TACROLIMUS SANDOZ

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

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Herunterladen Fachinformation (SPC)
23-06-2024

Wirkstoff:

Tacrolimus

Verfügbar ab:

Sandoz Pty Ltd

Klasse:

Medicine Registered

Fachinformation

                                _Product Information                                                               _
_Page                                                                                               _
_Tacrolimus Sandoz 0.5mg/1mg/5mg capsules _
_3/2012 _
 
_Sandoz Pty Ltd _
_ _
_Version 11   _
 
_1 _
 
PRODUCT INFORMATION 
TACROLIMUS SANDOZ
®
 0.5MG/ 1MG/ 5MG CAPSULES 
 
 
NAME OF THE MEDICINE  
_ _
Tacrolimus 
  
[3S[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*
]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5, 19
dihydroxy-3- 
[2-(4-hydroxy-3-methoxycyclohexyl) -1-methylethenyl]-14,
16-dimethoxy-
4,10,12,18-tetramethyl-8-(2-propenyl)-15,
19-epoxy-3H-pyrido[2,1c][1,4] 
oxaazacyclotricosine-1,7,20, 21(4H,23H)-tetrone, monohydrate 
 
 
 
CAS [104987-11-3]  
 
Empirical formula: C
44
H
69
NO
12
. H
2
O  
MW:  822.05 
 
 
 
DESCRIPTION 
_ _
Tacrolimus appears as white crystals or a crystalline powder,
very soluble in methanol 
and chloroform, freely soluble in acetone and ethanol and
practically insoluble in 
hexane and water. It is obtained by fermentation as
a single enantiomer but exists in 
tautomeric equilibration in aqueous solution. 
Excipients capsule filling: 
Hypromellose, lactose, croscarmellose sodium, magnesium stearate. 
Excipients capsule shell: 
_Product Information                                                               _
_Page                                                                                               _
_Tacrolimus Sandoz 0.5mg/1mg/5mg capsules _
_3/2012 _
 
_Sandoz Pty Ltd _
_ _
_Version 11   _
 
_2 _
Titanium dioxide, sodium laury
                                
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