Curtega 10 Mg/Ml Emulsion For Injection/Infusion

Package Leaflet : Information for the user Curtega 10mg/ml Emulsion for injection/infusion

Propofol

Read all of this leaflet carefully before you are given this medicine.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor/nurse or pharmacist.

• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor/ nurse or pharmacist.

In this leaflet:

1. What Curtega is and what it is used for

2. Before you are given Curtega

3. How you are given Curtega

4. Possible side effects

5. How to store Curtega

6. Further information.

1. WHAT CURTEGA IS AND WHAT IT IS USED FOR

Propofol 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 can also be used to sedate you (so that you are sleepy but not completely asleep).

Curtega 10 mg/ml is used to:

• induce and maintain general anaesthesia in adults and children >1 month

• sedate patients > 16 years of age receiving artificial respiration in intensive care

• sedate adults and children > 1 month during diagnostic and surgical procedures, alone or in combination with local or regional anaesthesia.

2. BEFORE YOU ARE GIVEN CURTEGA Do not use Curtega:

- in patients allergic (hypersensitive) to propofol or any of the other ingredients

- in patients allergic (hypersensitive) to soya or peanut

- in patients 16 years of age or younger for sedation in intensive care.

Take special care with Curtega

You should take Curtega, only under extreme caution and intensive monitoring, if you:

- have advanced heart failure

- have any other serious disease of the heart

The use of Curtega is not recommended if you are receiving electroconvulsive therapy (ECT, a treatment for psychiatric problems).

The use of Curtega 10 mg/ml is not recommended in newborn infants.

Special care should also be observed when administering Curtega to children less than 3 years of age. However, evidence now available does not suggest that this is any less safe than in older children. The safety of propofol for sedation in children and adolescents 16 years of age and younger in the intensive care unit has not been demonstrated.

In general, Curtega should be given with caution to elderly or weak patients.

Before receiving Curtega, tell your anaesthetist or intensive care doctor if you have:

- heart disease

- lung disease

- kidney disease

- liver disease

- seizures (epilepsy)

- a raised pressure inside the skull (raised intracranial pressure). In combination with low blood pressure the amount of blood reaching the brain may be decreased

- altered levels of fat in the blood. If you receiving total parenteral nutrition (feeding through a vein), the levels of fat in your blood must be monitored.

- had alcohol

- sensitivity to sodium

If you have any of the following conditions, they must be treated before you receive Curtega:

- heart failure

- when there is insufficient blood reaching the tissues (circulatory failure)

- severe breathing problems (respiratory failure)

- dehydration (hypovolaemia)

- seizures (epilepsy)

Curtega may increase the risk of

- epileptic seizures

- a nervous reflex that slows the heart rate (vagotonia, bradycardia)

- changes in the blood flow to the organs of the body (haemodynamic effects on the cardiovascular system) if you are overweight and receive high doses of Curtega

Involuntary movements can occur during sedation with Curtega. The doctors will take into account how this might affect surgical procedures being performed under sedation and will take the necessary precautions.

Very occasionally, after anaesthesia, there may be a period of unconsciousness associated with stiffness of the muscles. This requires observation by the medical staff but no other treatment. It will resolve spontaneously.

The injection of Curtega can be painful. A local anaesthetic can be used to reduce this pain but can have its own side effects.

You will not be allowed to leave the hospital until you are fully awake.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes medicines, herbal remedies, health foods or supplements that you have bought yourself.

You must take special care if you are also taking any of the following medicines:

• premedications (your anaesthetist will know this)

• anaesthetics

• analgesics (painkillers), e.g. fentanyl

• drugs that relax muscles, e.g. suxamethonium

• benzodiazepines (drugs for anxiety), e.g. diazepam

• parasympatholytic drugs (drugs that effect everyday activities such as salivation, digestion, and muscle relaxation, e.g. atropine)

• neostigmine (a treatment for muscle weakness)

• cyclosporin (used to prevent rejection of an organ)

Using Curtega with food and drink

Alcohol and propofol make the sedative effects of each other stronger. Therefore you should not drink alcohol just before or just after you have Curtega until fully recovered.

Pregnancy and breast-feeding

Curtega should not be given to pregnant women unless clearly necessary. If you are breast-feeding your child you should stop nursing and discard breast milk for 24 hours after you have received Curtega. Curtega is excreted in small amounts into the breast milk.

Driving and using machines

After you have been given Curtega, you must not drive, operate machinery, or work in dangerous situations. You should not go home alone and should not drink alcohol until fully recovered.

Important information about some of the ingredients in Curtega

Curtega contains soya-bean oil. If you are allergic to peanut or soya, do not use this medicinal product.

This medicinal product contains less than 1 mmol sodium (23 mg) sodium i. e. essentially ‘sodium free’.

3. HOW YOU ARE GIVEN CURTEGA Dosage

Curtega will be given to you by your anaesthetist or intensive care doctor.

The amount of Curtega you need depends on your age, size, fitness and the level of sleepiness or sleep that is needed. The doctor will give the correct dose to start and to sustain anaesthesia or to achieve the required level of sedation, by carefully watching your responses and vital signs (pulse, blood pressure, breathing, etc). It can also be affected by other medicines you may be taking. Most people need 1.5-2.5 mg per kg of body weight to make them sleepy or to put them to sleep, and then 4 to 12 mg/kg (body weight)/hour after this. For sedation, doses of 0.3 to 4.0 mg propofol per kg body weight per hour are usually sufficient.

Adults

For sedation during surgical and diagnostic procedures in adults, most patients will require 0.5 - 1 mg propofol per kg body weight over 1 to 5 minutes for onset of sedation. Maintenance of sedation may be accomplished by titrating Curtega infusion to the desired level of sedation. Most patients will require 1.5 - 4.5 mg propofol per kg body weight per hour.

The infusion may be supplemented by bolus administration of 10 - 20 mg (1 - 2 ml Curtega 10 mg/ ml if a rapid increase of the depth of sedation is required.

Curtega is given as an injection into a vein, usually on the back of the hand or in the forearm. Your anaesthetist may use a needle or cannula (a fine plastic tube). An electric pump may be used to give the injection for long operations and for use in intensive care.

Elderly and weak patients may require lower doses.

Children

Children usually require slightly higher doses. The dose should be adjusted according to age and/or body weight.

When used for sedation, Curtega must not be administered for more than 7 days.

If you received more Curtega than you should

It is unlikely that this occurs because the doses you receive are very carefully controlled.

If you are accidentally given an overdose, this could lead to depression of heart function, circulation and breathing. In this case your doctor will employ any necessary treatment immediately.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Curtega can cause side effects, although not everybody gets them.

Very common (affects more than 1 user in 10)

- Local pain during the injection

Common (affects 1 to 10 users in 100)

- low blood pressure (hypotension)

- shallow breathing (respiratory depression)

- spontaneous movements

- slow heartbeat (bradycardia)

- hot flushes

- temporary apnoea (stopping breathing)

- coughing after anaesthesia

- hiccups (singultus)

- hyperventilation (increased breathing)

Uncommon (affects 1 to 10 users in 1,000)

- severe low blood pressure (hypotension)

- slow heartbeat (bradycardia)

- coughing during anaesthesia

Rare (affects 1 to 10 users in 10,000)

- anaphylaxis (a severe allergic reaction)

- euphoria (feeling happy) and sexually aroused during recovery

- headache

- vertigo (spinning dizziness)

- shivering and sensations of cold during the recovery period

- epileptiform movements (resembling epilepsy)

- irregular heartbeat (arrhythmia) during recovery

- blood clots (thrombosis) and inflammation of the blood vessels (phlebitis)

- coughing during recovery

- feeling sick (nausea) or vomiting during recovery

- discoloration of urine

- post-operative fever

- red inflammation of the skin (erythema)

- low blood pressure (hypotension)

- bronchospasm (a condition that causes difficulty in breathing)

- angioneurotic oedema (Quincke's disease)

Very rare (affects less than 1 user in 10,000)

- delayed epileptiform attacks (epilepsy like symptoms after recovery)

- convulsions in epileptic patients

- unconsciousness after anaesthesia

- fluid in the lungs (pulmonary oedema)

- inflammation of the pancreas (pancreatitis)

- severe tissue responses after accidental injection into tissues

- rhabdomyolysis (breakdown of muscle fibres)

- metabolic acidosis (acidic blood)

- high blood potassium (hyperkalaemia)

- heart (cardiac) failure

When Curtega is administered in combination with lidocaine (a local anaesthetic used to reduce the pain at the site of injection), certain side effects may occur rarely:

- dizziness

- vomiting

- sleepiness

- fits

- a slowing of the heart rate (bradycardia)

- irregular heartbeat (cardiac arrhythmias)

- shock

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE CURTEGA

Keep out of the reach and sight of children.

Do not use Curtega after the expiry date, which is stated on the vial/bottle and the outer carton after “EXP.” The expiry date refers to the last day of that month.

Do not store above 25° C. Do not freeze.

Store in the original carton in order to protect from light.

After opening the product must be used immediately.

Shake before use.

Curtega can be diluted with solutions of glucose 5%, sodium chloride 0.9 % or combinations of 4% glucose and 0.18% sodium chloride.

The maximum dilution should not exceed 1 part Curtega 10 mg/ml for 4 parts of the solutions mentioned above (minimal concentration 2 mg / ml). Furthermore Curtega can be mixed with a lidocaine 1 % solution for injection without preservatives. One part lidocaine solution for injection should then be mixed with 20 parts Curtega 10 mg/ml.

The mixtures should be prepared aseptically immediately before administration.

Solutions in glass bottles or PVC bags can both be used, as long as they are well mixed prior to administration.

The simultaneous administration of Curtega 10 mg/ml together with an infusion of 5% glucose, 0.9% sodium chloride or combinations of 4% glucose with a 0.18% sodium chloride solution close to the Y-connector near the place of injection, is also possible.

For single use only. Any unused product or waste material should be disposed of in accordance with local requirements, immediately after use.

6. FURTHER INFORMATION

What Curtega contains

The active substance is propofol.

Each ml of emulsion for injection/infusion contains 10 mg of propofol.

Each 10 ml vial contains 100 mg propofol Each 20 ml vial contains 200 mg propofol Each 50 ml vial contains 500 mg propofol Each 100 ml vial contains 1000 mg propofol.

The other ingredients are: soybean oil refined, egg lecithin, glycerol, sodium oleate, sodium hydroxide (for pH adjustment) and water for injections.

What Curtega looks like and the content of the pack

White oil in water emulsion. Package with one glass vial (type II) with bromobutyl rubber stopper and plastic cap containing 10 ml, 20 ml, 50 ml or 100 ml emulsion for injection/infusion.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

This medicinal product is authorized in the Member States of EEA under the following name:

This leaflet was last approved in 06/2011

The following information is intended for medical or healthcare professionals only:

Curtega 10 mg/ml can only be administered in hospitals or well equipped units by doctors who are trained in anaesthesia or the treatment of intensive care patients.

Curtega must not be used in patients allergic to soya or peanuts.

Continuous surveillance of circulation and breathing (e.g. ECG, pulse oxymeter) is necessary. Facilities for maintenance of patient airways, artificial ventilation and other resuscitation facilities should be available immediately and at all times.

During surgical or diagnostic procedures Curtega 10 mg/ml should not be administered for sedation by the same person who executes the surgical or diagnostic intervention.

Containers should be shaken before use. If two layers can be seen after shaking, the emulsion should not be used.

Before using, the rubber stopper of the infusion vial must be disinfected with medicinal alcohol (spray or tissues). After use anything remaining should be discarded.

Curtega 10 mg/ml does not contain preservatives and is capable of supporting the growth of micro-organisms. The emulsion should immediately be drawn, aseptically, in a sterile syringe or the infusion system, after spiking the vial.

Administration should commence immediately afterwards. During the infusion the sterility of Curtega 10 mg/ml as well as the infusion system needs to be maintained.

Medicines or liquids that are added to a running Curtega 10 mg/ml infusion should be added close to the cannula. Curtega 10 mg/ml should not be administered via infusion systems that are provided with microbial filters.

The contents of one vial with Curtega 10 mg/ml and every syringe of Curtega 10 mg/ml is intended for single use for one patient.

The remainder must be discarded immediately after use.

Infusion of undiluted Curtega 10 mg/ml

When Curtega 10 mg/ml is administered through a continuous infusion, checking the rate of infusion through a burette, dropper, syringe pump or volumetric infusion pump is recommended. As applies to parenteral administration of all kinds of fat emulsions, the duration of use for one infusion system for a continuous infusion of Curtega 10mg/ml should be limited to maximum 12 hours. The infusion system and the container should be removed and changed after maximum 12 hours.

The simultaneous administration of Curtega 10 mg/ml together with an infusion of 5% glucose, 0.9% sodium chloride or combinations of 4% glucose with 0.18% sodium chloride solutions close to the Y-connector near the place of injection, is possible.

Any Curtega 10 mg/ml remaining at the end of the infusion period or after changing the system needs to be discarded and destroyed.

Infusion of diluted Curtega 10 mg/ml

When Curtega 10 mg/ml is administered diluted through a continuous infusion, the checking of the rate of administration by means of a burette, dropper, syringe pump or volumetric infusion pump is recommended, to prevent the accidental administration of too high doses of diluted Curtega 10 mg/ml.

Curtega 10 mg/ml must not be mixed with other injection or infusion liquids other than the ones mentioned.

To lessen the pain at the start of the injection, Curtega 10 mg/ml can be mixed with a lidocaine 1% solution for injection without preservatives.

Dilutions with a lidocaine solution should not be administered to patients with a hereditary predisposition to acute porphyria.

The neuromuscular blocking agents, atracurium and mivacurium should not be given through the same intravenous line as Curtega 10 mg/ml without prior flushing.

16/05/11 Version 5