NDC 10530-319 Nexavir

Liver Derivative Complex

NDC Product Code 10530-319

NDC 10530-319-07

Package Description: 20 mL in 1 VIAL, MULTI-DOSE

NDC Product Information

Nexavir with NDC 10530-319 is a a human prescription drug product labeled by Nexco Pharma. The generic name of Nexavir is liver derivative complex. The product's dosage form is injection and is administered via intramuscular; subcutaneous form.

Labeler Name: Nexco Pharma

Dosage Form: Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Nexavir Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • PORK LIVER 25.5 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • PHENOL (UNII: 339NCG44TV)
  • WATER (UNII: 059QF0KO0R)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Intramuscular - Administration within a muscle.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
  • Intramuscular - Administration within a muscle.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Nexco Pharma
Labeler Code: 10530
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-19-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Nexavir Product Label Images

Nexavir Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description:

NEXAVIR


® Injection (liver derivative complex) is a sterile solution containing 25.5mg liver derivative complex per ml in sterile water for injection.


NEXAVIR


® Injection is composed of peptides and amino acids. The product contains no protein and does not exhibit anti-anemia activity.


NEXAVIR


® Injection also contains as inactive ingredients: phenol 0.5%, sterile water for Injection, pH is adjusted with hydrochloric acid or sodium hydroxide when necessary.

Clinical Pharmacoi.Ogy:

The specific action of NEXAVIR


® is to enhance the resolution of inflammation and edema. In the late 1920's, it was demonstrated that liver was of benefit to patients suffering from acne vulgaris.


1 As a consequence, various techniques were employed for isolating the active "factor" from liver. Studies published in the late 1930's and early 1940's


2,3,4 showed activity in a specially purified liver fraction. During subsequent years, refinements in the isolation of the active material led to the marketing of NEXAVIR


®.


Initially it was thought that the primary action of NEXAVIR


® was on the capillaries and precapillary sphincters. However, it is now believed that this effect is a secondary one and that the primary action of NEXAVIR


® is in response to injury at the cellular level. The capillary changes observed following administration of NEXAVIR


® appear to be part of a more fundamental anti-inflammatory effect. In the normal animal, no consistent pharmacodynamic action has been demonstrated for NEXAVIR


®. In particular, there is no effect on systemic blood pressure, no action on the autonomic nervous system and no alteration in prothrombin, coagulation or bleeding times. It is concluded that the specific action of the product is only apparent when tissues have been subjected to injury and when inflammation and edema are present.

Indications And Usage:

A wide range of dermatological clinical conditions benefit from NEXAVIR


® therapy. The common denominator in these varied conditions is the presence of inflammation and edema. Favourable responses to the administration of NEXAVIR


® in patients with acne vulgaris


5,6,7,8, herpes zoster, "poison ivy" dermatitis, pityriasis rosea, seborrheic dermatitis, urticaria and eczema


9,10,11, severe sunburn


12 and rosacea


13 have been reported.

Contraindications:

Contraindicated in patients with hypersensitivity or intolerance to liver or pork products.

Warning:

Use with caution in patients suspected of being hypersensitive to liver or with other allergic diatheses.

Precautions:

Drug Interactions:NEXAVIR


® contains tyramine and should not be administered to patients taking MAO inhibitors because hypertensive crisis may occur.


Carcinogenesis, Mutagenesis, Impairment of Fertility:No long-term animal studies have examined the carcinogenic or mutagenic potential of NEXAVIR


®. NEXAVIR


®s effect upon reproductive capacity is similarly unknown.


Pregnancy- Pregnancy Category C:Animal reproduction studies have not been conducted with NEXAVIR


®. It is also not known whether NEXAVIR


® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. NEXAVIR


® should be given to a pregnant woman only if clearly needed.


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 NEXAVIR


® is administered to a nursing woman.

Adverse Reactions:

As with all Injectable medications, local reactions may occur. Local reactions may include pain. rash, stinging, swelling, and erythema.

Drug Abuse And Dependence:

The Information on drug abuse and dependence is limited to uncontrolled data derived from marketing experience. Such experience has revealed no evidence of drug abuse and dependence associated with NEXAVIR


® Injection.

Dosage And Administration:

For the management of skin disorders, the usual dose of NEXAVIR


® is 2 ml administered daily or as indicated. The product is given by intramuscular or subcutaneous injection only.


As with all parenteral drug products, NEXAVIR


® should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

How Supplied:

NEXAVIR


® Injection (liver derivative complex, 25.5 mg/mL) is a sterile, brown solution


20 ml multiple dose vial NDC 10530-319-07


Store at controlled room temperature 15°-30°C (59°-86°F)

Other

Manufactured for: Nexco Pharma, 10072 S. Ocean Drive, Suite 7N, Jensen Beach, Florida, 34957 (34957-2556)


Manufactured By: Maitland Labs, Florida, USA

Other Information

Tel: +1-772-229-2992


Email: nexco@nexco-pharma.com

References:

1. Sutton, R.L :. Liver Diets in Acne Vulgaris and in Furunculosis, Arch. Derm & Syph., 18:887, 1928. See also; Sutton, R.L, and Sutton, Jr, R.L.: Disease of the Skin, C.V. Mosby CO., St. Louis, 1939.


2. Marshall, V.: Further Studies on the Therapy of Acne Vulgaris with Modified Liver Extract. J . Invest. Derm.2:205, 1939.


3. Lichtenstein, M.A. and Stillians. A.W.: Liver Extract In Treatment of Acne Vulgaris in Tuberculosis Patients, Arch. Derm.& Syph.,45:959, 1942.


4. Boreen, C.A.: Boiled Liver In the Treatment of Acne Vulgaris, Minn. Med.,25:276, 1942.


5. Nierman, M.M.: Treatment of Cystic Acne Vulgaris with a Cutaneous Vasoconstrictor (Kutapressin) The Jour. of Ind. State Med. . Ass.n. 45:497,1952.


6. Knox. J.M.: Treatment of Cystic Acne with Kutapressin, U.S.N. News Letter, 20:9, 1952.


7. Lubowe, L.: Modern Treatment of Acne Vulgaris, Clin. Med. 59:8, 1952.


8. Pensky, N. and Goldber, N.: Treatment of Refractory Acne with Fractionated Type of Liver Extract, N.Y. State Jour. of Med. 53:2238, Oct. 1953


9. Burks, J.L, Jr.: The Modern Treatment of Acne Vulgaris, Jour. La. State Med. Soc. 106:92, 1954.


10. Burks,J. W and Knox, J.M.: S-Factor of Liver Extract In Acne Vulgaris, A.M.A. Archives of Derm. & Syphil., 70:508, 1954.


11. Barksdale, E. E.: The Use of S-Factor of Liver Extract (Kutapressin) in Dermatology, South. Med, Jour., 50:1524, 1957.


12. Heywood, H. W.: Use of Kutapressin in the treatment of Severe Sunburn, Clin. Med. 3:8, 1956.


13. Berrock, J.J.: Rosacea, Medical Times, 86:968, 1958

* Please review the disclaimer below.