Amoxil Vial for Injection 500mg
- Name:
Amoxil Vial for Injection 500mg
- Company:
GlaxoSmithKline (Ireland) Ltd
- Active Ingredients:
- 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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1. NAME OF THE MEDICINAL PRODUCT
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4. CLINICAL PARTICULARS
5. PHARMACOLOGICAL PROPERTIES
5. PHARMACOLOGICAL PROPERTIES
6. PHARMACEUTICAL PARTICULARS
6. PHARMACEUTICAL PARTICULARS
7. MARKETING AUTHORISATION HOLDER
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXT
GlaxoSmithKline (Ireland) Ltd
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Company Products
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 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 17 January 2018 SmPC
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 SmPC
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
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 SmPC
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 SmPC
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
Updated on 5 December 2014 SmPC
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 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 SmPC
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
………………..
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Blood and lymphatic system disorders |
|
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Very rare: |
Reversible leucopenia (including severe neutropenia or agranulocytosis), reversible thrombocytopenia and haemolytic anaemia. |
|
|
Prolongation of bleeding time and prothrombin time |
……………….
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 SmPC
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
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 SmPC
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 |
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#Common: Diarrhoea and nausea. |
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#Uncommon: Vomiting. |
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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 SmPC
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 SmPC
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 SmPC
Reasons for updating
- Improved electronic presentation
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 19 June 2003 SmPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may not be renewed (A)