Keral 50 mg/2ml Solution for injection/infusion *

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 July 2021

File name

ie-leaflet Keral Injection Clean Approved March 21_1626691191.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to further information section

Free text change information supplied by the pharmaceutical company

Section 4 - HPRA AE reporting details updated

Section 6 - product information in other countries section updated 

 

Updated on 01 August 2019

File name

ie-spc Keral injection 8-6-18_1564650211.pdf

Reasons for updating

  • File format updated to PDF

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

Free text change information supplied by the pharmaceutical company

File format updated to pdf

Updated on 28 June 2018

File name

ie-spc Keral injection 8-6-18.docx

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - 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 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • 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

Update to the SmPC to align to the current QRD template.

Also to update section 4.5 Interactions  including updated warning for mifepristone.  Tenofovir, deferasirox and pemetrexed added.

Updated on 28 June 2018

File name

ie-leaflet Keral Injection clean 8-6-18.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to other sources of information section

Updated on 10 May 2018

File name

ie-smpc_Keral_Injection_clean_9-4-18.docx

Reasons for updating

  • Change to section 3 - Pharmaceutical form

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

Free text change information supplied by the pharmaceutical company

Change of name of the pharmaceutical form from “solution for injection or concentrate for solution for infusion”  to the current standard term “solution for injection/ infusion”.

Updated on 04 May 2018

File name

ie-leaflet Keral Injection clean 9-4-18.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to name of medicinal product

Updated on 26 May 2015

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 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • 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 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

The main changes are described below:

 

3.       PHARMACEUTICAL FORM

pH has been changed from (6,5-8,5)  to (7.0-8.0)

 

4.2.    Posology and method of administration

Renal dysfunction:

Mild renal dysfunction has changed from "creatinine clearance 50-80 ml/min" to "creatinine clearance  60-89 ml/min)"

Moderate to severe renal dysfunction has changed from "creatinine clearance<50 ml/min" to "creatinine clearance <59 ml/min"

4.3.    Contraindications

The following contraindications have been added:

- known photoallergic or phototoxic reactions during treatment with ketoprofen or fibrates

- patients with severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake)

 The contraindication in case of history of gastrointestinal ulceration/bleeding is now better specified as :

- "patient with active peptic ulcer/gastrointestinal haemorrhage, or any history of gastrointestinal bleeding, ulceration or perforation";

The levels of severe renal dysfunction have been now better specified:

-Patients with moderate to severe renal dysfunction is now specified as "creatinine clearance <59 ml/min)"

4.4          Special warnings and special precautions for use 

The paragraph has been organized in sub-sections (Gastrointestinal safety, Renal Safety, Liver safety, Cardiovascular and cerebrovascular safety, Skin reactions, Other information; Paediatric population) where the information already present in the previous  SmPC have been reported. 

The following sentences have been added:

Renal Safety

Adequate fluid intake should be ensured during treatment to prevent dehydration and possibly associated increased renal toxicity.

Older patients are more likely to be suffering from impaired hepatic function (see section 4.2).

Other information

Particular caution is required in patients with:

- congenital disorder of porphyrin metabolism (e.g. acute intermittent porphyria)

-dehydration

- directly after major surgery

If the physician considers long-term dexketoprofen therapy to be necessary, hepatic and renal function and the blood count should be regularly checked.

Severe acute hypersensitivity reactions (anaphylactic shock, for example) have been observed on very rare occasions. Treatment must be discontinued at the first signs of severe hypersensitivity reactions following intake of Keral. Depending on the symptoms, any medically required procedures must be initiated by specialist healthcare professionals.

Patients with asthma combined with chronic rhinitis, chronic sinusitis, and/or nasal polyposis have a higher risk of allergy to acetylsalicylic acid and/or NSAIDs than the rest of the population. Administration of this medicinal product can cause asthma attacks or bronchospasm, particularly in subjects allergic to acetylsalicylic acid or NSAIDs (see section 4.3).

Exceptionally, varicella can be at the origin of serious cutaneous and soft tissues infectious complications. To date, the contributing role of NSAIDs in the worsening of these infections cannot be ruled out. Thus, it is advisable to avoid use of Keral in case of varicella.

Updated on 26 May 2015

Reasons for updating

  • New SPC for new product

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

Updated on 26 May 2015

File name

PIL_13889_850.pdf

Reasons for updating

  • New PIL for new product

Updated on 26 May 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.

Updated on 07 August 2012

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 12 August 2011

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
  • Change to section 10 - Date of revision of the text
  • Change to improve clarity and readability
  • Section 4.5 Interactions: information regarding interaction with aminoglycosides has been included.
  • Section 4.8 Undesirable effects: hepatitis, laryngeal oedema and acute renal failure have been included; hepatocellular damage and angioneurotic oedema have been replaced by hepatocellular injury and angioedema, respectively.
  • Minor discrepancies between the SmPC of the film-coated tablets and the solution for injection have been amended.

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

Free text change information supplied by the pharmaceutical company


  • Section 4.5 Interactions: information regarding interaction with aminoglycosides has been included.
  • Section 4.8 Undesirable effects: hepatitis, laryngeal oedema and acute renal failure have been included; hepatocellular damage and angioneurotic oedema have been replaced by hepatocellular injury and angioedema, respectively.
  • Minor discrepancies between the SmPC of the film-coated tablets and the solution for injection have been amended.

Updated on 09 August 2011

Reasons for updating

  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

Updated on 20 May 2011

Reasons for updating

  • Change to date of revision
  • Addition of manufacturer

Updated on 29 September 2009

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 18 November 2008

Reasons for updating

  • New PIL for medicines.ie

Updated on 18 November 2008

Reasons for updating

  • New SPC for medicines.ie

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