VarroMed

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

oxalic acid dihydrate, formic acid

MAH:

BeeVital GmbH

ATC_code:

QP53AG30

INN:

oxalic acid dihydrate / formic acid

therapeutic_group:

Bees

therapeutic_area:

Ectoparasiticides for topical use, incl. insecticides

therapeutic_indication:

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

leaflet_short:

Revision: 3

authorization_status:

Authorised

authorization_date:

2017-02-02

PIL

18
PARTICULARS TO APPEAR ON THE OUTER PACKAGE AND THE IMMEDIATE
PACKAGE
_MULTI-DOSE CONTAINER (BOTTLE)_
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
VarroMed 5 mg/ml + 44 mg/ml bee-hive dispersion for honey bees
Formic acid/oxalic acid dihydrate
2.
STATEMENT OF ACTIVE SUBSTANCES
Each ml contains:
ACTIVE SUBSTANCES:
Formic acid
5 mg
Oxalic acid dihydrate
44 mg
3.
PHARMACEUTICAL FORM
Bee-hive dispersion
4.
PACKAGE SIZE
555 ml
5.
TARGET SPECIES
Honey bees (
_Apis mellifera_
).
6.
INDICATION(S)
Treatment of varroosis (
_Varroa destructor_
) in honey bee colonies with and without brood.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
In-hive use.
Read the package leaflet before use.
Shake well before use.
8.
WITHDRAWAL PERIOD(S)
Withdrawal period(s): Honey: Zero days.
9.
SPECIAL WARNING(S), IF NECESSARY
19
During the application of the veterinary medicinal product, wear
protective clothing, acid-resistant
gloves and glasses.
Read the package leaflet before use.
10.
EXPIRY DATE
EXP
Shelf life after first opening container: 30 days.
Once opened, use by .…
11.
SPECIAL STORAGE CONDITIONS
Do not store above 25 °C.
Keep the bottle tightly closed.
Keep the bottle in the outer carton in order to protect from light.
12.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Disposal: read the package leaflet.
13.
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
For animal treatment only.
14.
THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”
Keep out of the sight and reach of children.
15.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
BeeVital GmbH
Wiesenbergstraße 19
A-5164 Seeham
AUSTRIA
16.
MARKETING AUTHORISATION NUMBER(S)
EU/2/16/203/001
17.
MANUFACTURER’S BATCH NUMBER
Batch
20
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
_CARDBOARD BOX WITH 12 SINGLE-DOSE SACHETS_
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
VarroMed 75 mg + 660 mg bee-hive dispersion for honey bees
Formic acid/oxalic acid dihydrate
2.
STATEMENT OF AC

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
VarroMed 5 mg/ml + 44 mg/ml bee-hive dispersion for honey bees
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCES:
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
Bee-hive dispersion.
Slightly brown to dark brown aqueous dispersion.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Honey bees (
_Apis mellifera_
).
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
This veterinary medical 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.
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 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.
3
All colonies placed at the same location should be treated at the same
time to minimize the risk of re-
infestation.
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. Per