59-11-4, Kadiyala Venkaiah Street Gayatrinagar Vijayawada - 520008
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Sudabreed

Sudabreed

COMPOSITION :

  • Each ml contains
  • Gonadorelin (as gonadorelin acetate) : 100 mcg
  • Benzyl alcohol : as preservative
  • Water for injection, USP : Q. S.

Usage:

  • To treat cystic ovaries in cattle.
  • For use with cloprostenol sodium to synchronize estrous cycles to allow for fixed time artificial insemination (FTAI) in lactating dairy cows and beef cows.

Product Description:

  • SUDAbreed is a sterile solution containing 100 micrograms of gonadorelin (GnRH) as gonadorelin acetate per milliliter suitable for intramuscular or intravenous administration according to the indication.

  • Gonadorelin is a decapeptide composed of the sequence of amino acids -5-oxoPro-His-Trp-Ser-Tyr¬Gly-Leu-Arg-Pro-Gly-NH2 - a molecular weight of 1182.32 and empirical formula C55H75N17013• The acetate salt has a molecular weight of 60.05 and an empirical formula C55H75N17013. C2H402.

  • Gonadorelin is the hypothalamic releasing factor responsible for the release of gonadotropins (e.g., LH, FSH) from the anterior pituitary. Synthetic gonadorelin is physiologically and chemically identical to the endogenous bovine hypothalamic releasing factor.

Hypothalamic-Pituitary in the control of Female reproductive function

Oestrous cycle is regulated by the hypothalamic-pituitary-gonadal axis, which produces hormones. The reproductive axis is composed of the hypothalamus, pituitary, and the ovary. The hypothalamus is a specialized portion of the ventral brain, its primary function is to release gonadotropin hormones (GnRH).
GnRH stimulates the anterior pituitary gland to produce and release FSH (follicular-stimulating hormone) & LH (luteinizing hormone). FSH and LH are transported through systemic blood circulation to the ovaries, where they initiate a series of morphological changes that lead to ovulation and pregnancy if fertilization occurs.
The primary hormones produced by the ovary are estrogen and progesterone. These hormones are transported by the blood stream to "target" tissues to cause a reaction. Estrogen is produced by the follicle, which is located on the surface of ovary. As the follicle grows, more estrogen is produced. As increasing amounts of estrogen are released into the blood stream and travel to the anterior pituitary, it acts in a positive feedback fashion, stimulating pulsatile LH release. It also affects the nervous system of the cow, causing restlessness and most importantly, the willingness to be mounted by other animals. Estrogen causes the uterus to contract, allowing sperm to be transported through the female reproductive tract more efficiently after insemination. Other effects of high estrogen concentrations in the blood include increased blood flow to the genital organs and the production of mucus by glands in the cervix and vagina. These characteristics are all signs of estrus, or sexual receptivity. Progesterone produced by the CL prevents cyclicity by acting on the anterior pituitary in a negative feedback fashion; therefore, decreasing the release of FSH and LH. It prepares the uterus for reception of fertilized ova and subsequent pregnancy. It also helps the cow maintain pregnancy by suppressing uterine contractions and promoting development of the uterine lining.
Last important hormone is prostaglandin F2,(PGF,a) which is secreted by the endometrium of the uterus, it affects structures on the ovary, helping to initiate ovulation by causing the demise of the CL, which results in withdrawal of progesterone's negative feedback mechanism.

Indications & Dosage:

Packs: Multidose vials of 20 ml & 100 ml.

SUDAbreed is indicated for the treatment of ovarian follicular cysts in dairy cattle. Ovarian cysts are non-ovulated follicles with incompleteluteinization which result in nymphomania or irregular estrus. Historically, cystic ovaries have responded to an exogenous source of luteinizing hormone (LH) such as human chorionic gonadotrophin. SUDAbreed initiates release of endogenous LH to cause ovulation and lutenization.

Dosage: 1 ml (100 mcg) of SUDAbreed per cow —Intravenous or intramuscular.

SUDAbreed is indicated for use with cloprostenol sodium to synchronize estrous cycles to allow for fixed time artificial insemination (FTAI) in lactating dairy cows and beef cows.

Dosage: lml (100 mcg) of SUDAbreed per cow- intramuscularly as following:

  • Administer the first SUDAbreed injection (1 ml)
    at Time 0.
  • Administer 500 mcg cloprostenol (as cloprostenol sodium) by intramuscular injection 6 to 8 days after the first SUDAbreed injection.
  • Administer the second SUDAbreed injection (1 ml) 30 to 72 hours after the cloprostenol sodium injection.
  • Perform Fixed Time Artificial Insemination (FTAI) 0 to 24 hours after the second SUDAbreed injection, or inseminate cows on detected estrus using standard herd practices.

Pharmacology & Toxicology:

Endogenous gonadorelin is synthesized and/or released from the hypothalamus during various stages of the bovine estrous cycle following appropriate neurogenic stimuli. It passes via the hypophyseal portal vessels, to the anterior pituitary to effect the release of gonadotropins (e.g. LH, FSH). Synthetic gonadorelin administered intravenously or intramuscularly also causes the release of endogenous LH or FSH from the anterior pituitary.
Gonadorelin acetate has been shown to be safe. The LDso for mice and rats is greater than 60 mg/kg, and for dogs, greater than 600 mcg/kg, respectively. No untoward effects were noted among rats or dogs administered 120 mcg/kg/day or 72 mcg/kg/day intravenously for 15 days. It has no adverse effects on heart rate, blood pressure, or EKG to anaesthetized dogs at 60 mcg/kg. In anesthetized dogs, it did not produce depression of myocardial or system hemodynamics or adversely affect coronary oxygen supply or myocardial oxygen requirements. The intravenous administration of 60 mcg/kg/day of gonadorelin acetate to pregnant rats and rabbits during organogenesis did not cause embryo-toxic or teratogenic effects. The intramuscular administration of 1,000 mcg to normally cycling dairy cattle had no effect on hematology or blood chemistry. Further, gonadorelin acetate does not cause irritation at the site of intramuscular administration in dogs. The dosage administered was 72 mcg/kg/day for seven (7) days.

Target animal safety:

In addition to the target animal safety information presented in the section addressing pharmacology and toxicology, target animal safety of, and injection site reactions to, SUDAbreed when used with cloprostenol sodium were evaluated during the conduct of the effectiveness field studies. The incidence of health abnormalities was not significantly greater in cows administered SUDAbreed than cows administered a placebo injection.

Precautions:

  • Not for use in humans.
  • Keep out of reach of children.
  • Discard remaining product 180 days after first use.
  • Once broached, product may be stored at temperatures up to 25°C (77°F).
  • Keep unopened vials refrigerated: 2°-8°C (36° 46°F).