Unifol

PACKAGE LEAFLET: INFORMATION FOR THE USER

Unifol 10 mg/ml injectable emulsion/for infusion

Propofol
Generic medicine
Please read all of this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Unifol 10 mg/ml is and what it is used for
2. What you need to know before using Unifol 10 mg/ml
3. How to use Unifol 10 mg/ml
4. Possible side effects
5. How to store Unifol 10 mg/ml
6. Contents of the pack and other information

1. What Unifol 10 mg/ml is and what it is used for

UNIFOL 10 mg/ml is a solution for injection and contains the active substance propofol. Propofol belongs to a group of medicines called general anaesthetics. General anaesthetics are used to cause unconsciousness (sleep) so that surgical operations and other procedures can be performed. They may also be used to sedate you (so that you are drowsy but not fully asleep).
UNIFOL 10 mg/ml is used for:

• Induction and maintenance of general anaesthesia in adults and children over 1 month of age.
• Sedation of adults and children over 1 month of age during diagnostic and surgical procedures, either alone or in combination with local or regional anaesthesia.
• Sedation of patients over 16 years of age who are on mechanical ventilation in an intensive care unit.

2. What you need to know before using Unifol 10 mg/ml
Do not use Unifol 10 mg/ml:

• if you are allergic to propofol or to any of the other ingredients of this medicine (listed in section 6).
• UNIFOL 10 mg/ml must not be used for sedation of children aged 16 years and younger in intensive care (see also "Warnings and precautions").

Warnings and precautions

• The use of Unifol 10 mg/ml is not recommended in neonates.
• UNIFOL 10 mg/ml must not be used for sedation of children aged 16 years and younger in intensive care, as its safety and efficacy have not been established in this age group. Talk to your doctor before using Unifol 10 mg/ml if:
• you have ever suffered from epileptic seizures or convulsions
• you have been told that you have high levels of fat in the blood or that your body has problems metabolising and processing lipids
• you suffer from other medical conditions such as heart, lung, kidney or liver problems
• or if you have been unwell for some time.
• you have an energy metabolism disorder (so-called "mitochondrial disease"). Taking UNIFOL 10 mg/ml may worsen your condition.
• The person administering UNIFOL 10 mg/ml to you will continuously monitor your condition. UNIFOL 10 mg/ml may be used in combination with other medicines such as hypnotics and analgesics. In such cases, you will be monitored to ensure adequate respiration and circulation.
• In some patients, long-term use of UNIFOL 10 mg/ml in intensive care may require supplementation with zinc (a mineral). The person administering UNIFOL 10 mg/ml will decide when such supplementation is necessary and which medicine to give you. In rare cases, patients have experienced periods of unconsciousness after surgery. These patients recovered without complications.
• If you suffer from any of the following conditions, you may experience very rare side effects. These conditions are:
• reduced blood flow to tissues
• severe nerve damage
• sepsis (septicaemia).

Other medicines and Unifol 10 mg/ml
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription.
If you are taking any of the following medicines in combination with propofol, you may experience side effects. This includes, for example, the following medicines:

• Other anaesthetics (administered via epidural or by inhalation)
• Premedication (your anaesthetist knows which medicines may be given)
• muscle relaxants (e.g. suxamethonium or benzodiazepines)
• analgesics (e.g. fentanyl)
• medicines affecting the heart (e.g. digoxin)
• rifampicin (an antibiotic).

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect you may be pregnant, or if you are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Unifol 10 mg/ml must not be used during pregnancy unless strictly necessary.
For the safety of your baby, breastfeeding must be discontinued during treatment with UNIFOL 10 mg/ml.

Driving and using machines
After the procedure, your ability to drive or operate machinery may be impaired for some time due to the effects of the product. If you go home on the day of the procedure, you may not be able to drive or operate dangerous machinery. If necessary, ask your doctor whether you can return to work.

Unifol 10 mg/ml contains soybean oil.
Unifol 10 mg/ml contains soybean oil. If you are allergic to peanuts or soy, do not use this medicine.

UNIFOL 10 mg/ml contains egg lecithin.
This substance may cause reactions in people who are hypersensitive to it.
This medicine contains less than 1 mmol of sodium (23 mg) per 20 ml, i.e. essentially "sodium-free".

3. How to take Unifol 10 mg/ml

• UNIFOL 10 mg/ml will be administered to you by an anaesthetist or an intensive care doctor.
• UNIFOL 10 mg/ml will be given as an injection into a vein, usually on the back of the hand or in the forearm.
• Sometimes, you may also be given a local anaesthetic (such as lidocaine) at the injection site. The aim is to reduce pain caused by the injection.
• The dose administered will depend on your age, weight, and physical condition. The doctor will administer the dose required to induce and maintain anaesthesia or to achieve the necessary sedation. Your doctor will closely monitor your response and vital signs (heart rate, blood pressure, breathing, etc.).

If you have any doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects have been reported:

Very common (may affect up to 1 in 10 patients)
localized pain at the time of anesthesia

Common (may affect from 1 in 100 to 1 in 10 patients)

• low heart rate (bradycardia)
• headache upon waking
• temporary breathing disturbances (apnea) during anesthesia
• nausea and vomiting upon waking
• reduced blood pressure (hypotension)

Uncommon (may affect from 1 in 1,000 to 1 in 100 patients)
formation of a blood clot in a vein or artery (thrombosis)
inflammation of the wall of an artery (phlebitis)

Rare (may affect from 1 in 10,000 to 1 in 1,000 patients)
at the beginning of anesthesia, during anesthesia, and upon waking: muscle contractions (epileptiform movements), including seizures/convulsions

Very rare (may affect fewer than 1 in 10,000 patients)
fluid accumulation in the lungs (pulmonary edema)
inflammation of the pancreas accompanied by severe pain in the upper abdomen radiating to the back, and nausea and vomiting (pancreatitis)
change in urine color (usually green)
fever after surgery
unconsciousness after surgery
hypersensitivity to certain substances (anaphylaxis), which may present as: sudden fluid accumulation in the skin and mucous membranes (e.g. throat or tongue), difficulty breathing and/or itching and skin rash (angioedema); labored breathing due to muscle or airway spasms (bronchospasm); skin redness (erythema); low blood pressure (hypotension)
sexual disinhibition
local tissue necrosis (only if UNIFOL is accidentally not administered into a vein)

Not known (frequency cannot be estimated from available data)
acidification of the blood (metabolic acidosis), excess potassium in the blood (hyperkalemia; symptoms may include muscle cramps, diarrhea, nausea or headache), excess lipids in the blood (hyperlipidemia)
excessively elevated mood (euphoria)
drug abuse
involuntary movements
irregular heartbeat (cardiac arrhythmias), impaired heart function (heart failure)
shortness of breath (depends on the amount of UNIFOL administered)
enlargement of the liver (hepatomegaly)
breakdown of muscle tissue accompanied by muscle cramps, fever, and brownish-red discoloration of urine (rhabdomyolysis)
impaired kidney function (renal failure)
injection site pain, swelling at injection site (only if UNIFOL is accidentally not administered into a vein)
an abnormality in the heart trace (ECG) known as Brugada-type ECG
prolonged erection of the penis accompanied by pain (priapism)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Unifol 10 mg/ml

Keep this medicine out of the sight and reach of children.
UNIFOL 10 mg/ml is stored in a hospital setting. Staff are responsible for the proper storage,
use, and disposal of Unifol 10 mg/ml.
Do not use Unifol 10 mg/ml after the expiry date stated on the carton after "Exp.".
The expiry date refers to the last day of that month.
Do not store above 25°C. Keep in the outer packaging to protect the medicine from light.
Do not refrigerate or freeze.
After opening, the product must be used immediately.
The container should be shaken before use.
If, after shaking, separation into two layers is observed, the emulsion must not be used.
Use only homogeneous preparations and undamaged containers.
For single use only. Any unused emulsion must be discarded.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required, so as to ensure responsible disposal. This will help protect the environment.

6. Contents of the pack and other information

What Unifol 10 mg/ml contains
The active substance is propofol.
Each ml of injectable/infusion emulsion contains 10 mg of propofol.
Each 10 ml vial contains 100 mg of propofol.
Each 20 ml vial contains 200 mg of propofol.
Each 50 ml vial contains 500 mg of propofol.
Each 100 ml vial contains 1000 mg of propofol.
The other components are: refined soybean oil, egg lecithin, glycerol, sodium oleate, sodium hydroxide (to adjust pH), and water for injections.

Description of the appearance of Unifol 10 mg/ml and contents of the pack
Unifol 10 mg/ml is a white oil-in-water emulsion for injection or infusion.
This medicinal product is available as:
Injectable/infusion emulsion in a colourless glass vial (type II) with a grey bromobutyl rubber stopper and plastic cap.

Pack sizes:

• 10 ml colourless glass vial (type II) with grey bromobutyl rubber closure, pack size: 1 unit
• 20 ml colourless glass vial (type II) with grey bromobutyl rubber closure, pack sizes: 1, 5 and 10 units
• 50 ml colourless glass vial (type II) with grey bromobutyl rubber closure, pack size: 1 unit
• 100 ml colourless glass vial (type II) with grey bromobutyl rubber closure, pack size: 1 unit

Not all pack sizes may be marketed.

Marketing Authorization Holder
Baxter Holding B.V.
Kobaltweg 49,
3542CE Utrecht, Netherlands (NL)

Responsible manufacturer for batch release
UAB Norameda
Meistru 8a, Vilnius,
02189, Lithuania
Bieffe Medital S.P.A.
Via Nuova Provinciale,
23034 Grosotto (SO)
Italy

This patient information leaflet was last approved on
The following information is intended exclusively for healthcare professionals or medical personnel:
Unifol 10 mg/ml must be administered only in hospitals or adequately equipped intensive care units by physicians experienced in anaesthesia or intensive care medicine.
Patients must be continuously monitored, and equipment for maintaining airway patency, artificial ventilation, oxygenation, and other resuscitation devices must always be readily available.
Unifol 10 mg/ml must not be administered by the person performing the diagnostic or surgical procedure.

Dilution may be performed using various controlled infusion techniques; however, a flow regulator alone does not prevent the risk of accidental and uncontrolled infusion of large volumes of diluted Unifol 10 mg/ml. A burette, drip chamber, or volumetric infusion pump must always be incorporated into the infusion line. The risk of uncontrolled infusion must always be considered when determining the maximum dosage of Unifol 10 mg/ml in the burette.

The container must be shaken before use. If, after shaking, separation into two layers is observed, the emulsion must not be used.
Use only homogeneous preparations and undamaged containers.
For single use only. Any unused emulsion must be discarded.

Before use, the rubber stopper must be cleaned using alcohol spray or an alcohol-impregnated swab. After use, re-capped vials must be discarded. Unifol 10 mg/ml does not contain antimicrobial preservatives, which may allow rapid microbial growth.

When Unifol 10 mg/ml is to be withdrawn, the emulsion must be aseptically drawn up using a sterile syringe or infusion system immediately after breaking the vial seal. Administration must begin immediately. Aseptic technique must be maintained for both Unifol 10 mg/ml and infusion devices throughout the entire administration period. Any infusion fluid added to the Unifol 10 mg/ml infusion line must be introduced close to the cannula site. Unifol 10 mg/ml must not be administered through a microbiological filter.

Unifol 10 mg/ml and every syringe containing Unifol 10 mg/ml are for single use in a single patient only.

As with other lipid emulsions, infusion of Unifol 10 mg/ml via a single infusion system must not exceed 12 hours. After 12 hours, the infusion system and any remaining Unifol 10 mg/ml must be discarded and replaced if necessary.

When Unifol 10 mg/ml is administered undiluted to maintain anaesthesia, it is recommended that infusion pumps or volumetric infusion pumps be used to control the infusion rate.

Unifol 10 mg/ml may be used for infusion either diluted or undiluted.

Unifol 10 mg/ml may be mixed only with the following products: 50 mg/ml (5%) glucose injection solutions, 9 mg/ml (0.9%) sodium chloride injection solutions, 1.8 mg/ml (0.18%) sodium chloride injection solutions, 40 mg/ml (4%) glucose injection solutions, or preservative-free 10 mg/ml (1%) lidocaine solution. The final concentration of Unifol 10 mg/ml must not be less than 2 mg/ml.

However, co-administration of Unifol 10 mg/ml with 50 mg/ml (5%) glucose injection solution, 9 mg/ml (0.9%) sodium chloride injection solution, 1.8 mg/ml (0.18%) sodium chloride injection solution, or 40 mg/ml (4%) glucose injection solution may be performed via a Y-site connector close to the injection site.

Unifol 10 mg/ml must not be administered through microbiological filters.

Unifol 10 mg/ml and any infusion equipment containing Unifol 10 mg/ml are for single use in a single patient only. After use, any remaining Unifol 10 mg/ml solution must be discarded.

PATIENT LEAFLET: INFORMATION FOR THE USER

Unifol 20 mg/ml injectable emulsion/for infusion

Propofol
Equivalent medicine
Please read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Unifol 20 mg/ml is and what it is used for
2. What you need to know before using Unifol 20 mg/ml
3. How to use Unifol 20 mg/ml
4. Possible side effects
5. How to store Unifol 20 mg/ml
6. Package contents and other information

1. What Unifol 20 mg/ml is and what it is used for

UNIFOL 20 mg/ml is a liquid for injection and contains the active substance propofol. Propofol belongs to a group of medicines called general anaesthetics. General anaesthetics are used to induce unconsciousness (sleep) so that surgical operations and other procedures can be performed. They may also be used to sedate patients (so they are drowsy but not fully asleep).
UNIFOL 20 mg/ml is used for:

• Induction and maintenance of general anaesthesia in adults and children over 3 years of age.
• Sedation of adults and children over 3 years of age during diagnostic and surgical procedures, either alone or in combination with local or regional anaesthesia.
• Sedation of patients over 16 years of age who are under mechanical ventilation in an intensive care unit.

2. What you need to know before using Unifol 20 mg/ml
Do not use Unifol 20 mg/ml:

• if you are allergic to propofol or to any of the other ingredients of this medicine (listed in section 6).
• UNIFOL 20 mg/ml must not be used for sedation of children aged 16 years and younger in intensive care (see also "Warnings and precautions").

Warnings and precautions
Unifol 20 mg/ml is not recommended in neonates.

• The use of Unifol 20 mg/ml is not recommended in children under 3 years of age.
• UNIFOL 20 mg/ml must not be used for sedation of children aged 16 years and younger in intensive care, as its safety and efficacy have not been established in this age group.

Talk to your doctor before using Unifol 20 mg/ml:

• if you have ever suffered from epileptic fits or convulsions
• if you have been told that you have high levels of fat in the blood or that your body has problems metabolising and processing lipids
• if you suffer from other diseases such as heart, lung, kidney or liver problems
• or if you have been unwell for some time.
• if you have an energy metabolism disorder (so-called "mitochondrial disease"). Taking UNIFOL 20 mg/ml may worsen your condition.
• The person administering UNIFOL 20 mg/ml will continuously monitor your condition. UNIFOL 20 mg/ml may be used in combination with other medicines such as hypnotics and analgesics. In such cases, you will be monitored to ensure adequate respiration and circulation.
• In some patients, long-term use of UNIFOL 20 mg/ml in intensive care may require supplementation with zinc (a mineral). The person administering UNIFOL 20 mg/ml will decide when such supplementation is necessary and which medicine to give you. In rare cases, patients have experienced periods of unconsciousness after surgery. These patients recovered without complications.
• If you suffer from any of the following conditions, you may experience very rare adverse effects. These conditions are:
• reduced blood flow to tissues
• severe nerve damage
• septicaemia (sepsis).

Other medicines and Unifol 20 mg/ml
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines without a prescription.
If you are taking any of the following medicines in combination with propofol, you may experience adverse effects. This includes, for example, the following medicines:

• Other anaesthetics (administered via epidural or by inhalation)
• Premedication (your anaesthetist knows which medicines may be administered)
• muscle relaxants (e.g. suxamethonium or benzodiazepines)
• analgesics (e.g. fentanyl)
• medicines affecting the heart (e.g. digoxin)
• rifampicin (an antibiotic).

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Unifol 20 mg/ml must not be used during pregnancy unless strictly necessary.
For the safety of your baby, breastfeeding must be discontinued during treatment with UNIFOL 20 mg/ml.

Driving and using machines
After the procedure, your ability to drive or operate machinery may be impaired for some time due to the effects of the product. If you go home on the day of the procedure, you may not be able to drive or operate dangerous machinery. If necessary, ask your doctor whether you can return to work.

Unifol 20 mg/ml contains soya seed oil.
Unifol 20 mg/ml contains soya oil. If you are allergic to peanuts or soya, do not use this medicine.

UNIFOL 20 mg/ml contains egg lecithin.
This substance may cause reactions in people who are hypersensitive to egg.

This medicine contains less than 1 mmol of sodium (23 mg) per 20 ml, i.e. essentially "sodium-free".

3. How to take Unifol 20 mg/ml

• UNIFOL 20 mg/ml will be administered to you by an anaesthetist or an intensive care physician.
• UNIFOL 20 mg/ml will be given as an injection into a vein, usually on the back of your hand or in your forearm.
• Sometimes, a local anaesthetic (such as lidocaine) may also be administered at the injection site to reduce injection-related pain.
• The dose administered will depend on your age, body weight, and physical condition. Your doctor will administer the appropriate dose to induce and maintain anaesthesia or to achieve the required sedation. Your doctor will closely monitor your response and vital signs (heart rate, blood pressure, respiration, etc.).

If you have any doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported:

Very common (may affect up to 1 in 10 people)
localized pain at the time of anaesthesia

Common (may affect from 1 in 100 to 1 in 10 people)

• slow heart rate (bradycardia)
• headache upon waking
• temporary breathing disturbances (apnoea) during anaesthesia
• nausea and vomiting upon waking
• low blood pressure (hypotension)

Uncommon (may affect from 1 in 1,000 to 1 in 100 people)
formation of a blood clot in a vein or artery (thrombosis)
inflammation of the artery wall (phlebitis)

Rare (may affect from 1 in 10,000 to 1 in 1,000 people)
at the beginning, during, or after anaesthesia: muscle contractions (epileptiform movements), including convulsive seizures/seizures

Very rare (may affect fewer than 1 in 10,000 people)
accumulation of fluid in the lungs (pulmonary oedema)
inflammation of the pancreas accompanied by severe pain in the upper abdomen spreading to the back, and nausea and vomiting (pancreatitis)
change in urine colour (usually green)
fever after surgery
unconsciousness after surgery
hypersensitivity to certain substances (anaphylaxis), which may present as: sudden accumulation of fluid in the skin and mucous membranes (e.g. throat or tongue), difficulty breathing and/or itching and skin rash (angioedema); laboured breathing due to muscle or airway spasms (bronchospasm); skin redness (erythema); low blood pressure (hypotension)
sexual disinhibition
local tissue death (only if UNIFOL is accidentally not administered into a vein)

Not known (frequency cannot be estimated from the available data)
acidification of the blood (metabolic acidosis), excess potassium in the blood (hyperkalaemia; symptoms may include muscle cramps, diarrhoea, nausea or headache), excess lipids in the blood (hyperlipidaemia)
excessively elevated mood (euphoria)
drug abuse
involuntary movements
irregular heartbeat (cardiac arrhythmias), improper heart function (heart failure)
shortness of breath (depends on the amount of UNIFOL administered)
enlargement of the liver (hepatomegaly)
breakdown of muscle tissue accompanied by muscle cramps, fever, and brownish-red discoloration of urine (rhabdomyolysis)
impaired kidney function (renal failure)
pain at injection site, swelling at injection site (only if UNIFOL is accidentally not administered into a vein)
an abnormality in the heart trace (ECG) known as Brugada-type ECG
prolonged erection of the penis accompanied by pain (priapism)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Unifol 20 mg/ml

Keep this medicine out of the sight and reach of children.
UNIFOL 20 mg/ml is stored in hospital settings. The staff is responsible for the proper storage,
use, and disposal of Unifol 20 mg/ml.
Do not use Unifol 20 mg/ml after the expiry date which is stated on the packaging after "Exp". The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the outer packaging to protect from light.
Do not refrigerate or freeze.
After opening, the product must be used immediately.
The container should be shaken before use.
If, after shaking, separation into two layers is observed, the emulsion must not be used.
Use only homogeneous preparations and undamaged containers.
For single use only. Any unused emulsion must be discarded.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use in an environmentally responsible manner. This will help protect the environment.

6. Contents of the pack and other information

What Unifol 20 mg/ml contains
The active substance is propofol.
Each ml of injectable/infusion emulsion contains 20 mg of propofol.
Each 50 ml vial contains 1000 mg of propofol.
The other components are: refined soybean oil, egg lecithin, glycerol, sodium oleate, sodium
hydroxide (to adjust pH), and water for injections.

Description of the appearance of Unifol 20 mg/ml and contents of the pack
Unifol 20 mg/ml is a white oil-in-water emulsion for injection or infusion.
This medicinal product is available as:
Injectable/infusion emulsion in a colourless glass vial (type II) with a grey bromobutyl rubber stopper and plastic cap.
Pack sizes:
Single 50 ml colourless glass vial (type II) with grey bromobutyl rubber stopper, individually packaged.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Baxter Holding B.V.
Kobaltweg 49,
3542CE Utrecht, Netherlands (NL)

Responsible manufacturer for batch release
UAB Norameda
Meistru 8a, Vilnius,
02189, Lithuania
Bieffe Medital S.P.A.
Via Nuova Provinciale,
23034 Grosotto (SO)
Italy

This patient leaflet was last reviewed on

The following information is intended exclusively for physicians or healthcare professionals:
Unifol 20 mg/ml must be administered only in hospitals or adequately equipped intensive care units by physicians experienced in anaesthesia or in the care of critically ill patients.
Patients must be continuously monitored, and equipment for maintaining airway patency, artificial ventilation, oxygenation, and other resuscitation equipment must always be readily available.
Unifol 20 mg/ml must not be administered by the person performing the diagnostic or surgical procedure.
The container must be shaken before use. If, after shaking, separation into two layers is observed, the emulsion must not be used.
Use only homogeneous preparations and undamaged containers.
For single use only. Unused emulsion must be discarded.
Before use, the rubber membrane must be cleaned using alcohol spray or an alcohol-impregnated swab. After use, recapped containers must be discarded. Unifol 20 mg/ml does not contain antimicrobial preservatives, which may allow rapid microbial growth.
When Unifol 20 mg/ml is to be aspirated, the emulsion must be withdrawn aseptically using a sterile syringe or an infusion system immediately after opening the vial seal.
Administration must begin immediately. Aseptic technique must be maintained for both Unifol 20 mg/ml and infusion devices throughout the entire administration period. Any infusion fluid added to the infusion line of Unifol 20 mg/ml must be introduced close to the cannula site. Unifol 20 mg/ml must not be administered through a microbiological filter.
Unifol 20 mg/ml and each syringe containing Unifol 20 mg/ml are for single use in a single patient only.

As with other lipid emulsions, infusion of Unifol 20 mg/ml via a single infusion system must not exceed 12 hours. After 12 hours, the infusion system and any remaining Unifol 20 mg/ml must be discarded and replaced if necessary.

When Unifol 20 mg/ml is infused undiluted to maintain anaesthesia, it is recommended that equipment such as syringe pumps or volumetric infusion pumps always be used to control the infusion rate.

Unifol 20 mg/ml is administered undiluted by intravenous route or by continuous infusion.

Unifol 20 mg/ml must not be administered by repeated bolus injection for maintenance of anaesthesia.

Unifol 20 mg/ml must not be mixed with other injectable or infusion solutions. However, co-administration with 50 mg/ml (5%) glucose injection solution, 9 mg/ml (0.9%) sodium chloride injection solution or 1.8 mg/ml (0.18%) sodium chloride injection solution, and 40 mg/ml (4%) glucose injection solution and preservative-free 10 mg/ml (1%) lidocaine solution is permitted via a Y-connector close to the injection site.

Unifol 20 mg/ml must not be administered through microbiological filters.

Unifol 20 mg/ml and any infusion equipment containing Unifol 20 mg/ml are for single use in a single patient only. After use, any remaining Unifol 20 mg/ml solution must be discarded.

Infusion of undiluted Unifol 20 mg/ml:
When Unifol 20 mg/ml is infused undiluted, it is recommended that equipment such as burettes, drip chambers, syringe pumps, or volumetric infusion pumps be used to control the infusion rate.

Unifol 20 mg/ml and each syringe containing Unifol 20 mg/ml are for single use in a single patient only.

As with other lipid emulsions, infusion of Unifol 20 mg/ml via a single infusion system must not exceed 12 hours. After 12 hours, the infusion system and any remaining Unifol 20 mg/ml must be discarded and replaced if necessary.

Unifol 20 mg/ml must not be mixed with other infusion or injectable solutions.
However, 5% w/v glucose solution, 0.9% w/v sodium chloride solution, 0.18% w/v sodium chloride solution, and 4% w/v glucose solution may be co-administered via appropriate side ports near the cannula site.

To reduce injection site pain, propofol may be administered into a larger vein or lidocaine may be injected prior to induction of anaesthesia with propofol.

Muscle relaxants such as atracurium and mivacurium must be administered only after flushing the same infusion site previously used for Unifol 20 mg/ml.