Methotrexate 100 mg/ml concentrate for solution for infusion

Država: Velika Britanija

Jezik: engleski

Izvor: myHealthbox

Aktivni sastojci:

Methotrexate

Dostupno od:

Accord Healthcare Limited

ATC koda:

L01BA01

INN (International ime):

Methotrexate

Doziranje:

100 mg/ml

Farmaceutski oblik:

Concentrate for solution for infusion

Administracija rute:

Intramuscularly, intravenously or intra-arterial

Jedinice u paketu:

1 or 5 vials. Vials contain 5ml, 10 ml or 50 ml

Tip recepta:

POM - Prescription Only Medicine

Proizveden od:

Accord Healthcare Limited

Terapijska grupa:

Cytostatic agent: folic acid analogue

Terapijske indikacije:

Acute lymphocytic leukaemia, Non-Hodgkin's lymphomas, osteogenic sarcoma, adjuvant and in advance disease of breast cancer, metastatic or recurrent head and neck cancer, choriocarcinoma and similar trophoblastic diseases, advanced cancer of urinary bladder.

Status autorizacije:

Authorised

Datum autorizacije:

2014-08-06

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE USER
METHOTREXATE 100 MG/ML 
CONCENTRATE FOR SOLUTION 
FOR INFUSION
Methotrexate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU 
START USING THIS MEDICINE BECAUSE IT CONTAINS 
IMPORTANT INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your 
doctor or pharmacist or nurse.
- This medicine has been prescribed for you only. 
Do not pass it on to others. It may harm them, 
even if their sign of illness are the same as yours.
- If you get any side effects, talk to your doctor, or 
pharmacist or nurse. This includes any possible 
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Methotrexate
  is and what it is used for
2. What you need to know before you use 
Methotrexate

3. How to use Methotrexate

4. Possible side effects
5. How to store Methotrexate

6. Contents of the pack and other information
  1.  WHAT METHOTREXATE IS AND 
     WHAT IT IS USED FOR
Methotrexate contains the active substance 
methotrexate.
 Methotrexate is a cytostatic that 
inhibits cell growth. Methotrexate has its greatest 
effect on cells which increase frequently like 
cancer cells, bone marrow cells and skin cells.
Methotrexate
 is used in the treatment of the 
following types of cancer: 
- acute lymphocytic leukaemia,
- non-Hodgkin’s lymphomas,
- osteogenic sarcoma,
- adjuvant and in advance disease of breast cancer,
- metastatic or recurrent head and neck cancer,
- choriocarcinoma and similar trophoblastic 
diseases,
- advanced cancer of urinary bladder.
  2.  WHAT YOU NEED TO KNOW BEFORE 
     YOU TAKE METHOTREXATE
DO NOT USE Methotrexate  
- If you are allergic (hypersensitive) to 
methotrexate or any of the other ingredients of 
this medicine (listed in section 6).
- If you have severe liver or kidney disease .
- If you have increased alcohol consumption.
-  If you have disorders of the blood-forming system.
- If

Svojstava lijeka

Methotrexate 100 mg/ml concentrate for solution for infusion
Summary of Product Characteristics Updated 09­Jun­2015 | Accord Healthcare Limited
1. Name of the medicinal product
Methotrexate 100 mg/ml concentrate for solution for infusion
2. Qualitative and quantitative composition
Each ml contains 100 mg methotrexate.
5 ml of solution contains 500 mg methotrexate.
10 ml of solution contains 1000 mg methotrexate.
50 ml of solution contains 5000 mg methotrexate.
Excipients with known effect:
10.60 mg/ml (0.461 mmol/ml) sodium.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Concentrate for solution for infusion
Clear, yellow solution with pH 7.0 to 9.0.
4. Clinical particulars
4.1 Therapeutic indications
Acute lymphocytic leukaemia, Non­Hodgkin's lymphomas, osteogenic sarcoma, adjuvant and in advance disease of
breast cancer, metastatic or recurrent head and neck cancer, choriocarcinoma and similar trophoblastic diseases,
advanced cancer of urinary bladder.
4.2 Posology and method of administration
WARNINGS
The dose must be adjusted carefully depending on the body surface area if methotrexate is used for the treatment
of tumour diseases.
Fatal cases of intoxication have been reported after administration of incorrect calculated doses. Health care
professionals and patients should be fully informed about toxic effects.
Methotrexate 100mg/ml is hypertonic and must not be administered intrathecally.
Method of administration:
Treatment should be initiated by or occur in consultation with a doctor with significant experience in cytostatic
treatment.
Methotrexate can be administered intramuscularly, intravenously or intra­arterial. Methotrexate 100mg/ml is hypertonic
and must not be administered intrathecally.The dosage is generally calculated per m
2
 body surface area or bo