Sensiblex 40 mg/ml solution for injection for cattle
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
Active substance:
Denaverine hydrochloride 40.0 mg (equivalent to 36.5 mg Denaverine)
Excipients:
Benzyl alcohol (E1519)20.0 mg
For the full list of excipients, see section 6.1.
PHARMACEUTICAL FORM
Solution for injection
Clear, colourless solution
CLINICAL PARTICULARS
Target Species
Cattle (cows, heifers)
Indications for use, specifying the target species
Cows, heifers:
– Promotes dilation of the soft tissues of the birth canal in cases where the birth
canal is insufficiently opened.
– Regulates uterine contractions in animals with hypertonic muscular contractions of
the uterus.
Heifers:
– Promotes dilation of the soft tissues of the birth canal to facilitate parturition.
Contraindications
Do not administer in cases of mechanical obstetrical disorders.
Do not use in cases of hypersensitivity to the active substance or to any of the
excipients.
Special warnings for each target species
The product is ineffective if no part of the foetus has entered the cervical canal and if
abdominal pressing has not started.
Before administering the product it is important to ensure there are no mechanical
obstructions (e.g. oversized foetus). If present, obstructions must be removed prior to
product administration (e.g. correction of abnormal presentation or uterine torsion).
Special precautions for use
Special precautions for use in animals
None.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
The product has a potential to affect uterine musculature. Therefore, pregnant
women and those women who are attempting to conceive should not handle or
administer the product.
Administration should be performed with caution in order to avoid accidental
self-injection.
In case of accidental self-injection, seek medical advice immediately and show the
package leaflet or the label to the physician.
Accidental spillage onto skin or into the eyes should be thoroughly rinsed off with
water.
People with known hypersensitivity to denaverine hydrochloride or to any of the
excipients should not administer the product.
Wash hands after use.
Adverse reactions (frequency and seriousness)
Increased restlessness; swellings at the injection site; absent or insufficient
effectiveness necessitating further obstetric measures.
Use during pregnancy, lactation or lay
Use at the time of parturition only. Not for use during other stages of pregnancy or
during lactation.
Interaction with other medicinal products and other forms of interaction
The product should not be mixed with other veterinary medicinal products. In the
case of additional administration of oxytocin or its analogues, the dose of this active
substance must be carefully selected because denaverine may amplify its effects.
Amounts to be administered and administration route
For intramuscular use.
Heifers: 10.0 ml product (400 mg Denaverine hydrochloride / animal)
Cows: 10.0 ml product (400 mg Denaverine hydrochloride / animal)
Timing of product administration:
– Use in heifers to facilitate parturition: the product should be administered as soon
as parts of the foetus are within the cervical canal and abdominal pressing has
started.
– Use in heifers and cows to promote dilation of the soft tissues of the birth canal:
the product can be administered immediately after the veterinary surgeon has
determined that insufficient opening of the soft birth canal is present (please also
refer to section 4.3 [contraindications] and 4.4 [special warnings] of the SPC).
In cases where full dilation is not achieved, product administration may be repeated
once after 40 – 60 minutes.
Overdose (symptoms, emergency procedures, antidotes), if necessary
In case of overdose or intravenous application, anticholinergic effects, e.g. increased
heart and decreased respiration rate may occur. Do not exceed the recommended
dose.
Withdrawal period(s)
Cattle: Meat and offal:1 day
Milk:24 hours
PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Genitourinary system and sex hormones; other
gynaecologicals
Pharmacodynamic properties
Denaverine hydrochloride is a spasmolytic agent with a relaxant effect on smooth
muscle. It has a relaxing effect on the uterus sub partu and increases the distensibility
of the soft-tissue of the birth canal. Following intramuscular injection the spasmolytic
effect commences within 15 to 30 minutes and lasts for several hours. The
mechanism of action is not known.
Pharmacokinetic properties
Denaverine is excreted rapidly from the treated animals.
PHARMACEUTICAL PARTICULARS
List of excipients
Benzyl alcohol (E1519)
Propylene glycol
Hydrochloric acid (for pH adjustment)
Water for injections
Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be
mixed with other veterinary medicinal products.
Shelf-life
Shelf life of the veterinary medicinal product as packaged for sale:
2 years
Shelf life after first opening the immediate packaging:
28 days
Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
Nature and composition of immediate packaging
Vial of colourless glass, type I, with a fluorinated bromobutyl rubber stopper and an
aluminium cap;
1 vial (10 ml) in a cardboard box.
1 vial (50 ml) in a cardboard box.