Summary of medicine characteristics - Nobilis Influenza H7N1
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose of 0.5ml contains:
Active substance:
Inactivated whole avian influenza virus antigen of H7N1 subtype (strain, A/CK/Italy/473/99), inducing an HI titre of >6.0 log2 as tested according to the potency test.
Adjuvant:
Liquid light paraffin 234.8 mg/0,5 ml
For a list of excipients see section 6.1
3. PHARMACEUTICAL FORM
Emulsion for injection
4. CLINICAL PARTICULARS
4.1 Target species
Chickens and ducks
4.2 Indications for use, specifying the target
For active immunisation of chickens and
avian influenza type A, subtype H7N1.
Efficacy has been evaluated on the basis of preliminary results in chickens and ringed teals.
-In chickens, reduction of clinical s mortality, excretion and transmission of virus after challenge ose vaccination.
were shown by two weeks after a sing
-In ducks, reduction of excreti after a single dose vaccination.
ansmission of virus after challenge were shown by two weeks
Although it has not been investigated with this particular AI vaccine strain, studies performed with other strains show that protective levels of serum antibody titres would be expected to persist in chickens for at least 12 months after administration of two doses of vaccine. The duration of
immunity in
own.
None.
Sp
4.4
4.3 Contraindi
cci
rnings for each target species
This ava h
has been tested for safety in chickens and only supportive data for safety in ducks are. If used in other avian species that are considered at risk of infection, its use in these species undertaken with care and it is advisable to test the vaccine on a small number of birds prior vaccination. The level of efficacy for other species may differ from that observed in chickens. vel of efficacy attained may vary depending on the degree of antigenic homology between the ine strain and circulating field strains.
4.5 Special precautions for use
Special precautions for use in animals
None
oduct to
Special precautions to be taken by the person administering the veterinary medici animals
To the user:
This product contains mineral oil. Accidental injection/self injection may res swelling, particularly if injected into a joint or finger, and in rare cases could affected finger if prompt medical attention is not given. If you are accid product, seek prompt medical advice even if only a very small amount is inje leaflet with you. If pain persists for more than 12 hours after medical advice again.
To the physician:
This product contains mineral oil. Even if small amounts have b this product can cause intense swelling, which may, for exampl the loss of a digit. Expert, PROMPT, surgical attention is requi and irrigation of the injected area, especially where there is
n severe pain and in the loss of the injected with this and take the package ination, seek medical
4.6 Adverse Reactions (frequency and
ol
jected, accidental injection with in ischaemic necrosis and even may necessitate early incision ent of finger pulp or tendon.
Safety has been assessed on the basis of results in chickens. A transient diffuse swelling may occur at the vaccination site in 50% of the animals, which persists for about 14 days.
Supportive data in ducks suggest that minor local swellings may occur at the injection sites but disappear within 3 weeks.
4.7 Use during pregnancy, lactation o
No information is available on the safe
s vaccine for birds in lay.
4.8 Interactions with other m
No information is available o
veterinary medicinal product. medicinal product therefore ne
roducts and other forms of interaction fety and efficacy of this vaccine when used with any other cision to use this vaccine before or after any other veterinary o be made on a case by case basis.
4.9 Amounts to be administered and administration route
Allow the vaccine to reach a temperature of 15°C – 25°C and shake well before use.
Use sterile syringes and needles.
It is recommended to use a closed multidose vaccination system.
Chickens
From 8 t
From
s old: 0.25 ml subcutaneously
to 6 weeks old: 0.25 or 0.5 ml subcutaneously or intramuscularly nd older: 0.5 ml subcutaneously or intramuscularly laying hens and breeders should get a second vaccination 4–6 weeks after first vaccination.
No information is available on vaccination in the presence of maternally derived antibodies. Immunisation of progeny from vaccinated birds should therefore be delayed until such antibodies have declined.
Ducks
From 2 to 6 weeks: 0.5 ml subcutaneously or intramuscularly.
Laying and breeder stock should get a second vaccination 6–10 weeks after the first vaccination.
A dose of 1 ml is advised.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Following the administration of a double dose no adverse reactions other than those described in section 4.6 have been observed.
4.11 Withdrawal period(s)
Zero days.
5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: inactivated vaccine, ATC-vet c
The vaccine stimulates active immunity against Avia
virus type A, subtype H7N1.
A23
If the circulating avian influenza field virus hasdifferent H and/or N component to the H7N1 included in the vaccine, it may be possible to differentiate between vaccinated and infected birds by
using a diagnostic test to detect haemagglutinin
6. PHARMACEUTICAL PARTIC
6.1 List of excipients
Liquid light paraffin Polysorbate 80 Sorbitane mono-oleate Glycine
6.2 Incompatibilities
euraminidase antibodies.
Do not mix with any other veterinary medicinal product.
6.4
6.3 Shelf life
PET vials: 2 y
Glass vials: 1
After cont
ial precautions for storage
use within 8 hours, provided the product is not subject to extreme temperatures or
efrigerated (2°C to 8°C). Do not freeze.
r waste
ry medicinal
AL OF THE AUTHORISATION
ND/OR USE
-
6.5 Nature and composition of immediate packaging 250 ml or 500 ml bottles of glass, hydrolytical class type II or of polyethylene terephthalate The bottles are closed with a nitryl rubber stopper and sealed with a coded aluminium cap.
Not all pack sizes may be marketed.
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6.6 Special precautions for the disposal of unused veterinary medicinal pro materials derived from the use of such products, if appropriate
Any unused veterinary medicinal product or waste materials derived from su products should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
8. MARKETING AUTHORISATION NUMBER
EU/2/07/073/001–004