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D-Clocel

D-Clocel

AGENTE LUTEOLITICO

DRAFT PROSPECTUS
VETERINARY USE
D-CLOCEL
Luteolytic AGENT
10 and 30 ml

Composition:
D-Cloprostenol
(As D-Cloprostenol Sodium 0.079 mg) 0.075 mg
Excipients authorized c.s.p 1 ml

Target species:
Cattle and pigs

Description:
Solution for injection of synthetic analogue of prostaglandin F2? Cloprostenol sodium to female reproductive hormone Bovine and Porcine
D-CLOCEL is a prostaglandin-based right-handed D-cloprostenol, designed to deliver 100% of luteolytic and uterotonic activity without side effects.
The D-cloprostenol (dextrorotatory isomer) has the highest affinity for target receptors in the ovary and uterus.
D-CLOCEL solution is supplied ready for use.
It is highly effective at low doses, demonstrating its high power with other prostaglandins available on the market.
D-CLOCEL is:
1. 100% asset to be 100% right-handed
2. 3.3 times more active than the racemic Cloprostenol
3. Maximum power to be luteolytic and uterotonic synthetic-
4. Maximum affinity for target to be dextrorotatory.
5. No side effects.

Action:
Sex hormone luteolytic agent. Its action gives rise to morphological regression of the corpus luteum (luteolysis), stimulation of uterine smooth muscle relaxing effect on the cervix in cattle and pigs, followed by return of normal estrus and ovulation. Thus, luteolytic effect can be used also for induction of labor in cattle and swine.
It is used to treat reproductive disorders and synchronization of estrus in cows and sows.
By its action on the smooth muscle of the uterus, promoting contractions and increasing uterine tone, gives it properties that are useful for dairy cattle.

Directions for use:
• Cows: induction and synchronization of estrus.
• Treatment of persistent corpus luteum.
• Adjunctive Treatment of chronic endometritis and pyometra.
• Induction to abortion
• Removal of mummified fetuses.
• Synchronization and induction of estrus in cows and heifers. Synchronization of oestrus in donors and recipients in TE programs
• Induction of labor in sows.
• functional disorders of the ovaries.
• Silent Jealousy by anestrus post-service or post-partum. Irregular cycles or anovulatory.
• puerperal diseases: endometritis, pyometra, etc..
• Therapeutic Abortions in the first third of pregnancy.

Dosage, mode and method of administration:
Administered subcutaneously (SC).
The dose to be administered is 2 ml (150 mg) in cattle and 1 ml (75 mg) in pigs.
Cattle: the point of application is in the neck or the back room.
Swine: applied in the neck behind the ear.

Contraindications and Warnings:
• In all animal species to manage acute or chronic respiratory diseases.
• Do not administer to pregnant animals.

Interactions and incompatibilities:
• In those animals which is administering a progestin, we can expect a lower response of this medicine.
• Do not administer to pregnant animals unless you want to induce labor or abortion.

Side effects:
Occasionally it can cause sweating. When used for induction of labor, passengers may cause changes in the behavior of the bristles.

Overdose:
At the recommended dose, the product has a wide safety margin. But the product should be applied under medical advice and veterinary control.

Comment:
• The product is only effective in cases of existence of suitable functional corpus luteum, thereby limiting the treatment to animals cyclical and not cases where there atrophic ovaries, so there will be a gynecological examination prior to treatment.
• In case of expulsion of mummified fetuses may be necessary obstetric manipulation to remove the fetus.
• It is unlikely that its administration in the first 4 days after ovulation results in luteolysis.

Use Restrictions:
Among the last treatment and slaughter for human consumption must take 24 hours.
Between the last treatment and the fate of milk for human consumption or industrialization must pass four hours.

Special security precautions taken by the person administering or handling the product:
• Asthma and pregnant women should be especially careful with handling the product, because they may cause bronchospasm or abortions.
• Avoid direct contact with the skin of the user. In case of accidental spills on skin, immediately wash the affected areas with water.

Form of presentation:
Solution for injection in amber glass bottles containing 10 and 30 ml.

  USD14.23
COD: #0068-0003
Categories:  Hormones

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AGENTE LUTEOLITICO

DRAFT PROSPECTUS
VETERINARY USE
D-CLOCEL
Luteolytic AGENT
10 and 30 ml

Composition:
D-Cloprostenol
(As D-Cloprostenol Sodium 0.079 mg) 0.075 mg
Excipients authorized c.s.p 1 ml

Target species:
Cattle and pigs

Description:
Solution for injection of synthetic analogue of prostaglandin F2? Cloprostenol sodium to female reproductive hormone Bovine and Porcine
D-CLOCEL is a prostaglandin-based right-handed D-cloprostenol, designed to deliver 100% of luteolytic and uterotonic activity without side effects.
The D-cloprostenol (dextrorotatory isomer) has the highest affinity for target receptors in the ovary and uterus.
D-CLOCEL solution is supplied ready for use.
It is highly effective at low doses, demonstrating its high power with other prostaglandins available on the market.
D-CLOCEL is:
1. 100% asset to be 100% right-handed
2. 3.3 times more active than the racemic Cloprostenol
3. Maximum power to be luteolytic and uterotonic synthetic-
4. Maximum affinity for target to be dextrorotatory.
5. No side effects.

Action:
Sex hormone luteolytic agent. Its action gives rise to morphological regression of the corpus luteum (luteolysis), stimulation of uterine smooth muscle relaxing effect on the cervix in cattle and pigs, followed by return of normal estrus and ovulation. Thus, luteolytic effect can be used also for induction of labor in cattle and swine.
It is used to treat reproductive disorders and synchronization of estrus in cows and sows.
By its action on the smooth muscle of the uterus, promoting contractions and increasing uterine tone, gives it properties that are useful for dairy cattle.

Directions for use:
• Cows: induction and synchronization of estrus.
• Treatment of persistent corpus luteum.
• Adjunctive Treatment of chronic endometritis and pyometra.
• Induction to abortion
• Removal of mummified fetuses.
• Synchronization and induction of estrus in cows and heifers. Synchronization of oestrus in donors and recipients in TE programs
• Induction of labor in sows.
• functional disorders of the ovaries.
• Silent Jealousy by anestrus post-service or post-partum. Irregular cycles or anovulatory.
• puerperal diseases: endometritis, pyometra, etc..
• Therapeutic Abortions in the first third of pregnancy.

Dosage, mode and method of administration:
Administered subcutaneously (SC).
The dose to be administered is 2 ml (150 mg) in cattle and 1 ml (75 mg) in pigs.
Cattle: the point of application is in the neck or the back room.
Swine: applied in the neck behind the ear.

Contraindications and Warnings:
• In all animal species to manage acute or chronic respiratory diseases.
• Do not administer to pregnant animals.

Interactions and incompatibilities:
• In those animals which is administering a progestin, we can expect a lower response of this medicine.
• Do not administer to pregnant animals unless you want to induce labor or abortion.

Side effects:
Occasionally it can cause sweating. When used for induction of labor, passengers may cause changes in the behavior of the bristles.

Overdose:
At the recommended dose, the product has a wide safety margin. But the product should be applied under medical advice and veterinary control.

Comment:
• The product is only effective in cases of existence of suitable functional corpus luteum, thereby limiting the treatment to animals cyclical and not cases where there atrophic ovaries, so there will be a gynecological examination prior to treatment.
• In case of expulsion of mummified fetuses may be necessary obstetric manipulation to remove the fetus.
• It is unlikely that its administration in the first 4 days after ovulation results in luteolysis.

Use Restrictions:
Among the last treatment and slaughter for human consumption must take 24 hours.
Between the last treatment and the fate of milk for human consumption or industrialization must pass four hours.

Special security precautions taken by the person administering or handling the product:
• Asthma and pregnant women should be especially careful with handling the product, because they may cause bronchospasm or abortions.
• Avoid direct contact with the skin of the user. In case of accidental spills on skin, immediately wash the affected areas with water.

Form of presentation:
Solution for injection in amber glass bottles containing 10 and 30 ml.

Luteolytic AGENT
Si
30
No
Si
Argentine