RAPAMUNE ORAL SOLUTION 1 mgml

Ülke: Singapur

Dil: İngilizce

Kaynak: HSA (Health Sciences Authority)

Aktif bileşen:

SIROLIMUS

Mevcut itibaren:

PFIZER PRIVATE LIMITED

ATC kodu:

L04AA10

Doz:

1 mg/mL

Farmasötik formu:

SOLUTION

Kompozisyon:

SIROLIMUS 1 mg/mL

Uygulama yolu:

ORAL

Reçete türü:

Prescription Only

Tarafından üretildi:

Patheon Inc.

Yetkilendirme durumu:

ACTIVE

Yetkilendirme tarihi:

2002-05-28

Bilgilendirme broşürü

RAPAMUNE
TABLE OF CONTENT
_Please click on either of the following links to access the required
information:_
PRESCRIBING INFORMATION
PATIENT INFORMATION LEAFLET
1.
NAME OF THE MEDICINAL PRODUCT
Rapamune
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sirolimus (INN)
Rapamune (sirolimus) is an immunosuppressive agent. Sirolimus is a
macrocyclic lactone
produced by _Streptomyces hygroscopicus_.
Chemical
Name
The chemical name of sirolimus (also known as rapamycin) is
(3_S_,6_R_,7_E_,9_R_,10_R_,12_R_,14_S_,15_E_,17_E_,19_E_,21_S_,23_S_,26_R_,27_R_,34a_S_)-
9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-hexadecahydro-9,27-dihydroxy-3-[(1_R_)-2-
[(1_S_,3_R_,4_R_)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-
6,8,12,14,20,26-hexamethyl-23,27-epoxy-3_H_-pyrido[2,1-_c_][1,4]
oxaazacyclohentriacontine-
1,5,11,28,29 (4_H_,6_H_,31_H_)-pentone.
Structure
The structural formula of sirolimus is shown below.
Molecular Formula
Its molecular formula is C
51
H
79
NO
13
Molecular Weight
Its molecular weight is 914.2.
Physical Characteristics
Sirolimus is a white to off-white powder and is insoluble in water,
but freely soluble in
benzyl alcohol, chloroform, acetone, and acetonitrile.
Composition and
P
harmaceutical
C
haracteristics
Rapamune is available for administration as an oral solution
containing 1 mg/mL sirolimus
Page 1 of
and as a tan, triangular-shaped tablet containing 0.5 mg sirolimus, as
a white, triangular-
shaped tablet containing 1 mg, and as a yellow-to-beige
triangular-shaped tablet containing
2 mg sirolimus.
Excipients: see SECTION 6.1. LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
Oral solution and tablets.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Rapamune (sirolimus) is indicated for the prophylaxis of organ
rejection in patients receiving
renal transplants.
In patients at low to moderate immunologic risk, it is recommended
that Rapamune be used
initially in a regimen with cyclosporine and corticosteroids.
Cyclosporine should be withdrawn 2 to 4 months after transplantation
and the Rapamu

Ürün özellikleri

1.
NAME OF THE MEDICINAL PRODUCT
Rapamune
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sirolimus (INN)
Rapamune (sirolimus) is an immunosuppressive agent. Sirolimus is a
macrocyclic lactone
produced by
_Streptomyces hygroscopicus_
.
Chemical Name
The chemical name of sirolimus (also known as rapamycin) is
(3
_S_
,6
_R_
,7
_E_
,9
_R_
,10
_R_
,12
_R_
,14
_S_
,15
_E_
,17
_E_
,19
_E_
,21
_S_
,23
_S_
,26
_R_
,27
_R_
,34a
_S_
)-
9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-hexadecahydro-9,27-dihydroxy-3-[(1
_R_
)-2-
[(1
_S_
,3
_R_
,4
_R_
)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-
6,8,12,14,20,26-hexamethyl-23,27-epoxy-3
_H_
-pyrido[2,1-
_c_
][1,4] oxaazacyclohentriacontine-
1,5,11,28,29 (4
_H_
,6
_H_
,31
_H_
)-pentone.
Structure
The structural formula of sirolimus is shown below.
Molecular Formula
Its molecular formula is C
51
H
79
NO
13
Molecular Weight
Its molecular weight is 914.2.
Physical Characteristics
Sirolimus is a white to off-white powder and is insoluble in water,
but freely soluble in benzyl
alcohol, chloroform, acetone, and acetonitrile.
Composition and Pharmaceutical Characteristics
Rapamune is available for administration as an oral solution
containing 1 mg/mL sirolimus and
as a tan, triangular-shaped tablet containing 0.5 mg sirolimus, as a
white, triangular-shaped
tablet containing 1 mg, and as a yellow-to-beige triangular-shaped
tablet containing 2 mg
sirolimus.
Excipients: see
SECTION 6.1. LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
Oral solution and tablets.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
_ _
Rapamune (sirolimus) is indicated for the prophylaxis of organ
rejection in patients receiving
renal transplants.
In patients at low to moderate immunologic risk, it is recommended
that Rapamune be used
initially in a regimen with cyclosporine and corticosteroids.
Cyclosporine should be withdrawn 2 to 4 months after transplantation
and the Rapamune dose
should be increased to reach recommended blood concentrations (see
SECTION 4.2. POSOLOGY
AND METHOD OF ADMINISTRAT