Oxycodone 50mg/1ml solution for injection ampoules

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Oxycodone hydrochloride

Предлага се от:

Wockhardt UK Ltd

АТС код:

N02AA05

INN (Международно Name):

Oxycodone hydrochloride

дозиране:

50mg/1ml

Лекарствена форма:

Solution for injection

Начин на приложение:

Intravenous; Subcutaneous

Клас:

Schedule 2 (CD)

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 04070200; GTIN: 5012727908601

Листовка

MPS READ DIRECTION
WOCKHARDT TRAVEL DIRECTION
Pharmacode:
MEASURE BAR SHOULD BE 150MM AT 100% SCALE
Customer
Description
Item Code
Profile
Size
Min. Point Size
Market
Language
Proof By
Proof No.
Date
Artwork No.
Pharma
Code
Colours Used
[e-mail]
CLEARLY MARK ANY AMENDMENTS ON ONE PROOF AND RETURN TO MPS
WARNING! We cannot accept responsibility for any errors
in this proof after approval. Whilst we take extreme care
at all times to ensure accuracy to our clientʼs brief,
the final responsibility must be taken by our client.
IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING
FULL APPROVAL OF DESIGN AND TEXT.
Process Black
Keylines (non-printing)
Text Free Area (non-printing)
Wockhardt UK Limited
Oxycodone injection 50mg/ml leaflet
105940/5
n-a
460 x 150mm
matt.pirie-scott
3
16/09/2016
686782
257
6pt (Main Body) / 7pt (Variables)
UK
English
257
PACKAGE LEAFLET: INFORMATION FOR THE USER
Oxycodone Hydrochloride 50 mg/ml
Solution for Injection or Infusion
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, ask your doctor, pharmacist or
nurse.
− 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, pharmacist or
nurse.
This includes any possible side effects not listed in this leaflet.
See section 4.
THE NAME OF YOUR MEDICINE IS OXYCODONE
HYDROCHLORIDE 50 MG/ML SOLUTION FOR INJECTION
OR INFUSION. IN THE REST OF THIS LEAFLET IT IS CALLED
OXYCODONE INJECTION.
WHAT IS IN THIS LEAFLET:
1. What Oxycodone Injection is and what it is used for
2. What you need to know before you use
Oxycodone Injection
3. How to use Oxycodone Injection
4. Possible side effects
5. How to store Oxycodone Injection
6. Contents of the pack and other information
1. What Oxycodone Injection is and what it
is used for
This injec

Данни за продукта

OBJECT 1
OXYCODONE HYDROCHLORIDE 50MG/ML SOLUTION FOR
INJECTION OR INFUSION
Summary of Product Characteristics Updated 06-Dec-2016 | Wockhardt UK
Ltd
1. Name of the medicinal product
Oxycodone Hydrochloride 50 mg/ml Solution for Injection or Infusion.
2. Qualitative and quantitative composition
Each ml contains oxycodone hydrochloride 50 mg (equivalent to 45 mg of
oxycodone base).
This medicinal product contains less than 1 mmol sodium (23 mg) per
dose.
For the full list of excipients, see Section 6.1.
3. Pharmaceutical form
Solution for injection or infusion (injection or infusion).
A clear, colourless solution practically free of particles.
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:
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 in 0.9% saline, 5% dextrose or water for
injections. Administer a bolus dose of 1 to 10
mg slowly over one to two minutes in opioid naive patients.
Doses should not be administered more frequently than every four
hours.
i.v. (Infusion): Dilute in 0.9% saline, 5% dextrose or water for
injections. A starting dose of 2 mg/hour is
recommended for opioid naive patients.
i.v. (PCA): Dilute 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 five minutes for
opioid naive patients.
s.c. (Bolus): Dilute in 0.9% saline, 5% dextrose or water for
injections. A starting dose of 5 mg is
recommended, repeated at four-hourly inte