Keral 50 mg/2ml Solution for injection/infusion
*Company:
A. Menarini Pharmaceuticals Ireland LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 13 April 2023
File name
ie-smpc Keral Injection clean Approved April 23.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- 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 4.6 - Information on pregnancy updated
Section 10 - Date of revision updated
Updated on 13 April 2023
File name
ie-leaflet Keral Injection Clean Approved April 23.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Section 2 - Information on pregnancy updated
Section 6 - Date of revision updated
Updated on 16 November 2022
File name
ie-smpc Keral Injection clean Approved Sept 22.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 2 - Sodium Chloride deleted
Section 4.4 - Ethanol warnings added
Updated on 16 November 2022
File name
ie-leaflet Keral Injection clean Approved Sept 22.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 6 - what the product contains
Free text change information supplied by the pharmaceutical company
Section 2 - Ethanol Warnings added
Section 4 - loss of appetite warning added
Section 6 - other ingredient section updated
Updated on 20 January 2022
File name
ie-smpc Keral Injection clean - Approved Jan 22.pdf
Reasons for updating
- 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 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 - "dysfunction" replaced with "impairment"
Section 4.3 - "dysfunction" replaced with "impairment"
Section 4.4 - new section added - "Masking of symptoms of underlying infections" and other minor amends
Section 4.6 - "dysfunction" replaced with "impairment"
Section 10 - Date of revision updated
Updated on 20 January 2022
File name
ie-leaflet Keral Injection clean - Approved Jan 22.pdf
Reasons for updating
- 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 3 - how to take/use
- Change to section 6 - date of revision
- Change to other sources of information section
Free text change information supplied by the pharmaceutical company
Section 2 - warnings and precautions - information on infections added
Section 2 - Interactions with other medicines - "beta blockers" deleted
Section 3 - How to take Keral - Dosing information updated and information on infections added
Section 10 - date of revision updated
Other information - product name in other countries updated
Updated on 19 July 2021
File name
ie-leaflet Keral Injection Clean Approved March 21.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.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
File name
PIL_13889_850.pdf
Reasons for updating
- New PIL for new product
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
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
- 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 SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 18 November 2008
Reasons for updating
- New PIL for medicines.ie