Oxycodone 10mg/ml oral solution sugar free

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Oxycodone hydrochloride

可用日期:

Wockhardt UK Ltd

ATC代码:

N02AA05

INN（国际名称）:

Oxycodone hydrochloride

剂量:

10mg/1ml

药物剂型:

Oral solution

给药途径:

Oral

类:

Schedule 2 (CD)

处方类型:

Valid as a prescribable product

產品總結:

BNF: 04070200; GTIN: 5012727906676

资料单张

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Wockhardt UK Limited
Oxycodone oral 10mg/ml leaflet
105263/4
n-a
297 x 210mm
matt.pirie-scott
1
08/08/2016
675315
n/a
8.5pt (Main Body) / 6pt (Variables)
UK
English
N/A
PACKAGE LEAFLET: INFORMATION FOR THE USER
Oxycodone Hydrochloride 10mg/ml Oral Solution
(referred to as Oxycodone 10mg/ml Solution in this leaflet)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
− Keep this leaflet. You may need to read it again.
− If you have any further questions, please ask your doctor or
pharmacist.
− This medicine has been prescribed for you only. Do not pass it on
to
others. It may harm them, even if their signs of illness are the same
as yours.
− If you get any side effects, talk to your doctor or pharmacist.
This includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Oxycodone 10mg/ml Solution is and what it is used for
2. What you need to know before you take Oxycodone 10mg/ml Solution
3. How to take Oxycodone 10mg/ml Solution
4. Possible side effects
5. How to store Oxycodone 10mg/ml Solution
6. Contents of the pack and other information
1. WHAT OXYCODONE 10MG/ML SOLUTION IS AND WHAT IT IS USED FOR
This medicine has been prescribed for you by your doctor to relieve
moderate to severe pain.
It contains

产品特点

OBJECT 1
OXYCODONE HYDROCHLORIDE 10MG/ML ORAL
SOLUTION (SUGAR FREE)
Summary of Product Characteristics Updated 12-Dec-2016 | Wockhardt UK
Ltd
1. Name of the medicinal product
Oxycodone Hydrochloride 10mg/ml Oral Solution
2. Qualitative and quantitative composition
Each 1ml contains oxycodone hydrochloride 10 mg (equivalent to 9 mg of
oxycodone base).
This medicinal product contains approximately 0.85mg sodium per ml.
For full list of excipients, see Section 6.1.
3. Pharmaceutical form
A clear, orange oral solution.
4. Clinical particulars
4.1 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.
4.2 Posology and method of administration
_Route of administration:_
Oral use.
_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:_
Oxycodone solution 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
Oxycodone solution. 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.
The usual starting dose for opioid naïve patients or patients
presenting with severe pain uncontrolled by
weaker opioids is 5 mg, 4-6 hourly. The dose should then be carefully
titrated, as frequently as once a day
if necessary, to achieve pain relief. The majority of patients will
not require a daily dose greater than 400
mg. However, a few patients may require higher doses.
Patients receiving oral morphine before oxycodone therapy should have
their daily dose based on the
following ratio: 10 mg of oral oxycodone is equivalent to 20 mg of
oral morphine. It must be