Methotrexate Injection BP 15mg/ml Technical Specification:

Product Name:Methotrexate Injection BP 15mg/ml
Brand Name:Methotrexate
Strength:7.5mg/ml, 15mg/ml, 20mg/ml, 25mg/ml, 50mg/2ml Ampoule,
5mg/ml (15mg/3ml), 25mg/ml (50mg/2ml, 250mg/10ml, 500mg/20ml, 1gm/40ml), 100mg/ml (500mg/5ml, 1000mg/10ml) – Vial
Dosage Form:Liquid Injection
Packing:SINGLE USE
Route of Administration:For I.M./I.A./ I.V. use
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Anti-Cancer
Indication: Methotrexate injection is used alone or together with other medicines to treat several types of cancer such as breast, head and neck, lung, blood, bone, lymph node, and uterus cancers.
Storage:Store vials between 20°C to 25°C (68° to 77° F) [see USP Controlled Room Temperature]. Protect from light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Methotrexate Injection BP 15mg/ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Methotrexate Injection BP 15mg/ml
    Each ml contains:
    Methotrexate BP………………15mg
    Excipients………………………..q.s.
    Water for Injection BP………q.s.
    Contains no preservatives.

THERAPEUTIC INDICATION:

Methotrexate injection is used alone or together with other medicines to treat several types of cancer such as breast, head and neck, lung, blood, bone, lymph node, and uterus cancers.

PACKING:

Vial

  • 5mg/ml (15mg/3ml)
  • 25mg/ml (50mg/2ml, 250mg/10ml, 500mg/20ml, 1gm/40ml)
  • 100mg/ml (500mg/5ml, 1000mg/10ml)

Ampoule

  • 5mg/ml
  • 15mg/ml
  • 20mg/ml
  • 25mg/ml
  • 50mg/2ml

DIRECTION OF USE:

Methotrexate Injection may be given by the intramuscular, intravenous, intraarterial or intrathecal routes.

CAUTION & WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter.

WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital/ Institution.

WARNINGS AND PRECAUTIONS

Methotrexate should be administered only under the supervision of a qualified physician experienced in the use of antineoplastic therapy. Special care should be taken when methotrexate is co-administered with non-steroidal anti-inflammatory drugs (NSAIDs). Severe side effects including fatalities (after high doses of methotrexate) have been reported. Consumption of alcohol even in low doses should be avoided. The patient should be informed about possible risks (side effects). Contraindications and precautions for use must be strictly observed because of possible severe (under particular circumstances lethal) toxic reactions. Plasma concentration of methotrexate

  • Higher than 1-2 times 10-5 mol/I (24 hours after initiating methotrexate therapy)
  • Twice 10-6 mol/1 (48 hours after initiating methotrexate therapy)
  • 10-7 mol/I (72 hours after initiating methotrexate therapy) indicate an increased risk of intoxication (myelosuppression, mucositis) and require a long-lasting and high dose of calcium folinate rescue therapy.

Intermediate dose of methotrexate therapy:

500-1000 mg/m2 IV infusion over 36-42 h; calcium folinate rescue required, given at 2-3 weeks intervals High-dose methotrexate therapy – calcium folinate rescue required:1-12 gm/m2 IV over 1-6 hours, given at 1-3 weeks intervals

METHOTREXATE 1000 MG – CONCENTRATE FOR INFUSION HAS TO BE DILUTED WITH STANDARD SOLUTIONS FOR INFUSIONS BEFORE ADMINISTRATION ACCORDING TO THERAPY PROTOCOL AND DURATION OF INFUSION. USE 5% GLUCOSE SOLUTION, RINGER’S LACTATE OR PHYSIOLOGICAL SALINE SOLUTION.

GENERALLY, 1-2% METHOTREXATE SOLUTION IS ADMINISTERED.

Do not use after the expiry date stated on the label.

After dilution, the product should be used within 24 hours if stored at 2-8°C.

Contains no preservatives.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

Discard unused portion.

Keep in a safe place out of the reach of children.

STORAGE & DOSAGE:

Storage: Store vials between 20°C to 25°C (68° to 77° F) [see USP Controlled Room Temperature]. Protect from light.

Dosage: As directed by the Oncologist. Please refer accompanying package insert for detailed dosage, directions for use and precautions.

GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Methotrexate Injection BP 5mg/ml (15mg/3ml)
b) Methotrexate Injection BP 25mg/ml (50mg/2ml, 250mg/10ml, 500mg/20ml,1gm/40ml)
c) Methotrexate Injection BP 100mg/ml (500mg/5ml, 1000mg/10ml)
d) Methotrexate Injection BP 7.5mg/ml
e) Methotrexate Injection BP 15mg/ml
f) Methotrexate Injection BP 20mg/ml
g) Methotrexate Injection BP 25mg/ml (25mg/ml, 50mg/2ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Methotrexate Injection BP 5mg/ml (15mg/3ml)
Each ml contains:
Methotrexate BP………………5mg
Excipients………………………..q.s.
Water for Injection BP………q.s.
Contains no preservatives.

b) Methotrexate Injection BP 25mg/ml (50mg/2ml, 250mg/10ml, 500mg/20ml,1gm/40ml)
Each ml contains:
Methotrexate BP………………25mg
Excipients………………………..q.s.
Water for Injection BP………q.s.
Contains no preservatives.

c) Methotrexate Injection BP 100mg/ml (500mg/5ml, 1000mg/10ml)
Each ml contains:
Methotrexate BP………………100mg
Excipients………………………..q.s.
Water for Injection BP………q.s.
Contains no preservatives.

d) Methotrexate Injection BP 7.5mg/ml
Each ml contains:
Methotrexate BP………………7.5mg
Excipients………………………..q.s.
Water for Injection BP………q.s.
Contains no preservatives.

e) Methotrexate Injection BP 15mg/ml
Each ml contains:
Methotrexate BP………………15mg
Excipients………………………..q.s.
Water for Injection BP………q.s.
Contains no preservatives.

f) Methotrexate Injection BP 20mg/ml
Each ml contains:
Methotrexate BP………………20mg
Excipients………………………..q.s.
Water for Injection BP………q.s.
Contains no preservatives.

g) Methotrexate Injection BP 25mg/ml (25mg/ml, 50mg/2ml)
Each ml contains:
Methotrexate BP………………20mg
Excipients………………………..q.s.
Water for Injection BP………q.s.
Contains no preservatives.

THERAPEUTIC INDICATION:

Methotrexate injection is used alone or together with other medicines to treat several types of cancer such as breast, head and neck, lung, blood, bone, lymph node, and uterus cancers.

PACKING:

Vial
1) 5mg/ml (15mg/3ml)
2) 25mg/ml (50mg/2ml, 250mg/10ml, 500mg/20ml, 1gm/40ml)
3) 100mg/ml (500mg/5ml, 1000mg/10ml)

Ampoule
1) 7.5mg/ml
2) 15mg/ml
3) 20mg/ml
4) 25mg/ml
5) 50mg/2ml

DIRECTION OF USE:

Methotrexate Injection may be given by the intramuscular, intravenous, intraarterial or intrathecal routes.

CAUTION & WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital/ Institution.
WARNINGS AND PRECAUTIONS
Methotrexate should be administered only under the supervision of a qualified physician experienced in the use of antineoplastic therapy. Special care should be taken when methotrexate is co-administered with non-steroidal anti-inflammatory drugs (NSAIDs). Severe side effects including fatalities (after high doses of methotrexate) have been reported. Consumption of alcohol even in low doses should be avoided. The patient should be informed about possible risks (side effects). Contraindications and precautions for use must be strictly observed because of possible severe (under particular circumstances lethal) toxic reactions. Plasma concentration of methotrexate
• Higher than 1-2 times 10-5 mol/I (24 hours after initiating methotrexate therapy)
• Twice 10-6 mol/1 (48 hours after initiating methotrexate therapy)
• 10-7 mol/I (72 hours after initiating methotrexate therapy) indicate an increased risk of intoxication (myelosuppression, mucositis) and require a long -lasting and high dose of calcium folinate rescue therapy.
Intermediate dose of methotrexate therapy:
500-1000 mg/m2 IV infusion over 36-42 h; calcium folinate rescue required, given at 2-3 weeks intervals High-dose methotrexate therapy - calcium folinate rescue required:1-12 gm/m2 IV over 1-6 hours, given at 1-3 weeks intervals
METHOTREXATE 1000 MG - CONCENTRATE FOR INFUSION HAS TO BE DILUTED WITH STANDARD SOLUTIONS FOR INFUSIONS BEFORE ADMINISTRATION ACCORDING TO THERAPY PROTOCOL AND DURATION OF INFUSION. USE 5% GLUCOSE SOLUTION, RINGER'S LACTATE OR PHYSIOLOGICAL SALINE SOLUTION.
GENERALLY, 1-2% METHOTREXATE SOLUTION IS ADMINISTERED.
Do not use after the expiry date stated on the label.
After dilution, the product should be used within 24 hours if stored at 2-8°C.
Contains no preservatives.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard unused portion.
Keep in a safe place out of the reach of children.

STORAGE & DOSAGE:

Storage: Store vials between 20°C to 25°C (68° to 77° F) [see USP Controlled Room Temperature]. Protect from light.
Dosage: As directed by the Oncologist. Please refer accompanying package insert for detailed dosage, directions for use and precautions.