dalmazin - Ethical Agents

COMPOSITION:
Active Substance:
d-cloprostenol 0.075mg/ml
Excipients:
Chlorocresol 1mg
Water for injections q.s 1ml
Injectable solution
Pharmacological Properties and
Pharmacokinetic Particlulars:
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 dcloprostenol
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 dcloprostenol,
with an elimination half life in the
order of 3 hours 10 minutes.
DALMAZIN
Product Information
Indications:
Target Species
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
Contraindications:
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.
Undesirable effects
No undesirable effects have been observed at up to
10 times the therapeutic dose
Special precautions for use
None.
Use during pregnancy and lactation
Avoid treating pregnant animals unless it is desirable
to induce parturition or therapeutic interruption of
pregnancy.
Interaction with other medicaments and other
forms of interaction
Do not administer the treatment together with nonsteroidal
anti-inflammatory drugs since they inhibit
endogenous prostaglandin synthesis.
Ethical Agents Veterinary Marketing Ltd, 54 Hobill Ave, Manukau, 2104, New Zealand.
P O Box 97110, Manukau City, Manukau, 2241, New Zealand.
Telephone 64-9-262 1388, Fax 64-9-262 1411, Freephone 0800 800 624.
E-mail eage@xtra.co.nz, Website www. ethicalagents.co.nz.

DALMAZIN (cont)
Dosage and Method of Administration:
Administer by intramuscular (IM) injection - Do not
administer intravenously:
COWS:
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.
In particular:
Induction of oestrus (also in cows showing
weak or silent heat) – after having established
the presence of a corpus luteum (6-18 th 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.
MARES
Administer 1ml of Dalmazin, equivalent to 75 µg of
d-cloprostenol, when induction of oestrus is
required.
SOWS
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.
Withholding periods
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.
Pharmaceutical Particulars
Incompatibilities (major)
None.
Storage, Shelf Life, Disposal:
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.
Ethical Agents Veterinary Marketing Ltd, 54 Hobill Ave, Manukau, 2104, New Zealand.
P O Box 97110, Manukau City, Manukau, 2241, New Zealand.
Telephone 64-9-262 1388, Fax 64-9-262 1411, Freephone 0800 800 624.
E-mail eage@xtra.co.nz, Website www. ethicalagents.co.nz.

DALMAZIN (cont)
Special precautions for storage
Do not store at a temperature above 25 o 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.
Manufactured by and registered by:
FATRO S.P.A. Industria Pharmaceutica Veterinaria
Via Emilia 285-40064 Ozzano Emilia
(Bologna) Italy
Registered pursuant to the ACVM Act 1997,
NoA10591
RESTRICTED VETERINARY MEDICINE
Dalmazin
For Animal Treatment Only
Website: www.nzfsa.govt.nz/acvm
Marketed and distributed by:
Ethical Agents Veterinary Marketing Ltd,
Ph: 09 262 1388
www.ethicalagents.co.nz
Ethical Agents Veterinary Marketing Ltd, 54 Hobill Ave, Manukau, 2104, New Zealand.
P O Box 97110, Manukau City, Manukau, 2241, New Zealand.
Telephone 64-9-262 1388, Fax 64-9-262 1411, Freephone 0800 800 624.
E-mail eage@xtra.co.nz, Website www. ethicalagents.co.nz.