PLUSET : MAIN FEATURES
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PLUSET : MAIN FEATURES Ramon Calonge Laboratorios Calier S.A. Barcelona - Spain Presentation prepared by Calier and given at AETS Conference August 2004. 2 vials of freeze-dried powder: 500 IU FSH + 500 IU LH each 1 vial of diluent: Normal saline to 20 ml. Background.

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PLUSET : MAIN FEATURES

Ramon Calonge

Laboratorios Calier S.A.

Barcelona - Spain

Presentation prepared by Calier and given at AETS Conference August 2004.


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Background

  • Developed by Serono (Italy)

  • First approval: 1991, in Italy. Later on in USA, Mexico, Argentina, Brazil, New Zealand.

  • 1998: acquired by Laboratorios Calier, S.A. Production plant moved to Barcelona (Spain). Settlement of the industrial extraction and production process.

  • Approval in Colombia, Venezuela, Ecuador.

  • 2003: Approved in 5 EU member states (UK, DE, NL, ES, PT)

  • 2004: Approved in Australia


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Acetonic phase

(2 days)

Extractionphase

(4 days)

FSH

LH

LH

FSH

Extraction Method

Frozen Pituitary Glands

Acetonic powder

Alcoholic phase

(3 days)

Alcoholic powder

Crude FSH / LH

Separationphase

(4 days)


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LH

FSH

FSH

LH

Final product

IU FSH

IU LH

Vial filling

Lyophilisation

Biological analysis

(to confirm activity)

Biological analysis

IU LH

IU FSH


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Biological analysis

  • FSH: Steelman & Pohley method (ovarian weight)

  • LH: Parlow method (Ascorbic Acid depletion)

    • Described by the WHO

    • The only ones accepted by pharmacopoeial monographsto determine FSH and LH potency of therapeutic preparations

    • Measures biologically active hormones

    • No equivalence with other methods (RIA)


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LH content

  • The same proportion of the hMG

  • (human Menopausal Gonadotrophin)

  • LH content is known and constant

  • Proportion in weight is  25:1

  • FSH t ½: 2:30 h

  • LH t ½: 40 min


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Recommended Administration Schedule

in Holstein-Friesian Dairy Cows - 800 I.U.

Day 1 AM

PM

3 ml i.m.

3 ml i.m.

Start treatment between 9thand 12thday

of the cycle, preferably on 11th day

Day 2 AM

PM

2.5 ml i.m.

2.5 ml i.m.

  • 2 AI: Inseminate at 12h and 24h of onset of oestrus

  • 3 AI: Inseminate at 12h, 24hand 36h of onset of oestrus

  • Optional: add a dose of GnRH or hCG at 1st AI to induce a contemporaneous ovulation

  • Flushing at 6-8 days (7 days) of the 1st AI

PGF2

Day 3 AM

PM

1.5 ml i.m.

1.5 ml i.m.

PGF2

Day 4 AM

PM

1 ml i.m.

1 ml i.m.

Onset of oestrus

* 1 ml Pluset: 50 I.U. FSH + 50 I.U. LH


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Recommended Administration Schedulein Spain

in Beef cows - 700 I.U.

Day 1 AM

PM

2.5 ml i.m.

2.5 ml i.m.

Day 2 AM

PM

2 ml i.m.

2 ml i.m.

  • Beef cows: 600-700 I.U.

  • Beef heifers: 500 I.U.

  • Dairy heifers: 500 I.U.

  • Bos Indicus (zebu): 200-300 I.U.

  • Buffalo: 250 I.U.

  • Sheep: 250-350 I.U.

PGF2

Day 3 AM

PM

1.5 ml i.m.

1.5 ml i.m.

PGF2

Day 4 AM

PM

1 ml i.m.

1 ml i.m.

AI

Onset of oestrus

* 1 ml Pluset: 50 I.U. FSH + 50 I.U. LH



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Use of different commercial FSH preparations in the superovulation of high producing Holstein cows

Fuentes, S. and De la Fuente, J.

Proceedings, XXI World Buiatrics Congress.

Punta del Este, Uruguay, 2000

Total dose: 850 IU

Day 1: PRID insertion

Day 9: 175 IU + 175 IU

Day 10: 125 IU + 125 IU

Day 11: 75 IU + 75 IU

PRID removal

PG (AM and PM)

Day 12: 50 IU + 50 IU

Holstein Cows, 5-6 years old

3-4 calvings

Interval calving-SOV treatment: 5.8-6.5 months

Mean milk prod: 27-30 kg/day


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Study of different doses of Pluset for the lactating cow superovulation

Fuentes, S. and De la Fuente, J.

Unpublished data

Holstein Cows, 5 years old

2.5 calvings

Interval calving-SOV : 6 months

Day 1: PRID insertion

Day 11: PRID removal

PG (AM and PM)


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Study of the effect of a similar dose of PLUSET over dairy cows with different parity number

Fuentes, S. and De la Fuente, J.

Unpublished data

Total dose: 850 IU

Day 1: PRID insertion

Day 9: 175 IU + 175 IU

Day 10: 125 IU + 125 IU

Day 11: 75 IU + 75 IU

PRID removal

PG (AM and PM)

Day 12: 50 IU + 50 IU

Holstein Cows

Interval calving-SOV : 4.5-6 months

Group A, First calving. n= 12.

Group B, Second calving. n= 14.

Group C, Third calving. n= 17.

Group D, Fourth calving. n= 14.


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Superovulation with different doses of PLUSET in relation to parturition number in high production dairy cows

Fuentes, S. and De la Fuente, J.

IX Jornadas sobre Producción Animal, ITEA, Zaragoza, abril’01

Day 1: PRID insertion

Day 11: PRID removal

PG (AM and PM)

Group A, 800 IU, one calving. n= 15

Group B, 850 IU, two calving. n= 15

Group C, 1000 IU, three calving. n= 14

Interval calving-SOV :

6 months (3-7 m)


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Superovulation of Holstein-Friesian cows with reduced dose of FSH-p

Bényei B, Barros CWC

Arq. Fac. Vet. UFRGS, Porto Alegre, V. 27, n. 1, 1999 (supl.): p. 203

Control: 1000 IU FSH/4 days (n=99)

Experiment: 600 IU FSH/4 days (n=83)

PG at the 3rd day; AI at 45 and 60h


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Effect of superovulation on performance of bovine embryo donors imported from temperate zone to tropical climate during the first two years of adaptation

Bényei B, Barros CCW

Arq Bras Med vet Zootec Vol 52, n 4, Belo Horizonte Aug 2000

Holstein-Friesian heifers imported pregnant from Hungary to Brazil

In the 2nd year were superovulated with Folltropin or Pluset (600 IU / 4 days)

FSH in decreasing doses for 4 days, PG at 3rd day, AI at 60-72h


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Heifers donors imported from temperate zone to tropical climate during the first two years of adaptation


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Superovulation in cattle: effect of FSH type and methods of administration on follicular growth, ovulatory response and endocrine patterns

Kelly P., Duffy P., Roche J.F. and Boland M.P.Animal Reproduction Science 46 (1997): 1-14

Group SF: (n=23) Single Folltropin. 270 mg NIH-FSH-P1 in a single s.c injection.

Group MF: (n=23) Multiple Folltropin, 270 mg in 4 days

Group SP: (n=22) Single Pluset, 1.000 IU in a single s.c injection

Group MP: (n=22) Multiple Pluset, 1.000 IU in 5 days


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Effect of timing of oestradiol benzoate injection relative to gonadotropin treatment on superovulatory response, and on embryo yield and quality in beef heifers

Yaakub H, Duffy P, O’Callaghan D, Boland MP

Animal Reproduction Science (1998) 52: 191-204

Group I: only CIDR for 9 days

Group II: 5 mg ODB at CIDR insertion

Group III: 5 mg ODB 1.5 days after CIDR insertion

Group IV: 5 mg ODB 3 days after CIDR insertion

Sov started 6.5d after CIDR insertion

3 doses: 400, 600, 800 IU Pluset

in 8 equal i.m injections each 12h

  • RESULTS:

  • No interaction between treatment and dose of Pluset

  • Combination of ODB and CIDR do not improve embryo yield

  • best results achieved with CIDR only


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Dose effect of porcine gonadotropin extract containing FSH and LH on superovulatory response and fertility of Friesian heifers

Mantovani R et al - 12nd Meeting AETE - Lyon, 1996: 168

60 cycling heifers, 13-16 months

Dose in 9 i.m doses, each 12h (4 1/2 days), giving 35%, 25%, 20%, 15% and 5% of the total dose

Results: Optimal response with 500 IU FSH, with no effects on subsequent reprod. Performance

higher dose affects embryo yield and quality, but not fertility


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Beef cows and LH on superovulatory response and fertility of Friesian heifers


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Effects of prepartum lipid supplementation on FSH superstimulation and embryo quality in multiparous beef cows

Bader JF et al

Theriogenology, v 57, n 1, 2002: 760

40 mature cows, prepartum lipid supplement 40 days prior to calving

WSB: whole soybean supplement

GnRH-7 days- GnRH- 7 days- PG: 28 cows responded

Superovulation started days 8-10 cycle (60d postpartum)

600 IU at decreasing doses for 4 days, PG: 96h and 108h after start treatment

27 cows showed oestrus: AI 0, 12 and 24h after onset oestrus


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Evaluation of an estrus synchronization protocol prior to superovulation in beef cows

Kojima FN et al

Theriogenology, v 57, n 1, 2002: 766

24 crossbred non-lactating beef cows

Protocol 7-11 synch (n=11) or control (n=13)

7-11 Synch: MGA for 7 days + PG 7th day + GnRH 11th day

Control synchronised with 2 PG 14 days apart

2 days after GnRH: 600 IU FSH, decreasing doses twice daily, for 4 days

PG: 2 adm. on the last day FSH - 5th Day: PG, AI at 48h and 60h


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Zebu ( superovulation in beef cowsBos indicus)


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Total Doses Recommended in Brazil superovulation in beef cows


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Efficiency of two different hormonal products for superovulation of

Nelore cows

Diniz EG et al

Rev. Bras. Reprod. Anim., v.23, n.3, 1999: 319-321

Comparison of 250 IU Pluset vs. 20 mg NIH Folltropin in Nelore Cows (Bos indicus)

FSH in decreasing doses, in 4 days. PG: 2 doses (AM-PM) of the 3rd day

AI: 12 + 24h post-oestrus


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Infuence of age on the superovulatory response of Nelore donors: preliminary results

Oliveira MAL et al

Rev. Bras. Reprod. Anim., v.26, n.3, 2002: 246 - 248

Comparison of superovulatory response of 100 Nelore donors allocated by age:

GI: 2-5 years; GII: 6-8 years; GIII: 9-12 years; GIV: >12 years

400 IU FSH in decreasing doses, in 4 days. PG: on the 3rd day.

AI: 12 + 24h post-oestrus


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Now available in Australia! donors: preliminary results

Sykes Vet International Pty Ltd

9740 Popes Rd,.

Keysborough Vic 3173

Ph: +61 3 9701 5044

Fax: + 61 3 9701 5134

[email protected]


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