Sensiblex 40 mg/ml Solution for Injection for Cattle

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Denaverine Hydrochloride

Available from:

Veyx-Pharma GmbH

ATC code:

QG02CX90

INN (International Name):

Denaverine Hydrochloride

Pharmaceutical form:

Solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle

Therapeutic area:

Neurological Agent uterine relaxant

Authorization status:

Authorized

Authorization date:

2017-06-15

Summary of Product characteristics

Revised: September 2022
AN: 00358/2022 & 00360/2022
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Sensiblex 40 mg/ml solution for injection for cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 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.
3.
PHARMACEUTICAL FORM
Solution for injection
Clear, colourless solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle (cows, heifers)
4.2
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
during
parturition
in
animals
with
hypertonic
muscular contractions of the uterus.
Heifers:
-
Promotes dilation of the soft tissues of the birth canal to facilitate
parturition.
4.3
CONTRAINDICATIONS
Do not administer in cases of mechanical obstetrical obstructions.
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
Revised: September 2022
AN: 00358/2022 & 00360/2022
Page 2 of 5
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
The product is ineffective if no part of the foetus has already
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, malpresentation, uterine
torsion). If present,
obstructions must be removed prior to product administration (e.g.
correction of
abnormal presentation or uterine torsion).
Signs of peripartum electrolyte imbalances (with special attention to
calcium and
phosphorus), as well as metabolic disturbances (e.g. ketosis), both
possibly causing
weak labour and thus insufficient dilation of the soft birth canal,
require particular
consideration and supportive measurements.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in