Table of Contents
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
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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 a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder for solution for infusion (powder for infusion).
Lyophilised orange cake or powder.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Tygacil is indicated in adults for the treatment of the following infections (see sections 4.4 and 5.1):
• Complicated skin and soft tissue infections, excluding diabetic foot infections (see section 4.4)
• Complicated intra-abdominal infections
Tygacil should be used only in situations where it is known or suspected that other alternatives are not suitable (see sections 4.4 and 4.8).
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 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.
Hepatic insufficiency
No dosage adjustment is warranted in patients with mild to moderate hepatic impairment (Child Pugh A and Child Pugh B).
In patients with severe hepatic impairment (Child Pugh C), the dose of Tygacil should be reduced to 25 mg every 12 hours following the 100 mg loading dose. Patients with severe hepatic impairment (Child Pugh C) should be treated with caution and monitored for treatment response (see sections 4.4 and 5.2).
Renal insufficiency
No dosage adjustment is necessary in patients with renal impairment or in patients undergoing haemodialysis (see section 5.2).
Elderly patients
No dosage adjustment is necessary in elderly patients (see section 5.2).
Paediatric population
The safety and efficacy of Tygacil in children below 18 years have not yet been established. (see section 4.4). Currently available data are described in section 5.2, but no recommendation on a posology can be made.
Method o
