Clostriporc A

CLOSTRIPORC A Suspension for injection for pigs (pregnant sows and gilts) Name of the veterinary medicinal product CLOSTRIPORC A Suspension for injection for pigs (pregnant sows and gilts) Statement of the active substances and other ingredients Each...

CLOSTRIPORC A
Suspension for injection for pigs (pregnant sows and gilts)

 Name of the veterinary medicinal product

CLOSTRIPORC A
Suspension for injection for pigs (pregnant sows and gilts)

 Statement of the active substances and other ingredients

Each dose of 2 ml contains:

Active substances:
Clostridium perfringens type A toxoids
alpha toxoid: min. 125 rU*/ ml
beta2 toxoid: min. 770 rU* /ml

*toxoid content in relative units per ml, determined in ELISA against an internal standard

Adjuvant:
Montanide Gel: 37.4 – 51.5 mmol/l titratable acrylate units

Excipient:
Thiomersal 0.2 mg

Suspension for injection.
Appearance after mixing: amber, opaque suspension

 Indication(s)

For the passive immunisation of piglets by active immunisation of pregnant sows and gilts to reduce clinical signs during the first days of life caused by Clostridium perfringens type A expressing alpha and beta2 toxins. This protection was proven in a challenge test with toxins on sucklers on the first day of life.
Serological data show that neutralising antibodies are present up to the 4th week after birth.

 Contraindications

Do not use in clinically sick or severely stressed animals.

 Adverse reactions

Very commonly slight increases in body temperature (up to max. 1.8 °C) on the day of vaccination are possible. Very commonly local reactions may be observed in the form of flat swellings (diameter up to max. 10 cm) at the injection site, but subside without treatment within 12 days.

The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)
- common (more than 1 but less than 10 animals in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals)
- rare (more than 1 but less than 10 animals in 10,000 animals)
- very rare (less than 1 animal in 10,000 animals, including isolated reports).

If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.

 Target species

Pigs (pregnant sows and gilts)

 Dosage for each species, route(s) and method of administration

One dose: 2 ml

For subcutaneous use.

Primary immunisation:
Administer one dose 5 weeks before the expected date of farrowing.
Administer a second dose 2 weeks before the expected date of farrowing.

Revaccination:
Administer one dose 2 weeks before the expected date of farrowing.
Shake well before use.

 Advice on correct administration

None.

 Withdrawal period

Zero days

 Special storage precautions

Keep out of the sight and reach of children.
Store in a refrigerator (2 °C – 8 °C).
Protect from frost.

Do not use this veterinary medicinal product after the expiry date which is stated on the carton.

Shelf life after first opening the container: 8 hours.
Between removals the vaccine should be stored at +2 °C - +8 °C.

During storage increased turbidity of the suspension and a slight, black precipitation may occur which have no impact on the efficacy, safety and quality of the product.

 Special warnings

Special precautions to be taken by the person administering the veterinary medicinal product to animals:
To the user:
This veterinary medicinal product contains traces of mineral oil. Accidental 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 veterinary medicinal product contains traces of 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.

Pregnancy and lactation:
CLOSTRIPORC A is intended for the immunisation of mother animals. The sucklers are passively protected via the colostrum from their mothers.

Interaction with other medicinal products and other forms of interaction:
No information is available on the safety and efficacy of this vaccine when used at the same time with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be taken on a case by case basis.

Overdose (symptoms, emergency procedures, antidotes):
After administration of the double dose no other symptoms other than those described under “Adverse Reactions” were observed.

Incompatibilities:
Do not mix with any other veterinary medicinal product.

 Special precautions for the disposal of unused product or waste materials, if any

Medicines should not be disposed of via wastewater or household waste.
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

 Date on which the package leaflet was last approved

July 2016

 Other information

Package sizes:
Cardboard box with 1 glass vial of 25 doses (50 ml)
Cardboard box with 1 glass vial of 50 doses (100 ml)
Cardboard box with 1 PET vial of 25 doses (50 ml)
Cardboard box with 1 PET vial of 50 doses (100 ml)

Not all pack sizes may be marketed.

Immunological properties:
The active immunisation of pregnant sows and gilts induces the formation of antibodies against the alpha and beta2 toxins of Clostridium perfringens type A.
The uptake of sufficient antibodies at the earliest opportunity, via the colostrum, results in a passive protection of the sucklers against the effects of the alpha and beta2 toxins of Clostridium perfringens. type A.

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