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SHORTEC 10MG/ML SOLUTION FOR INJECTION OR INFUSION

Active substance(s): OXYCODONE HYDROCHLORIDE

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196027 027001-I

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

Package leaflet: Information for the user
Shortec® 10 mg/ml,
solution for injection or infusion
Oxycodone hydrochloride
Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
• If any of the side effects become serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Shortec injection is and
what it is used for
2. Before you use Shortec injection
3. How to use Shortec injection
4. Possible side effects
5. How to store Shortec injection
6. Further information
1. What Shortec injection is and
what it is used for
This injection has been prescribed
for you by your doctor to relieve
moderate to severe pain. It contains
the active ingredient oxycodone
which belongs to a group of
medicines called strong analgesics
or ‘painkillers’.

2. Before you use Shortec
injection
Do not use Shortec injection if
you:
• are allergic (hypersensitive) to
oxycodone, or any of the other
ingredients of the injection (see
section 6 ‘Further Information’);
• have breathing problems, such as
chronic obstructive lung disease,
chronic bronchial asthma or
respiratory depression. Your
doctor will have told you if you
have any of these conditions.
Symptoms may include
breathlessness, coughing or
breathing more slowly or weakly
than expected;
• have a head injury that causes
a severe headache or makes
you feel sick. This is because

SHORTEC INJ 10MG-ML PIL UK 196027 027001-I V5.indd 2

• have myxoedema (a thyroid
the injection may make these
disorder with dryness, coldness and
symptoms worse or hide the
swelling [‘puffiness’] of the skin
extent of the head injury;
affecting the face and limbs);
• have a condition where the small
• have a severe headache or feel
bowel does not work properly
sick as this may indicate that the
(paralytic ileus) or you have
pressure in your skull is increased;
severe pain in your abdomen;
• have low blood pressure
• have a heart problem after
(hypotension);
long-term lung disease (cor
• have low blood volume
pulmonale);
(hypovolaemia); this can happen
• have severe kidney problems
with severe external or internal
or moderate to severe liver
bleeding, severe burns, excessive
problems. If you have other
sweating, severe diarrhoea or
long-term kidney or liver
vomiting;
problems you should only use
• have a mental disorder as a result
this injection if recommended
of an infection (toxic psychosis);
by your doctor;
• have inflammation of the pancreas
• have ongoing problems with
(which causes severe pain in the
constipation;
abdomen and back);
• are taking a type of medicine
known as a monoamine oxidase • have problems with your gall
bladder or bile duct;
inhibitor (examples include
• have inflammatory bowel disease;
tranylcypromide, phenelzine,
• have an enlarged prostate gland,
isocarboxazid, moclobemide
which causes difficulty in passing
and linezolid), or you have taken
urine (in men);
this type of medicine in the last
• have poor adrenal gland function
two weeks;
(your adrenal gland is not working
• are under 18 years of age.
properly which may cause
Take special care with Shortec
symptoms including weakness,
injection
weight loss, dizziness, feeling or
Before treatment with this
being sick), e.g. Addison’s disease;
injection tell your doctor or

have
breathing problems such as
pharmacist if you:
severe pulmonary disease. Your
• are elderly or weakened;
doctor will have told you if you
• have an under-active thyroid
have this condition. Symptoms
gland (hypothyroidism), as you
may include breathlessness and
may need a lower dose;
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.
Taking other medicines
Please tell your doctor or pharmacist
if you are taking or have recently
taken 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.
This injection must not be used
together with a monoamine oxidase
inhibitor, or if you have taken this
type of medicine in the last two weeks
(see section 2 “Do not use…”).
Tell your doctor or pharmacist if you
are taking:
• 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).
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.
Important information about some of the
ingredients of Shortec injection
This injection contains less than 1 mmol
sodium (23 mg) per 1 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.

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.

15/01/2016 11:46

196027 027001-I

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

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 UK 196027 027001-I V5.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.

• 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.
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,
anxiety, nervousness, difficulty in

sleeping, abnormal thoughts or
dreams.
• Difficulty in breathing or
wheezing, shortness of breath,
decreased cough reflex.
• Rash.
• Sweating, chills.
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, tooth
decay.
• 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.
• 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,
absence of menstrual periods.

• Fast, irregular heart beat, low
blood pressure, a feeling of
‘faintness’ especially on standing
up, flushing of the skin.
• Dehydration, thirst, swelling of
the hands, ankles or feet.
• Dry skin, severe flaking or peeling
of the skin, hives (nettle rash).
• 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)
Frequency unknown
(Frequency cannot be estimated from
the available data)
• An increased sensitivity to pain.
• Aggression.
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 out of the reach and sight 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.
Medicines should not be disposed of
via wastewater or household waste.
Ask your pharmacist how to dispose
of medicines no longer required.
These measures will help to protect
the environment.
6. Further 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 August 2015.
® QDEM and SHORTEC are registered trade marks.
TM
The ‘Qdem pharmaceuticals’ logo is a trade mark.
© 2013-2015 Qdem Pharmaceuticals Limited

15/01/2016 11:46

Expand view ⇕

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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