TARGIN® Prolonged Release Tablets 20mg 10mg

Држава: Сингапур

Језик: Енглески

Извор: HSA (Health Sciences Authority)

Активни састојак:

Naloxone 9.00mg eqv Naloxone Hydrochloride Anhydrous; Oxycodone 18.00mg eqv Oxycodone Hydrochloride Anhydrous

Доступно од:

MUNDIPHARMA PHARMACEUTICALS PTE. LTD.

АТЦ код:

N02AA55

Дозирање:

10.00 mg/tablet

Фармацеутски облик:

TABLET, FILM COATED, EXTENDED RELEASE

Састав:

Naloxone 9.00mg eqv Naloxone Hydrochloride Anhydrous 10 mg; Oxycodone 18.00mg eqv Oxycodone Hydrochloride Anhydrous 20 mg

Пут администрације:

ORAL

Тип рецептора:

Prescription Only

Произведен од:

Bard Pharmaceuticals Limited

Статус ауторизације:

ACTIVE

Датум одобрења:

2011-10-19

Информативни летак

TARGIN
®
 PROLONGED RELEASE TABLETS     
NAME OF THE MEDICINAL PRODUCT   
_TARGIN_
® 
5 mg/2.5 mg, 10 mg/5 mg, 20 mg/10 mg and 40
mg/20 mg prolonged-release tablets     
QUALITATIVE AND QUANTITATIVE COMPOSITION   
_TARGIN_
® 
5 mg/2.5 mg Each prolonged-release tablet contains 5 mg of
oxycodone hydrochloride equivalent to 
4.5 mg oxycodone, and 2.73 mg of naloxone hydrochloride dihydrate
equivalent to 2.5 mg naloxone 
hydrochloride and 2.25 mg naloxone.    Excipients:
Each prolonged-release tablet contains 68.17 mg lactose 
anhydrous  
_TARGIN_
®
 10 mg/5 mg Each prolonged-release tablet contains 10 mg of
oxycodone hydrochloride equivalent to 
9.0 mg oxycodone, and 5.45 mg of naloxone hydrochloride dihydrate
equivalent to 5.0 mg naloxone 
hydrochloride and 4.5 mg naloxone. Excipients:
Each prolonged-release tablet contains 61.04 mg lactose 
anhydrous  
_TARGIN_
®
 20 mg/10 mg Each prolonged-release tablet contains 20
mg of oxycodone hydrochloride equivalent to 
18.0 mg oxycodone, and 10.9 mg of naloxone hydrochloride dihydrate
equivalent to 10.0 mg naloxone 
hydrochloride and 9.0 mg naloxone Excipients: Each prolonged-release
tablet contains 51.78 mg lactose 
anhydrous  
_TARGIN_
® 
40 mg/20 mg Each prolonged-release tablet contains 40 mg of
oxycodone hydrochloride equivalent to 
36.0 mg oxycodone, and 21.8 mg of naloxone hydrochloride dihydrate
equivalent to 20.0 mg naloxone 
hydrochloride and 18.0 mg naloxone Excipients:
Each prolonged-release tablet contains 103.55 mg lactose 
anhydrous  
For a full list of excipients, refer to _Pharmaceutical
Particulars_. 

PHARMACEUTICAL FORM   
Prolonged-release tablet   
_TARGIN_
® 
5 mg/2.5 mg Oblong, blue film-coated tablets, marked “OXN” on
one side and 
  “5” on the other side.   

_TARGIN_
®
 10 mg/5 mg Oblong, white film-coated tablets, marked “OXN”
on one side and 
“10” on the other side.   
_TARGIN_
®
 

Карактеристике производа

TARGIN
® PROLONGED RELEASE TABLETS
NAME OF THE MEDICINAL PRODUCT
_TARGIN_
®
5 mg/2.5 mg, 10 mg/5 mg, 20 mg/10 mg and 40 mg/20 mg prolonged-release
tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION
_TARGIN_
®
5 mg/2.5 mg Each prolonged-release tablet contains 5 mg of oxycodone
hydrochloride equivalent to
4.5 mg oxycodone, and 2.73 mg of naloxone hydrochloride dihydrate
equivalent to 2.5 mg naloxone
hydrochloride and 2.25 mg naloxone. Excipient with known effect: Each
prolonged-release tablet contains
68.17 mg lactose anhydrous
_TARGIN_
®
10 mg/5 mg Each prolonged-release tablet contains 10 mg of oxycodone
hydrochloride equivalent
to 9.0 mg oxycodone, and 5.45 mg of naloxone hydrochloride dihydrate
equivalent to 5.0 mg naloxone
hydrochloride and 4.5 mg naloxone. Excipient with known effect: Each
prolonged-release tablet contains
61.04 mg lactose anhydrous
_TARGIN_
®
20 mg/10 mg Each prolonged-release tablet contains 20 mg of oxycodone
hydrochloride equivalent
to 18.0 mg oxycodone, and 10.9 mg of naloxone hydrochloride dihydrate
equivalent to 10.0 mg naloxone
hydrochloride and 9.0 mg naloxone Excipient with known effect: Each
prolonged-release tablet contains
51.78 mg lactose anhydrous
_TARGIN_
®
40 mg/20 mg Each prolonged-release tablet contains 40 mg of oxycodone
hydrochloride equivalent
to 36.0 mg oxycodone, and 21.8 mg of naloxone hydrochloride dihydrate
equivalent to 20.0 mg naloxone
hydrochloride and 18.0 mg naloxone Excipient with known effect: Each
prolonged-release tablet contains
103.55 mg lactose anhydrous
For the full list of excipients, refer to
_Pharmaceutical Particulars_
.
PHARMACEUTICAL FORM
Prolonged-release tablet
_TARGIN_
®
5 mg/2.5 mg Blue, oblong tablets, with a nominal length of 9.5mm and
with a film coating,
embossed “OXN” on one side and “5” on the other side.
_TARGIN_
®
10 mg/5 mg White, oblong tablets, with a nominal length of 9.5mm and
with a
film coating, embossed “OXN” on one side and “10” on the other
side.
_TARGIN_
®
20 mg/10 mg Pink, oblong tablets, with a nom