Pemetrexed Seacross 500 mg powder for concentrate for solution for infusion

Package leaflet: Information for the user

Pemetrexed Seacross 100 mg powder for concentrate for solution for infusion

Pemetrexed Seacross 500 mg powder for concentrate for solution for infusion

pemetrexed

1. What Pemetrexed Seacross is and what it is used for

Pemetrexed Seacross is a medicine used in the treatment of cancer.

This medicine is given in combination with cisplatin, another anti-cancer medicine, as treatment for malignant pleural mesothelioma, a form of cancer that affects the lining of the lung, to patients who have not received prior chemotherapy.

It is also given in combination with cisplatin for the initial treatment of patients with advanced stage of lung cancer.

Pemetrexed Seacross can be prescribed to you if you have lung cancer at an advanced stage if your disease has responded to treatment or it remains largely unchanged after initial chemotherapy.

This medicine is also a treatment for patients with advanced stage of lung cancer whose disease has progressed after other initial chemotherapy has been used.

2. What you need to know before you use Pemetrexed Seacross

3. How to use Pemetrexed Seacross

Always use this medicine exactly as your doctor or pharmacist has told you.

Check with your doctor or pharmacist if you are not sure.

The recommended dose is 500 milligrams for every square meter of your body's surface area. Your height and weight are measured to work out the surface area of your body. Your doctor will use this body surface area to work out the right dose for you. This dose may be adjusted, or treatment may be delayed depending on your blood cell counts and on your general condition.

A hospital pharmacist, nurse or doctor will have mixed the Pemetrexed Seacross powder with 9 mg/ml (0.9 %) sodium chloride solution for injection before it is given to you.

You will always receive Pemetrexed Seacross by infusion into one of your veins. The infusion will last approximately 10 minutes.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You must contact your doctor immediately if you notice any of the following:

• Fever or infection (respectively, common or very common): if you have a temperature of 38°C or greater, sweating or other signs of infection(since you might have less white blood cells than normal which is very common). Infection (sepsis) may be severe and could lead to death.
• If you start feeling chest pain (common) or having a fast heart rate (uncommon).
• If you have pain, redness, swelling or sores in your mouth (very common).
• Allergic reaction: if you develop skin rash (very common) / burning or prickling sensation (common), or fever (common). Rarely, skin reactions may be severe and could lead to death. Contact your doctor if you get a severe rash, or itching, or blistering (Stevens-Johnson Syndrome or Toxic epidermal necrolysis).
• If you experience tiredness, feeling faint, becoming easily breathless or if you look pale (since you might have less haemoglobin than normal which is very common).
• If you experience bleeding from the gums, nose or mouth or any bleeding that would not stop, reddish or pinkish urine, unexpected bruising (since you might have less platelets than normal which is common).
• If you experience sudden breathlessness, intense chest pain or cough with bloody sputum (uncommon)(may indicate a blood clot in the blood vessels of the lungs)

Side effects with pemetrexed may include:

Very common (may affect more than 1 in 10 people):

• Infection
• Pharyngitis (a sore throat)
• Low number of neutrophil granulocytes (a type of white blood cell)
• Low white blood cells
• Low haemoglobin level
• Diarrhoea
• Vomiting
• Pain, redness, swelling or sores in your mouth
• Nausea
• Loss of appetite
• Fatigue (tiredness)
• Skin rash
• Flaking skin
• Abnormal blood tests showing reduced functionality of kidneys

Common (may affect up to 1 in 10 people):

• Blood infection
• Fever with low number of neutrophil granulocytes (a type of white blood cell)
• Low platelet count
• Allergic reaction
• Loss of body fluids
• Taste change
• Damage to the motor nerves which may cause muscle weakness and atrophy (wasting) primary in the arms and legs)
• Damage to the sensory nerves that may cause lost of sensation, burning pain and unsteady gait
• Dizziness
• Inflammation or swelling of the conjunctiva (the membrane that lines the eyelids and covers the white of the eye
• Dry eye
• Dryness of the conjunctiva (the membrane that lines the eyelids and covers the white of the eye) and cornea (the clear layer in front of the iris and pupil.
• Swelling of the eyelids
• Eye disorder with dryness, tearing, irritation, and/or pain
• Cardiac Failure (Condition that affects the pumping power of your heart muscles)
• Irregular heart rhythm
• Indigestion
• Constipation
• Abdominal pain
• Liver: increases in the chemicals in the blood made by the liver
• Itchy skin
• Rash on the body where each mark resembles a bullseye
• Hair loss
• Hives
• Kidney stop working
• Reduced functionality of kidney
• Fever
• Pain
• Excess fluid in body tissue, causing swelling
• Chest pain
• Inflammation and ulceration of the mucous membranes lining the digestive tract
• Watery eyes
• Increased skin pigmentation

Uncommon (may affect up to 1 in 100 people):

• Reduction in the number of red, white blood cells and platelets
• Stroke
• Type of stroke when an artery to the brain is blocked
• Bleeding inside the skull
• Angina (Chest pain caused by reduced blood flow to the heart)
• Heart attack
• Narrowing or blockage of the coronary arteries
• Increased heart rythm
• Deficient blood distribution to the limbs
• Blockage in one of the pulmonary arteries in your lungs
• Inflammation and scarring of the lining of the lungs with breathing problems
• Passage of bright red blood from the anus
• Bleeding in the gastrointestinal tract
• Ruptured bowel
• Inflammation of the lining of the oesophagus
• Inflammation of the lining of the large bowel, which may be accompanied by intestinal or rectal bleeding (seen only in combination with cisplatin)
• Inflammation, edema, erythema, and erosion of the mucosal surface of the esophagus caused by radiation therapy
• Inflammation of the lung caused by radiation therapy

Rare (may affect up to 1 in 1,000 people):

• Destruction of red blood cells
• Inflammatory condition of the liver
• Redness of the skin
• Skin rash that develops throughout a previously irradiated area
• Anaphylactic shock (severe allergic reaction)

Very rare (affect up to 1 of 10,000 people)

• Infections of skin and soft tissues
• Stevens-Johnson syndrome (a type of severe skin and mucous membranes reaction that may be life threatening)
• Toxic epidermal necrolysis (a type of severe skin reaction that may be life threatening)
• Autoimmune disorder that results in skin rashes and blistering on the legs, arms, and abdomen
• Inflammation of the skin characterized by the presence of bullae which are filled with fluid
• Skin fragility, blisters and erosions and skin scarring
• Redness, pain and swelling mainly of the lower limbs
• Inflammation of the skin and fat beneath the skin (pseudocellulitis)
• Inflammation of the skin (dermatitis)
• Skin to become inflamed, itchy, red, cracked, and rough
• Intensely itchy spots

Not known: frequency cannot be estimated from the available data

• Form of diabetes primarily due to pathology of the kidney
• Disorder of the kidneys involving the death of tubular epithelial cells that form the renal tubules

You might have any of these symptoms and/or conditions. You must tell your doctor as soon as possible when you start experiencing any of these side effects.

If you are concerned about any side effects, talk to your doctor.

5. How to store Pemetrexed Seacross

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 & vial after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Reconstituted and diluted infusion solutions: When prepared as directed, chemical and physical in-use stability of reconstituted and further diluted infusion solutions of pemetrexed were demonstrated for 24 hours at 25°C and at refrigerated temperature (2-8°C). From microbiological point of view, the product should be used immediately.

This medicine is for single use only; any unused solution must be disposed of in accordance with local requirement.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

This medicinal product is authorised in the Member States of the EEA under the following names:

BG:

Pemetrexed Novamed 100 mg Прах за концентрат за инфузионен разтвор

Pemetrexed Novamed 500 mg Прах за концентрат за инфузионен разтвор

DE

Pemetrexed Seacross 100 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung

Pemetrexed Seacross 500 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung

IE

Pemetrexed Seacross 100 mg powder for concentrate for solution for infusion

Pemetrexed Seacross 500 mg powder for concentrate for solution for infusion

RO

Pemetrexed 100 mg Pulbere pentru concentrat pentru soluţie perfuzabilă

Pemetrexed 500 mg Pulbere pentru concentrat pentru soluţie perfuzabilă

CY

Pemetrexed Seacross 100 mg κόνις για πσκνό διάλσμα για παραζκεσή διαλύμαηος προς έγτσζη

Pemetrexed Seacross 500 mg κόνις για πσκνό διάλσμα για παραζκεσή διαλύμαηος προς έγτσζη

MT

Pemetrexed 100 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni

Pemetrexed 500 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni

NL

Pemetrexed 100 mg poeder voor concentraat voor oplossing voor intraveneuze infusie

Pemetrexed 500 mg poeder voor concentraat voor oplossing voor intraveneuze infusie

PT

Pemetrexed GFPH 100 mg pó para concentrado para solução para perfusão

Pemetrexed GFPH 500 mg pó para concentrado para solução para perfusão

ES

Pemetrexed Farmalider 100 mg polvo para concentrado para solución para perfusion EFG

Pemetrexed Farmalider 500 mg polvo para concentrado para solución para perfusion EFG

IT

Pemetrexed 100 mg polvere per concentrato per soluzione per infusione

Pemetrexed 500 mg polvere per concentrato per soluzione per infusione