10 mg / ml concentrate for solution for infusion
nivolumab
What OPDIVO is and what it is used for
OPDIVO is a medicine used to treat:
- advanced melanoma (a type of skin cancer) in adults
- adults with melanoma who have been completely removed by surgery (treatment after surgery is called adjuvant treatment)
- advanced non- small cell lung cancer (a type of lung cancer) in adults
- lung sac cancer (malignant pleural mesothelioma, a type of cancer that affects the tissue surrounding the lungs) in adults
- advanced renal cell carcinoma in adults
- Hodgkin’s lymphoma in adults, where the disease has returned after or not responded to previous treatments, including autologous stem cell transplantation (a transplant of your own blood-producing cells)
- advanced head and neck cancer in adults
- advanced urothelial cell cancer (bladder and urinary tract cancer) in adults
- advanced colorectal cancer (colon or rectal cancer) in adults
- advanced esophageal cancer (esophageal cancer) in adults
- esophageal cancer (esophageal cancer) or cancer of the gastroesophageal junction (the transition between esophagus and stomach) with persistent microscopic disease after chemoradiotherapy (chemotherapy and radiation therapy) followed by surgery in adults
- advanced gastric cancer, cancer in the transition between esophagus and stomach or esophageal cancer in adults.
It contains the active substance nivolumab which is a human monoclonal antibody, a kind of protein designed to recognize and bind to specific target substances in the body.
Nivolumab binds to a target protein called the programmed-dead-1 receptor (PD-1) and PD-1 can block the activity of T cells (a type of white blood cell that forms part of the immune system, the body’s natural defenses). By binding to PD-1, nivolumab blocks its activity and prevents it from shutting down your T cells. This increases the activity of T cells against melanoma, lung, kidney, lymph node, head, and neck, bladder, colon, rectum, stomach,
esophageal cancer cells or against cancer cells in the transition between the esophagus and stomach.
OPDIVO can be given in combination with other anticancer medicines. It is important that you also read the package leaflet for these medicines. Ask your doctor if you have any questions about these medicines.
What you need to know before using OPDIVO
You should not be given OPDIVO
- if you are allergic to nivolumab or any of the other ingredients of this medicine (see section 6 “Contents of the pack and other information”). Talk to your doctor if you are unsure.
Warnings and cautions
Talk to your doctor before using OPDIVO as it may cause:
- Problems with your heart such as changes in heart rate, heart rate or abnormal heart rhythm.
- Problems with your lungs such as difficulty breathing or coughing. This may be a sign of inflammation in the lungs ( pneumonitis or interstitial lung disease).
- Diarrhea (watery, loose or soft stools) or other symptoms of inflammation in the intestines ( colitis ) such as abdominal pain and mucus or blood in the stools.
- Inflammation of the liver ( hepatitis ). Signs and symptoms of hepatitis can be abnormal liver function values, yellow eyes or skin (jaundice), pain on the right side of the abdomen or fatigue.
- Inflammation or problems with the kidneys. Signs and symptoms can be abnormal kidney function values or decreased urine output.
- Problems with your hormone-producing glands (including the pituitary gland , thyroid gland, parathyroid glands and adrenal glands) that can affect how these glands work. Signs and symptoms that these glands are not working properly can be extreme fatigue, weight change or headaches, decreased levels of calcium in the blood and visual disturbances.
- Diabetes (symptoms such as excessive thirst, greatly increased urine output, increased appetite with weight loss, feeling tired, drowsiness, weakness, depression, irritability and general malaise) or diabetic ketoacidosis (acid in the blood that comes from diabetes ).
- Inflammation of the skin that can cause severe skin reaction (known as toxic epidermal necrolysis and Stevens-Johnson syndrome ). Signs and symptoms of severe skin reaction (sometimes fatal) can manifest as rash, itching and skin rash.
- Inflammation of the muscles such as myocarditis ( inflammation of the heart muscle), myositis ( inflammation of the muscles) and rhabdomyolysis (stiffness of muscles and joints, muscle cramps). Signs and symptoms of it can manifest as muscle pain, stiffness, weakness, chest pain or severe fatigue.
- Rejection of transplanted organs.
- Graft -versus-host disease.
- Hemophagocytic lymphohistiocytosis. An unusual disease in which the immune system produces histiocytes and lymphocytes for many of the otherwise normal anti-infective cells . Symptoms may include enlarged liver and / or spleen , rash, enlarged lymph nodes , difficulty breathing, bruising, kidney problems and heart problems.
Tell your doctor immediately if you have any of these signs or symptoms, or if they get worse. Do not try to treat your symptoms with other medicines on your own. Your doctor may:
- give you other medicines to prevent complications and reduce symptoms,
- postpone the next dose of OPDIVO,
- or completely discontinue treatment with OPDIVO.
Note that these signs and symptoms may be delayed and may develop weeks or months after your last dose. Before treatment, your doctor will check your general health. You will also be able to take blood samples during your treatment.
Talk to your doctor or nurse before receiving OPDIVO if:
- you have an autoimmune disease (a condition in which the body attacks its own cells)
- you have eye melanoma
- you have previously received ipilimumab, another medicine for the treatment of melanoma , and experienced serious side effects from this medicine
- you have been told that your cancer has spread to the brain
- you have previously had inflammation in the lungs
- you have taken medicines that suppress your immune system.
Complications of stem cell transplantation with donor stem cells ( allogeneic stem cell transplantation ) after treatment with OPDIVO. These complications can be serious and lead to death. If you have had an allogeneic stem cell transplant, your healthcare provider will monitor you for signs of complications.
Children and young people
OPDIVO should not be used by children and adolescents under 18 years of age.
Other medicines and OPDIVO
Before you receive OPDIVO, tell your doctor if you are taking any medicines that lower your immune system, such as corticosteroids, as these medicines may affect the effect of OPDIVO. However, once you have started treatment with OPDIVO, your doctor may give you corticosteroids to reduce the possible side effects that you may experience during your treatment and this will not affect the effectiveness of the medicine.
Tell your doctor if you are taking or have recently taken any other medicines. Do not take any other medicines during your treatment without first talking to a doctor.
Pregnancy and breastfeeding
Tell your doctor if you are or think you may be pregnant, if you are planning to have a baby or if you are breast-feeding.
Do not use OPDIVO if you are pregnant unless your doctor specifically tells you to. The effects of OPDIVO in pregnant women are not known, but it is possible that the active substance, nivolumab, may harm an unborn baby.
- You must use effective contraception during treatment and at least 5 months after the last dose of one with OPDIVO if you are a woman of childbearing potential .
- Tell your doctor if you become pregnant during treatment with OPDIVO.
It is not known if OPDIVO passes into breast milk. A risk to the breastfed baby can not be ruled out. Ask your doctor if you can breast-feed during or after treatment with OPDIVO.
Driving and using machines
OPDIVO or OPDIVO in combination with ipilimumab may have a minor effect on the ability to drive and use machines. Be careful until you are sure that OPDIVO does not affect you negatively.
OPDIVO contains sodium
Tell your doctor if you have been prescribed a low-salt diet (low in sodium) before receiving OPDIVO. This medicine contains 2.5 mg sodium (the main ingredient in table salt/table salt) per ml concentrate. OPDIVO contains 10 mg sodium per 4 ml vial , 25 mg sodium per 10 ml vial , 30 mg sodium per 12 ml
vial or 60 mg sodium per 24 ml vial, which corresponds to 0.5%, 1.25%, 1.5%, and 3% respectively of the maximum recommended daily intake of sodium for an adult.
You will also find the main messages from this leaflet in the patient care that you have received from your doctor. You must carry the patient card with you and show it to your partner or caregiver.
How to use OPDIVO
How much OPDIVO is given
When OPDIVO alone is given, the recommended dose is either 240 mg every two weeks or 480 mg every four weeks, depending on what it is used for.
When OPDIVO is given in combination with ipilimumab for the treatment of melanoma, the recommended dose is one of OPDIVO 1 mg nivolumab per kg body weight for the first four doses (combination phase). Thereafter, the recommended dose is one of OPDIVO 240 mg every two weeks or 480 mg every four weeks (monotherapy phase).
When OPDIVO is given in combination with ipilimumab for the treatment of advanced kidney cancer, the recommended dose is one of OPDIVO 3 mg nivolumab per kg body weight for the first four doses (combination phase). Thereafter, the recommended dose is one of OPDIVO 240 mg every two weeks or 480 mg every four weeks (monotherapy phase).
When OPDIVO is given in combination with ipilimumab for the treatment of advanced colon or rectal cancer, the recommended dose is one of OPDIVO 3 mg nivolumab per kg body weight for the first four doses (combination phase). Thereafter, the recommended dose is one of OPDIVO 240 mg every two weeks (monotherapy phase).
When OPDIVO is given in combination with ipilimumab for the treatment of lung cancer, the recommended dose is one of OPDIVO 360 mg every three weeks.
When OPDIVO is given in combination with chemotherapy for the treatment of advanced gastric cancer, cancer of the esophagus, gastric cancer, or esophageal cancer, the recommended dose is one of OPDIVO 360 mg every three weeks or 240 mg every two weeks.
When OPDIVO is given in combination with ipilimumab and chemotherapy for the treatment of advanced non-small-cell lung cancer, the recommended dose is one of OPDIVO 360 mg every three weeks.
After two cycles of chemotherapy, OPDIVO is given in combination with ipilimumab; the recommended dose of OPDIVO is 360 mg every three weeks.
When OPDIVO is given in combination with cabozantinib for the treatment of advanced renal cell carcinoma, the recommended dose is one of OPDIVO 240 mg every two weeks or 480 mg every four weeks.
Based on your dose, the correct amount of OPDIVO will be diluted with 9 mg/ml (0.9%) sodium chloride solution for injection or 50 mg/ml (5%) glucose solution for injection before use. More than one vial of OPDIVO may be required to obtain the correct dose.
How OPDIVO is given
You will receive treatment with OPDIVO in a hospital or clinic, under the supervision of an experienced doctor.
OPDIVO will be given to you by infusion (drip) into a vein ( intravenously ) for 30 or 60 minutes every two weeks or every four weeks, depending on the dose you receive. Your doctor will continue to give you OPDIVO for as long as you benefit from it or until you no longer tolerate the treatment.
When OPDIVO is given in combination with ipilimumab for the treatment of melanoma, advanced renal cell carcinoma, or advanced colon or rectal cancer, you will receive an infusion for 30 minutes, every three weeks for the first 4 doses (combination phase). You will then receive an infusion for 30 or 60 minutes, every two weeks, or every four weeks, depending on the dose you receive (the monotherapy phase).
When OPDIVO is given in combination with ipilimumab for the treatment of lung cancer, you will receive an infusion for 30 minutes every three weeks.
When OPDIVO is given in combination with chemotherapy for the treatment of advanced gastric cancer, cancer of the esophagus, and gastric cancer or esophageal cancer, you will receive an infusion for 30 minutes every three weeks or every two weeks depending on the dose you receive.
When OPDIVO is given in combination with ipilimumab and chemotherapy for the treatment of advanced non-small-cell lung cancer, you will receive an infusion for 30 minutes every three weeks.
When OPDIVO is given in combination with cabozantinib, you will receive an infusion for 30 minutes or 60 minutes, every two or four weeks, depending on the dose you receive.
If you miss a dose of OPDIVO
It is very important for you that you come to your booked visits to get OPDIVO. If you miss a visit, ask your doctor when to schedule your next dose.
If you stop using OPDIVO
If you stop your treatment, the effect of the medicine may not be there. Do not end treatment with OPDIVO without discussing it with your doctor.
If you have any further questions on the use of this product, ask your doctor.
When OPDIVO is given in combination with other anticancer medicines, you will first be given OPDIVO followed by another medicine.
See the package leaflet for the other medicines to understand how they are to be used. If you have any further questions, ask your doctor.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Your doctor will discuss these with you and explain the risks and benefits of your treatment.
Pay attention to important symptoms of inflammation. OPDIVO affects your immune system and can cause inflammation in parts of the body. Inflammation can cause serious damage to the body and certain inflammatory conditions can be life-threatening and need treatment or the use of OPDIVO is discontinued.
The following side effects have been reported with OPDIVO alone:
Very common (may affect more than 1 in 10 people)
- Infection is in the upper respiratory tract
- Diarrhea (watery, loose or soft stools), vomiting, nausea, constipation, stomach pain
- Skin rash, sometimes with blisters, itching
- Feeling tired or weak, fever, edema (swelling)
- Decreased appetite
- Headache
- Shortness of breath ( dyspnoea ), cough
- Pain in muscles, bones (musculoskeletal pain) and joints ( arthralgia )
Common (can affect up to 1 in 10 people)
- Severe pneumonia , respiratory tract infection ( bronchitis )
- Allergic reactions, reactions associated with infusion one of the drug including life-threatening allergic reaction
- Impaired thyroid function (which may cause fatigue or weight gain) or overactive thyroid gland (which may cause palpitations, sweating and weight loss), swelling of the thyroid gland
- Inflammation of the nerves (causing numbness, weakness, tingling or burning pain in arms and legs), dizziness
- High blood pressure ( hypertension )
- Inflammation of the lungs ( pneumonitis , characterized by cough and difficulty breathing), fluid around the lungs
- Inflammation of the intestines ( colitis ), sores in the mouth and lips ( stomatitis ), dry mouth
- Spots of discoloration of the skin (vitiligo), dry skin, redness of the skin, unusual hair loss or thinning of the hair.
- Arthritis ( arthritis )
- Pain, chest pain
- Dimsyn,
- Dry eyes
- Dehydration
- High heart rate
- Renal failure (including abrupt loss of renal function)
Uncommon (may affect up to 1 in 100 people)
- Increase in some white blood cells
- Decreased secretion of hormones produced by the adrenal glands ( glands located above the kidneys), underactive function ( hypopituitarism ) or inflammation (pituitary gland) of the pituitary gland one located in the lower part of the brain, diabetes
- Increased level of acid in the blood
- Damage to nerves causing numbness and weakness ( polyneuropathy ), inflammation of the nerves caused by the body attacking itself causing numbness, weakness, tingling or burning pain (autoimmune neuropathy )
- Eye inflammation (which causes pain and redness)
- Inflammation and fluid outflow in the pericardium (pericardial disorders), abnormal pulse , changes in heart rate or heart rate
- Fluid in the lungs
- Inflammation of the pancreas ( pancreatitis ), inflammation of the stomach ( gastritis )
- Hepatitis, blockage of bile ducts
- Skin disease with thickened patches of red skin, often with silvery flakes ( psoriasis ), skin condition of the face where the nose and cheeks are unusually red ( rosacea ), hives (itchy, lumpy rash), severe condition of the skin causing red, often itchy spots, similar measles rash, starting on the arms and legs and sometimes on the face and on the rest of the body (erythema multiforme)
- Inflammation of the muscles which causes pain or stiffness (muscle rheumatism)
- Inflammation of the kidneys
- Chronic disease associated with an increase in inflammatory cells in various organs and tissues , most often in the lungs ( sarcoidosis )
Rare (may affect up to 1 in 1000 people)
- A disease that causes inflammation or enlargement of a lymph node (Kikuchi lymphadenitis)
- Acid in the blood caused by diabetes (diabetic ketoacidosis )
- A temporary inflammation of the nerves that causes pain, weakness and paralysis of the arms and legs ( Guillain-Barré syndrome ), loss of the protective sheath around the nerves (demyelination), a condition in which the muscles easily become weak and tired (myasthenic syndrome)
- Encephalitis
- Temporary and reversible non- infectious inflammation of protective membranes surrounding the brain and spinal cord (aseptic meningitis )
- Decreased function of the parathyroid gland
- Inflammation of the heart muscle
- Inflammation of blood vessels
- Ulcers in the small intestine
- Severe skin detachment ( toxic epidermal necrolysis or Stevens-Johnson syndrome ) which can be fatal
- Disease in which the immune system attacks the glands that produce moisture for the body, such as tears and saliva ( Sjögren’s syndrome ), pain, tenderness or weakness in the muscles, not caused by exercise ( myopathy ), muscle inflammation (myositis), stiffness in muscles and joints or muscle cramps ( rhabdomyolysis )
- Inflammation of the bladder. Signs and symptoms may include frequent and / or painful urination, urge to urinate, blood in the urine, pain or pressure in the lower abdomen
Other side effects reported without known frequency (can not be calculated from the available data):
- Rejection of transplanted organ
- A group of metabolic complications that occur after cancer treatment and are characterized by high levels of potassium and phosphate as well as low levels of calcium in the blood (tumor lysis syndrome)
- An inflammatory condition (most likely of autoimmune origin) that affects the eyes, skin and membranes of the ears, brain and spinal cord (Vogt ‑ Koyanagi ‑ Harada syndrome)
- Skin changes in any part of the body and / or on the genitals associated with dehydration, thinning, itching and pain ( lichen sclerosus or other lichen diseases)
- A condition in which the immune system produces too many anti-infective cells, so-called histiocytes and lymphocytes , which can cause various symptoms. This is called haemophagocytic lymphohistiocytosis.
The following side effects have been reported with OPDIVO in combination with other anticancer medicines (the frequency and severity of the side effects may vary with the combination of the anticancer medicines you get)
Very common (may affect more than 1 in 10 people)
- Impaired thyroid function (may cause fatigue or weight gain), overactive thyroid gland , (may cause palpitations, sweating and weight loss), upper respiratory tract infection
- Decreased appetite, altered taste experience
- Inflammation of the nerves (causes numbness, weakness, tingling or burning pain in arms and legs), headache, dizziness
- High blood pressure ( hypertension )
- Abnormal sound in the voice ( dysphonia )
- Shortness of breath ( dyspnoea ), cough
- Inflammation of the intestines ( colitis ), diarrhea (watery, loose or soft stools), constipation, vomiting, nausea, stomach pain, sores in the mouth and on the lips ( stomatitis )
- Skin rash, sometimes with blisters, itching , pain in the hands or on the soles of the feet, rash or redness of the skin, dry skin, stinging sensation and tenderness that develops into symmetrical redness , swelling and pain mainly in the palm and sole of the foot (hand ‑ foot syndrome)
- Joint pain ( arthralgia ), muscle and bone pain (musculoskeletal pain), muscle cramps
- Too much protein in the urine
- Feeling tired or weak, fever, swelling ( edema )
Common (can affect up to 1 in 10 people)
- Severe pneumonia , bronchitis , eye inflammation ( conjunctivitis )
- Increase in some white blood cells , decrease in neutrophils with fever
- Allergic reactions, reactions associated with infusion one of the drug.
- Decreased secretion of hormones produced by the adrenal glands ( glands located above the kidneys), underactive function (hypopituiarism) in or inflammation (pituitary gland) of the pituitary gland , located in the lower part of the brain, swelling of the thyroid gland, diabetes
- Dehydration, decreased levels of albumin and phosphate in your blood
- Feeling of numbness and tingling ( paresthesia ), hearing a persistent sound in the ear when no sound exists ( tinnitus )
- Eye inflammation (which causes pain and redness), blurred vision, dry eyes
- High heart rate , abnormal heart rate , inflammation of the heart muscle
- Blood clot ( thrombosis )
- Inflammation of the lungs ( pneumonia ), characterized by cough and difficulty breathing, fluid in the lungs, blood clots, nosebleeds
- Inflammation of the pancreas ( pancreatitis ), dry mouth , inflammation of the stomach ( gastritis ), pain in the mouth, hemorrhoids
- Liver inflammation
- Spots of discoloration of the skin (including vitiligo), redness of the skin, unusual hair loss or thinning of the hair, change of hair color, hives (itchy rash)
- Inflammation of the joints ( arthritis ), weakness in the muscles, pain in the muscles
- Renal failure (including abrupt loss of renal function)
- Pain, chest pain, chills
Uncommon (may affect up to 1 in 100 people)
- Temporary and reversible non- infectious inflammation of protective membranes surrounding the brain and spinal cord (aseptic meningitis )
- Chronic disease associated with an increase in inflammatory cells in various organs and tissues , most often in the lungs ( sarcoidosis )
- Increased level of acid in the blood
- Acid in the blood caused by diabetes (diabetic ketoacidosis )
- Decreased function of the parathyroid gland
- A temporary inflammation of the nerves that causes pain, weakness and paralysis of the arms and legs ( Guillain-Barré syndrome ); damage to nerves causing numbness and weakness ( polyneuropathy ); inflammation of the nerves; droppfot (peroneuspares); inflammation of the nerves caused by the body attacking itself and causing numbness, weakness, tingling or burning pain ( autoimmune neuropathy ); weakness and fatigue in the muscles without wasting ( myasthenia gravis or myasthenia syndrome).
- Encephalitis
- Changes in heart rate or heart rate
- Perforation of the intestines, inflammation of the duodenum , burning or painful sensation in the tongue ( glossodynia )
- Skin disease with thickened patches of red skin, often with silvery flakes ( psoriasis ), severe condition of the skin causing red, often itchy spots, similar to measles rash, starting on arms and legs and sometimes on face and rest of body (erythema multiforme)
- Severe and possibly fatal skin detachment ( Stevens-Johnson syndrome )
- Chronic joint disease (spondylarthritis); disease that leads to the immune system attacking the glands that make fluid to the body, such as tears and saliva ( Sjögren’s syndrome ), soreness or weakness in the muscles, not caused by exercise ( myopathy ), inflammation in the muscles (myositis), stiffness in muscles and joints , muscle spasm ( rhabdomyolysis ), inflammation in the muscles which causes pain or stiffness (muscle rheumatism), bone damage in the jaw, abnormal opening between two body parts such as an organ or blood vessel and another part ( fistula )
- Inflammation of the kidneys; inflammation of the bladder. Signs and symptoms may include frequent and / or painful urination, urge to urinate, blood in the urine, pain or pressure in the lower abdomen
Rare (may affect up to 1 in 1000 people )
- Severe skin detachment ( toxic epidermal necrolysis ) which can be fatal
Other side effects reported without known frequency (can not be calculated from the available data)
- Rejection of transplanted organ
- A group of metabolic complications that occur after cancer treatment and are characterized by high levels of potassium and phosphate as well as low levels of calcium in the blood (tumor lysis syndrome)
- An inflammatory condition (most likely of autoimmune origin) that affects the eyes, skin and membranes of the ears, brain and spinal cord (Vogt ‑ Koyanagi ‑ Harada syndrome)
- Inflammation and fluid outflow in the pericardium (pericardial disorders)
- Skin changes in any part of the body and / or on the genitals associated with dehydration, thinning, itching and pain ( lichen sclerosus or other lichen diseases)
- A condition in which the immune system produces too many anti-infective cells, so-called histiocytes and lymphocytes , which can cause various symptoms. This is called haemophagocytic lymphohistiocytosis.
Tell your doctor immediately if you get any of the above side effects. Do not try to treat the symptoms with other medicines on your own.
Changes in test results
OPDIVO alone or in combination may cause changes in the results of certain tests performed by your doctor. These include:
- Abnormal liver function values (increased amount of the liver enzymes aspartate aminotransferase ( AST ), alanine aminotransferase ( ALT ), gamma-glutamyltransferase or alkaline phosphatase in the blood, increased amount of the waste product bilirubin in the blood)
- Abnormal kidney function values (increased levels of creatinine in the blood)
- High ( hyperglycaemia ) or low ( hypoglycaemia ) blood sugar
- Decreased number of red blood cells (which carry oxygen), white blood cells (which are important in defending against infections ) or platelets (cells that help the blood to clot)
- Increased level of an enzyme that breaks down fats and of an enzyme that breaks down starch
- Increased or decreased level of calcium or potassium
- Increased or decreased level of magnesium or sodium in the blood
- Weight loss
- Increased level of thyroid stimulating hormone
- Increased levels of triglyceride are in the blood
- Increased level of cholesterol in the blood
How to store OPDIVO
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and label on the vial after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C).
Do not freeze.
Store in the original package. Sensitive to light.
The unopened vial can be stored at controlled room temperature (up to 25 ° C) and room lighting for up to 48 hours.
Do not save unused infusion fluid for reuse. Any unused product or waste material should be disposed of by local requirements.
Contents of the pack and other information
Content declaration
- The active substance is nivolumab.One ml concentrate for solution for infusion contains 10 mg nivolumab One vial contains either 40 mg (in 4 ml), 100 mg (in 10 ml), 120 mg (in 12 ml) or 240 mg (in 24 ml) nivolumab.
- The other ingredients are sodium citrate dihydrate, sodium chloride (see section 2 “OPDIVO contains sodium”), mannitol (E421), fatty acid, polysorbate 80 (E433), sodium hydroxide, hydrochloric acid and water for injections.
What the medicine looks like and contents of the pack
OPDIVO concentrate for solution for infusion (sterile concentrate), is a clear to opalescent, colorless to light yellow liquid that may contain a few light particles.
It is available in pack sizes of 1 vial with 4 ml, 1 vial with 10 ml, 1 vial with 12 ml, or 1 vial with 24 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Bristol-Myers Squibb Pharma EEIG
Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867
Ireland
Manufacturer
Swords Laboratories Unlimited Company to Bristol-Myers Squibb Cruiserath Biologics
Cruiserath Road, Mulhuddart
Dublin 15, D15 H6EF
Ireland