Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Tacrolimus
Sandoz Pty Ltd
Medicine Registered
_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 Read the complete document