UNIFOL <10 мг/мл Эмульсия для инъекционной/инфузионной подготовки

Содержание инструкции

1. Unifol 10 mg/ml injectable emulsion/infusion
   1. What is Unifol 10 mg/ml and what is it used for
   2. What you need to know before using Unifol 10 mg/ml
   3. How to administer Unifol 10 mg/ml
   4. Possible side effects
   5. How to store Unifol 10 mg/ml
   6. Contents of the pack and other information
2. Unifol 20 mg/ml injectable emulsion/infusion
   1. What is Unifol 20 mg/ml and what is it used for
   2. What you need to know before using Unifol 20 mg/ml
   3. How to administer Unifol 20 mg/ml
   4. Possible side effects
   5. How to store Unifol 20 mg/ml
   6. Contents of the pack and other information

Unifol 10 mg/ml injectable emulsion/infusion

Propofol
Generic medicine

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 pass it on to others, even if they have the same symptoms as you, as it could be harmful
• If you get any side effects, even 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 you use 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 is Unifol 10 mg/ml and what is it used for

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

• To induce and maintain general anesthesia in adults and children over 1 month of age.
• To sedate adults and children over 1 month of age during diagnostic and surgical procedures, alone or in combination with local or regional anesthesia.
• To sedate patients over 16 years of age undergoing 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 any of the other ingredients of this medicine (listed in section 6).
• UNIFOL 10 mg/ml should not be used for the sedation of children aged 16 years and under in intensive care (see also "Warnings and precautions").

Warnings and precautions

• The use of Unifol 10 mg/ml is not recommended in newborns.
• UNIFOL 10 mg/ml should not be used for the sedation of children aged 16 years and under 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
• if you have been told that you have high levels of fats in your blood or that your body has problems with the metabolism and processing of lipids
• if you suffer from other conditions such as heart, lung, kidney or liver problems
• or if you have been unwell for some time.
• if you have a disorder of energy metabolism (so-called "mitochondrial disease"). Taking UNIFOL 10 mg/ml may worsen your condition
• The person administering UNIFOL 10 mg/ml will continuously monitor your condition. UNIFOL 10 mg/ml may be used in combination with other medicines, such as sleeping pills and painkillers. In this case, you will be monitored to ensure that breathing and circulation remain good.
• In some patients, long-term use of UNIFOL 10 mg/ml in intensive care may require zinc supplementation (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 the tissues
• serious damage to a nerve
• septicemia (sepsis).

Other medicines and Unifol 10 mg/ml
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. These
include over-the-counter medicines.
If you are taking any of the following medicines in combination with propofol, you may experience side
effects. This concerns, for example, the following medicines:

• Other anesthetics (administered via epidural or by inhalation)
• Premedications (your anesthesiologist knows which medicines can be administered)
• muscle relaxants (e.g. suxamethonium or benzodiazepines)
• painkillers (e.g. fentanyl)
• medicines with an effect on the heart (e.g. digoxin)
• rifampicin (an antibiotic).

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

Driving and using machines
After the procedure, your ability to drive vehicles and use machines may be impaired for some
time as an effect of the product. If you go home on the day of the operation, you may not be able to drive or
use dangerous machinery. If necessary, ask your doctor if 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 problems in case of hypersensitivity to it.
This medicine contains less than 1 mmol of sodium (23 mg) in 20 ml, i.e. essentially "sodium-free".

3. How to administer Unifol 10 mg/ml

• UNIFOL 10 mg/ml will be administered to you by an anesthesiologist or an intensive care physician.
• UNIFOL 10 mg/ml will be administered as an injection into a vein, usually on the back of the hand or in the forearm.
• Sometimes, a local anesthetic (lidocaine, for example) may also be administered at the injection site. The aim is to reduce the pain due to the injection.
• The dose administered will depend on your age, weight and physical condition. The doctor will administer the dose indicated to induce and maintain anesthesia or to obtain the necessary sedation. The doctor will closely monitor your reaction and vital signs (heartbeat, blood pressure, breathing, etc.).

If you have any doubts about the use of this medicine, please contact 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 when anesthesia is administered

Common (may affectfrom 1 in 100 to 1 in 10 people)

• low heart rate (bradycardia)
• headache upon waking
• temporary changes in breathing (apnea) when anesthesia is administered
• nausea and vomiting upon waking
• low blood pressure (hypotension)

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

Rare (may affectfrom 1 in 10,000 to 1 in 1,000 people)
at the beginning of anesthesia, during anesthesia and upon waking: muscle contraction (epileptiform movements),
including convulsions/seizures

Very rare (may affectless than 1 in 10,000 people)
fluid accumulation in the lungs (pulmonary edema)
inflammation of the pancreas accompanied by severe pain in the upper part of the abdomen that radiates 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 manifest as: sudden fluid
accumulation in the skin and mucous membranes (e.g. throat or tongue), difficulty breathing and/or a feeling of
itching and rash (angioedema); wheezing due to muscle or airway cramps (bronchospasm); skin redness (erythema); low blood pressure (hypotension)
sexual disinhibition
death of local tissues (only if UNIFOL is accidentally administered into a vein)

Not known (the frequency cannot be estimated from the available data)
blood acidification (metabolic acidosis), excess potassium in the blood (hyperkalemia; you may
notice this from muscle cramps, diarrhea, nausea or headache), excess lipids in the blood
(hyperlipidemia)
excessively good 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)
muscle tissue breakdown accompanied by muscle cramps, fever and brownish-red coloration
of the urine (rhabdomyolysis)
kidney failure (renal insufficiency)
pain at the injection site, swelling at the injection site (only if UNIFOL is accidentally not
administered into a vein)
an abnormality in the cardiac tracing (ECG) called Brugada type ECG
prolonged penile erection accompanied by pain (priapism)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly through
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 hospital. The staff is responsible for the correct storage,
use and disposal of Unifol 10 mg/ml.
Do not use Unifol 10 mg/ml after the expiry date that isstated on the pack after Exp.
The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C. Store 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 must be shaken before use.
If, after shaking, separation into two layers is noted, the emulsion must not be used.
Use only homogeneous preparations and undamaged containers.
For single use. Unused emulsion must be discarded.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to eliminate the
medicines you no longer use in a responsible manner. This will help protect the environment.

6. Contents of the pack and other information

What Unifol 10 mg/ml contains
The active ingredient is propofol
Each ml of injectable/infusion emulsion contains 10 mg of propofol.
Each vial of 10 ml contains 100 mg of Propofol
Each vial of 20 ml contains 200 mg of Propofol
Each vial of 50 ml contains 500 mg of Propofol
Each vial of 100 ml contains 1000 mg of Propofol
The other ingredients are: refined soybean oil, egg lecithin, glycerol, sodium oleate, sodium
hydroxide (for pH adjustment) 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 medicine is presented as:
Injectable/infusion emulsion in a colorless glass vial (type II) with a grey bromobutyl rubber stopper and plastic caps.
Pack sizes:
Colorless glass vial (type II) of 10 ml with grey bromobutyl rubber closure, packs
of 1 unit
Colorless glass vial (type II) of 20 ml with grey bromobutyl rubber closure, packs
of 1, 5 and 10 units
Colorless glass vial (type II) of 50 ml with grey bromobutyl rubber closure, packs
of 1 unit
Colorless glass vial (type II) of 100 ml with grey bromobutyl rubber closure,
packs of 1 unit
Not all pack sizes may be marketed.

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

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

The following information is intended exclusively for doctors or healthcare professionals:
Unifol 10 mg/ml must only be administered in hospitals or adequately
equipped intensive care units by doctors experienced in anaesthesia or in the care of patients in intensive care.
Patients must be constantly monitored and equipment for maintaining
patient breathing, artificial ventilation, oxygenation and other resuscitation equipment must always be available.
Unifol 10 mg/ml should not be administered by the person performing the diagnostic or
surgical procedure.
Dilution can be performed using multiple controlled infusion techniques, but a
drip chamber used alone does not avoid the risk of accidental and uncontrolled infusion of large volumes of
Unifol 10 mg/ml diluted. A burette, a drop counter or a volumetric infusion pump must
always be inserted into the infusion line. The risk of uncontrolled infusion must always be
taken into consideration when deciding 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 noted, the emulsion must not be used.
Only homogeneous preparations and undamaged containers should be used.
For single use only. Unused emulsion must be discarded.
Before use, the rubber membrane must be cleaned using spray alcohol or a swab
soaked in alcohol. After use, resealed containers must be discarded. Unifol 10 mg/ml does
not contain antimicrobial preservatives and this may lead to rapid development of microorganisms.
When Unifol 10 mg/ml is to be aspirated, the emulsion must be drawn up aseptically with
a sterile syringe or an infusion system, immediately after opening the vial seal.
Administration must begin immediately. Asepsis must be maintained for both Unifol 10 mg/ml and
infusion devices throughout the administration period. Any infusion fluid
added to the Unifol 10 mg/ml infusion line must be added near the
cannula. Unifol 10 mg/ml must not be administered through a microbiological filter.
Unifol 10 mg/ml and each syringe containing Unifol 10 mg/ml are for singleuse for a single
patient. As with other lipid emulsions, the infusion of Unifol 10 mg/ml through a single infusion system
must not exceed 12 hours. After 12 hours, the infusion system and the remaining Unifol 10 mg/ml
must be discarded and replaced if necessary.
When Unifol 10 mg/ml is infused undiluted to maintain anaesthesia, it is recommended that
equipment such as syringe pumps or volumetric infusion pumps are always used to
control the infusion rate.
Unifol 10 mg/ml can be used for infusion diluted or undiluted.
Unifol 10 mg/ml can only be mixed with the following products: glucose 50
mg/ml (5%) injection solutions, sodium chloride 9 mg/ml (0.9%) injection solutions or sodium chloride 1.8 mg/ml
(0.18%) and glucose 40 mg/ml (4%) injection solutions and lidocaine 10 mg/ml (1%) solution without preservatives.
The final concentration of Unifol 10 mg/ml must not be below 2 mg/ml.
However, the co-administration of Unifol 10 mg/ml with glucose 50 mg/ml (5%) injection solution,
sodium chloride 9 mg/ml (0.9%) injection solution or sodium chloride 1.8 mg/ml
(0.18%) and glucose 40 mg/ml (4%) injection solution is possible via a Y-site device near
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 singleuse for
a singlepatient. After use, any remaining solution of Unifol 10 mg/ml must be discarded.

Unifol 20 mg/ml injectable emulsion/infusion

Propofol
Generic medicine

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 pass it on to others, even if they have the same symptoms as you, as it could be harmful
• If any side effects occur, including those not listed in this leaflet, tell 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 you use 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. Contents of the pack and other information

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

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

• Inducing and maintaining general anesthesia in adults and children over 3 years of age.
• Sedating adults and children over 3 years of age during diagnostic and surgical procedures, alone or in combination with local or regional anesthesia.
• Sedating patients over 16 years of age undergoing 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 any of the other ingredients of this medicine (listed in section 6).
• UNIFOL 20 mg/ml should not be used for the sedation of children aged 16 years and under in intensive care (see also "Warnings and precautions").

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

• The use of Unifol 20 mg/ml is not recommended in children under 3 years of age.
• UNIFOL 20 mg/ml should not be used for the sedation of children aged 16 years and under 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 seizures or convulsions
• if you have been told that you have high levels of fats in your blood or that your body has problems with the metabolism and processing of lipids
• if you suffer from other conditions such as heart, lung, kidney or liver problems
• or if you have been unwell for some time.
• if you have a disorder of energy metabolism (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 can be used in combination with other medicines, such as sleeping pills and painkillers. In this case, you will be monitored to ensure that breathing and circulation remain good.
• In some patients, long-term use of UNIFOL 20 mg/ml in intensive care may require zinc supplementation (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 side effects. These conditions are:
• reduced blood flow to the tissues
• serious nerve damage
• septicemia (sepsis).

Other medicines and Unifol 20 mg/ml
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. These
include over-the-counter medicines.
If you are taking any of the following medicines in combination with propofol, you may experience side
effects. This concerns, for example, the following medicines:

• Other anesthetics (administered via epidural or by inhalation)
• Premedications (your anesthesiologist knows which medicines can be administered)
• muscle relaxants (e.g. suxamethonium or benzodiazepines)
• painkillers (e.g. fentanyl)
• medicines with an effect on the heart (e.g. digoxin)
• rifampicin (an antibiotic).

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

Driving and using machines
After the procedure, your ability to drive vehicles and use machines may be impaired for some
time as an effect of the product. If you go home on the day of the operation, you may not be able to drive or
use dangerous machinery. If necessary, ask your doctor if you can return to work.

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

UNIFOL 20 mg/ml contains egg lecithin.
This substance may cause problems in case of hypersensitivity to it.
This medicine contains less than 1 mmol of sodium (23 mg) in 20 ml, i.e. essentially "sodium-free".

3. How to administer Unifol 20 mg/ml

• UNIFOL 20 mg/ml will be administered to you by an anesthesiologist or an intensive care physician.
• UNIFOL 20 mg/ml will be administered as an injection into a vein, usually on the back of the hand or in the forearm.
• Sometimes, a local anesthetic (lidocaine, for example) may also be administered at the injection site. The aim is to reduce the pain due to the injection.
• The administered dose will depend on your age, weight and physical condition. The doctor will administer the dose indicated to induce and maintain anesthesia or to obtain the necessary sedation. The doctor will closely monitor your reaction and vital signs (heartbeat, blood pressure, breathing, etc.).

If you have any doubts about the use of this medicine, please 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 when the anesthesia is administered

Common (may affectfrom 1 in 100 to 1 in 10 people)

• low heart rate (bradycardia)
• headache upon waking
• temporary changes in breathing (apnea) when the anesthesia is administered
• nausea and vomiting upon waking
• low blood pressure (hypotension)

Uncommon (may affectfrom 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 affectfrom 1 in 10,000 to 1 in 1,000 people)
at the beginning of anesthesia, during anesthesia and upon waking: muscle contraction (epileptiform movements),
including convulsions/seizures

Very rare (may affectless than 1 in 10,000 people)
fluid accumulation in the lungs (pulmonary edema)
inflammation of the pancreas accompanied by severe pain in the upper abdomen that radiates 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 manifest as: sudden fluid
accumulation in the skin and mucous membranes (e.g. throat or tongue), difficulty breathing and/or a feeling of
itching and rash (angioedema); wheezing due to muscle or airway spasms (bronchospasm); skin redness (erythema); low blood pressure (hypotension)
sexual disinhibition
death of local tissues (only if UNIFOL is accidentally 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; you may
notice this from muscle cramps, diarrhea, nausea or headache), excess lipids in the blood
(hyperlipidemia)
excessively good 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)
muscle tissue breakdown accompanied by muscle cramps, fever and brownish-reddish coloration of the
urine (rhabdomyolysis)
kidney failure (renal insufficiency)
pain at the injection site, swelling at the injection site (only if UNIFOL is accidentally not
administered into a vein)
an abnormality in the cardiac tracing (ECG) called Brugada type ECG
prolonged penile erection, accompanied by pain (priapism)

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through
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. The staff is responsible for the correct storage,
use and disposal of Unifol 20 mg/ml.
Do not use Unifol 20 mg/ml after the expiry date that isstated on the package after Exp. The expiry
date refers to the last day of that month.
Do not store at a temperature above 25°C. Store 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 must be shaken before use.
If, after shaking, separation into two layers is noted, the emulsion must not be used.
Use only homogeneous preparations and undamaged containers.
For single use. Unused emulsion must be discarded.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use in a responsible manner. This will help protect the environment.

6. Contents of the pack and other information

What Unifol 20 mg/ml contains
The active ingredient is propofol
Each ml of injectable/infusion emulsion contains 20 mg of propofol.
Each vial of 50 ml contains 1000 mg of propofol
The other components are: refined soybean oil, egg lecithin, glycerol, sodium oleate, sodium
hydroxide (for pH adjustment) 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 medicine is presented as:
Injectable/infusion emulsion in a colorless glass vial (type II) with a gray bromobutyl rubber stopper and plastic
capsule.
Pack sizes:
Colorless glass vial (type II) of 50 ml with a gray bromobutyl rubber stopper, single
pack.
Not all pack sizes may be marketed.

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

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

The following information is intended exclusively for doctors or healthcare professionals:
Unifol 20 mg/ml should only be administered in hospitals or adequately equipped therapy units by
doctors experienced in anesthesia or in the care of patients in intensive care.
Patients must be constantly monitored and equipment for maintaining
patient breathing, artificial ventilation, oxygenation and other resuscitation equipment must always be available.
Unifol 20 mg/ml should 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 noted, the emulsion should 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 spray alcohol or an alcohol-soaked swab.
After use, resealed containers must be discarded. Unifol 20 mg/ml does not
contain antimicrobial preservatives and this may lead to rapid development of microorganisms.
When Unifol 20 mg/ml is to be aspirated, the emulsion must be drawn up aseptically with
a sterile syringe or with an infusion system, immediately after opening the vial seal.
Administration must begin immediately. Asepsis must be maintained for both Unifol 20 mg/ml and
infusion devices throughout the administration period. Any infusion fluid
added to the Unifol 20 mg/ml infusion line must be added near the
cannula. Unifol 20 mg/ml should not be administered through a microbiological filter.
Unifol 20 mg/ml and every syringe containing Unifol 20 mg/ml are for single use for a single
patient.
As with other lipid emulsions, the infusion of Unifol 20 mg/ml through a single infusion system
should not exceed 12 hours. After 12 hours, the infusion system and the remaining Unifol 20 mg/ml
must be discarded and replaced if necessary.
When Unifol 20 mg/ml is infused undiluted to maintain anesthesia, it is recommended that
equipment such as syringe pumps or volumetric infusion pumps are always used to
control the infusion rate.
Unifol 20 mg/ml is used undiluted intravenously or for continuous infusion.
Unifol 20 mg/ml should not be administered by repeated bolus injection for the
maintenance of anesthesia.
Unifol 20 mg/ml should not be mixed with other solutions for injection or infusion. However, co-
administration with 50 mg/ml (5%) glucose injection solutions, 9 mg/ml (0.9%) sodium chloride injection solutions or 1.8 mg/ml (0.18%) sodium chloride solutions and 40 mg/ml (4%) glucose injection solutions and 10 mg/ml (1%) lidocaine solution without preservatives is possible via
a Y-connector near the injection site.
Unifol 20 mg/ml should not be administered through microbiological filters.
Unifol 20 mg/ml and any infusion equipment containing Unifol 20 mg/ml are for singleuse for
a singlepatient. After use, the remaining solution of Unifol 20 mg/ml must be discarded.
Infusion of Unifol 20 mg/ml undiluted:
When Unifol 20 mg/ml is infused undiluted, it is recommended that equipment such as burettes,
drip chambers, syringe pumps or volumetric infusion pumps are always used to control the
infusion rate.
Unifol 20 mg/ml and every syringe containing Unifol 20 mg/ml are for single use for a single
patient.
As with other lipid emulsions, the infusion of Unifol 20 mg/ml through a single infusion system
should not exceed 12 hours. After 12 hours, the infusion system and the remaining UNIFOL 20 mg/ml
must be discarded and replaced if necessary.
Unifol 20 mg/ml should not be mixed with other infusion or injection solutions
But 5% w/v glucose solution, 0.9% w/v sodium chloride solution or 0.18% w/v sodium chloride solution and 4% w/v glucose solution can be administered through appropriate connectors
at the cannula site.
To reduce pain at the injection site, propofol can be administered in a larger vein or lidocaine can be injected before inducing
anesthesia with Propofol.
Muscle relaxants such as atracurium and mivacurium should be administered only after flushing the same infusion site used for Unifol 20 mg/ml.