Tigecycline Mylan 50 mg powder for solution for infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TIGECYCLINE

Available from:

Mylan Ireland Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

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:

Authorised

Authorization date:

2017-07-18

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
TIGECYCLINE MYLAN 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 is and what it is used for
2.
What you need to know before you receive Tigecycline
3.
How Tigecycline is given
4.
Possible side effects
5.
How to store Tigecycline
6.
Contents of the pack and other information
1.
WHAT TIGECYCLINE IS AND WHAT IT IS USED FOR
Tigecycline is an antibiotic of the glycylcycline group that works by
stopping the growth of
bacteria that cause infections.
Your doctor has prescribed tigecycline 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 is only used when your doctor thinks other antibiotics are
not suitable.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE TIGECYCLINE
DO NOT USE TIGECYCLINE
•
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:
•
If you have poor or slow wound healing.
•
If you are suffering from diarrhoea before you are given tigecycline.
If you develop
diarrhoea during or after your treatment, tell your doctor at once. Do
not take any
diarrhoea medicine without first checking with your doctor.
•
If you have or previously had a

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Tigecycline Mylan 50 mg powder for solution for infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 50 mg of tigecycline.
After reconstitution, 1 ml contains 10 mg of 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, lyophilized 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 is an initial dose of 100 mg followed by 50 mg
every 12 hours for 5 to
14 days.
_Children and adolescents (8 to 17 years of age) _
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.
The duration of therapy should be guided by the severity, site of the
infection, and the patient’s
clinical response.
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_Elderly _
No dosage adjustment is necessary in elderly patients (see section
5.2).
_ _
_Hepatic impairment _
No dosage adjustment is warranted in patients with mild to moderate
hepatic impairment (Child
Pugh A