Tenkasi (previously Orbactiv)

Land: Europese Unie

Taal: Engels

Bron: EMA (European Medicines Agency)

Werkstoffen:

oritavancin (diphosphate)

Beschikbaar vanaf:

Menarini International Operations Luxembourg S.A.

ATC-code:

J01XA05

INN (Algemene Internationale Benaming):

oritavancin

Therapeutische categorie:

Antibacterials for systemic use,

Therapeutisch gebied:

Soft Tissue Infections; Skin Diseases, Bacterial

therapeutische indicaties:

Tenkasi is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults and paediatric patients aged 3 months and older (see sections 4.2, 4.4 and 5.1).Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Product samenvatting:

Revision: 14

Autorisatie-status:

Authorised

Autorisatie datum:

2015-03-19

Bijsluiter

41
B. PACKAGE LEAFLET
42
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TENKASI 400 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
oritavancin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Tenkasi is and what it is used for
2.
What you need to know before you are given Tenkasi
3.
How you will be given Tenkasi
4.
Possible side effects
5.
How to store Tenkasi
6.
Contents of the pack and other information
1.
WHAT TENKASI
IS AND WHAT IT IS USED FOR
Tenkasi
is an antibiotic that contains the active substance oritavancin.
Oritavancin is a type of
antibiotic (a lipoglycopeptide antibiotic) that can kill or stop the
growth of certain bacteria.
Tenkasi
is used to treat infections of the skin and underlying tissues.
It is for use in adults and paediatric patients aged 3 months and
older.
Tenkasi can only be used to treat infections caused by bacteria known
as Gram-positive bacteria. In
mixed infections where other types of bacteria are suspected, your
doctor will give you other
appropriate antibiotics together with Tenkasi.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN TENKASI
YOU MUST NOT BE GIVEN TENKASI
-
if you are allergic to oritavancin or any of the other ingredients of
this medicine (listed in
section 6).
-
if it is expected that you may need to be given a blood thinning
medicine (unfractionated heparin
sodium) within 5 days (120 hours) of the dose of Tenkasi.
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before receiving Tenkasi if you:
•
have ever had an allergic reaction to another glycopeptide antibiotic
(such as vancomycin and
telavancin)
•
have developed severe diarrhoea during or following antibiotic
treatment in the past
•
have or

Productkenmerken

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Tenkasi 400 mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains oritavancin diphosphate equivalent to 400 mg
oritavancin.
After reconstitution, 1 ml of the solution contains 10 mg oritavancin.
After dilution, 1 ml of the solution for infusion contains 1.2 mg
oritavancin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion (powder for
concentrate).
White to off-white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tenkasi is indicated for the treatment of acute bacterial skin and
skin structure infections (ABSSSI) in
adults and paediatric patients aged 3 months and older (see sections
4.2, 4.4 and 5.1).
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
1 200 mg administered as a single dose by intravenous infusion over 3
hours.
_Paediatric patients aged 3 months to < 18 years _
15 mg/kg administered as a single dose by intravenous infusion over 3
hours (maximum 1 200 mg).
Please refer to Table 1 for relevant example, and to section 6.6 for
further details.
TABLE 1: 15 MG/KG BODY WEIGHT DOSE OF ORITAVANCIN: 3-HOUR INFUSION
(CONCENTRATION OF 1.2
MG/ML)
PATIENT’S WEIGHT
(KG)
CALCULATED
ORITAVANCIN DOSE
(MG)
TOTAL INFUSION
VOLUME
(ML)
VOLUME OF
RECONSTITUTED
ORITAVANCIN
(ML)
VOLUME OF D5W
TO ADD TO IV BAG
(ML)
5
75
62.5
7.5
55
10
150
125
15
110
15
225
187.5
22.5
165
3
20
300
250
30
220
25
375
312.5
37.5
275
30
450
375
45
330
35
525
437.5
52.5
385
40
600
500
60
440
Special populations
_Elderly (≥ 65 years) _
No dose adjustment is required for patients ≥ 65 years of age (see
section 5.2).
_Renal impairment _
No dose adjustment is needed in patients with mild or moderate renal
impairment. Very limited data
are available in patients with severe renal impairment. Renal
impairment had no c