Kaletra

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Lopinavir 100mg; Ritonavir 25mg ((pharmacokinetic enhancer))

Available from:

AbbVie Limited

INN (International Name):

Lopinavir 100 mg

Dosage:

100mg/25mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Lopinavir 100mg Ritonavir 25mg ((pharmacokinetic enhancer)) Excipient: Colloidal silicon dioxide Copovidone Opadry yellow 85F32450 Sodium stearyl fumarate Sorbitan laurate

Units in package:

Bottle, HDPE with polypropylene cap, 60 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

AbbVie S.r.l

Therapeutic indications:

Kaletra is indicated for the treatment of HIV-1 infection, in combination with other antiretroviral agents in adults and children aged 2 years and older.

Product summary:

Package - Contents - Shelf Life: Bottle, HDPE with polypropylene cap - 60 tablets - 3 years from date of manufacture stored at or below 30°C

Authorization date:

2007-05-17

Patient Information leaflet

KALETRA
Version 23
KALETRA
_TABLETS AND ORAL SOLUTION _
_lopinavir and ritonavir _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Kaletra.
It does not contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Kaletra against
the benefits they expect it will have
on you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT KALETRA IS
USED FOR
Kaletra is used to control Human
Immunodeficiency Virus (HIV)
infection in adults and children 2
years of age and older. Kaletra does
this by slowing down the spread of
the infection in your body.
Kaletra is an antiretroviral medicine.
It belongs to a group of medicines
called protease inhibitors.
Kaletra is prescribed for use in
combination with other antiviral
medicines. Your doctor will
determine which medicines are best
for you.
Kaletra is available only with a
doctor's prescription.
Kaletra is not addictive.
BEFORE YOU TAKE
KALETRA
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE KALETRA IF YOU HAVE AN
ALLERGY TO:
−
any medicine containing lopinavir
or ritonavir;
−
any of the ingredients listed at the
end of this leaflet.
Some symptoms of an allergic
reaction may include:
˗
shortness of breath;
˗
wheezing or difficulty breathing;
˗
swelling of the face, lips, tongue
or other parts of the body;
˗
hives, rash or itching of the skin.
DO NOT TAKE KALETRA IF YOU HAVE
SEVERE LIVER PROBLEMS.
DO NOT TAKE KALETRA IF YOU ARE
PREGNANT.
If may affect your developing baby if
you take it during pregnancy.
DO NOT BREASTFEED IF YOU ARE TAKING
THIS MEDICINE.
The active ingredient in Kaletra
passes into breast milk and there is a
possibility your baby may be
affected.
DO NOT GIVE KALETRA TO A CHILD
UNDER THE AGE OF 2 YEARS.
DO NOT TAKE KALETRA WITH ANY OF THE
FOLLOWING MEDICINES:
−
alfuz

Summary of Product characteristics

Kaletra Tablets and Oral Solution
Version 30
6 May 2020
Page 1 of 57
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
KALETRA

100 mg/25 mg film-coated tablets
KALETRA

200 mg/50 mg film-coated tablets
KALETRA

80 mg/20 mg per mL oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
FILM-COATED TABLETS
Kaletra 100/25 mg: Each film-coated tablet contains 100 mg of
lopinavir co-formulated with 25 mg of
ritonavir as a pharmacokinetic enhancer.
Kaletra 200/50 mg: Each film-coated tablet contains 200 mg of
lopinavir co-formulated with 50 mg of
ritonavir as a pharmacokinetic enhancer.
ORAL SOLUTION
Kaletra 80/20 mg: Each 1 mL of oral solution contains 80 mg of
lopinavir co-formulated with 20 mg of
ritonavir as a pharmacokinetic enhancer.
EXCIPIENTS WITH KNOWN EFFECT
Kaletra oral solution contains alcohol (42.4% v/v), high fructose
maize syrup, propylene glycol (15.3% w/v)
(see section 4.3), Castor oil – PEG 40 hydrogenated and acesulfame
potassium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
FILM-COATED TABLETS
Kaletra 100/25 mg film-coated tablets are pale yellow, debossed with
the Abbott logo
and ‘KC’.
Kaletra 200/50 mg tablets are yellow, ovaloid, film-coated tablets
debossed with the Abbott logo
and
‘KA’.
ORAL SOLUTION
Kaletra oral solution is a light yellow to golden coloured liquid,
supplied in 60 mL amber-coloured multiple-
dose bottle containing 400 mg lopinavir and 100 mg ritonavir per 5 mL
marked dosing syringe, equivalent to
80 mg lopinavir and 20 mg ritonavir per 1 mL of oral solution.
Kaletra Tablets and Oral Solution
Version 30
6 May 2020
Page 2 of 57
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Kaletra is indicated for the treatment of HIV-1 infection, in
combination with other antiretroviral agents in
adults and children aged 2 years and older. This indication is based
on analyses of plasma HIV RNA levels
and CD4 cell counts from controlled clinical studies (see section 5.1
- Clinical Efficacy and Safety Results).
4.2 DOSE AND METHOD OF ADMINISTRATION
FIL