ΠΑΡΑΡΤΗΜΑ 1: SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINE:
OXYTO-KEL injection10 i.u.,solution for injection for horses, cattle, sheep, goat, pig, dog
and cat.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION:
Oxytocin
10 I.U.
Excipients:
For a full list of excipients,see section 6.1.
3. PHARMACEUTICAL FORM:
Solution for injection.
4. CLINICAL DATA
4.1 Target species
Horse, cattle, sheep, goat, pig, dog, cat.
4.2 Indications for use specifying the target species
Horse:
- Partus induction,
- Improvement of uterine involution,
- Supporting treatment of endometritis evacuating the intra-uterine fluid (only
effective with older merries of > 8 years)
- To stimulate milk letdown (post-partum agalactia) and milking out of residual
milk.
Cattle:
-
Improvement of uterine ivolution (uterus atonia, after reposition of uterus
prolaps, aid in retentio secundinarum in case of uterus atonia)
To stimulate milk letdown (post-partum agalactia in heifers) and milking out of
residual milk.
Sheep and goat:
- Improvement of uterine involution.
- To stimulate milk letdown and milking out of residual milk.
Pig:
-
Primary and secondary uterine inertia
To stimulate milk letdown (adjunctive treatment of MMA)
Dog and cat:
- Primary and secondary uterine inertia
- Improvement of uterine involution
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4.3 Contra-indications
- Closed pyometra
- Incomplete or no opening of cervix.
- Mechanic obstruction of partus, e.g. physical obstruction, an abnormal presentation or
position of foetus, convulsive contractions, risk on uterus rupture, torsio uteri, relative
large foetuses or malformations of birth channel.
4.4 Special warnings for each target species
None.
4.5 Special precautions for use
Special precautions for use in animals
When used before parturition, degree of relaxation of cervix and position of foetus
should be controlled. Prior to oxytocin therapy, a complete relaxation of the cervix
should be accomplished either naturally or by administration of oestrogens and if
necessary position of the foetus should be corrected.
Parturition should only be induced in mares that show readiness to birth (udder
development + colostrums drops, softened cervix and relaxed pelvic ligaments, length of
gestation > 320-330 days....).
Special precautions to be taken by the person administering the medicinal
product to animals:
Pregnant women, post-partum women and lactating women should not use this product
to avoid accidental exposure. In pregnant women, uterus contractions can be
introduced by an accidental self-injection.
4.6 Undesirable effects
When used appropriately at recommended dosages, oxytocin rarely causes significant
adverse reactions.
Oxytocin given during the early stage of oestrus may cause a decrease of the oestrus
cycle length in ruminants and sows.
4.7 Use during pregnancy and lactation
OXYTOCINE kela 10 i.u. is indicated only for use at parturition and in the early
puerperium and for the induction of milk letdown.
4.8 Interactions with other medicaments and other forms of interaction
Oxytocin can enhance the hypertensive effects of sympathicomimetics. When used
simultaneously with cyclopropane anesthesia, hypotensia and heart arrythmias may
occur.
4.9 Posology and method of administration
Horse:
- Partus induction, stimulation of uterus involution, supporting treatment of
endometritis :
I.M. : 50 IU or 5 ml OXYTOCINE kela /animal (500 kg BW)
I.V. : 10-20 IU or 1-2 ml OXYTOCINE kela / animal (500 kg BW)
Partus induction : delivery is usually accomplished within 15-90 minutes.
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-
For the removal of intra uterine fluid (endometritis) 20 IU or 2 ml OXYTOCINE
kela per animal (500 kg) should be injected intravenously in association with
oestrus, mating or insemination (before expected ovulation).
Administration may be repeated minimum 30 minutes after intravenous
injection and minimum 1 hour after I.M. injection.
Stimulation of milk letdown (post-partum agalactia) and milking out of residual
milk
I.M. : 20 IU or 2 ml OXYTOCINE kela / animal (500 kg BW)
I.V. : 10 IU or 1 ml OXYTOCINE kela / animal (500 kg BW)
Cow:
-
-
Stimulation of uterus involution
I.M. : 30-60 IU or 3 – 6 ml OXYTOCINE kela / animal (500 kg BW)
Since the responsiveness of the uterus rapidly declines after delivery,
injections should be given within 24 hours after delivery.
Administration may be repeated minimum 1 hour after the I.M. injection.
Stimulation of milk letdown and milking out of residual milk
I.M. : 20 IU or 2 ml OXYTOCINE kela / animal (500 kg BW)
I.V. : 10 IU or 1 ml OXYTOCINE kela / animal (500 kg BW)
For the removal of residual milk the product should be administered
immediately after milking. The intramuscular injection should be followed by
stripping (milking out) 2-3 minutes later.
Sheep and goat:
- Stimulation of uterus involution
I.M. : 10 IU or 1 ml OXYTOCINE kela / animal (50 kg BW)
Since the responsiveness of the uterus rapidly declines after delivery,
injections should be given within 24 hours after delivery.
Administration may be repeated minimum 1 hour after intramuscular
administration.
- Stimulation of milk letdown and milking out of residual milk
I.M. : 10 IU or 1 ml OXYTOCINE kela / animal (50 kg BW)
Pig:
-
-
Primary and secondary uterine inertia
I.M. : 10-20 IU or 1-2 ml OXYTOCINE kela / animal (200 kg BW)
I.V. : 5 IU or 0.5 ml OXYTOCINE kela / animal (200 kg BW)
Administration may be repeated minimum 30 minutes after intravenous
injection and minimum 1 hour after intramuscular administration.
Stimulaton of milk letdown (supporting treatment in case of MMA)
I.M. : 10-20 IU or 1-2 ml OXYTOCINE kela / animal (200 kg BW)
I.V. : 5 IU or 0.5 ml OXYTOCINE kela / animal (200 kg BW)
Dog and cat:
- Primary and secondary inertia, stimulation of uterus involution
I.M., S.C., I.V. : 0.5-1 IU / kg BW at a maximum of 20 IU per animal
in bitches and 5 IU per animal in queens.
Administration may be repeated minimum 30 minutes after intravenous
injection and minimum 1 hour after I.M. or S.C. administration
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4.10 Overdose
Too high doses or too frequent administration at parturition may cause prolonged spastic
contractions of the uterus leading to tumultuous labour and more discomfort to the
mother animal, a delay of birth process, increased incidence of dystocia and increased
danger for harmful effects in the mother animal (e.g. uterus rupture) and foetus.
4.11 Withdrawal periods
Meat : 0 days
Milk : 0 days
5. PHARMACOLOGICAL PROPERTIES:
5.1. Pharmacodynamic properties
OXYTOCINE kela 10 I.U. is an aqueous solution that contains synthetic oxytocine (10
IU/ml), which directly stimulates contractions of smooth musculature of the uterus and the
mammary gland. The mechanism of this stimulating action implies mediation by oxytocin
receptors, and initiation of contractions by influx of calcium ions in smooth muscle cells.
Oxytocin receptors develop under the influence of increased oestrogene and decreased
progesterone levels. Oxytocin stimulates both the frequency and force of uterine
contractions with a maximum response at parturition and a gradual decrease in the
puerperal phase. Uterine responsiveness to oxytocin is higher during oestrus than during
dioestrus and anoestrus. The intensity, onset and duration of action on the uterus not only
depends on the reproductive status of the female but also on the dose and route of
administration.
Oxytocin stimulates contraction of the myoepithelial cells of alveoli and small milk ducts in
the mammary gland, in this way stimulating milk let-down into the large ducts and
increasing total milk yield by making the residual milk available for milking. Magnitude and
onset of this action are related to dose and route of administration.
5.2. Pharmacokinetic data:
Oxytocin is rapidly absorbed after i.m. and s.c. injection (effects within few minutes). It
circulates in blood mostly as its free form, partly loosely bound to carrier proteins. It is
widely distributed into various tissues with a certain affinity for kidneys, liver, hypophysis,
uterus and mammary gland. After a large increase after injection, oxytocin blood levels
rapidly decline and oxytocin is rapidly degraded in various tissues into smaller peptides
and amino acids. A biphasical elimination from the blood is observed, with according to
animal species an initial half-life of about 0.5 to 4 minutes (distribution phase) followed by
a slower elimination process with a half-live of 22 to 30 minutes. Part of injected oxytocin
is excreted with urine within few hours after administration, partly as its unchanged active
form, partly as inactive metabolites.
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6. PHARMACEUTICAL DATA:
6.1. List of excipients
Phenol
Citric acid monohydrate
Sodium chloride
Water for injections
6.2 Incompatibilities:
To avoid possible incompatibilities, oxytocin should not be mixed with other drugs for
simultaneous injection.
6.3. Shelf-life:
Unopened vials : 3 years
In-use shelf-life : 28 days.
6.4. Special precautions for storage:
Store cool (2° - 8° C) and protected from light.
6.5. Nature and composition of the immediate packaging
Box with one glass vial x50ml
Box with 12 glass vials x 50 ml
6.6. Special precautions for the elimination of unused products or products waste
material, if necessary
Any unused product or waste materials should be disposed of in accordance with
national requirements.
7. NAME OF MARKETING AUTHORIZATION HOLDER
N A CHANCE TRADING CO
ARISTOFANOUS 18A, STROVOLOS , NICOSIA
8. NUMBER OF MARKETING AUTHORIZATION
10220
9. DATE OF FIRST AUTHORIZATION/ RENEWAL OF AUTHORIZATION
4/10/1985,22/3/2012
10. DATE OF REVISION OF TEXT
22/3/2012
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