Zinnat 250mg/5ml Granules for Oral Suspension.

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Zinnat 250mg/5ml Granules for Oral Suspension.

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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 20 March 2019 PIL

Reasons for updating

Change to section 2 - excipient warnings
Change to section 5 - how to store or dispose
Change to section 6 - what the product contains
Change to section 6 - manufacturer
Change to section 6 - date of revision
Improved presentation of PIL

Updated on 20 March 2019 SmPC

Reasons for updating

Change to section 2 - Qualitative and quantitative composition
Change to section 3 - Pharmaceutical form
Change to section 4.4 - Special warnings and precautions for use
Change to section 6.1 - List of excipients
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 6.5 - Nature and contents of container
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

2. Qualitative and Quantitative Composition: Addition of excipients with known effects
3. Pharmaceutical Form: Amended wording removed description of granules
4.4 Special warnings and precautions for use: Addition of information about excipients
6.1 List of excipients: Amendment to the list of excipients and addition of corresponding E numbers
6.2 Incompatibilities: Addition of positive Coombs' test
6.3 Shelf Life: Formatting change to include reconstituted and unconstituted storage conditions
6.4 Special precautions for storage: formatting change to only mention a sentence stating the storage temperature
6.5 Nature and contents of container: Updated pack size

Updated on 8 February 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 8 February 2018 SmPC

Reasons for updating

Change to section 4.2 - Posology and method of administration
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)

Free text change information supplied by the pharmaceutical company

Section 4.2: Formatting corrections
Section 5.1: Spelling correction
Section 10: Update of date of revision of the text

Updated on 22 December 2017 SmPC

Reasons for updating

Change to section 10 - Date of revision of the text
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

Section 6.6 -Update of reconstitution instructions
Section 10 - Update of Date of Revision of the Text

Updated on 21 December 2017 PIL

Reasons for updating

New PIL for new product

Updated on 21 December 2017 PIL

Reasons for updating

Change to section 3 - how to take/use
Change to section 6 - manufacturer
Change to section 6 - date of revision
Improved presentation of PIL

Updated on 19 January 2016 SmPC

Reasons for updating

Change to section 4.2 - Posology and method of administration
Change to section 4.8 - Undesirable effects
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 6.5 - Nature and contents of container
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

SPC:

Section 4.2 – updated dosing recommendation wording for clarity, minor typographical amendments

Section 4.8 – addition cross-reference to Section 4.4 (500mg tablet only)

Section 5.1 – updated Staphylococcus spp. resistance category

Section 5.2 – minor typographical amendments, alignment with QRD template

Section 5.3 – minor typographical amendments,

Section 6.5 - minor typographical amendments

Section 7 – IE MAH address change

Updated on 18 January 2016 PIL

Reasons for updating

Change to date of revision
Change to MA holder contact details
Change to improve clarity and readability

Updated on 16 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

Section 7 - change to Ireland MAH address

Updated on 15 July 2015 PIL

Reasons for updating

Change to date of revision
Change to MA holder contact details

Updated on 13 March 2015 SmPC

Reasons for updating

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)

Free text change information supplied by the pharmaceutical company

Section 4.8- administrative changes and addition of reporting details.
Section 5.1 update to the Microbiological susceptibility table

Updated on 12 March 2015 PIL

Reasons for updating

Change of trade or active ingredient name
Change to side-effects
Change to further information section
Change to date of revision
Addition of information on reporting a side effect.

Updated on 28 January 2014 SmPC

Reasons for updating

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

Change due to harmonisation or user testing of the patient leaflet

Updated on 27 January 2014 PIL

Reasons for updating

Change due to harmonisation of PIL
Change due to user-testing of patient information

Updated on 8 September 2011 PIL

Reasons for updating

Change due to user-testing of patient information

Updated on 12 January 2010 PIL

Reasons for updating

Change of trade or active ingredient name
Change to storage instructions

Updated on 8 January 2010 SmPC

Reasons for updating

Change to section 1 - Name of medicinal product
Change to section 2 - Qualitative and quantitative composition
Change to section 6.1 - List of excipients
Change to section 6.2 - Incompatibilities
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

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

Free text change information supplied by the pharmaceutical company

250mg Granules for Oral Suspension

1. TRADE NAME OF THE MEDICINAL PRODUCT

Zinnat ~~suspension~~ 250mg/5ml Granules for Oral Suspension.

2.       QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5ml of reconstituted suspension contains 250mg cefuroxime (as cefuroxime axetil).

Excipients: Contains approximately 2.289 g of sucrose and 45 mg of aspartame (E951) per 5ml dose.

For a full list of excipients, see section 6.1.

6.1     List of excipients

Stearic acid

Sucrose

Tutti Frutti flavour

Povidone K30

Acesulfame potassium

Aspartame

Xantham gum

~~Sucrose quantity (g per dose): 250mg/5ml suspension 2.289g~~

6.2     Incompatibilities

The reconstituted suspension or granules should not be mixed with hot liquids.

6.4     Special precautions for storage

Unconstituted granules: Do not store above 30°C.

Reconstituted suspension: ~~Must be refrigerated between 2 and 8°C.~~ Store in a refrigerator at 2^oC to 8^oC.

6.5     Nature and contents of container

Type III amber glass bottles with an induction heat seal membrane containing granules for 70ml of suspension for the 250mg/5ml suspension.

6.6     Instructions for use/handling

Constitution/Administration Instructions:-

~~The reconstituted suspension or granules should not be mixed with hot liquids.~~

Directions for reconstituting suspension in bottles:

1.      Shake the bottle to loosen the granules and remove the cap.
2.      Add the total amount of water to the bottle as is stated on its label. Replace the cap.
3.      Invert the bottle and rock vigorously (for about 15 seconds) as shown below.

4.      Turn the bottle into an upright position and shake vigorously.
~~5.      ~~Refrigerate immediately at between 2 and 8~~C.~~

~~The reconstituted suspension when refrigerated between 2 and 8°C can be kept for up to 10 days.~~

Further diluted suspension from bottles in cold fruit juices, or milk drinks should be taken immediately.

Patients Instructions

Shake the bottle vigorously before use

If desired, the dose of the reconstituted suspension may be added to cold fruit juices or milk, and should be taken immediately.

Updated on 14 November 2007 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

4.4 Special Warnings and Precautions for Use

[…]

As with other antibiotics, ~~prolonged~~ use of cefuroxime may result in the overgrowth of Candida. Prolonged use may also result in the overgrowth of non-susceptible organisms (e.g. ~~Candida~~, Enterococci and Clostridium difficile), which may require interruption of treatment.

[…]

4.8 Undesirable Effects

[…]

Infections and infestations

Common: Candida overgrowth ~~from prolonged use~~.

[…]

Updated on 3 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 Medicaments and Other Forms of Interaction

Drugs which reduce gastric acidity may result in a lower bioavailability of cefuroxime axetil compared with that of the fasting state and tend to cancel the effect of enhanced absorption after food.

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

As a false negative result may occur in the ferricyanide test, it is recommended that either the glucose oxidase or hexokinase methods are used to determine blood/plasma glucose levels in patients receiving cefuroxime axetil. This antibiotic does not interfere in the alkaline picrate assay for creatinine.

4.8

........Infections and infestations

Candida overgrowth from prolonged use...............

Updated on 3 November 2006 PIL

Reasons for updating

Change to warnings or special precautions for use

Updated on 23 May 2006 PIL

Reasons for updating

Improved electronic presentation

Updated on 28 March 2006 PIL

Reasons for updating

Improved electronic presentation

Updated on 28 March 2006 SmPC

Reasons for updating

Change to section 2 - Qualitative and quantitative composition
Change to section 3 - Pharmaceutical form
Change to section 4.7 - Effects on ability to drive and use machines
Change to section 4.8 - Undesirable effects
Change to section 5.1 - Pharmacodynamic properties

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

Updated on 4 August 2005 PIL

Reasons for updating

Improved electronic presentation

Updated on 17 August 2004 PIL

Reasons for updating

New PIL for medicines.ie

Updated on 16 June 2004 SmPC

Reasons for updating

Change to section 4.4 - Special warnings and precautions for use
Change to section 6.1 - List of excipients
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)

Updated on 3 July 2003 SmPC

Reasons for updating

New SPC for medicines.ie

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