PACKAGE LEAFLET: INFORMATION FOR THE USER

Propoven 1%

emulsion for injection/ infusion in pre-filled syringe

Active substance: Propofol

The name of this medicine is Propoven 1% emulsion for injection/for infusion in pre-filled syringe. In the rest of this leaflet it will be referred to as Propoven 1%.

What is in this leaflet:

1.    What Propoven 1% is and what it is used for

2.    What you need to know before you are given Propoven 1%

3.    How to use Propoven 1%

4.    Possible side effects

5.    How to store Propoven 1%

6.    Contents of the pack and other information

1.    What Propoven 1% is and what it is used for

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).

Propoven 1% 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 Propoven 1%

Do not use Propoven 1%

-    if you are allergic to propofol, soya, peanut or to 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 or pharmacist before you are given Propoven 1% and if any of the subsequent mentioned applies to you or applied to you in the past.

You should not receive 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, Propoven 1% should be given with caution to elderly or weak patients.

Before receiving 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 you have any of the following conditions, they must be treated before you receive Propoven 1%:

-    heart failure

-    when there is insufficient blood reaching the tissues (circulatory failure)

-    severe breathing problems (respiratory failure)

-    dehydration (hypovolaemia)

-    seizures (epilepsy)

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 Propoven 1%.

Involuntary movements can occur during sedation with 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 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.

Children and adolescents (Propoven 1%)

The use of Propoven 1% is not recommended in newborn infants or children younger than 1 month.

Special care should also be observed when administering Propoven 1% to children less than 3 years of age. However, evidence now available does not suggest that this is any less safe than in older children.

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 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 any of the following medicines:

-    premedications (your anaesthetist will know which medicines may interact with Propoven 1%)

-    other anaesthetics, including general, regional, local and inhalational anaesthetics (Lower doses of Propoven 1% may be required. Your anaesthetist will know this.)

-    analgesics (painkillers)

-    drugs that relax muscles, e.g. suxamethonium

-    benzodiazepines (drugs for anxiety)

-    drugs that affect many of the internal body functions such as the heart rate, e.g. atropine

-    strong painkillers, e.g. fentanyl

-    alcohol

-    neostigmine (a treatment for muscle weakness)

-    cyclosporin (used to prevent transplant rejections)

Propoven 1% with food, drink and alcohol

After you have been given Propoven 1%, you should not eat, drink or consume alcohol until fully recovered.

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 taking this medicine. Propoven 1% should not be given to pregnant women unless clearly necessary. Mothers should stop breast-feeding and discard any breast milk for 24 hours after receiving Propoven 1%.

Driving and using machines

After you have been given Propoven 1%, you must not drive, operate machinery, or work in dangerous situations. You should not go home alone.

Propoven 1% contains soya-bean oil and sodium

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 Propoven 1%

Propoven 1% will only be given to you in hospitals or suitable therapy units by your anaesthetist or by an 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). It can also be affected by other medicines you may be taking.

Adults

Most people need 1.5 to 2.5mg 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 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 Propoven 1%) if a rapid increase of the depth of sedation is required.

Use in children and adolescents over one month of age

The use of Propoven 1% is not recommended in children younger than 1 month.

Special care should also be observed when administering Propoven 1% 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 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 Propoven 1% most paediatric patients require 1 - 2 mg/kg bodyweight propofol for onset of sedation. Maintenance of sedation may be accomplished by titrating 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.

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.

Elderly and weak patients

Elderly and weak patients may require lower doses.

Method of administration

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). Propoven 1% will be injected into a vein either manually or by electric pumps. Your doctor will make sure that the pump is compatible with the pre-filled syringes. 10 ml and 20 ml glass syringes and 10 ml plastic syringes are suitable for manual use only and must not be used with a pump.

Propoven 1% is for single use only. Any unused emulsion

The following information is intended for medical or    Propoven 1% should not be administered by the same

healthcare professionals only:    person conducting the surgical or diagnostic procedure.

Propoven 1% 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 (10mg/ml) solution for injection. Final propofol concentration must not be below.

For single use only. Any unused emulsion must be discarded.

Pre-filled syringes 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 pre-filled syringes.

After use, tapped pre-filled syringes must be discarded.

Propoven 1% must only be given in hospitals or adequately equipped day therapy units by physicians trained in anaesthesia or in the care of patients in intensive care. Circulatory and respiratory functions should be constantly monitored (e.g. ECG, pulse oxymetry) and facilities for maintenance of patient airways, artificial ventilation, and other resuscitation facilities should be immediately available at all times.

For sedation during surgical and diagnostic procedures

Propoven 1% 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.

Propoven 1% must not be mixed with any other solutions for infusion or injection except those mentioned above.

Co-administration of 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 with Propoven 1% is permitted via a Y-piece connector close to the injection site.

Co-administration of other medicinal products or fluids added to the Propoven 1% infusion line must occur close to the cannula site using a Y-piece connector or a three-way valve.

Propoven 1% is a lipid containing emulsion without antimicrobial preservatives and may support rapid growth of microorganisms.

The emulsion must be drawn aseptically. Administration must commence without delay.

Asepsis must be maintained for both Propoven 1% and the infusion equipment throughout the infusion peri-

M0xxxxx/xx UK V005

must be discarded. The pre-filled syringes 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 pre-filled syringes. Application of pre-filled syringes (for pre-assembled syringes step 2 can be omitted):

Sterility has to be ensured. The outer surface of the syringe and the plunger rod are not sterile.

1)    Take out the syringe from the packaging and shake it.

2)    Insert the plunger rod by screwing it clock-wise into the syringe.

3)    Remove the tip cap from the syringe and connect the infusion line, needle or cannula to the syringe. Get rid of the air bubble (a small bubble can remain) and the ready-to-use syringe will be installed in the pump or administered manually.

Duration of treatment

When used for sedation, Propoven 1% must not be administered for more than 7 days.

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.

These side effects may occur during the induction of anaesthesia (common may affect up to 1 in 10 people):

-    spontaneous movements

-    muscle jerks (myoclonus)

-    muscle twitching (minimal excitation)

-    low blood pressure (hypotension)

-    slow heartbeat (bradycardia)

-    rapid heartbeat (tachycardia)

-    hot flushes

-    increased breathing (hyperventilation)

-    stopping breathing (temporary apnoea)

-    coughing after anaesthesia

-    hiccups (singultus)

If you think you have any of the below mentioned side effects or any other side effects, please inform a physician as soon as possible.

Very common (may affect more than 1 in 10 people):

-    local pain during the injection.

Common( may affect up to 1 in 10 people):

-    increase of levels of fat in the blood (hypertriglyceridemia)

Uncommon (may affect up to 1 in 100 people):

-    severe low blood pressure (hypotension)

-    coughing during anaesthesia

-    slowing of the pulse rate (progressive bradycardia)

Rare (may affect up to 1 in 1,000 people):

-    a severe allergic reaction (anaphylaxis), including:

-    swelling of the skin of the face, mouth and throat (angioedema)

-    narrowing of the airways in the lungs that makes it difficult to breathe (bronchospasm)

-    reddening of the skin (erythema)

-    low blood pressure (hypotension)

-    headache

-    dizziness (vertigo)

-    epileptiform movements (involuntary movements similar to epilepsy), including convulsions and opisthotonus (a rigid posture with the head arched backwards)

-    blood clots (thrombosis)

-    inflammation of the blood vessels (phlebitis)

-    discoloration of urine

-    postoperative fever

These rare side effects may occur during the recovery period (waking up):

-    euphoria (feeling happy) and sexual arousal

-    shivering and feeling cold

-    irregular heartbeat (arrhythmia)

-    coughing

-    feeling sick (nausea) or vomiting

When 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

Very rare (may affect up to 1 in 10,000 people):

-    allergic reactions caused by soya-bean oil

-    delayed epileptiform attacks (involuntary movements similar to epilepsy after waking up)

-    convulsions in epileptic patients

-    unconsciousness after anaesthesia

-    fluid on the lungs (pulmonary oedema)

-    inflammation of the pancreas (pancreatitis)

-    severe tissue responses after accidental injection into tissues

-    rhabdomyolysis (a disorder of muscle)

-    a change in the acidity of the blood (metabolic acidosis)

-    a high level of potassium in the blood (hyperkalaemia)

-    heart failure.

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

5.    How to store 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 syringe and the outer packaging after EXP. The expiry date refers to the last day of that month.

Store at or below 25 °C.

Do not freeze.

After first opening the product must be used immediately. Administration systems with undiluted Propoven 1% should be replaced 12 hours after opening of the syringe. 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 (10mg/ml) 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.

6. Contents of the pack and other information What Propoven 1% contains

- The active substance is propofol.

Each ml emulsion contains 10 mg propofol.

Each 10 ml syringe contains 100 mg propofol.

Each 20 ml syringe contains 200 mg propofol.

Each 50 ml syringe contains 500 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 Propoven 1% looks like and contents of the pack

Propoven 1% is a white oil-in-water emulsion for injection or infusion in a pre-filled syringe.

Propoven 1% is available in plastic and glass pre-filled syringes.

Pack sizes:

Packs containing 5 glass pre-filled syringes with 10 ml emulsion

Packs containing 6 plastic pre-filled syringes with 10 ml emulsion

Packs containing 5 glass pre-filled syringes with 20 ml emulsion

Packs containing 6 plastic pre-filled syringes with 20 ml emulsion

Packs containing 1 plastic pre-filled syringe with 50 ml emulsion

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Fresenius Kabi, Cestrian Court, Eastgate Way,

Manor Park, Runcorn, Cheshire,

WA71NT

Manufacturer:

Fresenius Kabi Austria GmbH A-8055 Graz, HafnerstraUe 36 Austria

This medicinal product is authorised in the Member States of the EEA under the following names:

Country	Trade Name
Austria	Propofol „Fresenius” 1 % mit MCT Emulsion zur Injektion oder Infusion in einer Fertigspritze
Belgium	Propolipid 1 %
Cyprus	Propofol MCT/LCT/ Fresenius 1% (10 mg/ml) YaAaKTWja Yia £YXUOTI H £V£OT| ct£ npOY£jiaj£vr| aupiYYa
Czech Republic	Propofol MCT Fresenius 10 mg/ml injekcni/infuzni emulze v predplnene injekcnl strikacce
Denmark	Propolipid
Estonia	Propoven 1%
Germany	Propofol Fresenius MCT 10 mg/ml Emulsion zur Injektion/Infusion in einer Fertigspritze
Greece	Propofol MCT/LCT/ Fresenius 1% (10mg/ml) YaAaKTWja Yia £YXUCTH H £v£ot| ct£ npOY£jiaj£vn aupiYYa
Finland	Propolipid 10 mg/ml injektio-/ infuusioneste, emulsio, esitaytetyssa ruiskussa
Hungary	Propofol MCT Fresenius 10 mg/ml emulzio injekciohoz vagy infuziohoz eloretoltott fecskendoben
Iceland	Propolidid 10 mg/ml, stungu- eda innrennslislyf, fleyti 1 afylltri sprautu
Ireland	Propoven 1% emulsion for injection/infusion in pre-filled syringe
Italy	Propofol Kabi
Latvia	Propoven 1 % emulsija injekcijam vai infuzijam pilnslirce
Lithuania	Propoven 1% injekcine/infuzine emulsija uzpildytame svirkste
Luxembourg	Propofol MCT Fresenius 10 mg/ml Emulsion zur Injektion/Infusion in einer Fertigspritze
Netherlands	Propofol 10mg/ml MCT/LCT Fresenius
Norway	Propolipid
Poland	Propofol 1% MCT/LCT Fresenius
Portugal	Propofol 1% MCT/LCT Fresenius
Slovakia	Propofol MCT Fresenius 10 mg/ml injekcna/infuzna emulzia v naplnenej injekcnej striekacke
Slovenia	Propoven 10 mg/ml emulzija za injiciranje/infundiranje v napolnjeni injekcijski brizgi
Spain	Propofol Lipomed Fresenius 10 mg/ml emulsion inyectable y para perfusion en jeringa precargada
Sweden	Propolipid
United Kingdom	Propoven 1% emulsion for injection/infusion in pre-filled syringe

This leaflet was last revised Jun 2015

od. Propoven 1% must not be administered through a microbiological filter.

Infusion of Propoven 1%:

The use of a burette, drop counter, syringe pump or volumetric infusion pump to control the infusion rate is recommended when Propoven 1% is infused undiluted.

As usual for fat emulsions, the infusion of Propoven 1% via one infusion system must not exceed 12 hours. The infusion set for Propoven 1% must be changed at least every 12 hours.

Infusion of diluted 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 Propoven 1% to 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 and administered within 6 hours.

If the same injection system used for Propoven 1% is to be used for the injection of muscle relaxants (e.g. atracurium and mivacurium), the injection system must first be flushed.

To reduce pain on the injection site, Propoven 1% should be administered in a larger vein or lidocaine injection solution may be administered before induction of anaesthesiawithPropoven 1%.Alternatively, Lidocainemay be added to the solution (20 parts of Propoven 1% to 1 part of 10mg/ml preservative free lidocaine solution for injection) to reduce pain at the site of injection of Propoven 1%.

Intravenous lidocaine is to be avoided in patients with acute porphyrias.