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Propofol-Lipuro 10 mg/ml and 20 mg/ml

Product

Total
Volume
200 mg/ 20 ml

Propofol-Lipuro
10 mg/ml

200 mg/ 20 ml
500 mg/ 50 ml
1000 mg/100 ml

Container
Sales
Type
Unit
Glass
5 x 20 ml
Ampoule
Single Dose
10 x 20 ml
Glass Vial
Single Dose
10 x 50 ml
Glass Vial
Single Dose
10 x 100 ml
Glass Vial

Propofol-Lipuro 1% (10 mg/ml)


Propofol-Lipuro 2% (20 mg/ml)
Composition
Propofol-Lipuro 1% (10 mg/ml)
1 ml emulsion for injection or infusion contains 10 mg Propofol.
Excipients: Soya-bean oil, refined, medium-chain triglycerides, glycerol, egg lecithin, sodium oleate, water for injections.
Propofol-Lipuro 2% (20 mg/ml)
1 ml emulsion for injection or infusion contains 20 mg Propofol.
Excipients: Soya-bean oil, refined, medium-chain triglycerides, glycerol, egg lecithin, sodium oleate, water for injections.
Therapeutic indications
Propofol-Lipuro 10 mg/ml is a short-acting intravenous general anaesthetic for
- induction and maintenance of general anaesthesia in adults and
children > 1 month
- sedation of ventilated patients >16 years of age in the intensive
care unit
- sedation for diagnostic and surgical procedures, alone or in
combination with local or regional anaesthesia in adults and
children > 1 month.
Propofol-Lipuro 20 mg/ml is a short-acting intravenous general anaesthetic for
- induction and maintenance of general anaesthesia in adults and
children > 3 years
- sedation of ventilated patients >16 years of age in the intensive
care unit
- sedation for diagnostic and surgical procedures, alone or in
combination with local or regional anaesthesia in adults and
children > 3 years.
Contraindications
Propofol-Lipuro 10 mg/ml and Propofol-Lipuro 20 mg/ml are contraindicated in patients with a known hypersensitivity to propofol or to any
of the excipients.
Propofol-Lipuro 10 mg/ml and Propofol-Lipuro 20 mg/ml containing
soya-bean oil and should not be used in patients who are hypersensitive
to peanut or soya.
Propofol-Lipuro 10 mg/ml and Propofol-Lipuro 20 mg/ml must not be
used in patients of 16 years of age or younger for sedation for intensive
care.

Product
Propofol-Lipuro
20 mg/ml

Special warnings and precautions for use


Propofol should be given by those trained in anaesthesia (or, where
appropriate, doctors trained in the care of patients in Intensive Care).
Patients should be constantly monitored and facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment and
other resuscitative facilities should be readily available at all times.
Propofol should not be administered by the person conducting the
diagnostic or surgical procedure.
Undesirable effects
Induction and maintenance of anaesthesia or sedation with propofol
is generally smooth with minimal evidence of excitation. The most
commonly reported ADRs are pharmacologically predictable side effects of an anaesthetic/sedative agent, such as hypotension. The nature, severity and incidence of adverse events observed in patients
receiving propofol may be related to the condition of the recipients
and the operative or therapeutic procedures being undertaken.
Immune system disorders
Very rare: Anaphylaxis may include angioedema, bronchospasm,
erythema and hypotension
Metabolism and Nutritional disorder
Frequency not known (Not known as it cannot be estimated from the
available clinical trial data.): Metabolic acidosis, hyperkalaemia, hyperlipidaemia
Psychiatric disorders
Frequency not known: Euphoric mood, drug abuse (Drug abuse, predominantly by health care professionals.)
Nervous system disorders
Common: Headache during recovery phase
Rare: Epileptiform movements, including convulsions and opisthotonus
during induction, maintenance and recovery
Very rare: Postoperative unconsciousness
Frequency not known: Involuntary movements
Cardiac disorders
Common: Bradycardia (Serious bradycardias are rare. There have been
isolated reports of progression to asystole.)
Very rare: Pulmonary oedema
Frequency not known: Cardiac arrhythmia, cardiac failure, (Rapidly
progressive cardiac failure (in some cases with fatal outcome) in
adults. The cardiac failure in such cases was usually unresponsive
to inotropic supportive treatment.)
Vascular disorders
Common: Hypotension (Occasionally, hypotension may require use of
intravenous fluids and reduction of the administration rate of propofol.)

B. Braun Melsungen AG | Hospital Care | 34209 Melsungen | Germany


Tel. +49 5661 71-0 | www.bbraun.com

Total
Volume
1000 mg/50 ml

Container
Type
Single Dose
Glass Vial

Sales
Unit
10 x 50 ml

Uncommon: Thrombosis and phlebitis


Respiratory, thoracic and mediastinal disorders
Common: Transient apnoea during induction
Gastrointestinal disorders
Common: Nausea and vomiting during recovery phase
Very rare: Pancreatitis
Hepatobiliary disorders
Frequency not known: Hepatomegaly
Musculoskeletal and connective tissue disorders
Frequency not known: Rhabdomyolysis (Very rare reports of rhabdomyolysis have been received where propofol has been given at doses
greater than 4 mg/kg/hr for ICU sedation.)
Renal and urinary disorders
Very rare: Discolouration of urine following prolonged administration
Frequency not known: Renal failure
Reproductive system and breast
Very rare: Sexual disinhibition
General disorders and administration site conditions
Very common: Local pain on induction (May be minimised by using
the larger veins of the forearm and antecubital fossa. With PropofolLipuro local pain can also be minimised by the
co-administration of lidocaine.)
Investigations
Frequency not known: Brugada type ECG
Injury, poisoning and procedural complications
Very rare: Postoperative fever
Combinations of rhabdomyolysis, metabolic acidosis, hyperkalaemia,
hyperlipidaemia, hepatomegaly, renal failure and cardiac failure, reported as Propofol infusion syndrome, may be seen in seriously ill
patients who often have multiple risk factors for the development of
the events.
For prescription only!
Version 10/2011
Marketing authorization holder
B. Braun Melsungen AG
Carl-Braun-Strae 1
D-34212 Melsungen, Germany
See local Prescribing Information for full details, as Prescribing
Information may vary from country to country.

X. 00.00.00/0 Nr. 000 0000A

Go for the original Lipuro-Technology by B. Braun

Injectable Drugs

Injectable Drugs

Lipuro-Technology
Technology & Innovation:
Propofol-Lipuro is a highly innovative product from B. Brauns
unique Lipuro-Technology, which uses MCT/LCT lipid emulsion
as the drug delivery base with excellent solubility and stability.
Clinical approval:
Since its launch in 1999, Propofol-Lipuro has been administered
to millions of patients in over 120 countries. Data from clinical
studies have published in scores in prestigious medical journals.
Setting standards:
Propofol-Lipuro sets standards that inspire imitators. The clinical benefits of MCT/LCT are superior to LCT or MCT emulsions.
To date, Propofol-Lipuro remains the only formulation proven to
reduce pain on injection.
Service continuity:
In line with our slogan Sharing Expertise, Propofol-Lipuro is
further proof of B. Brauns continued commitment to patients and
doctors, hospital and community.
There is only one Propofol-Lipuro. Go for the original.

Clinical benefits of innovation


Propofol-Lipuro 10 mg/ml

Propofol-Lipuro 20 mg/ml

Significant reduction of injection pain

Reduced lipid and fluid load

Rapid onset and quick recovery

Improved lung function

Excellent anesthesia control

Enhanced liver function

Sustained immune function

Injectable Drugs

Propofol-Lipuro 10 mg/ml

Propofol-Lipuro 20 mg/ml

Minimum pain. Maximum comfort.


Local pain on propofol injection is a well-known problem in
anesthesiology, especially in pediatric settings. Compared to
conventional LCT or MCT emulsions, Propofol-Lipuro has been
formulated with 30 % less free propofol in the aqueous phase (a).
The result is a significant reduction in pain at the injection site.

Proven clinical benefits


B. Braun applied its over 30 years experience with lipid emulsions
in combining Lipuro-Technology with propofol. The result,
Propofol-Lipuro 20 mg/ml is an anesthetic with outstanding
safety and good tolerability. It is ideally suited for patients requiring long-term sedation.

Overall incidence of pain on injection

Severe pain reported on questioning

% of Patients

% of Patients

60

12

50

10

40

30

6
37 %

20

10

0
Propofol-Lipuro

Propofol-LCT

Fig. 1: Significantly reduced injection pain. Adapted from (b).

a) Mller RH, Harnisch S. Physico chemical characterization of propofol-loaded


emulsions and interaction with plasma proteins. Eur Hosp Pharm 2000; 6: 24-31
b) Larsen B, Beerhalter U, et al. Less pain on injection by a new formulation of
propofol? A comparison with propofol LCT. Anaesthesist 2001; 50(11): 842-5
c) Rau J, Roizen MF, et al. Propofol in an emulsion of long- and medium-chain
triglycerides: the effect on pain. Anesth Analg 2001; 93(2): 382-4

Neutrophils cell activity

days

% killed bacteria

15

90

p<0.05

p<0.05

80
10

70
60

0%

64 %

Ventilation period in COPD patients

10

10.7%

14

76.3%

79.4%

79.9%

67.4%

day 0

day 2

day 0

day 2

50
40

Propofol-Lipuro

Propofol-LCT

Fig. 2: Significantly reduced sensitivity to severe pain.


Adapted from (c).

0
MCT/LCT emulsion

LCT emulsion

Fig. 3: MCT/LCT lipid emulsion shortens ventilation period.


Adapted from (d).

d) Marsili I, Iovinelli G, et al. Parenteral nutrition in COPD patients: long vs. mediumchain triglycerides (MCT). Clinical Nutrition 1992; 11: 45, special supplement
e) Waitzberg DL, Bellinati-Pires R, et al. Effect of total parenteral nutrition with
different lipid emulsions on human monocyte and neutrophil funcions.
Nutrition 1997; 13: 128-132

MCT/LCT emulsion

LCT emulsion

Fig. 4: MCT/LCT lipid emulsion sustains immune function.


Adapted from (e).

Injectable Drugs

Propofol-Lipuro: Continuously pioneer


Lipuro-Technology: Perfectly documented

1984
Lipofundin MCT/LCT
First MCT/LCT emulsion
is developed

Literature on ...
Reduction of injection pain

Pediatric patients

1999
Propofol-Lipuro 10 mg/ml First propofol in MCT/LCT
emulsion is launched
Bachmann-Mennenga B, Ohlmer A, et al.
Incidence of pain after intravenous injection of
a medium-/long-chain triglyceride
emulsion of propofol. An observational study
in 1375 patients.
Arzneimittelforschung 2003; 53(9): 621-6

2001
Propofol-Lipuro 20 mg/ml
First Propofol 20 mg/ml in
MCT/LCT emulsion is
introduced
4.

Kam E, Abdul-Latif MS, et al. Comparison of


Propofol-Lipuro with propofol mixed with
lidocaine 10 mg on propofol injection pain.
Anaesthesia 2004; 59(12): 1167-9

1.

Larsen B, Beerhalter U, et al. Less pain on


injection by a new formulation of propofol?
A comparison with propofol LCT.
Anaesthesist 2001; 50(11): 842-5

2.

Rau J, Roizen MF, et al. Propofol in an


emulsion of long- and medium-chain
triglycerides: the effect on pain.
Anesth Analg 2001; 93(2): 382-4

3.

8.

Nagao N, Uchida T, et al. Medium-/long-chain


triglyceride emulsion reduced severity of pain
during propofol injection.
Can J Anaesth 2005; 52(6): 660-1

9.

Nishiyama T. How to decrease pain at


rapid injection of propofol: effectiveness of
flurbiprofen.
J Anesth 2005; 19(4): 273-6

10. Ohmizo H, Obara S, et al. Mechanism of


injection pain with long and long-medium
chain triglyceride emulsive propofol.
Can J Anaesth 2005; 52(6): 595-9

11. Sun NC, Wong AY, et al. A comparison of


pain on intravenous injection between two
preparations of propofol.
Anesth Analg 2005; 101(3): 675-8

12. Yamakage M, Iwasaki S, et al. Comparative


study between propofol in a long-chain
triglyceride and propofol in a medium/longchain triglyceride during sedation with
targetcontrolled infusion.
Anaesth Intensive Care 2005; 33(3): 351-5

Improved lung function

Enhanced liver function

Sustained immune function

5.

Kunitz O, Losing R, et al. Propofol-LCT versus


propofol-MCT/LCT with or without lidocaine:
a comparison on pain on injection.
Anasthesiol Intensivmed Notfallmed
Schmerzther 2004; 39(1): 10-4

15. Ozawa A, Isono M, et al. Comparison of


propofol LCT and propofol MCT/LCT regarding
the injection pain at different sites and the
memory.
Masui 2005; 54 (11): 1241-6

16. Elliot SC, Mallick A, et al. A prospective


randomised double-blind comparison of
propofolLipuro vs propofol with or without
lidocaine: effect on injection pain.
Anesthesia 2006; 61: 81-2

17. Liljeroth A, Low-dose propofol reduces reduces


the incidence of moderate to severe local pain
induced by the main dose;
Acta Anesthesiol Scand 2007; 521: 460-463

18. Krobbuaban B, Does Addition of Lidocaine to


Medium- and Long-Chain Triglyceride Propofol
Emulsions Significantly Reduce Pain on Injection?
J Med Assoc Thai 2008; 91 (3): 383-7

19. Sethi N, Prevention of Propofol Pain: A


Comperative Study,
M.E.J. Anesth 20 (1), 2009, 71-74

20. Bresson JL, Narcy P, et al. Energy substrate


competition: comparative study of LCT and
MCT utilization during continuos TPN in
infants.
Clinical Nutrition 1986; 5, 54, Special
supplement

21. Lai HS, Chen WJ. Effects of medium and


long-chain triacylglycerols in pediatric surgical
patients.
Nutrition 2000; 16: 401-406

22. Larsen R, Beerhalter U, et al. Propofol in a new


formulation (Propofol MCT/LCT): Effect on
injection pain in children.
A comparison with Propofol-LCT Anaesthesist,
2001; 50: 676-678

23. Angsten G, Boberg M, et al. Metabolic effects


in neonates receiving intravenous mediumchain triglycerides.
Acta Paediatr 2002; 91: 188-197

24. Donnell SC, Lloyd DA, et al. The metabolic


response to intravenous medium-chain
triglycerides in infants after surgery.
J. Pediatr 2002;141:689-694

28. Lnstedt B, Deltz E, et al. Randomisierte Studie


zum Vergleich zwischen langkettigen (LCT)
und mittelkettigen (MCT) Triglyceriden als
Kalorientrger in der ostoperativen Ernhrungstherapie.
Infusionstherapie 1987; 14: 61-64

29. Dennison AR, Ball M, et al. Total parenteral


nutrition using conventional and mediumchain
triglycerides: effects on liver function tests,
complement, and nitrogen balance.
JPEN 1988; 12: 15-19

30. Ball M. Parenteral nutrition in the critically ill:


use of a medium-chain triglyceride emulsion.
Intensive Care Med 1993; 19: 89-95

31. Marsili I, Iovinelli G, et al. Parenteral


nutritionin COPD patients: long vs. mediumchain triglycerides (MCT).
Clinical Nutrition 1992; 11: 45, special
supplement

32. Smyrniotis VE, Kostopanagiotou GG, et al.


Long-chain versus medium-chain lipids in
acute pancreatitis complicated by acute
respiratory distress syndrome: effects on
pulmonary hemodynamics and gas exchange.
Clinical Nutrition 2001; 20:1 39-143

33. Faucher M, Bregeon F, et al. Cardiopulmonary


effects of lipid emulsions in patients with
ARDS.Chest 2003; 124: 285-291

35. Goulet O, Postaire M, et al. Medium-chain


triglycerides and long-term parenteral
nutrition in children.
Nutrition 1992; 8: 333-337

36. Kuse ER, Kemnitz J, et al. Fat emulsions in


parenteral nutrition after liver transplantation:
the recovery of the allografts RES function and
histological observations.
Clinical Nutrition 1990; 9: 331-336

37. Carpentier YA, Siderova V, et al. Long-term


TPN and liver dysfunction. Clinical Nutrition
1989; 8: 31, special supplement

38. Gelas P, Cotte L, et al. Effect of parenteral medium and long-chain triglycerides on lymphocytes
subpopulations and functions in patients with
acquired immunodeficiency syndrome:
a prospective study. JPEN 1998; 22: 67-71

39. Waitzberg DL, Bellinati-Pires R, et al. Effect of


total parenteral nutrition with different lipid
emulsions on human monocyte and neutrophil
functions.
Nutrition 1997; 13: 128-132

27. Soltsz S, Effect of a 0.5% Dilution of Propofol


on Pain on Injection during Induction of
Anesthesia in Children,
Anesthesiology 2007; 106:80-4

Facilitated lipid metabolism

2002
Propofol-Lipuro 10 mg/ml First propofol for induction and
maintenance of anesthesia in
children one month or older

34. Theilen HJ, Adam S, et al. Propofol in a


Medium-Long-Chain Triglyceride Emulsion:
Pharmcological Characteristics and Potential
Beneficial Effects.
Anesth Analg 2002; 95: 923-9

6.

2008
Propofol-Lipuro 5 mg/ml
First Propofol 5 mg/ml in
MCT/LCT emulsion is
introduced
Auerswald K, Pfeiffer F, et al. Pain on injection
with propofol. Anasthesiol Intensivmed
Notfallmed Schmerzther 2005; 40(5): 259-66

7.

2012
Propofol-Lipuro is
marketed in > 120
countries

Liljeroth E, Akeson J. Less local pain on


intravenous infusion of a new propofol
emulsion.
Acta Anaesthesiol Scand 2005; 49(2): 248-51

13. Yamakage M, Iwasaki S, et al. Changes


in concentrations of free propofol by
modification of the solution.
Anesth Analg 2005; 101(2): 385-8

14. Yew WS, Chong SY, et al. The effects of


intravenous lidocaine on pain during
injection of medium-and long-chain
triglyceride propofol emulsions.
Anesth Analg 2005; 00(6): 1693-5

25. Menci RA. A comparative study on effects of


lipid emulsions in neonatal TPN.
Clinical Nutrition 2004; 23: 906

26. Rochette A, Avoiding propofol injection pain in


children: a prospective, randomized, doubleblinded, placebo-controlled study BJA 2008