Medine.co.uk

Gallimune 303 Nd + Ib + Art

Revised: 9 July 2009

AN: 01951/2008

1. NAME OF THE VETERINARY MEDICINAL PRODUCT


GALLIMUNE 303 ND+IB+ART*

* for all countries except Austria, Belgium, Denmark and Sweden.


2. QUALITATIVE AND QUANTITATIVE COMPOSITION


Each 0.3-ml dose of vaccine contains:


Active substances:

Inactivated Newcastle Disease virus, Ulster 2C strain, at least 50PD501

Inactivated Infectious Bronchitis virus, Mass41 strain, at least 18 HI.U

Inactivated Avian Rhinotracheitis virus (Swollen Head Syndrome), VCO3 strain, at least 60 IP.U

(culture substrate: hen eggs, Vero cells)*

The concentrations are expressed by the antibody titre obtained during the potency test. One unit (U) corresponding to an antibody titre of 1.

HI: haemagglutination inhibiting - IP: interference percentage

(1): Minimum protective dose according to monograph 0870 of Ph. Eur.

(culture substrate: hen eggs, Vero cells)*: for Germany only


Adjuvant(s):

Paraffin oil 170 to 186 mg


Excipient(s):

Thiomersal, at most 30 μg

Formaldehyde, at most 45 µg

For a full list of excipients, see section 6.1.


3. PHARMACEUTICAL FORM


Water-in oil emulsion for injection.


4. CLINICAL PARTICULARS


4.1 Target species


Chickens (breeder and layer pullets).

4.2 Indications for use, specifying the target species


Booster immunisation of breeder and layer pullets after vaccination with live vaccines against:


Newcastle Disease and Infectious Bronchitis components:

Avian Rhinotracheitis component:

Immunity has been demonstrated by challenge 14 weeks after vaccination and persists until the end of the laying period.


4.3 Contraindications


None


4.4 Special warnings


None.


4.5 Special precautions for use


Special precautions for use in animals


Vaccinate only healthy animals.


Special precautions to be taken by the person administering the veterinary medicinal product to animals


To the user:

This product contains mineral oil. Accidental injection/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 insert 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 ischaemic necrosis and even the loss of a digit. Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.

4.6 Adverse reactions (frequency and seriousness)


No palpable reactions were observed following the injection of one dose of vaccine.

In clinical studies, lesions linked to the oily adjuvant were observed histologically three weeks after injection in 87% of cases, e.g. small quantities of oily residues and occasional aseptic micro-abscesses.


4.7 Use during lay


Not to be used within 2 weeks before the onset of the laying and during the laying period.


4.8 Interaction with other medicinal products and other forms of interaction


No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.


4.9 Amounts to be administered and administration route


Administer one dose (0.3-ml) by intramuscular route from the age of 18 weeksand at least 4 weeks after the priming with live vaccines against Newcastle Disease (strain Hitchner B1 or VG/GA), Infectious Bronchitis (strain Mass H120), and avian pneumovirus (strain PL21).


Shake well before use.

Apply usual aseptic procedures.

Do not use syringes with natural rubber or butyl elastomer pistons.

Equipment including needles and syringes must be sterile before use.


4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary


In addition to the adverse effects mentioned in paragraph «Adverse reactions (frequency and seriousness)», transitory apathy and slight oedema at injection site may occur after the administration of a double dose of vaccine.


4.11 Withdrawal period(s)


Zero days.


5. IMMUNOLOGICAL PROPERTIES


ATCvet code: QI01AA21

Inactivated vaccine in oily adjuvant against Newcastle Disease, Infectious Bronchitis and Avian Rhinotracheitis.


The vaccine stimulates active immunity of breeder and layer pullets against Newcastle Disease, Infectious Bronchitis and Avian Rhinotracheitis (Swollen Head Syndrome), subsequent to priming with live vaccines against these diseases.

6. PHARMACEUTICAL PARTICULARS


6.1 List of excipients


Paraffin oil

Thiomersal


6.2 Incompatibilities


Do not mix with any other vaccine/immunological product.


6.3 Shelf life


Shelf-life: 18 months.

Use immediately after opening.


6.4. Special precautions for storage


Store and transport between +2°C and +8°C, protected from light. Do not freeze.


6.5 Nature and composition of immediate packaging


Nature of primary packaging elements:


Sales presentations:


6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products


Any unused product or waste material should be disposed of in accordance with national requirements.

7. MARKETING AUTHORISATION HOLDER


MERIAL ANIMAL HEALTH LTD

PO Box 327

Sandringham House

Harlow Business Park

HARLOW Essex

CM19 5TG

United-Kingdom


8. MARKETING AUTHORISATION NUMBER


Vm 08327/4216


9. RENEWAL OF THE AUTHORISATION


28 July 2009


10. DATE OF REVISION OF THE TEXT


9 July 2009

Page 5 of 5