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SHORTEC 10MG/ML SOLUTION FOR INJECTION OR INFUSION

Active substance(s): OXYCODONE HYDROCHLORIDE / OXYCODONE HYDROCHLORIDE / OXYCODONE HYDROCHLORIDE

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• have a heart problem after
long-term lung disease (cor
pulmonale);
• have moderate to severe liver
problems. If you have other
long-term problems you should
only use this injection if
recommended by your doctor;
• have ongoing problems with
Read all of this leaflet carefully before you start using this medicine
constipation;
because it contains important information for you.
• are under 18 years of age.
• Keep this leaflet. You may need to read it again.
Warnings and precautions
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. Talk to your doctor, pharmacist
or nurse before treatment with
It may harm them, even if their signs of illness are the same as yours.
Shortec injection if you:
• If you get any side effects, talk to your doctor, pharmacist or nurse. This
• are elderly or weakened;
includes any possible side effects not listed in this leaflet. See section 4.
• have an under-active thyroid
gland (hypothyroidism), as you
In this leaflet:
2. What you need to know before
may need a lower dose;
1. What Shortec injection is and
you use Shortec injection
• have myxoedema (a thyroid
what it is used for
disorder with dryness, coldness
Do not use Shortec injection if you:
2. What you need to know before
and swelling [‘puffiness’] of
• are allergic to oxycodone, or any
you use Shortec injection
the skin affecting the face and
of the other ingredients of the
3. How to use Shortec injection
limbs);
injection (listed in section 6 );
4. Possible side effects
• have breathing problems, such as • have a head injury, severe
5. How to store Shortec injection
headache or feel sick as this may
severe obstructive lung disease,
6. Contents of the pack and other
indicate that the pressure in your
severe bronchial asthma or severe
information
skull is increased;
respiratory depression. Your
• have low blood pressure
1. What Shortec injection is
doctor will have told you if you
(hypotension);
and what it is used for
have any of these conditions.
• have low blood volume
Symptoms may include
This injection has been prescribed
(hypovolaemia); this can
breathlessness, coughing or
for you by your doctor to relieve
happen with severe external or
breathing more slowly or weakly
moderate to severe pain. It contains
internal bleeding, severe burns,
than expected;
the active ingredient oxycodone
excessive sweating, severe
• have a condition where the small
which belongs to a group of
diarrhoea or vomiting;
bowel does not work properly
medicines called strong analgesics
• have a mental disorder as a
(paralytic ileus) or you have
or ‘painkillers’.
result of an infection (toxic
severe pain in your abdomen;
psychosis);

Shortec 10 mg/ml,
solution for injection or infusion
Oxycodone hydrochloride
®

196027 027002-I

550x148mm (LSN-CON-42) (L) V2

Package leaflet: Information for the user

SHORTEC INJ 10MG-ML PIL 1ML UK 196027 027002-I V2.indd 2

• have inflammation of the pancreas
(which causes severe pain in the
abdomen and back);
• have problems with your gall
bladder or bile duct;
• have inflammatory bowel disease;
• have an enlarged prostate gland,
which causes difficulty in passing
urine (in men);
• have poor adrenal gland function
(your adrenal gland is not working
properly which may cause
symptoms including weakness,
weight loss, dizziness, feeling or
being sick), e.g. Addison’s disease;
• have breathing problems such as
severe pulmonary disease. Your
doctor will have told you if you
have this condition. Symptoms
may include breathlessness and
coughing;
• have kidney or liver problems;
• have previously suffered from
withdrawal symptoms such as
agitation, anxiety, shaking or
sweating upon stopping taking
alcohol or drugs;
• are or have ever been addicted to
alcohol or drugs or have a known
opioid dependence;
• have an increased sensitivity to
pain;
• need to take increasingly higher
doses of Shortec to gain the same
level of pain relief (tolerance).
If you are going to have an operation,
please tell the doctor at the hospital
that you are taking this medicine.

Other medicines and Shortec
injection
Please tell your doctor or pharmacist
if you are taking, have recently taken
or might take any other medicines,
including medicines obtained without
a prescription. If you use this
injection with some other medicines,
the effect of this injection or the other
medicines may be changed.
Tell your doctor or pharmacist if you
are taking:
• a type of medicine known as a
monoamine oxidase inhibitor
or you have taken this type of
medicine in the last two weeks;
• medicines to help you sleep or stay
calm (for example tranquillisers,
hypnotics or sedatives);
• medicines to treat depression (such
as paroxetine);
• medicines to treat psychiatric
or mental disorders (such as
phenothiazines or neuroleptics);
• other strong analgesics
(‘painkillers’);
• muscle relaxants;
• medicines to treat high blood
pressure;
• quinidine (a medicine to treat a fast
heart beat);
• cimetidine (a medicine for stomach
ulcers, indigestion or heartburn);
• antifungal medicines (such as
ketoconazole, voriconazole,
itraconazole and posaconazole);
• antibiotics (such as clarithromycin,
erythromycin or telithromycin);

• medicines known as ‘protease
inhibitors’ to treat HIV (e.g.
boceprevir, ritonavir, indinavir,
nelfinavir or saquinavir);
• rifampicin (to treat tuberculosis);
• carbamazepine (a medicine treat
seizures, fits or convulsions and
certain pain conditions);
• phenytoin (a medicine to treat
seizures, fits or convulsions);
• a herbal remedy called St. John’s
Wort (also known as Hypericum
perforatum);
• antihistamines;
• medicines to treat Parkinson’s
disease.
Also tell your doctor if you have
recently been given an anaesthetic.
Using Shortec injection with food,
drink and alcohol
Drinking alcohol during your
treatment with this injection may
make you sleepy or increase the
risk of serious side effects such
as shallow breathing with a risk
of stopping breathing, and loss of
consciousness. It is recommended
not to drink alcohol while you are
taking Shortec injection.
You should avoid drinking grapefruit
juice during your treatment with this
medicine.
Pregnancy and breastfeeding
Do not use this injection if you are
pregnant or breastfeeding.
Ask your doctor or pharmacist for
advice before taking any medicine.

Driving and using machines
This injection may cause a number
of side effects such as drowsiness
which could affect your ability to
drive or use machinery (see section
4 for a full list of side effects). These
are usually most noticeable when you
first start using the injection, or when
changing to a higher dose. If you are
affected you should not drive or use
machinery.
This medicine can affect your ability
to drive as it may make you sleepy
or dizzy.
• Do not drive while taking this
medicine until you know how it
affects you.
• It is an offence to drive while
you have this medicine in your
body over a specified limit unless
you have a defence (called the
‘statutory defence’).
• This defence applies when:
• The medicine has been prescribed
to treat a medical or dental
problem; and
• You have taken it according to
the instructions given by the
prescriber and in the information
provided with the medicine.
• Please note that it is still an offence
to drive if you are unfit because of
the medicine (i.e. your ability to
drive is being affected).
Details regarding a new driving
offence concerning driving after
drugs have been taken in the UK may
be found here:

https://www.gov.uk/drug-driving-law.
Talk to your doctor or pharmacist if you are
not sure whether it is safe for you to drive
while taking this medicine.
Shortec injection contains less than 1
mmol sodium (23mg) per ml
i.e. it is essentially “sodium-free”.
3. How to use Shortec injection
A doctor or nurse will usually prepare
and administer the injection for you. The
injection should be used immediately
after opening. The dose and how often
the injection is given may be adjusted
according to the severity of your pain.
Adults (over 18 years of age)
The usual starting dose is dependent upon
how the injection is administered. The usual
starting doses are as follows:
• As a single injection into a vein, the usual
dose is 1 to 10 mg given slowly over 1 to
2 minutes. This can be repeated every 4
hours.
• As an infusion into a vein, the usual
starting dose is 2 mg/hour.
• As a single injection through a fine
needle into the tissue under the skin, the
usual starting dose is 5 mg repeated at
4-hourly intervals if needed.
• As an infusion through a fine needle
into the tissue under the skin, the usual
starting dose is 7.5 mg/day.
• If given by patient controlled analgesia
(PCA), the dose is worked out according
to your weight (0.03 mg per kg of body
weight). Your doctor or nurse will set a
suitable frequency.

Information for Healthcare Professionals
Shortec® 10 mg/ml,
solution for injection or infusion
Oxycodone hydrochloride
This leaflet provides technical
information for the healthcare
professional about Shortec 10 mg/
ml, solution for injection or
infusion.
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 1-2 minutes
in opioid naïve patients. Doses
should not be administered more

frequently than every 4 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 naïve 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 5 minutes for
opioid naïve patients.
s.c. (Bolus): A starting dose
of 5 mg is recommended,
repeated at 4-hourly intervals
as required for opioid naïve
patients.
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 transferring
from oral oxycodone may
require much higher doses (see
below).

Transferring patients between
oral and parenteral oxycodone:
The dose should be based on
the following ratio: 2 mg of
oral oxycodone is equivalent to
1 mg of parenteral oxycodone. It
must be emphasised that this is a
guide to the dose required. Interpatient variability requires that
each patient is carefully titrated
to the appropriate dose.
Elderly patients:
Elderly patients should be
treated with caution. The lowest
dose should be administered
with careful titration to pain
control.
Patients with renal and hepatic
impairment:
The dose initiation should follow
a conservative approach in these
patients. The recommended
adult starting dose should be
reduced by 50% (for example a
total daily dose of 10 mg orally
in opioid naive patients), and
each patient should be titrated to
adequate pain control according
to their clinical situation.

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Children under 18 years:
There are no data on the use of
Shortec injection in patients under
18 years of age.
Use in non-malignant pain:
Opioids are not first-line therapy
for chronic non-malignant pain,
nor are they recommended as the
only treatment. Types of chronic
pain which have been shown to
be alleviated by strong opioids
include chronic osteoarthritic pain
and intervertebral disc disease.
The need for continued treatment
in non-malignant pain should be
assessed at regular intervals.
Duration of treatment:
Oxycodone should not be used for
longer than necessary.
Discontinuation of treatment:
When a patient no longer requires
therapy with oxycodone, it may
be advisable to taper the dose
gradually to prevent symptoms of
withdrawal.
Instructions for use/handling
Each ampoule is for single use in a
single patient. The injection should
be given immediately after opening
the ampoule and any unused
portion should be discarded.
Chemical and physical in-use
stability has been demonstrated for
24 hours at room temperature.

From a microbiological point
of view, the product should be
used immediately. If not used
immediately, in-use storage times
and conditions prior to use are
the responsibility of the user and
would normally not be longer
than 24 hours at 2 to 8°C, unless
reconstitution / dilution (etc) has
taken place in controlled and
validated aseptic conditions.
Shortec injection, undiluted or
diluted to 1 mg/ml with 0.9% w/v
saline, 5% w/v dextrose or water
for injections, is physically and
chemically stable when in contact
with representative brands of
polypropylene or polycarbonate
syringes, polyethylene or PVC
tubing and PVC or EVA infusion
bags, over a 24 hour period at
room temperature.
The injection, whether undiluted or
diluted to 1 mg/ml in the infusion
fluids used in these studies
and contained in the various
assemblies, does not need to be
protected from light.
Inappropriate handling of the
undiluted solution after opening
of the original ampoule, or of the
diluted solutions may compromise
the sterility of the product.

SHORTEC INJ 10MG-ML PIL 1ML UK 196027 027002-I V2.indd 3

This leaflet was last revised in
January 2016.
® QDEM and SHORTEC are
registered trade marks.
TM
The ‘Qdem pharmaceuticals’
logo is a trade mark.
© 2013-2016 Qdem
Pharmaceuticals Limited.

Children
Children and adolescents under 18 years
of age should not be given the injection.
Patients with kidney or liver
problems
Please tell your doctor if you suffer
from kidney or liver problems as they
may prescribe a lower dose depending
on your condition.
The dose recommended by the doctor
should not be exceeded. Check with the
doctor or pharmacist if you are unsure.
If you find that you are still in pain
whilst being given this injection discuss
this with your doctor.
If you use more Shortec injection than
you should, or if someone else uses
your injection
Call your doctor or hospital straight
away. People who have been given an
overdose may feel very sleepy, sick or
dizzy. They may also have breathing
difficulties leading to unconsciousness
or even death and may need emergency
treatment in hospital. When seeking
medical attention make sure that you
take this leaflet and any remaining
injection with you to show to the doctor.
If you stop using Shortec injection
You should not suddenly stop using
this injection unless your doctor tells
you to. If you want to stop using your
injection, discuss this with your doctor
first. They will tell you how to do this,
usually by reducing the dose gradually
so you do not experience unpleasant

effects. Withdrawal symptoms such
as agitation, anxiety, palpitations,
shaking or sweating may occur
if you suddenly stop using this
injection.
If you have any further questions on
the use of this injection, ask your
doctor or pharmacist.
4. Possible side effects
Like all medicines, this injection
can cause side effects, although not
everybody gets them.
All medicines can cause allergic
reactions, although serious allergic
reactions are rare. Tell your doctor
immediately if you get any sudden
wheeziness, difficulties in breathing,
swelling of the eyelids, face or lips,
rash or itching especially those
covering your whole body.
The most serious side effect is a
condition where you breathe more
slowly or weakly than expected
(respiratory depression).
Tell your doctor immediately if
this happens to you.
As with all strong painkillers, there
is a risk that you may become
addicted or reliant on this injection.
Very common side effects
(May affect more than 1 in 10
people)
• Constipation (your doctor can
prescribe a laxative to overcome
this problem).

• Feeling or being sick (this should
normally wear off after a few days,
however your doctor can prescribe
an anti-sickness medicine if it
continues to be a problem).
• Drowsiness (this is most likely
when you start taking your
medicine or when your dose is
increased, but it should wear off
after a few days).
• Dizziness.
• Headache.
• Itchy skin.
Common side effects
(May affect up to 1 in 10 people)
• Dry mouth, loss of appetite,
indigestion, abdominal pain or
discomfort, diarrhoea.
• Confusion, depression, a feeling
of unusual weakness, shaking,
lack of energy, tiredness anxiety,
nervousness, difficulty in sleeping,
abnormal thoughts or dreams.
• Difficulty in breathing or wheezing,
shortness of breath, decreased
cough reflex.
• Rash.
• Sweating.
Uncommon side effects
(May affect up to 1 in 100 people)
• Difficulty in swallowing, belching,
hiccups, wind, a condition where
the bowel does not work properly
(ileus), inflammation of the
stomach, changes in taste.
• A feeling of dizziness or ‘spinning’,
hallucinations, mood changes,

unpleasant or uncomfortable
mood, a feeling of extreme
happiness, restlessness, agitation,
generally feeling unwell, loss of
memory, difficulty in speaking,
reduced sensitivity to pain or
touch, tingling or numbness in
the hands or feet, seizures, fits
or convulsions, blurred vision,
fainting, unusual muscle stiffness
or slackness, involuntary muscle
contractions.
• Difficulty passing urine,
impotence, decreased sexual drive,
low levels of sex hormones in the
blood (‘hypogonadism’, seen in a
blood test).
• Fast, irregular heart beat, flushing
of the skin.
• Dehydration, thirst, chills, swelling
of the hands, ankles or feet.
• Dry skin, severe flaking or peeling
of the skin.
• Redness of the face, reduction
in size of the pupils in the eye,
muscle spasm, high temperature.
• A need to take increasingly higher
doses of this medicine to obtain
the same level of pain relief
(tolerance).
• Colicky abdominal pain or
discomfort.
• A worsening of liver function tests
(seen in a blood test)
Rare side effects
(May affect up to 1 in 1,000 people)
• Low blood pressure.

• A feeling of ‘faintness’ especially
on standing up.
• Hives (nettle rash).
Frequency not known
(Frequency cannot be estimated from
the available data)
• An increased sensitivity to pain.
• Aggression.
• Tooth decay.
• Absence of menstrual periods.
• A blockage in the flow of bile
from the liver (cholestasis). This
can cause itchy skin, yellow skin,
very dark urine and very pale
stools.
• Long term use of Shortec
injection during pregnancy may
cause life-threatening withdrawal
symptoms in the newborn.
Symptoms to look for in the baby
include irritability, hyperactivity
and abnormal sleep pattern, high
pitched cry, shaking, being sick,
diarrhoea and not putting on
weight.
Reporting of side effects
If you get any side effects, talk to
your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. You
can also report side effects directly
via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can
help provide more information on
the safety of this medicine.

5. How to store Shortec injection
Keep this medicine out of the sight
and reach of children. Accidental
overdose by a child is dangerous and
may be fatal.
Do not use this injection after the
expiry date which is stated on the
ampoule label and carton. EXP 08
2020 means that you should not
use the injection after the last day
of that month i.e. August 2020.
There are no special precautions for
storage prior to use however once
the ampoule is opened the injection
should be used immediately. Any
unused portion should be discarded
immediately.
Do not throw away any medicines
via wastewater or household waste.
Ask your pharmacist how to throw
away medicines you no longer use.
These measures will help to protect
the environment.
6. Contents of the pack and
other information
What Shortec injection contains
The active ingredient is oxycodone
hydrochloride.
The other ingredients are:
• Citric acid monohydrate
• Sodium citrate
• Sodium chloride
• Hydrochloric acid, dilute
• Sodium hydroxide
• Water for injections

What Shortec injection looks like
and the contents of the pack
This injection is a clear, colourless
solution supplied in clear glass
ampoules. The 10 mg/ml strength
is available as either 1 ml or 2 ml
of solution (containing 10 mg or
20 mg of oxycodone hydrochloride
respectively).

Marketing Authorisation Holder
and Manufacturer
This injection is manufactured by
Bard Pharmaceuticals Limited,
Cambridge Science Park, Milton
Road, Cambridge CB4 0GW, UK.
The marketing authorisation holder
is Qdem Pharmaceuticals Limited,
Cambridge Science Park, Milton
Road, Cambridge CB4 0AB, UK.

This leaflet is also available in large print, Braille or
as an audio CD. To request a copy, please call the
RNIB Medicine Information line (free of charge) on:

0800 198 5000
You will need to give details of the
product name and reference number.
These are as follows:
Product name: Shortec solution for
injection or infusion
Reference number: 40431/0015
This leaflet was last revised in April 2016.
® QDEM, SHORTEC and the ‘Qdem pharmaceuticals’ logo
are registered trade marks.
© 2013-2016 Qdem Pharmaceuticals Limited

05/07/2016 11:43

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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