Solvent for cell associated poultry vaccines

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Available from:

Boehringer Ingelheim Vetmedica GmbH

ATC code:

QV07AB

Dosage:

.

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

Solvents and diluting agents, incl. irrigating solutions

Authorization status:

Authorised

Authorization date:

2005-11-18

Summary of Product characteristics

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Solvent for cell associated poultry vaccines
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Aqueous diluents q.s. 1 ml
3.
PHARMACEUTICAL FORM
Solution for injection.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In chickens:
For the suspension preparation of Boehringer Ingelheim frozen vaccines
against
Marek’s disease.
4.3
CONTRAINDICATIONS
Do not use alone.
4.4
SPECIAL WARNINGS
None.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Read special precautions for use of Boehringer Ingelheim frozen
vaccines against
Marek’s disease.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY
MEDICINAL PRODUCT TO ANIMALS
In the case of accidental self-injection, seek medical advice
immediately and show
the package leaflet or the label to the physician.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
None.
4.7
USE DURING PREGNANCY, LACTATION OR LAY
Read corresponding information of Boehringer Ingelheim frozen vaccines
against
Marek’s disease.
4.8
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None.
4.9
AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE
Refer to posology and method of administration of Boehringer Ingelheim
frozen
vaccines against Marek’s disease.
4.10 OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES), IF
NECESSARY
None.
4.11 WITHDRAWAL PERIOD(S)
Zero days.
5.
IMMUNOLOGICAL PROPERTIES
Not applicable.
ATCvet code: QV07AB. Solvents and diluting agents, incl. irrigating
solutions.
6.
PHARMACEUTICAL PARTICULARS
6.1
LIST OF EXCIPIENTS
Sucrose
Casein hydrolysate
Dipotassium phosphate
Potassium dihydrogen phosphate
Phenol red 1% solution
Hydrochloric acid concentrated
Sodium hydroxide
Water for injections
6.2
INCOMPATIBILITIES
Do not mix with any other medicinal products except Boehringer
Ingelheim frozen
vaccines against Marek’s disease.
6.3
SHELF LIFE
Sh