Animal NDC 54771-8112-2 Re-sorb

Sodium Chloride, Potassium Phosphate, Unspecified Form, Sodium Citrate, Potassium Citrate, Glycine, And Dextrose

Animal Product Information

Field Name Field Value
Animal NDC Code 54771-8112-2
Proprietary Name Re-sorb What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Sodium Chloride, Potassium Phosphate, Unspecified Form, Sodium Citrate, Potassium Citrate, Glycine, And Dextrose What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Zoetis Inc.
Product Type Otc Animal Drug
Usage Information
    Re-Sorb (glucose, glycine, and electrolytes for oral solution) is a readily absorbed source of fluids and electrolytes. It is a convenient and effective means of increasing absorption of water, energy sources, and electrolytes. Re-Sorb is indicated for use in the control of dehydration associated with diarrhea (scours) in calves, including veal calves. Re-Sorb may be used by the livestock owner as an early treatment at the first signs of scouring. It may also be used as follow-up treatment for the dehydrated calf following intravenous fluid therapy.Re-Sorb, because of its ready source of fluid and electrolytes, makes it an ideal first feed (upon arrival) for newly purchased or severely stressed calves.
Active Ingredient(s)
  • Potassium Citrate
  • Glycine
  • Sodium Chloride
  • Sodium Citrate
  • Potassium Phosphate
  • Dextrose
Marketing Category NADA - NEW ANIMAL DRUG APPLICATION 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.
FDA Application Number NADA125961 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Re-sorb Animal 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.

Table of Contents



Description



The 3 main causes of calf scours and resulting dehydration are bacteria (E. coli and Salmonella, etc.), viruses, and nutritional factors. In all cases, there is a loss of water and electrolytes due to the scours, which can lead to severe dehydration and death. Generally, whatever the cause of the scours, dehydration is the main cause of death. When fecal loss of water exceeds the water intake, dehydration occurs. This can be corrected with administration of either oral or intravenous fluids. In the severely dehydrated calf, intravenous administration is the route of choice.

Oral rehydration is of particular value as it permits the livestock owner to start rehydration therapy at the initial signs of scours which, in many cases, will reduce the severity of the condition. Re-Sorb (glucose, glycine, and electrolytes for oral solution) also provides the owner with a practical method of following up intravenous therapy.

Re-Sorb formula contains the following ingredients: sodium chloride 8.82 grams, potassium phosphate 4.2 grams, citric acid, anhydrous 0.5 grams, potassium citrate 0.12 grams, aminoacetic acid (glycine) 6.36 grams and glucose (dextrose) 44 grams. Osmolarity of the reconstituted solution is approximately 315 m0sm/kg. The pH of the reconstituted solution is approximately 4.3.


Action



Oral glucose/glycine compounds have been used with excellent success to treat dehydration accompanying human cholera for many years.1–3 The rationale for oral rehydration therapy is based upon the active absorption of glucose and glycine when given orally to scouring animals. Their absorption is linked to the simultaneous absorption of sodium and water. This principle has been verified in scouring animals.4

E. coli produces scours by secreting toxins in the small intestine. These toxins, while causing profuse secretion of water and electrolytes, have no effect on glucose/glycine absorption in the calf.5 When Re-Sorb is administered, the glucose/glycine along with the water and sodium are absorbed resulting in a net gain in water thereby correcting the dehydration.

In diarrhea caused by viruses, the disease process causes a flattening of the intestinal mucosa which reduces digestion and absorption of milk. The undigested milk passes into the colon where bacterial fermentation results in additional diarrhea.6 The replacement of milk with Re-Sorb for 2 days followed by a gradual re-introduction of milk mixed with Re-Sorb, provides an opportunity for the gastrointestinal mucosa to rest.

Since Re-Sorb is readily absorbed, it provides the livestock owner with an ideal first feed for the stressed or newly purchased calf. It is widely believed that it is often beneficial to starve or only provide half of the initial feeding of milk to newly purchased calves to reduce stress on the gastrointestinal system. Re-Sorb may be given as the initial feeding following by a 50:50 mixture of Re-Sorb and milk at the second feeding to reduce stress on the gastrointestinal tract.


Indications And Usage



Re-Sorb (glucose, glycine, and electrolytes for oral solution) is a readily absorbed source of fluids and electrolytes. It is a convenient and effective means of increasing absorption of water, energy sources, and electrolytes. Re-Sorb is indicated for use in the control of dehydration associated with diarrhea (scours) in calves, including veal calves. Re-Sorb may be used by the livestock owner as an early treatment at the first signs of scouring. It may also be used as follow-up treatment for the dehydrated calf following intravenous fluid therapy.

Re-Sorb, because of its ready source of fluid and electrolytes, makes it an ideal first feed (upon arrival) for newly purchased or severely stressed calves.


Warning



For use in calves only.

Not for Human Use


Precautions



Re-Sorb should not be used in animals with severe dehydration (down, comatose, or in a state of shock). Such animals need intravenous fluids since oral therapy in these cases is too slow. A veterinarian should be consulted in such severely scouring calves or in cases requiring antibacterial therapy.

Antibacterial therapy is often indicated in bacterial scours due to E. coli and/or Salmonella. Re-Sorb does not contain antibacterial agents.

Adequate colostrum intake during the first 12 hours is essential for healthy, vigorous calves.

Re-Sorb is not nutritionally complete if administered by itself for long periods of time. It should not be administered beyond the recommended treatment period without the addition of milk or milk replacer.


Mixing Directions



Add the contents of 1 packet (both sides) to 2 quarts of warm water. Stir until dissolved.


Scouring Calves



Feed 2 quarts of Re-Sorb solution made up as directed, twice daily for 2 days (4 feedings). No milk or milk replacer should be fed during this period. For the next 4 feedings (days 3 and 4), use 1 quart of Re-Sorb solution mixed together with 1 quart of milk or milk replacer. Thereafter, feed as normal.


Newly Purchased Calves



Feed 2 quarts of Re-Sorb solution made up as directed instead of milk as the first feed upon arrival. For the next scheduled feeding, use 1 quart of Re-Sorb solution mixed together with 1 quart of milk or milk replacer. Thereafter, feed as normal.


How Supplied



Re-Sorb is supplied in boxes containing 12 packets (double-sided) and in buckets containing 72 packets (double-sided).


Storage



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


References



  • Nalin DR: GUT 11:768–772, 1970.
  • Pierce NF and Hirshhorn N: WHO Chron 31:87–93, 1977.
  • J Hopkins Med J 132:197–205, 1973.
  • Bywater R: AJVR 38:1983, 1977.
  • Bywater R: J Comp Path 80:565, 1970.
  • Halpin CS and Caple IW: Aust Vet J 52:438, 1976.

Principal Display Panel - 12 Packet Carton





Principal Display Panel - 72 Packet Pail Label





* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.