FrancophonIA/ELRC3.0 huggingface dataset:
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amended SPC, labelling and package leaflet in Annex III.
Danish: Listen over de pågældende lægemiddelnavne fremgår af bilag I. De faglige konklusioner findes i bilag II og det ændrede produktresumé, etikettering og indlægsseddel i bilag III.
English: The CHMP gave a positive opinion on 1 June 2006 recommending the harmonisation of the SPC, labelling and package leaflet for Neurontin and associated names.
Danish: Den 1. juni 2006 vedtog CHMP en positiv udtalelse, som anbefalede en harmonisering af produktresuméet, etiketteringen og indlægssedlen for Neurontin og tilknyttede navne.
English: Article 30 of Directive 2001/83/EC, in order to harmonise the nationally authorised summaries of product characteristics, PL and labelling of the medicinal product Neurontin and associated names.
Danish: Den 2. september 2004 indbragte Italien (Agencizia Italiana del Farmaco) en sag for EMEA i henhold til artikel 30 i direktiv 2001/83/EF med henblik på at harmonisere de nationalt godkendte produktresuméer, indlægssedler og etiketteringer for lægemidlet Neurontin og tilknyttede navne.
English: Local and/or systemic reactions have been observed in some people after exposure.
Danish: Lokale og/eller systemiske reaktioner er observeret hos nogle mennesker efter eksponering.
English: A dry white residue may be also observed.
Danish: Tørre hvide rester kan også ses.
English: Used pipettes should be disposed of immediately.
Danish: Brugte pipetter skal smides ud med det samme.
English: Date of first authorisation: 18/02/2011.
Danish: Dato for første markedsføringstilladelse: 18/02/2011.
English: ATCvet code: QP53AX27.
Danish: ATCvet-kode: QP53AX27.
English: Date of latest renewal: 07/01/2016.
Danish: Dato for seneste fornyelse: 07/01/2016.
English: Activyl should not enter water courses as this may be dangerous for fish and other aquatic organisms.
Danish: Activyl må ikke udledes i vandløb, da dette kan være farligt for fisk og andre organismer i vandet.
English: One pipette of Activyl delivers:
Danish: 1 pipette af Activyl giver:
English: All signs are generally reversible following supportive treatment.
Danish: Alle symptomer er generelt reversible efter understøttende behandling.
English: People with known hypersensitivity to indoxacarb should avoid contact with this product.
Danish: Personer med kendt overfølsomhed over for indoxacarb bør undgå kontakt med dette produkt.
English: Step 2: Part the hair until the skin is visible.
Danish: Trin 2: Skil hårene, indtil huden er synlig.
English: A clear, colourless to yellow solution.
Danish: En klar, farveløs til gul opløsning.
English: This is not a sign of intoxication and disappears within some minutes without treatment.
Danish: Dette er ikke et tegn på forgiftning og forsvinder uden behandling efter nogle minutter.
English: Interaction with other medicinal products and other forms of interaction: Consult a veterinarian if you intend to use the product on cats with other products or medication.
Danish: Interaktion med andre lægemidler og andre former for interaktion: Kontakt en dyrlæge, hvis du påtænker at bruge produktet til katte, der får andre produkter eller lægemidler.
English: Minimum of 15
Danish: Minimum 15
English: Absorption through the skin also occurs, but this systemic absorption is partial and not relevant for the clinical efficacy.
Danish: Der sker absorption igennem huden, men den systemiske absorption er kun delvis og ikke relevant for den kliniske virkning.
English: Ethyl acetoacetate Isopropyl alcohol.
Danish: Ethyl acetoacetat Isopropylalkohol
English: This results in a rapid cessation of feeding within 0 to 4 hours after treatment followed by cessation of egg laying (oviposition), paralysis and death occurring within 4 to 48 hours.
Danish: Dette medfører et hurtigt indsættende stop for fødeindtagelse inden for 0-4 timer efter behandling, efterfulgt af et stop i æglægning, paralyse og død inden for 4-48 timer.
English: Do not eat, drink or smoke while handling the veterinary medicinal product.
Danish: Spis, drik og ryg ikke samtidig med, at dette veterinærlægemiddel håndteres.
English: Efficacy against new infestations with fleas persists for 4 weeks following a single application.
Danish: Effekt over for nye loppeinfestationer opretholdes i 4 uger efter en enkelt applikation.
English: In clinical studies, Activyl was co-administered with deltamethrin collars impregnated with up to 4% deltamethrin without evidence of associated adverse reactions.
Danish: I kliniske undersøgelser blev Activyl administreret samtidigt med deltamethrin-halsbånd, imprægneret med op til 4% deltamethrin, uden tegn på relaterede bivirkninger.
English: The pipette consists of a blister film (polypropylene/cyclic-olefin-copolymer/polypropylene) and a foil lidstock (aluminium/polypropylene co-extruded) sealed into aluminium sachets.
Danish: Pipetten består af en blisterfilm (polypropylen/cyclic-olefin-copolymer/polypropylen) og et folielåg (aluminium-polypropylen co-ekstruderet) forseglet i aluminiumsbreve.
English: One size of unit-dose pipette only per box.
Danish: Kun en størrelse enkeltdosispipetter pr. æske.
English: Consult a veterinarian if you intend to use the product on dogs with other products or medication.
Danish: Kontakt en dyrlæge, hvis du påtænker at bruge produktet til hunde, der får andre produkter eller lægemidler.
English: In larger dogs, the entire contents of the pipette(s) should be applied evenly to 2-4 spots along the backline from the shoulder to the base of the tail.
Danish: Hos store hunde bør hele indholdet af en eller flere pipetter fordeles ligeligt på 2 - 4 steder langs ryggens midtlinje fra skulderen til haleroden.
English: Treatment and prevention of flea infestation (Ctenocephalides felis).
Danish: Forebyggelse og behandling af loppeangreb (Ctenocephalides felis).
English: Ensure that animals do not groom each other immediately following treatment.
Danish: Endvidere skal man sikre sig, at dyrene ikke slikker på hinanden umiddelbart efter behandlingen.
English: Squeeze the pipette firmly and apply the entire contents directly to the skin.
Danish: Klem fast om pipetten og påfør hele indholdet direkte på huden.
English: Intervet International BV
Danish: Intervet International B.V.
English: A proper treatment of the pet´s environment by additional chemical or physical measures is recommended.
Danish: Derudover anbefales en grundig behandling af kæledyrets omgivelser med kemiske midler eller andet udstyr.
English: The bioactivated metabolite acts as a voltage-dependent sodium channel antagonist in insects, by blocking the sodium channels that regulate the flow of sodium ions in the insect's nervous system.
Danish: Hos insekter virker den bioaktiverede metabolit som en spændingsafhængig natriumkanal-antagonist ved at blokkere de natriumkanaler, som regulerer natriumionernes passage i insektets nervesystem.
English: Developing stages of fleas in the pet's immediate surroundings are killed following contact with Activyl treated pets.
Danish: Loppens forskellige udviklingsstadier, der findes i kæledyrets nærmeste omgivelser, bliver dræbt, når de kommer i kontakt med Activyl-behandlede dyr.
English: • wash hands immediately after use and wash off any product in contact with the skin immediately with soap and water;
Danish: • vask hænder straks efter brug og vask straks med vand og sæbe, hvis lægemidlet kommer i kontakt med huden
English: 6.6 - 10 Small dogs
Danish: 6,6 - 10 Små hunde
English: • do not handle recently treated animals until the application site is dry;
Danish: • berør ikke nyligt behandlede dyr, før påføringsstedet er tørt
English: The veterinary medicinal product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
Danish: Det veterinære lægemiddel kan anvendes som del af en behandlingsstrategi til kontrol af loppebetinget allergisk dermatitis (flea allergy dermatitis, FAD).
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals ) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Danish: Hyppigheden af bivirkninger er defineret som: - meget almindelige (mere end 1 ud af 10 dyr får bivirkninger i løbet af en behandling) - almindelige (mere end 1, men færre end 10 dyr ud af 100 dyr) - ualmindelige (mere end 1, men færre end 10 dyr ud af 1.000 dyr) - sjældne (mere end 1, men færre end 10 dyr ud af 10.000 dyr) - meget sjældne (færre end 1 dyr ud af 10.000 dyr, herunder isolerede rapporter).
English: One ml contains 195 mg indoxacarb.
Danish: 1 ml indeholder 195 mg indoxacarb.
English: Treatment and prevention of flea infestations.
Danish: Til behandling og forebyggelse af loppeangreb.
English: The product remains effective following shampoo treatment, water immersion (swimming, bathing) and exposure to sunlight.
Danish: Produktet forbliver effektivt efter vask med shampoo, vandgang (svømning, badning) og udsættelse for sollys.
English: After being converted into a metabolite, indoxacarb is active against adult, larval and egg stages of insects.
Danish: Efter at være omdannet til en metabolit, er indoxacarb aktivt over for voksne, larvestadier og æg af insekter.
English: For dogs: Veterinary medicinal product not subject to prescription.
Danish: Hunde: Lægemidlet er ikke veterinærreceptpligtigt.
English: Do not use after the expiry date stated on the carton, foil and pipette after “EXP”.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på æsken, aluminiumsfoliebrevet og pipetten efter “EXP”.
English: Following a single spot-on application of the product, indoxacarb can still be detected in both skin and hair coat after 4 weeks post-treatment.
Danish: Efter en enkelt spot-on dosering af produktet kan indoxacarb stadig findes i både hud og hår 4 uger senere.
English: The safety of the product has not been established in cats weighing less than 0.6 kg.
Danish: Sikkerheden af produktet er ikke fastlagt hos katte, der vejer mindre end 0,6 kg.
English: The product should not be used in dogs younger than 8 weeks of age as the safety of the product has not been established in these dogs.
Danish: Produktet bør ikke anvendes til hunde yngre end 8 uger, da sikkerheden af lægemidlet ikke er fastlagt hos disse hunde.
English: The appropriate combination of pipettes should be used
Danish: > 60 Den rette kombination, af pipetter bør anvendes
English: The product should not be used in dogs weighing less than 1.5 kg as the safety of the product has not been established in these dogs.
Danish: Produktet bør ikke anvendes til hunde, der vejer mindre end 1,5 kg, da sikkerheden af lægemidlet ikke er fastlagt hos disse hunde.
English: Cats ≤ 4 kg
Danish: Katte ≤ 4 kg
English: insecticides: indoxacarb.
Danish: insekticider: indoxacarb.
English: Do not give the product by mouth or any other route.
Danish: Produktet må ikke indgives gennem munden eller via nogen anden indgivelsesvej.
English: No adverse effects were observed in dogs aged 8 weeks or older when administered 5 times the recommended dose on 8 occasions at 4 weeks intervals or administered 5 times the recommended dose on 6 occasions at 2 weeks intervals.
Danish: Der blev ikke set bivirkninger hos hunde i alderen 8 uger eller ældre, som blev behandlet enten med 5 gange den anbefalede dosis 8 gange med 4 ugers interval, eller med 5 gange den anbefalede dosis 6 gange med 2 ugers interval.
English: The safety of the product has not been established in cats younger than 8 weeks of age.
Danish: Sikkerheden af produktet er ikke fastlagt hos katte yngre end 8 uger.
English: No adverse effects were observed in cats aged 8 weeks or older when administered 5 times the recommended dose on 8 occasions at 4 weeks intervals or administered 5 times the recommended dose on 6 occasions at 2 weeks intervals.
Danish: Der blev ikke set bivirkninger hos katte i alderen 8 uger eller ældre, som blev behandlet enten med 5 gange den anbefalede dosis 8 gange med 4 ugers interval, eller med 5 gange den anbefalede dosis 6 gange med 2 ugers interval.
English: Cats > 4 kg
Danish: Katte > 4 kg
English: Apply the product only to the skin surface and on intact skin.
Danish: Produktet skal kun påføres på hudoverfladen og på uskadt hud.
English: The recommended dose is 15 mg indoxacarb/kg body weight, equivalent to 0.077 ml/kg body weight.
Danish: Den anbefalede dosis er 15 mg indoxacarb/kg kropsvægt, svarende til 0,077 ml/kg kropsvægt.
English: Hold the pipette in an upright position away from your face.
Danish: Hold pipetten med spidsen opad og pegende væk fra dit ansigt.
English: In the mid-gut of susceptible insect species, the insect's enzymes remove the carbomethoxy group from parent indoxacarb, and convert it into its biologically active form.
Danish: I det midterste tarmstykke hos følsomme insekter, spalter insektets enzymer en carboxymetylgruppe fra modersubstansen til indoxacarb, som derved omdannes til sin bioaktive form.
English: Indoxacarb is a pro-drug that requires bioactivation by the insect enzymes to exert its pharmacodynamic effects.
Danish: Indoxacarb er et pro-drug, som skal aktiveres af insekternes egne enzymer, før det kan udøve sin farmakodynamiske virkning.
English: The absorbed indoxacarb is extensively metabolised by the liver to a variety of metabolites.
Danish: Den absorberede indoxacarb metaboliseres i udstrakt grad i leveren til en lang række metabolitter.
English: EU/02/10/118/003 EU/02/10/118/004 EU/02/10/118/005 EU/02/10/118/006 EU/02/10/118/007 EU/02/10/118/008 EU/02/10/118/009 EU/02/10/118/010 EU/02/10/118/015 EU/02/10/118/016 EU/02/10/118/017 EU/02/10/118/018 EU/02/10/118/019
Danish: EU/02/10/118/001 EU/02/10/118/002 EU/02/10/118/003 EU/02/10/118/004 EU/02/10/118/005 EU/02/10/118/006 EU/02/10/118/007 EU/02/10/118/008 EU/02/10/118/009 EU/02/10/118/010 EU/02/10/118/015 EU/02/10/118/016 EU/02/10/118/017 EU/02/10/118/018 EU/02/10/118/019
English: Place the pipette tip against the skin between the shoulder blades.
Danish: Placér pipettespidsen mod huden mellem hundens skulderblade.
English: The recommended dose is 25 mg indoxacarb/kg body weight, equivalent to 0.128 ml/kg body weight.
Danish: Den anbefalede dosis er 25 mg indoxacarb/kg kropsvægt, svarende til 0,128 ml/kg kropsvægt.
English: Step 1: The dog should be standing for easy application.
Danish: Trin 1: Hunden bør stå op for at lette påføringen.
English: Apply the dose to an area where the dog cannot lick it off and ensure that animals do not groom each other following treatment.
Danish: Påfør dosis på et område, hvor hunden ikke kan slikke det af og sørg for, at dyr ikke slikker på hinanden efter behandlingen.
English: All cats in a household should be treated with a suitable flea product.
Danish: Alle katte i husstanden bør behandles med et egnet loppemiddel.
English: Do not apply an excessive amount of solution at any one spot in order to prevent run-off.
Danish: Undgå at påføre for meget af produktet på et enkelt sted, for at sikre, at det ikke løber.
English: Isopropyl alcohol 354 mg/ml.
Danish: Isopropylalkohol 354 mg/ml.
English: • avoid contact with eyes, as the product may cause moderate eye irritation.
Danish: • undgå kontakt med øjnene, da lægemidlet kan forårsage moderat øjenirritation; hvis det sker, skylles øjnene langsomt og forsigtigt med vand.
English: One unit-dose pipette holds 0.51 ml, 0.77 ml, 1.54 ml, 3.08 ml or 4.62 ml spot-on solution.
Danish: Hver enkeltdosispipette indeholder 0,51 ml, 0,77 ml, 1,54 ml, 3,08 ml eller 4,62 ml spot-on, opløsning.
English: The application of the veterinary medicinal product may produce a local, temporary oily appearance or hair clumping at the application site.
Danish: Anvendelse af det veterinære lægemiddel kan resultere i dannelsen af et lokalt midlertidigt fedtet udseende eller sammenfiltring af hårene på applikationsstedet.
English: Keep away from heat, sparks, open flame or other sources of ignition.
Danish: Må ikke opbevares i nærheden af varme, gnister, åben ild eller andre antændelseskilder.
English: Keep pipettes in the original packaging until ready to use.
Danish: Opbevar pipetterne i den originale emballage indtil lige før brug.
English: Apply the dose to an area where the cat cannot lick it off and ensure that animals do not groom each other following treatment.
Danish: Dosis skal påføres på et område, hvor katten ikke kan slikke det af, og det skal sikres, at dyr ikke slikker på hinanden efter behandlingen.
English: Keep away from heat, sparks, open flame or other source of ignition.
Danish: Må ikke opbevares i nærheden af varme, gnister, åben ild eller anden antændingskilde.
English: Following a single administration, the veterinary medicinal product will prevent further flea infestation for 4 weeks.
Danish: Behandlingsskema: En enkelt behandling med det veterinære lægemiddel vil forhindre yderligere loppeangreb i 4 uger.
English: Correct application (see section 4.9) will minimise licking of the application site.
Danish: 4.9) vil minimere slikken på applikationsstedet.
English: Minimum of 25
Danish: 0,51 Minimum 25
English: One unit-dose pipette holds 0.51 ml or 1.03 ml spot-on solution.
Danish: Hver enkeltdosispipette indeholder 0,51 ml eller1,03 ml spot-on, opløsning.
English: Special precautions for use in animals:
Danish: Særlige forsigtighedsregler vedrørende brug hos dyr:
English: Pregnancy and Fertility: Do not use on pregnant cats and breeding cats.
Danish: Drægtighed og fertilitet: Må ikke anvendes til drægtige katte og avlskatte.
English: Step 1: The cat should be standing for easy application.
Danish: Trin 1: Katten skal stå op for at lette påføringen.
English: Also contains isopropyl alcohol 354 mg/ml.
Danish: Indeholder også isopropylalkohol 354 mg/ml.
English: Activyl for small cats (≤ 4 kg) Activyl for large cats (> 4 kg)
Danish: Activyl til små katte (≤ 4 kg) Activyl til store katte (> 4 kg)
English: Indoxacarb is an ectoparasiticide belonging to the oxadiazine chemical family.
Danish: Indoxacarb er et ektoparasitært middel med insekticid virkning tilhørende gruppen af oxadiazinforbindelser.
English: Special precautions for use in animals: Ensure that the dosage (pipette) corresponds to the weight of the treated cat (see section 8).
Danish: Særlige forsigtighedsregler vedrørende brug hos dyr: Det skal sikres, at doseringen (pipetten) svarer til vægten af katten, der skal behandles (se pkt.
English: In rare cases, neurological signs (e.g. incoordination, tremor, ataxia, convulsions, mydriasis and impaired vision) have been observed.
Danish: I sjældne tilfælde er der observeret neurologiske symptomer (fx manglende koordination, tremor, ataksi, konvulsioner, mydriasis og nedsat synsevne).
English: In fleas, in addition to its adulticidal activity, indoxacarb activity on the developing larval stages in the immediate surroundings of the treated pet has been demonstrated.
Danish: Ud over at være dræbende for voksne lopper er indoxacarbs virkning på de af loppens larvestadier, der befinder sig i det behandlede dyrs umiddelbare omgivelser, også blevet påvist.
English: To be supplied only on veterinary prescription.
Danish: Katte: Må kun udleveres efter veterinærrecept.
English: Other signs observed include emesis in rare cases or anorexia, lethargy, hyperactivity and vocalisation in very rare cases.
Danish: Andre symptomer, som er observeret, omfatter emese (set i sjældne tilfælde) eller anoreksi, letargi, hyperaktivitet og vokalisation (set i meget sjældne tilfælde).
English: Volume (ml) Indoxacarb (mg)
Danish: Volumen (ml) Indoxacarb (mg)
English: For application to the cat's skin only.
Danish: Kun til anvendelse på kattens hud.
English: PACKAGE LEAFLET Activyl spot-on solution for dogs
Danish: INDLÆGSSEDDEL TIL: Activyl spot-on, opløsning, til hunde
English: Marketing authorisation holder: Intervet International BV Wim de Körverstraat 35
Danish: Indehaver af markedsføringstilladelsen: Intervet International B.V.
English: Store the pipettes in the original package in order to protect from moisture.
Danish: Opbevar pipetterne i den originale emballage for at beskytte mod fugt.
English: Dogs 1.5 - 6.5 kg Dogs 6.6 - 10 kg Dogs 10.1 - 20 kg Dogs 20.1 - 40 kg Dogs 40.1 - 60 kg
Danish: Hunde 1,5 - 6,5 kg Hunde 6,6 - 10 kg Hunde 10,1 - 20 kg Hunde 20,1 - 40 kg Hunde 40,1 - 60 kg
English: Place the pipette tip against the skin at the base of the skull, where the cat cannot lick it off.
Danish: Placér pipettespidsen mod huden i nakken, der hvor man kan mærke, kraniet slutter, hvor katten ikke kan slikke det af.
English: Lactation: Do not use on lactating cats.
Danish: Laktation: Må ikke anvendes til diegivende katte.
English: Lactation: Do not use on lactating dogs.
Danish: Laktation: Må ikke anvendes til diegivende hunde.
English: 1.5 - 6.5 Very small dogs
Danish: 1,5 - 6,5 Miniaturehunde
English: This product is for skin application on dogs only.
Danish: Dette produkt er kun til anvendelse på hundens hud.
English: Small cats
Danish: ≤ 4 Små katte
English: This product is for skin application on cats only.
Danish: Dette produkt er kun til anvendelse på kattens hud.
English: Other signs observed include emesis (vomiting) in rare cases or anorexia (loss of appetite), lethargy (drowsiness), hyperactivity and vocalisation in very rare cases.
Danish: Andre symptomer, som er observeret, omfatter emese (opkastning), som er set i sjældne tilfælde, eller anoreksi (appetitløshed), letargi (søvnlignende sløvhedstilstand), hyperaktivitet og hylen (set i meget sjældne tilfælde).
English: However, animals should not be allowed to swim or treated with shampoo within 48 hours after treatment.
Danish: Imidlertid bør dyr i de første 48 timer efter behandling ikke svømme eller vaskes med shampoo.
English: Care should be taken to avoid the product coming into contact with the eyes of the dog.
Danish: Man bør omhyggeligt undgå, at produktet kommer i kontakt med hundens øjne.
English: In very rare cases, a brief period of hypersalivation may occur if the animal licks the application site immediately after treatment.
Danish: I meget sjældne tilfælde kan der forekomme en kort periode med hypersalivation, hvis dyret umiddelbart efter behandling slikker på applikationsstedet.
English: Care should be taken to avoid the product coming into contact with the eyes of the cat.
Danish: Man bør omhyggeligt undgå, at produktet kommer i kontakt med kattens øjne.
English: Unit dose (ml) Indoxacarb (mg)
Danish: Enkeltdosis (ml) Indoxacarb (mg)
English: Activyl 100 mg for small cats Activyl 200 mg for large cats
Danish: Activyl 100 mg til små katte Activyl 200 mg til store katte
English: Activyl for very small dogs (1.5 - 6.5 kg) Activyl for small dogs (6.6 - 10 kg) Activyl for medium dogs (10.1 - 20 kg) Activyl for large dogs (20.1 - 40 kg) Activyl for extra large dogs (40.1 - 60 kg)
Danish: Activyl til miniaturehunde (1,5 - 6,5 kg) Activyl til små hunde (6,6 - 10 kg) Activyl til mellemstore hunde (10,1 - 20 kg) Activyl til store hunde (20,1 - 40 kg) Activyl til ekstra store hunde (40,1 - 60 kg)
English: In rare cases, neurological signs, such as incoordination, tremor (shakiness), ataxia (unsteady movement), convulsions, mydriasis (pupil dilation) and impaired vision, have been observed.
Danish: I sjældne tilfælde er der observeret symptomer fra nervesystemet såsom manglende koordination, tremor (rysten), ataksi (manglende muskelkontrol), kramper, mydriasis (unaturlig udvidelse af pupillerne) og nedsat synsevne.
English: Large cats
Danish: > 4 Store katte
English: However, cats should not be allowed to swim or treated with shampoo within 48 hours after treatment.
Danish: Imidlertid bør katten i de første 48 timer efter behandling ikke svømme eller vaskes med shampoo.
English: However, dogs should not be allowed to swim or treated with shampoo within 48 hours after treatment.
Danish: Imidlertid bør hunden i de første 48 timer efter behandling ikke svømme eller vaskes med shampoo.
English: Lactation: Do not use during lactation.
Danish: Må ikke anvendes under laktation.