RIPOL 10 mg /Ml Injectable Emulsion

Зміст інструкції

1. RIPOL 10 mg/ml injectable emulsion/infusion
   1. WHAT IS RIPOL 10 MG/ML AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE RIPOL 10 MG/ML
   3. HOW TO USE RIPOL 10 MG/ML
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE RIPOL 10 MG/ML
   6. CONTENT OF THE PACK AND OTHER INFORMATION
2. RIPOL 20 mg/ml injectable emulsion/infusion
   1. WHAT IS RIPOL 20 MG/ML AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE RIPOL 20 MG/ML
   3. HOW TO USE RIPOL 20 MG/ML
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE RIPOL 20 MG/ML
   6. CONTENT OF THE PACK AND OTHER INFORMATION

RIPOL 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 personally. Do not give it to other people, even if their symptoms are the same as yours because it could be dangerous.
• 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 RIPOL 10 mg/ml is and what it is used for
• 2. What you need to know before you use RIPOL 10 mg/ml. How to use RIPOL 10 mg/ml
• 4. Possible side effects
• 5. How to store RIPOL 10 mg/ml
• 6. Contents of the pack and other information

1. WHAT IS RIPOL 10 MG/ML AND WHAT IS IT USED FOR

RIPOL 10 mg/ml belongs to a group of medicines called “general anesthetics”. General anesthetics
are used to cause unconsciousness (sleep) so that surgical operation or other procedures
can be performed. They can also be used to sedate you (so that you are drowsy
but not completely asleep).
RIPOL 10 mg/ml will be administered to you by injection by a doctor.
RIPOL 10 mg/ml injectable emulsion/for infusion
RIPOL 10 mg/ml is used for:

• inducing and maintaining general anesthesia in adults and in pediatric patients over one month of age.
• sedating patients over 16 years of age undergoing mechanical ventilation in intensive care.
• sedating adults and pediatric patients over one month of age during diagnostic and surgical procedures, alone or in combination with local and/or regional anesthesia.

2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE RIPOL 10 MG/ML

Do not use RIPOL 10 mg/ml

• in patients allergic (hypersensitive) to propofol or to any of the other ingredients of RIPOL 10 mg/ml (listed in section 6).
• in patients allergic to peanuts or soy. This is because RIPOL 10 mg/ml contains soybean oil.
• in patients aged 16 years or below for sedation in intensive care.

Warnings and precautions
The use of Ripol is not recommended in newborns.
Take particular care in these cases:

• If you have any other health problems, such as problems with the heart, kidneys, liver or breathing.
• If your body has lost a lot of fluids (if you are hypovolemic).
• If you have had an epileptic seizure or convulsion.
• If you have been told you have very high levels of fats in your blood. In these cases, your doctor will need to determine your blood fat levels.
• If you have been told that your body has problems using fats. In these cases, your doctor may need to determine your blood fat levels.
• If you suffer from a mitochondrial disease (diseases due to alterations of the mitochondria).
• If you have had a head injury with increased pressure in your head.
• If you have a condition called a hereditary predisposition to acute porphyria (presence of neurological symptoms).
• If you are elderly or debilitated or severely overweight.

RIPOL 10 mg/ml emulsion for injection/infusion
The use of RIPOL 10 mg/ml is not recommended in newborns.
If you can return home shortly after receiving propofol, you should not go home unattended.
If you are not sure whether the above applies to your situation, talk to your doctor or
nurse before you are given RIPOL 10 mg/ml.

Other medicines and RIPOL
Tell your doctor if you are taking or have recently taken any other medicines, including those
available without a prescription. This includes medicines, herbal remedies, dietary foods or supplements
that you have bought yourself.
Be particularly careful if you are taking or are given the following medicines:
Certain premedications (the anesthesiologist knows which drugs may be affected)
Other anesthetics (including general, local, or volatile anesthetics)
Pain relievers (analgesics)
Stronger pain relievers (fentanyl or opioids), you may experience increased apnea due to increased
levels of propofol in the blood
Sympatholytic agents (medicines used to treat, for example, painful cramps of the
organs, asthma or Parkinson's disease)
Benzodiazepines (medicines used to treat anxiety)
Suxamethonium (muscle relaxant), a slowing of the heartbeat and
cardiac arrest may occur.
Neostigmine (medicine used to treat a disease called myasthenia gravis), a slowing of the heartbeat and cardiac arrest may occur.
Cyclosporine (medicine used to prevent transplant rejection), a brain disease may occur
Rifampicin (antibiotic used to treat, for example, Tuberculosis), as low blood pressure may occur

Use of RIPOL 10 mg/ml 20 mg/mlwith food and drink
If you are given propofol you mustavoid drinking alcohol for at least 8 hours before and after the
administration of RIPOL 10 mg/ml - 20 mg/ml.
Pregnancy and breastfeeding
If you are pregnant, RIPOL 10 mg/ml should only be given if absolutely necessary. If you are
planning a pregnancy or are breastfeeding, talk to your doctor or nurse before you are
given the medicine.
You should not breastfeed while you are given propofol and breast milk should be
discarded for 24 hours after the administration of propofol. The milk produced during this period of time

must notbe used.

Driving and operating machinery
After receiving RIPOL 10 mg/ml you may still feel sleepy for a while. Do not
drive vehicles or use machinery until you are sure the effect has worn off.
If you are able to return home shortly after receiving propofol, you should not drive a vehicle.
Ask your doctor when you can start these activities again and when you can return to work.

RIPOL contains soybean oil.
If you are allergic to peanuts or soy, do not use this medicine (see above “Do not use RIPOL 10
mg/ml”).
This medicine contains less than 1 mmol of sodium (23 mg) per 100 ml, and is considered
essentially ‘sodium-free’.

3. HOW TO USE RIPOL 10 MG/ML

RIPOL 10 mg/ml will be administered to you by the anesthesiologist or under the direct supervision of the anesthesiologist, or
by an intensive care physician. It will be administered with an injection or an infusion (drip) into
a vein. This is normally done on the back of the hand or in the forearm.
The doctor will administer the injection using a needle or through a fine plastic tube
called a ‘cannula’.
To maintain anesthesia or for sedation, the medicine can be administered as
an intravenous infusion (drip) using an electric pump that automatically controls the
infusion rate. This can be done if you are undergoing long anesthesia or if you are in an Intensive Care Unit.
The dose of RIPOL 10 mg/ml will vary depending on other medications you are taking, including premedication,
age, body weight and physical condition. The doctor will give you the correct dose to start and to
sustain anesthesia or to achieve the required sedation level (drowsiness), carefully observing
your response and vital signs (pulse, blood pressure, breathing, etc.).
You may need different medications to keep you asleep or drowsy, without pain, with
healthy breathing and stable blood pressure. The doctor will decide which medications you need and
when.

General Anesthesia

Adults
For induction of anesthesia, most adult patients under 55 years of age generally require
1.5 to 2.5 mg propofol/kg of body weight.
For maintenance of general anesthesia, doses of 4 to 12 mg of
propofol/kg body weight/hour or repeated bolus injections (using RIPOL 10 mg/ml) with incremental doses
of 25 mg up to 50 mg are generally administered.
Dosages may be lower in elderly patients.

Sedationof patients on mechanical ventilation in intensive care units

Adults and adolescents over 16 years of age
For sedation of adults and adolescents over 16 years of age in intensive care, the dose must
be adjusted according to the required sedation levels. Infusion rates of 0.3 to 4.0 mg propofol/kg body weight/hour are normally used.
Infusion rates greater than 4.0 mg propofol/kg body weight/hour are not recommended.

Adults
For sedation during diagnostic and surgical procedures in adults and adolescents over 16
years of age, doses of 0.5 to 1 mg propofol/kg body weight are required, administered over 1 to 5
minutes to initiate sedation. Maintaining sedation will require 1.5 - 4.5 mg
propofol/kg body weight/hour. In addition, single doses of 10 - 20 mg propofol
may be administered if a rapid increase in sedation levels
(drowsiness) is required.

General Anesthesia
RIPOL 10 mg/ml emulsion for injection/infusion

Paediatric patients over 1 month of age

• For induction of anesthesia, most paediatric patients over 8 years of age will likely require 2.5 mg propofol/kg body weight. In patients under 8 years of age, the dose may be higher (2.5-4 mg propofol/kg body weight).
• For maintenance of anesthesia using a continuous infusion of doses of 9 -15 mg of propofol/kg body weight/hour, satisfactory anesthesia is usually achieved. Younger children, especially between the ages of 1 month and 3 years, may require higher doses.

Lower doses may be necessary in patients belonging to ASA classes III and IV.

Sedation
RIPOL 10 mg/ml emulsion for injection/infusion

Paediatric patients over 1 month of age
For the sedationof paediatric patients during diagnostic procedures and surgical interventionsthe
dose must be adjusted according to the required sedation levels. Most
paediatric patients require a dose of 1 - 2 mg propofol/kg body weight to initiate
sedation. Maintaining sedation requires 1.5 - 9 mg propofol/kg body weight/hour. In
addition, a single dose of up to 1 mg of propofol/kg body weight may be administered if
a rapid increase in sedation is required.
RIPOL 10 mg/ml should not be used in paediatric patients of 16 years of age or younger
for the indication for sedation in intensive care units.

Duration of treatment
If used for sedation, RIPOL 10 mg/ml should not be administered for more than 7 days.

If you are given more RIPOL 10 mg/ml than you should
The doctor will ensure that you receive the correct dose of propofol for you and the procedure you are
undergoing. However, different people require different dosages and if you are given too much, the anesthesiologist may need to ensure that your heart and breathing are adequately
supported. For these reasons, anesthetic drugs are only administered by doctors trained in
anesthesia or in the care of patients in intensive care. If you have further questions about the use of this product, speak to your anesthesiologist or intensive care physician.

4. POSSIBLE SIDE EFFECTS

Like all medicines, RIPOL 10 mg/ml can cause side effects, although not everybody gets them.
manifest.

Side effects that may occur during anesthesia
The following side effects may occur during anesthesia (while the injection is being given
or when you are drowsy or asleep). The doctor will pay attention to these effects. If they
occur, the doctor will give you appropriate treatment.

Very common (may affect more than 1 in 10 people)
Pain at the injection site (while the injection is being given, before you
fall asleep)

Common (may affect up to 1 in 10 people)
Slow heartbeat
Low blood pressure
Changes in your breathing rate, cough (can also happen when you are awake)

Rare (may affect up to 1 in 1,000 people)
Convulsions and agitation of your body, or convulsions (can also happen when you are awake)

Very rare (may affect up to 1 in 10,000 people)
Allergic reactions, even serious ones that can cause difficulty breathing or dizziness
Fluid accumulation in the lungs that can make you feel breathless (can also happen when
you are awake)
Unusual urine color (can also happen when you are awake)
Tissue necrosis following accidental administration outside the vein

Not known (the frequency cannot be estimated from the available data)
Involuntary movements
Pain or swelling following accidental administration outside the vein
Cardiac and respiratory failure

Side effects that may occur after anesthesia
The following side effects may occur after anesthesia (while you are waking up or after you have
woken up).

Common (may affect up to 1 in 10 people)
Headache
Feeling unwell (nausea), feeling sick (vomiting)

Uncommon (may affect up to 1 in 100 people)
Swelling and redness or blood clots in the vein at the injection site

Rare (may affect up to 1 in 1,000 people)
Dizziness, chills and feeling cold

Very rare (may affect up to 1 in 10,000 people)
Loss of consciousness after surgery (when this has happened, patients have recovered without
problems)
Inflammation of the pancreas (pancreatitis), which causes severe stomach pain (a causal
link cannot be demonstrated)
Fever after surgery
Sexual disinhibition

Not known (the frequency cannot be estimated from the available data)
Feeling of euphoria
Irregular heartbeat
Increased liver size
Renal failure
Changes in Electrocardiogram (ECG type Brugada)
Abuse and dependence of the medicine, predominantly by healthcare professionals
Breakdown of muscle cells (rhabdomyolysis), increased blood acidity, high levels of potassium and of
fats in the blood, cardiac failure with fatal outcome (seen when propofol is used in intensive
care at doses higher than those recommended)

Reporting of side effects
If you get any side effect, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at https://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 RIPOL 10 MG/ML

Keep this medicine out of the sight and reach of children.
Do not use RIPOL 10 mg/ml after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of the month.
Store at a temperature below 25  C.
Do not freeze.
Keep the vial/ampoule in the original outer packaging to protect it from light.
Shelf life before opening
Vials/ampoules: 3 years.
Period of validity after first opening / dilution
RIPOL 10 mg/ml injectable/infusion emulsion
The mixture must be prepared under aseptic conditions immediately before administration and
must be administered within 6 hours of preparation.
In accordance with the guidelines established for other lipid emulsions, a single infusion of RIPOL 10
mg/ml should not exceed 12 hours. At the end of the procedure or after 12 hours, whichever comes first, both the container of RIPOL 10
mg/ml and the infusion line must be discarded and replaced appropriately.
RIPOL 10 mg/ml injectable/infusion emulsion and injectable/infusion emulsion
Chemical and physical stability during use of the reconstituted product has been demonstrated for 24 hours at 25 °C.
From a microbiological point of view, the product must be used immediately. If not used
immediately, storage times and conditions prior to use are the responsibility of
the user.
Do not use RIPOL 10 mg/ml if you notice the presence of particles.
Medicines should not be disposed of via wastewater or household waste. The doctor or hospital pharmacist is responsible for the correct storage, use and disposal.

6. CONTENT OF THE PACK AND OTHER INFORMATION

What RIPOL 10 mg/ml contains

• The active ingredient is propofol. 1 millilitre of injectable/infusion emulsion contains 10 mg of propofol.
• The excipients are refined soybean oil, purified egg phospholipids, glycerol, sodium hydroxide (for pH adjustment), water for injections.

Description of the appearance of RIPOL 10 mg/ml and contents of the pack
RIPOL 10 mg/ml injectable/infusion emulsion is a white oil-in-water emulsion,
isotonic. It is available in glass Type I vials of 20 ml or glass Type I bottles of 20, 50 and 100 ml
with bromobutyl rubber stoppers.
Packs:
5 x 20 ml vials
5 x 20 ml bottles
1 x 50 ml bottles
1 x 100 ml bottles
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Istituto Biochimico Italiano G. Lorenzini S.p.A.
via Fossignano, 2
04011 Aprilia (LT)

Manufacturer
Corden Pharma S.p.A.,
Viale dell’Industria, 3
20867 Caponago (MB)
--------------------------------------------------------
The following information is intended exclusively for doctors or healthcare professionals:
Route of administration
For intravenous use.
RIPOL 10 mg/ml must not be administered via a controlled infusion system (TCI-Target Controlled Infusion) for sedation in intensive care.
The use of propofol emulsion for infusion in intensive care sedation has been associated with numerous
metabolic alterations and disorders of the organism that can cause death.
Single use.
Parenteral products must be visually inspected for the presence of particles before
administration. If particles are evident, the emulsion should not be used.
RIPOL 10 mg/ml injectable/infusion emulsion:
The containers must be shaken before use. If two layers are visible after shaking, the emulsion
should not be used.
RIPOL 10 mg/ml can be used for infusion undiluted or diluted with glucose 50 mg/ml (5%)
solution for intravenous infusion or sodium chloride 9 mg/ml (0.9%) solution for intravenous infusion or a combination of glucose 40 mg/ml (4%) and sodium chloride 1.8 mg/ml
(0.18%).
Before use, the neck of the vial and the rubber stopper must be disinfected using a
medicinal alcohol (spray or swab). After use, any remaining contents must be discarded.
RIPOL 10 mg/ml does not contain antimicrobial preservatives and is able to support the growth of
microorganisms. The emulsion must be aspirated aseptically into a sterile syringe or an infusion system immediately after opening the vial or breaking the seal of the bottle.
Administration must begin without delay. During infusion, sterility of RIPOL 10 mg/ml as well as that of the infusion system must be maintained.
The medicinal product or liquids that are added while the RIPOL 10 mg/ml infusion is running must
be added near the cannula.
RIPOL 10 mg/ml must not be administered through infusion systems that are equipped with a
microbiological filter.
The contents of a vial of RIPOL 10 mg/ml and any infusion equipment are intended for singleuse in onepatient.
Any remaining product must be discarded immediately after use.

Undiluted infusion of RIPOL 10 mg/ml
When RIPOL 10 mg/ml is administered in continuous infusion, it is recommended that equipment such as burettes, drop counters, syringe pumps or volumetric pumps be always
used to control the infusion rate.
As with parenteral administrations of all types of emulsions, the duration of use for oneRIPOL infusion system must not exceed 12 hours. The infusion system and container must be
discarded and replaced after a maximum of 12 hours.
The simultaneous administration of RIPOL 10 mg/ml together with a glucose 50 mg/ml (5%) infusion solution, sodium chloride 9 mg/ml (0.9%) solution for intravenous infusion or a
combination of a glucose 40 mg/ml (4%) and sodium chloride 1.8 mg/ml (0.18%) solution near the
Y-connector at the injection site.
The RIPOL 10 mg/ml residue at the end of the infusion period or after replacement of the system must be
discarded and destroyed.

Infusion of RIPOL 10 mg/ml diluted
When RIPOL 10 mg/ml is administered diluted in continuous infusion, it is recommended that
equipment such as burettes, drop counters, syringe pumps or volumetric infusion pumps be always
used to control the infusion rate and prevent the accidental administration of
large volumes of RIPOL 10 mg/ml diluted.
The maximum dilution should not exceed 1 part of RIPOL 10 mg/ml and 4 parts of glucose 50 mg/ml (5%)
(at least 2 mg propofol/ml) solution for intravenous infusion or sodium chloride 9 mg/ml (0.9%)
solution for intravenous infusion or a combination of glucose 40 mg/ml (4%) and sodium chloride 1.8
mg/ml (0.18%). The mixture must be prepared under aseptic conditions immediately before
administration and must be administered within 6 hours of preparation.
RIPOL 10 mg/ml must not be mixed with other injection or infusion solutions except those
mentioned above.
To reduce pain at the injection site, lidocaine should be injected immediately before use
of RIPOL 10 mg/ml, or alternatively RIPOL 10 mg/ml can be mixed, immediately before
administration, with a lidocaine injection without preservatives.
The infusion system must be flushed before the administration of muscle relaxants such as
atracurium and mivacurium if the same infusion system as RIPOL 10 mg/ml is used.
Disposal
Any remaining contents after use must be discarded.
Unused medicine and waste from this medicine should be disposed of in accordance with
local regulations. Ask your pharmacist how to dispose of medicines you no longer use. This
will help protect the environment.

RIPOL 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 personally. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What RIPOL 20 mg/ml is and what it is used for
• 2. What you need to know before you use RIPOL 20 mg/ml
• 3. How to use RIPOL 20 mg/ml
• 4. Possible side effects
• 5. How to store RIPOL 20 mg/ml
• 6. Contents of the pack and other information

1. WHAT IS RIPOL 20 MG/ML AND WHAT IS IT USED FOR

RIPOL 20 mg/ml belongs to a group of medicines called “general anesthetics”. General anesthetics
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 drowsy
but not completely asleep).
RIPOL 20 mg/ml will be given to you by injection by a doctor.
RIPOL 20 mg/ml injectable emulsion/for infusion
RIPOL 20 mg/ml is used for:

• inducing and maintaining general anesthesia in adults and in pediatric patients over 3 years of age.
• sedating patients over 16 years of age who are on mechanical ventilation in intensive care.
• sedating adults and pediatric patients over 3 years of age during diagnostic and surgical procedures, alone or in combination with local or regional anesthesia.

2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE RIPOL 20 MG/ML

Do not use RIPOL 20 mg/ml

• in patients allergic (hypersensitive) to propofol or to any of the other ingredients of RIPOL 20 mg/ml (listed in section 6).
• in patients allergic to peanuts or soy. This is because RIPOL 20 mg/ml contains soybean oil.
• in patients aged 16 years or younger for sedation in intensive care.

Warnings and precautions
The use of Ripol is not recommended in newborns.
Take particular care in these cases:

• If you have any other health problems, such as problems with the heart, kidneys, liver or breathing.
• If your body has lost a lot of fluids (if you are hypovolemic).
• If you have had an epileptic seizure or convulsion.
• If you have been told you have very high levels of fats in your blood. In these cases, your doctor will need to determine your blood fat levels.
• If you have been told that your body has problems using fats. In these cases, your doctor may need to determine your blood fat levels.
• If you suffer from a mitochondrial disease (diseases due to alterations of the mitochondria).
• If you have had a head injury with high pressure in your head.
• If you have a condition called hereditary predisposition to acute porphyria (presence of neurological symptoms).
• If you are elderly or debilitated or severely overweight.

RIPOL 20 mg/ml emulsion for injection/infusion
RIPOL 20 mg/ml is not recommended in children under 3 years of age.
If you can return home shortly after receiving propofol, you should not go home alone.
If you are not sure whether the above applies to your situation, talk to your doctor or nurse before you are given RIPOL 20 mg/ml.

Other medicines and RIPOL
Tell your doctor if you are taking or have recently taken any other medicines, including those without a prescription. This includes medicines, herbal remedies, dietary foods or supplements that you have bought yourself.
Be particularly careful if you are taking or are given the following medicines:
Certain premedications (the anesthesiologist knows which drugs may be affected)
Other anesthetics (including general, local, or volatile anesthetics)
Pain relievers (analgesics)
Stronger pain relievers (fentanyl or opioids), you may experience increased apnea due to increased levels of propofol in the blood
Sympatholytic agents (medicines used to treat, for example, painful cramps of the organs, asthma or Parkinson's disease)
Benzodiazepines (medicines used to treat anxiety)
Suxamethonium (muscle relaxant), a slowing of the heartbeat and cardiac arrest may occur.
Neostigmine (medicine used to treat a disease called myasthenia gravis), a slowing of the heartbeat and cardiac arrest may occur.
Cyclosporine (medicine used to prevent transplant rejection), a brain disease may occur
Rifampicin (antibiotic used to treat, for example, Tuberculosis), as low blood pressure may occur

Use of RIPOL 20 mg/mlwith food and drink
If you are given propofol you mustavoid drinking alcohol for at least 8 hours before and after the
administration of RIPOL 20 mg/ml.
Pregnancy and breastfeeding
If you are pregnant, RIPOL 20 mg/ml should only be given if absolutely necessary. If you are planning a pregnancy or are breastfeeding, talk to your doctor or nurse before you are given the medicine.
You should not breastfeed while you are given propofol and breast milk should be discarded for 24 hours after the administration of propofol. The milk produced during this period of time

must notbe used.

Driving and operating machinery
After the administration of RIPOL 20 mg/ml you may still feel drowsy for some time. Do
not drive vehicles or use machinery until you are sure the effect has worn off.
If you are able to return home shortly after receiving propofol, you should not drive a vehicle.
Ask your doctor when you can start these activities again and when you can return to work.

RIPOL contains soybean oil.
If you are allergic to peanuts or soy, do not use this medicine (see above “Do not use RIPOL 20
mg/ml”).
This medicine contains less than 1 mmol of sodium (23 mg) per 100 ml, and is considered
essentially ‘sodium-free’.

3. HOW TO USE RIPOL 20 MG/ML

It will be administered to you by the anesthesiologist or under the direct supervision of the anesthesiologist, or
by an intensive care physician. It will be administered with an injection or an infusion (drip) into
a vein. This is normally performed on the back of the hand or in the forearm.
The doctor will administer the injection using a needle or through a fine plastic tube
called a ‘cannula’.
To maintain anesthesia or for sedation, the medicine can be administered as
an intravenous infusion (drip) using an electric pump that automatically controls the
infusion rate. This can be done if you undergo long anesthesia or if you are in an Intensive Care Unit.
The dose of RIPOL 20 mg/ml will vary depending on other medications you are taking, including premedication,
age, body weight, and physical condition. The doctor will give you the correct dose to start and to
sustain the anesthesia or to achieve the required sedation level (drowsiness), carefully observing
your response and vital signs (pulse, blood pressure, breathing, etc.).
You may need different medicines to keep you asleep or drowsy, without pain, with
healthy breathing and stable blood pressure. The doctor will decide which medicines you need and
when.

General Anesthesia

Adults
For the induction of anesthesia, most adult patients under 55 years of age generally require
1.5 to 2.5 mg propofol/kg body weight.
For the maintenance of general anesthesia, doses of 4 to 12 mg of
propofol/kg body weight/hour or repeated bolus injections (using RIPOL 20 mg/ml) with incremental doses
of 25 mg up to 50 mg are generally administered.
Dosages may be lower in elderly patients.

Sedationof patients on mechanical ventilation in intensive care units

Adults and adolescents over 16 years of age
For the sedation of adults and adolescents over 16 years of age in intensive care, the dose must
be adjusted according to the required sedation levels. Continuous infusion doses of 0.3 to 4.0 mg propofol/kg body weight/hour are normally used. Infusion rates greater than 4.0 mg propofol/kg body weight/hour are not recommended.

Adults
For sedation during diagnostic and surgical procedures in adults and adolescents over 16
years of age, doses of 0.5 to 1 mg propofol/kg body weight are required, administered over 1 to 5
minutes to initiate sedation. Maintaining sedation will require 1.5 - 4.5 mg
propofol/kg body weight/hour. In addition, single administrations of 10 - 20 mg propofol
may be given if a rapid increase in sedation levels (drowsiness) is required
.

General anesthesia
RIPOL 20 mg/ml injectable emulsion/for infusion

Younger pediatric patients under 3 years of age

• RIPOL 20 mg/ml is not recommended for the induction and maintenance of anesthesia in pediatric patients between 1 month and 3 years of age, because the 20 mg/ml formulation is difficult to titrate in pediatric patients for the very small volumes required.

Pediatric patients over 3 years of age

• For the induction of anesthesia, most pediatric patients over 8 years of age require approximately 2.5 mg propofol/kg body weight. In younger patients under 8 years of age, the dose may be higher (2.5-4 mg propofol/kg body weight).
• For the maintenance of anesthesia using continuous infusions of doses of 9 - 15 mg propofol/kg body weight/hour, satisfactory anesthesia is usually achieved. In younger patients, the required dosages may be higher.

Lower doses may be necessary in patients belonging to ASA classes III and IV.

Sedation
RIPOL 20 mg/ml injectable emulsion/for infusion

Pediatric patients over 3 years of age
For the sedationof pediatric patients during surgical and diagnostic proceduresthe dose must
be adjusted according to the required sedation levels. Most pediatric patients
require doses of 1-2 mg of propofol/kg body weight for the induction of sedation. Maintaining sedation requires 1.5-9 mg propofol/kg body weight/hour.
RIPOL 20 mg/ml should not be used in pediatric patients 16 years of age or younger
in the indication sedation in intensive care.

Duration of treatment
If used for sedation, RIPOL 20 mg/ml should not be administered for more than 7 days.

If you are given more RIPOL 20 mg/ml than you should
The doctor will ensure that you receive the correct dose of propofol for you and the procedure you are
undergoing. However, different people need different dosages and if you are given too much, the anesthesiologist may need to ensure that your heart and breathing are adequately
supported. For these reasons, anesthetic drugs are only administered by doctors trained in
anesthesia or in the care of patients in intensive care.
If you have further questions about the use of this product, speak to your anesthesiologist or intensive care physician.

4. POSSIBLE SIDE EFFECTS

Like all medicines, RIPOL 20 mg/ml can cause side effects, although not everybody gets them.
manifest.

Side effects that may occur during anesthesia
The following side effects may occur during anesthesia (while the injection is being given
or when you are drowsy or asleep). The doctor will pay attention to these effects. If they
occur, the doctor will give you appropriate treatment.

Very common (may affect more than 1 in 10 people)
Pain at the injection site (while the injection is being given, before you
fall asleep)

Common (may affect up to 1 in 10 people)
Slow heartbeat
Low blood pressure
Changes in your breathing rate, cough (can also happen when you are awake)

Rare (may affect up to 1 in 1,000 people)
Convulsions and agitation of your body, or convulsions (can also happen when you are awake)

Very rare (may affect up to 1 in 10,000 people)
Allergic reactions, including severe ones that can cause difficulty breathing or dizziness
Fluid accumulation in the lungs that can make you feel breathless (can also happen when
you are awake)
Unusual urine color (can also happen when you are awake)
Tissue necrosis following accidental administration outside the vein

Not known (frequency cannot be estimated from the available data)
Involuntary movements
Pain or swelling following accidental administration outside the vein
Cardiac and respiratory failure

Side effects that may occur after anesthesia
The following side effects may occur after anesthesia (while you are waking up or after you have
woken up).

Common (may affect up to 1 in 10 people)
Headache
Feeling unwell (nausea), feeling sick (vomiting)

Uncommon (may affect up to 1 in 100 people)
Swelling and redness or blood clots in the vein at the injection site

Rare (may affect up to 1 in 1,000 people)
Dizziness, chills and feeling cold

Very rare (may affect up to 1 in 10,000 people)
Unconsciousness after surgery (when this has happened, patients have recovered without
problems)
Inflammation of the pancreas (pancreatitis), which causes severe stomach pain (a causal
link cannot be demonstrated)
Fever after surgery
Sexual disinhibition

Not known (frequency cannot be estimated from the available data)
Feeling of euphoria
Irregular heartbeat
Increased liver size
Kidney failure
Changes in the Electrocardiogram (ECG type Brugada)
Abuse and dependence of the medicine, predominantly by healthcare professionals
Breakdown of muscle cells (rhabdomyolysis), increased blood acidity, high levels of potassium and fat in the
blood, cardiac failure with fatal outcome (seen when propofol is used in intensive care at doses higher than those recommended)

Reporting of side effects
If you get any side effect, including any not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at https://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 RIPOL 20 MG/ML

Keep this medicine out of the sight and reach of children.
Do not use RIPOL 20 mg/ml after the expiry date stated on the label after EXP. The expiry date refers to the last day of the month.
Store at a temperature below 25  C.
Do not freeze.
Keep the vial/ampoule in the original outer packaging to protect it from light.
Shelf life before opening
Vials/ampoules: 3 years.
Period of validity after first opening / dilution
RIPOL 20 mg/ml injectable/infusion emulsion
To be used immediately.
It must not be diluted.
RIPOL 20 mg/ml injectable/infusion emulsion
Chemical and physical stability during use of the reconstituted product has been demonstrated for 24 hours at 25 °C.
From a microbiological point of view, the product must be used immediately. If it is not
used immediately, the storage times and conditions prior to use are the responsibility of
the user.
Do not use RIPOL 20 mg/ml if you notice the presence of particles.
Medicines should not be disposed of via drains or household waste. The doctor or hospital pharmacist
is responsible for the correct storage, use and disposal.

6. CONTENT OF THE PACK AND OTHER INFORMATION

What RIPOL 20 mg/ml contains

• The active ingredient is propofol. 1 millilitre of injectable/infusion emulsion contains 20 mg of propofol.
• The excipients are refined soybean oil, purified egg phospholipids, glycerol, sodium hydroxide (for pH adjustment), water for injections.

Description of the appearance of RIPOL 20 mg/ml and contents of the pack
RIPOL 20 mg/ml injectable/infusion emulsion is a white oil-in-water aqueous emulsion,
isotonic. It is available in glass Type I vials of 20 ml or glass Type I ampoules of 20, 50 and 100 ml
with bromobutyl rubber stoppers.
Packs:
1 x 50 ml ampoules
It is possible that not all packs are marketed.

Marketing Authorisation Holder
Istituto Biochimico Italiano G. Lorenzini S.p.A.
via Fossignano, 2
04011 Aprilia (LT)

Manufacturer
Corden Pharma S.p.A.,
Viale dell’Industria, 3
20867 Caponago (MB)
--------------------------------------------------------
The following information is intended exclusively for doctors or healthcare professionals:
Route of administration
For intravenous use.
RIPOL 20 mg/ml must not be administered via a target-controlled infusion (TCI-Target Controlled Infusion) system for sedation in intensive care.
The use of propofol emulsion for infusion in intensive care sedation has been associated with numerous
metabolic alterations and disorders of the organism that can cause death.
Single use.
Parenteral products must be visually inspected for the presence of particles before
administration. If particles are evident, the emulsion must not be used.
RIPOL 20 mg/ml injectable/infusion emulsion
The containers must be shaken before use. If two layers are visible after shaking, the emulsion
must not be used.
RIPOL 20 mg/ml is administered intravenously as an injection or continuously, undiluted.
Before use, the neck of the vial and the rubber stoppers must be disinfected using medicinal alcohol
(spray or on a swab). After use, any remaining quantity must be discarded.
RIPOL 20 mg/ml does not contain antimicrobial preservatives and is able to support the growth of
microorganisms. The emulsion must be drawn up aseptically into a sterile syringe or an infusion system immediately after opening the ampoule.
Administration must begin without delay. During the infusion, the sterility of RIPOL 20 mg/ml
as well as of the infusion system must be maintained.
It is recommended to administer Ripol 20mg/ml slowly until clinical evidence of the onset
of anesthesia is observed.
Medicinal products or fluids that are added to an infusion solution of RIPOL 20 mg/ml in
operation must be added near the cannula.
RIPOL 20 mg/ml must not be administered via infusion systems that are equipped with a
microbiological filter.
The contents of an ampoule of RIPOL 20 mg/ml and any infusion equipment must be
used for a singleuse in onesingle patient.
Any remainder must be discarded immediately after use.
RIPOL 20 mg/ml must not be diluted.

Infusion of RIPOL 20 mg/ml
When RIPOL 20 mg/ml is administered as a continuous infusion, it is recommended to use
equipment such as burettes, drop counters, syringe pumps or volumetric infusion pumps to
control the infusion rate.
As with parenteral infusions of all types of lipid emulsions, the duration of use of oneinfusion system for a continuous infusion of RIPOL 20 mg/ml must not exceed 12 hours. The infusion system
and the container must be discarded and replaced after a maximum of 12 hours.
The simultaneous administration of RIPOL 20 mg/ml together with an infusion of glucose 50 mg/ml
(5%), sodium chloride 9 mg/ml (0.9%) solution for intravenous infusion or a combination of
glucose 40 mg/ml (4%) and sodium chloride 1.8 mg/ml (0.18%) solutions near the Y-connector in
proximity to the injection site, is possible.
The RIPOL 20 mg/ml that remains at the end of the infusion period or after changing the system must
be discarded and destroyed .
To reduce pain at the injection site, lidocaine may be injected immediately before use of
RIPOL 20 mg/ml.
The infusion system must be flushed before the administration of muscle relaxants such as
atracurium and mivacurium if the same infusion system as RIPOL 20 mg/ml is used.
Disposal
The remaining contents after use must be discarded.
Unused medicinal products and waste derived from such medicinal products must be disposed of in accordance with
current local regulations. Ask your pharmacist how to dispose of medicines you no longer use. This
will help protect the environment.