- d-cloprostenol 0.075mg/ml
- Chlorocresol 1mg
- Water for injections q.s 1ml
DALMAZIN is a sterile aqueous solution containing 75 µg/ml of dextrorotatory cloprostenol, a synthetic analogue of the prostaglandin F2α. 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.
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 administration of 150 µg intramuscular d-cloprostenol in the cow, the peak plasma level (Cmax) of 1.4 µg/l is reached after approximately 90 minutes, while the elimination half life (T½ β) is in the order of 1 hour 37 minutes. In sows, A Cmax of approximately 2 µg/l is observed between 30 and 80 minutes following administration of 75 µg d-cloprostenol, with an elimination half life in the order of 3 hours 10 minutes.
Cows, mares and sows.
Indications for use
COWS: Indications for reproduction: synchronisation or induction of oestrus. induction of parturition. improvement of reproductive parameters.
Therapeutic indications: ovarian dysfunction (persistent corpus luteum, luteal cyst), Interruption of pregnancy including foetal mummification, endometritis/pyometra, post-puerperal metropathy (delayed uterine involution, retained placenta).
MARES: Indications for reproduction: induction of oestrus
SOWS: Indications for reproduction: induction of parturition
- Do not administer to pregnant animals, unless it is desirable to induce parturition or for therapeutic interruption of pregnancy.
- Do not administer the treatment together with non-steroidal anti-inflammatory drugs since they inhibit endogenous prostaglandin synthesis.
No undesirable effects have been observed at up to 10 times the therapeutic dose
Special precautions for use
Use during pregnancy and lactation
Avoid treating pregnant animals unless it is desirable to induce parturition or therapeutic interruption of pregnancy.
Dosage and administration
Administer by intramuscular (IM) injection - Do not administer intravenously:
Administer 2ml of Dalmazin, equivalent to 150 µg of d-cloprostenol. Repeat after 11 days for the synchronisation of oestrus.
The dose of 2ml can be repeated for the induction of oestrus and for the treatment of ovarian dysfunction, endometritis/pyometra, post-puerperal metropathy.
- Induction of oestrus (also in cows showing weak or silent heat) – after having established the presence of a corpus luteum (6-18th day of the cycle), administer 2ml of Dalmazin; 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 2ml of 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 2ml of Dalmazin after 270 days of pregnancy. Birth usually results within 30-60 hours of treatment.
- Mummified foetus: administer 2ml of Dalmazin. Expulsion of the foetus is observed within 3-4 days.
- Interruption of pregnancy: administer 2ml of Dalmazin in the first half of pregnancy.
- Ovarian dysfunction (persistent corpus luteum, luteal cysts): administer 2ml of 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 2ml of Dalmazin. If necessary, repeat the treatment after 10-11 days. Proceed with insemination only 72-96 hours post injection.
- Post-puerperal metropathy (delayed uterine involution, retained placenta): administer 2ml of Dalmazin and, if considered necessary, carry out one or two successive treatments of 1-2ml at 24 hour intervals.
Administer 1ml of Dalmazin, equivalent to 75 µg of d-cloprostenol, when induction of oestrus is required.
Administer 1ml of Dalmazin, equivalent to 75 µg of d-cloprostenol, not earlier than 112 days of pregnancy. The dose of 1ml can be either repeated after 6 hours, or a single dose of 1ml can be followed after 20 hours by administration of an ecbolic (Oxytocin or carazolol).
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.
Overdose (symptoms, emergency procedures, antidotes)
DALMAZIN is well tolerated even at dosages up to 10 times the therapeutic dose. As no specific antidote has been identified, in the case of overdose, symptomatic therapy is advisable.
Special warnings for each target species
- Side effects of prostaglandins (perspiration, diarrhoea) have been observed in mares, administration of Dalmazin is not advisable in mares affected by serious respiratory and/or gastrointestinal diseases.
- Milk: 0 hours
- Meat and offal: 0 days
Special precautions to be taken by the person administering the product to animals
Prostaglandins of F2α type can be absorbed through the skin and may cause bronchospasm or miscarriage. Accidental spillage on the skin should be washed off immediately with soap and water. Should respiratory embarrassment result from accidental inhalation or injection, a rapidly-acting bronchodilator, e.g. isoprenaline or salbutamol by inhalation, is indicated. Consult your doctor immediately.
Shelf-life and, if necessary, after reconstitution of the product, or when the container is opened for the first time
- Shelf-life: 3 years
- Use product within 28 days after opening.
Special precautions for storage
- Do not store at a temperature above 25°C.
- Keep out of reach of children.
Nature and contents of container
DALMAZIN is stored in labelled vials in glass type I or type II, or 100ml plastic HDPE closed with a rubber stopper with an aluminium over seal.
Special precautions for the disposal of unused product or waste materials, if any
Disposal of unused product and empty vials must comply with national regulations governing waste disposal.
20ml & 100ml Vaxi
Registered pursuant to the ACVM Act 1997, NoA10591