RAPIVA 10 мг/мл Инъекционная эмульсия

Содержание инструкции

1. Rapiva 10 mg/ml injectable emulsion or for infusion
   1. WHAT RAPIVA IS AND WHAT IT IS USED FOR
   2. BEFORE YOU ARE GIVEN RAPIVA
   3. HOW RAPIVA WILL BE ADMINISTERED TO YOU
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE RAPIVA
   6. OTHER INFORMATION
   7. WHAT RAPIVA IS AND WHAT IT IS USED FOR
   8. BEFORE YOU ARE GIVEN RAPIVA
   9. HOW RAPIVA WILL BE ADMINISTERED TO YOU
   10. POSSIBLE SIDE EFFECTS
   11. HOW TO STORE RAPIVA
   12. OTHER INFORMATION

Rapiva 10 mg/ml injectable emulsion or for infusion

Propofol
Equivalent medicinal product

Read this leaflet carefully before this medicine is administered to you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If any of the side effects gets worse, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

• 1. What Rapiva is and what it is used for
• 2. Before you are administered Rapiva
• 3. How Rapiva will be administered to you
• 4. Possible side effects
• 5. How to store Rapiva
• 6. Further information

1. WHAT RAPIVA IS AND WHAT IT IS USED FOR

Propofol belongs to a group of medicines called general anaesthetics. General anaesthetics are
used to cause loss of consciousness (deep sleep) while operations
are being carried out or other procedures are performed. They can also be used to sedate you (they make you fall asleep without you
going to sleep).

Rapiva is used for:

• To induce and maintain general anaesthesia in adults and children aged > 1 month
• To sedate patients aged > 16 years undergoing artificial ventilation in intensive care
• To sedate adults and children aged > 1 month during diagnostic and surgical procedures, alone or in combination with local or regional anaesthesia

2. BEFORE YOU ARE GIVEN RAPIVA

Do not use Rapiva:

• in patients allergic (hypersensitive) to propofol or to any of the other ingredients of this medicine
• in patients allergic (hypersensitive) to soy or peanuts
• in patients aged 16 years or under for sedation in intensive care

Take particular care with Rapiva
You must not receive Rapiva, or only with extreme caution and intensive monitoring, if:

• you have advanced heart failure
• you have any other serious heart condition
• you are undergoing electroconvulsive therapy (ECT, a treatment for psychiatric problems)

The use of Rapiva is not recommended in newborns.
Particular attention must be paid when Rapiva is used for anesthesia in children under the age of
3 years. However, the currently available data do not suggest significant differences in
terms of safety compared to children of older age.
The safety of propofol for sedation in children and adolescents under the age of 16 years in
intensive care has not been demonstrated.
In general, Rapiva should be administered with caution in elderly or debilitated patients.
Before receiving Rapiva, inform the anesthesiologist or intensive care physician if you have:

• heart disease
• lung disease
• kidney disease
• liver disease
• convulsions (epilepsy)
• increased pressure inside the skull (increased intracranial pressure). In combination with low blood pressure, the amount of blood reaching the brain may be decreased.
• altered levels of fats in the blood. If you are receiving total parenteral nutrition (feeding through a vein), your blood fat levels must be monitored.

If you suffer from any of the following conditions, these must be treated before you receive
Rapiva:

• heart failure
• when there is insufficient blood reaching the tissues (circulatory insufficiency)
• severe breathing problems (respiratory failure)
• dehydration (hypovolemia)
• convulsions (epilepsy)

Rapiva may increase the risk of:

• epileptic seizures
• a nervous reflex that slows the heart rate (vagal reaction, bradycardia)
• changes in blood flow to the organs of the body (hemodynamic effects on the cardiovascular system), if you are overweight and receive high doses of Rapiva.

Involuntary movements may occur during sedation with Rapiva. Doctors will take into account
how this may affect surgical procedures that are performed under sedation and
will take the necessary precautions.
Very rarely, after anesthesia, there may be a period of unconsciousness associated with muscle rigidity. This requires observation by medical personnel, but no other treatment. This will
resolve spontaneously.
The injection of Rapiva may be painful. A local anesthetic may be used to reduce the pain
but the side effects of the latter may occur
You will not be allowed to leave the hospital until you are fully conscious.

Taking Rapiva with other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, even those available without a prescription. This includes medicines, herbal
medicines, dietary products or supplements that you have purchased.
Particular care must be taken if you are also taking any of the following medicines:

• premedications (the anesthesiologist must be informed)
• anesthetics
• analgesics (pain relievers)
• muscle relaxants, for example succinylcholine
• benzodiazepines (medicines for anxiety), for example valium
• parasympatholytic drugs (drugs that inhibit the action of the parasympathetic nervous system, which controls the contraction of smooth muscles, regulates the heart muscle, or stimulates or inhibits glandular secretion.)
• drugs that act on many of the body's internal functions, such as heart rate, for example, atropine
• potent pain relievers, for example fentanyl
• alcohol
• neostigmine (treatment for muscle weakness)
• cyclosporine (used to prevent organ rejection)

Taking Rapiva with food and drink
Alcohol and propofol enhance each other's sedative effects. Therefore, you should not drink alcohol immediately before or immediately
after receiving Rapiva until fully recovered.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Rapiva should not be given to pregnant women unless strictly necessary. If you are
breastfeeding, you should stop breastfeeding and discard breast milk for 24 hours after
receiving Rapiva. Propofol is excreted in small amounts in breast milk.

Driving and using machines
After receiving Rapiva, you must not drive, operate machinery or work in hazardous situations.
You must not go home alone and must not drink alcoholuntil fully recovered.

Important information about some of the excipients of Rapiva:
Rapiva contains soybean oil. If you are allergic to peanuts or soy, do not use this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per 20 ml, i.e. it is practically “sodium-free”.

3. HOW RAPIVA WILL BE ADMINISTERED TO YOU

Dosage
Rapiva will be administered by your anesthesiologist or intensive care physician.
The amount of propofol needed depends on your age, size, physical condition and the level of drowsiness or
sleep that needs to be achieved. The doctor will administer the correct dose to start and maintain
anesthesia or to reach the necessary level of sedation, carefully monitoring your responses
and vital signs (pulse, blood pressure, breathing, etc.). This may also be affected by
other medications you are taking. Most people need 1.5-2.5 mg per
kg of body weight to achieve drowsiness or to fall asleep, and subsequently 4 to 12
mg/kg (body weight)/hour. For sedation, doses of propofol between 0.3-
4.0 mg per kg of body weight/hour are usually sufficient.
Adults
To induce sedation during surgical and diagnostic procedures in adults, in most
patients it is necessary to administer 0.5-1 mg propofol/kg of body weight for 1 – 5 minutes to
initiate sedation. Maintenance of sedation can be achieved by titrating the infusion of
Rapiva according to the required level of sedation. For most patients, it is necessary to
administer 1.5 - 4.5 mg propofol/kg of body weight/hour.
Rapiva is administered by injection or infusion into a vein, usually on the back of the hand or
forearm. The anesthesiologist may use a needle or a cannula (a thin plastic tube). An electric pump may be
used to administer the injection during long operations and for use in intensive
care.
Elderly and debilitated patients may require lower doses.
Children
Usually children require slightly higher doses. The dose must be adjusted according to age
and/or body weight.
When used for sedation, Rapiva should not be administered for more than 7 days.

If you receive more Rapiva than you should
It is unlikely that this will happen because the doses you receive are carefully controlled.
If you are accidentally given an overdose, this could lead to depression
of cardiac, circulatory and respiratory function. In this case, the doctor will immediately
resort to any necessary treatment.
If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Rapiva can cause side effects, although not everybody gets them.
These effects depend on the dose of propofol administered but also on the type of premedication and
the concomitant use of other medicines.

Very common(more than 1 in 10 people)

• local pain during injection

Common(between 1 in 10 and 1 in 100 people)

• low blood pressure (hypotension)
• weak breathing (respiratory depression)
• involuntary movements
• slowed heartbeat (bradycardia)
• rapid heartbeat (tachycardia)
• hot flushes
• temporary apnea (cessation of breathing)
• cough after anesthesia
• hiccups
• hyperventilation (increased breathing rate)
• hypertriglyceridemia (high cholesterol or triglycerides in the blood)

Uncommon(between 1 in 100 and 1 in 1,000 people)

• severe low blood pressure (hypotension)
• cough during anesthesia

Rare(between 1 in 1,000 and 1 in 10,000 people)

• anaphylaxis (a severe allergic reaction)
• euphoria (feeling of happiness) and sexual excitement during recovery
• headache
• dizziness
• shivering and feeling cold during the recovery period
• convulsive movements (similar to epilepsy)
• irregular heartbeat (arrhythmia) during recovery
• cough during recovery
• discoloration of urine
• post-operative fever
• blood clots (thrombosis) and inflammation of blood vessels (phlebitis)
• redness of the skin (erythema)
• low blood pressure (hypotension)
• bronchospasm (a condition that causes difficulty breathing)
• nausea or vomiting

Very rare(less than 1 in 10,000 people)

• delayed seizures (similar to epilepsy after recovery)
• fluid in the lungs (pulmonary edema)
• inflammation of the pancreas (pancreatitis)
• severe tissue reactions after accidental injection into tissues
• rhabdomyolysis (breakdown of muscle fibers)
• metabolic acidosis (acidic blood)
• high potassium concentration in the blood (hyperkalemia)
• heart failure (cardiac dysfunction)
• post-operative unconsciousness

When Rapiva is administered in association with lidocaine (a local anesthetic used to reduce
pain at the injection site), some side effects may occur rarely:

• dizziness
• vomiting
• drowsiness
• seizures
• slowed heartbeat (bradycardia)
• irregular heartbeat (cardiac arrhythmia)
• shock

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly through the national reporting
system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.Reportingside
effects you can help provide more information on the safety of this
medicine.If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, tell your doctor or pharmacist.

5. HOW TO STORE RAPIVA

Keep out of the reach and sight of children.
Do not use Rapiva after the expiry date which is stated on the vial and the package after “EXP”.
The expiry date refers to the last day of the month.
Do not store at a temperature above 25°C.
Do not freeze.
After opening, the product must be used immediately.
Dilutions with glucose 50 mg/ml (5%) injectable solution, sodium chloride 9 mg/ml (0.9%) solution
injectable or sodium chloride 1.8 mg/ml (0.18%) and glucose 40 mg/ml (4%) injectable solution and lidocaine
10 mg/ml (1%) injectable solution without preservatives. The mixture must be prepared in a
aseptic manner (controlled and validated conditions) immediately before administration and must be
administered within 12 hours of preparation.
Shake the container before use.
If two layers are seen after shaking, the emulsion must not be used.
Use only homogeneous preparations and intact containers.
For single use only. Any unused emulsions must be discarded.
The anaesthetist and hospital pharmacist are responsible for the correct storage, use and
disposal of propofol.

6. OTHER INFORMATION

What Rapiva contains
The active ingredient is propofol.
Each ml of injectable or infusion emulsion contains 10 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 excipients are: Refined soybean oil, medium-chain triglycerides, glycerol, egg lecithin, sodium
oleate, sodium hydroxide (for pH adjustment), water for injections.

Description of the appearance of Rapiva and contents of the pack
Oil-in-water emulsion for injection or infusion, white,.
This medicinal product is supplied as:
Injectable or infusion emulsion in colorless glass vials (type II) with gray bromobutyl rubber stoppers.
Packs:
Colorless glass vials (type II) of 20 ml with gray bromobutyl rubber stoppers,
packs of 1, 5 and 10 units.
Colorless glass vials (type II) of 50 ml with gray bromobutyl rubber stoppers,
packs of 1 and 10 units.
Colorless glass vials (type II) of 100 ml with gray bromobutyl rubber stoppers,
packs of 1 and 10 units.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Baxter Holding BV,
Kobaldweg 49,
3542CE Utrecht,
Netherlands

Manufacturer
Peckforton Pharmaceuticals Limited
Golden Gate Lodge Crewe Hall, Weston Road, Crewe
CW1 6UL, United Kingdom.

UAB Norameda
Vilnius, Lithuania.

SIDEFARMA- Sociedada Industrial de Expansão Farmacêutica, S.A.,
Guiné 26, 2685, Portugal.

SIA “UNIFARMA”
Vangažu iela 23,
Rīga, Latvia

This medicinal product is authorised in the Member States of the European Community under the following names:
European StateCommercial Name
Germany (RMS) Propofol Claris 1% (10mg/ml) MCT Emulsion for Injection/Infusion
Austria Propofol Claris 1% (10 mg/ml) MCT Emulsion for Injection/Infusion
Czech Republic Propofol Norameda10mg/ml Emulsion for Injection/Infusion
Denmark Profast (Propofol, 10mg/ml Emulsion for injection/Infusion)
Estonia Spiva (Propofol, 10mg/ml Emulsion for Injection/Infusion)
Greece Spiva (Propofol, 10mg/ml Emulsion for Injection/Infusion)
Finland Rapiva (Propofol, 10mg/ml Emulsion for Injection/Infusion)
France Spiva (Propofol, 10mg/ml Emulsion for Injection/Infusion)
Hungary Spiva (Propofol, 10mg/ml Emulsion for Injection/Infusion)
Ireland Propofol, 10mg/ml Emulsion for Injection/Infusion
Italy Rapiva (Propofol, 10mg/ml Emulsion for Injection/Infusion)
Latvia
Rapiva 10 mg/ml emulsion for injection/infusion (Rapiva 10 mg/ml emulsija
injekcijām/infūzijām)
Lithuania Spiva (Propofol Norameda 10 mg/ml injekcinë/infuzinë emulsija)
Luxembourg Spiva (Propofol, 10mg/ml Emulsion for Injection/Infusion)
Netherlands Rapiva (Propofol, 10mg/ml Emulsion for Injection/Infusion)
Norway Spifol (Propofol, 10mg/ml Emulsion for Injection/Infusion)
Poland Propofol Norameda
Portugal Rapiva (Propofol, 10mg/ml Emulsion for Injection/Infusion)
Romania Profast 10mg/ml emulsie injectabila/perfuzabila
Sweden Spiva (Propofol, 10mg/ml Emulsion for Injection/Infusion)
Slovenia Rapiva 10mg/ml emulzija za injiciranje/infundiranje
Slovakia Profast 10mg/ml Emulsion for Injection/Infusion
United Kingdom Propofol 10 mg/ml Emulsion for injection/infusion
-----------------------------------------------------------------------------------------------------------------------------

The following information is intended exclusively for physicians or healthcare professionals:
Rapiva must be administered by specialist physicians in anaesthesia or in the care of patients in intensive
care only in hospitals or in adequately equipped day care units. Circulatory and respiratory functions
must be continuously monitored (e.g. ECG, pulse oximeter) and the means for maintaining airway patency,
artificial ventilation and other resuscitation measures must always be readily available.
For sedation during surgical or diagnostic procedures, Rapiva should not be
administered by the same person performing the surgical or diagnostic procedure.
During the administration of Rapiva via continuous infusion, the use of burettes,
drip chambers, syringe pumps or volumetric pumps is recommended to control the infusion rate.
Shake the container before use. If two layers are seen after shaking, the emulsion should not
be used.
Use only homogeneous preparations and intact containers.
For single use only. Any unused emulsion must be discarded.
Before use, clean the rubber stopper of the vial with alcohol (spray or swab).
After use, the reclosed containers must be discarded.
Rapiva is an emulsion containing lipids without antimicrobial preservatives and, therefore, rapid
growth of microorganisms may occur.
The emulsion must be drawn up under aseptic conditions into a sterile syringe or infusion set
immediately after breaking the seal. Administer immediately.
Aseptic conditions must be maintained for both Rapiva and the infusion system for
the entire duration of the infusion.
The co-administration of other drugs or fluids added to the Rapiva infusion line must occur in
proximity to the cannula insertion site using a Y-connector or a three-way valve.
Rapiva can be used for infusion in diluted or undiluted form.
Rapiva must only be mixed with the following products: glucose 50 mg/ml (5%) solution for injection, sodium
chloride 9 mg/ml (0.9%) solution for injection or sodium chloride 1.8 mg/ml (0.18%) and glucose 40 mg/ml (4%)
solution for injection, and lidocaine 10 mg/ml (1%) solution for injection without preservatives.
The final propofol concentration must not be less than 2 mg/ml.
However, the co-administration of Rapiva with glucose 50 mg/ml (5%) solution
for injection, sodium chloride 9 mg/ml (0.9%) solution for injection or sodium chloride 1.8 mg/ml (0.18%) and
glucose 40 mg/ml (4%) solution for injection via a Y-connector near the injection site is possible.
Rapiva must not be administered through infusion sets equipped with microbiological filters.
Rapiva and any infusion sets containing Rapiva are intended for singleuse in a single
patient. After use, dispose of any unused residues.
Infusion of undiluted Rapiva solutions:
During the administration of Rapiva via continuous infusion of the undiluted solution, the use of burettes,
drip chambers, syringe pumps or volumetric pumps is recommended to control the
infusion rate.
As established for the parenteral administration of any type of fat emulsion, the duration
of continuous Rapiva infusion via agiven infusion system must not exceed 12
hours. The infusion tube and the Rapiva container must be disposed of or replaced at the latest after 12
hours.
Infusion of diluted Rapiva solutions:
During the administration of Rapiva via continuous infusion of the diluted solution, the use of burettes,
drip chambers, syringe pumps or volumetric pumps is recommended to control the infusion rate and avoid the risk of accidental, uncontrolled infusion of large volumes of diluted Rapiva.
This risk should be taken into consideration when deciding on the maximum dilution in the burette.
The maximum dilution should not exceed 1 part of Rapiva with 4 parts of glucose 50 mg/ml (5%)
solution for injection, sodium chloride 9 mg/ml (0.9%) solution for injection or sodium chloride 1.8 mg/ml
(0.18%) and glucose 40 mg/ml (4%) solution for injection (minimum propofol concentration 2 mg/ml).
The mixture must be prepared aseptically (controlled and validated conditions) immediately
before administration and must be administered within 12 hours of preparation.
This medicinal product must not be mixed with other products except those mentioned above.
To reduce pain at the injection site, lidocaine may be injected immediately before
injection of Rapiva or Rapiva may be mixed, immediately before use, with a
solution for injection of lidocaine without preservatives (20 parts of Rapiva with a maximum of 1 part of
lidocaine 10 mg/ml (1%) solution for injection) under controlled and validated aseptic conditions. The
mixture must be administered within 12 hours of preparation.
The muscle relaxants atracurium or mivacurium must not be administered through the same intravenous administration system as Rapiva without flushing the system.
Rapiva 20 mg/ml emulsion for injection or infusion
Propofol
Essentially similar medicinal product

Read this leaflet carefully before you are given this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

• 1. What Rapiva is and what it is used for
• 2. Before you are given Rapiva
• 3. How Rapiva will be given to you
• 4. Possible side effects
• 5. How to store Rapiva
• 6. Further information

1. WHAT RAPIVA IS AND WHAT IT IS USED FOR

Propofol belongs to a group of medicines called general anesthetics. General anesthetics are
used to cause loss of consciousness (deep sleep) while surgeries or other procedures are being performed. They can also be used to sedate you (they induce sleep without you
falling asleep).

Rapiva is used for:

• To induce and maintain general anesthesia in adults and children aged > 3 years
• To sedate patients aged > 16 years undergoing mechanical ventilation in intensive care
• To sedate adults and children aged > 3 years during diagnostic and surgical procedures, alone or in combination with local or regional anesthesia

2. BEFORE YOU ARE GIVEN RAPIVA

Do not use Rapiva:

• in patients allergic (hypersensitive) to propofol or to any of the other components of this medicine
• in patients allergic (hypersensitive) to soy or peanuts
• in patients aged 16 years or under for sedation in intensive care

Take particular care with Rapiva
You must not receive Rapiva, or only with extreme caution and intensive monitoring, if:

• you have advanced heart failure
• you have any other serious heart disease
• you are undergoing electroconvulsive therapy (ECT, a treatment for psychiatric problems)

The use of Rapiva 20 mg/ml is not recommended in children under the age of 3 years
Particular care must be taken when Rapiva is used for anesthesia in children under the age of 3 years. However, currently available data do not suggest significant differences in
terms of safety compared to children of older age.
The safety of propofol for sedation in children and adolescents under the age of 16 years in
intensive care has not been demonstrated.
In general, Rapiva should be administered with caution in elderly or debilitated patients.
Before receiving Rapiva, tell the anesthesiologist or intensive care physician if you have:

• heart disease
• lung disease
• kidney disease
• liver disease
• convulsions (epilepsy)
• an increased pressure inside the skull (increased intracranial pressure). In combination with low blood pressure, the amount of blood reaching the brain can be decreased.
• altered levels of fats in the blood. If you are receiving total parenteral nutrition (feeding through a vein), your blood fat levels must be monitored.

If you suffer from any of the following conditions, these must be treated before you receive
Rapiva:

• heart failure
• when there is insufficient blood reaching the tissues (circulatory failure)
• severe breathing problems (respiratory failure)
• dehydration (hypovolemia)
• convulsions (epilepsy)

Rapiva may increase the risk of:

• epileptic seizures
• a nervous reflex that slows the heart rate (vagotonia, bradycardia)
• changes in blood flow to the organs of the body (hemodynamic effects on the cardiovascular system), if you are overweight and receive high doses of Rapiva.

Involuntary movements may occur during sedation with Rapiva. Doctors will take into account
how this may affect surgical procedures that are performed under sedation and
will take the necessary precautions.
Very rarely, after anesthesia, there may be a period of unconsciousness associated with muscle rigidity. This requires observation by medical staff, but no other treatment.
This will resolve spontaneously.
The injection of Rapiva may be painful. A local anesthetic may be used to reduce the pain
but the side effects of the latter may occur.
You will not be allowed to leave the hospital until you are fully conscious.

Taking Rapiva with other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, even those available without a prescription. This includes medicines, herbal
medicines, dietary products or supplements that you have purchased.
You must be particularly careful if you are also taking any of the following medicines:

• premedications (the anesthesiologist must be informed)
• anesthetics
• analgesics (pain relievers)
• muscle relaxants, for example succinylcholine
• benzodiazepines (drugs for anxiety), for example Valium
• parasympatholytic drugs (drugs that inhibit the action of the parasympathetic nervous system which controls the contraction of smooth muscles, regulates the heart muscle, stimulates or inhibits glandular secretion.)
• drugs that act on many of the internal functions of the body, such as heart rate, for example, atropine
• potent pain relievers, for example fentanyl
• alcohol
• neostigmine (treatment for muscle weakness)
• cyclosporine (used to prevent organ rejection)

Taking Rapiva with food and drink
Alcohol and propofol enhance each other's sedative effects. Therefore, you should not drink alcohol immediately before or
immediately after receiving Rapiva until fully recovered.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Rapiva should not be administered to pregnant women unless strictly necessary. If you are
breastfeeding, you should stop breastfeeding and discard breast milk for 24 hours after
receiving Rapiva. Propofol is excreted in small amounts in breast milk.

Driving and operating machinery
After receiving Rapiva, you must not drive, operate machinery or work in dangerous situations.
You must not go home alone and must not drink alcoholuntil fully recovered.

Important information about some excipients of Rapiva:
Rapiva contains soybean oil. If you are allergic to peanuts or soy, do not use this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) in 20 ml, i.e. it is practically “sodium-free”.

3. HOW RAPIVA WILL BE ADMINISTERED TO YOU

Dosage
Rapiva will be administered by your anesthesiologist or intensive care physician.
The amount of propofol needed depends on your age, size, physical condition and the level of drowsiness or
sleep that needs to be achieved. The doctor will administer the correct dose to start and maintain
anesthesia or to reach the necessary level of sedation, carefully monitoring your responses
and vital signs (pulse, blood pressure, breathing, etc.). This can also be affected by
other medications you are taking. Most people need 1.5-2.5 mg per
kg of body weight to achieve drowsiness or to make them fall asleep, and subsequently 4 to 12
mg/kg (body weight)/hour. For sedation, doses of propofol between 0.3-
4.0 mg per kg of body weight/hour are usually sufficient.
Adults
To induce sedation during surgical and diagnostic procedures in adults, in most
patients it is necessary to administer 0.5-1 mg propofol/kg of body weight for 1 – 5 minutes to
initiate sedation. Maintaining sedation can be achieved by titrating the infusion of
Rapiva according to the required level of sedation. For most patients, it is necessary
to administer 1.5 - 4.5 mg propofol/kg of body weight/hour.
The infusion may be supplemented with the administration of boluses of 10 – 20 mg (0.5 – 1 ml of Rapiva),
if a rapid increase in the depth of sedation is necessary.
Rapiva is administered by injection or infusion into a vein, usually on the back of the hand or
forearm. The anesthesiologist may use a needle or a cannula (a thin plastic tube). An electric pump may be
used to administer the injection during long operations and for use in intensive
care.
Elderly and debilitated patients may require lower dosages.
Children
Usually children require slightly higher doses. The dose must be adjusted according to age
and/or body weight.
When used for sedation, Rapiva should not be administered for more than 7 days.

If you receive more Rapiva than you should
It is unlikely that this will happen because the doses you receive are carefully controlled.
If you are accidentally given an overdose, this could lead to depression
of cardiac, circulatory and respiratory function. In this case, the doctor will immediately
resort to any necessary treatment.
If you have further questions about the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Rapiva can cause side effects, although not everybody gets them.
These effects depend on the dose of propofol administered but also on the type of premedication and
the concomitant use of other medicines.

Verycommon(more than 1 in 10 people)

• local pain during the injection

Common(between 1 in 10 and 1 in 100 people)

• low blood pressure (hypotension)
• shallow breathing (respiratory depression)
• spontaneous movements
• slowed heartbeat (bradycardia)
• rapid heartbeat (tachycardia)
• hot flushes
• temporary apnea (cessation of breathing)
• cough after anesthesia
• hiccups (singultus)
• hyperventilation (increased breathing rate)
• hypertriglyceridemia (high cholesterol or triglycerides in the blood)

Uncommon(between 1 in 100 and 1 in 1,000 people)

• severe low blood pressure (hypotension)
• cough during anesthesia

Rare(between 1 in 1,000 and 1 in 10,000 people)

• anaphylaxis (a severe allergic reaction)
• euphoria (feeling of happiness) and sexual excitement during recovery
• headache
• dizziness
• shivering and feeling cold during the recovery period
• epileptiform movements (similar to epilepsy)
• irregular heartbeat (arrhythmia) during recovery
• cough during recovery
• discoloration of urine
• post-operative fever
• blood clots (thrombosis) and inflammation of blood vessels (phlebitis)
• skin redness (erythema)
• low blood pressure (hypotension)
• bronchospasm (a condition that causes difficulty breathing)
• nausea or vomiting

Veryrare(less than 1 in 10,000 people)

• delayed seizures (epilepsy-like symptoms after recovery)
• fluid in the lungs (pulmonary edema)
• inflammation of the pancreas (pancreatitis)
• severe tissue reactions after accidental injection into the tissues
• rhabdomyolysis (muscle fiber breakdown)
• metabolic acidosis (acidic blood)
• high potassium concentration in the blood (hyperkalemia)
• heart dysfunction (cardiac)
• post-operative unconsciousness

When Rapiva is administered in association with lidocaine (a local anesthetic used to reduce
pain at the injection site), some side effects may occur rarely:

• dizziness
• vomiting
• drowsiness
• seizures
• slowed heartbeat (bradycardia)
• irregular heartbeat (cardiac arrhythmia)
• shock

Reporting of side effects
If you get any side effects, 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 http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.Reportingside
effects you can help provide more information on the safety of this
medicine.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

5. HOW TO STORE RAPIVA

Keep out of the reach and sight of children.
Do not use Rapiva after the expiry date which is stated on the vial and the carton after “EXP”.
The expiry date refers to the last day of the month.
Do not store at a temperature above 25°C.
Do not freeze.
After opening, the product must be used immediately.
Shake the container before use.
If two layers are seen after shaking, the emulsion should not be used.
Use only homogeneous preparations and intact containers.
For single use. Any unused emulsions must be discarded.
The anaesthetist and hospital pharmacist are responsible for the correct storage, use and
disposal of propofol.

6. OTHER INFORMATION

What Rapiva contains
The active ingredient is propofol.
Each ml of injectable or infusion emulsion contains 20 mg of propofol.
Each vial of 50 ml contains 1000 mg of propofol
The other excipients are: Refined soybean oil, medium-chain triglycerides, glycerol, egg lecithin, sodium
oleate, sodium hydroxide (for pH adjustment), water for injections.

Description of the appearance of Rapiva and contents of the pack
Oil-in-water emulsion for injection or infusion, white,.
This medicinal product is supplied as:
Injectable or infusion emulsion in colorless glass vials (type II) with gray bromobutyl rubber stoppers.
Packs:
Colorless glass vials (type II) of 50 ml with gray bromobutyl rubber stoppers,
packs of 1 and 10 units.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Baxter Holding BV,
Kobaldweg 49,
3542CE Utrecht,
Netherlands

Manufacturer
Peckforton Pharmaceuticals Limited
Golden Gate Lodge Crewe Hall, Weston Road, Crewe
CW1 6UL, United Kingdom.

UAB Norameda
Vilnius, Lithuania.

SIDEFARMA- Sociedada Industrial de Expansão Farmacêutica, S.A.,
Guiné 26, 2685, Portugal.

This medicinal product is authorised in the member states of the European Community under the following
names:
CMS
country
Invented Names
Germany(RMS
)
Propofol Claris 2% (20mg/ml) Emulsion zur Injektion/Infusion
Austria Propofol Claris 2% (20 mg/ml) MCT Emulsion zur Injektion/Infusion
Czech
Republic
Propofol Norameda 20mg/ml Emulsion for Injection/Infusion
Denmark Profast (Propofol, 20mg/ml Emulsion for injection/Infusion)
Estonia Spiva (Propofol, 20mg/ml Emulsion for Injection/Infusion)
Finland Rapiva (Propofol, 20mg/ml Emulsion for Injection/Infusion)
France Spiva (Propofol, 20mg/ml Emulsion for Injection/Infusion)
Hungary Spiva (Propofol, 20mg/ml Emulsion for Injection/Infusion)
Ireland Propofol, 20mg/ml Emulsion for Injection/Infusion
Italy Rapiva (Propofol, 20mg/ml Emulsion for Injection/Infusion)
Latvia
Rapiva 20 mg/ml emulsion for injection/infusion (Rapiva 20 mg/ml emulsija
injekcijām/infūzijām)
Lithuania Spiva (Propofol Norameda 20 mg/ml injekcinë/infuzinë emulsija)
Luxembourg Spiva (Propofol, 20mg/ml Emulsion for Injection/Infusion)
Netherlands Rapiva (Propofol, 20mg/ml Emulsion for Injection/Infusion)
Norway Spifol (Propofol, 20mg/ml Emulsion for Injection/Infusion)
Poland Propofol Norameda
Portugal Spiva (Propofol, 20mg/ml Emulsion for Injection/Infusion)
Romania Profast 20 mg/ml emulsie injectabila/perfuzabila
Sweden Spiva (Propofol, 20mg/ml Emulsion for Injection/Infusion)
Slovenia Rapiva 20mg/ml emulzija za injiciranje/infundiranje
United Kingdom Propofol 20 mg/ml Emulsion for injection/infusion
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The following information is intended exclusively for physicians or healthcare professionals:
Rapiva must be administered by specialist physicians in anaesthesia or in the care of patients in intensive
care only in hospitals or in adequately equipped day care units. Circulatory and respiratory functions must be continuously monitored (e.g. with ECG,
pulse oximeter) and the means for maintaining airway patency, artificial ventilation and other resuscitation measures must always be readily available.
For sedation during surgical or diagnostic procedures, Rapiva should not be
administered by the same person performing the surgical or diagnostic procedure.
When administering Rapiva via continuous infusion, it is recommended to use burettes,
drip chambers, syringe pumps or volumetric pumps to control the infusion rate.
Shake the container before use. If two layers are seen after shaking, the emulsion should not
be used.
Use only homogeneous preparations and intact containers.
For single use only. Any unused emulsion must be discarded.
Before use, clean the rubber stopper of the vial with alcohol (spray or swab).
After use, the reclosed containers must be discarded.
Rapiva is an emulsion containing lipids without antimicrobial preservatives and, therefore, rapid growth of
microorganisms may occur.
The emulsion must be drawn up under aseptic conditions into a sterile syringe or infusion set
immediately after breaking the seal. Administer immediately.
Aseptic conditions must be maintained for both Rapiva and the infusion system throughout the
duration of the infusion.
Co-administration of other drugs or fluids added to the Rapiva infusion line should occur in
proximity to the cannula insertion site using a Y-connector or a three-way valve.
Rapiva 20 mg/ml is administered intravenously undiluted in continuous infusion.
Rapiva 20 mg/ml should not be administered by repeated bolus injection for the maintenance
of anaesthesia.
Rapiva 20 mg/ml should not be mixed with other injectable or infusion solutions.
However, co-administration of Rapiva with glucose 50 mg/ml (5%) solution
injectable, sodium chloride 9 mg/ml (0.9%) solution injectable or sodium chloride 1.8 mg/ml (0.18%) and
glucose 40 mg/ml (4%) solution injectable and lidocaine 10 mg/ml (1%) solution injectable without
preservatives is possible via a Y-connector near the injection site.
Rapiva should not be administered through infusion sets equipped with microbiological filters.
Rapiva and each infusion set containing Rapiva are intended for singleuse in one
patient. After use, dispose of any unused residue.
Infusion of undiluted Rapiva solutions:
When administering Rapiva via continuous infusion of the undiluted solution, it is
recommended to use burettes, drip chambers, syringe pumps or volumetric pumps to control the
infusion rate.
As established for the parenteral administration of any type of fat emulsion, the duration
of continuous Rapiva infusion using oneparticular infusion system should not exceed 12
hours. The infusion tube and Rapiva container must be disposed of or replaced after a maximum of 12
hours.
Rapiva should not be mixed with other injectable or infusion solutions. But 5% w/v
glucose solutions, 0.9% w/v sodium chloride solutions or 0.18% w/v sodium chloride and 4% w/v glucose
solutions can be administered via suitable appendages at the site where the cannula has been inserted.
To reduce pain at the injection site, Rapiva should be administered in a larger vein or a lidocaine solution
can be administered before induction of anaesthesia with
Rapiva.
The muscle relaxants atracurium or mivacurium should not be administered through the same intravenous administration system as Rapiva without flushing the system.