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Amoxil Vial for Injection 500mg

  • Name:

    Amoxil Vial for Injection 500mg

  • Company:
    info
  • Active Ingredients:

    Amoxicillin sodium

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 19/03/19

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Summary of Product Characteristics last updated on medicines.ie: 17/1/2018
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GlaxoSmithKline (Ireland) Ltd

GlaxoSmithKline (Ireland) Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Amoxil Vial for Injection 500mg Active Ingredients Amoxicillin sodium
Medicine Name ANORO ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed Active Ingredients Umeclidinium bromide, Vilanterol trifenatate
Medicine Name Augmentin 250 mg/125 mg film-coated tablets Active Ingredients Amoxicillin trihydrate, Potassium clavulanate
Medicine Name Augmentin 500mg/125mg Film-coated Tablets Active Ingredients Amoxicillin trihydrate, Potassium clavulanate
Medicine Name Augmentin 875/125mg Film Coated tablets Active Ingredients Amoxicillin trihydrate, Clavulanic Acid
Medicine Name Augmentin Duo Mixed Fruit 400 mg/57 mg /5 ml Powder for Oral Suspension Active Ingredients Amoxicillin trihydrate, Clavulanic Acid
Medicine Name Augmentin Paediatric 125mg/31.25mg per 5ml Powder for Oral Suspension Active Ingredients Amoxicillin trihydrate, Potassium clavulanate
Medicine Name AVAMYS 27.5 micrograms/spray nasal spray suspension Active Ingredients Fluticasone furoate
Medicine Name Avodart Soft Capsules 0.5mg Active Ingredients Dutasteride
Medicine Name Babyhaler Active Ingredients No Active Ingredients
Medicine Name Bactroban Nasal Ointment Active Ingredients Mupirocin calcium
Medicine Name Bactroban Ointment Active Ingredients Mupirocin
Medicine Name Becotide Evohaler 100 Active Ingredients Beclometasone Dipropionate
Medicine Name Becotide Evohaler 250 Active Ingredients Beclometasone Dipropionate
Medicine Name Becotide Evohaler 50 Active Ingredients Beclometasone Dipropionate
Medicine Name Benlysta 120 mg and 400 mg powder for concentrate for solution for infusion Active Ingredients Belimumab
Medicine Name Betnovate C 0.1% / 3% w/w Cream Active Ingredients Betamethasone Valerate, Clioquinol
Medicine Name Betnovate Cream 0.1% w/w Active Ingredients Betamethasone Valerate
Medicine Name Betnovate Ointment 0.1% w/w Active Ingredients Betamethasone Valerate
Medicine Name Betnovate RD Cream Active Ingredients Betamethasone Valerate
Medicine Name Betnovate RD Ointment Active Ingredients Betamethasone Valerate
Medicine Name Betnovate Scalp Application 0.1% w/v Cutaneous Solution Active Ingredients Betamethasone Valerate
Medicine Name Bexsero, suspension for injection in pre-filled syringe Active Ingredients Meningococcal group-B vaccine (rDNA, component, adsorbed)
Medicine Name Boostrix - Suspension for injection Active Ingredients Diphtheria, Tetanus and Pertussis vaccine
Medicine Name Cervarix Suspension for Injection Active Ingredients human papillomavirus vaccine
1 - 0 of 132 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 19 March 2019 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 17 January 2018 SPC

Reasons for updating

  • New SPC for new product

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

Updated on 17 January 2018 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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

GDS No: 29, Update 1: TSC 3:
• Addition of the agreed wording from a PRAC recommendation on Drug Reaction with eosinophilia and systemic symptoms (DRESS) syndrome to:
-SmPC Sections 4.4 Special warnings and precautions for use
-SmPC 4.8 Undesirable effects

-PIL Section 4. Possible side effects
• Addition of ‘contains penicillin’ to Labelling Section 7. Other special warning(s) - for IE only, as this warning was already present on UK cartons
• Addition of ‘EXP’ abbreviation to PIL Section 5. (How to store Amoxil)
• Update of MHRA adverse event reporting details in Section 4.8 of SmPC and Section 4 of PIL (UK only - all except for the combined PIL for Amoxil Vials for Injection 500 mg and 1 g)

Workshare variation Procedure Number: FR/H/XXXX/WS/101

Updated on 16 January 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 16 January 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 18 October 2017 SPC

Reasons for updating

  • 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 4.4 - Special warnings and precautions for use
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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

SPC updates:
Section 2 - Update to how information on active substance and excipients is presented
Section 3 - Update to how information on pharmaceutical form is presented
Section 4.2 - Additional information on standard recommended route of administration and weight limits for intramuscular administration.
Section 4.4 - Corrected spelling of abbreviation 'AGEP'. Addition of 'Important information about excipients'.
Section 6.3 - Update to shelf life information.
Section 6.4 - Update to storage information
Section 6.5 - Update to container description
Section 6.6 - Update to reconstitution instructions
Section 10 - Update to date of revision of the text

Updated on 17 October 2017 PIL

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 3 - use in children/adolescents
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 21 April 2016 SPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to section 11 - Dosimetry
  • Change due to harmonisation of SPC

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

Free text change information supplied by the pharmaceutical company

·         Section 4.1 – harmonisation of indications across the EU

·         Section 4.2 – harmonisation of the recommendations on how to use Amoxil.

·         Section 4.3 – editorial changes

·         Section 4.4 – harmonisation of warnings across the EU

·         Section 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3 – harmonisation of information across the EU
Section 4.8 - addition of reporting of suspected adverse reactions

·         Section 9 – editorial changes

·         Section 11 – legal status removed

Updated on 21 April 2016 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change to dosage and administration
  • Changes to therapeutic indications
  • Change due to harmonisation of PIL
  • Addition of information on reporting a side effect.

Updated on 17 July 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 17 July 2015 SPC

Reasons for updating

  • 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

Change to address of the MA Holder

Updated on 5 December 2014 SPC

Reasons for updating

  • Removal of black triangle
  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • 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

Section 2- Administrative changes
Section 4.1- Addition of Gonorrhoea as an indication
Section 4.2- Administrative changes
Section 4.4- Administrative changes
Section 4.5- Additional information of interaction with acenocoumarol and warfarin
Section 4.6- Additional information about use in pregnancy.
Section 4.8- Administrative changes and removal of black hairy tongue and superficial tooth discoluoration, addition of reporting side effects.
Section 6.6 - Addition of 'All solutions should be shaken vigorously before injection'.

Updated on 4 December 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to further information section
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 15 May 2012 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 26 April 2010 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company



SPC

 

4.4       Special Warnings and Special Precautions for Use

……..

 

Prolongation of prothrombin time has been reported rarely in patients receiving amoxicillin. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently.

 

Abnormal prolongation of prothrombin time (increased INR) has been reported rarely in patients receiving amoxicillin and oral anticoagulants.  Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently.  Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation.

…………

 

4.8       Undesirable Effects

 

             ………………..

 

Blood and lymphatic system disorders

Very rare:

Reversible leucopenia (including severe neutropenia or agranulocytosis), reversible thrombocytopenia and haemolytic anaemia.

 

Prolongation of bleeding time and prothrombin time (See Warnings and Precautions).

          ……………….

 

 

 

Updated on 20 January 2010 PIL

Reasons for updating

  • Change to side-effects
  • Change to drug interactions

Updated on 11 December 2007 PIL

Reasons for updating

  • Change to drug interactions
  • Improved electronic presentation

Updated on 31 October 2007 SPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Free text change information supplied by the pharmaceutical company

2.         QUALITATIVE AND QUANTITATIVE COMPOSITION

 

500mg amoxicillin per vial.

The amoxicillin is present as the sodium salt in ‘Amoxil’ injection.

 

            For a full list of excipients, see section 6 .1.

 

4.4              Special warnings and special precautions for use

 

Before initiating therapy with amoxicillin, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins. Cross-sensitivity between penicillins and cephalosporins is well documented.
...........................................................................................................................................................................
The sodium content must be taken into account in patients on a sodium restricted diet if the parenteral administration of high doses is necessary. Each 250mg 500mg vial of amoxicillin contains 19mg 38mg of sodium.
 

6.2       Incompatibilities

 

‘Amoxil’ should not be mixed with blood products, other proteinaceous fluids such as protein hydrolysates, or with intravenous lipid emulsions.

 

If ‘Amoxil’ is prescribed concurrently with an aminoglycoside, the antibiotics should not be mixed in the syringe, intravenous fluid container or giving set because loss of activity of the aminoglycoside can occur under these conditions.

 

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.3 and 6.6.

 

6.3              Shelf life

 

Unopened: 18 months (reconstitution: see below)  2 Years

 

Reconstituted:

When prepared for intramuscular or direct intravenous injection, ‘Amoxil’ should be administered immediately after reconstitution. Infusions should be administered over a period of one-half to one hour although ‘Amoxil’ maintains a satisfactory degree of activity at room temperature in various infusion fluids as follows:

 

Intravenous Fluids                                                                     Stability Time

 

Sodium Chloride Injection (Normal saline)                                   6 hours

Compound Sodium Chloride Injection (Ringer`s solution)  6 hours

Sodium Lactate Injection                                                            3 hours

Compound Sodium Lactate Injection (Hartmann`s solution)          3 hours

Dextrose Injection (5%)                                                             1 hour

Sodium Chloride and (4%) Dextrose Injection                             1 hour

 

Amoxicillin is less stable in infusions containing carbohydrate. Reconstituted solutions of amoxicillin may be injected into the drip tubing over a period of one-half to one hour.

 

Any residual antibiotic solution should be discarded.

Amoxicillin vials are not suitable for multi-dose use.

 

6.4              Special precautions for storage

 

Do not store above 250C.

 

For reconstituted product, see section 6.3.

 

6.6       Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product  Instructions for use/handling

 

Preparation of Injections

 

500mg Vial             For IM use, add 2.5ml Water for Injections BP and shake vigorously.

For IV use, dissolve contents in 10 ml Water for Injections BP.

 

For other routes:      A 500mg adult dose may be prepared as follows:

 

Intraperitoneal:        Dissolve in 10 ml Water for Injections BP.

Intrapleural:             Dissolve in 5-10 ml Water for Injections BP.

Intra-articular:         Dissolve in up to 5ml Water for Injections BP 0.5% procaine

      hydrochloride, or a sterile 1% solution of lignocaine hydrochloride.

 

A transient pink coloration or slight opalescence may appear during reconstitution. Reconstituted solutions are normally a pale straw colour.

 

Updated on 9 November 2006 SPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

4.5 Interaction with other medicinal products and other forms of interaction

Probenecid decreases the renal tubular excretion of amoxicillin. Concurrent use with amoxicillin may result in increased and prolonged blood levels of amoxicillin.

Concurrent administration of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions.

In common with other antibiotics, amoxicillin may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives

4.8: Undesirable effects

Infections and Infestations

Very rare:Mucocutaneous candidiasis

Gastrointestinal disorders

#Common: Diarrhoea and nausea.

#Uncommon: Vomiting.

Very rare:Antibiotic associated colitis (including pseudomembraneous colitis and haemorrhagic colitis). [44, 45]

Black hairy tongue

Updated on 9 November 2006 PIL

Reasons for updating

  • Change to side-effects

Updated on 19 July 2005 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 14 December 2004 SPC

Reasons for updating

  • Change to section 4.9 - Overdose

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

Updated on 22 November 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 12 May 2004 SPC

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 4.9 - Overdose

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

Updated on 3 July 2003 SPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 19 June 2003 SPC

Reasons for updating

  • New SPC for medicines.ie

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