Linco-Spectin 100, 222/444.7 mg/g Powder for use in drinking water for pigs and chickens

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

Lincomycin; Spectinomycin

Pieejams no:

Kernfarm BV

ATĶ kods:

QJ01FF52

SNN (starptautisko nepatentēto nosaukumu):

Lincomycin; Spectinomycin

Deva:

222, 444.7 milligram(s)/gram

Zāļu forma:

Powder for oral solution

Receptes veids:

POM: Prescription Only Medicine as defined in relevant national legislation

Ārstniecības joma:

lincomycin, combinations

Autorizācija statuss:

Authorised

Autorizācija datums:

2018-08-10

Produkta apraksts

Health Products Regulatory Authority
23 April 2021
CRN00C7SC
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Linco-Spectin 100, 222/444.7 mg/g Powder for use in drinking water for
pigs and chickens
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains:
ACTIVE SUBSTANCES:
​
Lincomycin (as lincomycin hydrochloride)
​222 mg
​
Spectinomycin (as spectinomycin sulphate)
​444.7 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
_Product imported from Spain:_
Powder for use in drinking water.
White pale powder
4 CLINICAL PARTICULARS
As per VPA 10387/040/001
5 PHARMACOLOGICAL OR IMMUNOLOGICAL PROPERTIES
As per VPA 10387/040/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Sodium benzoate
Lactose monohydrate
6.2 MAJOR INCOMPATIBILITIES
In the absence of compatibility studies, this veterinary medicinal
product must not be mixed with other veterinary medicinal
products.
6.3 SHELF-LIFE
Shelf life of the veterinary medicinal product as packaged for sale: 5
years
Shelf life after first opening the immediate packaging: 6 months
Shelf life after dilution according to directions: 24 hours
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This veterinary medicinal product does not require any special storage
conditions.
6.5 NATURE AND COMPOSITION OF IMMEDIATE PACKAGING
White high density polyethylene (HDPE) bottle containing 1.5 kg powder
for use in drinking water with a white tamper evident
low density polyethylene (LDPE) lid.
Health Products Regulatory Authority
23 April 2021
CRN00C7SC
Page 2 of 2
White high density polyethylene (HDPE) bottle containing 150 g powder
for use in drinking water with a white tamper evident
low density polyethylene (LDPE) lid with an aluminium cap.
Not all pack sizes may be marketed.
6.6 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY
MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM THE
USE OF SUCH PRODUCTS
Any unused veterinary medicinal product or waste materials derived
from such veterinary medicinal