GONABREED AND ESTROPLAN SYNCHRONIZATION PACK 80 COW- gonadorelin acetate, cloprostenol sodium   
GONABREED AND ESTROPLAN SYNCHRONIZATION PACK 200 COW- gonadorelin acetate, cloprostenol sodium   
Parnell Technologies Pty Ltd

----------

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:

80 Cow Pack -

  • 8 x GONAbreed (20 mL) (20 dose each, or 160 doses total)
  • 8 x estroPLAN (20 mL) (10 doses each, or 80 doses total)

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.

samples dosing regimens

PRINCIPAL DISPLAY PANEL - 80 Cow Pack

GONAbreed (gonadorelin acetate) + estroPLAN (cloprostenol sodium)

SYNCHRONIZATION PACK 80 Cow

GONAbreed (gonadorelin acetate)

Equivalent to 100 mcg gonadoreiln/mL

8 vials of 20 mL

estroPLAN (cloprostenol sodium)

Equivalent to 250 mcg cloprostenol/mL

8 vials of 20 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

80 Cow 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

200 cow pack

GONABREED AND ESTROPLAN SYNCHRONIZATION PACK 80 COW 
gonadorelin acetate, cloprostenol sodium kit
Product Information
Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:68504-003
Packaging
#Item CodePackage Description
1NDC:68504-003-011 in 1 PACKAGE, COMBINATION
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 18 VIAL, MULTI-DOSE 160 mL
Part 28 VIAL, MULTI-DOSE 160 mL
Part 1 of 2
GONABREED 
gonadorelin acetate injection, solution
Product Information
Item Code (Source)NDC:68504-002
Route of AdministrationINTRAMUSCULAR, INTRAVENOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GONADORELIN ACETATE (GONADORELIN) GONADORELIN100 ug  in 1 mL
Packaging
#Item CodePackage Description
1NDC:68504-002-0120 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANADAANADA20054103/31/2013
Part 2 of 2
ESTROPLAN 
cloprostenol sodium injection, solution
Product Information
Item Code (Source)NDC:68504-001
Route of AdministrationINTRAMUSCULARDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOPROSTENOL SODIUM (CLOPROSTENOL) CLOPROSTENOL250 ug  in 1 mL
Packaging
#Item CodePackage Description
1NDC:68504-001-0120 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANADAANADA20031003/01/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANADAANADA20054104/01/2013
GONABREED AND ESTROPLAN SYNCHRONIZATION PACK 200 COW 
gonadorelin acetate, cloprostenol sodium kit
Product Information
Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:68504-004
Packaging
#Item CodePackage Description
1NDC:68504-004-011 in 1 PACKAGE, COMBINATION
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 14 VIAL, MULTI-DOSE 400 mL
Part 24 VIAL, MULTI-DOSE 400 mL
Part 1 of 2
GONABREED 
gonadorelin acetate injection, solution
Product Information
Item Code (Source)NDC:68504-002
Route of AdministrationINTRAMUSCULAR, INTRAVENOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GONADORELIN ACETATE (GONADORELIN) GONADORELIN100 ug  in 1 mL
Packaging
#Item CodePackage Description
1NDC:68504-002-02100 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANADAANADA20054103/31/2013
Part 2 of 2
ESTROPLAN 
cloprostenol sodium injection, solution
Product Information
Item Code (Source)NDC:68504-001
Route of AdministrationINTRAMUSCULARDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOPROSTENOL SODIUM (CLOPROSTENOL) CLOPROSTENOL250 ug  in 1 mL
Packaging
#Item CodePackage Description
1NDC:68504-001-02100 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANADAANADA20031003/01/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANADAANADA20054104/01/2013
Labeler - Parnell Technologies Pty Ltd (742511504)
Registrant - Parnell Technologies Pty Ltd (742511504)

Revised: 04/2013
 
Parnell Technologies Pty Ltd