DOXIPULVIS 500 MG/G POWDER FOR USE IN DRINKING WATER / MILK REPLACER

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

DOXYCYCLINE (AS DOXYCYCLINE HYCLATE)

MAH:

SP Veterinaria, S.A.

ATC_code:

QJ01AA02

INN:

DOXYCYCLINE (AS DOXYCYCLINE HYCLATE)

dosage:

500 mg/g

pharmaceutical_form:

Oral Powder

prescription_type:

POM

therapeutic_group:

Bovine, Fowl - Chicken, Fowl - Turkey, Porcine

therapeutic_area:

Doxycycline

therapeutic_indication:

Antibiotics

authorization_status:

Authorised

authorization_date:

2016-09-30

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Doxipulvis 500 mg/g powder for use in drinking water / milk replacer
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains:
ACTIVE SUBSTANCE:
Doxycycline
500.0 mg
(As doxycycline hyclate 577.1 mg)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for use in drinking water / milk replacer
Yellow fine powder
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (pre-ruminant calves), pigs, chickens (broilers, breeders) and turkeys (broilers, breeders)
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In calves:
-
Treatment and metaphylaxis of respiratory and digestive infections caused by micro-organisms susceptible to
doxycycline.
In pigs:
-
Treatment and metaphylaxis of respiratory infections caused by micro-organisms susceptible to doxycycline.
In chickens and turkeys:
-
Treatment and metaphylaxis of respiratory infections due to micro-organisms susceptible to doxycycline.
The presence of the disease in the herd/flock should be established before metaphylactic treatment.
4.3 CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to doxycycline other tetracyclines or the excipient.
Do not use in case of known resistance to tetracyclines.
Do not use in animals with renal or hepatic disorders.
Do not use in ruminating animals.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The uptake of medication by animals can be altered as a consequence of illness. In case of insufficient uptake of
drinking water, calves and pigs should be treated parenterally.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 30/09/2016_
_CRN 7020854_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
Special