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Germentin 500 mg/125 mg Film-coated Tablets

*
Pharmacy Only: Prescription

  • Company:

    Mylan IRE Healthcare Ltd

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

  • Active Ingredient(s):

    Co-Amoxiclav

    *Additional information is available within the SPC or upon request to the company

Updated on 02 October 2024

File name

ie-smpc-PR3455073-MIC breakpoints-clean.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 26 March 2024

File name

ie-combined-577034003-maht_PIL_Amo_Clav.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number

Updated on 26 March 2024

File name

ie-combined-577034003-maht_SPC_Amo_Clav.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 03 May 2023

File name

ie-pil-de0208-v090-clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 03 May 2023

File name

ie-smpc-de0208-v090-clean.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 21 November 2022

File name

ie-pl-de0208-v087-clean.pdf

Reasons for updating

  • Change to name of medicinal product

Updated on 06 July 2021

File name

ie-spc-v080-clean.pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 06 July 2021

File name

ie-pil-v080-clean.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 20 July 2018

File name

Package leaflet Germentin.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents

Updated on 19 July 2018

File name

Summary of Product Characteristics Germentin.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 21 November 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 21 November 2017

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

1. NAME OF THE MEDICINAL PRODUCT
Germentin 500 mg/125 mg film -coated tTablets.

4.2 Posology and method of administration
Children < 40 kg
20 mg/5 mg/kg/day to 60 mg/15 mg/kg/day given in three divided doses.

Children may be treated with Germentin tablets, suspensions or paediatric sachets. Children aged 6 years and below should preferably be treated with a Germentin suspension or paediatric sachets.

As the tablets cannot be divided, children weighing less than 25 kg must not be treated with Germentin 500 mg/125 mg tablets.

The table below presents the received dose (mg/kg body weight) in children weighing 25 kg to 40 kg upon administering a single 500 mg/125 mg tablet.

Method of administration
For rOral use .

4.4 Special warnings and precautions for use
Before initiating therapy with amoxicillin/clavulanic acid, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other beta-lactam agents (see sections 4.3 and 4.8).

Serious and occasionally fatal hypersensitivity (including anaphylactoid and severe cutaneous adverse) reactions) have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and in atopic individuals. If an allergic reaction occurs, amoxicillin/clavulanic acid therapy must be discontinued and appropriate alternative therapy instituted.

4.8 Undesirable effects

 

Renal and urinary disorders

Interstitial nephritis

Not known

Crystalluria8

Not known

Drug reaction with eosinophilia and systemic symptoms (DRESS)

Not known

5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Antibacterials for systemic use. Beta-lactam antibacterials penicillins. Combinations of penicillins, incl. beta-lactamase inhibitors; ATC code: J01CR02.

5.2 Pharmacokinetic properties

Mean (± SD) pharmacokinetic parameters

 

Active substance(s)

administered

Dose

Cmax

Tmax *

AUC (0-24h

T 1/2

(mg)

(µg/ml)

(h)

(µg.h/ml)

(h)

Amoxicillin

AMX/CA

500 mg/125 mg

500

7.19

± 2.26

1.5

(1.0-2.5)

53.5

± 8.87

1.15

± 0.20

Clavulanic acid

AMX/CA

500 mg/125 mg

125

2.40

± 0.83

1.5

(1.0-2.0)

15.72

± 3.86

0.98

± 0.12

AMX – amoxicillin, CA – clavulanic acid

* Median (range)

7. MARKETING AUTHORISATION HOLDER
McDermott Laboratories Limited, t/a T/A Gerard Laboratories
35/-36 Baldoyle Industrial Estate
Grange Road
Dublin 13

10. DATE OF REVISION OF THE TEXT
SeptemberMarch 20176



Updated on 20 November 2017

File name

PIL_8888_761.pdf

Reasons for updating

  • New PIL for new product

Updated on 20 November 2017

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 17 October 2017

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 16 May 2016

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about missed dose
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to further information section
  • Change to date of revision
  • Change to dosage and administration
  • Addition of information on reporting a side effect.

Updated on 19 May 2015

Reasons for updating

  • Change of trade or active ingredient name
  • Change to date of revision

Updated on 20 October 2014

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
  • Introduction of new pack/pack size

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 6.5:
Pack size 21 added

Updated on 05 September 2014

Reasons for updating

  • Introduction of new pack/pack size

Updated on 21 July 2011

Reasons for updating

  • Correction of spelling/typing errors

Updated on 20 July 2011

Reasons for updating

  • Change of manufacturer
  • Change to side-effects
  • Change to date of revision

Updated on 10 April 2008

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Updated on 16 September 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 19 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may not be renewed (A)