VarroMed - Patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

PACKAGE LEAFLET:

VarroMed 5 mg/ml + 44 mg/ml bee-hive dispersion for honey bees

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

Marketing authorisation holder :

BeeVital GmbH

Wiesenbergstraße 19

A-5164 Seeham

AUSTRIA

+43 6219 20645

Manufacturer responsible for batch release:

Lichtenheldt GmbH

Industriestr. 7–9

DE-23812 Wahlstedt

GERMANY

+49-(0)4554–9070–0

Labor LS SE & Co. KG

Mangelsfeld 4, 5, 6

DE-97708 Bad Bocklet-Großenbrach

GERMANY

+49-(0)9708–9100–0

service@,labor-ls.de

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

VarroMed 5 mg/ml + 44 mg/ml bee-hive dispersion for honey bees Formic acid / oxalic acid dihydrate

• 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

Each ml contains:

Active substances:

Formic acid 5 mg

Oxalic acid dihydrate 44 mg (equivalent to 31.42 mg oxalic acid anhydrous)

Excipient:

Caramel colour (E150d)

Slightly brown to dark brown aqueous dispersion.

• 4. INDICATION(S)

Treatment of varroosis (Varroa destructor) in honey bee colonies with and without brood.

• 5. CONTRAINDI­CATIONS

Do not use during nectar flow.

• 6. ADVERSE REACTIONS

Increased mortality in worker bees was very commonly observed in the clinical and preclinical trials following treatment with VarroMed. This effect is considered to be associated with the oxalic acid in VarroMed, and increased with increasing doses and/or repeated treatments.

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

• – very common (more than 1 in 10 colonies treated displaying adverse reaction(s))

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

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

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

• – very rare (less than 1 colony in 10,000 colonies 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.

• 7. TARGET SPECIES

Honey bees (Apis mellifera ).

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

In-hive use.

To be trickled onto bees in occupied bee-spaces of the brood chamber.

Dose:

Shake well before use.

The dose should carefully be adjusted to the colony size (see dosing table). Determine the colony size and number of occupied bee spaces to be treated, and select the correct amount of product required.

The following dosing scheme applies:

No. of bees	5,000 – 7,000	7,000 – 12,000	12,000 – 30,000	> 30,000
VarroMed (ml)	15 ml	15 to 30 ml	30 to 45 ml	45 ml

The use of the veterinary medicinal product with the above dosing scheme only applies for hive types with vertical frames that can be accessed from the top, as the treatment of bees in other types of hives has not been investigated.

The multi-dose container has a graduated dosing scale for accurate dosing.

Frequency of treatment :

Repeated administration of the veterinary medicinal product might be required for spring or autumn treatment at intervals of 6 days; repeated applications should only be performed as indicated by mitefall in accordance with the following table:

Season	No of applications	Threshold for first treatment	Repeated Treatments:
Spring	1× or 3×	Treatment should be conducted at the start of the season with increasing colony population and when the natural mite fall is more than 1 mite per day	The treatment should be repeated twice more (that is to a maximum of 3 treatments), if more than 10 mites are detected on the floorboard within 6 days after the first treatment (maximum of 3 treatments).
Autumn —	3× up to 5×	Treatment should be conducted as soon as possible in late summer/early autumn with decreasing colony population, and when the natural mite fall is more than 4 mites per day	The treatment should be repeated twice, 6 days apart (i.e. 3 administrations). The treatment should be repeated twice more (that is to a maximum of 5 treatments), if more than 150 mites (colonies from the second year) or more than 90 mites (nucleus colonies in the first year) are detected on the floorboard within 6 days after the third administration.
Winter	1×	Treatment should be	Not applicable

(broodless)

conducted at the start of the broodless period in hives with Varroa infestation

(single treatment only)

9.

ADVICE ON CORRECT ADMINISTRATION

Timing of application: the product should be used primarily at times when bees have low flight activity (late afternoon, evening). Darkness facilitates distribution of the product between the bees.

To avoid overdoses to individual bees, care should be taken to administer the veterinary medicinal product evenly over the bees, particularly in the winter cluster.

The veterinary medicinal product should not be used during the nectar flow, or when honey chambers are attached to the hive.

Before use, the product should be warmed up to the temperature from 25 to 35 °C and then shaken well.

It is recommended to remove the wax bridges between the top bars of the frames before administration of the product.

Do not lift frames during administration and for approximately one week after the last treatment.

In order to establish the Varroa infestation level in a hive, the mite mortality must be monitored: mite fall should be recorded on the hive floorboard before the first treatment, and up to 6 days after each treatment.

Do not use the veterinary medicinal product if you notice visible signs of deterioration of the product.

• 10. WITHDRAWAL PERIOD(S)

Honey: Zero days.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Do not store above 25 °C.

Keep the bottle tightly closed.

Keep the bottle in the outer carton in order to protect from light.

Do not use this veterinary medicinal product after the expiry date, which is stated on the bottle after “EXP”.

Shelf life after first opening the container: 30 days.

• 12. SPECIAL WARNING(S)

Special warnings for each target species

This veterinary medicinal product should only be used as part of an integrated Varroa control programme. Mite levels should be monitored regularly.

Efficacy was only investigated in hives with low to moderate mite infestation rates.

Special precautions for use in animals

Following treatment, worker bees with a protruding proboscis were found. This might be associated with insufficient access to drinking water. Ensure, therefore, that treated bees have sufficient access to drinking water.

The long-term tolerance of the veterinary medicinal product has only been tested over 18 months, i.e. a negative impact of the product on queens or colony development after longer treatment periods cannot be excluded. It is advised to check regularly that the queen is present, but avoid disturbing the hives in the days following treatment.

All colonies placed at the same location should be treated at the same time to minimize the risk of reinfestation.

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

• - The veterinary medicinal product is irritating to skin and eye. Avoid contact with skin, eyes and mucous membranes. Personal protective equipment consisting of protective clothing, acidresistant gloves and glasses should be worn when handling the veterinary medicinal product. Change heavily contaminated clothes as soon as possible and wash before re-use. In case of accidental spillage onto skin, wash the affected areas immediately with running water. In case of accidental spillage into the eye(s), flush the eye(s) immediately with clear running water for 10 minutes.

• - Children should not come into contact with this veterinary medicinal product. Accidental ingestion may cause adverse reactions.

• - People with known sensitivity to formic acid or oxalic acid should administer the veterinary medicinal product with caution.

• - Do not eat, drink or smoke while using the product.

Interaction with other medicinal products and other forms of interaction

None known.

The concomitant use of other acaricidal products should be avoided because increased toxicity to bees might occur.

Overdose (symptoms, emergency procedures, antidotes)

Following the administration of a 10% solution of oxalic acid dihydrate in 50% sugar solution, permanent lesions in digestive and excretory organs were noted after 72 hours (h).

Oxalic acid concentrations of 20% in a 50% sugar solution led to acute bee mortalities of more than 60%.

In case of accidental overdose (e.g. spilling of large amounts of veterinary medicinal product into a hive) the best counter measure includes exchanging the hive body and cleaning the frames with water from visible spills of the dispersion.

Incompatibili­ties:

Do not mix with any other veterinary medicinal product.

• 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 or pharmacist 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

VarroMed 5 mg/ml + 44 mg/ml bee-hive dispersion for honey bees is available in one pack size: multi-dose bottles (1 × 555 ml).

Not all pack sizes may be marketed.

PACKAGE LEAFLET:

VarroMed 75 mg + 660 mg bee-hive dispersion for honey bees

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

Marketing authorisation holder :

BeeVital GmbH

Wiesenbergstraße 19

A-5164 Seeham

AUSTRIA

+43 6219 20645

Manufacturer responsible for batch release:

Lichtenheldt GmbH

Industriestr. 7–9

DE-23812 Wahlstedt

GERMANY

+49-(0)4554–9070–0

Labor LS SE & Co. KG

Mangelsfeld 4, 5, 6

DE-97708 Bad Bocklet-Großenbrach

GERMANY

+49-(0)9708–9100–0

service@,labor-ls.de

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

VarroMed 75 mg + 660 mg bee-hive dispersion for honey bees Formic acid / oxalic acid dihydrate

• 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

Each single-dose sachet contains:

Active substances:

Formic acid 75 mg

Oxalic acid dihydrate 660 mg (equivalent to 471.31 mg oxalic acid anhydrous)

Excipient:

Caramel colour (E150d)

Slightly brown to dark brown aqueous dispersion.

• 4. INDICATION(S)

Treatment of varroosis (Varroa destructor) in honey bee colonies with and without brood.

Do not use during nectar flow.

Increased mortality in worker bees was very commonly observed in the clinical and preclinical trials following treatment with VarroMed. This effect is considered to be associated with the oxalic acid in VarroMed, and increased with increasing doses and/or repeated treatments.

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

• – very common (more than 1 in 10 colonies treated displaying adverse reaction(s))

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

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

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

• – very rare (less than 1 colony in 10,000 colonies 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.

• 7. TARGET SPECIES

Honey bees (Apis mellifera ).

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

In-hive use.

To be trickled onto bees in occupied bee-spaces of the brood chamber.

Dose :

Shake well before use.

The dose should carefully be adjusted to the colony size (see dosing table). Determine the colony size and number of occupied bee spaces to be treated, and select the correct amount of product required.

The following dosing scheme applies:

No. of bees	5,000 – 7,000	7,000 – 12,000	12,000 – 30,000	> 30,000
VarroMed (ml)	15 ml	15 to 30 ml	30 to 45 ml	45 ml

The use of the veterinary medicinal product with the above dosing scheme only applies for hive types with vertical frames that can be accessed from the top, as the treatment of bees in other types of hives has not been investigated.

Frequency of treatment :

Repeated administration of the veterinary medicinal product might be required for spring or autumn treatment at intervals of 6 days; repeated applications should only be performed as indicated by mitefall in according with the following table:

Season	No of applications	Threshold for first treatment	Repeated Treatments:
Spring	1× or 3×	Treatment should be conducted at the start of the season with increasing colony population and when the natural mite fall is more than 1 mite per day	The treatment should be repeated twice more (that is to a maximum of 3 treatments), if more than 10 mites are detected on the floorboard within 6 days after the first treatment (maximum of 3 treatments).
Autumn —	3× up to 5×	Treatment should be conducted as soon as possible in late summer/early autumn with decreasing colony population, and when the natural mite fall is more than 4 mites per day	The treatment should be repeated twice, 6 days apart (i.e. 3 administrations). The treatment should be repeated twice more (that is to a maximum of 5 treatments), if more than 150 mites (colonies from the second year) or more than 90 mites (nucleus colonies in the first year) are detected on the floorboard within 6 days after the third administration.
Winter (broodless)	1×	Treatment should be conducted at the start of the	Not applicable (single treatment only)

broodless period in hives with Varroa infestation

• 9. ADVICE ON CORRECT ADMINISTRATION

Timing of application: the product should be used primarily at times when bees have low flight activity (late afternoon, evening). Darkness facilitates distribution of the product between the bees.

To avoid overdoses to individual bees, care should be taken to administer the veterinary medicinal product evenly over the bees, particularly in the winter cluster.

The veterinary medicinal product should not be used during the nectar flow, or when honey chambers are attached to the hive.

Before use, the product should be warmed up to the temperature from 25 to 35 °C and then shaken well.

It is recommended to remove the wax bridges between the top bars of the frames before administration of the product.

Do not lift frames during administration and for approximately one week after the last treatment.

In order to establish the Varroa infestation level in a hive, the mite mortality must be monitored: mite fall should be recorded on the hive floorboard before the first treatment, and up to 6 days after each treatment.

Do not use the veterinary medicinal product if you notice visible signs of deterioration of the product.

• 10. WITHDRAWAL PERIOD(S)

Honey: Zero days.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Do not store above 25 °C.

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

Keep the sachets in the outer carton in order to protect from light.

Opened sachets should not be stored.

• 12. SPECIAL WARNING(S)

Special warnings for each target species

This veterinary medicinal product should only be used as part of an integrated Varroa control programme. Mite levels should be monitored regularly.

Efficacy was only investigated in hives with low to moderate mite infestation rates.

Special precautions for use in animals

Following treatment, worker bees with a protruding proboscis were found. This might be associated with insufficient access to drinking water. Ensure, therefore, that treated bees have sufficient access to drinking water.

The long-term tolerance of the veterinary medicinal product has only been tested over 18 months, i.e. a negative impact of the product on queens or colony development after longer treatment periods cannot be excluded. It is advised to check regularly that the queen is present, but avoid disturbing the hives in the days following treatment.

All colonies placed at the same location should be treated at the same time to minimize the risk of reinfestation.

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

• - The veterinary medicinal product is irritating to skin and eye. Avoid contact with skin, eyes and mucous membranes. Personal protective equipment consisting of protective clothing, acidresistant gloves and glasses should be worn when handling the veterinary medicinal product. Change heavily contaminated clothes as soon as possible and wash before re-use. In case of accidental spillage onto skin, wash the affected areas immediately with running water. In case of accidental spillage into the eye(s), flush the eye(s) immediately with clear running water for 10 minutes.

• - Children should not come into contact with this veterinary medicinal product. Accidental ingestion may cause adverse reactions.

• - People with known sensitivity to formic acid or oxalic acid should administer the veterinary medicinal product with caution.

• - Do not eat, drink or smoke while using the product.

Interaction with other medicinal products and other forms of interaction

None known.

The concomitant use of other acaricidal products should be avoided because increased toxicity to bees might occur.

Overdose (symptoms, emergency procedures, antidotes)

Following the administration of a 10% solution of oxalic acid dihydrate in 50% sugar solution, permanent lesions in digestive and excretory organs were noted after 72 hours (h).

Oxalic acid concentrations of 20% in a 50% sugar solution led to acute bee mortalities of more than 60%.

In case of accidental overdose (e.g. spilling of large amounts of the veterinary medicinal product into a hive) the best counter measure includes exchanging the hive body and cleaning the frames with water from visible spills of the dispersion.

Incompatibili­ties:

Do not mix with any other veterinary medicinal product.

• 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 or pharmacist 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