Reasons for adding or updating:

• Improved presentation of SPC

Date of revision of text on the SPC: 07-Sep-2011

Legal Category:POM

Black Triangle (CHM): NO

Reasons for adding or updating:

• Change to section 4.8 - Undesirable effects

Date of revision of text on the SPC: 21-Apr-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 4.8

4.8 Undesirable effects

Side-effects include vestibular damage or hearing loss, particularly after exposure to

ototoxic drugs or in the presence of renal dysfunction. Nephrotoxicity (usually

reversible) and occasionally acute renal failure, hypersensitivity, anaemia, blood

dycrasias, purpura, stomatitis, convulsions and effects on liver function occur

occasionally.

Rarely hypomagnesia on prolonged therapy and antibiotic–associated colitis have

been reported.

Nausea, vomiting and rash have also been reported.

Central neurotoxicity, including encephalopathy, confusion, lethargy, mental

depression and hallucinations, has been reported in association with gentamicin

therapy but this is extremely rare.

Peripheral neuropathy – Frequency not known

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is

important. It allows continued monitoring of the benefit/risk balance of the medicinal

product. Healthcare professionals are asked to report any suspected adverse reactions

via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Reasons for adding or updating:

• Change to section 4.2 - Posology and method of administration
• Change to section 4.4 - Special warnings and precautions for Use

Date of revision of text on the SPC: 07-Sep-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.2 - "please refer to section 4.4" added
Section 4.4 - "when administrating Gentamicin twice daily and 1 mg/l for a once daily dose" added

Reasons for adding or updating:

• Change to section 4.1 - Therapeutic indications
• Change to section 4.2 - Posology and method of administration
• Change to section 4.4 - Special warnings and precautions for Use
• Change to section 5.2 - Pharmacokinetic Properties
• Change to section 10 date of revision of the text

Date of revision of text on the SPC: 14-Sep-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.1: Therapeutic Indications

addition of : "Consideration should be given to official local guidance on the appropriate use of antibacterial agents."

Section 4.2: Posology and method of administration
addition of:

PAEDIATRIC PATIENTS:

The daily dose recommended in children aged 1 year and above and adolescents with normal renal function, is 3-6 mg/kg body weight per day as 1 (preferred) up to 2 single doses.

The daily dose in infants after the first month of life is 4.5-7.5 mg/kg body weight per day as 1 (preferred) up to 2 single doses.

The daily dose in neonates and pre-term infants (aged 0-4 weeks old) is 4-7 mg/kg body weight per day. Due to the longer half-life, newborns are given the required daily dose in 1 single dose.

and deletion of:

CHILDREN:

Premature infants or full term neonates up to 2 weeks of age:  3mg/kg 12 hourly.  2 weeks to 12 years:  2mg/kg 8 hourly.

Section 4.4: Special warnings and precautions for use
addition of :
"To avoid adverse events, continuous monitoring (before, during and after) of renal function (serum creatinin, creatinin clearance), control of function of vestibule and cochlea as well as hepatic and laboratory parameters is recommended."

Section 5.2: Pharmacokinetic properties
addition of: 
"Paediatric patients – premature infants and neonates

Distribution

The distribution volume of gentamicin is about equivalent to the volume of extracellular water. In the newborn water makes up 70 to 75% of bodyweight, compared with 50 to 55% in adults. The extracellular water compartment is larger (40% of body weight compared with 25% of body weight in adults). Therefore, the volume of distribution of gentamicin per kg bodyweight is affected and decreases with increasing age from 0.5 to 0.7 L/kg for a premature newborn to 0.25 L/kg for an adolescent. The larger volume of distribution per kg bodyweight means that for adequate peak blood concentration a higher dose per kg bodyweight needs to be administered.

 

Elimination

Gentamicin is not metabolized in the body but is excreted unchanged in microbiologically active form predominantly via the kidneys. In patients with normal renal function the elimination half life is about 2 to 3 hours. In neonates elimination rate is reduced due to immature renal function.

Elimination half life averages approximately 8 hours in neonates at a gestational age of 26 to 34 weeks compared with about 6.7 hours in neonates at a gestational age of 35 to 37 weeks.

Correspondingly, clearance values increase from about 0.05 L/h in neonates at a gestational age of 27 to 0.2 L/h in neonates at a gestational age of 40 weeks."

Section 10 : date of revision of text - update accordingly

Reasons for adding or updating:

• Change to section 1 -Name of the Medicinal product
• Change to section 2 - Qualitative and quantitative composition
• Change to section 3 - Pharmaceutical form
• Change to section 4.2 - Posology and method of administration
• Change to section 4.3 - Contraindications
• Change to section 5.1 - Pharmacodynamic Properties
• Change to section 6. 5 - Nature and Contents of Container
• Change to section 6. 6 - Instructions for use, handling and disposal
• Change to section 7 - Marketing Authorisation Holder
• Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
• Change to section 9 - Date of first Authorisation/renewal of the Authorisation
• Change to section 10 date of revision of the text

Date of revision of text on the SPC: 30-Jul-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



To update sections 1, 2, 4.3, 5.1, 6.5 and 6.6 of the SPC in line with European Guidelines

 

Section 1 – change of name

Section 2 – Addition of ‘Also contains 3.6 mg of methyl parahydroxybenzoate

(E218) and 0.4 mg of propyl parahydroxybenzoate (E216).’

Section 5 – Added ‘Pharmacotherapeutic group: Antibacterials for systemic use

ATC Code: J01GB03’

Sections 4.3, 6.5, 6.6 – minor changes to wording

 

Updates to sections 3, 4.2 and 9 to correct typographical errors

 

Sections 7 & 8 - Change of Ownership from Roussel Laboratories Ltd (PL 00109/5065R) to

Aventis Pharma Limited (PL 04425/0181)

 

Section 10 – new date of revision

 

Reasons for adding or updating:

• Change to section 7 - Marketing Authorisation Holder

Date of revision of text on the SPC: 01-Jul-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Marketing authorisation holder changed to;

Sanofi-aventis

One Onslow Street

Guildford

Surrey

UK

Reasons for adding or updating:

• Change to section 10 (date of (partial) revision of the text
• Change from BAN to rINN

Reasons for adding or updating:

• Change to section 9 - Date of Renewal of Authorisation

Reasons for adding or updating:

• New SPC for new product