AGGRASTAT CONCENTRATE FOR INFUSION 0.25 mgml

Nchi: Singapoo

Lugha: Kiingereza

Chanzo: HSA (Health Sciences Authority)

Viambatanisho vya kazi:

Tirofiban Hydrochloride Monohydrate

Inapatikana kutoka:

DCH AURIGA SINGAPORE

ATC kanuni:

Pending

Kipimo:

0.281 mg/mL

Dawa fomu:

INJECTION

Tungo:

Tirofiban Hydrochloride Monohydrate 0.281 mg/mL

Njia ya uendeshaji:

INTRAVENOUS

Dawa ya aina:

Prescription Only

Viwandani na:

Patheon Manufacturing Services LLC

Idhini hali ya:

ACTIVE

Idhini ya tarehe:

1999-05-17

Taarifa za kipeperushi

PRODUCT 
CIRCULAR 
   SG-ARS-IV/SI-102001
CONCENTRATE FOR INFUSION
AGGRASTAT
TM
(TIROFIBAN HYDROCHLORIDE)
I.  THERAPEUTIC CLASS
AGGRASTAT*

 (tirofiban hydrochloride), a non-peptide antagonist of the platelet
GP IIb/IIIa receptor, is a platelet 
aggregation inhibitor.
II.  INDICATIONS
AGGRASTAT, in combination with heparin, is indicated for patients with
unstable angina or non-Q-wave 
myocardial infarction to prevent cardiac ischemic events and is also
indicated for patients with coronary 
ischemic syndromes undergoing coronary angioplasty or atherectomy to
prevent cardiac ischemic 
complications related to abrupt closure of the treated coronary
artery.  (See CLINICAL PHARMACOLOGY and 
DOSAGE AND ADMINISTRATION.)
III.  DOSAGE AND ADMINISTRATION
THE VIAL OF AGGRASTAT (CONCENTRATE) MUST BE DILUTED PRIOR TO
ADMINISTRATION (SEE INSTRUCTIONS FOR 
USE).
_AGGRASTAT is for intravenous use only using sterile
equipment.  _AGGRASTAT may be co-administered with 
heparin through the same line.
AGGRASTAT is recommended for use with a calibrated infusion device. 
Care should be taken to avoid a 
prolonged loading infusion.  Care should also be taken in calculating
the bolus dose and infusion rates based 
on patient weight.
In clinical studies patients received aspirin, unless contraindicated.
_UNSTABLE ANGINA PECTORIS OR NON-Q-WAVE MYOCARDIAL INFARCTION:_
AGGRASTAT should be administered intravenously, in combination with
heparin, at the initial infusion rate of 
0.4 microgram/kg/min for 30 minutes.  Upon completion of the initial
infusion, AGGRASTAT should be continued 
at a maintenance infusion rate of 0.1 microgram/kg/min. The table
below is provided as a guide to dosage 
adjustment by weight.
AGGRASTAT INJECTION MUST FIRST BE DILUTED PRIOR TO ADMINISTRATION (SEE
INSTRUCTIONS FOR USE).
MOST PATIENTS
SEVERE RENAL INSUFFICIENCY
Patient
Weight (kg)
30 Min Loading 
Infusion Rate  
(mL/hr)
Maintenance Infusion 
Rate 
(mL/hr)
30 Min Loading 
Infusion Rate 
(mL/hr)
Maintenance Infusion 
Ra

Tabia za bidhaa

PRODUCT CIRCULAR
SG-ARS-IV/SI-102001
CONCENTRATE FOR INFUSION
AGGRASTAT
TM
(TIROFIBAN HYDROCHLORIDE)
I. THERAPEUTIC CLASS
AGGRASTAT
*
(tirofiban hydrochloride), a non-peptide antagonist of the platelet GP
IIb/IIIa receptor, is a
platelet aggregation inhibitor.
II. INDICATIONS
AGGRASTAT, in combination with heparin, is indicated for patients with
unstable angina or non-Q-wave
myocardial infarction to prevent cardiac ischemic events and is also
indicated for patients with coronary
ischemic syndromes undergoing coronary angioplasty or atherectomy to
prevent cardiac ischemic
complications related to abrupt closure of the treated coronary
artery. (See CLINICAL PHARMACOLOGY
and DOSAGE AND ADMINISTRATION.)
III. DOSAGE AND ADMINISTRATION
THE VIAL OF AGGRASTAT (CONCENTRATE) MUST BE DILUTED PRIOR TO
ADMINISTRATION (SEE INSTRUCTIONS
FOR USE).
_AGGRASTAT is for intravenous use only using sterile equipment.
_AGGRASTAT may be co-administered with
heparin through the same line.
AGGRASTAT is recommended for use with a calibrated infusion device.
Care should be taken to avoid a
prolonged loading infusion. Care should also be taken in calculating
the bolus dose and infusion rates based
on patient weight.
In clinical studies patients received aspirin, unless contraindicated.
_UNSTABLE ANGINA PECTORIS OR NON-Q-WAVE MYOCARDIAL INFARCTION:_
AGGRASTAT should be administered intravenously, in combination with
heparin, at the initial infusion rate
of 0.4 microgram/kg/min for 30 minutes. Upon completion of the initial
infusion, AGGRASTAT should be
continued at a maintenance infusion rate of 0.1 microgram/kg/min. The
table below is provided as a guide to
dosage adjustment by weight.
AGGRASTAT INJECTION MUST FIRST BE DILUTED PRIOR TO ADMINISTRATION (SEE
INSTRUCTIONS FOR USE).
MOST PATIENTS
SEVERE RENAL INSUFFICIENCY
Patient
Weight
(kg)
30 Min Loading
Infusion Rate
(mL/hr)
Maintenance
Infusion Rate
(mL/hr)
30 Min Loading
Infusion Rate
(mL/hr)
Maintenance
Infusion Rate
(mL/hr)
30-37
16
4
8
2
38-45
20
5
10
3
46-54
24
6
12
3
55-62
28
7
14
4
63-