FRESENIUS PROPOVEN

Main information

  • Trade name:
  • FRESENIUS PROPOVEN 1 %w/v Emulsion for Inj/Inf
  • Dosage:
  • 1 %w/v
  • Pharmaceutical form:
  • Emulsion for Inj/Inf
  • Prescription type:
  • Product subject to prescription which may not be renewed (A)
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FRESENIUS PROPOVEN 1 %w/v Emulsion for Inj/Inf
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • Other general anesthetics

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization status:
  • Authorised
  • Authorization number:
  • PA0566/036/001
  • Authorization date:
  • 22-04-2005
  • Last update:
  • 20-10-2016

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

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

nurse.

This

includes

possible side effects not listed in this leaflet.

See section 4.

What is in this leaflet:

What Fresenius Propoven 1% is and what it is

used for

What you need to know before you are given

Fresenius Propoven 1%

How to use Fresenius Propoven 1%

Possible side effects

How to store Fresenius Propoven 1%

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)

that

surgical

operations

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

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.

should

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

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)

raised

pressure

inside

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

treated

before

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

nervous

reflex

that

slows

heart

rate

(vagotonia, bradycardia)

changes in the blood flow to the organs of the

body

(haemodynamic

effects

cardiovascular system) if you are overweight

and receive high doses of Fresenius Propoven

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 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.

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.

Other medicines and Fresenius Propoven 1%

Tell your doctor or pharmacist if you are taking, have

recently taken or might take any other medicines.

You must take special care if you are also taking/

receiving any of the following medicines:

Premedications (your anaesthetist will know

which

medicines

influenced

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 gluco-

se 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 emulsi-

on should not be used.

Use only homogeneous preparations and undama-

ged containers.

Prior to use, the ampoule neck or rubber membra-

ne should be cleaned using an alcohol spray or a

swab dipped in alcohol. After use, tapped contai-

ners must be discarded.

Propofol should be given by those trained in anaes-

thesia (or, where appropriate, doctors trained in the

care of patients in Intensive Care).

Patients should be constantly monitored and faci-

lities for maintenance of a patent airway, artificial

ventilation, oxygen enrichment and other resuscita-

tive facilities should be readily available at all times.

Propofol should not be administered by the person

M088702/03 GB

V004/GZ

Fresenius Propoven 1%

emulsion for injection or infusion

Propofol

conducting the diagnostic or surgical procedure.

Abuse of, and dependence on propofol, predo-

minantly 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 seda-

tion, for surgical and diagnostic procedures, pati-

ents should be continually monitored for early signs

of hypotension, airway obstruction and oxygen de-

saturation.

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 %) solu-

tion for injection.

Fresenius Propoven 1% emulsion for injection or

infusion must not be mixed with any other solu-

tions for infusion or injection except those menti-

oned above.

Glucose 50 mg/ml (5 %) solution for injection, so-

dium 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 in-

jection may be given through the same infusion set.

Co-administration of other medicinal products or

fluids added to the Fresenius Propoven 1% infusi-

on 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 emul-

sion without antimicrobial preservatives and may

Other anaesthetics, including general, regional,

local

inhalational

anaesthetics

(Lower

doses

Fresenius

Propoven

required. Your anaesthetist will know this.)

Painkillers (analgesics)

Strong

painkillers

(fentanyl

opioids)

Parasympatholytic

agents

(medicines

used

to treat e.g. painful cramps of organs, asthma

or Parkinson’s disease)

Benzodiazepines

(medicines

used

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

prevent

transplant rejections)

Cyclosporine

(medicine

used

prevent

transplant rejections)

Valproate (medicine used to treat epilepsy or

mental disorders)

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,

drive

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 ´sodium-

free`.

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.

sedation

during

surgical

diagnostic

procedures in adults, most patients will require

0.5 - 1 mg propofol per kg body weight over 1 to

minutes

onset

sedation.

Maintenance

sedation

accomplished

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.

Elderly and weak patients

Elderly and weak patients may require lower doses.

Use

in

children

and

adolescents

over

one

month of age

Fresenius

Propoven

recommended in children younger than 1 month.

Special

care

should

also

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

keep

them

asleep (maintenance of anaesthesia). In younger

children, especially between the age of 1 month

and 3 years, dose requirements may be higher.

sedation

during

surgical

diagnostic

procedures in children over 1 month of age with

Fresenius

Propoven

emulsion

injection

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.

Fresenius

Propoven

emulsion

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.

Package leaflet: Information for the user

Product Name:

Type of Packaging:

Dosage:

Territory:

Pharma-Code (Laetus)

Code:

Font:

Smallest Size:

2-D-Matrix Code

Material number:

Colour:

BLACK

1. Draft

11.07. 2016

06.40 Uhr

1. Correction 19.07. 2016

11.22 Uhr

2. Correction 22.08. 2016 08.45 Uhr

3. Correction 06.02. 2017 07.53 Uhr

4. Correction 13.06. 2017

13.33 Uhr

Variable Data:

Operator: Christian Nagy +43(0) 34 52 72266-22 P. Marko +43(0) 34 52 72266-20

FRESENIUS PROPOVEN 1%

GB

PIL

20ml

M088702/03 GB

x

M088702/03 GB

Arial

9 Pt.

Dimension:

180 x 882 mm

support rapid growth of microorganisms.

The emulsion must be drawn aseptically into a ste-

rile syringe and giving set immediately after ope-

ning the ampoule or breaking the vial seal. Admi-

nistration must commence without delay.

Asepsis must be maintained for both Fresenius

Propoven 1% and the infusion equipment throug-

hout 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 ex-

ceed 12 hours. The infusion set for Fresenius Prop-

oven 1% must be changed at least every 12 hours.

Infusion of diluted Fresenius Propoven 1%:

Burettes,

drop

counters

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 injec-

tion 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 concen-

tration 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 ad-

ministered before induction of anaesthesia with

Fresenius Propoven 1%. Alternatively, lidocaine

may be added to the solution (20 parts of Freseni-

us 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 in-

jection 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%.

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

use,

rubber

membrane

should

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

following

side

effects

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.

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).

Common (may affect up to 1 in 10 people)

Slow or fast heartbeat

Low blood pressure

Changes

your

breathing

pattern

(low

respiratory rate, breathing arrest)

Hiccups

Cough (may also happen when you wake up)

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

tissue

reaction

following

accidental application beside the vein.

Side effects that can happen after anaesthesia

following

side

effects

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

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.

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

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.

other

ingredients

soya-bean

oil,

refined,

medium-chain

triglycerides,

purified

egg phosphatides, glycerol, oleic acid, sodium

hydroxide, water for injections.

What Fresenius Propoven 1% looks like and

contents of the pack

Fresenius

Propoven

white

oil-in-water

emulsion for injection or infusion.

Fresenius Propoven 1% is available in colourless

glass ampoules or glass vials. The glass vials are

sealed with rubber stoppers.

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

Holder

and

Manufacturer

Marketing Authorisation Holder:

Fresenius Kabi Ltd

Cestrian Court, Eastgate Way

Manor Park, Runcorn

Cheshire, WA7 1NT

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

Name of the

state

medicinal product

Austria

Propofol

“Fresenius”

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

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%

emulsion for injection or

infusion

Italy

Propofol Kabi 10mg/ml

Latvia

Propoven 1%

Lithuania

Propoven 1%

Luxembourg

Propofol

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

mg/ml

emulzija za injiciranje

ali infundiranje

Spain

Propofol

Lipomed

mg/ml

Fresenius

emulsión

para

inyección o perfusión

Sweden

Propolipid 10 mg/ml

United Kingdom

Fresenius Propoven 1%

emulsion for injection or

infusion

This leaflet was last revised in March 2017

&

Package leaflet: Information for the user

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

years

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.

What

need

know

before

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).

336 414

(replace 335 055)

Tryckspecifikation

Format:

594 x 210 mm

Colour:

PMS svart

Fontsize:

8 pt

Perforering

3:e korr 2017-06-13

Niklas Baudin

+46 18 64 43 69

336 414

Fresenius Propoven 1%

emulsion for injection or infusion

Propofol

21121212111

21121212111

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)

raised

pressure

inside

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

insufficient

blood

reaching

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

cardiovascular

system)

if you are overweight and receive high doses of Fresenius

Propoven 1%.

Involuntary

movements

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 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.

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.

Other medicines and Fresenius Propoven 1%

Tell your doctor or pharmacist if you are taking, have recently

taken or might take any other medicines.

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%)

- Other anaesthetics, including general, regional, local

and inhalational anaesthetics (Lower doses of Fresenius

Propoven

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

treat

disease

called

myasthenia gravis)

Cyclosporine (medicine used to prevent transplant rejections)

Valproate (medicine used to treat epilepsy or mental disorders)

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 ´sodium-free`.

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.

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.

dose

should

adjusted

according

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.

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.

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.

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.

only

homogeneous

preparations

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

diagnostic

procedures,

patients

should

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

mg/ml

(0.18

solution

injection

glucose

40 mg/ml (4 %) solution for injection may be given through

the same infusion set.

21121212111

21121212111

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

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

reporting

side

effects

help

provide

more

information on the safety of this medicine.

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

should

replaced

hours

after

opening

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.

throw

away

medicines

wastewater

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.

What Fresenius Propoven 1% looks like and contents of

the pack

Fresenius Propoven 1% is a white oil-in-water emulsion for

injection or infusion.

Fresenius

Propoven

available

colourless

glass

ampoules or glass vials. The glass vials are sealed with rubber

stoppers.

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 Holder and Manufacturer

Marketing Authorisation Holder:

Fresenius Kabi Ltd

Cestrian Court, Eastgate Way

Manor Park, Runcorn

Cheshire, WA7 1NT

Manufacturer:

Fresenius Kabi Austria GmbH

A-8055 Graz, Hafnerstrasse 36

Austria

Fresenius Kabi AB, Rapsgatan 7, S-75174 Uppsala, Sweden

Method of administration

Fresenius

Propoven

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

used.

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.

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).

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)

Co-administration

other

medicinal

products

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 support rapid growth of

microorganisms.

The emulsion must be drawn aseptically into a sterile syringe

giving

immediately

after

opening

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%:

burette,

drop

counter,

syringe

pump

volumetric infusion pump to control the infusion rate is

recommended

when

Fresenius

Propoven

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 administration 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%.

V004/UP

336 414

This medicinal product is authorised in the Member

States of the EEA under the following names:

Name of the

Name of the medicinal product

member state

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% emulsion for

injection or infusion

Italy

Propofol Kabi 10mg/ml

Latvia

Propoven 1%

Lithuania

Propoven 1%

Luxembourg

Propofol 1% MCT 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% emulsion for

injection or infusion

This leaflet was last revised in March 2017