Active ingredient
- pemetrexed disodium
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 41013/0014.
Pemetrexed 100 mg/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
Read all of this leaflet carefully before you start receiving this medicine because it contains important information for you.
What is in this leaflet:
1. What Pemetrexed Seacross is and what it is used for
2. What you need to know before you use Pemetrexed Seacross
3. How to use Pemetrexed Seacross
4. Possible side effects
5. How to store Pemetrexed Seacross
6. Contents of the pack and other information
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
Do not use Pemetrexed Seacross
Warnings and Precautions
Talk to your doctor, hospital pharmacist or nurse before using Pemetrexed Seacross.
Children and adolescents
This medicine should not be used in children or adolescents, since there is no experience with this medicine in children and adolescents under 18 years of age.
Other medicines and Pemetrexed Seacross
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Especially any medicine for pain or inflammation (swelling), such as medicines called "nonsteroidal anti-inflammatory drugs" (NSAIDs), including medicines purchased without a doctor's prescription (such as ibuprofen). There are many sorts of NSAIDs with different durations of activity.
Based on the planned date of your infusion of pemetrexed and/or on the status of your kidney function, your doctor needs to advise you on which medicines you can take and when you can take them. If you are unsure, ask your doctor or pharmacist if any of your medicines are NSAIDs.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
The use of Pemetrexed Seacross should be avoided during pregnancy. Your doctor will discuss with you the potential risk of taking this medicine during pregnancy. Women must use effective contraception during treatment with pemetrexed.
Breast-feeding
Breast-feeding must be discontinued during pemetrexed treatment.
Fertility
Men are advised not to father a child during and up to 6 months following treatment with pemetrexed and should therefore use effective contraception during treatment with pemetrexed and for up to 6 months afterwards. If you would like to father a child during the treatment or in the 6 months following receipt of treatment, seek advice from your doctor or pharmacist. You may want to seek counselling on sperm storage before starting your therapy.
Driving and using machines
Pemetrexed Seacross may make you feel tired. Be careful when driving a car or using machines.
Pemetrexed Seacross contains sodium
Pemetrexed Seacross 100 mg contains less than 1 mmol (11 mg) sodium per vial and is therefore considered essentially "sodium-free".
Pemetrexed Seacross 500 mg contains approximately 2.35 mmol (54 mg) sodium (main component of cooking/table salt) per vial. This is equivalent to 2,7 % of the recommended maximum daily dietary intake of sodium for an adult.
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.
When using Pemetrexed Seacross in combination with cisplatin:
The doctor or hospital pharmacist will work out the dose you need based on your height and weight. Cisplatin is also given by infusion into one of your veins, and is given approximately 30 minutes after the infusion of pemetrexed has finished. The infusion of cisplatin will last approximately 2 hours.
You should usually receive your infusion once every 3 weeks.
Additional medicines:
Corticosteriods: your doctor will prescribe you steroid tablets (equivalent to 4 milligram of dexamethasone twice a day) that you will need to take on the day before, on the day of, and the day after pemetrexed treatment. This medicine is given to you to reduce the frequency and severity of skin reactions that you may experience during your anticancer treatment.
Vitamin supplementation: your doctor will prescribe you oral folic acid (vitamin) or a multivitamin containing folic acid (350 to 1000 micrograms) that you must take once a day while you are taking pemetrexed. You must take at least 5 doses during the seven days before the first dose of pemetrexed. You must continue taking the folic acid for 21 days after the last dose of pemetrexed. You will also receive an injection of Vitamin B12 (1000 micrograms) in the week before administration of pemetrexed and then approximately every 9 weeks (corresponding to 3 courses of pemetrexed treatment). Vitamin B12 and folic acid are given to you to reduce the possible toxic effects of the anticancer treatment.
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:
Side effects with pemetrexed may include:
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1,000 people):
Very rare (affect up to 1 of 10,000 people)
Not known: frequency cannot be estimated from the available data
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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in the leaflet.
You can also report side effects directly via Yellow Card Scheme: www.mhra.gov.uk/yellowcard or
By reporting side effects you can help provide more information on the safety of this medicine.
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
What Pemetrexed Seacross contains
After reconstitution, the solution contains 25 mg/ml of pemetrexed. Further dilution by a healthcare provider is required prior to administration.
What Pemetrexed Seacross looks like and contents of the pack
Pemetrexed Seacross is a powder for concentrate for solution for infusion in a vial. It is a white to either light yellow or green-yellow lyophilised powder; a clear, colorless to yellow or yellow-green colored solution, once reconstituted.
Each pack of Pemetrexed Seacross consists of one vial.
Marketing Authorisation Holder in the IE
Marketing Authorisation Holder in the UK
Manufacturer in the IE
Manufacturer in the UK
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
This leaflet was last revised in 03/2021
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