VarroMed (oxalic acid dihydrate / formic acid) – Summary of product characteristics - QP53AG
Updated on site: 09-Feb-2018
Ravimi nimetus: | VarroMed |
ATC: | QP53AG |
Toimeaine: | oxalic acid dihydrate / formic acid |
Tootja: | BeeVital GmbH |
Liigid: Bees
Artikli sisu
- 1. NAME OF THE VETERINARY MEDICINAL PRODUCT
- 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
- 3. PHARMACEUTICAL FORM
- 4. CLINICAL PARTICULARS
- 4.1 Target species
- 4.2 Indications for use, specifying the target species
- 4.3 Contraindications
- 4.4 Special warnings for each target species
- 4.5 Special precautions for use
- 4.6 Adverse reactions (frequency and seriousness)
- 4.7 Use during pregnancy, lactation or lay
- 4.8 Interaction with other medicinal products and other forms of interaction
- 4.9 Amounts to be administered and administration route
- No. of bees
- 5. PHARMACOLOGICAL PROPERTIES
- 6. PHARMACEUTICAL PARTICULARS
- 7. MARKETING AUTHORISATION HOLDER
- 8. MARKETING AUTHORISATION NUMBER(S)
- 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
1.NAME OF THE VETERINARY MEDICINAL PRODUCT
VarroMed 5 mg/ml + 44 mg/ml
2.QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substances: |
|
Each ml contains: |
|
Formic acid | 5 mg |
Oxalic acid dihydrate | 44 mg (equivalent to 31.42 mg oxalic acid anhydrous) |
Excipients: |
|
Caramel colour (E150d) |
|
For the full list of excipients, see section 6.1.
3.PHARMACEUTICAL FORM
Slightly brown to dark brown aqueous dispersion.
4.CLINICAL PARTICULARS
4.1Target species
Honey bees
4.2Indications for use, specifying the target species
Treatment of varroosis (Varroa destructor) in honey bee colonies with and without brood.
4.3Contraindications
Do not use during nectar flow.
4.4Special 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.
4.5Special precautions for use
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
Special precautions to be taken by the person administering the veterinary medicinal product to animals
−This veterinary medicinal product is irritating to the skin and eyes. Avoid contact with the 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,
−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.
4.6Adverse reactions (frequency and seriousness)
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.
4.7Use during pregnancy, lactation or lay
Not applicable.
4.8Interaction 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.
4.9 Amounts to be administered and administration route
To be trickled onto bees in occupied

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 hives 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
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
Season | No. of | Threshold for first | Repeated Treatment: | |
| applications | treatment | ||
|
| |||
|
|
|
| |
|
| Treatment should be | The treatment should be repeated | |
|
| twice more (that is to a maximum | ||
|
| conducted at the start of the | ||
| 1x | of 3 treatments), if more than 10 | ||
Spring | season with increasing | |||
mites are detected on the | ||||
or 3x | colony population and | |||
| floorboard within 6 days after the | |||
|
| when the natural mite fall is | ||
|
| first treatment (maximum of 3 | ||
|
| more than 1 mite per day | ||
|
| treatments). | ||
|
|
| ||
|
|
|
| |
Autumn | 3x | Treatment should be | The treatment should be repeated | |
conducted as soon as | twice, 6 days apart (i.e. 3 | |||
|
|
| ||
|
|
|
| up to 5x | possible in late | administrations). | |
|
| summer/early autumn with |
| |
|
| decreasing colony | The treatment should be repeated | |
|
| population, and when the | twice more (that is to a maximum | |
|
| natural mite fall is more | of 5 treatments), if more than 150 | |
|
| than 4 mites per day. | ||
|
| 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 |
| Treatment should be | Not applicable | |
1x | conducted at the start of the | |||
(broodless) | broodless period in hives | (single treatment only). | ||
| ||||
|
| with Varroa infestation |
|
Advice on correct administration
Timing of administration: 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, particular 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 the 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.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
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. spillage of a large quantity of VarroMed into a hive) the best counter measure includes exchanging the hive body and cleaning the frames with water from all visible spills of the dispersion.
4.11 Withdrawal period(s)
Honey: Zero days.
5.PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Ectoparasiticides for topical use, including insecticides, organic acids, combinations
ATCvet code: QP53AG30
5.1 Pharmacodynamic properties
Formic acid probably kills Varroa mites by inhibiting electron transport in their mitochondria through the binding of cytochrome c oxidase, thereby inhibiting energy metabolism and may produce a neuro- excitatory effect on arthropod neurons after evaporation in the hive air (at least 500 ppm). No data are available which confirm this activity after trickling of 0.5% formic acid; however, formic acid in the fixed combination of VarroMed is considered to extend the duration of the effect of oxalic acid, and to improve the tolerance of the product.
The mode of action of oxalic acid against Varroa mites is unknown, but direct contact between the mites and oxalic acid is required. It is assumed that oxalic acid acts via direct contact or by ingestion of oxalic haemolymph. The acaricidal effect may be due mainly to the low pH of the formulation. Oxalic acid treatments administered in water are ineffective, but administration in sugar water improves efficacy by increasing its adhesion to the bees.
5.2Pharmacokinetic particulars
The pharmacokinetics of VarroMed have not been studied.
However, literature data show that oxalic acid is absorbed to a limited extent after topical application at therapeutic doses under normal beekeeping conditions. Data have also shown that oxalic acid can be orally ingested by bees due to increased
The pharmacokinetics of formic acid in bees is not known.
6.PHARMACEUTICAL PARTICULARS
6.1List of excipients
Caramel colour (E150d)
Sucrose syrup
Propolis tincture 20%
Star anise oil
Lemon oil
Citric acid monohydrate
Purified water
6.2Incompatibilities
Do not mix with any other veterinary medicinal product.
6.3Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after first opening the immediate packaging: 30 days.
6.4.Special precautions for storage
Do not store above 25 °C.
Keep the bottle tightly closed.
Keep the bottle in the outer carton in order to protect from light.
6.5Nature and composition of immediate packaging
Cardboard box containing an HDPE bottle with dropper nozzle (LDPE) and screw cap (with tamper evident seal). The bottle has a graduated dosing scale.
Box containing 1 bottle of 555 ml dispersion.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
7.MARKETING AUTHORISATION HOLDER
BeeVital GmbH
Wiesenbergstrasse 19
5164 Seeham
AUSTRIA
8.MARKETING AUTHORISATION NUMBER(S)
9.DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10 DATE OF REVISION OF THE TEXT
DD month YYYY
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
PROHIBITION OF SALE, SUPPLY AND/OR USE
- Equip wnv (duvaxyn wnv)
- Leucogen
- Melovem
- Nobilis influenza h5n2
- Quadrisol
- Sileo
Retseptiravimite loetelu:
Not applicable.
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
VarroMed 75 mg + 660 mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substances:
Each single dose sachet contains:
Formic acid | 75 mg |
Oxalic acid dihydrate | 660 mg (equivalent to 471.31 mg oxalic acid anhydrous) |
Excipients: |
|
Caramel colour (E150d) |
|
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Slightly brown to dark brown aqueous dispersion.
4. CLINICAL PARTICULARS
4.1 Target species
Honey bees
4.2 Indications for use, specifying the target species
Treatment of varroosis (Varroa destructor) in honey bee colonies with and without brood.
4.3 Contraindications
Do not use during nectar flow.
4.4 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.
4.5 Special precautions for use
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
Special precautions to be taken by the person administering the veterinary medicinal product to animals
−This veterinary medicinal product is irritating to the skin and eyes. Avoid contact with the 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,
−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.
4.6 Adverse reactions (frequency and seriousness)
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.
4.7 Use during pregnancy, lactation or lay
Not applicable.
4.8 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.
4.9 Amounts to be administered and administration route
To be trickled onto bees in occupied

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 hives 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
Season | No. of | Threshold for first | Repeated Treatment: | |
| applications | treatment | ||
|
| |||
|
|
|
| |
|
| Treatment should be | The treatment should be repeated | |
|
| twice more (that is to a maximum | ||
|
| conducted at the start of the | ||
| 1x | of 3 treatments), if more than 10 | ||
Spring | season with increasing | |||
mites are detected on the | ||||
or 3x | colony population and | |||
| floorboard within 6 days after the | |||
|
| when the natural mite fall is | ||
|
| first treatment (maximum of 3 | ||
|
| more than 1 mite per day | ||
|
| treatments). | ||
|
|
| ||
|
|
|
| |
| 3x | Treatment should be |
| |
Autumn | conducted as soon as | The treatment should be repeated | ||
| up to 5x | possible in late | twice, 6 days apart (i.e. 3 | |
|
| summer/early autumn with |
| |
|
|
|
|
| decreasing colony | administrations). | |
|
| population, and when the |
| |
|
| natural mite fall is more | The treatment should be repeated | |
|
| than 4 mites per day. | 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 |
| Treatment should be | Not applicable | |
1x | conducted at the start of the | |||
(broodless) | broodless period in hives | (single treatment only). | ||
| ||||
|
| with Varroa infestation |
|
Advice on correct administration
Timing of administration: 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, particular 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 the 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.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
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. spillage of a large quantity of VarroMed into a hive) the best counter measure includes exchanging the hive body and cleaning the frames with water from all visible spills of the dispersion.
4.11 Withdrawal period(s)
Honey: Zero days.
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Ectoparasiticides for topical use, including insecticides, organic acids, combinations
ATCvet code: QP53AG30
5.1 Pharmacodynamic properties
Formic acid probably kills Varroa mites by inhibiting electron transport in their mitochondria through the binding of cytochrome c oxidase, thereby inhibiting energy metabolism and may produce a neuro- excitatory effect on arthropod neurons after evaporation in the hive air (at least 500 ppm). No data are available which confirm this activity after trickling of 0.5% formic acid; however, formic acid in the fixed combination of VarroMed is considered to extend the duration of the effect of oxalic acid, and to improve the tolerance of the product.
The mode of action of oxalic acid against Varroa mites is unknown, but direct contact between the mites and oxalic acid is required. It is assumed that oxalic acid acts via direct contact or by ingestion of oxalic haemolymph. The acaricidal effect may be due mainly to the low pH of the formulation. Oxalic acid treatments administered in water are ineffective, but administration in sugar water improves efficacy by increasing its adhesion to the bees.
5.2 Pharmacokinetic particulars
The pharmacokinetics of VarroMed have not been studied.
However, literature data show that oxalic acid is absorbed to a limited extent after topical application at therapeutic doses under normal beekeeping conditions. Data have also shown that oxalic acid can be orally ingested by bees due to increased
The pharmacokinetics of formic acid in bees is not known.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Caramel colour (E150d)
Sucrose syrup
Propolis tincture 20%
Star anise oil
Lemon oil
Citric acid monohydrate
Purified water
6.2 Incompatibilities
Do not mix with any other veterinary medicinal product.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years
Shelf life after first opening the immediate packaging: use immediately.
6.4.Special precautions for storage
Do not store above 25 °C.
Keep the sachets in the outer carton in order to protect from light.
Opened sachets should not be stored.
6.5 Nature and composition of immediate packaging
Cardboard box containing 12
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
BeeVital GmbH
Wiesenbergstrasse 19
5164 Seeham
AUSTRIA
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10 DATE OF REVISION OF THE TEXT
DD month YYYY
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.