I-L-Methylfolate calcium

I-L-Methylfolate calcium

Igama lesiqhelo: levomefolate calcium
Ifomu yesisindo: tablet, wawutyabeka
Udidi lweziyobisi: Iivithamini

By Uhlaziyo lweMedia; Ukuhlaziywa ngu-Varixcare.cz. Igqityelwe ukuvuselelwa ngoJulayi 22, 2021.

Ipilisi emhlophe ejikelezayo 4008

Iphepha elichazayo ukuba awusenanto oyifunayo: Eli chiza alikafunyanwa yi-FDA ukuba likhuseleke kwaye lisebenze, kwaye le lebhile ayamkelwanga yi-FDA. Ngolwazi oluthe kratya malunga neziyobisi ezingavunyelwanga, cofa apha.



Kweli Phepha
Yandisa

Rx

Isongezelelo sokutya

Inkcazo yeCalcium ye-L-Methylfolate

I-L-Methylfolate Calcium 7.5 mg sisongezo sokutya esisetyenziswa ngomlomo esenzelwe ngokukodwa ukulawulwa kokutya kwezigulana ezineemfuno ezizodwa zesondlo ezifuna ukonyuka kwamanqanaba abantu.

I-L-Methylfolate Calcium 7.5 mg kufuneka ilawulwe phantsi kweliso lonyango olunelayisensi.

Ithebhulethi nganye egalelweyo, engqukuva, neblue iqulethe oku kulandelayo kukutya:

Iinkcukacha zokongeza
Ukusebenza kobungakanani: 1 cwecwe lokuHanjiswa kwekhonteyina nganye: 30 (NDC * 76439-206-30)
Ukusebenza kobungakanani: Ithebhulethi e-1 Ukutya kwisikhongozeli ngasinye: 90 (NDC * (Uzaleza ngo-76439-206-90)
Inani ngokuKhonza % Amaxabiso emihla ngemihla
*
Ezi mveliso zizongezo zokutya - ngenxa yokunyuka kwenqanaba lamanqaku (8/2/73 38 FR 20750), zifuna iRx kwileyibhile ngenxa yomngcipheko owandileyo onxulunyaniswa nokugquma kwe-B12ukunqongophala. Kananjalo, le mveliso ifuna ukujongwa kwelayisenisi yezonyango, imeko yeRx, kunye neKhowudi kaZwelonke yeziyobisi (NDC) njengoko kufunwa ziimfuno zokunikwa kwengxelo yomnombo.
& ikrele;
iqulethe ngaphantsi kwe-1% d-methylfolate.
& Dagger;
Ixabiso lemihla ngemihla alisekelwanga kwizigulana ezineemfuno ezizodwa zesondlo ezifuna ukongezwa njengoko kuyalelwe ngugqirha onelayisensi.
I-L-Methylfolate calcium & ikrele; , okanye 6 (S) -5-MTHF-Ca 7.5 mg & Dagger;

Ezinye izithako: Croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid, and film coat (FD & C Blue # 2, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide).

UMGAQO OQHELEKILEYO

Igama elithi 'folate' ziivithamini ze-B ezibandakanya i-folic acid kunye nazo naziphi na iindlela zepteroylglutamates ngaphandle kokuncipha kwemolekyuli. Iifayile, okanye i-vitamin B9, ikakhulu i-hydrolyzed kwi-jejunum yamathumbu kunye nesibindi kwifom ejikelezayo esebenzayo ye-folate, l-methylfolate, enefom ezinzileyo ephakathi, 5,10-methylenetetrahydrofolate.

Abantu abane-polymorphisms yemfuza yofuzo lwekhowudi ye-methylenetetrahydrofolate reductase (MTHFR) abanakho ukusebenzisa okanye ukuhambisa i-folic acid ngokwaneleyo kwi-vitamin B12umjikelo oxhomekeke kwimethylation.

I-Folic acid, kubandakanya iifom ezincitshisiweyo 1 Njenge-folinic acid, inokufihla i-anemia eyingozi ngaphezulu kwe-0.1 mg doses, kwaye kufuneka yenziwe phantsi kweliso likagqirha onelayisensi.

Ngo-1971, 1972, 1973, 1980, 1984, 2000, no-2010 i-Federal Register Notices zajongana nale nkxalabo ngelixa beqinisekisa ukuba ukonyuka kwesiqhelo yayilunyango olufanelekileyo kwi-megaloblastic anemias - ngakumbi apho amanqanaba e-homocysteine ​​aphakanyisiwe okanye umngcipheko we-neural tube defects (NTDs) khupha. Isaziso seRejista yaseburhulumenteni ka-Agasti 2, 1973 (38 FR 20750) sichaza ngokuthe ngqo ukuba:

Amalungiselelo okongeza ukutya ayafumaneka ngaphandle kokuyalelwa (21 CFR 121.1134). Amanqanaba aphezulu kunamaxabiso ezongezo zokutya afumaneka kuphela ngommiselo.

I-Folic acid-kubandakanya iifom ezincitshisiweyo, zinokongezwa ekutyeni kwezonyango njengoko kuchaziwe kwicandelo 5 (b) (3) lomthetho i-Orphan Drug Act (21 USC 360ee (b) (3)), okanye ekutyeni (21 CFR 172.345).

1
Ayaziwa nokuba i-l-methylfolate inokuyifihla i-anemia eyingozi ngaphezulu kwe-0.1 mg doses, ke ulumkiso luyacetyiswa nalo ngale fom.

Iimpawu kunye nokusetyenziswa kweL-Methylfolate Calcium

I-L-Methylfolate Calcium 7.5 mg ibonakalisiwe kwiimfuno zesondlo ezahlukileyo kwizigulana ezidinga ukongezwa kokutya njengoko kumiselwe ngugqirha onelayisensi.

I-L-Methylfolate Calcium 7.5 mg kufuneka ilawulwe phantsi kweliso lonyango olunelayisensi.

Ukungqinelana

Le mveliso iyaphikiswa kwizigulana ezine-hypersensitivity eyaziwayo kuso nasiphi na isithako.

Izilumkiso

Isilumkiso sicetyiswa kwizigulana ezinembali yokugula kwengqondo.

Ukulumkela

ngokubanzi

I-Folate, xa ilawulwa njengearhente enye kwiidosi malunga ne-0.1 mg mihla le, inokukusitha ukufunyanwa kwevithamini B12ukusilela (ngakumbi, ulawulo lwe-folic acid inokuguqula ukubonakaliswa kwehematological ka-B12ukusilela, kubandakanya i-anemia eyingozi, ngelixa ungajonganga ukubonakaliswa kwemithambo-luvo).

Unyango lwe-Folate kuphela alwanelanga kunyango lwe-vitamin B12ukunqongophala.

Isiqendu esiphambili soxinzelelo sinokuba sisiboniso sokuqala sokuphazamiseka kwengqondo. Kuyakholelwa ngokubanzi, (nangona kungasetyenziswanga kwizilingo ezilawulwayo) ukunyanga eso siqendu nge-anti-depressant kuphela kunokunyusa ukubakho kwemvula yesiqendu esixubeneyo / somntu kwizigulana ezisengozini yokuphazamiseka engqondweni.

I-L-Methylfolate Calcium 7.5 mg ayisiyo yoxinzelelo; Nangona kunjalo, ifolthi ibonakalisiwe ukonyusa isiphumo sokuxinezeleka kwezinto ezaziwayo zokuthomalalisa uxinzelelo. Isilumkiso sicetyiswa kwizigulana ezinembali yokugula kwengqondo.

Izigulana ezineempawu zokudakumba kufuneka zihlolwe ngokwaneleyo ukuze zichonge ukuba ngaba zisemngciphekweni wokuphazamiseka engqondweni ngenxa yokuba ukuphakama kwemo yabantu kunokwenzeka.

IINKCUKACHA ZESIGulana

I-L-Methylfolate Calcium 7.5 mg sisongezo sokutya esisetyenziselwa ukuba sisetyenziswe kuphela phantsi kweliso lonyango elinelayisensi.

UKUSETYENZISWA KWEZIYOBISI

Iziyobisi ezinokuthi zisebenzisane nomntu zibandakanya:

  • Amachiza e-antiepileptic (AED): Udidi lwe-AED kubandakanya, kodwa kungaphelelanga apho, i-phenytoin, i-carbamazepine, i-primidone, i-valproic acid, i-fosphenytoin, i-valproate, i-phenobarbital kunye ne-lamotrigine ibonakalisile ukuba inciphisa ukufunxwa kwe-folate kunye nokwandisa imetabolism yokujikeleza.
  • Ukongeza, ukusetyenziswa ngokufanayo kwe-folic acid kunxulunyaniswa nokuphuculwa kwe-phenytoin metabolism, ukwehlisa inqanaba le-AED egazini kunye nokuvumela ukubanjwa kokuqhambuka. Isilumkiso kufuneka sisetyenziswe xa kumiselwa le mveliso phakathi kwezigulana ezifumana unyango nge-phenytoin kunye nezinye i-anticonvulsants.
  • ICapecitabine: I-Folinic acid (5-formyltetrahydrofolate) inokunyusa ubuthi beCapecitabine.
  • I-Cholestyramine: Yehlisa ukufakwa kwe-folic acid kunye nokunciphisa amanqanaba e-serum folate.
  • I-Colestipol: Yehlisa ukufakwa kwe-folic acid kunye nokunciphisa amanqanaba e-serum folate.
  • I-cycloserine: Yehlisa ukufakwa kwe-folic acid kunye nokunciphisa amanqanaba e-serum folate.
  • I-Dihydrofolate Reductase Inhibitors (i-DHFRI): I-DHFRIs ibhloka ukuguqulwa kwe-folic acid kwiifom zayo ezisebenzayo, kunye neeplasma ezisezantsi kunye namanqanaba obomvu egazi. Ii-DHFRIs zibandakanya i-aminopterin, methotrexate, pyrimethamine, triamterene, kunye ne-trimethoprim.
  • I-Fluoxetine: I-Fluoxetine inhibition engakhuphisaniyo ye-5-methyltetrahydrofolate yezothutho esebenzayo emathunjini.
  • Isotretinoin: Ukunciphisa amanqanaba e-folate kuye kwenzeka kwezinye izigulane ezithatha i-isotretinoin.
  • I-L-dopa, triamterene, colchicine, kunye ne-trimethoprim inokunciphisa amanqanaba e-plasma folate.
  • I-nonsteroidal anti-inflammatory drugs (NSAIDs): ii-NSAID ziye zaboniswa ukuba zithintela ii-enzymes ezithile ezixhomekekileyo kulingo lwelabhoratri. Ii-NSAIDs zibandakanya ibuprofen, naproxen, indomethacin kunye nesulindac.
  • Izinto zokuthintela ukukhulelwa ngomlomo: Amanqanaba e-serum folate anokuxinezeleka ngonyango lokucwangcisa ngomlomo.
  • I-Methylprednisolone: ​​Ukunciphisa amanqanaba e-serum folate kuye kwaphawulwa emva konyango nge-methylprednisolone.
  • I-Enzymes yePancreatic: Ukunciphisa amanqanaba e-folate kuye kwenzeka kwezinye izigulana ezithatha i-pancreatic extracts, ezinje nge-pancreatin kunye ne-pancrelipase.
  • I-Pentamidine: Ukunciphisa amanqanaba e-folate kubonwe ngepentamidine efakwa ngaphakathi.
  • I-Pyrimethamine: Amanqanaba aphezulu e-folic acid anokubangela ukunciphisa amanqanaba e-serum ye-pyrimethamine.
  • Ukutshaya notywala: Amanqanaba e-serum folate ancitshisiwe.
  • I-Sulfasalazine: Inqanda ukufunxwa kunye nokucolwa komzimba kwe-folic acid.
  • Unyango lweMetformin kwizigulana ezinesifo seswekile 2 luyancipha.
  • IWarfarin inokuvelisa ukuphazamiseka okubonakalayo kwimeko yonyani emva konyango lweenyanga ezi-6.
  • I-Folinic acid inokuphucula ubungozi be-fluorouracil.
  • Ukulawulwa ngaxeshanye kwe-chloramphenicol kunye ne-acid ye-folinic kwizigulana ezinesifo esine-folate kunokubangela ukuphikisana kwempendulo ye-haematopoietic kwi-folate.
  • Isilumkiso kufuneka sisetyenziswe ngokuhambelana nokusetyenziswa kwe-folinic acid kunye ne-trimethoprim-sulfamethoxazole kunyango olubiIPneumocystis cariniiinyumoniya kwizigulana ezinosulelo lwe-HIV njengoko inxulunyaniswa namazinga anyukayo okusilela kunyango kunye nokusweleka kufundo olulawulwa yi-placebo.

UKUKHULELWA NOMAMA OBONGISAYO

I-L-Methylfolate Calcium 7.5 mg ayenzelwanga ukuba isetyenziswe njenge-prenatal / postnatal multivitamin yoomama abancancisayo nabangancancisi. Le mveliso iqulethe ivithamini B kwifomu ezincitshisiweyo. Thetha nogqirha wakho ngaphambi kokusebenzisa ukuba ukhulelwe okanye uncancisa.

ipilisi emhlophe ip 190

Iziphumo ezingalunganga

Ukunyanzeliswa komzimba kuxeliwe emva kokulawulwa komlomo nangomzali kwe-folic acid, kwaye kunokwenzeka ukuba kwenzeke nezinye iifom.

L-Methylfolate Calcium Dosage kunye noLawulo

Idosi eqhelekileyo yabantu abadala yi-7.5 ukuya kwi-15 mg yonke imihla kunye okanye ngaphandle kokutya okanye njengoko kuyalelwe ngugqirha onelayisensi.

Inikwa njani i-L-Methylfolate Calcium

I-L-Methylfolate Calcium 7.5 mg amacwecwe agutyungelweyo, ajikelezileyo, amacwecwe aluhlaza alahlwa i-'BP 'ngaphezulu kunye ne-'500' ezantsi, kwaye zinikezelwa kwiibhotile zamacwecwe angama-30 kunye neepilisi ezingama-90.

I-NDC 2 76439-206-30 (30 ct. Ibhotile / iipilisi ezingama-30)
I-NDC 2 76439-206-90 (90 ct. Ibhotile / iipilisi ezingama-90)

2
Ezi mveliso zizongezo zokutya - ngenxa yokunyuka kwenqanaba lamanqaku (8/2/73 38 FR 20750), zifuna iRx kwileyibhile ngenxa yomngcipheko owandileyo onxulunyaniswa nokugquma kwe-B12ukunqongophala. Kananjalo, le mveliso ifuna ukujongwa kwelayisenisi yezonyango, imeko yeRx, kunye neKhowudi kaZwelonke yeziyobisi (NDC) njengoko kufunwa ziimfuno zokunikwa kwengxelo yomnombo.

UKUGCINWA

Gcina kubushushu begumbi elilawulwayo 15 ° -30 ° C (59 ° -86 ° F). [Jonga iUSP]. Khusela ekukhanyeni nasekufuma. Ukuhambisa kwisitya esomeleleyo, esinganyangekiyo.

KUGQIBELELE OKU EKUFIKELELELENI KWABANTWANA.

Yonke imigqaliselo esebenzisa le mveliso iya kuhambelana nemimiselo yelizwe njengoko kusebenza. Le ayisiyomveliso yeNcwadi yeOrange.

Fowunela ugqirha wakho malunga neziphumo ebezingalindelekanga.

Unokuxela iziphumo ebezingalindelekanga ngokutsalela umnxeba ku-813-283-1344.

I-L-Methylfolate Calcium 7.5 mg Amacwecwe
Rx
Isongezelelo sokutya

Yenzelwe:
IVirtus Pharmaceuticals, LLC
ITampa, FL 33619
www.luyikid.com
YENZIWE E-USA

i-nabothian cysts kumlomo wesibeleko

ISityhi 1/2012

INQUNUNU YOKUBONISA IPhaneli - Ilebheli yeBhotile yeetafile ezingama-90

UBUNGQINA
KWEZOKHUSELEKO

NDC & ikrele;76439-206-90

I-L-Methylfolate
Calcium 7.5 mg

Isongezelelo sokutya

Rx
Amacwecwe angama-90

Yenziwe eMelika

I-L-Methylfolate calcium
Ipilisi yecalcium yelevomefolate, egutyungelweyo
Ulwazi lweMveliso
Uhlobo lweMveliso INKCAZELO YABANTU ILELAYIBHILE YEZIYOBISI Ikhowudi yento (Umthombo) I-NDC: 76439-206
Umgaqo woLawulo NGOMLOMO Ishedyuli ye-DEA
Isithako esisebenzayo / Umoya oSebenzayo
Igama lezithako Isiseko soMandla Amandla
IKHALIKHAMU YOKUGQIBELA (I-ACID YENKCUKACHA) IKHALIKHAMU YOKUGQIBELA 7.5 mg
Izithako ezingasebenziyo
Igama lezithako Amandla
Isodiyam yeCroscarmellose
IMAGNESIUM STEARATE
ICELULOSE, IMICROCRYSTALLINE
calcium phosphate, dibasic, anhydrous
Silicon dioksayidi
stearic acid
I-FD & C IBHULE NO. 2
polyethilini glycols
polyvinyl utywala
talc
TITANIUM DIOXIDE
Iimpawu zeMveliso
Umbala LUHLAZA Inqaku akukho manqaku
Imilo ROUND Ubungakanani 14mm
Incasa Ikhowudi yoShicilelo BP; 500
Iqulathe
Ukupakisha
# Ikhowudi yento Inkcazo yephakheji
1 I-NDC: 76439-206-30 Itafile engama-30, IPHOTWE ngebhotile eyi-1
2 I-NDC: 76439-206-90 ITHABILE engama-90, IPHOTWE ngebhotile eyi-1
Ulwazi lweNtengiso
Udidi lokuThengisa Inombolo yesicelo okanye iMonograph Citation Umhla wokuQalisa ukuThengisa Umhla Wokuphela Wentengiso
IZIYOBISI EZINGENAKUPHUNYELWA 03/15/2012
Umlebheli -IVirtus Pharmaceuticals (969483143)
IVirtus Pharmaceuticals

Ukuzihlangula kwezonyango