GONABREED and ESTROPLAN SYNCHRONIZATION PACK description, usages, side effects, indications, overdosage, supplying and lots more!

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GONABREED and ESTROPLAN SYNCHRONIZATION PACK

Parnell Technologies Pty Ltd
Parnell Technologies Pty Ltd

GONAbreed & estroPLAN Synchronization Pack


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

GONAbreed (gonadorelin acetate) + estroPLAN (cloprostenol sodium)

GONAbreed (gonadorelin acetate)

Equivalent to 100 mcg gonadoreiln/mL

estroPLAN (cloprostenol sodium)

Equivalent to 250 mcg cloprostenol/mL

CAUTION: Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.

Indications for Use: GONAbreed 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 AND ADMINISTRATION: See individual package inserts for complete indication and dosage information.

Not all indications listed on the individual package inserts require the use of both GONAbreed and estroPLAN.

GONAbreed 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.

The recommended intramuscular dosage of GONAbreed is 100 mcg (1 mL) per cow, used in reproductive synchrony programs similar to the following:

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

See inside of carton flap for examples of more specific dosing regimens.

PRECAUTIONS: FOR ANIMAL USE ONLY.

NOT FOR HUMAN USE.

KEEP OUT OF REACH OF CHILDREN.

Women of child-bearing age, asthmatics, and persons with bronchial and other respiratory problems should exercise extreme caution when handling this product. In the early stages women may be unaware of their pregnancies.

estroPLAN® is readily absorbed through the skin and may cause abortion and/or bronchospasms: direct contact with the skin should therefore be avoided. Accidental spillage on the skin should be washed off immediately with soap and water.

Each mL of GONAbreed contains: 100 mcg gonadorelin as gonadorelin acetate, 10 mg benzyl alcohol, 7.47 mg sodium chloride, 8.3 mg sodium phosphate monobasic, 4.8 mg sodium phosphate dibasic, and water for injection, USP, q.s. pH adjusted with  hydrochloric acid or sodium hydroxide.

Each mL of estroPLAN contains cloprostenol sodium (equivalent to 250 mcg of cloprostenol) 263 mcg, chlorocresol 1.0 mg, citric acid anhydrous 0.66 mg, sodium citrate 5.03 mg, sodium chloride 6.76 mg. pH adjusted with sodium hydroxide or citric acid.

STORAGE:

KEEP REFRIGERATED: 2° - 8°C (36° - 46°F).

PROTECT FROM LIGHT.

STORE IN CARTON.

NET CONTENTS:

200 Cow Pack -

  • 4 x GONAbreed (100 mL) (100 dose each, or 400 doses total)
  • 4 x estroPLAN (100 mL) (50 doses each, or 200 doses total)

Manufactured by:  PARNELL TECHNOLOGIES PTY. LTD.

 4/476 Gardeners Road

 Alexandria NSW 2015 Australia

Owner of the trademark GONAbreed and estroPLAN

Distributed by: PARNELL U.S. 1, Inc.

9401 Indian Creek Parkway, Suite 1170

Overland Park, KS 66210

ANADA 200-541, Approved by FDA

PARNELL

living SCIENCE

Carton flap with examples of more specific dosing regimens.

GONABREED and ESTROPLAN SYNCHRONIZATION PACK

PRINCIPAL DISPLAY PANEL - 200 Cow Pack

GONAbreed (gonadorelin acetate) + estroPLAN (cloprostenol sodium)

SYNCHRONIZATION PACK 200 Cow

GONAbreed (gonadorelin acetate)

Equivalent to 100 mcg gonadoreiln/mL

4 vials of 100 mL

estroPLAN (cloprostenol sodium)

Equivalent to 250 mcg cloprostenol/mL

4 vials of 100 mL

CAUTION: Federal (U.S.A.) law restricts this drug to use by, or on the order of, a licensed veterinarian.

Indications for Use: GONAbreed 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.

PARNELL

living SCIENCE

GONABREED and ESTROPLAN SYNCHRONIZATION PACK

GONABREED and ESTROPLAN SYNCHRONIZATION PACK

gonadorelin acetate, cloprostenol sodium KIT

Product Information

Product Type Prescription animal drug label Item Code (Source) NDC:68504-003
Route of Administration DEA Schedule

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68504-003-02 1 in 1 PACKAGE, COMBINATION

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200541 2013-04-01


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