Pradaxa 150mg Hard Capsules

Nazione: Singapore

Lingua: inglese

Fonte: HSA (Health Sciences Authority)

Principio attivo:

Dabigatran etexilate mesilate 172.95mg eqv Dabigatran etexilate

Commercializzato da:

BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.

Codice ATC:

B01AE07

Dosaggio:

150.00mg

Forma farmaceutica:

CAPSULE

Composizione:

Dabigatran etexilate mesilate 172.95mg eqv Dabigatran etexilate 150.00mg

Via di somministrazione:

ORAL

Tipo di ricetta:

Prescription Only

Prodotto da:

Boehringer Ingelheim Pharma GmbH & Co. KG (Ingelheim/Rhein site)

Stato dell'autorizzazione:

ACTIVE

Data dell'autorizzazione:

2011-03-31

Foglio illustrativo

0266-10 (SG)                                      

20140313  
1
PRADAXA
®
Abcd
COMPOSITION 
1 Capsule contains                                  

 86.48 mg,  126.83 mg or 172.95 mg 
of beta-alanine, N-[[2-[[[4(hexyloxy)carbonyl]amino]iminomethyl]
phenyl]amino]methyl]-1-methyl-1H-
benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester,
methane-sulfonate, being the methane sulfonic acid 
salt   

(corresponding to dabigatran etexilate base form  

         75 mg,  110 mg or 150 mg)

Excipients: Tartaric acid, acacia, hypromellose, dimethicone 350,
talc, hydroxypropyl cellulose  
_HPMC capsule shell:_  Carragenan, potassium chloride, titanium
dioxide, Sunset Yellow (E110), Indigo 
Carmin (E132), hypromellose. 
_Printing ink:_ Shellac, N-butyl alcohol, isopropyl alcohol,
industrial methylated spirit, Iron oxide black (E172), 
purified water, propylene glycol 

DESCRIPTION 
75 mg capsule: Consist of an imprinted hydroxypropylmethylcellulose
(HPMC) capsule with light blue 
opaque cap and cream-coloured, opaque body of size 2 filled with
yellowish pellets. The cap is imprinted 
with the Boehringer Ingelheim company symbol, the body with
“R75”. The colour of the imprint is black. 
110 mg capsule: Consist of an imprinted hydroxypropylmethylcellulose
(HPMC) capsule with light blue 
opaque cap and cream-coloured, opaque body of size 1 filled with
yellowish pellets. The cap is imprinted 
with the Boehringer Ingelheim company symbol, the body with
“R110”. The colour of the imprint is black. 
150 mg capsule: Consist of an imprinted hydroxypropylmethylcellulose
(HPMC) capsule with light blue 
opaque cap and creamcoloured, opaque body of size 0 filled
with yellowish pellet

Scheda tecnica

1
PRADAXA
®
Abcd
1. NAME OF THE MEDICINAL PRODUCT
PRADAXA 75 mg hard capsules
PRADAXA 110 mg hard capsules
PRADAXA 150 mg hard capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 75 mg or 110 mg or 150 mg of dabigatran
etexilate (as mesilate).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
75 mg capsule: Consist of an imprinted hydroxypropylmethylcellulose
(HPMC) capsule with white opaque
cap and white opaque body of size 2. The cap is imprinted with the
Boehringer Ingelheim company symbol,
the body with “R75”. The colour of the imprint is black.
110 mg capsule: Consist of an imprinted hydroxypropylmethylcellulose
(HPMC) capsule with light blue
opaque cap and light blue opaque body of size 1. The cap is imprinted
with the Boehringer Ingelheim
company symbol, the body with “R110”. The colour of the imprint is
black.
150 mg capsule: Consist of an imprinted hydroxypropylmethylcellulose
(HPMC) capsule with light blue
opaque cap and white opaque body of size 0. The cap is imprinted with
the Boehringer Ingelheim company
symbol, the body with “R150”. The colour of the imprint is black.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
75mg capsule:
Primary prevention of venous thromboembolic events in adult patients
who have undergone elective total hip
replacement surgery or total knee replacement surgery.
110mg capsule:
Primary prevention of venous thromboembolic events in adult patients
who have undergone elective total hip
replacement surgery or total knee replacement surgery.
Prevention of stroke and systemic embolism in patients with
non-valvular atrial fibrillation.
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE),
and prevention of recurrent DVT
and PE in adults.
150mg capsule:
Prevention of stroke and systemic embolism in patients with
non-valvular atrial fibrillation.
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE),
and prevention of recurrent DVT
and PE in adults.
4.2 DOSAGE AND ADMINISTRATION
_PRIMARY