ABIDEC MULTIVITAMIN

Main information

  • Trade name:
  • ABIDEC MULTIVITAMIN
  • Pharmaceutical form:
  • Oral Drops Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ABIDEC MULTIVITAMIN
    Ireland
  • Language:
  • English

Other information

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA1562/050/001
  • Authorization date:
  • 22-07-2011
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage,interactions,side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AbidecMultivitaminOralDropsSolution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

AbidecMultivitaminDropscontains1333IUretinol(asvitaminApalmitate),400IUergocalciferol,0.4mgthiamine

hydrochloride,0.8mgriboflavinsodiumphosphate,0.8mgpyridoxinehydrochloride,8mgnicotinamide,and40mg

ascorbicacidineach0.6mldose.

Excipients-containssucroseandarachisoil(refinedpeanutoil)

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Oraldrops,solution

ProductimportedfromtheUK:

Ayellowtoorangebrownoraldrops,solutionwhichdarkensuponstorage,withsomecloudiness.

4CLINICALPARTICULARS

4.1TherapeuticIndications

AbidecMultivitaminDropsisindicatedforthepreventionofvitamindeficienciesandforthemaintenanceofnormal

growthandhealthduringtheearlyyearsofinfancyandchildhood;multivitaminsupplement.

4.2Posologyandmethodofadministration

Adultsandchildrenover12years:

Notappropriate.

Childrenaged1to12years:

Oral.

One0.6mldosetakendaily.

Maximumdailydose:0.6ml.

Childrenunder1year:

Oral.

One0.3mldosetakendaily.

Maximumdailydose:0.3ml.

TheElderly:

Notappropriate.

Hepatic/renaldysfunction:

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4.3Contraindications

AbidecMultivitaminDropsiscontra-indicatedinindividualswithknownhypersensitivitytotheproductoranyofits

componentsincludingpeanutoil.

VitaminApalmitatecontainsrefinedpeanutoil(Arachisoil)andshouldnotbetakenbypatientsknowntobeallergic

topeanut.Asthereisapossiblerelationshipbetweenallergytopeanutandallergytosoya,patientswithsoyaallergy

shouldalsoavoidAbidecMultivitaminDrops.

4.4Specialwarningsandprecautionsforuse

WhenprescribingAbidecMultivitaminDrops,aswithallmultivitaminpreparations,allowanceshouldbemadefor

vitaminsobtainedfromothersources.

WhilechildrenaretakingAbidecMultivitaminDropsnoothervitaminsupplementcontainingvitaminsAandD

shouldbetakenunlessundermedicalsupervision.

Thismultivitaminsupplementshouldnotbegiventobabieswhoarereceivingmorethan500mlsofformulamilkper

daytoavoidexceedingthesafeupperlimitofVitaminA.

ExcessivedosageofvitaminAandDmayleadtohypervitaminoses.Dueallowanceshouldalwaysbemadeforintake

ofthesevitaminsfromothersources.

Patientswithrarehereditaryproblemsoffructoseintolerance,glucose-galactosemalabsorptionorsucrase-isomaltase

insufficiencyshouldnottakethismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

None.

4.6Fertility,pregnancyandlactation

Notindicatedinthisagegroup.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

VitaminApalmitate

Adverseeffectsareextremelyrareatdailydosesoflessthan9mg.(16363.6IU).

Ergocalciferol(VitaminD

2 )

TheonlyknownadverseeffectsofvitaminDoccurwhenexcessivedosesaretaken.Adverseeffectsarenotanticipated

atthequantitypresentinAbidecMultivitaminDrops.

AscorbicAcid(C),Nicotinamide,Pyridoxine(B

6 ),Riboflavin(B

2 )&Thiamine(B

1 )

Thesewatersolublevitaminsaregenerallynontoxiccompoundswithawidemarginofsafety,theexcessamounts

beingrapidlyexcretedintheurine.AdverseeffectsarenotanticipatedatthequantitiespresentinAbidecMultivitamin

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4.9Overdose

Symptomsandsigns

AbidecMultivitaminDropscontainslevelsofvitaminswhichpresentlittleriskofoverdose.

VitaminApalmitate

AcuteadministrationofhighdosesofvitaminAcancauseheadache,nausea,vomitingandirritability.Ininfantsacute

toxicitycanleadtotransienthydrocephalus.Alltheseeffectsdisappearwithin24hoursoftakingretinol.

Ergocalciferol(VitaminD

2 )

ExcessivedosesofvitaminD,60000unitsperday,canresultinhypercalcaemiaandhypercalciuria.Adverseeffects

ofhypercalcaemiamayincludemuscleweakness,apathy,headache,anorexia,nauseaandvomiting,hypertensionand

cardiacarrhythmias.

Thiaminehydrochloride(VitaminB

1 )

Whentakenorally,thiamineisnon-toxic.Iflargedosesareingestedtheyarenotstoredbythebodybutexcreted

unchangedbythekidneys.

Riboflavin(VitaminB

2 )

Riboflavinhasbeenfoundtobepracticallynon-toxic.

Pyridoxinehydrochloride(VitaminB

6 )

Acutedoseslessthan500mgperdayappeartobesafe.Excessivedosesmaylowerserumfolateconcentrations.

Sensoryneuropathyhasbeendescribedwithchronicdosingof200mgdaily.

Nicotinamide

Asinglelargeoverdoseofnicotinamideisunlikelytohaveseriousilleffects,throughtransientabnormalitiesofliver

functionmightoccur.

Ascorbicacid(VitaminC)

Ascorbicacidisnotstoredtoagreatextentbythebody,anyexcessamountsareeliminatedintheurine.Ascorbicacid

isthoughtobecometoxicatchronicdosesinexcessof6g.

Treatment

Treatmentshouldbesupportiveandsymptomatic.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

VitaminApalmitate

VitaminAplaysanessentialroleinthefunctionoftheretina,thegrowthandfunctionofepithelialtissue,bone

growth,reproductionandembryonicdevelopment.

Ergocalciferol(VitaminD

2 )

VitaminDisaregulatorofbothcalciumandphosphatehomeostasis.

Thiaminehydrochloride(VitaminB

1 )

VitaminB

isessentialforpropercarbohydratemetabolismandplaysanessentialroleinthedecarboxylationofalpha

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Riboflavin(VitaminB

2 )

Riboflavinisessentialfortheutilisationofenergyfromfood.Itisacomponentofco-enzymeswhichplayanessential

roleinoxidative/reductivemetabolicreactions.Riboflavinisalsonecessaryforthefunctioningofpyridoxineand

nicotinicacid.

Pyridoxinehydrochloride(VitaminB

6 )

VitaminB

isaconstituentoftheco-enzymes,pyridoxalpyrophosphateandpyridoxaminephosphate,bothofwhich

playanimportantroleinproteinmetabolism.

Nicotinamide

Nicotinamideisanessentialcomponentofco-enzymesresponsibleforpropertissuerespiration.

Ascorbicacid(VitaminC)

Ascorbicacidisawatersolublevitaminandapowerfulantioxidant.Itisacofactorinnumerousbiologicalprocesses,

suchasthemetabolismoffolicacid,aminoacidoxidationandtheabsorptionandtransportofiron.Itisalsorequired

fortheformation,maintenanceandrepairofintercellularcementmaterial.Ascorbicacidisimportantinthedefence

againstinfection,thenormalfunctioningofT-lymphocytesandfortheeffectivephagocyticactivityofleucocytes.It

alsoprotectscellsagainstoxidationdamagetoessentialmolecules.

5.2Pharmacokineticproperties

Absorption

VitaminsA,B

,B

,B

,C,D

andnicotinamidearewellabsorbedfromthegastro-intestinaltract.

Distribution

ThevitaminspresentinAbidecMultivitaminDropsarewidelydistributedtoalltissuesinthebody.

Metabolismandelimination

VitaminApalmitate

VitaminApalmitateishydrolysedintheintestinallumentoretinolwhichisthenabsorbed.

Retinolcirculatesinthebloodboundtoretinolbindingproteinwhichprotectsitfromglomerularfiltration.The

complexcirculatestotargettissueswherethevitaminisreleased,permeatesthecellandbindsintracellularlytocellular

retinolbindingprotein.Oftheabsorbedretinol20-50%iseitherconjugatedoroxidisedtovariousproductsand

excretedoveramatterofdaysintheurineandfaeces,whiletheremainderisstored.Thisstoredretinolisgradually

metabolisedbytheliverandperipheraltissues.

Ergocalciferol(VitaminD

2 )

VitaminDcirculatesinthebloodassociatedwithvitaminDbindingprotein.Itisstoredinfatdeposits.Ergocalciferol

ishydroxylatedintheliverandgutto25-hydroxycholecalciferolwhichisthenfurthermetabolisedinthekidneytothe

activeform1,25-dihydroxycholecalciferolandotherhydroxylatedmetabolites.Ergocalciferolanditsmetabolitesare

excretedlargelyinbilewitheventualeliminationinthefaeces,withonlysmallamountsofsomeofthemetabolites

appearingintheurine.

Thiaminehydrochloride(VitaminB

1 )

Thiaminehasaplasmahalflifeof24hoursandisnotstoredtoanygreatextentinthebody.Excessingestedthiamine

isexcretedintheurineaseitherthefreevitaminorasthemetabolite,pyrimidine.

Riboflavin(VitaminB

2 )

Followingabsorptionriboflavinisconvertedintothecoenzymes:flavinmononucleotide(FMN)andflavinadenine

dinucleotide(FAD).Riboflavinisnotstoredinbodytissuetoanygreatextentandamountsinexcessofthebody’s

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Date Printed 21/09/2011 CRN 2105463 page number: 4

Pyridoxinehydrochloride(VitaminB

6 )

Thehalflifeofpyridoxinerangesfrom15-20days.OnceabsorbedvitaminB

isconvertedtoitsactiveco-enzyme

frompyridoxal5-phosphate.Muscleisthemajorstoragesiteforpyridoxal5-phosphate.Itisdegradedintheliverto4-

pyridoxicacidwhichiseliminatedbythekidneys.

Nicotinamide

Nicotinamideisreadilytakenupintotissuesandutilisedforthesynthesisofthecoenzymeformsnicotinamideadenine

dinucleotide(NAD)andnicotinamideadeninedinucleotidephosphate(NADP).

Nicotinamideisdegradedintheliverandotherorganstoanumberofproductsthatareexcretedintheurine,themajor

metabolitesbeingN-methyl-2-pyridone-5-carboxamideandn-methylnicotinamide.

Ascorbicacid(VitaminC)

Ascorbicacidreachesamaximumplasmaconcentration4hoursfollowingoraladministrationafterwhichthereis

rapidurinaryexcretion.Followingoraladministration60%ofthedoseisexcretedin24hourseitherasascorbicacidor

itsmetabolitedihydroascorbicacid.

PharmacokineticsinRenalImpairment

TherehavebeennospecificstudiesofAbidecMultivitaminDropsinrenalimpairment.

PharmacokineticsintheElderly

Notappropriate.

5.3Preclinicalsafetydata

Mutagenicity

Thereisinsufficientinformationtodeterminethemutagenicpotentialoftheactiveingredients.However,verylarge

dosesofvitaminCareclaimedtobemutagenic.

Carcinogenicity

Thereisinsufficientinformationtodeterminethecarcinogenicpotentialoftheactiveingredients.

Teratogenicity

HighdosesofvitaminDareknowntobeteratogenicinexperimentalanimals,butdirectevidenceforthisislackingin

humans.TheteratogenicityofvitaminAinanimalsiswellknown,bothhighandlowlevelsofthevitaminresultin

defects.Butsignificanceofthisforhumansisindispute.SyntheticversionsofvitaminA(IsotretinoinandEtretinate)

havebeenshowntobepowerfulteratogens.Thereisinsufficientinformationtodeterminetheteratogenicpotentialof

theactiveingredients.

Fertility

Notappropriate.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sodiumhydroxide

Sucrose

Refinedpeanutoil(acarrierforVitaminApalmitate)

Polysorbate60

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Date Printed 21/09/2011 CRN 2105463 page number: 5

6.2Incompatibilities

Noneknown.

6.3Shelflife

Theshelflifeexpirydateforthisproductshallbethedateshownonthebottleandouterpackageoftheproductonthe

marketinthecountryoforigin.

Onceopenedusewithin4weeks.

6.4Specialprecautionsforstorage

Donotstoreabove25 o

C.Keepthebottleintheoutercartontoprotectfromlight.

6.5Natureandcontentsofcontainer

AbidecMultivitaminDropsarepresentedinanamberTypeIIIglassbottle,withaROPPaluminiumcapcontaininga

PET/Aluminium/Polyethylene/ExpandedPolyethylenelaminatedwad.

One25mlbottleenclosedinaprintedcardboardcartonwithonepolyethylene/polystyrenesyringegraduatedat0.3ml

and0.6ml.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Washanddrysyringethoroughlyafteruse(notinasteamsteriliser).

Makesurenowaterisleftinside.

Resealthebottlewithoriginalcapaftereachuse.

Storesyringeinacleandryplace.Thesyringeisforusewiththisproductonly.

7PARALLELPRODUCTAUTHORISATIONHOLDER

LTTPharmaLimited

Unit18,OxleasowRoad

EastMoonsMoat

Redditch

WorcestershireB980RE

UnitedKingdom

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA1562/50/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:22 nd

July2011

Irish Medicines Board

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22-3-2019

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Published on: Thu, 21 Mar 2019 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on l‐lysine monohydrochloride and l‐lysine sulfate produced using Corynebacterium glutamicum CCTCC M 2015595 when used as nutritional additive in feed and water for drinking for all animal species. The active substance is l‐lysine and it is produced in two different forms (monohydrochloride or sulfate). O...

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Safety and efficacy of l‐lysine monohydrochloride and concentrated liquid l‐lysine (base) produced by fermentation using Corynebacterium glutamicum strain NRRL B‐50775 for all animal species based on a dossier submitted by ADM

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Published on: Thu, 31 Jan 2019 The European Commission asked EFSA for an opinion on the safety for the target animals, consumer, user and the environment and on the efficacy of a l‐lysine monohydrochloride (HCl, minimum 98.5%) and of a concentrated liquid l‐lysine (base, minimum 50%) produced by a genetically modified strain of Corynebacterium glutamicum(NRRL B‐50775). They are intended to be used in feed or water for drinking for all animal species and categories. Neither the production strain C. gluta...

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Opinion/decision on a Paediatric investigation plan (PIP): Macrogol 3350,sodium sulfate,sodium chloride,sodium ascorbate,potassium chloride (NER1006),Ascorbic acid, decision type: , therapeutic area: , PIP number: P/0315/2018

Opinion/decision on a Paediatric investigation plan (PIP): Macrogol 3350,sodium sulfate,sodium chloride,sodium ascorbate,potassium chloride (NER1006),Ascorbic acid, decision type: , therapeutic area: , PIP number: P/0315/2018

Opinion/decision on a Paediatric investigation plan (PIP): Macrogol 3350,sodium sulfate,sodium chloride,sodium ascorbate,potassium chloride (NER1006),Ascorbic acid, decision type: , therapeutic area: , PIP number: P/0315/2018

Europe - EMA - European Medicines Agency