Jurnista Prolonged Release Tablet 8mg

Riik: Singapur

keel: inglise

Allikas: HSA (Health Sciences Authority)

Toimeaine:

(Drug Layer) Hydromorphone HCl

Saadav alates:

JOHNSON & JOHNSON PTE. LTD.

ATC kood:

N02AA03

Annus:

8.72mg

Ravimvorm:

TABLET, EXTENDED RELEASE

Koostis:

(Drug Layer) Hydromorphone HCl 8.72mg

Manustamisviis:

ORAL

Retsepti tüüp:

Prescription Only

Valmistatud:

Alza Corporation

Volitamisolek:

ACTIVE

Loa andmise kuupäev:

2009-03-18

Infovoldik

 
NAME OF THE MEDICINAL PRODUCT 
Trade name: JURNISTA
®
 (hydromorphone hydrochloride) 

QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each JURNISTA
®
 8 mg prolonged-release tablet contains 8.72mg and delivers 8
mg 
hydromorphone HCl, equivalent to 7.12 mg hydromorphone base. 
For a full list of excipients, see
section “Pharmaceutical Particulars”. 

PHARMACEUTICAL FORM 
JURNISTA
®
  8 mg prolonged-release tablet: red, round, biconvex tablet,
with ‘HM 8’ 
printed in black ink on one side. 

CLINICAL PARTICULARS 

THERAPEUTIC INDICATIONS 
Treatment of severe chronic cancer pain.  
JURNISTA
®
 should be used in patients requiring continuous analgesia. 

POSOLOGY AND METHOD OF ADMINISTRATION 
As with other opioid analgesics, safe and
effective administration of JURNISTA
®
  to 
patients with pain depends upon
a comprehensive assessment of the patient. The nature 
of the pain as well as the concurrent medical
status of the patient will affect selection of 
the dose. Owing to the varied response observed to
opioids between individuals, it is 
recommended that all patients be started
at the lowest appropriate dose of opioid therapy 
and titrated to an adequate
level of analgesia, balanced against an acceptable frequency 
of adverse reactions.  

As with any strong opioid, appropriate prophylaxis for known
adverse reactions (for 
example constipation), should be considered. 
Patients should be instructed to swallow the JURNISTA
®
  tablet whole with a glass of 
water, at approximately the same time each day, and
never to chew, divide, or crush it. 
JURNISTA
®
  may  be taken with or without food (see _Pharmacokinetic
Properties_). 
JURNISTA
®
 should not be taken more than once every 24 hours.  
_ _
_Patients currently not routinely receiving opioids: _
The starting dose of Jurnista should be 8mg every 24

Toote omadused

2
PRODUCT NAME
JURNISTA
®
(hydromorphone hydrochloride)
DOSAGE FORMS AND STRENGTHS
JURNISTA
®
8 mg prolonged-release tablet: red, round, biconvex tablet, with ‘HM
8’ printed
in black ink on one side.
Each JURNISTA
®
8 mg prolonged-release tablet contains 8.72mg and delivers 8 mg
hydromorphone HCl, equivalent to 7.12 mg hydromorphone base.
For a full list of excipients, see section “Pharmaceutical
Particulars”.
CLINICAL INFORMATION
INDICATIONS
Treatment of severe chronic cancer pain.
JURNISTA
®
should be used in patients requiring continuous analgesia.
DOSAGE AND ADMINISTRATION
As with other opioid analgesics, safe and effective administration of
JURNISTA
®
to patients
with pain depends upon a comprehensive assessment of the patient. The
nature of the pain as
well as the concurrent medical status of the patient will affect
selection of the dose. Owing to
the varied response observed to opioids between individuals, it is
recommended that all
patients be started at the lowest appropriate dose of opioid therapy
and titrated to an adequate
level of analgesia, balanced against an acceptable frequency of
adverse reactions. The lowest
effective dose should be used for the shortest period of time (see
_Dosage and Administration _
_– Stopping Treatment_
).
As with any strong opioid, appropriate prophylaxis for known adverse
reactions (for example
constipation), should be considered.
DOSAGE - ADULTS
JURNISTA
®
should not be taken more than once every 24 hours.
_ _
_PATIENTS CURRENTLY NOT ROUTINELY RECEIVING OPIOIDS_
_ _
The initial dose in patients currently not routinely receiving opioids
should not exceed 8 mg
every 24 hours. The dosage should not be titrated more frequently than
every fourth dose (for
example, if the first dose is given on a Monday, the dosage could be
increased no earlier than
the fourth dose, on Thursday).
Because it may be more time consuming to titrate a patient to adequate
analgesia using a
controlled-release
opioid
preparation,
it
may
be
advisable
to
begin
treatment
with
conventiona