Tigecycline Teva 50mg powder for solution for infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TIGECYCLINE

Available from:

Teva B.V. Swensweg 5, 2031 GA Haarlem, Netherlands

ATC code:

J01AA12

INN (International Name):

TIGECYCLINE 50 mg

Pharmaceutical form:

POWDER FOR SOLUTION FOR INFUSION

Composition:

TIGECYCLINE 50 mg

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Withdrawn

Authorization date:

2017-07-18

Patient Information leaflet

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
TIGECYCLINE TEVA 50 MG POWDER FOR SOLUTION FOR INFUSION
tigecycline
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 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 Tigecycline Teva is and what it is used for
2.
What you need to know before you receive Tigecycline Teva
3.
How Tigecycline Teva is given
4.
Possible side effects
5.
How to store Tigecycline Teva
6.
Contents of the pack and other information
1.
WHAT TIGECYCLINE TEVA IS AND WHAT IT IS USED FOR
Tigecycline Teva is an antibiotic of the glycylcycline group that
works by stopping the growth of
bacteria that cause infections.
Your doctor has prescribed Tigecycline Teva because you or your child
at least 8 years old has one of
the following types of serious infections:
•
Complicated infection of the skin and soft tissues (the tissue below
the skin), excluding diabetic
foot infections.
•
Complicated infection in the abdomen
Tigecycline Teva is only used when your doctor thinks other
antibiotics are not suitable.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE TIGECYCLINE TEVA
DO NOT USE TIGECYCLINE TEVA
•
If you are allergic to tigecycline or any of the other ingredients of
this medicine (listed in
section 6). If you are allergic to tetracycline class antibiotics
(e.g., minocycline, doxycycline,
etc.), you may be allergic to tigecycline.
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before receiving Tigecycline Teva:
•
If you have poor or slow wound healing.
•
If you are suffering from diarrhoea before you are given Tigecycline
Teva. If you develop
diarrhoea during or after your treatment, tell your doctor at once. Do
not take any diarrhoea
medicine without first checki

Summary of Product characteristics

Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Tigecycline Teva 50 mg powder for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 50 mg tigecycline.
After reconstitution, 1 ml contains 10 mg tigecycline.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for infusion (powder for infusion).
Orange to orange-red, lyophilised cake or powder, free of visible
evidence of contamination.
The pH of the reconstituted solution ranges between 4.0 and 6.0, and
the osmolarity ranges between
240 – 320 mOsm/Kg depending on the reconstitution solvent.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tigecycline is indicated in adults and in children from the age of
eight years for the treatment of the
following infections (see sections 4.4 and 5.1):
• Complicated skin and soft tissue infections (cSSTI), excluding
diabetic foot infections (see section
4.4)
• Complicated intra-abdominal infections (cIAI)
Tigecycline should be used only in situations where other alternative
antibiotics are not suitable (see
sections 4.4, 4.8 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 _
The recommended dose for adults is an initial dose of 100 mg followed
by 50 mg every 12 hours for 5
to 14 days.
The duration of therapy should be guided by the severity, site of the
infection, and the patient’s
clinical response.
_ _
_Children and adolescents (8 to 17 years of age) _
Tigecycline is only to be used to treat patients aged 8 years and
older after consultation with a
physician with appropriate experience in the management of infectious
diseases.
Page 2 of 15
Children aged 8 to <12 years: 1.2 mg/kg of tigecycline every 12 hours
intravenously to a
maximum dose of 50 mg every 12 hours for 5 to 14 days.
Adolescents aged 12 to <18 years: 50 mg of tigecycline every 12 hours
for 5 to 14 days.
_Elderly _
No dosage adju