PROPOVEN 2% EMULSION FOR INJECTION/INFUSION IN PRE-FILLED SYRINGE - patient leaflet, side effects, dosage

Patient leaflet - PROPOVEN 2% EMULSION FOR INJECTION/INFUSION IN PRE-FILLED SYRINGE

Propoven 2%

emulsion for injection/ infusion in pre-filled syringe

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 Propoven 2% is and what it is used for
2. What you need to know before you are given Propoven 2%
3. How to use Propoven 2%
4. Possible side effects
5. How to store Propoven 2%
6. Contents of the pack and other information

1. what propoven 2% is and what it is used for

Propoven 2% 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 2% is used to:

induce and maintain general anaesthesia in adults, adolescents and children older than 3 years.
sedate patients older than 16 years of age receiving artificial respiration in intensive care.
sedate adults, adolescents and children older than 3 years 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 2%

Do not use Propoven 2%

– 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 Propoven 2% and if any of the subsequent mentioned applies to you or applied to you in the past.

You should not receive Propoven 2%, 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 2% should be given with caution to elderly or weak patients.

Before receiving Propoven 2%, 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 Propoven 2%:

– heart failure
– when there is insufficient blood reaching the tissues (circulatory failure)
– severe breathing problems (respiratory failure)
– dehydration (hypovolaemia)
– seizures (epilepsy)

Propoven 2% 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 2%.

Involuntary movements can occur during sedation with Propoven 2%. 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 2% 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 Propoven 2% is not recommended for use in children younger than 3 years of age.

Propoven 2% 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 2%

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 Propoven 2%)
– Other anaesthetics, including general, regional, local and inhalational anaesthetics (Lower doses of Propoven 2% 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)
– Valproate (medicine used to treat epilepsy or mental disorders)

Propoven 2% with food, drink and alcohol

After you have been given Propoven 2%, 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.

Propoven 2% 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 Propoven 2%.

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.

Propoven 2% contains soya-bean oil and sodium

Propoven 2% 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 2%

Propoven 2% 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 Propoven 2% 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 (0.5 – 1 ml Propoven 2%) 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 three years of age

The use of Propoven 2% is not recommended in children younger than 3 years of age.

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 2% to make them go to sleep (induction of anaesthesia). In younger children 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 dose requirements may be higher.

For sedation during surgical and diagnostic procedures in children over 3 years of age with Propoven 2% most paediatric patients require 1 – 2 mg/kg bodyweight propofol for onset of sedation. Maintenance of sedation may be accomplished by titrating Propoven 2% infusion to the desired level of sedation. Most patients require 1.5 – 9 mg/kg/h propofol.

Method of administration

Propoven 2% 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 2% 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.

Propoven 2% is for single use only. Any unused emulsion 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:

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 2% 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.

The following information is intended for healthcare professionals only:

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.

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.

Propoven 2% is administered undiluted intravenously by continuous infusion.

Propoven 2% must not be mixed with other solutions for infusion or injection.

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 Propoven 2% infusion line must occur close to the cannula site using a Y-piece connector or a three-way valve.

M0xxxxx/00 UK/IE

V007/GZ

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)
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 Propoven 2% 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 system

For the UK:

You can report side effects directly via the

Yellow Card Scheme

Website: or search for MHRA Yellow Card in the Google Play or Apple App Store.

For Ireland:

You can also report side effects directly via HPRA Pharmacovigilance Website:

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store propoven 2%

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.

Do not store above 25 °C. Do not freeze.

After first opening the medicinal product must be used immediately.

Administration systems with Propoven 2% should be replaced 12 hours after opening of the syringe.

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 Propoven 2% contains

– The active substance is propofol.

Each ml emulsion contains 20 mg propofol.

Each 50 ml syringe 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 Propoven 2% looks like and contents of the pack

Propoven 2% is a white oil-in-water emulsion for injection/ infusion in a pre-filled syringe.

Propoven 2% is available in plastic pre-filled syringes.

Pack sizes:

Packs containing 1 pre-filled syringe with 50 ml emulsion

Marketing Authorisation Holder:

For UK

Fresenius Kabi Limited

Cestrian Court,

Eastgate Way, Manor Park, Runcorn, Cheshire, WA71NT UK

For IE

Fresenius Kabi Deutschland GmbH

Else-Kroener Strasse 1,

Bad Homburg v.d.H. 61352, Germany

Manufacturer:

Fresenius Kabi Austria GmbH

A-8055 Graz, Hafnerstralie 36

Austria

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

Name of the member state	Name of the medicinal product
Austria	Propofol „Fresenius” 2 % mit MCT Emulsion zur Injektion oder Infusion in einer Fertigspritze
Belgium	Propolipid 2%
Cyprus	Propofol MCT/LCT/ Fresenius 2% (20 mg/ml) YaAaKTwpa Yia EYxuⁿ n tvECTn ct£ npoY£piCTp£vn CTUpiYYa
Czech Republic	Propofol MCT Fresenius 20 mg/ml injekcni/infuzni emulze v predplnene injekcni stnkacce
Denmark	Propolipid
Estonia	Propoven 2%
Germany	Propofol MCT Fresenius 20 mg/ml Emulsion zur Injektion/Infusion in einer Fertigspritze
Greece	Propofol MCT/LCT/ Fresenius 2% (20 mg/ml) YaAaKTwpa Yia EYxuⁿ n tv£CTn ct£ npoY£piCTp£vn CTUpiYYa
Finland	Propolipid 20 mg/ml injektio-/ infuusioneste, emulsion, esitaytetyssa ruiskussa
Hungary	Propofol MCT Fresenius 20 mg/ml emulzio injekciohoz vagy infuziohoz eloretoltott fecskendoben
Iceland	Propolidid 20 mg/ml, stungu- eda innrennslislyf, fleyti i afylltri sprautu
Ireland	Propoven 2% emulsion for injection/ infusion in pre-filled syringe
Italy	Propofol Kabi
Latvia	Propoven 2 % emulsija injekcijam vai infuzijam pilnslirce
Lithuania	Propoven 2% injekcine/infuzine emulsija uzpildytame svirkste
Norway	Propolipid
Poland	Propofol 2% MCT/LCT Fresenius
Portugal	Propofol 2% MCT/LCT Fresenius
Slovakia	Propofol MCT Fresenius 20 mg/ml injekcna/infuzna emulzia v naplnenej injekcnej striekacke
Slovenia	Propoven 20 mg/ml emulzija za injiciranje/infundiranje v napolnjeni injekcijski brizgi
Spain	Propofol Lipoven Fresenius 20 mg/ml emulsion inyectable y para perfusion en jeringa precargada EFG
Sweden	Propolipid
United Kingdom	Propoven 2% emulsion for injection/ infusion in pre-filled syringe

This leaflet was last revised February 2021

Propoven 2% is not advised for general anaesthesia in children younger than 3 years of age since the 20 mg/ ml strength is difficult to be titrated in small children due to the extremely small volumes needed. The use of Propoven 1% should be considered in children between 1 month and 3 years of age if a dose less than e.g. 100 mg/h is expected.

Propoven 2% is a lipid containing emulsion without antimicrobial preservatives and may support rapid growth of microorganisms.

The emulsion must be drawn aseptically into a giving set immediately after opening the syringe. Administration must commence without delay.

Asepsis must be maintained for both Propoven 2% and the infusion equipment throughout the infusion period. Propoven 2% must not be administered through a microbiological filter.

The use of a burette, drop counter, syringe pump or volumetric infusion pump to control the infusion rate is recommended when Propoven 2% is infused.

As usual for fat emulsions, the infusion of Propoven 2% via one infusion system must not exceed 12 hours.

The infusion set for Propoven 2% must be changed at least every 12 hours.

To reduce pain on the injection site, Propoven 2% should be administered in a larger vein and/or lidocaine injection solution may be administered before induction of anaesthesia with Propoven 2%.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 Propoven 2%.