Pharmaceutical Products

Alecensa is an oral medicine, used for the treatment of people with non-small cell lung cancer (NSCLC) whose tumours are identified as anaplastic lymphoma kinase (ALK)-positive.

Alecensa contains the active substance alectinib and it belongs to a group of drugs called small molecule kinase inhibitors.

Alecensa blocks the action of an enzyme called ‘ALK tyrosine kinase’. Abnormal forms of this enzyme help to encourage cancer cell growth.

Patient Information Leaflet

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Patient Information Leaflet- Alecensa 150mg hard capsules

Avastin was the first anti-angiogenic therapy for the treatment of patients with metastatic colorectal, ovarian, breast, renal cell or non-small cell lung cancer.

Avastin is an intravenous anti-angiogenic therapy that contains the active substance bevacizumab. It belongs to a group of medicines called monoclonal antibodies.

A monoclonal antibody is a type of protein designed to attach to a specific target in the body made by the immune system to help defend the body from infection and cancer. These therapies stop the process of developing new blood vessels in cancer tumours (angiogenesis).

Avastin is used for the treatment of advanced stages of breast, colorectal, non-small cell lung, kidney, ovarian and cervical cancers. 

Patient Information Leaflet (PIL)

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Patient Information Leaflet -Avastin 25mg/ml concentrate for solution for infusion.

CellCept is used in the prevention of organ rejection in patients receiving kidney, heart, or liver transplants.

CellCept is an oral immunosuppressant therapy that contains the active agreement mycophenolate mofetil. CellCept works by reducing the activity of the body's immune system. 

Patient Information Leaflet (PIL)

This link will take you to the www.medicines.ie which is a non-Roche website.

Manufactured in Clarecastle, Ireland.

Patient Information Leaflet - Cellcept 250mg Capsules

Patient Information Leaflet - Cellcept 500mg powder for concentrate for solution for infusion
Patient Information Leaflet - Cellcept 500mg Tablets
Patient Information Leaflet - Cellcept suspension

Cotellic is indicated for use in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

Cotellic contains the active agreement cobimetinib. It belongs to a group of drugs called small molecule kinase inhibitors and the drug belongs to a family of tyrosine kinase inhibitors.  

Cotellic is an oral drug used in combination with another drug vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

Patient Information Leaflet (PIL)

This link will take you to the www.medicines.ie which is a non-Roche website.

Patient Information Leaflet - Cotellic 20 mg film-coated tablets

Erivedge is for the treatment of patients with symptomatic metastatic Basal Cell Carcinoma (mBCC) or locally advanced Basal Cell Carcinoma.

Erivedge is a capsule taken once daily to treat adults with a type of skin cancer, called basal cell carcinoma that has spread to other parts of the body or cannot be treated effectively with surgery or radiation.  

The drug contains the active ingredient called vismodegib.

Patient Information Leaflet (PIL)

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Patient Information Leaflet - Erivedge 150 mg Hard Capsules

Esbriet is an oral medicine approved for the treatment of Idiopathic Pulmonary Fibrosis (IPF) and is available in approximately 40 countries worldwide.

Esbriet is an oral tablet with an active ingredient pirfenidone. Pirfenidone is an anti-fibrotic drug used for the treatment of mild to moderate idiopathic pulmonary fibrosis.  

Patient Information Leaflet (PIL)

This link will take you to the www.medicines.ie which is a non-Roche website.

Patient Information Leaflet - Esbriet 267 mg Hard Capsules

Patient Information Leaflet - Esbriet 267 mg, 534 mg and 801 mg Film-coated Tablets

Gazyvaro is for the treatment of patients with Chronic Lymphocytic Leukaemia (CLL), the common form of Leukaemia and Follicular Lymphoma (FL).

Gazyvaro contains the active ingredient obinutuzumab. It belongs to a group of medicines called monoclonal antibodies. A monoclonal antibody is a type of protein designed to recognise and attach to a specific target in the body made by the immune system to help defend the body from infection and cancer.

Gazyvaro is approved as an intravenous drug in combination with chlorambucil for the treatment of patients with previously untreated chronic lymphocytic leukaemia. Gazyvaro in combination with chemotherapy, followed by Gazyvaro maintenance therapy in patients achieving a response, is indicated for the treatment of patients with previously untreated advanced follicular lymphoma (FL). Gazyvaro in combination with bendamustine followed by Gazyvaro maintenance is indicated for the treatment of patients with follicular lymphoma (FL) who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen.

 

Patient Information Leaflet (PIL)

This link will take you to the www.medicines.ie which is a non-Roche website.

Patient Information Leaflet - Gazyvaro 1,000 mg concentrate for solution for infusion

Hemlibra is a prescription medicine used for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with haemophilia A with factor VIII inhibitors or severe haemophilia A without inhibitors. It is given as an injection under the skin (subcutaneous injection).

 

Haemophilia A is a bleeding condition people can be born with where a missing or faulty blood clotting factor (factor VIII) prevents blood from clotting normally.

 

Hemlibra is a therapeutic antibody that bridges clotting factors to help the blood clot. Like factor VIII, HEMLIBRA binds to factor IXa and factor X and mimics the effect of factor VIII in the body. It links factor IXa and factor X, and the clotting pathway can continue.

 

HEMLIBRA is not the same as factor VIII replacement therapy, so it is not thought that factor VIII inhibitors will affect HEMLIBRA.

 

Hemlibra is not a cure for haemophilia.

 

Patient Information Leaflet (PIL)

This link will take you to the www.medicines.ie which is a non-Roche website.

Patient Information Leaflet - Hemlibra 150 mg/mL Solution for Injection

Patient Information Leaflet - Hemlibra 30 mg/mL Solution for Injection

Herceptin is for the treatment of HER2 positive breast or gastric cancer. Since 1998 more than 1.3 million patients worldwide have been treated with Herceptin.

Herceptin contains the active ingredient trastuzumab and is classed as humanised monoclonal. It belongs to a group of medicines called monoclonal antibodies. A monoclonal antibody is a type of protein designed to recognise and attach to a specific target in the body made by the immune system to help defend the body from infection and cancer.

Herceptin is an antibody directed against a cell surface protein produced by the human epidermal growth factor receptor 2 (HER2) gene. HER2 protein is overexpressed in about one-third of all breast cancers.

Herceptin (trastuzumab) is used in the treatment of breast cancer with such characteristics. It is also used with combination chemotherapy in HER2-positive metastatic gastric cancer. Herceptin is an intravenous and subcutaneous used to treat early and advanced breast and gastric cancer.

Patient Information Leaflet (PIL)

This link will take you to the www.medicines.ie which is a non-Roche website.

Patient Information Leaflet - Herceptin 150mg Powder for concentrate for solution for infusion

Patient Information Leaflet - Herceptin 600 mg Solution for Injection in Vial

Hypnovel is a short-acting benzodiazepine that works on the nervous system inducing sedation.

 

Hypnovel contains the active ingredient of Midazolam. Hypnovel is a short-acting benzodiazepine and it works on the nervous system inducing conscious sedation: anesthesia, sedation in intensive care units.

 

It has potent amnestic action, it is administered by intravenous (IV) injection or IV infusion.

Patient Information Leaflet (PIL)

This link will take you to the www.medicines.ie which is a non-Roche website.

Patient Information Leaflet - Hypnovel 10mg/2ml solution for injection
SPC - Hypnovel 10mg/5ml solution for injection

Kadcyla is the first antibody drug conjugate used for the treatment of patients with HER2 positive metastatic breast cancer, improving survival and quality of life.

Kadcyla contains the active ingredient of trastuzumab emtansine, it is an antibody drug conjugate. Antibody drug conjugates are a combination of a targeted monoclonal antibody, a stable linker, and a potent cytotoxic agent. These three components are designed to deliver a potent cytotoxic drug to achieve an effective drug dose directly at the tumour site that over express the HER2 protein, and to reduce normal tissue drug exposure.

Kadcyla is administered as an intravenous (IV) infusion for the treatment of adults with HER2 positive advanced or metastatic breast cancer as a single agent.

 

Patient Information Leaflet (PIL)

This link will take you to the www.medicines.ie which is a non-Roche website.

Patient Information Leaflet - Kadcyla 100mg & 160mg powder for concentrate for solution for infusion

Lexotan is used in the short-term treatment of severe or disabling anxiety, tension or agitation.

Lexotan contains the active ingredient of bromazepam, the drug belongs to a group of drugs called benzodiazepines. Benzodiazepines are a class of drug that work on the nervous system inducing sedation, relieving anxiety.

Lexotan has been used in the short-term treatment of severe or disabling anxiety disorders.

 

Patient Information Leaflet (PIL)

This link will take you to the www.medicines.ie which is a non-Roche website.

Patient Information Leaflet - Lexotan 1.5mg/3mg Tablets

MabThera may be used for the treatment of several different conditions in adults. It can be prescribed for the treatment of Non-Hodgkin’s Lymphoma (NHL); chronic lymphocytic leukaemia (CLL); rheumatoid arthritis; severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) and moderate to severe pemphigus vulgaris (PV). Over 2.5 million patients worldwide have been treated with MabThera since 1998.

MabThera is a humanised monoclonal antibody it contains the active ingredient rituximab and it belongs to a group of medicines called monoclonal antibodies. A monoclonal antibody is a type of protein designed to recognise and attach to a specific target in the body made by the immune system to help defend the body from infection and cancer.

MabThera suppresses a protein called CD20 which is found on the surface of blood cells. CD20 can be over expressed on certain tumour types. These cells are central to many blood cancers, including common forms of lymphoma and leukaemia.

MabThera is available as an intravenous (IV) and subcutaneous (SC) therapy.

The IV formulation of MabThera is also used for the treatment of Rheumatoid Arthritis. Rheumatoid Arthritis is a disease of the joints. B-lymphocytes are involved in the cause of some of the symptoms displayed.

The SC formulation contains active ingredient of Rituximab combined with Hyaluronidase which allows administration of the product subcutaneously over 5-7 minutes.

Patient Information Leaflet (PIL)

This link will take you to the www.medicines.ie which is a non-Roche website.

Patient Information Leaflet - MabThera 500 mg concentrate for solution for infusion

Patient Information Leaflet - MabThera 1400 mg Solution for Subcutaneous Injection

Patient Information Leaflet - MabThera 100 mg Concentrate for Solution for Infusion

Madopar works on the central nervous system in the treatment of Parkinson’s disease and restless leg syndrome.

Madopar is an oral tablet contains the active ingredients of levodopa and benserazide. It belongs to a group of medicines called antiparkinsonian agents and is used for the treatment of patients with Parkinson’s disease and restless leg syndrome.  

Madopar works on the central nervous system. Parkinson disease inhibits dopamine levels in certain parts of the brain. This can result in slow movements stiff muscles and tremor. In the body levodopa is changed into dopamine. Dopamine is the active medicine that is needed in your brain to help Parkinson’s disease.

The benserazide allows more of the levodopa you take to get into your brain before it is changed into dopamine.

Patient Information Leaflet (PIL)

This link will take you to the www.medicines.ie which is a non-Roche website.

Patient Information Leaflet - Madopar 250 Capsules
Patient Information Leaflet - Madopar Dispersible Tablets

NeoRecormon is used to treat patients with symptomatic anaemia associated with chronic kidney disease (CKD) and to treat chemotherapy-related anaemia in cancer patients.

 

NeoRecormon is a clear, colourless solution for injection under the skin (subcutaneously) or into a vein (intravenously).It contains a hormone called epoetin beta, which stimulates the production of red blood cells.

 

Epoetin beta is produced by a specialised genetic technology and works in exactly the same way as the natural hormone erythropoietin. NeoRecormon is used to treat patients with symptomatic anaemia associated with chronic kidney disease (CKD) and to treat chemotherapy-related anaemia in cancer patients.

Patient Information Leaflet (PIL)

This link will take you to the www.medicines.ie which is a non-Roche website.

Patient Information Leaflet - NeoRecormon solution for injection Pre-Filled Syringe.

Ocrevus (ocrelizumab) is licensed to treat relapsing forms of Multiple Sclerosis (RMS) and early Primary Progressive Multiple Sclerosis (PPMS) in adults. It is the first and only medicine approved in the European Union to treat PPMS, a debilitating form of MS in which patients can experience rapidly worsening and irreversible disability.

 

MS affects approximately 700,000 patients in Europe, of which around 96,000 are diagnosed with PPMS.  Most patients with MS have either RMS or PPMS at diagnosis.

 

Ocrevus (ocrelizumab) belongs to a group of medicines called monoclonal antibodies. A monoclonal antibody is a type of protein designed to recognise and attach to certain cells in the human body.

 

Ocrevus (ocrelizumab) targets a certain type of immune cell (CD20-positive B cells). These B cells are believed to contribute to the damage to nerve cells and the nerve cell insulation (myelin). This nerve cell damage can lead to relapses and disability in patients with MS.

Patient Information Leaflet (PIL)

This link will take you to the www.medicines.ie which is a non-Roche website.

Patient Information Leaflet - Ocrevus 300 mg concentrate for solution for infusion

Pegasys is for the treatment of patients who have chronic infection from either the Hepatitis C or B Virus.

 

Pegasys contains the active substance peginterferon alfa-2a, which is a long-acting interferon. Interferon is a protein that modifies the response of the body's immune system to help fight infections and severe diseases.

 

Pegasys is used to treat chronic Hepatitis B or chronic Hepatitis C in adults. It is also used to treat chronic Hepatitis B in children and adolescents aged 3 years and older and chronic Hepatitis C in children and adolescents aged 5 years and older, who have not been treated before.

 

Both chronic Hepatitis B and C are viral infections of the liver. Chronic Hepatitis B: Pegasys is usually used alone. Chronic Hepatitis C: Pegasys is used in combination with other medicines, for the treatment of chronic Hepatitis C.

 

Patient Information Leaflet (PIL)

This link will take you to the www.medicines.ie which is a non-Roche website.

Patient Information Leaflet - Pegasys 135 and 180 micrograms solution for injection in pre-filled syringe.

Perjeta is for the treatment of HER2 positive early and metastatic breast cancer. It is a first in class HER2 dimerisation inhibitor designed to work synergistically with Herceptin and chemotherapy.

 

Perjeta contains the active ingredient Pertuzumab and is classed as humanised monoclonal. It belongs to a group of medicines called monoclonal antibodies. A monoclonal antibody is a type of protein designed to recognise and attach to a specific target in the body made by the immune system to help defend the body from infection and cancer.

 

Perjeta is designed to prevent the HER2 receptor from pairing with other HER receptors on the surface of cells, a mechanism that is complementary to another drug called Herceptin.

Perjeta is approved in combination with Herceptin for the treatment of patients with previously untreated HER2-positive metastatic breast cancer. 

Patient Information Leaflet (PIL)

This link will take you to the www.medicines.ie which is a non-Roche website.

Patient Information Leaflet - Perjeta 420 mg Concentrate for Solution for Infusion

Pulmozyme is used in the treatment of people with cystic fibrosis.

 

Pulmozyme is a nebulizer inhaled medication with active ingredient of dornase alfa. It is a man-made version of a protein found in your body called ‘DNase’.

 

Pulmozyme is used for people with cystic fibrosis. It helps by breaking down the thick mucus found in lungs. This helps lungs of people with cystic fibrosis to work better. Pulmozyme is breathed in (inhaled) using something called a nebulizer.

Patient Information Leaflet (PIL)

This link will take you to the www.medicines.ie which is a non-Roche website.

Patient Information Leaflet - Pulmozyme

Rivotril is used to treat epilepsy in infants, children and adults.

 

Rivotril contains active ingredient called clonazepam. This belongs to a group of medicines called ‘benzodiazepines’. Benzodiazepines are a class of drug that work on the nervous system.  

 

Rivotril is used to treat epilepsy in infants, children and adults. It lowers the number of fits (seizures) that patient experience.

Patient Information Leaflet (PIL)

This link will take you to the www.medicines.ie which is a non-Roche website.

Patient Information Leaflet - Rivotril 0.5mg Tablets

Patient Information Leaflet - Rivotril 2mg Tablets

Roaccutane is used to treat patients with severe forms of acne.

 

Roaccutane is a tablet which contains active ingredient of isotretinoin – a substance related to vitamin A, and one of a group of medicines called retinoids (for treatment of acne).

 

Retinoids work by reducing the amount of the oily substance (i.e. sebum) made by glands in your skin, reducing bacteria and inflammation and opening clogged pores.

 

Therapy should be supervised by a dermatologist. Roaccutane is a possible teratogen (an agent or factor which causes malformation of an embryo). Female patients should be on the pregnancy prevention program whilst on Roaccutane therapy.

Patient Information Leaflet (PIL)

This link will take you to the www.medicines.ie which is a non-Roche website.

Patient Information Leaflet - Roaccutane 10mg Capsules
Patient Information Leaflet - Roaccutane 20mg Capsules

RoACTEMRA is used to treat moderate-to-severe Rheumatoid Arthritis in adults, systemic juvenile idiopathic arthritis (sJIA), juvenile idiopathic polyarthritis (pJIA) in children, and Giant Cell Arteritis (GCA) in adults.

 

RoACTEMRA (tocilizumab) contains the active substance tocilizumab which is a protein made from specific immune cells that blocks the action of a specific protein cytokine called interleukin-6 (IL-6). IL-6 is believed to play a key role in activating the inflammatory pathway that contributes to the signs and symptoms of RA and other inflammatory autoimmune conditions. RoActemra (tocilizumab) binds to IL-6 receptors, blocking the pro-inflammatory effect of IL-6 cytokines.

 

RoActemra (tocilizumab) is available in both subcutaneous (SC) and intravenous (IV) formulations.

Patient Information Leaflet (PIL)

This link will take you to the www.medicines.ie which is a non-Roche website.

Patient Information Leaflet - RoActemra 20 mg/ml concentrate for solution for infusion.

Patient Information Leaflet - RoActemra 162 mg solution for injection in pre-filled syringe

Patient Information Leaflet - RoActemra 162 mg solution for injection in pre-filled pen

 

Rocephin is an antibiotic given to adults and children intravenously (IV) by infusion or by injection (including newborn babies). It contains the active ingredient ceftraxione and works by killing bacteria that cause infections.

 

It belongs to a group of medicines called cephalosporins. Rocephin is administered by injection into a muscle in a solution containing lidocaine, which reduces the pain associated with the injection.

It can be given: to treat specific sexually transmitted infections (gonorrhoea and syphilis), to treat patients with low white blood cell counts (neutropenia) who have fever due to bacterial infection, to treat infections of the chest in adults with chronic bronchitis and to treat Lyme disease (caused by tick bites) in adults and children including newborn babies from 15 days of age.

Patient Information Leaflet (PIL)

This link will take you to the www.medicines.ie which is a non-Roche website.

Patient Information Leaflet - Rocephin 1g Powder and Solvent for IM Injection.
Patient Information Leaflet - Rocephin Vials.

Tamiflu is used for the prevention and treatment of influenza.

 

Tamiflu contains the active ingredient oseltamivir, it is an oral anti-viral agent which belongs to a group of medicines named neuraminidase inhibitors.

 

Tamiflu binds to the neuraminidase on the surface of the virus particles and hence inhibits the new viral particles' chemical ability to escape from the infected cell. The influenza virus is thereby restricted to a smaller number of cells and the body's immune system has a better chance of killing the virus.

 

Tamiflu helps to ease or prevent the symptoms of the flu virus infection.

Patient Information Leaflet (PIL)

This link will take you to the www.medicines.ie which is a non-Roche website.

Patient Information Leaflet - Tamiflu 30 mg Hard Capsules
Patient Information Leaflet - Tamiflu 45 mg Hard Capsules
Patient Information Leaflet - Tamiflu 75 mg Hard Capsules
Patient Information Leaflet - Tamiflu 30mg, 45mg and 75mg Hard Capsules
Patient Information Leaflet - Tamiflu 6 mg/ml Powder for Oral Suspension

Tarceva is used for the treatment of patients with lung and pancreatic cancer.

 

Tarceva is a tablet that contains the active substance erlotinib. It belongs to a group of drug called tyrosine kinase inhibitors.

 

Tarceva is a medicine used to treat cancer by preventing the activity of a protein called epidermal growth factor receptor (EGFR). This protein is known to be involved in the growth and spread of cancer cells.  When the ECFR protein has certain types of genetic mutations, Tarceva can interfere with these signals. This may cause the cancer cells to die.

Patient Information Leaflet (PIL)

This link will take you to the www.medicines.ie which is a non-Roche website.

Patient Information Leaflet - Tarceva 25mg, 100mg and 150mg Film-Coated Tablets

TECENTRIQ is used to treat a cancer that affects the lungs, called non-small cell lung cancer. It is also used to treat a cancer that affects the bladder and the urinary system, called urothelial carcinoma.

 

TECENTRIQ is a monoclonal antibody that contains active substance atezolizumab. A monoclonal antibody is a type of protein designed to recognise and attach to a specific target in the body. It is a type of medication called immunotherapy.

 

TECENTRIQ works by attaching to a specific protein in your body called programmed death-ligand 1

(PD-L1). This protein suppresses the body’s immune (defence) system, thereby protecting cancer cells from being attacked by the immune cells. By attaching to the protein, TECENTRIQ helps your immune system to fight your cancer.

Patient Information Leaflet (PIL)

This link will take you to the www.medicines.ie which is a non-Roche website.

Patient Information Leaflet - Tecentriq 1,200 mg concentrate for solution for infusion

Valcyte is used for the prevention of cytomegalovirus (CMV) infections in kidney, heart, and pancreas transplant patients. Also used in the treatment of CMV retinitis in patients with AIDS.

Valcyte is a tablet or oral solution that contains the active ingredient called valganciclovir. It belongs to a group of medicines called valganciclovir which work directly to prevent the growth of viruses. In the body the active ingredient in the tablets, valganciclovir, is changed into ganciclovir. Ganciclovir prevents a virus called cytomegalovirus (CMV) from multiplying and invading healthy cells.

In patients with a weakened immune system, CMV can cause an infection in the body’s organs. This can be life threatening.

Patient Information Leaflet (PIL)

This link will take you to the www.medicines.ie which is a non-Roche website.

Patient Information Leaflet - Valcyte 450mg film-coated tablets.

Patient Information Leaflet - Valcyte 50mg/ml powder for oral solution.

Zelboraf is for the treatment of patients with metastatic melanoma with BRAF V600 mutation.

Zelboraf is an anticancer medicine that contains the active substance vemurafenib. It belongs to a group of drugs called small molecule kinase inhibitors.

It is used to treat adult patients with melanoma that has spread to other parts of the body or cannot be removed by surgery. It can only be used in patients whose cancer has a change (mutation) in the “BRAF” gene - BRAF V600 mutations. This change may have led to the development of melanoma. Zelboraf targets proteins made from this modified gene and slows down or stops the development of the cancer.

Patient Information Leaflet (PIL)

This link will take you to the www.medicines.ie which is a non-Roche website.

Patient Information Leaflet - Zelboraf 240mg Film-coated Tablets