Kaletra 80mg20mg1ml oral solution

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ritonavir; Lopinavir

Available from:

AbbVie Ltd

INN (International Name):

Ritonavir; Lopinavir

Dosage:

20mg/1ml ; 80mg/1ml

Pharmaceutical form:

Oral solution

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05030100; GTIN: 5013158768239 8054083016504

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
KALETRA (80 MG + 20 MG) / ML ORAL SOLUTION
(lopinavir + ritonavir)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU OR YOUR CHILD.
−
Keep this leaflet. You may need to read it again.
−
If you have any further questions, ask your doctor or pharmacist.
−
This medicine has been prescribed for you or your child only. Do not
pass it on to others. It
may harm them, even if their signs of illness are the same as yours.
−
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Kaletra is and what it is used for
2.
What you need to know before you or your child takes Kaletra
3.
How to take Kaletra
4.
Possible side effects
5.
How to store Kaletra
6.
Contents of the pack and other information
1.
WHAT KALETRA IS AND WHAT IT IS USED FOR
•
Your doctor has prescribed Kaletra to help to control your Human
Immunodeficiency Virus
(HIV) infection. Kaletra does this by slowing down the spread of the
infection in your body.
•
Kaletra is not a cure for HIV infection or AIDS.
•
Kaletra is used by children 14 days of age and older, adolescents and
adults who are infected
with HIV, the virus which causes AIDS.
•
Kaletra contains the active substances lopinavir and ritonavir.
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
discuss with you and determine which medicines are best for you.
2.
WHAT YOU NEED TO KNOW BEFORE YOU OR YOUR CHILD TAKES KALETRA
DO NOT TAKE KALETRA IF:
•
you are allergic to lopinavir, ritonavir or any of the other
ingredients of Kaletra (see section 6);
•
you have severe liver problems.
DO NOT TAKE KALETRA WITH ANY OF THE FOLLOWING MEDICINES:
•
astemizole or terfenadine (commonly used to treat allergy symptoms �

Summary of Product characteristics

OBJECT 1
KALETRA 80MG/20MG ORAL SOLUTION
Summary of Product Characteristics Updated 06-Jun-2018 | AbbVie
Limited
1. Name of the medicinal product
Kaletra (80 mg + 20 mg) / ml oral solution
2. 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.
3. Pharmaceutical form
Oral solution
The solution is light yellow to orange.
4. Clinical particulars
4.1 Therapeutic indications
Kaletra is indicated in combination with other antiretroviral
medicinal products for the treatment of
human immunodeficiency virus (HIV-1) infected adults, adolescents and
children aged from 14 days and
older.
The choice of Kaletra to treat protease inhibitor experienced HIV-1
infected patients should be based on
individual viral resistance testing and treatment history of patients
(see sections 4.4 and 5.1).
4.2 Posology and method of administration
Kaletra should be prescribed by physicians who are experienced in the
treatment of HIV infection.
Posology
_Adults and adolescents_
The recommended dosage of Kaletra is 5 ml of oral solution (400/100
mg) twice daily taken with food.
_Paediatric population aged from 14 days and older_
The oral solution formulation is the recommended option for the most
accurate dosing in children based
on body surface area or body weight. However, if it is judged
necessary to resort to solid oral dosage form
for children weighing less than 40 kg or with a BSA between 0.5 and
1.4 m
2
and able to swallow tablets,
Kaletra 100 mg/25 mg tablets may be used. The adult dose of Kaletra
tablets (400/100 mg twice daily)
may be used in children 40 kg or greater or with a Body Surface Ar