Tygacil
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
11-10-2022
Karatteristiċi tal-prodott
(SPC)
11-10-2022
Rapport ta 'Valutazzjoni Pubblika
(PAR)
31-07-2015
Ingredjent attiv:
Tigecycline
Disponibbli minn:
Pfizer Europe MA EEIG
Kodiċi ATC:
J01AA12
INN (Isem Internazzjonali):
tigecycline
Grupp terapewtiku:
Antibacterials for systemic use,
Żona terapewtika:
Bacterial Infections; Skin Diseases, Bacterial; Soft Tissue Infections
Indikazzjonijiet terapewtiċi:
Tygacil is indicated in adults and in children from the age of eight years for the treatment of the following infections: , Complicated skin and soft tissue infections (cSSTI), excluding diabetic foot infections, Complicated intra-abdominal infections (cIAI) , Tygacil should be used only in situations where other alternative antibiotics are not suitable. Consideration should be given to official guidance on the appropriate use of antibacterial agents. appropriate use of antibacterial agents.,
Sommarju tal-prodott:
Revision: 34
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2006-04-24
Fuljett ta 'informazzjoni
24
B. PACKAGE LEAFLET
25
PACKAGE LEAFLET: INFORMATION FOR THE USER
TYGACIL 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 Tygacil is and what it is used for
2.
What you need to know before you receive Tygacil
3.
How Tygacil is given
4.
Possible side effects
5.
How to store Tygacil
6.
Contents of the pack and other information
1.
WHAT TYGACIL IS AND WHAT IT IS USED FOR
Tygacil is an antibiotic of the glycylcycline group that works by
stopping the growth of bacteria that
cause infections.
Your doctor has prescribed Tygacil 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.
Tygacil is only used when your doctor thinks other antibiotics are not
suitable.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE TYGACIL
DO NOT USE TYGACIL
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 TYGACIL:
If you have poor or slow wound healing.
If you are suffering from diarrhoea before you are given Tygacil. 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 any side effects due to antibiotics
belonging
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Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Tygacil 50 mg powder for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml Tygacil 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 cake or powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tygacil 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).
Tygacil 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.
_Elderly_
No dosage adjustment is necessary in elderly patients (see section
5.2).
3
_Hepatic impairment_
No dosage adjustment is warranted in patients with mild to moderate
hepatic impairment (Child Pugh
A and Child Pugh B).
In patients (including paediatrics) with severe hepatic impairment
(Child Pugh C), the dose of
tigecycline should be reduced by 50 %. Adult dose should be reduced to
25 mg every 12 hours
following the 100 mg loading dose. Patients wit
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