PIRESOL 300 mg/ml solution for use in drinking water for pigs

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Paracetamol

Beschikbaar vanaf:

SP Veterinaria, S.A.

ATC-code:

QN02BE01

INN (Algemene Internationale Benaming):

Paracetamol

Dosering:

300 milligram(s)/millilitre

farmaceutische vorm:

Solution for use in drinking water

Prescription-type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutisch gebied:

paracetamol

Autorisatie-status:

Authorised

Autorisatie datum:

2019-08-02

Productkenmerken

_[Version 9,03/2022] corr. 11/2022 _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
PIRESOL 300 mg/ml solution for use in drinking water for pigs
DK: APIRETAM 300 mg/ml solution for use in drinking water for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Paracetamol
300.00 mg
EXCIPIENTS:
QUALITATIVE
COMPOSITION
OF
EXCIPIENTS AND OTHER CONSTITUENTS
QUANTITATIVE COMPOSITION IF THAT INFORMATION IS
ESSENTIAL
FOR
PROPER
ADMINISTRATION
OF
THE
VETERINARY MEDICINAL PRODUC
t
Benzyl alcohol (E 1519)
0.01 ml
Azorubine (E 122)
0.025 mg
Macrogol 300
Dimethylacetamide
Saccharin Sodium
Purified water
Red, clear solution.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Pigs
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Symptomatic treatment of fever in the context of respiratory diseases
in combination with an
appropriate anti infective therapy, if necessary.
3.3
CONTRAINDICATIONS
- Do not use in cases of hypersensitivity to the active substance or
to any of the excipients.
- Do not use in animals with severe hepatic impairment.
- Do not use in animals with severe renal impairment. See also section
3.8.
- Do not use in animals suffering from dehydration or hypovolaemia.
3.4
SPECIAL WARNINGS
The anti-pyretic effect of the veterinary medicinal product is
expected at 12 - 24 hours after the onset
of treatment.
The intake of medicated water by animals may be altered as a
consequence of illness. In case of
insufficient water intake, animals should be treated parenterally
instead.
In case of combined viral and bacterial aetiology of the disease, an
appropriate anti infective therapy
should be given concomitantly.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
Not applicable.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
This
veterinary
medicinal
product
may
cause
hypersensitivity
(allergy).
People
with
known
hypersensitivity to paracetamol or any of the excipients