Quifol 1 % Injection

QUIFOL contains a medicine called Propofol. This 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).

QUIFOL will be administered to you intravenously as an injection by a doctor.

QUIFOL is used to:

• Help to put you to sleep before an operation or other procedure and to keep you asleep during the procedure.
• Sedate you if you are an adult and in intensive care for periods up to 72 hours.

QUIFOL should not be administered to you:

• if you are hypersensitive (allergic) to propofol or any of the other ingredients of QUIFOL.(listed in section 6)
• if you are allergic to peanut or soya. This is because QUIFOL contains soya oil.
• if your child is younger than 3 years of age.
• if your child has croup (your child might have an upper airway infection that blocks breathing and has a distinctive barking cough) or epiglottitis (swelling around the windpipe) and is in intensive care in hospital.
• for sedation in intensive care if you are 16 years of age or younger.
• if you are pregnant.

In-use precautions: General

• Shake the container well before use.
• Before administration, check QUIFOL for any particulate matter or discoloration. Do not use if there is evidence of phase separation in the emulsion.
• QUIFOL contains no antimicrobial preservatives, and its vehicle can support the growth of microorganisms. Therefore, it must be handled carefully.
• When QUIFOL is to be drawn into a syringe or infusion set, it must be done aseptically, immediately after opening the ampoule or breaking the vial seal. Administration should begin without delay.
• Asepsis must be maintained for both QUIFOL and the infusion equipment throughout the infusion period. Any infusion fluids added to the QUIFOL line must be administered close to the cannula site.
• QUIFOL must not be administered via a microbiological filter.
• Any container or syringe containing QUIFOL is for single use in a single patient only.

General Anaesthesia:

• In accordance with guidelines for other lipid emulsions, a single infusion of QUIFOL must not exceed 6 hours. The syringe or giving set and any unused portion of QUIFOL or solution containing QUIFOL must be discarded at the end of the surgical procedure or after 6 hours, whichever occurs first.

Intensive Care Sedation:

• Administration should commence promptly and must be completed within 12 hours after the vial has been spiked. Any unused portions of QUIFOL and infusion tubing should be discarded after 12 hours.
• If QUIFOL is transferred to another container before administration, follow the guidelines for General Anaesthesia and discard the product and change the administration lines after 6 hours.

Warnings and precautions

Tell your doctor or health care provider before being given the injection

• if you have breathing problems or are using any medicines that assist with your breathing.
• if you have ever had a fit or convulsion or have been told previously by your healthcare provider that you have epilepsy.
• if you have any other health problems, such as problems with your heart, breathing, kidneys or liver.
• if you are debilitated (weak).
• if you have ever been told that you have high fat levels in your blood or that your body struggles to use fat.
• if you are elderly.
• if you or your child suffer from severe systemic disease that is a constant threat to life (ASA Grades 3 or 4 patients), which has caused you or your child to be unwell for some time.
• if your healthcare provider has informed you that you are hypovolaemic. Symptoms include, but are not limited to dizziness, nausea and you feel very thirst.
• if you have a serious head injury.
• if you have mitochondrial disease (poor growth, development delays, muscle weakness, decreased oxygen delivery, seizures, unexplained pain, partial or complete paralysis (as these are signs of serious neurological injury)), fever with chills, very low body temperature, urinating less than usual, rapid pulse and breathing, nausea, vomiting (as these are signs of sepsis) as these are risk factors for developing propofol infusion syndrome.
• if you or your child have a zinc shortage and use medication to treat this, especially if you have suffered from burns or had diarrhoea.

Your healthcare provider will continually monitor you and allow sufficient time to ensure full consciousness before you are discharged. Your healthcare provider will also advise that somebody accompany you when your leave the place of administration of QUIFOL and on the use of any other medicine that may cause sedation.

QUIFOL will be given to you as an intravenously injection into a vein. This is usually in the back of your hand or in your forearm. The dose of QUIFOL varies from one patient to another. The amount of QUIFOL that you need depends on your age, weight, physical fitness and the level of sleepiness or sleep that you need. Your doctor will give you the correct dose to start and to sustain anesthesia or to achieve the required level of sedation, by carefully watching your responses and vital signs (pulse, blood pressure, breathing etc.). You may need several different medicines to keep you asleep or sleepy, free from pain, breathing in a healthy way and to keep your blood pressure steady. Your doctor will decide which medicines you need and when you need them. If you have the impression that the effect of QUIFOL is too strong or too weak, tell your doctor or pharmacist. You will not be expected to give yourself QUIFOL. It will be given to you by a person who is qualified to do so.

If you receive more QUIFOL than you should

Since a healthcare provider will administer QUIFOL, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you forget to receive a dose of QUIFOL

Since a healthcare provider will administer QUIFOL, it is unlikely that the dose will be missed.

QUIFOL can have side effects. Not all side effects reported for QUIFOL are included in this leaflet. Should your general health worsen or if you experience any untoward effects while been given or after been given QUIFOL, please consult your healthcare provider for advice. The below listed side effects can happen during anesthesia when QUIFOL is administered. Your healthcare provider will be monitoring you during your procedure and will ensure that appropriate treatment is given to you if needed. If any of the following happens during your procedure, QUIFOL must be stopped. If you experience the below after your procedure tell your healthcare provider immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing (angioedema),
• rash or itching (erythema).

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to QUIFOL. You may need urgent medical attention or hospitalization.

Tell your healthcare provider immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• if you have pain, tightness, and a feeling of constriction in the chest and back with difficulty getting enough air or breathing (bronchospasm),
• changes in your breathing pattern (respiratory depression),
• slow or abnormally fast heartbeat (bradycardia, tachycardia) or abnormal heart rhythm (premature ventricular contractions),
• build-up of fluid in the lungs which can make you very breathless (pulmonary oedema),
• if you stop breathing for a period of 20 seconds or longer means you could have suffered from transient apnoea during induction,
• if you have been told that you have a chronic condition in which your heart doesn't pump blood as well as it should or you have shortness of breath, fatigue, swollen legs and rapid heartbeat, as you could suffer from cardiac failure,
• if you notice that you are going to urinate less than usual and you notice that you are swelling due to fluid retention and have nausea, fatigue and shortness of breath, this could mean that you have renal failure,
• you struggle to be woken up after the procedure has been completed (postoperative unconsciousness),
• you could have temporary loss of consciousness caused by a fall in blood pressure (syncope).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• pain where the drip for the anaesthesia was inserted (local pain on induction),
• your blood pressure has increased (hypertension) or you could have a drop in your blood pressure (hypotension),
• headaches during the recovery phase,
• your child could have a change in body temperature from hot to cold or cold to hot (flushing in children),
• you could feel nauseous or vomit while recovering from the procedure,
• children may experience withdrawal symptoms.

Less frequent side effects:

• If your skin is red, swollen, tender and warm to the touch in the affected area you could have phlebitis (inflammation of a vein),
• if you have leg pain or swelling of the legs, you could have thrombosis (clotting of your blood),
• twitching and shaking of your body, or a fit (epileptiform movements) or body movements that you cannot control (involuntary movement),
• unusual colour of urine (urine discolouration),
• you have a fever after the procedure,
• you have short sudden pain in your abdomen/back with nausea, or vomiting and loss of appetite you could have pancreatitis,
• you do not have the need or desire to be sexually active (sexual disinhibition),
• you feel very tired, weak with dizziness, vomiting, nausea and have a fever with chills and sweating, as you could be suffering from tissue necrosis.

Side effects with an unknown frequency:

• if you or your child are/is breathing fast with confusion and vomiting, you could be suffering from metabolic acidosis,
• if you or your child are/is tired, weak, nauseous, vomiting and have chest pain you could be suffering from hyperkalaemia,
• if you or your child have a feeling of always being happy and that nothing can go wrong (euphoric moods),
• you notice that you are taking medication more than usual to function through the day and can’t cope without taking unnecessary medication you might have a drug abuse problem or might have developed a drug dependency problem,
• your body parts such as your arms, legs move without you being aware of them doing so this could be involuntary movement,
• you have dark, reddish urine, a decreased amount of urine, weakness and muscle aches (rhabdomyolysis),
• you have previously had blood tests done and your doctor advised that you have hyperlipidaemia (high cholesterol),
• your doctor could tell you that you have a Brugada type ECG,
• you have pain where QUIFOL was given to you, with swelling in the area (local pain),
• you could suffer from an enlarged liver (hepatomegaly),
• you have an abnormal feeling or happiness and need to celebrate (excitation),
• you have continuous hiccups,
• involuntary muscle contractions that cause repetitive or twisting movements (dystonia) or abnormality or impairment of voluntary movement (dyskinesia),
• a prolonged erection of the penis, usually without sexual arousal (priapism).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website.

Aculife Healthcare: E-mail: [email protected]

By reporting side effects, you can help provide more information on the safety of QUIFOL.

Store all medicines out of reach of children. Store at or below 30 °C. Do not freeze OR refrigerate. Keep in original packaging until required for use. Do not store in a bathroom. Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist. Propofol is compatible with Glucose Intravenous Infusion 5%, Dextrose 5% in Lactate Ringers solution, Sodium chloride 0.9% w/v intravenous infusion, and Dextrose 4% with 0.18% sodium chloride intravenous infusion for 8 hour at room temperature. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).