 |
| Magnabiotic |
• In serious infections: I200mgioagnabioticsvwy6hours. Magnabiotic Chlldras:3months-l2years:3timglkgeverythours.
Film coated tablets, Powder for oral Suspension & Vials eT5h hours (In premature
infants and ir full teen iniants during the prenatal period), increasing toe
Reconstituted saspecolon tablets hourly intervals there altar.
Composition ant St 112.1 di St 5,5:
itd nqltnd mgItsI mile sjlda .s rl -Each3omgotMagnabloticvialcuntains2cergamnoydilinandftmg
tOm Ma Otsg a,s a.1 M. ttts -Therapy con he stadod parseteraily ard conitnaed with an oral
titan prspawitue.
{apotsdest) sore m re 5t tort uts fore -Trnohrrsnt with Magnabistlcshnutu not sotsnd bepoed 14 days without
Castnadndicatsss:
campositlan Vials Ahssorpstallsrgicreachonstopanicdln.
5 Stdeeffswta toesydselaadmotl 550 mg icon mg Mograbloac is geseretywell tolerated. The nraionitiesafside effects are
Sted)ade) rca mg 200 mg mild and transient and canslsl mainly ci diarrhea, nausea, abdominal
dlucsmfcn, skin raehns and urticaria which disappear upon
dlsnonbnuatioc of therapy.
Inactive isgrsdtents: Dreg leseraestssac
Film coated tablets: - Pmbenenid decreases thu renal tubular secretion of amscycdlin.
Csdoidai silicon diclode, sodium starch glycolate, magnesium stearate Concurrent use with ewoyncitin / danulenots potassium may meat In
and mrcmcrystailne cellulose. increased and prolonged blood levels of arrrnrryciilrn . Coadminletratun
Puma., lareral ssap.nstan: of pmbsnecid cannel be recommended.
codium saccharine, sodium beozoate, dtric add anhyntmus, sodium - The concurrent administration of ailacpurlnel and amsoydilin
dtrate anhydrous, minrncrystailne cellulose, canthan gum, slicon increases substantially the incidence of rashes in patients rscelnisg
diocide, slticinanhydridecctoidel,cherryltaccurpomdecu mansfol. both drugs as compared to pahents rasendcg anrccyclllin alone. trio
Pharmawalegisal Actions: not known whether this poinctiatluc cf aecosycililn rashes Is due to
Magnabichc in an anti-bacterial combination at amusycihic and ailcpunrmi orthe hypwnurcem:a present :0 these pabentu. Them am
danulenic add. riuncoycillin is semi-synthetic penicirr with a broad no data with amuuycllllc I dacuianaie potassium and aitopudnol
spectrum against Grem+co and Gram-co mlum-arganisms. Clacuienic administered concurrently. add is a y-iactam structurally related to peniudlins that inacticaten - in common reth other bmad-epecteuw antibiotics,
lactamaun enaymee commonly found in micm-organisme resistant to amucyctiln I daculanate potassium may reduce the efficacy of oral
penidli:ne and cephalosynrins. The combination ot amrinydhiln and ccohecoPbnes.
ciauulanic cart ectunds the ankbicbc spectrum of emocyciilin to indude Pregsaoep & Laeiattanr
bacteria normally reeistanfthamccydilin and other -lecfam actibictics. -Magnublotic should be scolded during pregnancy enpeulaty during the
Alter oral administration, Magnabiutic is wed aheothed from the timtblmauter.
gastrointestinal Paul, stable in the presence of gashtc add and may he - Gunno lactation, Pace quantities cf yendirns ceo he detected in breast
admlnleteredwithnutmgecdtnmeeis. eritb.
Phermawakineelco: Precastlass & Worsings:
After oral administration of Magnebiwrlc, appmsimateiy 50% -70 % sri - lntnacercus Magnabloftc uhuoid be used mitt cautico in pullnciu with
amooyditn and 25% -40% of the danulan’wadd iseocreted unchenged ecldnncnofsecemhepatlcdyshuncttun
in urine darling the tret sb heum. tdlttosee readily Into most body tissues - Magnabiotic dosage should he adjusted fee paftenfe with eeuera m aednuldearolcanhedetected :nmlddieearaffusion. ewderate rensiimpdrmant.
lsdtsattsiss: Steroge: - Upperrespiratcrpnact and E.N.T infacflccw: e.g. Tonetbtie, pharyngius, f-Film coated tabiste;
iaryngltiu,slnueitis,ndhnmedb,etc... Fac3lftmgend t gre:
• Losner raupiratury Pad inlectiaes: e.g. trnnchitis, pneumonia, Keeytimcwatedtabieru:ndryplaceattereperutsrennteuceedlng3drC.
emphynema, iungabsceee. etc... Fnrti2timg:
oastmintewtinal infectlcnc:e.g. cnieritisandbwlaryhectinfectinns. Keeptimcwatndtublnfoindrypiaceuttemperaturennteoceedlcg2pro.
oenrin-urinarytractlntoctione:e.g. Cystce, urethritis, grinnmheaetc... -Pewderfereralseapsesien: - 0km 6 softbseue infections: e.g. Celiuilhs, sryeipeias, boils corbrunden tefore reconstitution:
etc... Store aitempecatura not ecceeding 3C in dry place.
Oftrem: Pg. Sepricemia, uctnnmyellhs, etc... Alter reconsrituricn:
Meshed of r.senstitstlee and admieistraeieou Sime at? C-tcCfm7days.
Oraisuspeetioe; -Stats:
-Thesuspensionehould bereccnshtutsd)ustbefnm use. Ksepc:aieattempecatumiseethae3bC.
-Add watnr to the contents, to the math In 2 pon:une and shako wet after Keep medtutn000i se reach efshtldrse.. each sddftnn. Package:
it should headmicisteredwithic7dayscfracorstituticn. 1-Film coated tablets:
-Shakewel bslcrntaklng cachdoso. 37fimgtlabist:tnfimccatnd tabietepacked inambnngiaesbnthe
-Thereccnsthutndeuspann:onmusthentaredatrnthgnrator. (35 ml) type 3 with 2 silico gel copeules and auto plastic cap with rod
Vials: plastic ring inacortnn bccwrith pamphlet.
5.5: tsomgylabiei: gfim coated tablets packed in arehergiass bulge
Magnabictic intravenous may he administrated corer by intravenous (35 ml) type 3 mith 2 silica gel capsules and white plastic cap wgh red
ie)sct’wn crby intnnniftent i.Vintus’unn (ills not suitable fur inhe muncolar plastic ring inacorionhouwthpemphiet
admicistration) I gm/tablet; 10 tim coated fakiets pecked In amber glues bothe (30 ml)
etc mg nial: to reconut:tcte, dnooice contents in 10 ml at waler icr type 3with 2 silica gel capsules and with white plastic cop with red piontic
iri)ecticn eR (teal column 10.5 ml). ring macodor hocwith pamphlnt.
12W srg dat: to reconstitute, diseolce contents in 00 rd ci water for 2-Pewderferoratsospeeeiee:
in)ecctarrg.P. )fcaicoiunw2ti.ftrdf. )ltiti.2SwgISwI), )230mg/5m1), )312.Omg/bmt)cr)4f0 mg/Smi).
Adansioetpiekcoinrmayappeardunngreconsttuftnrr. Acadonheoconfalnieg itnpe3lbntiecfttiurgoreieltermccosgtuaon
Recocetitutedeulurinnsaracoenatipa pale straw color.
lstravs.eas injeotiess
The stability cl Magnabmctic intracennut solution Is e concentration
dependent, thus Magrabinfic )inhecenous injector or slew i.y infuslurc)
shwuidheunedlrereedtatalycponrecwnsthutlon.
Istranessas iseesles: Magnabicbc isdacenocu reap he infused in water ho ic)ectnn OP. or Sodium chloride inpaccoous injection t.R )O.ft%wlc).
Add tco mg of fire reccwstsuted sducunthsc ml ci Infusion nuid or 1200
mgrecceetttutedeuiutinntw iccwi inrceisntuid)prnferabiyuningaminl ba
or in une burette).
Infuse ccer3o-dO winutes and complete withindhuum of reconstitution.
Any rusidcoi antibicticsciutior shcuidhediecarded.
Dosage:
Gases am administered under medical addco according to case severity
and petianfe response
Oral suspeesiwn asd tire caatediahiose:
Adults and cthidrun ocer t2 yoam of age:
-Miiduedmnderatainlectiuns:
Megcabiahc4tignrg: 2teaspcontcIs)tOmi)ennry 12 hours.
Or: OcofiimcoatedfatsotctMagcatuotic37crngecerytihsurn.
Or: OnatimcoatedtabtetafMagnabretictgmenery 12 hours.
-Secere lntedicrm:
One IimcoatedtablatnfMagnabiatct2nmgecerythoum.
Or: One tire cwatud tatiletof 1 gmncerythuum.
Children:
ft months -2 yearn: Halt teaspauntsl )2.5 ml) of Magnebictic tst.25 mg
ecaryt hours.
Or:tiaitteaspucnfuI 2.0 mi)cfMagoabictlc 230 mg every i2 hccm.
2-7 yaam: One feaspcanho joint) cf Magnabictic 156.25 mg every
hcum,
Oc nrreteaspconthi )ft ml) nt230 mg nuery l2houm.
7-12 peam: Twnteaspconfcis )iS ml) Magnabobccf 156.25 regeceryt
hours. Or: use teaspoonful )5 ml) Megcabbullu3t2.5 mg suery t boom.
Or: use teaspoonful )5 ml )ofMagnebictic of dtO mg eceny l2haum.
in severe infectcns, these docages reaphednubied. Stole:) IV. ln)edlcnnrinhudco)Aduitsandchuldrenucscl2yeam:
l200mgecwyghoum.
Film coated tablets, Powder for oral Suspension & Vials eT5h hours (In premature
infants and ir full teen iniants during the prenatal period), increasing toe
Reconstituted saspecolon tablets hourly intervals there altar.
Composition ant St 112.1 di St 5,5:
itd nqltnd mgItsI mile sjlda .s rl -Each3omgotMagnabloticvialcuntains2cergamnoydilinandftmg
tOm Ma Otsg a,s a.1 M. ttts -Therapy con he stadod parseteraily ard conitnaed with an oral
titan prspawitue.
{apotsdest) sore m re 5t tort uts fore -Trnohrrsnt with Magnabistlcshnutu not sotsnd bepoed 14 days without
Castnadndicatsss:
campositlan Vials Ahssorpstallsrgicreachonstopanicdln.
5 Stdeeffswta toesydselaadmotl 550 mg icon mg Mograbloac is geseretywell tolerated. The nraionitiesafside effects are
Sted)ade) rca mg 200 mg mild and transient and canslsl mainly ci diarrhea, nausea, abdominal
dlucsmfcn, skin raehns and urticaria which disappear upon
dlsnonbnuatioc of therapy.
Inactive isgrsdtents: Dreg leseraestssac
Film coated tablets: - Pmbenenid decreases thu renal tubular secretion of amscycdlin.
Csdoidai silicon diclode, sodium starch glycolate, magnesium stearate Concurrent use with ewoyncitin / danulenots potassium may meat In
and mrcmcrystailne cellulose. increased and prolonged blood levels of arrrnrryciilrn . Coadminletratun
Puma., lareral ssap.nstan: of pmbsnecid cannel be recommended.
codium saccharine, sodium beozoate, dtric add anhyntmus, sodium - The concurrent administration of ailacpurlnel and amsoydilin
dtrate anhydrous, minrncrystailne cellulose, canthan gum, slicon increases substantially the incidence of rashes in patients rscelnisg
diocide, slticinanhydridecctoidel,cherryltaccurpomdecu mansfol. both drugs as compared to pahents rasendcg anrccyclllin alone. trio
Pharmawalegisal Actions: not known whether this poinctiatluc cf aecosycililn rashes Is due to
Magnabichc in an anti-bacterial combination at amusycihic and ailcpunrmi orthe hypwnurcem:a present :0 these pabentu. Them am
danulenic add. riuncoycillin is semi-synthetic penicirr with a broad no data with amuuycllllc I dacuianaie potassium and aitopudnol
spectrum against Grem+co and Gram-co mlum-arganisms. Clacuienic administered concurrently. add is a y-iactam structurally related to peniudlins that inacticaten - in common reth other bmad-epecteuw antibiotics,
lactamaun enaymee commonly found in micm-organisme resistant to amucyctiln I daculanate potassium may reduce the efficacy of oral
penidli:ne and cephalosynrins. The combination ot amrinydhiln and ccohecoPbnes.
ciauulanic cart ectunds the ankbicbc spectrum of emocyciilin to indude Pregsaoep & Laeiattanr
bacteria normally reeistanfthamccydilin and other -lecfam actibictics. -Magnublotic should be scolded during pregnancy enpeulaty during the
Alter oral administration, Magnabiutic is wed aheothed from the timtblmauter.
gastrointestinal Paul, stable in the presence of gashtc add and may he - Gunno lactation, Pace quantities cf yendirns ceo he detected in breast
admlnleteredwithnutmgecdtnmeeis. eritb.
Phermawakineelco: Precastlass & Worsings:
After oral administration of Magnebiwrlc, appmsimateiy 50% -70 % sri - lntnacercus Magnabloftc uhuoid be used mitt cautico in pullnciu with
amooyditn and 25% -40% of the danulan’wadd iseocreted unchenged ecldnncnofsecemhepatlcdyshuncttun
in urine darling the tret sb heum. tdlttosee readily Into most body tissues - Magnabiotic dosage should he adjusted fee paftenfe with eeuera m aednuldearolcanhedetected :nmlddieearaffusion. ewderate rensiimpdrmant.
lsdtsattsiss: Steroge: - Upperrespiratcrpnact and E.N.T infacflccw: e.g. Tonetbtie, pharyngius, f-Film coated tabiste;
iaryngltiu,slnueitis,ndhnmedb,etc... Fac3lftmgend t gre:
• Losner raupiratury Pad inlectiaes: e.g. trnnchitis, pneumonia, Keeytimcwatedtabieru:ndryplaceattereperutsrennteuceedlng3drC.
emphynema, iungabsceee. etc... Fnrti2timg:
oastmintewtinal infectlcnc:e.g. cnieritisandbwlaryhectinfectinns. Keeptimcwatndtublnfoindrypiaceuttemperaturennteoceedlcg2pro.
oenrin-urinarytractlntoctione:e.g. Cystce, urethritis, grinnmheaetc... -Pewderfereralseapsesien: - 0km 6 softbseue infections: e.g. Celiuilhs, sryeipeias, boils corbrunden tefore reconstitution:
etc... Store aitempecatura not ecceeding 3C in dry place.
Oftrem: Pg. Sepricemia, uctnnmyellhs, etc... Alter reconsrituricn:
Meshed of r.senstitstlee and admieistraeieou Sime at? C-tcCfm7days.
Oraisuspeetioe; -Stats:
-Thesuspensionehould bereccnshtutsd)ustbefnm use. Ksepc:aieattempecatumiseethae3bC.
-Add watnr to the contents, to the math In 2 pon:une and shako wet after Keep medtutn000i se reach efshtldrse.. each sddftnn. Package:
it should headmicisteredwithic7dayscfracorstituticn. 1-Film coated tablets:
-Shakewel bslcrntaklng cachdoso. 37fimgtlabist:tnfimccatnd tabietepacked inambnngiaesbnthe
-Thereccnsthutndeuspann:onmusthentaredatrnthgnrator. (35 ml) type 3 with 2 silico gel copeules and auto plastic cap with rod
Vials: plastic ring inacortnn bccwrith pamphlet.
5.5: tsomgylabiei: gfim coated tablets packed in arehergiass bulge
Magnabictic intravenous may he administrated corer by intravenous (35 ml) type 3 mith 2 silica gel capsules and white plastic cap wgh red
ie)sct’wn crby intnnniftent i.Vintus’unn (ills not suitable fur inhe muncolar plastic ring inacorionhouwthpemphiet
admicistration) I gm/tablet; 10 tim coated fakiets pecked In amber glues bothe (30 ml)
etc mg nial: to reconut:tcte, dnooice contents in 10 ml at waler icr type 3with 2 silica gel capsules and with white plastic cop with red piontic
iri)ecticn eR (teal column 10.5 ml). ring macodor hocwith pamphlnt.
12W srg dat: to reconstitute, diseolce contents in 00 rd ci water for 2-Pewderferoratsospeeeiee:
in)ecctarrg.P. )fcaicoiunw2ti.ftrdf. )ltiti.2SwgISwI), )230mg/5m1), )312.Omg/bmt)cr)4f0 mg/Smi).
Adansioetpiekcoinrmayappeardunngreconsttuftnrr. Acadonheoconfalnieg itnpe3lbntiecfttiurgoreieltermccosgtuaon
Recocetitutedeulurinnsaracoenatipa pale straw color.
lstravs.eas injeotiess
The stability cl Magnabmctic intracennut solution Is e concentration
dependent, thus Magrabinfic )inhecenous injector or slew i.y infuslurc)
shwuidheunedlrereedtatalycponrecwnsthutlon.
Istranessas iseesles: Magnabicbc isdacenocu reap he infused in water ho ic)ectnn OP. or Sodium chloride inpaccoous injection t.R )O.ft%wlc).
Add tco mg of fire reccwstsuted sducunthsc ml ci Infusion nuid or 1200
mgrecceetttutedeuiutinntw iccwi inrceisntuid)prnferabiyuningaminl ba
or in une burette).
Infuse ccer3o-dO winutes and complete withindhuum of reconstitution.
Any rusidcoi antibicticsciutior shcuidhediecarded.
Dosage:
Gases am administered under medical addco according to case severity
and petianfe response
Oral suspeesiwn asd tire caatediahiose:
Adults and cthidrun ocer t2 yoam of age:
-Miiduedmnderatainlectiuns:
Megcabiahc4tignrg: 2teaspcontcIs)tOmi)ennry 12 hours.
Or: OcofiimcoatedfatsotctMagcatuotic37crngecerytihsurn.
Or: OnatimcoatedtabtetafMagnabretictgmenery 12 hours.
-Secere lntedicrm:
One IimcoatedtablatnfMagnabiatct2nmgecerythoum.
Or: One tire cwatud tatiletof 1 gmncerythuum.
Children:
ft months -2 yearn: Halt teaspauntsl )2.5 ml) of Magnebictic tst.25 mg
ecaryt hours.
Or:tiaitteaspucnfuI 2.0 mi)cfMagoabictlc 230 mg every i2 hccm.
2-7 yaam: One feaspcanho joint) cf Magnabictic 156.25 mg every
hcum,
Oc nrreteaspconthi )ft ml) nt230 mg nuery l2houm.
7-12 peam: Twnteaspconfcis )iS ml) Magnabobccf 156.25 regeceryt
hours. Or: use teaspoonful )5 ml) Megcabbullu3t2.5 mg suery t boom.
Or: use teaspoonful )5 ml )ofMagnebictic of dtO mg eceny l2haum.
in severe infectcns, these docages reaphednubied. Stole:) IV. ln)edlcnnrinhudco)Aduitsandchuldrenucscl2yeam:
l200mgecwyghoum.
with distilled water, dcead tip pitor preuf plestc cap with induction sealing wIth pamphlet
3-Vials:
)tiocmglcialor 12130 mgpiial)Aciai)glesstype flpacked macedon boo with pamphlet, lsstreetlensof Patients:
Patients should he counseled that antibacterial drugs induding awosycilhr I clavulenata potassium, should coly he used to flat hectedal infections. They do ret heal dm1 infections e.g., the common cold). flier amnnydiln Idaccianete potassium is prescribed to beat a bacterial infectiun. pabeats should he told thai although It is common te feel better eeriy In the course of therapy, the nradicatiun should be taken euautly as directed. Stopping mean or not completing fire tall course of therapy nray:
1) decrease the nffactceuess ni the immediate treatment.
)2) increase the cknlihoud that heutaria will develop resistance and will not he tinatabin by awacydllin I dauruienete potassium or other antibadnrial drugs re the hufcre.
.nuaap.,,w.ccoacs
-ruwwreaco.w.eeuenm.en .c.anrefl
sceico
Preaucad te Suatr Easel Snug ieduoetes Pampany
- SEDICO -
:sct000rcits-egppn
yob:rasdtMelstls:ch4-pae:gaSdrral
3-Vials:
)tiocmglcialor 12130 mgpiial)Aciai)glesstype flpacked macedon boo with pamphlet, lsstreetlensof Patients:
Patients should he counseled that antibacterial drugs induding awosycilhr I clavulenata potassium, should coly he used to flat hectedal infections. They do ret heal dm1 infections e.g., the common cold). flier amnnydiln Idaccianete potassium is prescribed to beat a bacterial infectiun. pabeats should he told thai although It is common te feel better eeriy In the course of therapy, the nradicatiun should be taken euautly as directed. Stopping mean or not completing fire tall course of therapy nray:
1) decrease the nffactceuess ni the immediate treatment.
)2) increase the cknlihoud that heutaria will develop resistance and will not he tinatabin by awacydllin I dauruienete potassium or other antibadnrial drugs re the hufcre.
.nuaap.,,w.ccoacs
-ruwwreaco.w.eeuenm.en .c.anrefl
sceico
Preaucad te Suatr Easel Snug ieduoetes Pampany
- SEDICO -
:sct000rcits-egppn
yob:rasdtMelstls:ch4-pae:gaSdrral
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