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SHORTEC 50MG/ML SOLUTION FOR INJECTION OR INFUSION

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

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Shortec 50 mg/ml,
solution for injection or infusion
Oxycodone hydrochloride
®

196028 028002-I

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

Package leaflet: Information for the user

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 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, pharmacist or nurse. This
includes any side effects not listed in this leaflet. See section 4.
In this leaflet:
1. What Shortec injection is and what
it is used for
2. What you need to know before you
use Shortec injection
3. How to use Shortec injection
4. Possible side effects
5. How to store Shortec injection
6. Contents of the pack and other
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’. The other ingredients
are listed in section 6 of this leaflet.

2. What you need to know before
you use Shortec injection
Do not use Shortec injection if
you:
• are allergic to oxycodone, or any
of the other ingredients of Shortec
injection (listed in section 6);
• have breathing problems, such as
severe obstructive lung disease,
severe bronchial asthma or severe
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 condition where the small
bowel does not work properly
(paralytic ileus) or you have
severe pain in your abdomen;

SHORTEC INJ 50MG-ML PIL 1M UK 196028 028002-I V3.indd 2

• have a heart problem after
long-term lung disease (cor
pulmonale);
• have moderate to severe liver
problems. If you have other long
term liver problems you should
only use Shortec injection if
recommended by your doctor;
• have ongoing problems with
constipation;
• are under 18 years of age.
Warnings and precautions
Talk to your doctor, pharmacist or
nurse before treatment with Shortec
injection if you:
• are elderly or weakened;
• have an under-active thyroid
gland (hypothyroidism), as you
may need a lower dose of Shortec
injection;
• have myxoedema (a thyroid
disorder with dryness, coldness
and swelling [‘puffiness’] of the
skin affecting the face and limbs);
• have a head injury, severe
headache or feel sick as this may
indicate that the pressure in your
skull is increased;
• have low blood pressure
(hypotension);
• have low blood volume
(hypovolaemia); this can happen
with severe external or internal
bleeding, severe burns, excessive
sweating, severe diarrhoea or
vomiting;
• have a mental disorder as a result
of an infection (toxic psychosis);

• 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 Shortec
injection with some other medicines,
the effect of Shortec 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;
• 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 to
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.
Using Shortec injection with food,
drink and alcohol
Drinking alcohol during your
treatment with Shortec 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 Shortec injection if you
are pregnant or breastfeeding.
Ask your doctor or pharmacist for
advice before taking any medicine.
Driving and using machines
You may feel sleepy when you first
start using Shortec injection, or
when increasing 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 (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.
• 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.

Information for Healthcare Professionals
Shortec® 50 mg/ml,
solution for injection or infusion
Oxycodone hydrochloride
This leaflet provides technical
information for the healthcare
professional about Shortec 50 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): Use the 10 mg/ml
or the 50 mg/ml strength and
dilute in 0.9% saline, 5%
dextrose or water for injections
if required. 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. Inter-patient
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.

05/07/2016 15:47

196028 028002-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
The injection should be given
immediately after opening the
ampoule. Once opened 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.
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.

SHORTEC INJ 50MG-ML PIL 1M UK 196028 028002-I V3.indd 3

Patients with kidney or liver
4. Possible side effects
problems
Please tell your doctor if you suffer
from kidney or liver problems as they Like all medicines, Shortec injection
may prescribe a lower dose depending can cause side effects, although not
everybody gets them.
on your condition.
The dose recommended by the doctor All medicines can cause allergic
should not be exceeded. Check with the reactions, although serious allergic
doctor or pharmacist if you are unsure. reactions are rare. Tell your doctor
immediately if you get any sudden
If you find that you are still in pain
wheeziness, difficulties in breathing,
whilst being given Shortec injection
swelling of the eyelids, face or lips,
discuss this with your doctor.
rash
or itching especially those
If you use more Shortec injection than
covering your whole body.
you should, or if someone else uses
The most serious side effect is a
your injection
condition where you breathe more
Call your doctor or hospital straight
slowly or weakly than expected
away. People who have been given
an overdose may feel very sleepy and (respiratory depression). Tell your
doctor immediately if this happens
sick. They may also have breathing
difficulties leading to unconsciousness to you.
or even death and may need emergency As with all strong painkillers, there
is
a risk that you may become
treatment in hospital. When seeking
medical attention make sure that you addicted or reliant on Shortec
injection.
take this leaflet and any remaining
injection with you to show to the doctor.Very common side effects
(May affect more than 1 in 10
If you stop using Shortec injection
You should not suddenly stop using this people)
injection unless your doctor tells you to. • Constipation (your doctor can
If you want to stop using your injection, prescribe a laxative to overcome
discuss this with your doctor first. They this problem).
will tell you how to do this, usually by • Feeling or being sick (this
should normally wear off after a
reducing the dose gradually so you do
few days, however your doctor
not experience unpleasant effects.
can prescribe an anti-sickness
If you have any further questions on
medicine if it continues to be a
the use of Shortec injection, ask your
problem).
doctor or pharmacist.

• 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 Shortec 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. Content 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
Shortec injection is a clear,
colourless solution supplied
in clear glass ampoules. The
50 mg/ml strength is available as
1 ml of solution (containing 50 mg
of oxycodone hydrochloride).

Marketing Authorisation Holder
and Manufacturer
Shortec 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: 40431/0016
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 15:47

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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