Emulsion 1 3 9

Territory:
Product Name:
GB
FRESENIUS PROPOVEN 1%
Type of Packaging:
Dosage:
PIL
20ml
Material number:
2-D-Matrix Code
M088702/03 GB
M088702/03 GB
Pharma-Code (Laetus)
EAN
Code:
x
Dimension:
Font:
Arial
Smallest Size: 9 Pt.
180 x 882 mm
Colour:
BLACK
Package leaflet: Information for the user
1. Draft
11.07. 2016 06.40 Uhr
1. Correction 19.07. 2016 11.22 Uhr
2. Correction 22.08. 2016 08.45 Uhr
Operator: Christian Nagy +43(0) 34 52 72266-22 P. Marko +43(0) 34 52 72266-20
-
Fresenius Propoven 1%
emulsion for injection or infusion
Propofol
Read all of this leaflet carefully before you
are given 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.
- 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.
What is in this leaflet:
1. What Fresenius Propoven 1% is and what it is
used for
2. What you need to know before you are given
Fresenius Propoven 1%
3. How to use Fresenius Propoven 1%
4. Possible side effects
5. How to store Fresenius Propoven 1%
6. Contents of the pack and other information
1. What Fresenius Propoven 1% is and what it
is used for
Fresenius Propoven 1% belongs to a group of
medicines called ‘general anaesthetics'. General
anaesthetics are used to cause unconsciousness
(sleep) so that surgical operations or other
procedures can be performed. They can also be
used to sedate you (so that you are sleepy but not
completely asleep).
Fresenius Propoven 1% emulsion for injection
or infusion is used to:
• induce and maintain general anaesthesia
in adults, adolescents and children older than 1
month.
• sedate patients older than 16 years of age
receiving artificial respiration in intensive care.
• sedate adults, adolescents and children older
than 1 month during diagnostic and surgical
procedures, alone or in combination with local
or regional anaesthesia.
2. What you need to know before you are given
Fresenius Propoven 1%
Do not use Fresenius Propoven 1%
-
-
if you are allergic to propofol, soya, peanut or
any of the other ingredients of this medicine
(listed in section 6).
in patients of 16 years of age or younger for
sedation in intensive care.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before you
are given Fresenius Propoven 1% and if any of the
subsequent mentioned applies to you or applied to
you in the past.
You should not receive Fresenius Propoven
1%, or only under extreme caution and intensive
monitoring, if you:
- have advanced heart failure
- have any other serious disease of the heart
- are receiving electroconvulsive therapy (ECT, a
treatment for psychiatric problems)
In general, Fresenius Propoven 1% should be
given with caution to elderly or weak patients.
Before receiving Fresenius Propoven 1%, tell your
anaesthetist or intensive care doctor if you have:
- heart disease
- lung disease
- kidney disease
- liver disease
- seizures (epilepsy)
- a raised pressure inside the skull (raised
intracranial pressure). In combination with low
blood pressure the amount of blood reaching
the brain may be decreased.
- altered levels of fat in the blood. If you are
receiving total parenteral nutrition (feeding
through a vein), the levels of fat in your blood
must be monitored.
- if your body has lost lots of water (you are
hypovolaemic).
If you have any of the following conditions, they
must be treated before you receive Fresenius
Propoven 1%:
- heart failure
- when there is insufficient blood reaching the
tissues (circulatory failure)
- severe breathing problems (respiratory failure)
- dehydration (hypovolaemia)
- seizures (epilepsy)
Fresenius Propoven 1% may increase the risk of
- epileptic seizures
- a nervous reflex that slows the heart rate
(vagotonia, bradycardia)
- changes in the blood flow to the organs of the
body (haemodynamic effects on the
cardiovascular system) if you are overweight
and receive high doses of Fresenius Propoven
1%.
Variable Data:
-
-
Other anaesthetics, including general, regional,
local and inhalational anaesthetics (Lower
doses of Fresenius Propoven 1% may be
required. Your anaesthetist will know this.)
Painkillers (analgesics)
Strong painkillers (fentanyl or opioids)
Parasympatholytic agents (medicines used
to treat e.g. painful cramps of organs, asthma
or Parkinson's disease)
Benzodiazepines (medicines used to treat
anxiety)
Suxamethonium (muscle relaxant)
Drugs that affect many of the internal body
functions such as the heart rate, e.g. atropine
Alcohol containing medicines or beverages
Neostigmine (medicine used to treat a disease
called myasthenia gravis)
Cyclosporine (medicine used to prevent
transplant rejections)
Fresenius Propoven 1% with food, drink and
alcohol
After you have been given Fresenius Propoven
1%, you should not eat, drink or consume alcohol
until fully recovered.
Pregnancy and breastfeeding
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
taking this medicine.
Fresenius Propoven 1% should not be given to
pregnant women unless clearly necessary.
You should stop breast-feeding and discard any
breast milk for 24 hours after receiving Fresenius
Propoven 1%.
Driving and using machines
After having propofol you may still feel sleepy for
some time.
Do not drive or use any tools or machines until you
are sure the effects have worn off.
If you are able to go home shortly after receiving
Propofol, do not drive a car or go home
unaccompanied.
Ask your doctor when you can start doing these
activities again and when you can go back to work.
Fresenius Propoven 1% contains soya-bean oil
and sodium
Fresenius Propoven 1% contains soya-bean oil. If
you are allergic to peanut or soya, do not use this
medicinal product.
This medicinal product contains less than 1 mmol
(23 mg) sodium per 100 ml, i.e. essentially ´sodiumfree`.
3. How to use Fresenius Propoven 1%
Fresenius Propoven 1% will only be given to you in
hospitals or suitable therapy units by or under the
direct supervision of your anaesthetist or intensive
care doctor.
Dosage
The dose you are given will vary depending on
your age, body weight and physical condition. The
doctor will give the correct dose to start and to
sustain anaesthesia or to achieve the required level
of sedation by carefully watching your responses
and vital signs (pulse, blood pressure, breathing,
etc).
You may need several different medicines to keep
you asleep or sleepy, free from pain, breathing in
a healthy way and to keep your blood pressure
steady. The doctor will decide which medicines you
need and when you need them.
Adults
Most people need 1.5 - 2.5 mg propofol per kg
body weight to make them go to sleep (induction of
anaesthesia), and then 4 to 12 mg propofol per kg
body weight per hour after this to keep them asleep
(maintenance of anaesthesia). For sedation, doses
of 0.3 to 4.0 mg propofol per kg body weight per
hour are usually sufficient.
For sedation during surgical and diagnostic
procedures in adults, most patients will require
0.5 - 1 mg propofol per kg body weight over 1 to
5 minutes for onset of sedation. Maintenance
of sedation may be accomplished by titrating
Fresenius Propoven 1% infusion to the desired level
of sedation. Most patients will require 1.5 - 4.5 mg
propofol per kg body weight per hour. The infusion
may be supplemented by bolus administration of
10 - 20 mg propofol (1 - 2 ml Fresenius Propoven
1% emulsion for injection or infusion ) if a rapid
increase of the depth of sedation is required.
To provide sedation for ventilated patients older
than 16 years of age under intensive care conditions
the dose will be adjusted according to the depth of
sedation required. Usually satisfactory sedation is
achieved by continuous infusion with administration
rates in the range of 0.3 to 4.0 mg propofol per kg
body weight per hour. Rates of infusion greater
than 4.0 mg propofol per kg bodyweight per hour
are not recommended.
You will not be allowed to leave the hospital until
you are fully awake.
If you are able to go home shortly after receiving
propofol you should not go home unaccompanied.
Elderly and weak patients
Elderly and weak patients may require lower doses.
Use in children and adolescents over one
month of age
The use of Fresenius Propoven 1% is not
recommended in children younger than 1 month.
Special care should also be observed when
administering Fresenius Propoven 1% emulsion for
injection or infusion to children less than 3 years
of age. However, evidence now available does not
suggest that this is any less safe than in children
older than 3 years.
The dose should be adjusted according to age
and/or body weight. Most patients over 8 years of
age require approximately 2.5 mg/kg bodyweight
Fresenius Propoven 1% to make them go to sleep
(induction of anaesthesia). In younger children,
especially between the age of 1 month and 3 years,
dose requirements may be higher (2.5 - 4 mg/kg
bodyweight).
Rates in the region of 9 - 15 mg/kg/h usually
achieve satisfactory anaesthesia to keep them
asleep (maintenance of anaesthesia). In younger
children, especially between the age of 1 month
and 3 years, dose requirements may be higher.
Children and adolescents
The use of Fresenius Propoven 1% emulsion for
injection or infusion is not recommended for use in
new-born infants or children younger than 1 month.
Due to the limited data available, the use of target
controlled infusion (TCI) in the paediatric population
below 2 years of age cannot be recommended.
Fresenius Propoven 1% must not be given to
children and adolescents younger than 16 years of
age for sedation in the intensive care unit, since its
safety has not been demonstrated in this patient
group for this indication.
For sedation during surgical and diagnostic
procedures in children over 1 month of age with
Fresenius Propoven 1% emulsion for injection
or infusion most paediatric patients require
1 - 2 mg/kg bodyweight propofol for onset of sedation.
Maintenance of sedation may be accomplished by
titrating Fresenius Propoven 1% infusion to the
desired level of sedation. Most patients require
1.5 - 9 mg/kg/h propofol. The infusion may be
supplemented by bolus administration of up to
1 mg/kg bodyweight if a rapid increase of depth of
sedation is required.
Other medicines and Fresenius Propoven 1%
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Fresenius Propoven 1% emulsion for injection
or infusion must not be given to children and
adolescents younger than 16 years of age for
sedation in the intensive care unit, since its safety
has not been demonstrated in this patient group for
this indication.
Involuntary movements can occur during sedation
with Fresenius Propoven 1%. The doctors will
take into account how this might affect surgical
procedures being performed under sedation and
will take the necessary precautions.
Very occasionally, after anaesthesia, there may
be a period of unconsciousness associated with
stiffness of the muscles. This requires observation
by the medical staff but no other treatment. It will
resolve spontaneously.
The injection of Fresenius Propoven 1% can be
painful. A local anaesthetic can be used to reduce
this pain but can have its own side effects.
You must take special care if you are also taking/
receiving any of the following medicines:
- Premedications (your anaesthetist will know
which medicines can be influenced by
Fresenius Propoven 1%)
The following information is intended for
healthcare professionals only:
Fresenius Propoven 1% emulsion for injection or
infusion should not be mixed prior to administration
with injection or infusion solutions other than glucose 50 mg/ml (5 %) solution for injection or sodium
chloride 9 mg/ml (0.9 %) solution for injection or
preservative free lidocaine 10 mg/ml (1 %) solution
for injection. Final propofol concentration must not
be below 2 mg/ml.
For single use only. Any unused emulsion must be
discarded.
Containers should be shaken before use.
If two layers can be seen after shaking the emulsion should not be used.
Use only homogeneous preparations and undamaged containers.
Prior to use, the ampoule neck or rubber membrane should be cleaned using an alcohol spray or a
swab dipped in alcohol. After use, tapped containers must be discarded.
Propofol should be given by those trained in anaesthesia (or, where appropriate, doctors trained in the
care of patients in Intensive Care).
Patients should be constantly monitored and facilities for maintenance of a patent airway, artificial
ventilation, oxygen enrichment and other resuscitative facilities should be readily available at all times.
Propofol should not be administered by the person
conducting the diagnostic or surgical procedure.
Abuse of, and dependence on propofol, predominantly by health care professionals, have been
reported. As with other general anaesthetics, the
administration of propofol without airway care may
result in fatal respiratory complications.
When propofol is administered for conscious sedation, for surgical and diagnostic procedures, patients should be continually monitored for early signs
of hypotension, airway obstruction and oxygen desaturation.
Fresenius Propoven 1% emulsion for injection
or infusion may be administered undiluted or
diluted in glucose 50 mg/ml (5 %) solution for
injection or sodium chloride 9 mg/ml (0.9 %) solution for injection.
Fresenius Propoven 1% emulsion for injection or
infusion must not be mixed with any other solutions for infusion or injection except those mentioned above.
Glucose 50 mg/ml (5 %) solution for injection, sodium chloride 9 mg/ml (0.9 %) solution for injection
or sodium chloride 1.8 mg/ml (0.18 %) solution for
injection and glucose 40 mg/ml (4 %) solution for injection may be given through the same infusion set.
Co-administration of other medicinal products or
fluids added to the Fresenius Propoven 1% infusion line must occur close to the cannula site using a
Y-piece connector or a three-way valve.
Fresenius Propoven 1% is a lipid containing emulsion without antimicrobial preservatives and may
M088702/03 GB
V003/GZ
Method of administration
Fresenius Propoven 1% is for intravenous use,
usually administered on the back of your hand or in
the forearm. Your anaesthetist may use a needle or
cannula (a fine plastic tube). Fresenius Propoven
1% will be injected into a vein either manually or by
electric pumps.
Fresenius Propoven 1% is for single use only. Any
unused emulsion must be discarded. Containers
should be shaken before use If two layers can
be seen after shaking the emulsion should not be
used. Use only homogeneous preparations and
undamaged containers.
Prior to use, the rubber membrane should be
cleaned using an alcohol spray or a swab dipped
in alcohol.
Duration of treatment
When used for sedation, Fresenius Propoven 1%
must not be administered for more than 7 days.
If you received more propofol than you should
Your doctor will ensure that you receive the right
amount of propofol for you and for the procedure
you are undergoing.
However, different people need different doses and
if you do receive too much for you, your anaesthetist
may need to take measures to make sure your
heart and breathing are adequately supported. This
is why anaesthetic drugs are only administered by
doctors trained in anaesthesia or in the care of
patients in intensive care.
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.
Side effects that can happen during anaesthesia
The following side effects can happen during
anaesthesia (while the injection is being given to
you or when you are sleepy or asleep). Your doctor
will be looking out for these. If they happen, your
doctor will give you appropriate treatment.
5. How to store Fresenius Propoven 1%
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
which is stated on the ampoule/vial and the outer
packaging after EXP. The expiry date refers to the
last day of that month.
Do not store above 25 °C.
Do not freeze.
After first opening the medicinal product must be
used immediately.
Administration systems with undiluted Fresenius
Propoven 1% should be replaced 12 hours after
opening of the ampoule or vial.
Dilutions with glucose 50 mg/ml (5 %) solution for
injection or sodium chloride 9 mg/ml (0.9 %) solution
for injection or an admixture with preservative-free
lidocaine 10 mg/ml (1 %) solution for injection (at
least 2 mg propofol per ml) should be prepared
aseptically (controlled and validated conditions
preserved) immediately before administration
and has to be administered within 6 hours after
preparation.
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 protect the environment.
6. Contents of the pack and other information
What Fresenius Propoven 1% contains
-
The active substance is propofol.
Each ml emulsion contains 10 mg propofol.
Each 20 ml ampoule contains 200 mg propofol.
Each 20 ml vial contains 200 mg propofol.
Each 50 ml vial contains 500 mg propofol.
Each 100 ml vial contains 1000 mg propofol.
-
The other ingredients are soya-bean oil,
refined, medium-chain triglycerides, purified
egg phosphatides, glycerol, oleic acid, sodium
hydroxide, water for injections.
Very common (may affect more than 1 in 10
people)
• A feeling of pain at the site of the injection
(while the injection is being given, before you
fall asleep).
What Fresenius Propoven 1% looks like and
contents of the pack
Common (may affect up to 1 in 10 people)
• Slow or fast heartbeat
• Low blood pressure
• Changes in your breathing pattern (low
respiratory rate, breathing arrest)
• Hiccups
• Cough (may also happen when you wake up)
Fresenius Propoven 1% is available in colourless
glass ampoules or glass vials. The glass vials are
sealed with rubber stoppers.
Uncommon (may affect up to 1 in 100 people)
•
Swelling and redness or blood clots at the vein
along the injection site.
Rare (may affect up to 1 in 1,000 people)
• Twitching and shaking of your body, or fits (may
also happen when you wake up).
Very rare (may affect up to 1 in 10, 000 people)
• Serious allergic reaction which causes difficulty
in breathing, swollen and reddened skin, hot
flushes
• Build up of fluid in the lungs which can make
you very breathless (may also happen when
you wake up)
• Unusual colour of urine (may also happen
when you wake up).
Not known (frequency cannot be estimated
from the available data)
• Involuntary movements
• Severe skin and tissue reaction following
accidental application beside the vein.
Side effects that can happen after anaesthesia
The following side effects can happen after
anaesthesia (when you are waking up or after you
have woken up).
Common (may affect up to 1 in 10 people)
• Headache
• Feeling sick (nausea), being sick (vomiting).
• Cough.
Rare (may affect up to 1 in 1,000 people)
• Dizziness, chills and sensations of cold
• Excitations
Very rare (may affect up to 1 in 10,000 people)
• Being unconscious after the operation (when
this has happened, the patients have recovered
without problems)
• Inflamed pancreas (pancreatitis) which causes
severe stomach pain (a causal relationship
could not be shown)
• Fever following surgery
Not known (frequency cannot be estimated
from the available data)
• Feeling euphoric
• Feeling sexually aroused
• Irregular heart beat
• Changes in ECG (Brugada type ECG)
• Increase in liver size
• Kidney failure
• Breakdown of muscle cells (rhabdomyolysis),
increase in acidity of your blood, high potassium
and fat levels in your blood, heart failure
• Drug abuse, mostly by healthcare professionals
When Fresenius Propoven 1% is administered in
combination with lidocaine (a local anaesthetic
used to reduce the pain at the site of injection),
certain side effects may occur rarely:
- dizziness
- vomiting
- sleepiness
- fits
- a slowing of the heart rate (bradycardia)
- irregular heartbeat (cardiac arrhythmias)
- shock
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 national reporting
For the UK:
You can report side effects directly via the Yellow
card Scheme
www.mhra.gov.uk/yellowcard
For Ireland:
You can also report side effects directly via
HPRA Pharmacovigilance,
Earlsfort Terrace,
IRL - Dublin 2;
Tel: +353 1 6764971;
Fax: +353 1 6762517.
Website: www.hpra.ie;
E-mail: medsafety@hpra.ie
By reporting side effects you can help provide more
information on the safety of this medicine.
Fresenius Propoven 1% is a white oil-in-water
emulsion for injection or infusion.
Pack sizes:
Packs containing 5 glass ampoules with 20 ml
emulsion
Packs containing 10 glass ampoules with 20 ml
emulsion
Packs containing 1 glass vial with 20, 50 or 100 ml
emulsion
Packs containing 5 glass vials with 20 ml emulsion
Packs containing 10 glass vials with 20, 50 or
100 ml emulsion
Packs containing 15 glass vials with 50 or 100 ml
emulsion
Not all pack sizes may be marketed.
Marketing
Authorisation
Manufacturer
Holder
and
Marketing Authorisation Holder:
Fresenius Kabi Ltd
Cestrian Court, Eastgate Way
Manor Park, Runcorn
Cheshire, WA7 1NT
UK
Manufacturer:
Fresenius Kabi Austria GmbH
A-8055 Graz, Hafnerstrasse 36
Austria
Fresenius Kabi AB
S-75174 Uppsala, Rapsgatan 7
Sweden
This medicinal product is authorised in the
Member States of the EEA under the following
names:
Name of the member
medicinal state
Name
product
of
the
Austria
Propofol 'Fresenius'
1 % mit MCT Emulsion zur Injektion
oder Infusion
Belgium
Propolipid 1 %
Cyprus
Propofol 1% MCT/LCT
Fresenius
Czech Republic
Propofol 1% MCT/LCT
Fresenius
Denmark
Propolipid
Estonia
Propoven 1%
Germany
Propofol 1%
(10 mg/1 ml) MCT
Fresenius, Emulsion
zur
Injektion
oder
Infusion
Greece
Propofol MCT/LCT 1%
Finland
Propolipid 10 mg/ml
Hungary
Propofol 1% MCT/LCT
Fresenius
Iceland
Propolipid 10 mg/ml
Ireland
Fresenius Propoven 1%
Italy
Propofol Kabi 10mg/ml
Latvia
Propoven 1%
Lithuania
Propoven 1%
Luxembourg
Propofol 1%
Fresenius
Netherlands
Propofol
10mg/ml
MCT/LCT Fresenius
Norway
Propolipid 10 mg/ml
Poland
Propofol 1% MCT/LCT
Fresenius
Portugal
Propofol 1% MCT/LCT
Fresenius
Slovakia
Propofol 1% MCT/LCT
Fresenius
Slovenia
Propoven 10 mg/ml
emulzija za injiciranje
ali infundiranje
Spain
Propofol
Lipomed
10 mg/ml Fresenius
emulsión
para
inyección o perfusión
Sweden
Propolipid 10 mg/ml
United Kingdom
Fresenius Propoven 1%
MCT
This leaflet was last revised in August 2016
&
support rapid growth of microorganisms.
The emulsion must be drawn aseptically into a sterile syringe or giving set immediately after opening
the ampoule or breaking the vial seal. Administration must commence without delay.
Asepsis must be maintained for both Fresenius
Propoven 1% and the infusion equipment throughout the infusion period. Fresenius Propoven 1%
must not be administered through a microbiological
filter.
Infusion of undiluted Fresenius Propoven 1%:
The use of a burette, drop counter, syringe pump or
volumetric infusion pump to control the infusion rate
is recommended when Fresenius Propoven 1% is
infused undiluted.
As usual for fat emulsions, the infusion of Fresenius
Propoven 1% via one infusion system must not exceed 12 hours. The infusion set for Fresenius Propoven 1% must be changed at least every 12 hours.
Infusion of diluted Fresenius Propoven 1%:
Burettes, drop counters or volumetric infusion
pumps should always be used to control infusion
rates. The maximum dilution must not exceed 1
part of Fresenius Propoven 1% emulsion for injection or infusion with 4 parts of glucose 50 mg/ml (5
%) solution for injection or sodium chloride 9 mg/
ml (0.9%) solution for injection (minimum concentration 2 mg propofol per ml). The mixture should
be prepared aseptically (controlled and validated
conditions preserved) immediately prior to admi-
nistration and must be administered within 6 hours
after preparation.
To reduce pain on the injection site, Fresenius
Propoven 1% should be administered in a larger
vein and/or lidocaine injection solution may be administered before induction of anaesthesia with
Fresenius Propoven 1%. Alternatively, lidocaine
may be added to the solution (20 parts of Fresenius Propoven 1% emulsion for injection or infusion
with up to 1 part of 1 % preservative free lidocaine
solution for injection) to reduce pain at the site of
injection of Fresenius Propoven 1% emulsion for injection or infusion . Intravenous lidocaine must not
be used in patients with hereditary acute porphyria.
Muscle relaxants like atracurium and mivacurium
should only be administered after flush of the same
infusion site used for Fresenius Propoven 1%.