, homeopathic See insert or www.viatrexx.com Inactives: Benzyl Alcohol 1%, Isotonic saline NDC: 73069-102-46 Item: VSPC0092 Viatrexx Bio Incorporated Viatrexx-Mesenchyme Rx Box of 12 X 10 ml vials Sterile multi-dose injectable For IV, IM, SC, Parenteral Use Preserved with Benzyl Alcohol Osmolarity around 0.3 mOsmol/ml. Expiry date: Lot #: Manufactured for: Viatrexx Bio Incorporated Newark, DE, USA, 19713 www.Viatrexx.com Ingredients, homeopathic See insert or www.viatrexx.com Inactives: Benzyl Alcohol 1%, Isotonic saline NDC: 73069-102-47 Item: VSPC0092 Viatrexx Bio Incorporated Viatrexx-Mesenchyme Rx Box of 25 X 10 ml vials Sterile multi-dose injectable For IV, IM, SC, Parenteral Use Preserved with Benzyl Alcohol Osmolarity around 0.3 mOsmol/ml. Expiry date: Lot #: Manufactured for: Viatrexx Bio Incorporated Newark, DE, USA, 19713 www.Viatrexx.com Ingredients, homeopathic See insert or www.viatrexx.com Inactives: Benzyl Alcohol 1%, Isotonic saline NDC: 73069-102-48 Item: VSPC0092 Viatrexx Bio Incorporated Viatrexx-Mesenchyme Rx Box of 50 X 10 ml vials Sterile multi-dose injectable For IV, IM, SC, Parenteral Use Preserved with Benzyl Alcohol Osmolarity around 0.3 mOsmol/ml. Expiry date: Lot #: Manufactured for: Viatrexx Bio Incorporated Newark, DE, USA, 19713 www.Viatrexx.com Ingredients, homeopathic See insert or www.viatrexx.com Inactives: Benzyl Alcohol 1%, Isotonic saline NDC: 73069-102-49 Item: VSPC0092 Viatrexx Bio Incorporated Viatrexx-Mesenchyme Rx Box of 100 X 10 mlvials Sterile multi-dose injectable For IV, IM, SC, Parenteral Use Preserved with Benzyl Alcohol Osmolarity around 0.3 mOsmol/ml. Expiry date: Lot #: Manufactured for: Viatrexx Bio Incorporated Newark, DE, USA, 19713 www.Viatrexx.com Ingredients, homeopathic See insert or www.viatrexx.com Inactives: Benzyl Alcohol 1%, Isotonic saline

INDICATIONS & USAGE SECTION.


Indications and Use Viatrexx-Mesenchymea 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.

DOSAGE & ADMINISTRATION SECTION.


Dosage Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Viatrexx-Mesenchymeis 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 vial. Never use expired product.

SPL UNCLASSIFIED SECTION.


Product availability 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 Date of last revision March 2019 For Questions and comments Info@Viatrexx.com www.Viatrexx.com Formula Ingredients Dilution Adrenal (4C, 201K), Ascorbic acid (3C, 31K), BDNF (6C, 31K),DHEA (4C, 31K), Malic acid (4C, 31K),bFGF (31K), Fucus vesiculosus (3C, 31K),Histidine (3C, 31K), Hyaluronidase (4C, 31K),IL-6 (31K),Lactic acid (31K),Lymph node (31K), Mesenchyme (4C, 31K), NAD (31K), Natrum oxalaceticum (31K), Natrum pyruvicum (31K),Natrum sulphuricum (4C, 201K), Phenylalanine (3C, 31K), Prolactin (4C, 31K), Pyrogenium (31K), Thuja occidentalis (4C, 201K), Trichinoyl (4C, 31K). These statements are for educational purposes only & have not been verified by any government authority or agency. This product is not intended to diagnosis, cure, treat, mitigate or heal any health condition

DESCRIPTION SECTION.


Description Viatrexx-Mesenchymeis a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These nano particles are designed to nourish the system.

OVERDOSAGE SECTION.


Over dosage No over dosage has been reported with this product.

NURSING MOTHERS SECTION.


Nursing Mothers 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.

STORAGE AND HANDLING SECTION.


Storage 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 36to 46 F / 2to 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.

USE IN SPECIFIC POPULATIONS SECTION.


Use in Children 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.

CONTRAINDICATIONS SECTION.


Contraindications 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 SECTION.


Warnings 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.