OxyNorm® Sterile Solution for Injection or Infusion 10mgml

Země: Singapur

Jazyk: angličtina

Zdroj: HSA (Health Sciences Authority)

Aktivní složka:

Oxycodone hydrochloride 10mg/ml eqv to Oxycodone base

Dostupné s:

DKSH SINGAPORE PTE. LTD.

ATC kód:

N02AA05

Dávkování:

9 mg/ml

Léková forma:

INJECTION, SOLUTION

Složení:

Oxycodone hydrochloride 10mg/ml eqv to Oxycodone base 9 mg/ml

Podání:

INTRAVENOUS

Druh předpisu:

Prescription Only

Výrobce:

Rafa Laboratories Ltd

Stav Autorizace:

ACTIVE

Datum autorizace:

2009-11-18

Informace pro uživatele

OXYNORM
®
 STERILE SOLUTION FOR INJECTION OR INFUSION 

NAME OF THE MEDICINAL PRODUCT 

_OXYNORM_
_® _
10 mg/ml, solution for injection or infusion 

QUALITATIVE AND QUANTITATIVE COMPOSITION 

Oxycodone hydrochloride
10 mg/ml (equivalent to 9 mg/ml oxycodone) 

_LIST OF EXCIPIENTS _
Citric acid monohydrate 
Sodium citrate 
Sodium chloride 
Hydrochloric acid, dilute 
Sodium hydroxide 
Water for injections 

PHARMACEUTICAL FORM 
Clear, colourless, sterile solution for injection or infusion. 

CLINICAL PARTICULARS 
_THERAPEUTIC INDICATIONS _
For the treatment of moderate to severe pain in patients with
cancer and post-operative pain. 
For the treatment of severe pain requiring the use of a
strong opioid. 

_POSOLOGY AND METHOD OF ADMINISTRATION _
_Route of administration: _
Subcutaneous injection or infusion 
Intravenous injection or infusion. 
_ _
_Posology: _
The dose should
be adjusted according to the severity of pain, the total condition of the 
patient and previous or concurrent medication. 
_ _
_Adults over 18 years: _
The following starting doses
are recommended. A gradual increase in dose may be required 
if analgesia is inadequate or if pain severity increases. 

i.v. (Bolus): Dilute to
1 mg/ml in 0.9% saline, 5% dextrose or water for injections. Administer 
a bolus dose of 1 to
10 mg slowly over 1-2 minutes. Doses should
not be administered more 
frequently than every 4 hours. 

i.v. (Infusion): Dilute to 1 mg/ml in
0.9% saline, 5% dextrose or water for injections. A starting 
dose of 2 mg/hour is recommended. 

i.v. (PCA): Dilute to
1 mg/ml in 0.9% saline, 5% dextrose or water for injections. Bolus doses 
of 0.03 mg/kg should be administered with
a minimum lock-out time of 5 minutes. 

s.c. (Bolus): Use as 10 mg/ml concentration. A starting dose
of 5 mg 

Charakteristika produktu

OXYNORM
® STERILE SOLUTION FOR INJECTION OR INFUSION
NAME OF THE MEDICINAL PRODUCT
_OXYNORM_
_® _
10 mg/ml, solution for injection or infusion
QUALITATIVE AND QUANTITATIVE COMPOSITION
Oxycodone hydrochloride 10 mg/ml (equivalent to 9 mg/ml oxycodone)
_LIST OF EXCIPIENTS _
Citric acid monohydrate
Sodium citrate
Sodium chloride
Hydrochloric acid, dilute
Sodium hydroxide
Water for injections
PHARMACEUTICAL FORM
Clear, colourless, sterile solution for injection or infusion.
CLINICAL PARTICULARS
_THERAPEUTIC INDICATIONS _
For the treatment of moderate to severe pain in patients with cancer
and post-operative pain.
For the treatment of severe pain requiring the use of a strong opioid.
_POSOLOGY AND METHOD OF ADMINISTRATION _
_Route of administration: _
Subcutaneous injection or infusion
Intravenous injection or infusion.
_ _
_Posology: _
The dose should be adjusted according to the severity of pain, the
total condition of the
patient and previous or concurrent medication.
_ _
_Adults over 18 years: _
The following starting doses are recommended. A gradual increase in
dose may be required
if analgesia is inadequate or if pain severity increases.
i.v. (Bolus): Dilute to 1 mg/ml in 0.9% saline, 5% dextrose or water
for injections. Administer
a bolus dose of 1 to 10 mg slowly over 1-2 minutes. Doses should not
be administered more
frequently than every 4 hours.
i.v. (Infusion): Dilute to 1 mg/ml in 0.9% saline, 5% dextrose or
water for injections. A starting
dose of 2 mg/hour is recommended.
i.v. (PCA): Dilute to 1 mg/ml in 0.9% saline, 5% dextrose or water for
injections. Bolus doses
of 0.03 mg/kg should be administered with a minimum lock-out time of 5
minutes.
s.c. (Bolus): Use as 10 mg/ml concentration. A starting dose of 5 mg
is recommended,
repeated at 4-hourly intervals as required.
s.c. (Infusion): Dilute in 0.9% saline, 5% dextrose or water for
injections if required. A starting
dose of 7.5 mg/day is recommended in opioid naïve patients, titrating
gradually according to
symptom control. Cancer patients transfer