PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

RIPOL 10 mg/ml injectable emulsion / for infusion

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

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for you personally. Do not give it to others, even if their symptoms are the same as yours, as it could be dangerous.
If you experience any side effects, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What RIPOL 10 mg/ml is and what it is used for
What you need to know before using RIPOL 10 mg/ml
How to use RIPOL 10 mg/ml
Possible side effects
How to store RIPOL 10 mg/ml
Contents of the pack and other information

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

RIPOL 10 mg/ml belongs to a group of medicines called "general anaesthetics".
General anaesthetics are used to cause unconsciousness (sleep) so that surgical operations
or other procedures can be performed. They may 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 anaesthesia in adults and paediatric patients over one month of age.
sedating patients over 16 years of age who are on mechanical ventilation in intensive care.
sedating adults and paediatric patients over one month of age during diagnostic and surgical procedures, either alone or in combination with local and/or regional anaesthesia.

2. WHAT YOU SHOULD KNOW BEFORE TAKING RIPOL 10 MG/ML

Do not use RIPOL 10 mg/ml

in patients allergic (hypersensitive) to propofol or to any of the other components 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 younger for sedation in intensive care.

Warnings and precautions
The use of Ripol is not recommended in neonates.

Take particular care in the following cases:

If you have any other health problems, such as heart, kidney, liver, or respiratory problems.
If your body has lost a lot of fluids (if you are hypovolemic).
If you have had a seizure or convulsion.
If you have ever been told you have very high levels of fats in your blood. In such cases, your doctor will need to determine your blood fat levels.
If you have ever been told that your body has difficulty using fats. In such cases, your doctor may need to determine your blood fat levels.
If you suffer from a mitochondrial disease (diseases caused by mitochondrial abnormalities).
If you have had head trauma with increased pressure inside the 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 10 mg/ml emulsion for injection/infusion
The use of RIPOL 10 mg/ml is not recommended in neonates.
If you are able to return home shortly after receiving propofol, you must not go home unaccompanied.
If you are unsure whether any of the above applies to your situation, speak with your doctor or nurse before being administered RIPOL 10 mg/ml.

Other medicines and RIPOL 10 mg/ml
Inform 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 purchased yourself.
Take particular care if you are taking or are being given the following medicines:

Certain premedications (your anaesthetist knows which medicines may be affected)
Other anaesthetics (including general, local, or volatile anaesthetics)
Painkillers (analgesics)
Strong painkillers (fentanyl or opioids), as apnea may occur more frequently due to increased levels of propofol in the blood
Sympatholytic agents (medicines used to treat, for example, painful spasms of organs, asthma, or Parkinson's disease)
Benzodiazepines (medicines used to treat anxiety)
Suxamethonium (muscle relaxant), which may cause slowed heart rate and cardiac arrest
Neostigmine (medicine used to treat a disease called myasthenia gravis), which may cause slowed heart rate and cardiac arrest
Cyclosporine (medicine used to prevent transplant rejection), which may cause brain disease
Rifampicin (an antibiotic used to treat, for example, tuberculosis), as low blood pressure may occur

Use of RIPOL 10 mg/ml with food and drinks
If you are administered propofol, you must avoid drinking alcohol for at least 8 hours before and after administration of RIPOL 10 mg/ml.

Pregnancy and breastfeeding
If you are pregnant, RIPOL 10 mg/ml should be administered only if absolutely necessary. If you are planning a pregnancy or if you are breastfeeding, speak with your doctor or nurse before being administered this medicine.
You must not breastfeed while receiving propofol, and breast milk must be discarded for 24 hours after administration of propofol. Breast milk produced during this time period must not be used.

Driving and using machines
After administration of RIPOL 10 mg/ml, you may still feel drowsy for some time. Do not drive or operate machinery until you are sure that the effect has worn off.
If you are able to return home shortly after receiving propofol, you must not drive a vehicle.
Ask your doctor when you can resume these activities 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 an anaesthetist or under the direct supervision of an anaesthetist, or by an intensive care physician. It will be given as an injection or infusion (intravenous infusion) into a vein, usually on the back of your hand or in your forearm.
Your doctor will administer the injection using a needle or through a thin plastic tube called a ‘cannula’.
For maintenance of anaesthesia or for sedation, the medicine may be administered as an intravenous infusion using an electric pump that automatically controls the infusion rate. This may be done if you are undergoing prolonged anaesthesia 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, as well as your age, body weight, and physical condition. Your doctor will give you the appropriate dose to induce and maintain anaesthesia or to achieve the required level of sedation (drowsiness), carefully monitoring your response and vital signs (pulse, blood pressure, respiration, etc.).
You may require additional medications to keep you asleep or drowsy, pain-free, with stable breathing and blood pressure. Your doctor will decide which medications you need and when they should be given.

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

Sedation of patients receiving 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 should be adjusted according to the required level of sedation.

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 administered over 1 to 5 minutes are required to initiate sedation. Maintenance of sedation will require 1.5 – 4.5 mg propofol/kg body weight/hour. Additionally, single doses of 10 – 20 mg propofol may be administered if a rapid increase in sedation level (drowsiness) is required.

General Anaesthesia
RIPOL 10 mg/ml emulsion for injection/infusion
Paediatric patients over 1 month of age

For induction of anaesthesia, 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 anaesthesia, a continuous infusion of 9–15 mg propofol/kg body weight/hour usually provides satisfactory anaesthesia. Younger children, especially those between 1 month and 3 years of age, may require higher doses.

Lower doses may be required in patients classified as ASA III and IV.

Sedation
RIPOL 10 mg/ml emulsion for injection/infusion
Paediatric patients over 1 month of age
For sedation of paediatric patients during diagnostic procedures and surgical interventions, the dose should be adjusted according to the required level of sedation.
Most paediatric patients require a dose of 1–2 mg propofol/kg body weight to initiate sedation. Maintenance of sedation requires 1.5–9 mg propofol/kg body weight/hour. In addition, a single dose of up to 1 mg propofol/kg body weight may be administered if a rapid increase in sedation is required.

RIPOL 10 mg/ml must not be used in paediatric patients aged 16 years or younger for the indication of sedation in intensive care units.

Duration of treatment
When used for sedation, RIPOL 10 mg/ml must not be administered for longer than 7 days.

If you are given more RIPOL 10 mg/ml than you should
Your doctor will ensure you receive the correct dose of propofol for your condition and procedure. However, different individuals require different doses, and if you are given too much, the anaesthetist may need to ensure adequate support of your heart and breathing. For this reason, anaesthetic medicines are administered only by doctors trained in anaesthesia or intensive care.

If you have any further questions about the use of this medicine, please speak with your anaesthetist or intensive care physician.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, RIPOL 10 mg/ml can cause adverse reactions, although not everyone experiences them.
Adverse reactions that may occur during anaesthesia
The following adverse reactions may occur during anaesthesia (while the injection is being administered or when you are drowsy or unconscious). Your doctor will monitor for these effects. If they occur, your doctor will administer appropriate treatment.
Very common (may affect more than 1 in 10 people)
Feeling of pain at the injection site (while the injection is being administered, before you fall asleep)
Common (may affect up to 1 in 10 people)
Slow heart rate
Lowering of blood pressure
Changes in breathing rate, coughing (may also occur when you are awake)
Rare (may affect up to 1 in 1,000 people)
Body contractions and agitation, or convulsions (may also occur when you are awake)
Very rare (may affect up to 1 in 10,000 people)
Allergic reactions, even severe ones, which may cause difficulty in breathing or dizziness
Fluid accumulation in the lungs, which may make you feel breathless (may also occur when you are awake)
Unusual urine colour (may also occur when you are awake)
Tissue necrosis following accidental injection outside the vein
Not known (frequency cannot be estimated from the available data)
Involuntary movements
Pain or swelling following accidental injection outside the vein
Cardiac and respiratory failure
Adverse reactions that may occur after anaesthesia
The following adverse reactions may occur after anaesthesia (while waking up or after regaining consciousness).
Common (may affect up to 1 in 10 people)
Headache
Feeling unwell (nausea), illness (vomiting)
Uncommon (may affect up to 1 in 100 people)
Swelling, 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 occurred, patients have recovered without complications)
Inflammation of the pancreas (pancreatitis), causing severe stomach pain (a causal relationship cannot be established)
Fever after surgery
Sexual disinhibition
Not known (frequency cannot be estimated from the available data)
Feeling of euphoria
Irregular heartbeat
Increased liver size
Renal failure
Changes in the electrocardiogram (ECG pattern of Brugada type)
Abuse and dependence on the medicine, primarily among healthcare personnel
Hepatitis (liver inflammation), acute liver failure whose symptoms may include yellowing of the skin and eyes, itching, dark-coloured urine, stomach pain, and liver tenderness (pain felt under the front part of the rib cage on the right side), sometimes accompanied by loss of appetite
Rhabdomyolysis (breakdown of muscle cells), increased blood acidity, elevated potassium and fat levels in the blood, cardiac failure with fatal outcome (observed when propofol is used in intensive care at doses higher than recommended)
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report adverse reactions directly through the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting adverse reactions, 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 stated on the label after EXP.
The expiry date refers to the last day of the month.
Store below 25 °C.
Do not freeze.
Keep the vial/bottle in the original outer packaging to protect from light.

Shelf life before first opening
Vials/bottles: 3 years.

Shelf life after first opening / dilution
RIPOL 10 mg/ml emulsion for injection/for infusion
The mixture must be prepared under aseptic conditions immediately before administration and must be administered within 6 hours of preparation.
In accordance with guidelines established for other lipid emulsions, a single infusion of RIPOL 10 mg/ml must not exceed 12 hours. At the end of the procedure or after 12 hours, whichever comes first, both the RIPOL 10 mg/ml container and the infusion line must be properly discarded and replaced.

RIPOL 10 mg/ml emulsion for injection/for infusion and emulsion for injection/for infusion
Chemical and physical in-use stability has been demonstrated for 24 hours at 25 °C.
From a microbiological standpoint, the product should 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 particles are observed.

Medicines must not be disposed of via wastewater or household waste. The physician or hospital pharmacist is responsible for proper storage, use, and disposal.

6. PACK CONTENTS AND OTHER INFORMATION

What RIPOL 10 mg/ml contains

The active substance 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), and water for injections.

Description of the appearance of RIPOL 10 mg/ml and pack contents
RIPOL 10 mg/ml injectable/infusion emulsion is a white, isotonic, oil-in-water aqueous emulsion.
It is available in 20 ml Type I glass vials or 20, 50, and 100 ml Type I glass bottles with bromobutyl rubber stoppers.
Pack sizes:
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 Authorization 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 physicians or healthcare professionals:

Method of administration
For intravenous use only.
RIPOL 10 mg/ml must not be administered via a target-controlled infusion (TCI) system for sedation in intensive care.
The use of propofol infusion emulsion for sedation in intensive care has been associated with numerous metabolic disturbances and organ dysfunction that may result in death.
For single use only.

Parenteral products should be inspected visually for particulate matter prior to administration. If particles are visible, the emulsion must not be used.

RIPOL 10 mg/ml injectable/infusion emulsion:
Containers must be shaken before use. If two layers are visible after shaking, the emulsion must not be used.

RIPOL 10 mg/ml may be used undiluted or diluted for infusion with glucose 50 mg/ml (5%) solution for intravenous infusion, sodium chloride 9 mg/ml (0.9%) solution for intravenous infusion, or a combination of glucose 40 mg/ml (4%) solution and sodium chloride 1.8 mg/ml (0.18%) solution.

Before use, the vial neck and rubber stopper must be disinfected using a medicinal alcohol spray or swab. After use, any remaining content must be discarded.

RIPOL 10 mg/ml contains no antimicrobial preservatives and is capable of supporting microbial growth. The emulsion must be aseptically withdrawn into a sterile syringe or infusion system immediately after opening the vial or breaking the seal of the bottle.

Administration must begin immediately. Sterility of RIPOL 10 mg/ml and of the infusion system must be maintained during infusion.
Medicinal products or fluids added during infusion of RIPOL 10 mg/ml must be introduced close to the cannula.

RIPOL 10 mg/ml must not be administered through infusion systems equipped with a microbiological filter.

The contents of one vial of RIPOL 10 mg/ml and any infusion equipment are intended for single use in one patient only.
Any remaining solution must be discarded immediately after use.

Undiluted infusion of RIPOL 10 mg/ml
When RIPOL 10 mg/ml is administered by continuous infusion, infusion equipment such as burettes, drip sets, syringe pumps, or volumetric infusion pumps should always be used to control the infusion rate.

As with all parenteral administrations of emulsions, the duration of use for one infusion system with RIPOL must not exceed 12 hours. The infusion system and container must be discarded and replaced after a maximum of 12 hours.

Simultaneous administration of RIPOL 10 mg/ml together with a 50 mg/ml (5%) glucose solution, 9 mg/ml (0.9%) sodium chloride solution for intravenous infusion, or a combination of 40 mg/ml (4%) glucose and 1.8 mg/ml (0.18%) sodium chloride solution may be performed via a Y-connector near the injection site.

Any residual RIPOL 10 mg/ml remaining at the end of the infusion period or after changing the infusion system must be discarded and destroyed.

Diluted infusion of RIPOL 10 mg/ml
When RIPOL 10 mg/ml is administered diluted by continuous infusion, infusion equipment such as burettes, drip sets, syringe pumps, or volumetric infusion pumps should always be used to control the infusion rate and prevent accidental administration of large volumes of diluted RIPOL 10 mg/ml.

Maximum dilution must not exceed 1 part RIPOL 10 mg/ml and 4 parts of 50 mg/ml (5%) glucose solution (at least 2 mg propofol/ml) for intravenous infusion, 9 mg/ml (0.9%) sodium chloride solution for intravenous infusion, or a combination of 40 mg/ml (4%) glucose and 1.8 mg/ml (0.18%) sodium chloride solution. The mixture must be prepared aseptically immediately before administration and administered within 6 hours of preparation.

RIPOL 10 mg/ml must not be mixed with other injectable or infusion solutions except those mentioned above.

To reduce injection site pain, lidocaine should be injected immediately before using RIPOL 10 mg/ml. Alternatively, RIPOL 10 mg/ml may be mixed immediately before administration with a preservative-free lidocaine injection.

The infusion system must be flushed before administering muscle relaxants such as atracurium and mivacurium if the same infusion system used for RIPOL 10 mg/ml is to be reused.

Disposal
Any remaining content after use must be discarded.
Unused medicine and waste material derived from this medicine must be disposed of in accordance with local regulations. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

RIPOL 20 mg/ml injectable emulsion/for infusion

Propofol
Generic medicine
Please read this leaflet carefully before using this medicine because 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 others, 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, inform your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What RIPOL 20 mg/ml is and what it is used for
What you need to know before using RIPOL 20 mg/ml
How to use RIPOL 20 mg/ml
Possible side effects
How to store RIPOL 20 mg/ml
Package contents and other information

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

RIPOL 20 mg/ml belongs to a group of medicines called "general anaesthetics".
General anaesthetics are used to induce unconsciousness (sleep) so that surgical operations or other procedures can be performed.
They may also be used to sedate you (so that you are drowsy but not completely asleep).
RIPOL 20 mg/ml will be administered 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 anaesthesia in adults and paediatric patients over 3 years of age.
sedating patients over 16 years of age who are on mechanical ventilation in intensive care.
sedating adults and paediatric patients over 3 years of age during diagnostic and surgical procedures, either alone or in combination with local or regional anaesthesia.

2. WHAT YOU SHOULD KNOW BEFORE TAKING RIPOL 20 MG/ML

Do not use RIPOL 20 mg/ml

in patients allergic (hypersensitive) to propofol or to any of the other components of RIPOL 20 mg/ml (listed in section 6).
in patients allergic to peanuts or soya. 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 neonates.
Exercise particular caution in the following cases:

If you have any other health problems, such as heart, kidney, liver, or respiratory issues.
If your body has lost a significant amount of fluid (if you are hypovolemic).
If you have had a seizure or convulsion.
If you have ever been told you have very high levels of fats in your blood. In such cases, your doctor will need to determine your blood fat levels.
If you have ever been told that your body has difficulty using fats. In such cases, your doctor may need to determine your blood fat levels.
If you suffer from a mitochondrial disease (diseases caused by mitochondrial abnormalities).
If you have sustained a head injury with increased pressure inside the head.
If you have a condition known as hereditary predisposition to acute porphyria (presence of neurological symptoms).
If you are elderly or debilitated or severely overweight.

RIPOL 20 mg/ml injectable emulsion/for infusion
RIPOL 20 mg/ml is not recommended in children under 3 years of age.
If you are allowed to go home soon after receiving propofol, you must not go home unaccompanied.
If you are unsure whether any of the above apply to your situation, speak with your doctor or nurse before RIPOL 20 mg/ml is administered to you.

Other medicines and RIPOL
Inform 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 purchased yourself.
Pay particular attention if you are taking or are administered the following medicines:
Certain premedications (your anaesthetist knows which medicines may be affected)
Other anaesthetics (including general, local, or volatile anaesthetics)
Painkillers (analgesics)
Strong painkillers (fentanyl or opioids), as apnoea may occur more frequently due to increased levels of propofol in the blood
Sympatholytic agents (medicines used to treat, for example, painful organ spasms, asthma or Parkinson's disease)
Benzodiazepines (medicines used to treat anxiety)
Suxamethonium (a muscle relaxant), as slowing of the heartbeat and cardiac arrest may occur
Neostigmine (a medicine used to treat a disease called myasthenia gravis), as slowing of the heartbeat and cardiac arrest may occur
Cyclosporine (a medicine used to prevent transplant rejection), which may lead to brain disease
Rifampicin (an antibiotic used to treat, for example, tuberculosis), as low blood pressure may occur

Use of RIPOL 20 mg/ml with food and drink
If you are administered propofol, you must avoid drinking alcohol for at least 8 hours before and after administration of RIPOL 20 mg/ml.

Pregnancy and breastfeeding
If you are pregnant, RIPOL 20 mg/ml should be administered only if absolutely necessary. If you are planning a pregnancy or if you are breastfeeding, speak with your doctor or nurse before the medicine is administered to you.
You must not breastfeed while receiving propofol, and breast milk must be discarded for 24 hours after administration of propofol. Breast milk produced during this time period must not be used.

Driving and using machines
After administration of RIPOL 20 mg/ml, you may still feel drowsy for some time. Do not drive or operate machinery until you are certain that the effects have worn off.
If you are able to return home shortly after receiving propofol, you must not drive a vehicle.
Ask your doctor when you may resume these activities and when you may return to work.

RIPOL contains soybean oil.
If you are allergic to peanuts or soya, 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

RIPOL 20 mg/ml will be administered to you by an anaesthetist or under the direct supervision of an anaesthetist, or by an intensive care physician. It will be given as an injection or infusion (intravenous drip) into a vein, usually on the back of your hand or forearm.
The doctor will administer the injection using a needle or through a thin plastic tube called a 'cannula'.
For maintenance of anaesthesia or for sedation, the medicine may be administered as an intravenous infusion (intravenous drip) using an electric pump that automatically controls the infusion rate. This may be done if you are undergoing prolonged anaesthesia 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, as well as your age, body weight, and physical condition. Your doctor will give you the appropriate starting dose and adjust it to maintain anaesthesia or achieve the required level of sedation (drowsiness), carefully monitoring your response and vital signs (pulse, blood pressure, respiration, etc.).
You may require additional medications to keep you asleep or drowsy, pain-free, with stable breathing and blood pressure. Your doctor will decide which medications you need and when to administer them.

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

Sedation of 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 should be adjusted according to the required level of sedation.

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 administered over 1 to 5 minutes are required to initiate sedation. Maintenance of sedation will require 1.5 to 4.5 mg propofol/kg body weight/hour. Additionally, single doses of 10 to 20 mg propofol may be administered if a rapid increase in the level of sedation (drowsiness) is required.

General Anaesthesia
RIPOL 20 mg/ml injectable emulsion/for infusion
Paediatric patients under 3 years of age

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

Paediatric patients over 3 years of age

For induction of anaesthesia, most paediatric patients over 8 years of age require approximately 2.5 mg propofol/kg body weight. In patients younger than 8 years, the dose may be higher (2.5–4 mg propofol/kg body weight).
For maintenance of anaesthesia, continuous infusions of 9 to 15 mg propofol/kg body weight/hour usually achieve satisfactory anaesthesia. In younger patients, higher doses may be required.

Lower doses may be required in patients classified as ASA III and IV.

Sedation
RIPOL 20 mg/ml injectable emulsion/for infusion
Paediatric patients over 3 years of age
For sedation of paediatric patients during surgical and diagnostic procedures, the dose should be adjusted according to the required level of sedation. Most paediatric patients require doses of 1–2 mg propofol/kg body weight for induction of sedation. Maintenance of sedation requires 1.5–9 mg propofol/kg body weight/hour.
RIPOL 20 mg/ml must not be used in paediatric patients aged 16 years or younger for the indication sedation in intensive care.

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

If you are given more RIPOL 20 mg/ml than you should
Your doctor will ensure that you receive the correct dose of propofol according to your individual needs and the procedure being performed. However, different individuals require different doses, and if too much is administered, the anaesthetist may need to ensure that your heart and breathing are adequately supported. For this reason, anaesthetic medicines are administered only by doctors trained in anaesthesia or intensive care.
If you have any further questions about the use of this product, please speak with your anaesthetist or intensive care physician.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, RIPOL 20 mg/ml can cause adverse reactions, although not everybody experiences them.
Adverse reactions that may occur during anaesthesia
The following adverse reactions may occur during anaesthesia (while the injection is being administered or when you are drowsy or unconscious). Your doctor will monitor for these effects. If they occur, your doctor will administer appropriate treatment.
Very common (may affect more than 1 in 10 people)
Pain at the injection site (during injection, before you fall asleep)
Common (may affect up to 1 in 10 people)
Slow heart rate
Low blood pressure
Changes in breathing rate, cough (may also occur when you are awake)
Rare (may affect up to 1 in 1,000 people)
Body contractions and agitation, or convulsions (may also occur when you are awake)
Very rare (may affect up to 1 in 10,000 people)
Allergic reactions, even severe ones, which may cause breathing difficulties or dizziness
Fluid accumulation in the lungs, causing breathlessness (may also occur when you are awake)
Unusual urine colour (may also occur when you are awake)
Tissue necrosis following accidental injection outside the vein
Not known (frequency cannot be estimated from available data)
Involuntary movements
Pain or swelling following accidental injection outside the vein
Cardiac and respiratory failure
Adverse reactions that may occur after anaesthesia
The following adverse reactions may occur after anaesthesia (while waking up or after regaining consciousness).
Common (may affect up to 1 in 10 people)
Headache
Feeling unwell (nausea), illness (vomiting)
Uncommon (may affect up to 1 in 100 people)
Swelling, 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 occurred, patients have recovered without complications)
Inflammation of the pancreas (pancreatitis), causing severe stomach pain (causal relationship cannot be established)
Fever after surgery
Sexual disinhibition
Not known (frequency cannot be estimated from available data)
Feeling of euphoria
Irregular heartbeat
Increased liver size
Renal failure
Changes in electrocardiogram (ECG, Brugada-type)
Misuse and dependence on the medicine, primarily among healthcare personnel
Hepatitis (liver inflammation), acute liver failure, whose symptoms may include yellowing of the skin and eyes, itching, dark urine, stomach pain and liver tenderness (pain felt under the front part of the rib cage on the right side), sometimes with loss of appetite
Rhabdomyolysis (breakdown of muscle cells), increased blood acidity, elevated levels of potassium and fats in the blood, cardiac failure resulting in death (observed when propofol is used in intensive care at doses higher than recommended)
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting adverse reactions, 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 below 25 °C.
Do not freeze.
Keep the vial/bottle in the outer original packaging to protect it from light.

Shelf life before opening
Vials/bottles: 3 years.

Period of validity after first opening / dilution
RIPOL 20 mg/ml emulsion for injection/for infusion
Use immediately.
Must not be diluted.

RIPOL 20 mg/ml emulsion for injection/for infusion
Chemical and physical in-use stability has been demonstrated for 24 hours at 25 °C.
From a microbiological standpoint, the product should be used immediately. If 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 particles are observed.

Medicines must not be disposed of via wastewater or household waste. The physician or hospital pharmacist is responsible for proper storage, use, and disposal.

6. PACK CONTENTS AND OTHER INFORMATION

What RIPOL 20 mg/ml contains

The active substance 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 pack contents
RIPOL 20 mg/ml injectable/infusion emulsion is a white, isotonic, oil-in-water aqueous emulsion. It is available in 20 ml Type I glass vials or 20 ml, 50 ml and 100 ml Type I glass bottles with bromobutyl rubber stoppers.
Pack sizes:
1 x 50 ml bottle
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 physicians or healthcare professionals:

Method of administration
For intravenous use.
RIPOL 20 mg/ml must not be administered using a target-controlled infusion (TCI) system for sedation in intensive care.
The use of propofol infusion emulsion for sedation in intensive care has been associated with numerous metabolic alterations and organ disturbances that may lead to death.

Single-use.
Parenteral products should be inspected visually for particulate matter prior to administration. If particles are visible, the emulsion must not be used.

RIPOL 20 mg/ml injectable/infusion emulsion
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 by continuous infusion, undiluted.
Before use, the vial neck and rubber stoppers must be disinfected using medicinal alcohol (spray or soaked swab). After use, any remaining solution must be discarded.

RIPOL 20 mg/ml does not contain antimicrobial preservatives and can support microbial growth. The emulsion must be aseptically withdrawn into a sterile syringe or infusion system immediately after opening the vial.
Administration must begin without delay. During infusion, the sterility of RIPOL 20 mg/ml and of the infusion system must be maintained.

It is recommended to administer Ripol 20 mg/ml slowly until the clinical onset of anaesthesia is evident.

Medicinal products or liquids added to an ongoing infusion solution of RIPOL 20 mg/ml must be injected close to the cannula.

RIPOL 20 mg/ml must not be administered through infusion systems equipped with a microbiological filter.

The contents of one vial of RIPOL 20 mg/ml and any infusion equipment must be used for single use in a single patient.
Any remaining solution must be immediately discarded 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, drip chambers, syringe pumps or volumetric infusion pumps to control the infusion rate.

As with all parenteral lipid emulsions, the duration of use of an infusion system for continuous infusion of RIPOL 20 mg/ml must not exceed 12 hours. The infusion system and container must be discarded and replaced after a maximum of 12 hours.

Concomitant administration of RIPOL 20 mg/ml together with 50 mg/ml (5%) glucose infusion solution, 9 mg/ml (0.9%) sodium chloride infusion solution, or a combination of 40 mg/ml (4%) glucose and 1.8 mg/ml (0.18%) sodium chloride solutions, via a Y-connector near the injection site, is permitted.

Any remaining RIPOL 20 mg/ml at the end of the infusion period or after changing the infusion system must be discarded and destroyed.

To reduce injection site pain, lidocaine may be administered immediately before using RIPOL 20 mg/ml.

The infusion system must be flushed before administering muscle relaxants such as atracurium and mivacurio, if the same infusion system used for RIPOL 20 mg/ml is to be reused.

Disposal
Any remaining contents after use must be discarded.
Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.