KALETRA Oral solution Ref.[107473] Active ingredients: Lopinavir Lopinavir and Ritonavir Ritonavir

Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany

Product name and form

Kaletra (80 mg + 20 mg) / ml oral solution.

Pharmaceutical Form
Oral solution. The solution is light yellow to orange.

Qualitative and quantitative composition

Each 1 ml of Kaletra oral solution contains 80 mg of lopinavir co-formulated with 20 mg of ritonavir as a pharmacokinetic enhancer.

Excipients with known effect:

Each 1 ml contains 356.3 mg of alcohol (42.4% v/v), 168.6 mg of high fructose corn syrup, 152.7 mg of propylene glycol (15.3% w/v) (see section 4.3), 10.2 mg of polyoxyl 40 hydrogenated castor oil and 4.1 mg of acesulfame potassium (see section 4.4).

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Lopinavir	Lopinavir is an inhibitor of the HIV-1 and HIV-2 proteases. Inhibition of HIV protease prevents cleavage of the gag-pol polyprotein resulting in the production of immature, non-infectious virus.
Lopinavir and Ritonavir	Lopinavir provides the antiviral activity of lopinavir/ritonavir. Lopinavir is an inhibitor of the HIV-1 and HIV-2 proteases. Inhibition of HIV protease prevents cleavage of the gag-pol polyprotein resulting in the production of immature, non-infectious virus.
Ritonavir	Ritonavir is an orally active peptidomimetic inhibitor of the HIV-1 and HIV-2 aspartyl proteases. Inhibition of HIV protease renders the enzyme incapable of processing the gag-pol polyprotein precursor which leads to the production of HIV particles with immature morphology that are unable to initiate new rounds of infection. Ritonavir has selective affinity for the HIV protease and has little inhibitory activity against human aspartyl proteases. Pharmacokinetic enhancement by ritonavir is based on ritonavir’s activity as a potent inhibitor of CYP3A-mediated metabolism.

List of Excipients
Oral solution contains: Alcohol (42.4% v/v) High fructose corn syrup Propylene glycol (15.3% w/v) Purified water Glycerol Povidone Magnasweet-110 flavour (mixture of monoammonium glycyrrhizinate and glycerol) Vanilla flavour (containing p-hydroxybenzoic acid, p-hydroxybenzaldehyde, vanillic acid, vanillin, heliotropin, ethyl vanillin) Polyoxyl 40 hydrogenated castor oil Cotton candy flavour (containing ethyl maltol, ethyl vanillin, acetoin, dihydrocoumarin, propylene glycol) Acesulfame potassium Saccharin sodium Sodium chloride Peppermint oil Sodium citrate Citric acid Levomenthol

Pack sizes and marketing

Kaletra oral solution is supplied in amber coloured multiple-dose polyethylene terephthalate (PET)
bottles in a 60 ml size.

Two pack sizes are available for Kaletra oral solution:

120 ml (2 bottles x 60 ml) with 2 × 2 ml syringes with 0.1 ml graduations
For volumes up to 2 ml. For larger volumes an alternative pack is available.
300 ml (5 bottles x 60 ml) with 5 × 5 ml syringes with 0.1 ml graduations
For volumes greater than 2 ml. For smaller volumes an alternative pack is available.

Marketing authorization holder

AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany

Marketing authorization dates and numbers

EU/1/01/172/003
EU/1/01/172/009

Date of first authorisation: 20 March 2001
Date of latest renewal: 20 March 2011

Drugs

Drug	Countries
KALETRA	Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

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