« Back to Medicines list

Isentress 600 mg tablets

  • Name:

    Isentress 600 mg tablets

  • Company:
    info
  • Active Ingredients:

    Raltegravir potassium

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 06/11/20

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 8/4/2021

Click on this link to Download PDF directly

MSD Ireland (Human Health) Limited

02852_MSD_Logo_W-Anthem_Horizontal_Teal&Grey_RGB_1589289143

Company Products

Medicine NameActive Ingredients
Medicine Name Adempas Film Coated Tablets Active Ingredients Riociguat
Medicine Name Arcoxia 30 60 90 120 film-coated tablets Active Ingredients Etoricoxib
Medicine Name Atozet 10mg/10mg, 10mg/20mg, 10mg/40mg and 10mg/80mg film-coated tablets Active Ingredients Atorvastatin calcium trihydrate, ezetimibe
Medicine Name Bridion Active Ingredients Sugammadex sodium
Medicine Name Cancidas 50mg Powder for concentrate for solution for infusion Active Ingredients caspofungin acetate
Medicine Name Cancidas 70mg Powder for concentrate for solution for infusion Active Ingredients caspofungin acetate
Medicine Name Cerazette 75 microgram film-coated tablet Active Ingredients Desogestrel
Medicine Name Cozaar 12.5mg, 50mg & 100mg Film-coated Tablets Active Ingredients Losartan potassium
Medicine Name Cozaar COMP 50 mg/12.5 mg, 100 mg/12.5 mg, 100 mg/25 mg film-coated tablets Active Ingredients Hydrochlorothiazide, Losartan potassium
Medicine Name Cubicin 350mg Powder for Solution for injection or infusion Active Ingredients Daptomycin
Medicine Name Cubicin 500mg powder for solution for injection or infusion Active Ingredients Daptomycin
Medicine Name Delstrigo 100 mg/300 mg/245 mg film-coated tablets Active Ingredients Lamivudine, Tenofovir disoproxil fumarate, Doravirine
Medicine Name Diprosalic Scalp Application Active Ingredients Betamethasone dipropionate, Salicylic Acid
Medicine Name Elocon Cream Active Ingredients Mometasone Furoate
Medicine Name Elocon Ointment Active Ingredients Mometasone Furoate
Medicine Name EMEND 80mg, 125mg hard Capsules Active Ingredients Aprepitant
Medicine Name Esmeron Active Ingredients Rocuronium Bromide
Medicine Name EZETROL 10 mg Tablets Active Ingredients ezetimibe
Medicine Name FOSAMAX Once Weekly 70 mg Tablets Active Ingredients Alendronate Sodium Trihydrate
Medicine Name FOSAVANCE Active Ingredients Alendronate Sodium Trihydrate, Colecalciferol (Vitamin D3)
Medicine Name GARDASIL Active Ingredients human papillomavirus vaccine
Medicine Name Gardasil 9 suspension for injection in a pre-filled syringe Active Ingredients Human papillomavirus 9-valent vaccine
Medicine Name HALF SINEMET CR 25mg/100mg Prolonged-Release Tablets Active Ingredients Carbidopa, Levodopa
Medicine Name HBVAXPRO 10mcg Active Ingredients Hepatitis B vaccine (rDNA)
Medicine Name HBVAXPRO 40mcg Active Ingredients Hepatitis B vaccine (rDNA)
1 - 0 of 78 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 8 April 2021 SPC

Reasons for updating

  • 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

ATC code update

Updated on 6 November 2020 PIL

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 6 November 2020 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

Update to implement the 2017 excipient guideline

Updated on 6 June 2019 PIL

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 6 June 2019 SPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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 SPC to replace the reference to “Merck” logo with “MSD corporate” logo

 

Updated on 1 March 2019 SPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text
  • Improved presentation of SPC

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

Free text change information supplied by the pharmaceutical company

Update of section 4.5 of the SmPC to reflect the data from 3 in vitro studies evaluating the inhibitory effect of raltegravir at higher concentrations and minor editorial updates

 

 

Updated on 21 November 2018 PIL

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility

Updated on 21 November 2018 SPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data

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

Free text change information supplied by the pharmaceutical company

Change to section 4.6 & 5.3 (update regarding pregnancy and risk of malformative or foetal toxicity (LEG)

Updated on 22 October 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

Change to section 4.4  & Change to section 4.8: addition of "autoimmune hepatitis”.

Updated on 26 June 2018 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 section 7 - Marketing authorisation holder

Present

Proposed

Merck Sharp & Dohme Ltd.
Hertford Road
Hoddesdon
Hertfordshire
EN11 9BU
United Kingdom

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

Updated on 26 June 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 3 May 2018 SPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

Change to section 4.1 (update regarding Paediatric population) Change to section 4.2 (update regarding Paediatric population); Change to Section 4.8 (update the safety information); Change to section 5.2 (update regarding Paediatric population)

Updated on 24 April 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 26 March 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 26 March 2018 SPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

Change to Section 4.8 (update the safety information);  Change to section 5.1 (update with information regarding study PN292 (ONCEMRK);

Updated on 6 November 2017 SPC

Reasons for updating

  • New SPC for new product
  • New SPC for medicines.ie

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 6 November 2017 PIL

Reasons for updating

  • New PIL for new product