Dactinomycin for Injection USP 500mcg (0.5mg) Technical Specification:
| Product Name: | Dactinomycin for Injection USP 500mcg (0.5mg) |
| Brand Name: | Dactinomycin |
| Strength: | 500mcg (0.5mg) |
| Dosage Form: | Lyophilized Dry Powder for Injection |
| Packing: | SINGLE USE VIAL |
| Route of Administration: | For I.V. use only. |
| 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: | Dactinomycin is used to treat a number of types of cancer. This includes Wilms tumor, rhabdomyosarcoma, Ewing’s sarcoma, trophoblastic neoplasm, testicular cancer, and certain types of ovarian cancer |
| Storage: | Store vials at 20°C to 25°C (68° to 77° F); excursions permitted between 15°C to 30°C (59° to 86° F) [See USP Controlled Room Temperature]. Protected from light and humidity. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Dactinomycin for Injection USP 500mcg (0.5mg)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Dactinomycin for Injection USP 500mcg (0.5mg)
Each vial contains:
Dactinomycin USP…………………….0.5mg
Mannitol USP……………………………20mg
THERAPEUTIC INDICATION:
Dactinomycin is used to treat a number of types of cancer. This includes Wilms tumor, rhabdomyosarcoma, Ewing’s sarcoma, trophoblastic neoplasm, testicular cancer, and certain types of ovarian cancer
DIRECTION OF USE:
For Intravenous infusion only.
RECONSTITUTION: Reconstitute dactinomycin for injection by adding 1.1 ml of Sterile Water for Injection (without preservative).
The resulting solution for dactinomycin will contain approximately 500mcg or 0.5mg per ml.
Do not use preservative diluent as precipitation may occur Solution is chemically stable or 24 hr at room temperature. Significant binding of drug occurs with micrometer nitrocellulose filter materials / Standard dilution
IV push: dose/syringe (500 mcg/mL).
The reconstituted solution is clear, gold colored and essentially free from visible particles.
CAUTION & WARNING:
CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
WARNINGS AND PRECAUTIONS
The drug should be administered under the supervision of an experienced cancer chemotherapy physician. If extravasation occurs, it may cause severe soft tissue damage. Contracture of the arms has occurred (rare). Avoid inhalation of vapors or contact with skin mucous membrane or eyes. Handle and dispose agent using appropriate precautions. Avoid exposure during pregnancy.
Contraindications: Hypersensitivity /Active chickenpox or herpes zoster. Caution in hepatic/renal impairment, elderly May cause hepatic sinusoidal obstruction syndrome. Toxic effects may take 1-2 weeks to reach maximum severity following treatment; discontinue treatment if severe diarrhea, myelosuppression, or stomatitis occur. Avoid pregnancy. Avoid use within 2 weeks of radiation treatment for right-sided tumor (may increase risk of hepatotoxicity) Avoid use of concomitant live virus vaccines. Use in myelosuppressive patients not recommended.
ACTINOMYCIN ANTIBIOTIC; INTERCALATES INTO DNA BASE PAIRS PREVENTING RNA, DNA, AND PROTEIN SYNTHESIS
DANGER: Contact poison. Avoid contact with skin, mucous membranes or eyes. Do not inhale the dust or vapor. In case of contact, wash with copious amounts for at least 15 minutes.
Do not give I.M. or S.C.
See PRECAUTIONS and HOW SUPPLIED in accompanying package insert.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard Unused portion.
Keep out of the reach of the children.
STORAGE & DOSAGE:
Storage: Store vials at 20°C to 25°C (68° to 77° F); excursions permitted between 15°C to 30°C (59° to 86° F) [See USP Controlled Room Temperature]. Protected from light and humidity.
Dosage: As directed by an Oncologist.
For use in the treatment of gestational trophoblastic neoplasia:
12 mcg/kg intravenously daily for five days as a single agent. Or 500 mcg intravenously on days 1 and 2 as part of a combination regimen with etoposide, methotrexate, folinic acid, vincristine, cyclophosphamide and cisplatin.
GENERIC NAME OF THE MEDICINAL PRODUCT:
Dactinomycin for Injection USP 500mcg (0.5mg)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Dactinomycin for Injection USP 500mcg (0.5mg)
Each vial contains:
Dactinomycin USP…………………….0.5mg
Mannitol USP……………………………20mg
Each vial contains:
Dactinomycin USP…………………….0.5mg
Mannitol USP……………………………20mg
THERAPEUTIC INDICATION:
Dactinomycin is used to treat a number of types of cancer. This includes Wilms tumor, rhabdomyosarcoma, Ewing's sarcoma, trophoblastic neoplasm, testicular cancer, and certain types of ovarian cancer
DIRECTION OF USE:
For Intravenous infusion only.
RECONSTITUTION: Reconstitute dactinomycin for injection by adding 1.1 ml of Sterile Water for Injection (without preservative).
The resulting solution for dactinomycin will contain approximately 500mcg or 0.5mg per ml.
Do not use preservative diluent as precipitation may occur Solution is chemically stable or 24 hr at room temperature. Significant binding of drug occurs with micrometer nitrocellulose filter materials / Standard dilution
IV push: dose/syringe (500 mcg/mL).
The reconstituted solution is clear, gold colored and essentially free from visible particles.
RECONSTITUTION: Reconstitute dactinomycin for injection by adding 1.1 ml of Sterile Water for Injection (without preservative).
The resulting solution for dactinomycin will contain approximately 500mcg or 0.5mg per ml.
Do not use preservative diluent as precipitation may occur Solution is chemically stable or 24 hr at room temperature. Significant binding of drug occurs with micrometer nitrocellulose filter materials / Standard dilution
IV push: dose/syringe (500 mcg/mL).
The reconstituted solution is clear, gold colored and essentially free from visible particles.
CAUTION & WARNING:
CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
WARNINGS AND PRECAUTIONS
The drug should be administered under the supervision of an experienced cancer chemotherapy physician. If extravasation occurs, it may cause severe soft tissue damage. Contracture of the arms has occurred (rare). Avoid inhalation of vapors or contact with skin mucous membrane or eyes. Handle and dispose agent using appropriate precautions. Avoid exposure during pregnancy.
Contraindications: Hypersensitivity /Active chickenpox or herpes zoster. Caution in hepatic/renal impairment, elderly May cause hepatic sinusoidal obstruction syndrome. Toxic effects may take 1-2 weeks to reach maximum severity following treatment; discontinue treatment if severe diarrhea, myelosuppression, or stomatitis occur. Avoid pregnancy. Avoid use within 2 weeks of radiation treatment for right-sided tumor (may increase risk of hepatotoxicity) Avoid use of concomitant live virus vaccines. Use in myelosuppressive patients not recommended.
ACTINOMYCIN ANTIBIOTIC; INTERCALATES INTO DNA BASE PAIRS PREVENTING RNA, DNA, AND PROTEIN SYNTHESIS
DANGER: Contact poison. Avoid contact with skin, mucous membranes or eyes. Do not inhale the dust or vapor. In case of contact, wash with copious amounts for at least 15 minutes.
Do not give I.M. or S.C.
See PRECAUTIONS and HOW SUPPLIED in accompanying package insert.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard Unused portion.
Keep out of the reach of the children.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
WARNINGS AND PRECAUTIONS
The drug should be administered under the supervision of an experienced cancer chemotherapy physician. If extravasation occurs, it may cause severe soft tissue damage. Contracture of the arms has occurred (rare). Avoid inhalation of vapors or contact with skin mucous membrane or eyes. Handle and dispose agent using appropriate precautions. Avoid exposure during pregnancy.
Contraindications: Hypersensitivity /Active chickenpox or herpes zoster. Caution in hepatic/renal impairment, elderly May cause hepatic sinusoidal obstruction syndrome. Toxic effects may take 1-2 weeks to reach maximum severity following treatment; discontinue treatment if severe diarrhea, myelosuppression, or stomatitis occur. Avoid pregnancy. Avoid use within 2 weeks of radiation treatment for right-sided tumor (may increase risk of hepatotoxicity) Avoid use of concomitant live virus vaccines. Use in myelosuppressive patients not recommended.
ACTINOMYCIN ANTIBIOTIC; INTERCALATES INTO DNA BASE PAIRS PREVENTING RNA, DNA, AND PROTEIN SYNTHESIS
DANGER: Contact poison. Avoid contact with skin, mucous membranes or eyes. Do not inhale the dust or vapor. In case of contact, wash with copious amounts for at least 15 minutes.
Do not give I.M. or S.C.
See PRECAUTIONS and HOW SUPPLIED in accompanying package insert.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard Unused portion.
Keep out of the reach of the children.
STORAGE & DOSAGE:
Storage: Store vials at 20°C to 25°C (68° to 77° F); excursions permitted between 15°C to 30°C (59° to 86° F) [See USP Controlled Room Temperature]. Protected from light and humidity.
Dosage: As directed by an Oncologist.
For use in the treatment of gestational trophoblastic neoplasia:
12 mcg/kg intravenously daily for five days as a single agent. Or 500 mcg intravenously on days 1 and 2 as part of a combination regimen with etoposide, methotrexate, folinic acid, vincristine, cyclophosphamide and cisplatin.
Dosage: As directed by an Oncologist.
For use in the treatment of gestational trophoblastic neoplasia:
12 mcg/kg intravenously daily for five days as a single agent. Or 500 mcg intravenously on days 1 and 2 as part of a combination regimen with etoposide, methotrexate, folinic acid, vincristine, cyclophosphamide and cisplatin.
