Kaletra 100mg25mg tablets

Country: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Ritonavir; Lopinavir

Fáanlegur frá:

AbbVie Ltd

INN (Alþjóðlegt nafn):

Ritonavir; Lopinavir

Skammtar:

25mg ; 100mg

Lyfjaform:

Tablet

Stjórnsýsluleið:

Oral

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: ; GTIN: 5013158778627

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE USER
KALETRA 100 MG/25 MG FILM-COATED TABLETS
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 2 years of age or 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 –
thes

Vara einkenni

OBJECT 1
KALETRA 100MG/25MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 06-Jun-2018 | AbbVie
Limited
1. Name of the medicinal product
Kaletra 100 mg/25 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 100 mg of lopinavir co-formulated
with 25 mg of ritonavir as a
pharmacokinetic enhancer.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
Pale yellow debossed with [Abbott logo] and “KC”.
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 children above the age
of 2 years, adolescents and
adults.
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.
Kaletra tablets must be swallowed whole and not chewed, broken or
crushed.
Posology
_Adults and adolescents_
The standard recommended dosage of Kaletra tablets is 400/100 mg (two
200/50 mg) tablets twice daily
taken with or without food. In adult patients, in cases where
once-daily dosing is considered necessary for
the management of the patient, Kaletra tablets may be administered as
800/200 mg (four 200/50 mg
tablets) once daily with or without food. The use of a once-daily
dosing should be limited to those adult
patients having only very few protease inhibitor (PI) associated
mutations (i.e. less than 3 PI mutations in
line with clinical trial results, see section 5.1 for the full
description of the population) and should take
into account the risk of a lesser sustainability of the virologic
suppression (see section 5.1) and higher risk
of diarrhoea (see section 4.8) compared to the recommended standard
twice-daily dosing.