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Revised: May 2020

AN: 01999/2019

PARTICULARS TO APPEAR ON THE OUTER PACKAGE (500 ml and 200 ml


cartons)

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Ivomec Injection for Pigs


(Ivermectin)

2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES

Sterile solution for injection containing 1% w/v ivermectin.

3. PHARMACEUTICAL FORM

Solution for injection.

4. PACKAGE SIZE

500 ml
200 ml

5. TARGET SPECIES

Pigs

6. INDICATIONS

For the treatment and control of internal and external parasites of pigs.

IVOMEC controls the following internal and external parasites which impact on the
health of pigs.

PARASITE Adult L4
Gastrointestinal Roundworms
Ascaris suum • •
Hyostrongylus rubidus • •
Oesophagostomum spp • •
Strongyloides ransomi * •
Lungworms
Metastrongylus spp •
Lice
Haematopinus suis
Mange Mites
Sarcoptes scabei var. suis
* Includes somatic larval stages.

Page 1 of 13
Revised: May 2020
AN: 01999/2019

7. METHOD AND ROUTES OF ADMINISTRATION

Dosage and Administration


• IVOMEC should be injected subcutaneously in the neck.
• Use at a rate of 1 ml/33 kg bodyweight.
• The use of a 17 gauge x 1/2-inch needle is recommended.

This table indicates the recommended dose volumes for various bodyweights and
the number of doses/pack.

In pigs, especially those under 16 kg for which less than 0.5 ml of IVOMEC is
indicated, dosing accuracy is important. The use of a syringe that can accurately
deliver 0.1 ml is recommended.

Syringes must be filled from the vial through a dry, sterile draw-off needle that has
been placed in the vial stopper.
Vial stoppers must not be broached more than 20 times. For piglets weighing less
than 16 kg administer at a dose rate of 0.1 ml/3 kg bodyweight.

Bodyweight (kg) Dose Volume (ml) Doses Per Pack


200 ml 500 ml
8 0.25 800 2000
8-16 0.5 400 1000
17-33 1.0 200 500
34-50 1.5 133 330
51-66 2.0 100 250
67-99 3.0 66 166
100-133 4.0 50 125
134-166 5.0 40 100
167-200 6.0 32 83

Over 200 kg bodyweight, give 1.0 ml/33 kg bodyweight.

8. WITHDRAWAL PERIOD

Pigs must not be treated within 19 days of slaughter for human consumption.

9. SPECIAL WARNINGS, IF NECESSARY

Precautions
This product is not for intravenous or intramuscular use.

IVOMEC Injection for Pigs is a low-volume product registered for use in pigs. It
should not be used in other species as severe adverse reactions, including fatalities
in dogs, may occur.

Transient discomfort occurs occasionally in injected pigs.

Page 2 of 13
Revised: May 2020
AN: 01999/2019

Do not smoke, drink or eat while handling the product.


Wash hands after use.
Take care to avoid accidental self-injection; the product may cause local irritation
and/or pain at the injection site.

Swab septum before removing each dose.


Use a dry sterile needle and syringe.
Do not use after the expiry date indicated.

10. EXPIRY DATE

Expiry Date:

11. SPECIAL STORAGE CONDITIONS

Protect from direct sunlight.


Do not store above 30°C.
Following withdrawal of the first dose, use the product within 6 months.
Discard unused material.

12. SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS


OR WASTE MATERIALS, IF ANY

CONTAINER DISPOSAL:
EXTREMELY DANGEROUS TO FISH AND AQUATIC LIFE.
Do not contaminate surface waters or ditches with product or used container.
Dispose of any unused product and empty containers in accordance with guidance
from your local waste regulation authority.

13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR


RESTRICTIONS REGARDING SUPPLY AND USE IF APPLICABLE [Distribution
category]

For animal treatment only.

POM-VPS

14. THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”

Keep out of the reach of children.

15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Animal Health UK Ltd, Bracknell, RG12 8YS, UK

16. MARKETING AUTHORISATION NUMBER(S)

Vm 08327/4179

Page 3 of 13
Revised: May 2020
AN: 01999/2019

17. MANUFACTURER’S BATCH NUMBER

Batch No.:

18. ADDITIONAL INFORMATION

IMPORTANT: Read package leaflet before use.

To be supplied only on veterinary prescription.

Further information is available on request.

If broken, do not accept.

Page 4 of 13
Revised: May 2020
AN: 01999/2019

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE (500 ml and 200


ml labels)

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Ivomec injection for pigs


(Ivermectin)

2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES

Sterile solution for injection containing 1% w/v ivermectin.

3. PHARMACEUTICAL FORM

Solution for injection.

4. PACKAGE SIZE

500 ml
200 ml

5. TARGET SPECIES

Pigs

6. INDICATIONS

For the treatment and control of gastro-intestinal roundworms, lungworms, lice and
mange mites of pigs.

7. METHOD AND ROUTES OF ADMINISTRATION

Inject subcutaneously in the neck at the rate of 1.0 ml per 33 kg bodyweight.

8. WITHDRAWAL PERIOD

Pigs must not be treated within 19 days of slaughter for human consumption.

9. SPECIAL WARNINGS, IF NECESSARY

Precautions
This product is not for intravenous or intramuscular use.

IVOMEC Injection for Pigs is a low-volume product registered for use in pigs. It
should not be used in other species as severe adverse reactions, including fatalities
in dogs, may occur.

Do not smoke, drink or eat while handling the product.


Wash hands after use.

Page 5 of 13
Revised: May 2020
AN: 01999/2019

Take care to avoid accidental self-injection; the product may cause local irritation
and/or pain at the injection site.

Do not use after the expiry date indicated.

See package leaflet for details of appropriate syringes for use with IVOMEC Injection
for Pigs.
Vial stoppers must not be broached more than 20 times.
Swab septum before removing each dose.

This product does not contain an antimicrobial preservative.

10. EXPIRY DATE

Expiry Date:

11. SPECIAL STORAGE CONDITIONS

Protect from direct sunlight.


Do not store above 30°C.
Following withdrawal of the first dose, use the product within 6 months.
Discard unused material.
Once broached, use by

12. SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS


OR WASTE MATERIALS, IF ANY

CONTAINER DISPOSAL:
EXTREMELY DANGEROUS TO FISH AND AQUATIC LIFE.
Do not contaminate surface waters or ditches with product or used container.
Dispose of any unused product and empty containers in accordance with guidance
from your local waste regulation authority.

13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR


RESTRICTIONS REGARDING SUPPLY AND USE IF APPLICABLE [Distribution
category]

For animal treatment only.

POM-VPS

14. THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”

Keep out of the reach of children.

15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Animal Health UK Ltd, Bracknell, RG12 8YS, UK

Page 6 of 13
Revised: May 2020
AN: 01999/2019

16. MARKETING AUTHORISATION NUMBER(S)

Vm 08327/4179

17. MANUFACTURER’S BATCH NUMBER

Batch No.:

18. ADDITIONAL INFORMATION

IMPORTANT: Read package leaflet before use.

To be supplied only on veterinary prescription.

Further information is available on request.

Page 7 of 13
Revised: May 2020
AN: 01999/2019

PACKAGE LEAFLET FOR: Ivomec Injection for Pigs (ivermectin)

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND


OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR
BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder:

Boehringer Ingelheim Animal Health UK Ltd, Bracknell, RG12 8YS, UK

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Ivomec Injection for Pigs (ivermectin)

3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS

Sterile solution for injection containing 1% w/v ivermectin.

4. INDICATIONS

For the treatment and control of internal and external parasites of pigs.

IVOMEC Injection is indicated for the effective treatment and control of the following
harmful parasites of pigs:

PARASITE Adult L4
Gastrointestinal Roundworms
Ascaris suum • •
Hyostrongylus rubidus • •
Oesophagostomum spp • •
Strongyloides ransomi * •
Lungworms
Metastrongylus spp •
Lice
Haematopinus suis
Mange Mites
Sarcoptes scabei var. suis
* Includes somatic larval stages.

5. CONTRAINDICATIONS

This product is not for intravenous or intramuscular use.

IVOMEC Injection for Pigs is a low-volume product registered for use in pigs. It
should not be used in other species as severe adverse reactions, including fatalities
in dogs, may occur.

Page 8 of 13
Revised: May 2020
AN: 01999/2019

6. ADVERSE REACTIONS

Transient discomfort occurs occasionally in injected pigs.

7. TARGET SPECIES

Pigs.

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

IVOMEC should be injected subcutaneously in the neck. Use at a rate of 1 ml/ 33 kg


of bodyweight.
The use of a 17 gauge x 1/2- inch needle is recommended.

The injection may be given with any standard automatic multi-dose injection
equipment or single dose syringe. As with any injection, aseptic technique should be
used. Injecting animals with wet or dirty skins is not recommended. Syringes must be
filled from the vial through a dry, sterile draw-off needle that has been placed in the
vial stopper.

Vial stoppers must not be broached more than 20 times.

For producers wishing to treat a small number of animals it is recommended that


they use the 50 ml size of PANOMEC® Injection which is available from veterinary
surgeons.

This table indicates the recommended dose volumes for various bodyweights and
the number of doses per pack. In young pigs, especially those weighing under 16 kg
for which less than 0.5 ml of IVOMEC is indicated, dosing accuracy is important. The
use of a syringe that can accurately deliver 0.1 ml is recommended. For piglets
weighing less than 16 kg give at 0.1 ml/3 kg.

Bodyweight (kg) Dose Volume (ml) Doses Per Pack


200 ml 500 ml
8 0.25 800 2000
8-16 0.5 400 1000
17-33 1.0 200 500
34-50 1.5 133 330
51-66 2.0 100 250

Page 9 of 13
Revised: May 2020
AN: 01999/2019

67-99 3.0 66 166


100-133 4.0 50 125
134-166 5.0 40 100
167-200 6.0 32 83

Over 200 kg bodyweight, give 1.0 ml per 33 kg bodyweight.


When treating pigs of less than 16 kg seek veterinary advice regarding the use of 1
ml disposable syringes graduated in increments of 0.1 ml.
When treating groups of animals use only an automatic dosing device.

9. ADVICE ON CORRECT ADMINISTRATION

RECOMMENDED TREATMENT PROGRAMME


BREEDING ANIMALS
At the time of initiating any parasite control programme, it is important to treat all
breeding animals in the herd. After the initial treatment use IVOMEC regularly as
follows:

Sows
Treat 7–14 days prior to farrowing

Gilts
Treat 7–14 days prior to service
Treat 7–14 days prior to farrowing

Boars
Boars are a key source of infestation of mange and other parasites.
Treat at least twice per year.

Arrivals and transfers


Treat on arrival and isolate for 7–10 days before mixing with the rest of the herd.
The above programme is a guide for effective parasite control using IVOMEC.
Alternatively, control can be achieved by “whole herd treatments’’ at six monthly
intervals.

Fatteners
All pigs received for fattening should be treated before placement in clean quarters.

Note (1): For effective mange control, care must be taken to prevent reinfestation
from exposure to untreated animals or contaminated facilities.
Note (2): Since louse eggs are unaffected by ivermectin and may take up to three
weeks to hatch, retreatment may be necessary.

INSTRUCTIONS FOR USE WITH AUTOMATIC INJECTION EQUIPMENT


• Remove cap from the IVOMEC bottle and disinfect the rubber stopper
(septum) with alcohol or another suitable chemical disinfectant.
• Hold the bottle upright and fully insert a draw-off needle into centre of
rubber stopper (see illustration A). Secure firmly with the screw-on cap that
is attached to tube.

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Revised: May 2020
AN: 01999/2019

• Hang the bottle comfortably in an inverted position from neck (see


illustration B), shoulder or belt.
• Gently prime injector. The equipment is now ready for use.
• After use, remove the draw-off assembly from the pack and flush out entire
apparatus with sterile water before storing.
• With single dose injectors disinfect the septum before each withdrawal.
• Store a partly-used bottle in the carton to protect it from light. Do not re-
use empty bottles.
• Only use sterile needles, syringes and draw-off assemblies.

10. WITHDRAWAL PERIOD

Pigs must not be treated within 19 days of slaughter for human consumption.

11. SPECIAL STORAGE PRECAUTIONS

Store the bottle in its carton to protect it from light.


Do not store above 30°C.
Following withdrawal of the first dose, use the product within 6 months.
Discard unused material.
Do not use after the expiry date.

When the container is broached for the first time, using the in-use shelf-life which is
specified on the package insert, the date on which any product remaining in the
container should be discarded should be worked out. This discard date should be
written in the space provided on the label.

12. SPECIAL WARNINGS

Do not smoke, drink or eat while handling the product.


Wash hands after use.
Take care to avoid accidental self-injection; the product may cause local irritation
and/or pain at the injection site.

For Animal Treatment Only

Page 11 of 13
Revised: May 2020
AN: 01999/2019

Keep out of the reach of children.

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR


WASTE MATERIALS, IF ANY

ENVIRONMENTAL SAFETY
Container disposal
EXTREMELY DANGEROUS TO FISH AND AQUATIC LIFE.
Do not contaminate surface waters or ditches with product or used container.
Dispose of any unused product and empty containers in accordance with guidance
from your local waste regulation authority.

14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

15. OTHER INFORMATION

POM-VPS

Vm 08327/4179

To be supplied only on veterinary prescription.

INTRODUCTION
IVOMEC Injection for Pigs is an injectable endectocide licensed for use in pigs. One
low-volume dose effectively controls the important internal and external parasites
which impact on the health of pigs.

PRODUCT DESCRIPTION
IVOMEC is a ready-to-use 1% w/v sterile non-aqueous solution of ivermectin.

Mode of action
The exposure of various parasitic nematodes and arthropods to ivermectin results in
paralysis and thereafter death due to interference with the transmission of nerve
impulses at synapses.

PRODUCT ADVANTAGES
Broad spectrum
IVOMEC Injection for Pigs provides an outstanding and proven standard of parasite
control.

Safety
Studies and widespread use over many years have demonstrated the wide margin of
safety of IVOMEC Injection. IVOMEC can be used at any stage in the breeding or
production cycle.

Dosing accuracy
The low volume injection increases dosing accuracy.

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Revised: May 2020
AN: 01999/2019

Ease of use
No special handling or protective clothing is necessary. IVOMEC Injection replaces
the need for combination of sprays or pour-ons and in-feed wormers.

Convenient packaging
IVOMEC Injection for Pigs is available in 200 ml and 500 ml bottles. Both packs are
soft collapsible presentations designed for use with automatic injection equipment.

For those producers wishing to treat individual or small numbers of animals it is


suggested that they use the 50 ml presentation of PANOMEC® Injection. This is
available from veterinary surgeons.

Approved: 28 May 2020

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