Pill Identifier App

PALLADONE 10MG/ML SOLUTION FOR INJECTION OR INFUSION

Active substance: HYDROMORPHONE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

Transcript
0319828

700x175mm (LSN-CON-11) (L) V1

Package leaflet: Information for the user
Palladone® 2 mg/ml, 10 mg/ml, 20 mg/ml and
50 mg/ml solution for injection or infusion
Hydromorphone 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 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.
What is in this leaflet:
1. What Palladone injection is and what it is used for
2. What you need to know before you use Palladone
injection
3. How to use Palladone injection
4. Possible side effects
5. How to store Palladone injection
6. Contents of the pack and other information
1. What Palladone injection is and what it is
used for
You have been prescribed Palladone injection to
relieve severe pain.
It contains the active substance hydromorphone
hydrochloride, which is a potent analgesic (strong
“painkiller”) of the opioid group.

2. What you need to know before you use
Palladone injection
Do not use Palladone injection if you:
• are allergic to hydromorphone or to any of the
other ingredients of this medicine (listed in section
6);
• have breathing problems (respiratory depression);
• suffer from a severe lung disease associated
with obstruction of the airways (severe chronic
obstructive pulmonary disease or severe COPD);
• have heart problem after long-term lung disease
(cor pulmonale);
• have severe pain in your abdomen;
• have a condition where the small bowel does not
work properly (paralytic ileus);
• are taking a type of medicine known as
monoamine oxidase inhibitor (examples include
tranylcypromine, phenelzine, isocarboxazid,
moclobemide and linezolid), or you have taken
this type of medicine in the last two weeks.
Palladone injection must not be used if the patient is
in a coma.
Warnings and precautions
Talk to your doctor or pharmacist before using
Palladone injection if you:
• have a dependence on strong painkillers;
• have a head injury (due to the risk of increased
brain pressure);
• suffer from seizures, fits or convulsions;
• have an addiction to alcohol;

• have previously suffered from withdrawal symptoms
such as agitation, anxiety, nervousness, difficulty
in sleeping, being unusually overactive, shaking
and gastrointestinal problems upon stopping taking
alcohol or drugs;
• suffer from a mental disorder as a result of an
intoxication (toxic psychosis);
• have low blood pressure associated with low
circulating blood volume (hypotension with
hypovolaemia);
• are feeling light-headed or faint;
• have problems with your gall bladder;
• have inflammation of the pancreas (pancreatitis);
• have any bowel problems (such as obstructive or
inflammatory bowel disease);
• have prostate problems (such as difficulties in
passing urine);
• have poor adrenal gland function (e.g. Addison’s
disease).
• have an under-active thyroid gland
(hypothyroidism);
• have a chronic obstructive airway disease (such as
COPD) or reduced pulmonary function;
• suffer from a debilitated general condition or are
elderly or infirm;
• suffer from severe kidney problems (including
ureteric colic);
• suffer from severe liver problems.
If this information applies to you or formerly applied to
you, please speak to your doctor.
Palladone injection is not recommended for children
under 12 years of age.
The major risk of opioid excess is difficulty in
breathing (respiratory depression).
Patients may develop a tolerance with long-term use
of this medicine. This means you may require higher
doses to achieve the desired pain control.

Long-term use of this medicine may lead to physical
dependence. If treatment is stopped abruptly,
withdrawal symptoms such as agitation, anxiety,
nervousness, difficulty in sleeping, involuntary muscle
contractions, shaking, and gastro-intestinal problems
may occur. If you no longer require therapy with
hydromorphone, your doctor will taper the daily dose
gradually to prevent these symptoms.
The active substance hydromorphone hydrochloride
has an abuse profile similar to other strong opioids.
There is potential for development of psychological
dependence. Therefore, this medicine should be used
with particular care in patients with a history of alcohol
and drug abuse.
An increase in sensitivity to pain (hyperalgesia)
that will not respond to a further dose increase of
this medicine may very rarely occur in particular in
high doses. Your doctor will decide whether a dose
reduction or change in analgesic (opioid) is required in
such a situation.
Please tell your doctor, if you experience small
bowel problems (paralytic ileus) during the treatment
with this medicine. He or she will take appropriate
measures.
If you are going to have an operation, please tell the
doctor at the hospital that you are using this medicine
as they may need to adjust the amount of injection you
are given.
The use of this medicine may produce positive results
in doping controls.
Other medicines and Palladone injection
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
When taken with some other medicines or alcohol, the
side effects of Palladone injection (such as drowsiness,
breathing problems, constipation, dry mouth, difficulty
in passing urine) or the other medicine may be altered.

Tell your doctor if you:
• are taking medicines to treat anxiety (for example
tranquillisers);
• have been given an anaesthetic (for example a
barbiturate);
• are taking medicines to help you sleep (hypnotics or
sedatives);
• are taking medicines to treat psychiatric or mental
disorders (neuroleptics or psychotropics);
• are taking medicines to treat depression
(antidepressants);
• are taking medicines used to stop you feeling sick or
being sick (antiemetics);
• are taking medicines used to prevent or relieve the
symptoms of an allergy (antihistamines);
• are taking medicines to treat Parkinson’s disease;
• are taking other strong analgesics or ‘painkillers’,
or have recently taken another painkiller from the
opioid class.
Do not take this medicine if you are taking a specific
type of medicine known as monoamine oxidase
inhibitor, or you have taken this type of medicine in
the last two weeks.
Palladone injection with food, drink and alcohol
Drinking alcohol during your treatment with this
medicine may make you drowsy. If you are affected
you should avoid drinking alcohol.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before using this
medicine.
Pregnancy
You should not use this medicine during pregnancy
and labour unless you have been specifically told by
your doctor. If you use this medicine during labour
uterine contractility may be impaired. In addition
slow and shallow breathing (respiratory depression)
may occur in the newborn infant.
If you use this medicine for a long time during
pregnancy, withdrawal symptoms may be observed
in the newborn infant.
Breast-feeding
This medicine should not be used while breastfeeding because the active substance can get into
breast milk.
Driving and using machines
This medicine may make you drowsy and thus
impair your ability to drive and use machines. This
applies particularly:
• at the beginning of treatment;
• if your dose is increased;
• if you have switched to this medicine from a
different opioid.
• if you drink alcohol or use medicines which
influence your brain function.
You should consult your doctor before driving or
using machinery.
Palladone injection contains sodium
This medicinal product contains less than 1 mmol
sodium (23 mg) per ml, i.e. essentially “sodiumfree”.

3. How to use Palladone injection
Always use this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
A doctor or nurse will usually prepare and administer
the injection for you.
Your doctor will decide how much Palladone injection
you require based on:
• the severity of your pain;
• the dose of painkiller you have previously been given;
• your age and weight.
Your doctor will increase the amount of this medicine
you are given until your pain is relieved. If you find that
you are still in pain whilst undergoing treatment with
this medicine discuss this with your doctor.
You should not use Palladone 10 mg, [20 mg, 50 mg]
injection as initial opioid therapy. This higher strength
may only be used as individual doses if you have
no longer sufficiently responded to lower doses of
hydromorphone preparations (Palladone 2 mg) or
comparably strong analgesics as part of long term pain
therapy.
The usual starting doses of Palladone injection are as
follows:
Use in adults and adolescents (older than 12 years of
age)
• As a single injection into a vein, the usual dose is 1 to
1.5 mg given slowly over 2 to 3 minutes. This can be
repeated every 3 to 4 hours.
• As a single injection through a fine needle into the
tissue under the skin, the usual dose is 1 to 2 mg. This
can be repeated every 3 to 4 hours.
• As an infusion into a vein or through a fine needle
into the tissue under the skin, the usual starting dose
is 0.15 to 0.45 mg/hour (or 0.004 mg/kg bodyweight/
hour).
• If given by patient controlled analgesia (PCA), the
usual recommended bolus dose is 0.2 mg with a stop
interval of 5 to 10 minutes.
0319828 R0V8 UK AW -20-04-12

PALLADONE INJ PIL UK 0319828 V7.indd 2

Information for Health Professionals
Palladone® 2 mg/ml, 10 mg/ml, 20 mg/ml and 50 mg/ml,
solutions for injection or infusion
Hydromorphone hydrochloride
This leaflet provides technical information for
the healthcare professional about Palladone
2 mg/ml, 10 mg/ml, 20 mg/ml and 50 mg/ml,
solutions for injection or infusion.
Posology and method of administration
Method of administration
Intravenous injection or infusion
Subcutaneous injection or infusion
Posology
The dosing of Palladone injection has to be
adjusted to the patients’ severity of pain and to
their individual response.
The dose should be titrated until optimum
analgesic effect is achieved.
While a sufficiently high dose should generally
be administered, the smallest dose to achieve
analgesia should be aimed at in the individual
case.
Palladone injection should not be administered
for longer than absolutely necessary. If longterm treatment is required careful and regular
monitoring should control whether and to
what degree further treatment is necessary.
When a patient no longer requires therapy with
hydromorphone, it may be advisable to taper
the daily dose gradually to prevent withdrawal
symptoms.

Age

Bolus

Infusion

Adults and adolescents (> 12 years) ≥ 50 kg BW
subcutaneous
(s.c.) use

1-2 mg s.c. every
3-4 hours

0.15-0.45 mg/h

intravenous
(i.v.) use

1-1.5 mg i.v. every
3-4 hours to be
injected slowly over
at least 2-3 minutes

0.15-0.45 mg/h

PCA (s.c. and i.v.) 0.2 mg bolus, stop interval 5-10 min.
Children (<12 years)
Not recommended

0319828 R0V5 12-04-12

13/07/2012 16:51

0319828

700x175mm (LSN-CON-11) (L) V1

Use in children (under 12 years of age)
Palladone injection is not recommended for children
under 12 years of age.
Use in elderly patients (over 75 years of age)
A lower dosage might be enough for adequate pain
relief in elderly patients.
Use in patients with liver and kidney problems
If you suffer from liver or kidney problems, you may
require less of this medicine in order to relieve your
pain.
Route of administration
A doctor or nurse will usually administer Palladone
injection for you.
This medicine is intended for injection or infusion
into a vein (intravenous = IV) or through a fine needle
under the skin (subcutaneous = SC).
Duration of treatment
This medicine should only be used as long as
necessary. Your doctor will decide when and how
the treatment will be stopped. If you get a long term
treatment, your doctor should verify regularly whether
you still need this medicine. Do not stop the treatment
without talking to your doctor (see “If you stop using
Palladone injection”).
If you use more Palladone injection than you should
Call your doctor, hospital or an ambulance, straight
away as the patient may need emergency treatment
in hospital. In severe cases an overdose may lead
to unconsciousness or even death. The following
symptoms may occur after an overdose:
• pin point pupils;
• slowing of heartbeat;
• respiratory problems;
• low blood pressure;
• unconsciousness leading to coma.
If you have used too much Palladone injection under
no circumstances should you put yourself in a situation
that requires you to be alert e.g. driving a car.

PALLADONE INJ PIL UK 0319828 V7.indd 3

When seeking medical attention make sure that you
take this leaflet and any remaining ampoules with you
to show to the doctor.
If you forget to use Palladone injection
Please use Palladone injection as soon as you notice
that you forgot a dose. Never double the dose.
If you forget to use Palladone injection or use
a smaller dose than prescribed, this will lead to
unsatisfactory and/or insufficient pain relief.
If you stop using Palladone injection
You should not suddenly stop using this medicine
unless your doctor tells you to. If you want to stop
using this medicine discuss this with your doctor first.
If you do stop using this medicine suddenly after
extended treatment, you may experience withdrawal
symptoms such as agitation, anxiety, nervousness,
difficulty in sleeping, involuntary muscle contractions,
shaking, and gastro-intestinal problems. Your doctor
will tell you how to stop your treatment, usually by
reducing the dose gradually so you do not experience
unpleasant effects.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
This medicine can very rarely cause allergic reactions
(hypersensitivity reactions). The incidence of serious
allergic reactions (anaphylactic reactions) is not
known. Tell your doctor immediately if you get any
sudden wheeziness, difficulties in breathing, swelling
of the eyelids, face, lips, mouth or throat, or any rash
or itching especially those covering your whole body.
Difficulty in breathing (respiratory depression) is the
chief hazard of an opioid overdose.
Most people will have constipation when using
this medicine. Increasing the amount of fibre (fruit,
vegetables, wholemeal bread, pasta, brown rice) and
fluids you eat and drink may help reduce the problem,
but if necessary your doctor may prescribe a laxative.
You may feel sick or vomit (be sick) when you use
this medicine, this should normally wear off after a
few days however your doctor can prescribe an antivomiting medicine if it continues to be a problem.
Common side effects (may affect up to 1 in 10
people)
• confusional state
• dizziness, feel more sleepy than normal
• low blood pressure
• constipation, dry mouth, feel sick, vomiting (be
sick)
• itchy skin, sweating
• difficulty in passing urine, urgency in passing urine
• a feeling of unusual weakness
• loss of appetite
• anxiety, sleeplessness
• abdominal pain or discomfort
• skin reactions at the injection site

Uncommon side effects (may affect up to 1 in 100
people)
• unpleasant or uncomfortable mood, feeling of
extreme happiness, hallucinations
• headache, shaking, muscle spasms, tingling in the
hands or feet
• reduction in size of the pupils in the eye, blurred
vision
• fast heartbeat
• indigestion
• rash, itching rash
• decreased sexual drive, impotence
• drug tolerance
• withdrawal symptoms such as agitation, anxiety,
nervousness, difficulty in sleeping, being unusually
overactive, shaking and gastrointestinal problems
• depression, nightmares
• shortness of breath
• diarrhoea, changes in taste
Rare side effects (may affect up to 1 in 1,000 people)
• drug dependence, agitation
• seizures, fits or convulsions, sedation
• slow heartbeat, irregular heartbeat
• difficulty in breathing or wheezing
• may affect the results of blood tests to check that
your pancreas is working properly
• facial flushing (redness of the face)
Very rare side effects (may affect up to 1 in 10,000
people)
• an increase in sensitivity to pain (hyperalgesia; see
“Warnings and precautions” in section 2)
• a condition where the small bowel (part of your gut)
does not work properly (paralytic ileus)
• may affect the results of blood tests to check that
your liver is working properly
• swelling of hands, ankles or feet, irritation
and hardening of the skin at the injection
site (particularly after repeated subcutaneous
administration)
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet.

5. How to store Palladone injection
Keep this medicine out of the sight and reach of
children.
Keep the ampoules in the outer carton in order to
protect from light.
Do not use this medicine after the expiry date which
is stated on the carton and the ampoule label after
“EXP”. The expiry date refers to the last day of that
month.
Instructions for stability of the medicinal product
after preparation
After opening this medicinal product should be used
immediately.
The physical and chemical in-use stability has been
demonstrated for a dilution of Palladone injection
with solutions for infusion/injection of sodium
chloride 9 mg/ml (0.9%), glucose 50 mg/ml (5%) or
water for injections for 24 hours at 25°C.
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 2-8°C, unless opening/ dilution
has taken place in controlled and validated aseptic
conditions.
The medicinal product is to be visually inspected prior
to use. Only clear solutions free from particles should
be used.
Do not use opened ampoules and previously diluted
solutions.
Any unused portion should be discarded immediately.
Instructions for stability after use or dilution:
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 you 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 Palladone injection contains:
Palladone 2 mg/ml injection:
• The active substance is hydromorphone
hydrochloride. Each ampoule contains 2 mg
hydromorphone hydrochloride (corresponding to
1.77 mg hydromorphone) in 1 ml solution.
Palladone 10 mg/ml injection:
• The active substance is hydromorphone
hydrochloride. Each ampoule contains 10 mg
hydromorphone hydrochloride (corresponding to
8.87 mg hydromorphone) in 1 ml solution.
Palladone 20 mg/ml injection:
• The active substance is hydromorphone
hydrochloride. Each ampoule contains 20 mg
hydromorphone hydrochloride (corresponding to
17.7 mg hydromorphone) in 1 ml solution.
Palladone 50 mg/ml injection:
• The active substance is hydromorphone
hydrochloride. Each ampoule contains 50 mg
hydromorphone hydrochloride (corresponding to
44.33 mg hydromorphone) in 1 ml solution.
The other ingredients are:
• Citric acid anhydrous
• Sodium citrate
• Sodium chloride
• Sodium hydroxide solution (4%)
• Hydrochloric acid 3.6%
• Water for injections
What Palladone injection looks like and contents of
the pack
Palladone injection is a clear, colourless to pale yellow,
pH 4.0 solution for injection or infusion supplied in
clear glass ampoules, available in packs of 5 x 1 ml
ampoules.

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: Palladone solution for
injection or infusion
Reference number: 16950/0163
Marketing Authorisation Holder and Manufacturer
Palladone injection is made by Hamol Ltd, 1 Thane
Road, Nottingham NG90 2DB, UK.
The marketing authorisation holder is Napp
Pharmaceuticals Limited, Cambridge Science Park,
Milton Road, Cambridge CB4 0GW, UK.
This leaflet was last revised in July 2012
® Palladone and the NAPP device (logo) are
Registered Trade Marks.
© 2012 Napp Pharmaceuticals Limited

0319828 R0V8 UK AW -20-04-12

Infants (Children < 12 years)
Palladone injection is not recommended for use in
children under 12 years, since there is not enough
evidence documented for this age group.
Elderly patients
Elderly patients (as a rule over 75 years) may require
a lower dosage than other adults to achieve adequate
analgesia.
Patients with hepatic and/or renal impairment
These patients may require lower doses than other
patient groups to achieve adequate analgesia. They
should be carefully titrated to clinical effect.
Cessation of therapy
When a patient no longer requires therapy with
hydromorphone, it may be advisable to taper
the daily dose gradually to prevent withdrawal
symptoms.
Special precautions for disposal and other
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
ambient temperature (25°C).
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
2-8  C, unless opening/dilution, etc has taken place in
°
controlled and validated aseptic conditions.
No evidence of incompatibility was observed
between Palladone injection and representative
brands of injectable forms of the following drugs,
when stored in high and low dose combinations in
polypropylene syringes over a 24 hour period at
ambient temperature.

Hyoscine butylbromide
Hyoscine hydrobromide
Dexamethasone sodium phosphate
Haloperidol
Midazolam hydrochloride
Metoclopramide hydrochloride
Levomepromazine hydrochloride
Glycopyrronium bromide
Ketamine hydrochloride
Palladone injection, undiluted or diluted with
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 ambient temperature (25°C).
The injection, whether undiluted or diluted 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 April 2012
® Palladone and the NAPP device (logo) are
Registered Trade Marks.
© 2012 Napp Pharmaceuticals Limited

0319828 R0V5 12-04-12

13/07/2012 16:51

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.

Hide
(web4)