Methotrexate 5g/50ml solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Methotrexate sodium

Available from:

medac UK

ATC code:

L01BA01

INN (International Name):

Methotrexate sodium

Dosage:

100mg/1ml

Pharmaceutical form:

Solution for infusion

Administration route:

Intraarterial; Intravenous; Intramuscular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08010300; GTIN: 4037353017207

Summary of Product characteristics

Methotrexate 100 mg/ml solution for injection
Summary of Product Characteristics Updated 19-Jan-2022 | medac GmbH
1. Name of the medicinal product
Methotrexate 100 mg/ml solution for injection
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 risks of
toxic effects.
2. Qualitative and quantitative composition
concentration
size
amount per vial
100 mg methotrexate per ml
(10.0 %)
10 ml
1,000 mg
100 mg methotrexate per ml
(10.0 %)
50 ml
5,000 mg
One vial with 10 ml contains 1,000 mg methotrexate.
One vial with 50 ml contains 5,000 mg methotrexate.
Excipient with known effect: sodium
3. Pharmaceutical form
Solution for injection
Clear orange-yellow solution
4. Clinical particulars
4.1 Therapeutic indications
Methotrexate 100 mg/ml solution for injection may be used for the
following indications:
• Acute lymphocytic leukaemias (ALL)
- in combination with other cytotoxic medicinal products
• Non-Hodgkin's lymphomas
- in combination with other cytotoxic medicinal products in adult
patients with Non-Hodgkin's lymphomas of intermediate
and high degree of malignancy
- -in combination with other cytotoxic medicinal products in
paediatric patients
• Head and neck cancer
- as palliative monotherapy in patients with metastatic or recurrent
disease
• Breast cancer
- in combination with other cytotoxic medicinal products in patients
for adjuvant treatment after tumour resection or
mastectomy and for palliative treatment in advanced disease
• Choriocarcinoma and similar trophoblastic diseases
- as monotherapy in patients with good prognosis (low risk)
- in combination with other cytotoxic medicinal products in patients
with poor prognosis (high risk)
• Osteosarcoma
- in combination with other cytotoxic medicinal products for adjuvant
and neoadjuvant therapy
•