Connectissue by VIATREXX BIO INCORPORATED / 8046255 Canada Inc Connectissue

Connectissue by

Drug Labeling and Warnings

Connectissue by is a Homeopathic medication manufactured, distributed, or labeled by VIATREXX BIO INCORPORATED, 8046255 Canada Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CONNECTISSUE- anti-interleukin-1.alpha. immunoglobulin g rabbit, ascorbic acid, metenkefalin, ersofermin, bos taurus cartilage, sus scrofa cartilage, pork collagen, bos taurus red blood cell, sus scrofa red blood cell, interleukin-3, interleukin-3, beef liver, pork liver, beef, pork, bos taurus tendon, sus scrofa tendon, cetermin injection 
VIATREXX BIO INCORPORATED

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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Connectissue

Description

Viatrexx-Connectissue 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

Viatrexx-Connectissue is 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

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

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

This product contains 2% 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

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

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

May use any injection technique appropriate to the condition being addressed.

Dosage

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Viatrexx-Connectissue is a clear, colorless solution. The product may be used directly as supplied. No dilution or reconstitution is necessary. 2% 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 ampoule, if so then discard the ampoule. Never use expired product.

Use with other Injectables

No adverse effects have been reported when combining with other Viatrexx injectables, stem cells, PRP, procaine or dextrose.

Overdosage

No over dosage has been reported with this product.

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 36 & 46 F / 2 & 8 C after first use.  Always use aseptic measures.  Do not use if tamper-evident seal is broken or removed. Discard the ampoule if the product has eclipsed the expiry date.

Product availability

Product may be acquired in 10 ml multi-dose ampoules in boxes of 1, 3 or 5 ampoules

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
For Questions and comments:
1-888-743-6652
Info@Viatrexx.com
www.Viatrexx.com

Manufactured by
8046255 Canada Inc
Beloeil, Qc, J3G 6S3

Date of last revision March 2019

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

Active Ingredients

Anti-Interleukin-1 9 9X 200K, Ascorbic acid 8X 30K, Beta endorphin 8 9X 200K, bFibroblast Growth Factor 8 9X 200K, Cartilage 6X 200K, Collagen 8X 200K, Erythrocytes 8X 200K, Interleukin 3 3 12X 200K, Liver 6X 200K, Muscle 6X 200K, Tendon 8X 200K, Transforming Growth Factor-2 11X 200K

Other Ingredients

Benzyl alcohol & Saline

Principal Display Panel

NDC: 63776-099-55
Item: VSPC0090
Rx Viatrexx-Connectissue©
10 ml
To support soft tissue health Sterile multi-dose injectable For IV, IM and SC Use Preserved with Benzyl Alcohol Osmolarity around 0.3mOsmol/ml.
Viatrexx Bio Incorporated

box
CONNECTISSUE 
anti-interleukin-1.alpha. immunoglobulin g rabbit, ascorbic acid, metenkefalin, ersofermin, bos taurus cartilage, sus scrofa cartilage, pork collagen, bos taurus red blood cell, sus scrofa red blood cell, interleukin-3, interleukin-3, beef liver, pork liver, beef, pork, bos taurus tendon, sus scrofa tendon, cetermin injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 63776-099
Route of AdministrationTRANSDERMAL, INTRA-ARTICULAR, INTRADERMAL, INTRAMUSCULAR, INTRAVENOUS, PARENTERAL, PERINEURAL, SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Anti-interleukin-1.alpha. Immunoglobulin G Rabbit (UNII: ML4QRZ1HCL) (Anti-interleukin-1.alpha. Immunoglobulin G Rabbit - UNII:ML4QRZ1HCL) Anti-interleukin-1.alpha. Immunoglobulin G Rabbit200 [kp_C]  in 1 mL
Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid30 [kp_C]  in 1 mL
Metenkefalin (UNII: 9JEZ9OD3AS) (Metenkefalin - UNII:9JEZ9OD3AS) Metenkefalin200 [kp_C]  in 1 mL
Ersofermin (UNII: 1NWT5SW3NW) (Ersofermin - UNII:1NWT5SW3NW) Ersofermin200 [kp_C]  in 1 mL
Bos Taurus Cartilage (UNII: UE77B10IIY) (Bos Taurus Cartilage - UNII:UE77B10IIY) Bos Taurus Cartilage200 [kp_C]  in 1 mL
Sus Scrofa Cartilage (UNII: 73ECW5WG2F) (Sus Scrofa Cartilage - UNII:73ECW5WG2F) Sus Scrofa Cartilage200 [kp_C]  in 1 mL
Pork Collagen (UNII: I8442U2G7J) (Pork Collagen - UNII:I8442U2G7J) Pork Collagen200 [kp_C]  in 1 mL
Bos Taurus Red Blood Cell (UNII: 5W4FLB0U2C) (Bos Taurus Red Blood Cell - UNII:5W4FLB0U2C) Bos Taurus Red Blood Cell200 [kp_C]  in 1 mL
Sus Scrofa Red Blood Cell (UNII: 5X23IGF970) (Sus Scrofa Red Blood Cell - UNII:5X23IGF970) Sus Scrofa Red Blood Cell200 [kp_C]  in 1 mL
Interleukin-3 (UNII: A802907MI4) (Interleukin-3 - UNII:A802907MI4) Interleukin-3200 [kp_C]  in 1 mL
Beef Liver (UNII: W8N8R55022) (Beef Liver - UNII:W8N8R55022) Beef Liver200 [kp_C]  in 1 mL
Pork Liver (UNII: 6EC706HI7F) (Pork Liver - UNII:6EC706HI7F) Pork Liver200 [kp_C]  in 1 mL
Beef (UNII: 4PIB2155QP) (Beef - UNII:4PIB2155QP) Beef200 [kp_C]  in 1 mL
Pork (UNII: O138UB266J) (Pork - UNII:O138UB266J) Pork200 [kp_C]  in 1 mL
Bos Taurus Tendon (UNII: 0470X06FYR) (Bos Taurus Tendon - UNII:0470X06FYR) Bos Taurus Tendon200 [kp_C]  in 1 mL
Sus Scrofa Tendon (UNII: R69Y34R8KU) (Sus Scrofa Tendon - UNII:R69Y34R8KU) Sus Scrofa Tendon200 [kp_C]  in 1 mL
Cetermin (UNII: 693Y43MXY4) (Cetermin - UNII:693Y43MXY4) Cetermin200 [kp_C]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Benzyl Alcohol (UNII: LKG8494WBH)  
Sodium Chloride (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 63776-099-551 in 1 BOX04/16/201906/28/2019
110 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2NDC: 63776-099-563 in 1 BOX04/16/201906/28/2019
210 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
3NDC: 63776-099-576 in 1 BOX04/17/201906/28/2019
310 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
4NDC: 63776-099-5812 in 1 BOX04/17/201906/28/2019
410 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/16/201906/28/2019
Labeler - VIATREXX BIO INCORPORATED (078419880)
Establishment
NameAddressID/FEIBusiness Operations
8046255 Canada Inc200651455manufacture(63776-099)

Revised: 6/2019