Table of Contents
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
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1. NAME OF THE MEDICINAL PRODUCT
Norvir 80 mg/ml oral solution
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of oral solution contains 80 mg of ritonavir.
Excipients:
Alcohol (43% v/v)
Polyoxyl 35 Castor Oil
Sunset Yellow (E110)
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Oral solution
The solution is a practically clear, orange solution for oral administration.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Ritonavir is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infected patients (adults and children of 2 years of age and older).
4.2 Posology and method of administration
Ritonavir should be administered by physicians who are experienced in the treatment of HIV infection.
Norvir solution is administered orally and should preferably be ingested with food.
Ritonavir dosed as a pharmacokinetic enhancer
When ritonavir is used as a pharmacokinetic enhancer with other protease inhibitors the Summary of Product Characteristics for the particular protease inhibitor must be consulted.
The following HIV-1 protease inhibitors have been approved for use with ritonavir as a pharmacokinetic enhancer at the noted doses.
Adult use:
Amprenavir 600 mg twice daily with ritonavir 100 mg twice daily
Atazanavir 300 mg once daily with ritonavir 100 mg once daily
Fosamprenavir 700 mg twice daily with ritonavir 100 mg twice daily
Lopinavirco-formulated with ritonavir (lopinavir/ritonavir) 400 mg/100 mg or 800 mg/200mg.
Saquinavir 1000 mg twice daily with ritonavir 100 mg twice daily
Tipranavir 500 mg twice daily with ritonavir 200 mg twice daily
Darunavir 600 mg twice daily with ritonavir 100 mg twice daily in antiretroviral treatment (ART) experienced patients
Darunavir 800mg once daily with ritonavir 100 mg once daily in ART-naïve patients
Paediatric use: Ritonavir is recommended for children 2 years of age and older. For further dosage recommendations, refer to the product information of other Protease Inhibitors approved for co-administration with ritonavir. Norvir is not recommended in children below 2 years of age due to lack of data on safety and efficacy.
Renal impairment: As ritonavir is primarily metabolise
