Dynastat Powder for Solution for Injection 40mg

Држава: Сингапур

Језик: Енглески

Извор: HSA (Health Sciences Authority)

Активни састојак:

Parecoxib Sodium 42.36mg eqv Parecoxib

Доступно од:

PFIZER PRIVATE LIMITED

АТЦ код:

M01AH04

Дозирање:

40mg

Фармацеутски облик:

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Састав:

Parecoxib Sodium 42.36mg eqv Parecoxib 40mg

Пут администрације:

INTRAVENOUS, INTRAMUSCULAR

Тип рецептора:

Prescription Only

Произведен од:

Pharmacia & Upjohn Company LLC

Статус ауторизације:

ACTIVE

Датум одобрења:

2012-05-14

Информативни летак

DYNASTAT
®
TABLE OF CONTENT
_Please click on either of the following links to access the required
information: _
PRESCRIBING INFORMATION
PATIENT INFORMATION LEAFLET
Page
1
of
14
DYNASTAT
®
1. NAME OF THE MEDICINAL PRODUCT
Dynastat Powder and Solvent for Solution for Injection 40 mg.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 40 mg parecoxib (present as 42.36 mg parecoxib
sodium) for reconstitution with
2 mL of solvent. After reconstitution, the final concentration of
parecoxib is 20 mg/mL.
Each ampoule contains 2 mL of sodium chloride 9 mg/mL.
3. PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Parecoxib is indicated for the short-term treatment of acute
post-operative pain.
There is limited clinical experience with parecoxib treatment beyond
three days.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Parecoxib may be administered as single or multiple IV or IM doses on
a regular or as needed
schedule. After initiation of therapy, dosage should be adjusted based
on patient response.
Parecoxib is only indicated for patients with a need for parenteral
therapy and for whom a similar
benefit could not be obtained from alternative oral therapy. It is
recommended that patients be
transitioned to alternative oral therapy as soon as clinically
indicated.
As the cardiovascular (CV) risk of cyclooxygenase-2 (COX-2) specific
inhibitors may increase with
dose and duration of exposure, the shortest duration possible and the
lowest effective daily dose
should be used.

Management of Acute Pain: The recommended single or initial dose for
treatment of acute pain
is 40 mg, administered either IV or IM, followed by 20 mg every 6 to
12 hours, as required. The
maximum daily dosage is 60 mg. The IV bolus injection may be given
directly into a vein or into
an existing IV line. The IM injection should be given slowly and
deeply into the muscle.

Concomitant Use with Opioid Analgesics: Opioid analgesics can be used
concurrently with
parecoxib, do

Карактеристике производа

DYNASTAT
®
1. NAME OF THE MEDICINAL PRODUCT
Dynastat Powder for Solution for Injection 40 mg.
Dynastat Powder and Solvent for Solution for Injection 40 mg.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 40 mg parecoxib (present as 42.36 mg parecoxib
sodium) for reconstitution with
2 mL of solvent. After reconstitution, the final concentration of
parecoxib is 20 mg/mL.
Each ampoule contains 2 mL of sodium chloride 9 mg/mL.
3. PHARMACEUTICAL FORM
Powder for solution for injection.
Powder and solvent for solution for injection.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Parecoxib is indicated for the short term treatment of acute
post-operative pain.
There is limited clinical experience with parecoxib treatment beyond
three days.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Parecoxib may be administered as single or multiple IV or IM doses on
a regular or as needed
schedule. After initiation of therapy, dosage should be adjusted based
on patient response.
Parecoxib is only indicated for patients with a need for parenteral
therapy and for whom a similar
benefit could not be obtained from alternative oral therapy. It is
recommended that patients be
transitioned to alternative oral therapy as soon as clinically
indicated.
As the cardiovascular (CV) risk of cyclooxygenase-2 (COX-2) specific
inhibitors may increase with
dose and duration of exposure, the shortest duration possible and the
lowest effective daily dose
should be used.

Management of Acute Pain: The recommended single or initial dose for
treatment of acute pain
is 40 mg, administered either IV or IM, followed by 20 mg every 6 to
12 hours, as required. The
maximum daily dosage is 60 mg. The IV bolus injection may be given
directly into a vein or into an
existing IV line. The IM injection should be given slowly and deeply
into the muscle.

Concomitant Use with Opioid Analgesics: Opioid analgesics can be used
concurrently with
parecoxib, dosing as described above. In clinical trials, the daily
requirement for opioids was
significa