Kaletra

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

lopinavir, ritonavir

Διαθέσιμο από:

AbbVie Deutschland GmbH Co. KG

Φαρμακολογική κατηγορία (ATC):

J05AR10

INN (Διεθνής Όνομα):

lopinavir, ritonavir

Θεραπευτική ομάδα:

Antivirals for systemic use, Protease inhibitors

Θεραπευτική περιοχή:

HIV Infections

Θεραπευτικές ενδείξεις:

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.

Περίληψη προϊόντος:

Revision: 61

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2001-03-19

Φύλλο οδηγιών χρήσης

124
9.
SPECIAL STORAGE CONDITIONS
STORE IN A REFRIGERATOR
In use storage: If kept outside of the refrigerator, do not store
above 25

C and discard any unused
contents after 42 days (6 weeks). It is advised to write the date of
removal from the refrigerator on the
package.
10.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
11.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
AbbVie (logo)
12.
MARKETING AUTHORISATION NUMBER(S)
13.
BATCH NUMBER
Lot
14.
GENERAL CLASSIFICATION FOR SUPPLY
15.
INSTRUCTIONS ON USE
16.
INFORMATION IN BRAILLE
17.
UNIQUE IDENTIFIER – 2D BARCODE
18.
UNIQUE IDENTIFIER - HUMAN READABLE DATA
125
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
200 MG/50 MG TABLETS – CARTON OF 1 BOTTLE
1.
NAME OF THE MEDICINAL PRODUCT
Kaletra 200 mg/50 mg film-coated tablets
lopinavir/ritonavir
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
Each film-coated tablet contains 200 mg of lopinavir co-formulated
with 50 mg of ritonavir as a
pharmacokinetic enhancer.
3.
LIST OF EXCIPIENTS
4.
PHARMACEUTICAL FORM AND CONTENTS
120 film-coated tablets
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
Read the package leaflet before use.
Oral use
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE SIGHT AND REACH OF CHILDREN
Keep out of the sight and reach of children.
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
8.
EXPIRY DATE
EXP
9.
SPECIAL STORAGE CONDITIONS
10.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
126
11.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany
12.
MARKETING AUTHORISATION NUMBER(S)
EU/1/01/172/004
13.
BATCH NUMBER
Lot
14.
GENERAL CLASSIFICATION FOR SUPPLY
15.
INSTRUCTIONS ON USE
16.
INFORMATION IN BRAILLE
Kaletra 200 mg/50 mg tablets
17.
UNIQUE IDENTIFIER – 2D BARCODE
2D barcode carrying the unique identifier included.
18.
UNIQUE IDENTIFIER –

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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 Area
(BSA)* greater than 1.4 m
2
. Kaletra tablets are administered