10 mg / ml and 20 mg / ml solution for injection / infusion, emulsion
propofol
1. What Diprivan is and what it is used for
Diprivan belongs to a group of medicines called anesthetics (general anesthetics). Anesthetics are used to induce unconsciousness (deep sleep) so that operations or other procedures can be performed. They can also be used as sedatives (so that you become sleepy, but do not fall asleep completely).
Diprivan is also used as a sedative in medical examinations and intensive care of patients on a respirator.
Diprivan is given as an injection by a doctor.
Diprivan 10 mg / ml is used:
- to induce and maintain anesthesia in adults and children over 1 month.
- as sedatives for adults and children over 1 month in diagnostic and surgical procedures, alone or combined with local or regional anesthesia.
- as a sedative for people over the age of 16 who receive artificial respiration in the intensive care unit.
Diprivan 20 mg / ml is used:
- to induce and maintain anesthesia in adults and children over 3 years of age.
- as sedatives for adults and children over 3 years of age in diagnostic and surgical procedures, alone or in combination with local or regional anesthesia.
- as a sedative for people over the age of 16 who receive artificial respiration in the intensive care unit.
Propofol contained in Diprivan may also be approved for the treatment of diseases not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
2. What you need to know before you are given Diprivan
You should not be given Diprivan
- if you are allergic to propofol or any of the other ingredients of this medicine (listed in section 6).
- if you are allergic to peanuts or soy, Diprivan contains soybean oil.
- as a sedative in intensive care if you are 16 years or younger.
Warnings and cautions
Talk to your doctor or nurse before giving Diprivan
- if you have impaired kidney, liver, heart, or respiratory function.
- if you have lost extremely much blood or have a reduced general condition.
- if you have very high levels of fat in your blood or disorders of fat metabolism in your body.
- if you have an increased risk of zinc deficiency, e.g. if you have burns, diarrhea, and/or severe blood poisoning.
- if you have epilepsy.
- if you have a so-called mitochondrial disease (a disease that is linked to a defect in the cells’ energy production).
You may feel overwhelmed after using Diprivan. You should therefore be accompanied by someone when you leave the hospital. Your doctor will tell you how long you have to wait before you can do demanding and risky tasks such as driving a car and how to use other medicines or substances that can cause drowsiness, such as alcohol, benzodiazepines, and strong painkillers (opiates).
Children and young people
Diprivan is not recommended for newborns.
Diprivan 20 mg/ml is not recommended for use in children below 3 years of age.
Other medicines and Diprivan
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Tell your doctor if you use
- certain sedatives and painkillers such as benzodiazepines and opiates as they may increase the effects of Diprivan.
- rifampicin as it may cause low blood pressure during anesthesia.
- midazolam (used to induce sedation (a very relaxed state of calm, drowsiness, or sleep) and relieves anxiety and muscle tension).
Pregnancy, breastfeeding, and fertility
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or nurse for advice before taking this medicine.
Diprivan should not be given to pregnant women unless clearly necessary.
You should not breast-feed for 24 hours after receiving Diprivan. Breast milk produced during the period must be discarded.
Driving and using machines
Once you have received Diprivan, you may feel sleepy for a while. Do not drive or use any tools or machines until you are sure the effects have disappeared.
- If you can go home shortly after receiving Diprivan, do not drive or use any tools or machines.
- Ask your doctor when you can start these activities again and when you can return to work.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Diprivan contains sodium and soybean oil
This medicine contains less than 1 mmol (23 mg) sodium per milliliter, ie it is essentially ‘sodium-free’.
Diprivan contains soybean oil. If you are allergic to peanuts or soy, do not use this medicine.
How to take Diprivan
The medicine is given to you by healthcare professionals with special training in anesthesia/pain relief, or by healthcare professionals with special expertise in intensive care.
The dose you receive varies depending on your age, body weight, and physical condition. Your doctor will give you the right dose to start and maintain anesthesia or to achieve the necessary degree of calm and sleepiness, by looking closely at your reaction and your body functions ( heart rate, blood pressure, respiration, etc.).
Several different medications may be needed to keep you asleep or sleepy, painless, to maintain breathing and keep blood pressure steady. Your doctor will decide which medicines you need and when you need them.
For adults and children over 3 years of age, both Diprivan 10 mg/ml and Diprivan 20 mg/ml are used. However, when Diprivan 10 mg/ml and Diprivan 20 mg/ml are given as sedatives to patients receiving artificial respiration in the intensive care unit, patients must be over 16 years of age.
For children over 1 month and up to 3 years, only Diprivan 10 mg/ml is used, and only for anesthesia or sedatives. However, Diprivan should not be used for anesthesia in newborns.
After the anesthesia, the care staff makes sure that you have recovered enough before you can go home.
If you have any further questions on the use of this product, ask your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
During the onset of anesthesia, low blood pressure and transient respiratory disturbances may occur.
Very common (may affect more than 1 user in 10):
- local pain near the injection site at the beginning of treatment
Common (may affect up to 1 in 10 people):
- low blood pressure
- slow pulse
- transient respiratory disturbances when you start taking Diprivan
- nausea, vomiting, and headache when you stop taking Diprivan
Uncommon (may affect up to 1 in 100 people):
- blood clot
- inflammation of a blood vessel
Rare (may affect up to 1 in 1,000 people):
- epilepsy-like movements, including generalized convulsions and convulsions that cause the body to bend backward like an arch and rest on the neck and heels (opisthotonus)
Very rare (may affect up to 1 in 10,000 people):
- inflammation of the pancreas
- fluid accumulation in the lungs
- unconsciousness after surgery
- discoloration of the urine
- fever after surgery
- skin damage at the injection site, if the medicine is not injected correctly
- severe allergic reaction ( anaphylaxis ) which may manifest as swelling of the skin and mucous membranes ( angioedema ), cramps in the tracheal muscles, abnormal redness of the skin, and low blood pressure
- sexual arousal
Has been reported (occurs in an unknown number of users):
- unexplained muscle pain, muscle cramps, or muscle weakness ( rhabdomyolysis )
- abnormally low pH in the body (metabolic acidosis )
- enlarged liver
- kidney failure
- high levels of potassium in the blood
- high levels of blood fats ( hyperlipidemia )
- exhilaration
- drug abuse
- involuntary movements
- changes in ECG curve
- heart rhythm disorders
- heart failure
- slow or weak breathing ( respiratory depression )
- local pain and swelling at the injection site, if the medicine has not been injected correctly.
5. How to store Diprivan
Store between 2 ° C to 25 ° C. Do not freeze. Shake before use.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton or ampoule / glass after EXP. The expiration date is the last day of the specified month.
Do not use Diprivan if you notice any visible signs of deterioration.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is propofol. 1 ml contains 10 mg and 20 mg of propofol, respectively.
- The other ingredients are soybean oil, egg phospholipids, glycerol , sodium edetate, sodium hydroxide and water for injections.
What the medicine looks like and contents of the pack
Diprivan is an emulsion for injection or infusion , available in the following packages:
Diprivan 10 mg / ml
Ampoule , glass, 5×20 ml
Vial , glass 50 ml
Pre-filled syringe , glass (for syringe pump) 50 ml
Diprivan 20 mg / ml
Vial , glass 50 ml
Pre-filled syringe , glass (for syringe pump) 50 ml
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Aspen Pharma Trading Limited
3016 Lake Drive, Citywest Business Campus
Dublin 24, Ireland
Tel .: 0046 856642572
Manufacturer:
AstraZeneca UK Ltd
Macclesfield
Cheshire SK 10 2NA
UK
Corden Pharma SpA
Viale dell`Industria 3
200 40 Caponago (Milan)
Italy