Porcilis PCV Emulsion for injection for pigs 100ml

Porcilis PCV Emulsion for injection for pigs 100ml, 50 Dose.

Qualitative and quantitative composition

Each dose of 2 ml contains:

Active substance:

Porcine circovirus type 2 ORF2 subunit antigen: at least 4.5 log2 ELISA units*

* Antibody titre obtained according to the in vivo potency test in chickens.

Adjuvants:

Dl-a-tocopheryl acetate 25 mg

Light liquid paraffin 346 mg

Excipients.

For the full list of excipients, see section "Pharmaceutical particulars".

Pharmaceutical form

Emulsion for injection.

Opalescent white, with brown resuspendable sediment.

Clinical particulars

Target species

Pigs.

Indications for use

For the active immunisation of pigs to reduce the virus load in blood and lymphoid tissues and to reduce mortality and weight loss associated with PCV2 infection occurring during the fattening period.

Onset of immunity: 2 weeks

Duration of immunity: 22 weeks.

Contra-indications

None.

Special warnings for each target species

From the data provided, it can be concluded that a single dose regimen of vaccination breaks through up to medium levels and double dose regimen through medium to high levels of maternally derived antibodies in piglets.

No data are available on the use of the vaccine in breeding boars.

Special precautions for use

Vaccinate only healthy animals.

Operator warnings:

To the user:

This veterinary medicinal 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 veterinary medicinal 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.

Adverse reactions

Transient local reactions at the injection site may occur after vaccination mainly in the form of a hard, warm and sometimes painful swelling (diameter up to 10 cm). These reactions resolve spontaneously over a period of approximately 14–21 days without any major consequence on the general health status of the animals. Immediate systemic hypersensitivity-like reactions may occur after vaccination, resulting in minor neurological symptoms such as tremors and/or excitation, which normally resolve within minutes without requiring treatment. A transient increase in body temperature, normally not exceeding 1 °C, may occur until 2 days after vaccination. Occasionally, an increase of rectal temperature up to 2.5 °C lasting less than 24 hours may occur. Some piglets may be depressed and show a reduced feed intake for up to 5 days. Vaccination may result in a transient impairment of growth rate in the immediate period after administration of the vaccine.

Use during pregnancy, lactation or lay

Do not use during pregnancy and lactation.

Interactions

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 decided on a case by case basis.

Amounts to be administered and administration route

Before using the vaccine, allow it to reach room temperature and shake well before use. Avoid multiple vial broaching. Use sterile syringes and needles. Avoid introduction of contamination. Avoid use of vaccination equipment with rubber parts.

Vaccination

Administer one dose of 2 ml by intramuscular injection in the neck, in the area behind the ear, according to the following schedule:

In the case of low to medium levels of maternally derived antibodies against PCV2 a single vaccination (2 ml) to pigs from an age of 3 weeks onwards is advised.

When it is expected that higher levels of maternally derived antibodies against PCV2 are present, the following schedule of two vaccinations is advised: the first injection (2 ml) can be given from an age of 3–5 days, the second injection (2 ml) 2–3 weeks later.

High levels of MDA may be expected when sows/gilts are vaccinated against PCV2 virus or when sows/gilts have recently been exposed to high levels of PCV2 virus. In such cases it is advised to perform PCV2 serology, using suitable diagnostics, to select the most appropriate vaccination schedule. In case of doubt, apply the two shot vaccination schedule.

Overdose

Following the administration of a double dose of vaccine no side effects other than those described in section "Adverse Reactions" have been observed.

Withdrawal periods

Zero days.

Pharmacological particulars

Immunological properties

Pharmacotherapeutic group: Inactivated porcine circovirus vaccine.

ATCvet code: QI09AA07.

Vaccine to stimulate active immunity against porcine circovirus type 2.

Pharmaceutical particulars

Excipients

Dl-a-tocopheryl acetate, Light liquid paraffin, Polysorbate 80, Simethicon and Water for injections.

Major incompatibilities

Do not mix with any other veterinary medicinal product.

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

Shelf life after first opening the immediate packaging: 8 hours.

Special precautions for storage

Store in a refrigerator (2 °C – 8 °C). Do not freeze. Protect from light.

Immediate packaging

Cardboard boxes with either 1 or 10 PET vials of 20, 50, 100, 200 or 500 ml.

Vials are closed with a nitryl rubber stopper and a coded aluminium cap.

Not all pack sizes may be marketed.

Disposal

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.