Sensiblex 40 mg/ml solution for injection for cattle

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Denaverine hydrochloride

Available from:

Veyx-Pharma GmbH

ATC code:

QG02CX90

INN (International Name):

Denaverine hydrochloride

Dosage:

40.0 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle

Therapeutic area:

denaverine

Therapeutic indications:

Miscellaneous

Authorization status:

Authorised

Authorization date:

2017-06-30

Summary of Product characteristics

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Sensiblex 40 mg/ml solution for injection for cattle (AT, BG, CY, CZ,
DE, EE, EL, ES, HR, HU, IE,
IT, LT, LU, LV, MT, NL, PL, PT, RO, SI, SK, UK)
Sensiblex Solution Injectable Pour Bovins (FR)
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.
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 pr