P.G. 600

VETERINARY MEDICINE

S4 P.G. 600 Monodose (Lyophilised powder for solution for injection)

S4 P.G. 600 5-Dose (Lyophilised powder for solution for injection)

COMPOSITION

Each reconstituted 5 mℓ contains:

P.G. 600 Monodose Chorionic gonadotrophin 200 i.u.

                                   Serum gonadotrophin*     400 i.u.

P.G. 600 5-Dose Chorionic gonadotrophin 200 i.u.

                                    Serum gonadotrophin*     400 i.u.

*Equine serum grade
Excipients for freeze-dried powder: Mannitol.
Excipients for solvent: Disodium phosphate dihydrate, sodium dihydrogen phosphate dehydrate and water for injection.

PHARMACOLOGICAL CLASSIFICATION

C.22.6 Female sex hormones

PHARMACOLOGICAL ACTION

P.G. 600 combines the two most important hormones playing a role in the development of follicles and their ovulation viz. FSH (follicle stimulating hormone) & LH (luteinising hormone). The combination of hormones promotes the development of a fertile estrus cycle in the pig by stimulating the development of follicles and promoting ovulation and the formation of corpora lutea.

INDICATIONS

The combination of gonadotrophins in P.G. 600 has been shown to be highly effective for the promotion of a fertile estrus cycle in the pig.
Gilts: Administration of a single dose of P.G. 600 to gilts over the age of 5 months will normally result in a fertile estrus within 5 days.
Sows post weaning: To promote early post-partum estrus (particularly where early weaning is practiced), it is recommended that a single injection of P.G. 600 be given within 48 hours of weaning.
Barren sows: Cases of sub estrus or anestrus due to hormonal imbalance (often associated with previous debility or stress) may respond favourably to a single dose of P.G. 600 exhibiting normal heat within 5 days of injection.

CONTRA-INDICATIONS

Animals known to be hypersensitive to human chorionic gonadotrophin, pregnant mare serum gonadotrophin and any of its excipients.

WARNINGS 

Withdrawal period: None.

DOSAGE AND DIRECTIONS FOR USE 

For subcutaneous/intramuscular injection.
Inject 1 dose behind the ear:

	Indications	Time of treatment
Sows	Cycle starter	0 to 2 days post weaning.
	Increasing litter size/Sub fertility	0 to 2 days post weaning.
	Anestrus/sub estrus	Approx. 10th day post weaning.
	Pregnancy diagnosis	Within 80 days post weaning or A.I. (artificial insemination).
Gilts	Anestrus/sub estrus	At the age of 8 to10 months.
	Estrus induction in prepuberal gilts	At the age of 5½ to 6½ months and/or a body mass of85 to 100 kg (Gilts may be inseminated at the 1st estrus following treatment. If insemination is delayed till the 2nd estrus following treatment, a larger litter may be expected).
	Pregnancy diagnosis	Within 80 days post service or A.I.

Note: Synchronisation of estrus: The use of P.G. 600 for all indications mentioned induces estrus 3 to 6 days post treatment. Dissolve the lyophilised substance and inject the contents of a single dose vial (5 mℓ) subcutaneously behind the ear.

Preparation of the Solution 5-Dose vial

With a syringe a few mℓ of the solvent are transferred to the vial with the freeze-dried substance.  Shake until dissolved. Transfer this solution to the solvent vial and mix thoroughly.

SIDE EFFECTS AND SPECIAL PRECAUTIONS

Individual anaphylactoid reactions may occur following administration.

KNOWN SIGNS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT

In case of anaphylactoid reactions 2 to 3 mℓ adrenaline 1:1 000 should be given intramuscularly.

IDENTIFICATION

P.G. 600 is a white freeze-dried cake or powder packed in a clear glass vial. The solvent is a clear aqueous solution in a clear glass vial.

PRESENTATION

P.G. 600 Monodose

Carton containing 5 x 5 mℓ colourless, Type l glass vials containing freeze dried cake, sealed with brown halogenated butyl rubber stoppers held in place with silver aluminium crimp caps.
Carton containing 5 x 5 mℓ colourless, Type l glass vials of solvent for reconstitution, sealed with grey halogenated butyl rubber stoppers held in place with red aluminium crimp caps. 
Package insert included.

P.G. 600 5-Dose

A carton containing 1 x 10 mℓ colourless, Type l glass vial containing freeze dried cake, sealed with brown halogenated butyl rubber stoppers held in place with silver aluminium crimp caps.
Carton containing 1 x 30 mℓ colourless, Type ll glass vial containing 25 mℓ of solvent for reconstitution, sealed with grey halogenated butyl rubber stoppers held in place with red aluminium crimp caps.
Package insert included.

STORAGE 

Store between 2 °C and 8 °C. Protect from light.
After reconstitution, the product may be stored between 2 °C and 8 °C for no longer than 24 hours.  
Do not use after the expiry date which is stated on the vial.
KEEP OUT OF REACH OF CHILDREN AND UNINFORMED PERSONS.

REGISTRATION NUMBER

P.G. 600 Monodose: 83/22.6/771 (Act 101/1965)
P.G. 600 5-Dose: 83/22.6/772 (Act 101/1965)

REGISTRATION HOLDER

Intervet South Africa (Pty) Ltd.
20 Spartan Road, Spartan 
1619, RSA
Tel: +27 (0) 11 923 9300
Fax: +27 (0) 11 392 3158
www.msd-animal-health.co.za

MANUFACTURER
Intervet International B.V.,
Wim de Körverstraat 35,
5831 AN Boxmeer, The Netherlands
and
Intervet International GmbH,
Feldstrasse 1a,
85716 Unterschleissheim, Germany

DATE OF NOTIFICATION OF APPROVAL OF THIS PACKAGE INSERT

17 March 2020

VETERINêRE MEDISYNE

S4 P.G. 600 Monodose (Gevriesdroogde poeier vir oplossing vir inspuiting)

S4 P.G. 600 5-Dose (Gevriesdroogde poeier vir oplossing vir inspuiting)

SAMESTELLING

Elke 5 mℓ aangemaakte oplossing bevat:

P.G. 600 Monodose Chorioniese gonadotrofien 200 i.u.

                                    Serum gonadotrofien*       400 i.u.

P.G. 600 5-Dose Chorioniese gonadotrofien 200 i.u.

                                    Serum gonadotrofien*       400 i.u.

* Serum perde graad
Hulpmiddel vir gevriesdroogde poeier: Mannitol.
Hulpmiddels vir oplosmiddel: Dinatriumfosfaatdihidraat, dehidreerde natriumdihidrogeenfosfaat en water vir inspuiting.

FARMAKOLOGIESE KLASSIFIKASIE

C.22.6 Vroulike geslagshormone

FARMAKOLOGIESE WERKING

P.G. 600 kombineer die twee belangrikste hormone in die ontwikkeling van follikels en hulle ovulasie wat ‘n rol speel nl. FSH (follikelstimulerende hormoon) en LH (luteïniserende hormoon). Die kombinasie van hormone bevorder die ontwikkeling van ‘n vrugbare estrus siklus by die vark deur die ontwikkeling van follikels te stimuleer, ovulasie te promoveer en die vorming van corpora lutea te bevorder.

INDIKASIES

Daar is bevind dat die kombinasie van gonadotrofien in P.G. 600 hoogs effektief is vir die bevordering van ‘n vrugbare estrus siklus in die vark.|
Jong sôe: Toediening van ‘n enkele dosis P.G. 600 aan jong sôe ouer as 5 maande, sal gewoonlik tot ‘n vrugbare estrus binne 5 dae lei.
Sôe na speening: Om vroeë post-partum estrus te bevorder (veral waar vroeg gespeen word), word aanbeveel dat ‘n enkele inspuiting van P.G. 600 gegee word binne 48 uur na gespeen is.
Onvrugbare sôe: Gevalle van subestrus of anestrus wat te wyte is aan ‘n hormoonwanbalans (dikwels met vorige swakheid of spanning geassosieer) mag gunstig reageer op ‘n enkele dosis P.G. 600, en bydrae tot ‘n normale proses van op hitte gaan binne 5 dae vanaf inspuiting.

KONTRA-INDIKASIES

Diere bekend vir hipersensitiwiteit teenoor chorioniese gonadotrofien, serum gonadotrofien en enige van die hulpstowwe in die produk.

WAARSKUWINGS 

Onttrekkingsperiode: geen.

DOSIS EN GEBRUIKSAANWYSINGS

Vir onderhuidse/binnespierse inspuiting. 
Spuit 1 dosis agter die oor:

	Indikasies	Behandelingstydperk
Sôe	Begin van siklus	0 tot 2 dae na speening.
	Vergroting van werpselgrootte/ ondervrugbaarheid.	0 tot 2 dae na speening.
	Anestrus/subestrus	Ongeveer die 10de dag na speening.
	Dragtigheidsdiagnose	Binne 80 dae na speening of K.I. (kunsmatige inseminasie).
Jong sôe	Anestrus/subestrus	Op die ouderdom van tussen 8 en 10 maande.
	Estrus induksie in puberteitsjare van die jong sôe.	Op die ouderdom van 5½ tot 6½ maande en/of liggaamsmassa tussen 85 en 100 kg (jong estrus na behandeling. Jong sôe kan geïnsemineer word met die 1ste estrus na behandeling. Indien inseminasie na die behandeling vertraag word tot na die 2de estrus na behandeling, kan ‘n groter werpsel verwag word.
	Dragtigheidsdiagnose	Binne 80 dae na dekking of K.I.

Nota: Sinkronisasie van oestrus: Die gebruik van P.G. 600 vir al die indikasies genoem, bring estrus 
3 tot 6 dae na behandeling aan. Los die gevriesdroogde poeier op en spuit die inhoud van ‘n enkeldosisflessie (5 mℓ) onderhuids agter die oor in.

Voorbereiding van die 5-Dose flessie oplossing

Met die spuit word ‘n paar mℓ van die oplosmiddel in die flessie met die gevriesdroogde prop daarin, oorgeplaas. Skud totdat dit opgelos is. Plaas hierdie oplossing oor in die oplosmiddelflessie en meng deeglik.

NEWE-EFFEKTE EN SPESIALE VOORSORGMAATREëLS 

Individuele anafilaktiese reaksies mag volg na toediening.

BEKENDE SIMPTOME VAN OORDOSERING EN BESONDERHEDE VAN BEHANDELING PER SPESIE 

In die geval van anafilaktiese reaksies, moet 2 tot 3 mℓ adrenalien (1:1 000) binnespiers toegedien word.

IDENTIFIKASIE

P.G. 600 is ‘n wit gevriesdroogde prop of poeier in ‘n deursigtige glasflessie. Die oplosmiddel is ‘n helder, kleurlose oplossing in ‘n deursigtige glasflessie.

AANBIEDING

P.G. 600 Monodose

Kartonhouer wat 5 x 5 mℓ kleurlose, Tipe l glasflessies met gevriesdroogde prop bevat, geseël met bruin gehalogeneerde butiel rubberstoppers wat in plek gehou word met silwer aluminiumdoppies. 
Kartonhouer wat 5 x 5 mℓ kleurlose, Tipe l glasflessies met oplosmiddel vir hersamestelling bevat, geseël met grys gehalogeneerde butiel rubberstoppers wat in plek gehou word met rooi aluminiumdoppies.
Voubiljet is ingesluit.

P.G. 600 5-Dose

Kartonhouer wat 1 x 10 mℓ kleurlose, Tipe 1 glasflessie met gevriesdroogde prop bevat, geseël met bruin gehalogeneerde butiel rubberstoppers wat in plek gehou word met goue aluminiumdoppies.
Kartonhouer wat 1 x 30 mℓ kleurlose, Tipe ll glasflessie met 25 mℓ oplosmiddel bevat vir hersamestelling, geseël met grys gehalogeneerde butiel rubberstoppers wat in plek gehou word met rooi aluminiumdoppies. 
Voubiljet is ingesluit.

BERGING

Berg tussen 2 °C en 8 °C. Beskerm teen lig.
Na hersamestelling mag die produk nie vir langer as 24 ure gebêre word tussen 2 °C en 8 °C nie. 
Moenie gebruik na die verval datum wat op die flessie aangebring is nie.
HOU BUITE BEREIK VAN KINDERS EN ONINGELIGTE PERSONE.

REGISTRASIENOMMER

P.G. 600 Monodose: 83/22.6/771 (Wet 101/1965)
P.G. 600 5-Dose: 83/22.6/772 (Wet 101/1965)

REGISTRASIEHOUER

Intervet South Africa (Pty) Ltd.
Spartanweg 20, Spartan
1619, RSA
Tel: +27 (0) 11 329 9300
Faks: +27 (0) 11 392 3158
www.msd-animal-health.co.za

VERVAARDIGER

Intervet International B.V.,
Wim de Körverstraat 35,
5831 AN Boxmeer, The Netherlands
en
Intervet International GmbH,
Feldstrasse 1a,
85716 Unterschleissheim, Germany

DATUM VAN PUBLIKASIE VAN HIERDIE VOUBILJET

17 Maart 2020