Ingelvac CircoFLEX - Patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

PACKAGE LEAFLET:

Ingelvac CircoFLEX suspension for injection for pigs

• 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder and manufacturer responsible for batch release

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelhe­im/Rhein

GERMANY

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Ingelvac CircoFLEX suspension for injection for pigs

• 3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS

Each dose (1 ml) contains:

Porcine circovirus type 2 ORF2 protein: RP* 1.0–3.75

• * Relative potency (ELISA test) by comparison with a reference vaccine.

Adjuvant: Carbomer

Clear to slightly opalescent, colourless to yellowish suspension for injection.

• 4. INDICATIONS

For active immunisation of pigs from the age of 2 weeks against porcine circovirus type 2 (PCV2) to reduce mortality, clinical signs – including weight loss – and lesions in lymphoid tissues associated with PCV2 related diseases (PCVD).

In addition, vaccination has been shown to reduce PCV2 nasal shedding, viral load in blood and lymphoid tissues, and duration of viraemia.

Onset of immunity: 2 weeks post vaccination

Duration of immunity: at least 17 weeks.

• 5. CONTRAINDI­CATIONS

None.

• 6. ADVERSE REACTIONS

A mild and transient hyperthermia very commonly occurs on the day of vaccination.

On very rare occasions anaphylactic reactions may occur and should be treated symptomatically.

The frequency of adverse reactions is defined using the following convention:

• – very common (more than 1 in 10 animals treated displaying adverse reactions)

• – common (more than 1 but less than 10 animals in 100 animals treated)

• – uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

• – rare (more than 1 but less than 10 animals in 10,000 animals treated)

• – very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon. Alternatively, you can report via your national reporting system {national system details}.

• 7. TARGET SPECIES

Pigs

• 8. DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION

Intramuscular use.

Single intramuscular (IM) injection of one dose (1 ml) to pigs, irrespective of body weight.

ADVICE ON CORRECT ADMINISTRATION

Shake well before use.

Avoid introduction of contamination during use.

Avoid multiple vial broaching.

Vaccination devices should be used in accordance with the device instructions provided by the manufacturer. After correct handling in accordance with the mixing instructions no leakage should occur. In case of any leakage or incorrect handling of the product the bottle should be discarded.

When mixed with Ingelvac MycoFLEX:

• Vaccinate only pigs as from 3 weeks of age.
• Cannot be administered in pregnant or lactating pigs.

When mixed with Ingelvac MycoFLEX the following equipment should be used:

• Use the same volumes of Ingelvac CircoFLEX and Ingelvac MycoFLEX.
• Use a pre-sterilised transfer needle. Pre-sterilised transfer needles (CE certified) are commonly available via medical equipment suppliers.

To ensure correct mixing follow the steps as described below:

• 1. Connect one end of the transfer needle to the vaccine bottle of Ingelvac MycoFLEX.

• 2. Connect the opposite end of the transfer needle to the vaccine bottle of Ingelvac CircoFLEX.

Transfer the Ingelvac CircoFLEX vaccine into the vaccine bottle of Ingelvac MycoFLEX. If needed, gently press the vaccine bottle of Ingelvac CircoFLEX to facilitate the transfer.

After the transfer of the full content of Ingelvac CircoFLEX, disconnect and discard transfer needle and empty vaccine bottle of Ingelvac CircoFLEX.

• 3. To ensure appropriate mixing of the vaccines, gently shake the vaccine bottle of Ingelvac MycoFLEX until the mixture is of uniform orange to reddish colour. During vaccination the uniformity of the coloured mixture should be monitored and maintained by continuous agitation.

• 4. Administer one single injection dose (2 ml ) of the mixture intramuscularly per pig, irrespective of body weight. For administration, vaccine devices should be used in accordance with the device instructions provided by the manufacturer.

  
  

To ensure correct mixing with the TwistPak bottles follow the steps as described below or using the

• 1. Twist and remove the red base of the bottle of Ingelvac MycoFLEX to uncover the connection system. The red base could be used upside down as a stand to position of the Ingelvac MycoFLEX bottle upside down.

Twist and remove the green base of the Ingelvac CircoFLEX bottle.

• 2. Rotate and align the connection ends of the two bottles until they engage.

• 3. Firmly push the bottles together until they touch one another completely.

A click confirms that the bottles are engaged.

• 4. Twist the two vaccine bottles clockwise to complete the coupling of both bottles.

• 5. To ensure appropriate mixing, slowly invert the locked bottles until the mixture is of uniform

orange to reddish colour. During vaccination the uniformity of the coloured mixture should be monitored and maintained by continuous agitation.

• 6. Administer one single injection dose (2 ml ) of the mixture intramuscularly per pig, irrespective of body weight. For administration, vaccine devices should be used in accordance with the device instructions provided by the manufacturer.

Use the entire mixture immediately after mixing. Any unused mixture or waste material should be disposed according with local requirements.

When mixed with Ingelvac PRRSFLEX EU:

• Vaccinate only pigs as from 17 days of age.
• Cannot be administered in pregnant or lactating pigs.

When mixed with Ingelvac PRRSFLEX EU the following equipment should be used:

• Use the same volumes of Ingelvac CircoFLEX and Ingelvac PRRSFLEX EU.
• Ingelvac CircoFLEX hereby replaces the solvent of PRRSFLEX EU
• Use a pre-sterilised transfer needle. Pre-sterilised transfer needles (CE certified) are commonly available via medical equipment suppliers.

To ensure correct mixing follow the steps as described below:

• 1. Connect one end of the transfer needle to the vaccine bottle of Ingelvac CircoFLEX.

• 2. Connect the opposite end of the transfer needle to the vaccine bottle of Ingelvac PRRSFLEX EU.

• 3. Transfer the Ingelvac CircoFLEX vaccine into the vaccine bottle of Ingelvac PRRSFLEX EU. If needed, gently press the vaccine bottle of Ingelvac CircoFLEX to facilitate the transfer.

After the transfer of the full content of Ingelvac CircoFLEX, disconnect and discard transfer needle and empty vaccine bottle of Ingelvac CircoFLEX.

• 4. To ensure appropriate mixing of the vaccines, gently shake the vaccine bottle of Ingelvac PRRSFLEX until the cake is fully dissolved.

• 5. Administer one single injection dose (1 ml ) of the mixture intramuscularly per pig, irrespective of body weight. For administration, vaccine devices should be used in accordance with the device instructions provided by the manufacturer.

Use the entire vaccine mixture within 4 hours after mixing. Any unused mixture or waste material should be disposed according to local requirements.

• 10. WITHDRAWAL PERIOD

Zero days.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Store and transport refrigerated (2 °C-8 °C).

Do not freeze.

Protect from light.

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

Shelf life after first opening the bottle: use immediately.

• 12. SPECIAL WARNINGS

Special warnings for each target species:

Vaccinate healthy animals only.

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

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

Pregnancy and lactation

Can be used during pregnancy and lactation.

Interactions with other medicinal products and other forms of interaction

Safety and efficacy data are available which demonstrate that this vaccine can be mixed either with Boehringer Ingelheim’s In­gelvac MycoFLEX or Ingelvac PRRSFLEX EU and administered at one injection site. The product literature of Ingelvac MycoFLEX and Ingelvac PRRSFLEX EU should be consulted before administration.

After administration of Ingelvac CircoFLEX mixed with Ingelvac PRRSFLEX EU the following adverse reactions may occur: In individual pigs, the temperature increase after associated use rarely exceeds 1.5°C but stays below an increase of 2°C. The temperature returns to normal within 1 day after the peak temperature is observed. Transient local injection site reactions, which are restricted to a slight redness, may rarely occur directly after vaccination. Reactions resolve within 1 day. Immediate mild hypersensitivity-like reactions were commonly observed after vaccination, resulting in transient clinical signs such as vomiting and rapid respiration, which resolved within a few hours without treatment. Transient purple skin discoloration was uncommonly observed and resolved without treatment. Appropriate precautions to minimise handling stress during the administration of the product may lower the frequency of hypersensitivity-like reactions.

No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above. 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.

Overdose (symptoms, emergency procedures, antidotes)

Following the administration of a 4-fold overdose of vaccine no adverse reactions other than those described under section “Adverse reactions” have been observed.

Incompatibilities

Do not mix with any other veterinary medicinal product, except with Boehringer Ingelheim's In­gelvac MycoFLEX or Ingelvac PRRSFLEX EU (both mixtures not for use in pregnant or lactating pigs).

• 13. 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.

• 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency.

• 15. OTHER INFORMATION