FrancophonIA/ELRC3.0 huggingface dataset:
English: − People with known sensitivity to formic acid or oxalic acid should administer the veterinary medicinal product with caution.
Slovenian: − Osebe z znano preobčutljivostjo na mravljično ali oksalno kislino naj zdravilo dajejo previdno.
English: Pharmacotherapeutic group: Ectoparasiticides for topical use, including insecticides, organic acids, combinations
Slovenian: Farmakoterapevtska skupina: Učinkovine proti ektoparazitom za lokalno zdravljenje, vključno z insekticidi, organske kisline, kombinacije.
English: +49-(0) 9708-9100-36 (fax) service@labor-ls.de
Slovenian: +49-(0) 9708-9100-36 (telefaks) service@labor-ls.de
English: +49-(0)4554-9070-901 (fax) info@lichtenheldt.de
Slovenian: +49-(0)4554-9070-901 (telefaks) info@lichtenheldt.de
English: PACKAGE SIZE 555 ml
Slovenian: VELIKOST PAKIRANJA 555 ml
English: The active substances in VarroMed, oxalic acid dihydrate and formic acid, are allowed substances as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Slovenian: C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Učinkovini v zdravilu VarroMed, oksalna kislina, dihidrat in mravljična kislina, sta dovoljeni učinkovini, kot sta navedeni v tabeli 1 priloge Uredbe Komisije (EU) št. 37/2010:
English: Keep the sachets in the outer carton in order to protect from light.
Slovenian: Vrečice shranjujte v zunanji ovojnini za zaščito pred svetlobo.
English: Caramel colour (E150d) Sucrose syrup Propolis tincture 20% Star anise oil Lemon oil
Slovenian: Karamelno barvilo (E150d) Saharozni sirup Tinktura propolisa, 20 % Olje zvezdastega janeža Limonino olje
English: The pharmacokinetics of formic acid in bees is not known.
Slovenian: Farmakokinetika mravljične kisline pri čebelah ni znana.
English: Treatment should be conducted as soon as possible in late summer/early autumn with decreasing colony population,
Slovenian: Zdravljenje je treba izvesti čim prej v poznem poletju/zgodnji jeseni, ko populacija kolonije upada
English: Do not lift frames during administration and for approximately one week after the last treatment.
Slovenian: Med dajanjem in približno en teden po zadnjem zdravljenju satnikov ne dvigujte.
English: It is assumed that oxalic acid acts via direct contact or by ingestion of oxalic haemolymph.
Slovenian: Domneva se, da oksalna kislina deluje prek neposrednega stika ali z zaužitjem oksalne kisline prek hemolimfe.
English: 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.
Slovenian: Toleranca za zdravilo VarroMed v daljšem obdobju je bila preskušena le za obdobje 18 mesecev, kar pomeni, da po daljših obdobjih zdravljenja ni mogoče izključiti negativnega vpliva zdravila na matice ali razvoj kolonije.
English: Oxalic acid concentrations of 20% in a 50% sugar solution led to acute bee mortalities of more than
Slovenian: 20-odstotna koncentracija oksalne kisline v 50-odstotni raztopini sladkorja je povzročila akutno umrljivost čebel, večjo od 60 %.
English: Not applicable.
Slovenian: SE NE UPORABLJA
English: Timing of application: the product should be used primarily at times when bees have low flight activity (late afternoon, evening).
Slovenian: Čas dajanja: zdravilo je treba uporabiti predvsem takrat, ko čebele manj pogosto izletajo (pozno popoldne, zvečer).
English: 19 A - 5164 Seeham AUSTRIA
Slovenian: 19 A-5164 Seeham AVSTRIJA
English: 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 neuroexcitatory effect on arthropod neurons after evaporation in the hive air (at least 500 ppm).
Slovenian: Mravljična kislina verjetno ubije varoje tako, da zavre prenos elektronov v njihovih mitohondrijih prek vezave citokrom c-oksidaze, s čimer zavira presnovo energije in lahko po izparevanju v zrak panja (vsaj 500 ppm) na nevrone členonožca učinkuje ekscitatorno.
English: Frequency of treatment:
Slovenian: Pogostost zdravljenja:
English: The mode of action of oxalic acid against Varroa mites is unknown, but direct contact between the mites and oxalic acid is required.
Slovenian: Način delovanja oksalne kisline proti varojam ni znan, vendar je znano, da je potreben neposreden stik med pršicami in oksalno kislino.
English: Darkness facilitates distribution of the product between the bees.
Slovenian: Tema olajšuje razporeditev zdravila med čebele.
English: During the application of the veterinary medicinal product, wear protective clothing, acid-resistant gloves and glasses.
Slovenian: − Pri ravnanju z zdravilom nosite osebno zaščitno opremo, ki sestoji iz zaščitne obleke, rokavic, odpornih proti kislini, in očal.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances:
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Učinkovina(e):
English: However, literature data show that oxalic acid is absorbed to a limited extent after topical application at therapeutic doses under normal beekeeping conditions.
Slovenian: Vendar podatki iz literature kažejo, da se oksalna kislina v normalnih pogojih čebelarjenja po topikalnem nanosu v terapevtskih odmerkih absorbira v omejenem obsegu.
English: 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.
Slovenian: Za določanje stopnje infestacije z varojo v panju je treba spremljati umrljivost pršic: pred prvim zdravljenjem in do 6 dni po vsakem zdravljenju je treba beležiti odpad pršic na dnu panja.
English: Slightly brown to dark brown aqueous dispersion.
Slovenian: Rjavkasta do temno rjava vodna disperzija.
English: MANUFACTURER'S BATCH NUMBER Batch {number}
Slovenian: IZDELOVALČEVA ŠTEVILKA SERIJE
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION In-hive use.
Slovenian: ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABE
English: BeeVital GmbH Wiesenbergstrasse 19 5164 Seeham AUSTRIA
Slovenian: BeeVital GmbH Wiesenbergstrasse 19 5164 Seeham AVSTRIJA
English: No. of bees VarroMed (ml)
Slovenian: VarroMed (ml)
English: Repeated Treatment:
Slovenian: Ponovljena zdravljenja:
English: Oxalic acid treatments administered in water are ineffective, but administration in sugar water improves efficacy by increasing its adhesion to the bees.
Slovenian: Zdravljenje z oksalno kislino, dano v vodo, ni učinkovito, učinkovitost pa se poveča z dajanjem oksalne kisline v sladkorno raztopino, zaradi česar se oksalna kislina bolje oprime čebel.
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Slovenian: Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi, ki nastanejo pri uporabi teh zdravil
English: Efficacy was only investigated in hives with low to moderate mite infestation rates.
Slovenian: Učinkovitost je bila raziskana le v panjih, ki so bili malo do zmerno infestirani s pršicami.
English: 1x
Slovenian: 1-krat
English: 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
Slovenian: Zdravljenje je treba izvesti ob začetku letnega časa, ko populacija kolonije narašča in naravni odpad pršic znaša več kot eno pršico na dan.
English: and when the natural mite fall is more than 4 mites per day
Slovenian: in naravni odpad pršic znaša več kot štiri pršice na dan.
English: Do not use this veterinary medicinal product after the expiry date, which is stated on the carton after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini po EXP.
English: In case of accidental spillage into the eye(s), flush the eye(s) immediately with clear running water for 10 minutes.
Slovenian: V primeru nenamernega razlitja v oči takoj začnite spirati oči s čisto tekočo vodo in jih spirajte 10 minut.
English: In case of accidental spillage onto skin, wash the affected areas immediately with running water.
Slovenian: V primeru nenamernega razlitja po koži prizadete predele takoj sperite s tekočo vodo.
English: 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 colonies in 10,000 colonies treated, including isolated reports).
Slovenian: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 kolonijah od10 zdravljenih kolonijah) - pogosti (pri več kot 1, toda manj kot 10 kolonijah od 100 zdravljenih kolonij) - občasni (pri več kot 1, toda manj kot 10 kolonijah od 1.000 zdravljenih kolonij) - redki (pri več kot 1, toda manj kot 10 kolonijah od 10.000 zdravljenih kolonij) - zelo redki (pri manj kot 1 koloniji od 10.000 zdravljenih kolonij, vključno s posamezneimi primerie).
English: Data have also shown that oxalic acid can be orally ingested by bees due to increased self-grooming after dermal application, which might lead to increased toxicity.
Slovenian: Podatki tudi kažejo, da lahko čebele oksalno kislino zaužijejo prek ust, ker se po nanosu na kožo pogosteje čistijo, kar lahko vodi k povečani toksičnosti.
English: 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.
Slovenian: Uporaba zdravila VarroMed v skladu z zgornjo shemo odmerjanja velja le za panje s pokončnimi satniki, do katerih je mogoč dostop od zgoraj, saj zdravljenje čebel v drugih vrstah panjev ni bilo raziskano.
English: 3x up to 5x
Slovenian: 3- krat do 5-krat
English: Repeated Treatments:
Slovenian: Ponovljeno zdravljenje:
English: − This veterinary medicinal product is irritating to the skin and eyes.
Slovenian: − To zdravilo draži kožo in oči.
English: Do not use during nectar flow.
Slovenian: Ne uporabljajte med čebeljo pašo.
English: To be trickled onto bees in occupied bee-spaces of the brood chamber.
Slovenian: Za nakapljanje na čebele v zasedenih čebeljih presledkih plodišča.
English: 1x or 3x
Slovenian: 1-krat ali 3krat
English: administrations).
Slovenian: Industriestr.
English: Special precautions for storage Do not store above 25 °C.
Slovenian: Posebna navodila za shranjevanje Ne shranjujte pri temperaturi nad 25 °C.
English: To avoid overdoses to individual bees, care should be taken to administer VarroMed evenly over the bees, particularly in the winter cluster.
Slovenian: Da bi preprečili preveliko odmerjanje pri posameznih čebelah je treba poskrbeti za enakomerno dajanje zdravila VarroMed po čebelah, še posebej v zimski gruči.
English: Incompatibilities: Do not mix with any other veterinary medicinal product.
Slovenian: Inkompatibilnosti Ne mešajte z nobenim drugim zdravilom.
English: decreasing colony population, and when the natural mite fall is more than 4 mites per day.
Slovenian: populacija kolonije upada in naravni odpad pršic znaša več kot štiri pršice na dan.
English: It is recommended to remove the wax bridges between the top bars of the frames before administration of the product.
Slovenian: Pred dajanjem zdravila je priporočljivo odstraniti voščene mostove med zgornjimi letvicami satnikov.
English: The multi-dose container has a graduated dosing scale for accurate dosing.
Slovenian: Za natančno odmerjanje ima večodmerni vsebnik merilno skalo.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product not subject to prescription.
Slovenian: B. POGOJI TER OMEJITVE GLEDE OSKRBE IN UPORABE Brez Rp-Vet.
English: VarroMed should not be used during the nectar flow, or when honey chambers are attached to the hive.
Slovenian: Zdravilo VarroMed se ne sme uporabljati med čebeljo pašo ali ko so na panj pritrjena medišča.
English: 5 mg/ml Oxalic acid dihydrate 44 mg/ml
Slovenian: 5 mg/ml oksalna kislina dihidrat 44 mg/ml
English: 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).
Slovenian: Zdravljenje je treba ponoviti še dvakrat (kar pomeni do največ 3 zdravljenja), če je v 6 dneh po prvem zdravljenju na dnu panja več kot 10 pršic (največ
English: Dose: Shake well before use.
Slovenian: Odmerek: Pred uporabo dobro pretresite.
English: 75 mg Oxalic acid dihydrate 660 mg
Slovenian: 75 mg Oksalna kislina dihidrat 660 mg
English: 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.
Slovenian: Zdravljenje je treba ponoviti še dvakrat (kar pomeni do največ 5 zdravljenj), če je na dnu panja v 6 dneh po tretjem dajanju več kot 150 pršic (kolonije iz drugega leta) ali več kot 90 pršic
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Formic acid
Slovenian: KOLIČINA UČINKOVIN(E) Mravljična kislina
English: 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.
Slovenian: Če pride do nenamernega prevelikega odmerjanja (npr. razlitja velike količine zdravila VarroMed v panj), sta med najboljšimi protiukrepi zamenjava naklade in čiščenje madežev disperzije, ki so vidni na satnikih, z vodo.
English: Season
Slovenian: Pomlad
English: 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.
Slovenian: Če pride do nenamernega prevelikega odmerjanja (npr. razlitja velike količine zdravila VarroMed v panj), sta med najboljšimi protiukrepi zamenjava naklade in čiščenje vseh madežev disperzije, ki so vidni na satnikih, z vodo.
English: Citric acid monohydrate Purified water
Slovenian: Citronska kislina monohidrat
English: INDICATION(S) Treatment of varroosis (Varroa destructor) in honey bee colonies with and without brood.
Slovenian: INDIKACIJA(E) Zdravljenje varoze (Varroa destructor) v kolonijah medonosnih čebel z zalego in brez nje.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box with 12 sachets
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN STIČNI OZ. PRIMARNI OVOJNINI Kartonska škatla z 12 vrečicami
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. PROIZVAJALEC (PROIZVAJALCI), ODGOVOREN ZA SPROŠČANJE SERIJ
English: Shelf life after first opening the container: 30 days
Slovenian: Rok uporabnosti po prvem odpiranju vsebnika: 30 dni.
English: The treatment should be repeated twice, 6 days apart (i.e. 3
Slovenian: Zdravljenje je treba ponoviti dvakrat v razmaku 6 dni (tj. 3 dajanja).
English: up to 5x possible in late summer/early autumn with decreasing colony population, and when the natural mite fall is more than 4 mites per day.
Slovenian: Zdravljenje je treba izvesti čim prej v poznem poletju/zgodnji jeseni, ko populacija kolonije upada in naravni odpad pršic znaša več kot štiri pršice na dan.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER PROIZVJALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ, ČE STA
English: Treatment of varroosis (Varroa destructor) in honey bee colonies with and without brood.
Slovenian: Zdravljenje varoze (Varroa destructor) v kolonijah medonosnih čebel z zalego in brez nje.
English: 44 mg (equivalent to 31.42 mg oxalic acid)
Slovenian: 44 mg (enakovredno 31,42 mg oksalne kisline, brezvodne)
English: 6.5 Nature and composition of immediate packaging Cardboard box containing an HDPE bottle with dropper nozzle (LDPE) and screw cap (with tamper evident seal).
Slovenian: Vrsta ovojnine in vsebina Kartonska škatla, v kateri je plastenka iz HDPE z nastavkom s kapalko (LDPE) in navojno zaporko (s pečatom, ki ga ni mogoče odpreti brez vidnih poškodb).
English: MARKETING AUTHORISATION NUMBER(S) EU/2/16/203/002 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 02/02/2017
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/16/203/001 DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 02/02/2017
English: 660 mg (equivalent to 471.31 mg oxalic acid)
Slovenian: 660 mg (enakovredno 471,31 mg oksalne kisline, brezvodne)
English: 15 to 30 ml
Slovenian: 15 ml od 15 do 30 ml od 30 do 45 ml
English: ADVICE ON CORRECT ADMINISTRATION
Slovenian: Nasvet o pravilni uporabi zdravila
English: Marketing authorisation holder :
Slovenian: Imetnik dovoljenja za promet z zdravilom:
English: MARKETING AUTHORISATION NUMBER(S) EU/2/16/203/002
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/16/203/002
English: PHARMACEUTICAL FORM Bee-hive dispersion.
Slovenian: FARMACEVTSKA OBLIKA Disperzija za čebeljo družino.
English: STATEMENT OF ACTIVE SUBSTANCES Each sachet contains:
Slovenian: NAVEDBA UČINKOVIN(E) Ena vrečica vsebuje:
English: Treatment should be conducted at the start of the broodless period in hives with Varroa infestation
Slovenian: Zdravljenje je treba izvesti v panjih, infestiranih z varojo, na začetku obdobja brez zalege.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/16/203/001
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/16/203/001
English: 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 accordance with the following table:
Slovenian: Pri spomladanskem ali jesenskem zdravljenju bo morda treba zdravilo VarroMed dati večkrat, v časovnih presledkih 6 dni.
English: ADVERSE REACTIONS
Slovenian: Kontraindikacije
English: Honey bees
Slovenian: Medonosne čebele
English: The bottle has a graduated dosing scale.
Slovenian: Plastenka ima merilno skalo za odmerjanje.
English: Formic acid
Slovenian: mravljična kislina
English: VarroMed should only be used as part of an integrated Varroa control programme.
Slovenian: Posebna opozorila za vsako ciljno živalsko vrsto Zdravilo VarroMed se lahko uporablja le kot del integriranega programa zatiranja varoje.
English: All colonies placed at the same location should be treated at the same time to minimize the risk of reinfestation.
Slovenian: Da kar najbolj zmanjšate tveganje za ponovno infestacijo, morate vse kolonije, nameščene na istem mestu, zdraviti hkrati.
English: SPECIAL STORAGE PRECAUTIONS
Slovenian: Posebni previdnostni ukrepi
English: Increased mortality in worker bees was very commonly observed in the clinical and preclinical trials following treatment with Varromed.
Slovenian: V kliničnih in predkliničnih preskušanjih je bila po zdravljenju z zdravilom VarroMed zelo pogosto opažena povečana umrljivost čebel delavk.
English: 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).
Slovenian: Po dajanju 10-odstotne raztopine oksalne kisline, dihidrat v 50-odstotni raztopini sladkorja so bile po
English: PACKAGE LEAFLET: VarroMed bee-hive dispersion for honey bees
Slovenian: VarroMed disperzija za čebeljo družino za medonosne čebele
English: No. of applications
Slovenian: B. NAVODILO ZA UPORABO
English: NAME OF THE VETERINARY MEDICINAL PRODUCT VarroMed 75 mg + 660 mg bee-hive dispersion for honey bees
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI VarroMed 75 mg + 660 mg disperzija za čebeljo družino za medonosne čebele
English: NAME OF THE VETERINARY MEDICINAL PRODUCT VarroMed 5 mg/ml + 44 mg/ml bee-hive dispersion for honey bees
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI VarroMed 5 mg/ml + 44 mg/ml disperzija za čebeljo družino za medonosne čebele
English: NAME OF THE VETERINARY MEDICINAL PRODUCT VarroMed bee-hive dispersion for honey bees Formic acid / oxalic acid dihydrate
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI VarroMed disperzija za čebeljo družino mravljična kislina/oksalna kislina dihidrat
English: Not applicable (single treatment only).
Slovenian: (Samo eno zdravljenje.)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT VarroMed 5 mg/ml + 44 mg/ml bee-hive dispersion Formic acid/oxalic acid dihydrate
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI VarroMed 5 mg/ml + 44 mg/ml disperzija za čebeljo družino mravljična kislina/oksalna kislina, dihidrat
English: EXPIRY DATE EXP {month/year} Once opened, use immediately.
Slovenian: Rok uporabnosti po prvem odpiranju stične ovojnine: uporabite takoj.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT VarroMed 75 mg + 660 mg bee-hive dispersion Formic acid/oxalic acid dihydrate
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI VarroMed 75 mg + 660 mg disperzija za čebeljo družino mravljična kislina/oksalna kislina, dihidrat
English: Oxalic acid dihydrate
Slovenian: Terapevtska razvrstitev oksalna kislina
English: WITHDRAWAL PERIOD(S) Honey: Zero days.
Slovenian: Karenca (med): nič dni.
English: 4.9 Amounts to be administered and administration route In-hive use.
Slovenian: 4.9 Odmerjanje in pot uporabe
English: Name and address of the manufacturer responsible for batch release
Slovenian: A. PROIZVAJALEC, ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov proizvajalca zdravila, odgovornega za sproščanje serije Lichtenheldt GmbH
English: No of applications
Slovenian: NAVODILO ZA UPORABO
English: TARGET SPECIES Honey bees.
Slovenian: Medonosne čebele.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
English: 6.5 Nature and composition of immediate packaging
Slovenian: Vrsta ovojnine in vsebina
English: N/A Bees
Slovenian: Št. čebel
English: Antiinfectious agents
Slovenian: učinkovine proti infekcijam mravljična kislina
English: PHARMACEUTICAL FORM Bee-hive dispersion
Slovenian: Disperzija za čebeljo družino
English: It may be necessary to monitor your blood.
Slovenian: Morda bo treba kontrolirati vašo kri.
English: No interaction studies have been performed.
Slovenian: Študije o medsebojnem delovanju niso bile izvedene.
English: Convulsions have been rarely reported (less than 1 every 1000 patients).
Slovenian: Redko so poročali o napadih krčev (pri manj kot enem od 1000 bolnikov).
English: Your doctor will consider what is the best treatment for you during your pregnancy.
Slovenian: Zdravnik bo presodil, kakšno zdravljenje je za vas najboljše med nosečnostjo.
English: A systematic review has also been performed involving more than 9000 cancer patients participating in 57 clinical trials.
Slovenian: Opravljen je bil tudi sistematični pregled podatkov več kot 9.000 bolnikov z rakom, ki so sodelovali v 57 kliničnih preskušanjih.
English: It acts as a mitosis stimulating factor and differentiation hormone.
Slovenian: Deluje kot dejavnik, ki stimulira mitozo, in diferenciacijski hormon.
English: Do not use any remaining liquid.
Slovenian: Ne uporabljajte preostale tekočine.
English: If these reactions occur they require the immediate attention of a physician and intensive medical care.
Slovenian: Če se pojavijo takšne reakcije, sta nemudoma potrebni zdravniška pomoč in intenzivna medicinska oskrba.
English: Pregnancy: Animal studies are insufficient with respect to effects on pregnancy (see section 5.3).
Slovenian: Nosečnost: Študije na živalih ne nudijo zadostnih podatkov, da bi lahko ugotovili, kakšne učinke ima zdravilo med nosečnostjo (glejte poglavje 5.3).