Zevtera 500mg powder for concentrate for solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ceftobiprole medocaril sodium

Available from:

Correvio UK Ltd

ATC code:

J01DI01

INN (International Name):

Ceftobiprole medocaril sodium

Dosage:

500mg

Pharmaceutical form:

Powder for solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010201; GTIN: 7640137530938

Patient Information leaflet

1
PACKAGE LEAFLET
This medicine is subject to additional monitoring. This will allow
quick identification of new
information. You can help by reporting any side effects you may get.
See the end of section 4 for how to
report side effects
READ ALL OF THIS LEAFLET CAR
INFORMATION FOR YOU
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your
-
If you get any side effects,
listed in this leaflet.
WHAT IS IN THIS LEAFLET
1.
What Zevtera is and what it is used for
2.
What you need to know before
3.
How to use Zevtera
4.
Possible side effects
5.
How to store Zevtera
6.
Contents of the pack and other
1.
WHAT
Zevtera is an antibiotic medicine that contains the active substance
to a group of medicines called
Zevtera is used to treat adults with infections of the lungs called
‘pneumonia’.
Zevtera works by killing certain bacteria, which can cause serious
lung infections.
2.
WHAT YOU
DO NOT USE
-
if you are allergic to
(listed in section
-
if you are allergic to other
-
if you have had previous severe allergic reactions
Do not use Zevtera
being given
WARNINGS AND PRECAUTIONS
Talk to your doctor
-
if you have kidney
-
if you have ever had any allergic reactions to other antibiotics like
penicillin or carbapenem
-
if you have ever had fits (seizures or convulsions)
-
if you have d
inflammation of the bowel known as ‘colitis’).
FIRST CHECKING WITH YOUR DOCTOR
-
if you are HIV positive
-
if your immune system is severely weakened
-
if your white blood counts are very low or your bone marrow function
is suppressed
ZEVTERA
This medicine is subject to additional monitoring. This will allow
quick identification of new
information. You can help by reporting any side effects you may get.
See the end of section 4 for how to
report side effects
READ ALL OF THIS LEAFLET CAR
INFORMATION FOR YOU.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your
If you get any side effects,
listed in this leaflet.
WHAT IS IN THIS LEAFLET
What Zevtera is and what

Summary of Product characteristics

OBJECT 1
ZEVTERA 500 MG POWDER FOR CONCENTRATE FOR
SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 18-Nov-2015 | Basilea
Pharmaceutica International Ltd
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
Zevtera 500 mg powder for concentrate for solution for infusion.
2. Qualitative and quantitative composition
Each vial contains 500 mg of ceftobiprole (as 666.6 mg ceftobiprole
medocaril sodium). After
reconstitution, each mL of concentrate contains 50 mg ceftobiprole (as
66.7 mg of ceftobiprole medocaril
sodium).
Excipient (s) with known effect:
Each vial contains approximately 1.3 mmol (29 mg) sodium.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for concentrate for solution for infusion.
White, yellowish to slightly brownish, cake to broken cake or powder.
The pH of the reconstituted solution is between 4.5 and 5.5.
4. Clinical particulars
4.1 Therapeutic indications
Zevtera is indicated for the treatment of the following infections in
adults (see sections 4.4 and 5.1):
- Hospital-acquired pneumonia (HAP), excluding ventilator-associated
pneumonia (VAP)
- Community-acquired pneumonia (CAP)
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 Posology and method of administration
Posology
The recommended dose of Zevtera is 500 mg administered as a 2-hour
intravenous infusion every 8
hours. For CAP, a switch to an appropriate oral antibiotic may be
considered after completion of at least 3
days of intravenous ceftobiprole medocaril sodium treatment, depending
on the patient's clinical response.
_Paediatric population_
The safety and efficacy of Zevtera in children aged birth to < 18
years have not yet been established.
Zevtera is not recommended for use in children or adolescents be