VarroMed (oxalic acid dihydrate / formic acid) – Package leaflet - QP53AG

Updated on site: 09-Feb-2018

Medication name: VarroMed
ATC: QP53AG
Substance: oxalic acid dihydrate / formic acid
Manufacturer: BeeVital GmbH

PACKAGE LEAFLET FOR:

VarroMed 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

Wiesenbergstr. 19

A - 5164 Seeham AUSTRIA

+43 6219 20645

+43 6219 20645 30 (fax) info@beevital.com

Manufacturer responsible for batch release:

+49-(0)4554-9070-901 (fax) info@lichtenheldt.de

Labor L+S AG

D-97708 Bad Bocklet-Grossenbrach GERMANY

+49-(0) 9708-9100-36 (fax) service@labor-ls.de

The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.

2.NAME OF THE VETERINARY MEDICINAL PRODUCT

VarroMed bee-hive dispersion for honey bees

Formic acid / oxalic acid dihydrate

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

Active substances:

 

Each ml contains:

 

Formic acid

5 mg

Oxalic acid dihydrate

44 mg (equivalent to 31.42 mg oxalic acid)

Excipients:

 

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 displaying adverse reaction(s) during the course of one treatment)

-common (more than 1 but less than 10 colonies in 100 colonies)

-uncommon (more than 1 but less than 10 colonies in 1,000 colonies)

-rare (more than 1 but less than 10 colonies in 10,000 colonies)

-very rare (less than 1 colonies in 10,000 colonies, including isolated reports.

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

7.TARGET SPECIES

Honey bees.

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 VarroMed 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 VarroMed might be required for spring or autumn treatment at intervals of 6 days; repeated applications should only be performed as indicated by mite-fall in according with the following table:

Season

No of applications

Threshold for

Repeated Treatments:

 

first treatment

 

 

 

 

 

 

 

 

 

 

Treatment

should

The treatment should be repeated

 

 

be conducted at the

 

 

start of the season

twice more (that is to a maximum

Spring

1x or 3x

with

increasing

of 3 treatments), if more than 10

colony population

mites are detected on the

 

 

and

when

the

floorboard within 6 days after the

 

 

natural mite fall is

first treatment (maximum of 3

 

 

more

than

mite

treatments).

 

 

per day

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Treatment

should

The treatment should be repeated

 

 

be

conducted

as

twice, 6 days apart

 

 

(i.e. 3 administrations).

 

 

soon as possible in

 

 

late

summer/early

The treatment should be repeated

 

 

autumn

with

Autumn

3x

decreasing

colony

twice more (that is to a maximum

population,

 

and

of 5 treatments), if more than 150

up to 5x

 

when

the

natural

mites (colonies from the second

 

 

 

 

mite

fall is more

year) or more than 90 mites

 

 

than

mites

per

(nucleus colonies in the first

 

 

day

 

 

 

 

year) are detected on the

 

 

 

 

 

 

 

 

 

 

 

 

 

 

floorboard within 6 days after the

 

 

 

 

 

 

 

third administration.

 

 

 

 

 

 

 

Treatment

 

 

 

 

 

should be

 

 

Winter

 

conducted at the

 

1x

start of the

 

Not applicable

(broodless)

broodless period

(single treatment only)

 

 

 

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 VarroMed evenly over the bees, particularly in the winter cluster.

VarroMed should not be used during the nectar flow, or when honey chambers are attached to the hive.

Before use, the product should be 25 to 35 °C warm, 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.

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

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

10.WITHDRAWAL PERIOD

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

VarroMed should only be used as part of an integrated Varroa control programme. 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 VarroMed 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.

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. 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.

Personal protective equipment consisting of protective clothing, acid-resistant 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.

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.

Overdose

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 VarroMed into a hive) the best counter measure includes exchanging the hive body and cleaning the frames with water from visible spills of the dispersion.

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.

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

15.OTHER INFORMATION

VarroMed is available in two pack sizes, multi-dose bottles (1 x 555 ml) and single-dose sachets (12 x 15 ml).

Not all pack sizes may be marketed.

PACKAGE LEAFLET FOR:

VarroMed 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

Wiesenbergstr. 19

A - 5164 Seeham AUSTRIA

+43 6219 20645

+43 6219 20645 30 (fax) info@beevital.com

Manufacturer responsible for batch release:

+49-(0)4554-9070-901 (fax) info@lichtenheldt.de

Labor L+S AG

D-97708 Bad Bocklet-Grossenbrach GERMANY

+49-(0) 9708-9100-36 (fax) service@labor-ls.de

The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

VarroMed bee-hive dispersion for honey bees

Formic acid / oxalic acid dihydrate

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

Active substances:

Each single dose sachet contains:

Formic acid

75 mg

Oxalic acid dihydrate

660 mg (equivalent to 471.31 mg oxalic acid)

Excipients:

 

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 displaying adverse reaction(s) during the course of one treatment)

-common (more than 1 but less than 10 colonies in 100 colonies)

-uncommon (more than 1 but less than 10 colonies in 1,000 colonies)

-rare (more than 1 but less than 10 colonies in 10,000 colonies)

-very rare (less than 1 colonies in 10,000 colonies, including isolated reports.

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

7. TARGET SPECIES

Honey bees.

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 VarroMed 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 VarroMed might be required for spring or autumn treatment at intervals of 6 days; repeated applications should only be performed as indicated by mite-fall in according with the following table:

Season

No of applications

Threshold for

Repeated Treatments:

 

first treatment

 

 

 

 

 

 

 

 

 

 

Treatment

should

 

 

 

be conducted at the

The treatment should be repeated

 

 

start of the season

 

 

with

increasing

twice more (that is to a maximum

 

 

colony population

of 3 treatments), if more than 10

Spring

1x or 3x

and

when

the

mites are detected on the

 

 

natural mite fall is

floorboard within 6 days after the

 

 

more

than 1 mite

first treatment (maximum of 3

 

 

per day

 

treatments).

 

 

 

 

 

 

 

 

 

 

 

 

 

Treatment

should

The treatment should be repeated

 

 

be

conducted

as

twice, 6 days apart

 

 

(i.e. 3 administrations).

 

 

soon as possible in

 

 

late

summer/early

The treatment should be repeated

 

 

autumn

with

Autumn

3x

decreasing

colony

twice more (that is to a maximum

population,

 

and

of 5 treatments), if more than 150

up to 5x

 

when

the

natural

mites (colonies from the second

 

 

 

 

mite

fall is more

year) or more than 90 mites

 

 

than

mites

per

(nucleus colonies in the first

 

 

day

 

 

 

 

year) are detected on the

 

 

 

 

 

 

 

 

 

 

 

 

 

 

floorboard within 6 days after the

 

 

 

 

 

 

 

third administration.

 

 

 

 

 

 

 

Treatment

 

 

 

 

 

should be

 

 

Winter

 

conducted at the

 

1x

start of the

 

Not applicable

(broodless)

broodless period

(single treatment only)

 

 

 

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 VarroMed evenly over the bees, particularly in the winter cluster.

VarroMed should not be used during the nectar flow, or when honey chambers are attached to the hive.

Before use, the product should be 25 to 35 °C warm, 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.

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

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

10. WITHDRAWAL PERIOD

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

VarroMed should only be used as part of an integrated Varroa control programme. 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 VarroMed 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.

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. 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.

Personal protective equipment consisting of protective clothing, acid-resistant 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.

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.

Overdose

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 VarroMed into a hive) the best counter measure includes exchanging the hive body and cleaning the frames with water from visible spills of the dispersion.

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.

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

15. OTHER INFORMATION

VarroMed is available in two pack sizes, multi-dose bottles (1 x 555 ml) and single-dose sachets (12 x 15 ml).

Not all pack sizes may be marketed.

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