Each ml contains

Active ingredient
d-cloprostenol 0.075 mg

Excipients
Ethanol 0.675 mg
Chlorocresol 1.000 mg

3.
Pharmaceutical form

Solution for injection.


4.
Clinical particulars

4.1 Target species

Cows and sows.


4.2 Indications for use, specifying the target species

COWS :

Indications for reproduction
synchronization or induction of oestrus. Induction of parturition

Therapeutic indications:
ovarian dysfunction (persistent corpus luteum, luteal cyst), interruption of pregnancy including foetal mummification, endometritis/pyometra, delayed uterine involution.

SOWS
Indications for reproduction: induction of parturition.

4.3 Contraindications

Do not administer to pregnant animals, unless it is desirable to induce parturition or interruption of pregnancy.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

i) Special precautions for use in animals

As with parenteral administration of any substance, basic antiseptic rules should be observed.
The injection site must be thoroughly cleaned and disinfected in order to reduce the risk of infection with anaerobic bacteria.

ii) Special precautions to be taken by the person administering the medicinal products to animals

Prostaglandins of the F2a type can be absorbed through the skin and may cause bronchospasm or miscarriage.
Care should be taken when handling the product to AVOID SELF-INJECTION OR SKIN CONTACT.
Women of child-bearing age, asthmatics and people with bronchial or other respiratory problems, should avoid contact with, or wear disposable plastic gloves when administering the product.
Should shortness of breath result from accidental inhalation or injection, seek urgent medical advice and show the doctor this warning.
Accidental spillage on the skin should be washed off immediately with soap and water.


iii) Other precautions

4.6 Adverses reactions (frequency and seriousness)

Occurrence of anaerobic infection is likely if anaerobic bacteria penetrate the tissue of the injection site. This applies especially to intramuscular injection and in particular to cows. Typcal local reactions due to anaerobic infection are swelling and crepitus at the injection site.

4.7 Use during pregnancy, lactation or lay

Avoid treating pregnant animals unless it is desirable to induce parturition or therapeutic interruption of pregnancy.



4.8 Interaction with other medicinal products and other forms of interaction

Do not administer the treatment together with non-steroidal anti-inflammatory drugs since they inhibit endogenous prostaglandin synthesis.



4.9 Amount(s) to be administered and administration route

COWS
Administer 2 ml of DALMAZIN, equivalent to 150 micrograms of d-cloprostenol/animal by intramuscular route. Repeat after 11 days for the synchronisation of oestrus.
The dose of 2 ml equivalent to 150 micrograms of d-cloprostenol/animal by intramuscular route can be repeated for the induction of oestrus and for the treatment of ovarian dysfunction, endometritis/pyometra, delayed uterine involution.
In particular:
Induction of oestrus (also in cows showing weak or silent heat): administer DALMAZIN after having established the presence of a corpus luteum (6-18th day of the cycle); heat usually appears within 48-60 hours. Proceed, therefore, with insemination 72-96 hours after injection. If oestrus is not evident, administration of the product needs to be repeated 11 days after the first injection.
Synchronisation of oestrus: administer DALMAZIN twice, with an interval of 11 days between each dose. Proceed therefore with two artificial inseminations at intervals of 72 and 96 hours from the second injection.
Induction of parturition: administer DALMAZIN after 270 days of pregnancy. Birth usually results within 30-60 hours of treatment.
Mummified foetus: Expulsion of the foetus is observed within 3-4 days after administration of DALMAZIN.
Interruption of pregnancy: administer DALMAZIN in the first half of pregnancy.
Ovarian dysfunction (persistent corpus luteum, luteal cysts): administer DALMAZIN, then proceed to inseminate at the first oestrus after injection. If oestrus is not evident, conduct a further gynaecological examination, and repeat the injection 11 days after the first administration. Insemination must always be carried out 72-96 hours after injection.
Endometritis, pyometra: administer DALMAZIN. If necessary repeat the treatment after 10-11 days.
Delayed uterine involution: administer DALMAZIN and, if considered necessary, carry out one or two successive treatments at 24 hour intervals.
SOWS
Administer 1 ml of DALMAZIN, equivalent to 75 micrograms of d-cloprostenol/animal, by intramuscular route, not earlier than 112 days of pregnancy. Repeat after 6 hours. Alternatively, 20 hours after the initial dose of DALMAZIN, a myometrial stimulant (oxytocin or carazolol) may be administered.
Following the protocol of the double administration, approximately 70-80% of the animals will give birth during the interval between 20 and 30 hours after the first administration.
As with every prostaglandin-based product, injection in contaminated skin areas is to be avoided in order to reduce the risk of infection with anaerobic bacteria.
The injection site must be thoroughly cleaned and disinfected before administration.



4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

At 10 times the therapeutic dose, no adverse reactions were reported.
As no specific antidote has been identified, in the case of overdose, symptomatic therapy is advisable



4.11 Withdrawal periods

Milk
Meat and offal:


0 day
cattle
0 day


swine
1 day

5.
Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group of d-cloprostenol: prostaglandins
ATCVet Code: QG02AD90

DALMAZIN is a sterile aqueous solution containing 75 micrograms/ml of dextrorotatory cloprostenol, a synthetic analogue of the prostaglandin F2a.
d-cloprostenol, the dextrorotatory enantiomer, constitutes the biologically active component of the racemic cloprostenol molecule and results in an approximate 3.5-fold increase in activity.
Administered in the luteal phase of the oestrus cycle, d-cloprostenol induces functional and morphological regression of the corpus luteum (luteolysis) resulting in a sharp fall in progesterone levels. The increased release of the follicle stimulating hormone (FSH), induces the follicular maturation followed by signs of oestrus and by ovulation.

5.2 Pharmacokinetic particulars

Pharmacokinetic studies demonstrate a rapid absorption of d-cloprostenol. The peak blood level is reached a few minutes following intramuscular administration, as well as a rapid diffusion to the ovaries and uterus, the organs in which the maximum concentration is reached 10-20 minutes after administration.
Following intramuscular administration of 150 micrograms of d-cloprostenol in the cow, the peak plasma level (Cmax) of 1.4 micrograms/l is reached after approximately 90 minutes, while the elimination half life (t½b) is in the order of 1 hour 37 minutes. In sows, a Cmax of approximately 2 micrograms/l is observed between 30 and 80 minutes following administration of 75 micrograms d-cloprostenol, with an elimination half life in the order of 3 hours 10 minutes.

Environnmental properties

6.Pharmaceutical particulars

6.1 List of excipients

6.2 Incompatibilities

None known.


6.3 Shelf-life

Shelf-life: 3 years.
Use the product within 28 days after opening.

6.4 Special precautions for storage.

Do not store at a temperature above 25°C.
Following withdrawal of the dose, use the product within 28 days.