OXYNORM® Concentrate Oral Solution 10mgml

Land: Singapore

Språk: engelsk

Kilde: HSA (Health Sciences Authority)

Aktiv ingrediens:

Oxycodone base 9mg/ml eqv. Oxycodone Hydrochloride

Tilgjengelig fra:

MUNDIPHARMA PHARMACEUTICALS PTE. LTD.

ATC-kode:

N02AA05

Dosering :

10 mg per ml

Legemiddelform:

SOLUTION, CONCENTRATE

Sammensetning:

Oxycodone base 9mg/ml eqv. Oxycodone Hydrochloride 10 mg per ml

Administreringsrute:

ORAL

Resept typen:

Prescription Only

Produsert av:

Mundipharma Pharmaceuticals Limited

Autorisasjon status:

ACTIVE

Autorisasjon dato:

2012-03-28

Informasjon til brukeren

_OXYNORM_
® 
ORAL SOLUTION 1MG/ML 
_OXYNORM_
® 
CONCENTRATE ORAL SOLUTION 10MG/ML 
NAME OF THE MEDICINAL PRODUCT 
_OXYNORM_
®
 oral solution 1mg/ml 
_OXYNORM_
® 
concentrate oral solution 10mg/ml 

QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each 5 ml _OXYNORM_
®
 oral solution 1mg/ml contains oxycodone base 4.5 mg
as oxycodone 
hydrochloride 5 mg.  
Each 1 ml _OXYNORM_
®
 concentrate oral solution 10mg/ml contains oxycodone base 9 mg
as 
oxycodone hydrochloride 10 mg.  
Go to top of the page
[http://emc.medicines.org.uk/medicine/3507/SPC/OxyNorm+liquid+and+OxyNorm+concentrate/#tableOfContents#tableOfContents]

[http://emc.medicines.org.uk/medicine/3507/SPC/OxyNorm+liquid+and+OxyNorm+concentrate/#tableOfContents#tableOfContents] 
PHARMACEUTICAL FORM 
_OXYNORM_
®
 oral solution 1mg/ml is a clear colourless/straw-coloured
solution.  
_OXYNORM_
®
 concentrate oral solution 10mg/ml is a clear, orange
solution. 
Go to top of the page
[http://emc.medicines.org.uk/medicine/3507/SPC/OxyNorm+liquid+and+OxyNorm+concentrate/#tableOfContents#tableOfContents]

[http://emc.medicines.org.uk/medicine/3507/SPC/OxyNorm+liquid+and+OxyNorm+concentrate/#tableOfContents#tableOfContents] 
CLINICAL PARTICULARS 

THERAPEUTIC INDICATION  

The management of acute exacerbation of moderate to severe
chronic pain unresponsive to non-
narcotic analgesia, and post-operative pain. 
POSOLOGY AND METHOD OF ADMINISTRATION 

_Route of administration:_

Oral  
_Post-operative pain: _ 
In common with other strong opioids, the need for continued
treatment should be assessed at 
regular intervals.  
_Elderly and adults over 18 years:_ 
_OXYNORM_
®
 oral solutions should be taken at 4-6 hourly intervals. The
dosage is dependent on 
the severity of the pain, and
the patient's previous history of analgesic requirements.  
Increasing severity of pain will require an
increased dosage of _OXYNOR

Preparatomtale

_OXYNORM_® oral solution 1mg/ml
_OXYNORM_® concentrate oral solution 10mg/ml
NAME OF THE MEDICINAL PRODUCT
_OXYNORM_® oral solution 1mg/ml
_OXYNORM_® concentrate oral solution 10mg/ml
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of _OXYNORM_® oral solution 1mg/ml contains oxycodone base
0.9 mg as oxycodone
hydrochloride 1 mg. Excipient with known effect: Each ml _OXYNORM_®
oral solution 1mg/ml contains 1
mg sodium benzoate.
Each 1 ml _OXYNORM_® concentrate oral solution 10mg/ml contains
oxycodone base 9 mg as oxycodone
hydrochloride 10 mg. Excipients with known effect: Each ml OxyNorm
concentrate contains 1 mg
sodium benzoate. It also contains 0.1 mg sunset yellow (E 110), which
may cause allergic reactions such
as asthma. This is more common in people who are allergic to aspirin.
PHARMACEUTICAL FORM
_OXYNORM_® oral solution 1mg/ml is a clear colourless/straw-coloured
solution.
_OXYNORM_® concentrate oral solution 10mg/ml is a clear, orange
solution.
CLINICAL PARTICULARS
THERAPEUTIC INDICATION
The management of acute exacerbation of moderate to severe chronic
pain unresponsive to non-
narcotic analgesia, and post-operative pain.
POSOLOGY AND METHOD OF ADMINISTRATION
_Route of administration: _
Oral
_Post-operative pain: _
In common with other strong opioids, the need for continued treatment
should be assessed at regular
intervals.
_Elderly and adults over 18 years: _
_OXYNORM_® oral solutions should be taken at 4-6 hourly intervals.
The dosage is dependent on the
severity of the pain, and the patient's previous history of analgesic
requirements.
Increasing severity of pain will require an increased dosage of
_OXYNORM_® oral solutions. The correct
dosage for any individual patient is that which controls the pain and
is well tolerated throughout the
dosing period. Patients should be titrated to pain relief unless
unmanageable adverse drug reactions
prevent this.
_OXYNORM_® oral solutions will generally be used in a short term
trial (4-6 weeks) to determine if the pain
is opioid responsive, before tr