Lapinject VHD

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: VMD (Veterinary Medicines Directorate)

Δραστική ουσία:

Rabbit hemorrhagic disease virus

Διαθέσιμο από:

Ceva Animal Health Ltd

Φαρμακολογική κατηγορία (ATC):

QI08AA01

INN (Διεθνής Όνομα):

Rabbit hemorrhagic disease virus

Φαρμακοτεχνική μορφή:

Emulsion for injection

Τρόπος διάθεσης:

POM-V - Prescription Only Medicine – Veterinarian

Θεραπευτική ομάδα:

Rabbits

Θεραπευτική περιοχή:

Inactivated Viral Vaccine

Καθεστώς αδειοδότησης:

Authorized

Ημερομηνία της άδειας:

2006-09-22

Αρχείο Π.Χ.Π.

Revised: February 2012
AN: 01636/2011
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
LAPINJECT VHD
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
For one dose of vaccine:
Calicivirus of rabbit hemorrhagic disease.
1 PD
100
*
Strain 3116-AP (suspension of inactivated virus)
Mineral oil.................................................
104.125 mg
Thiomersal................................................
0.05 mg
Excipient
q.s.
1 dose of 0.5 ml
* Protective Dose 100% tested in rabbits.
For full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Emulsion for injection.
4.
CLINICAL PARTICULARS
4.1
TARGET-SPECIES
Rabbit.
4.2
INDICATIONS FOR USE
For active immunisation of rabbit to prevent mortality caused by RHD
virus
Onset immunity: 6 days
Duration of Immunity: 1 year
4.3
CONTRA-INDICATIONS
None.
4.4
SPECIAL PRECAUTIONS FOR USE
None
4.5
SPECIAL PRECAUTIONS FOR USE, INCLUDING SPECIAL PRECAUTIONS TO BE TAKEN
BY
THE PERSON ADMINISTERING THE MEDICINAL PRODUCT TO THE ANIMALS
i.
Special
precautions for use in animals
Handle pregnant females with the usual precautions.
Revised: February 2012
AN: 01636/2011
Page 2 of 4
ii.
Special precautions for the person administering the veterinary
medicinal
product to animals
_To the user: _
This product contains mineral oil. Accidental i
n
jection /self injection
may result in severe pain and swelling, particularly if injected into
a
joint or finger, and in rare cases could result in the loss of the
affected finger if prompt medical attention is not given.
If you are accidentally injected with this product, seek prompt
medical
advice even if only a very small amount is injected and take the
package leaflet with you.
If pain persists for more than 12 hours after medical examination,
seek
medical advice again.
_To_
_ the physician: _
This product contains mineral oil. Even if small amounts have been
injected, accidental injection with this product can cause intense
swelling, which may, for example, result in ischeamic necrosis and
the loss o