JURNISTA

Nazione: Indonesia

Lingua: indonesiano

Fonte: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Principio attivo:

HYDROMORPHONE HYDROCHLORIDE

Commercializzato da:

KIMIA FARMA, Jakarta - Indonesia

INN (Nome Internazionale):

HYDROMORPHONE HYDROCHLORIDE

Dosaggio:

16 MG

Forma farmaceutica:

TABLET PELEPASAN LAMBAT

Confezione:

DUS @ 4 BLISTER @ 7 TABLET PELEPASAN LAMBAT

Prodotto da:

JANSSEN CILAG FARMACEUTICAL SpA - Italy

Data dell'autorizzazione:

2018-01-04

Scheda tecnica

JURNISTA
®
HYDROMORPHONE HYDROCHLORIDE
DOSAGE FORMS AND STRENGTHS
8 mg tablets:
Red, round, biconvex tablet, with ‘HM 8’ printed in black ink on
one side.
Each tablet contains 8.72 mg and delivers 8 mg hydromorphone HCl,
equivalent to 7.12 mg hydromorphone base.
16 mg tablets:
Yellow, round, biconvex tablet, with ‘HM 16’ printed in black ink
on one side.
Each tablet contains 16.35 mg and delivers 16 mg hydromorphone HCl,
equivalent to 14.24 mg hydromorphone base.
For excipients, see _List of Excipients. _
CLINICAL INFORMATION
INDICATIONS
JURNISTA is indicated for the management of moderate to severe cancer
pain in opioid tolerant patients requiring
continuous, around-the-clock opioid analgesia for an extended period
of time.
JURNISTA is NOT intended for use as an as needed analgesic.
JURNISTA is not indicated for the management of acute or postoperative
pain.
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.
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 should not be taken more than once every 24 hours.
If the patient did not take the regularly scheduled dose of JURNISTA,
the patient should be instructed