What Topotecan Hospira contains
The active substance in Topotecan Hospira is topotecan (as hydrochloride). 1 ml of concentrate for solution for infusion contains 1 mg topotecan (as hydrochloride). Each 4 ml vial of concentrate contains 4 mg topotecan (as hydrochloride).
The other ingredients are: tartaric acid (E334), water for injections and hydrochloric acid (E507) or sodium hydroxide (to adjust the pH of the solution).
What Topotecan Hospira looks like and the contents of the pack
Topotecan Hospira is a clear, yellow or yellow-green concentrate for solution for infusion, supplied in clear glass vials, each containing 4 ml concentrate. Topotecan Hospira is available in two pack sizes, containing either 1 vial or 5 vials. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Hospira UK Limited
Royal Leamington Spa
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
AT DE Hospira Deutschland GmbH Tel 49 0 89 43 77 77 0 BE LX NL Hospira Benelux BVBA TélTel 32 2 332 03 15
CZ EE EL IE LT LV MT PL RO SI SK UK Hospira UK Limited Tel 44 0 1926 820820 CY Name N.Karoullas Pharmaceutical Trading Co Ltd 33, Artemidos avenue, 6025 Larnaca Tel 24656165 Mob. 99403969 Email n.karoullasptc-ltd.com
DK FI IS NO SE Hospira Nordic AB Tel 46 0 8 672 85 00 ES Hospira Productos Farmacéuticos y Hospitalarios S.L. Tel 34 914847100
FR Hospira France Tél 33 0 826 30 03 02 HU Pharmacenter Hungary Ltd Tel. 36-1-209-5927
IT Hospira Italia Srl Tel 39 0812405912 PT Hospira Portugal Lda Tel 351 214857434
This leaflet was last approved in
The following information is intended for medical or health care professionals only.
Storage, Use, Handling & Disposal of Topotecan Hospira
Unopened vial: Store in a refrigerator (2°C-8°C). Do not freeze. Keep the vial in the outer carton in order to protect from light.
Refer to the SPC for full details.
Topotecan Hospira 4 mg/4 ml concentrate for solution for infusion requires dilution to a final concentration of 25-50 micrograms/ml, prior to administration to the patient. The approved diluents for the concentrate are sodium chloride 9 mg/ml (0.9%) solution for injection and glucose 50 mg/ml (5%) solution for injection. Use the aseptic technique during any further dilution of the solution for infusion.
Parenteral products should be visually inspected for particulate matter and discolouration prior to administration. Topotecan Hospira is a yellow/yellow green solution. If visible particles areobserved, the product should not be administered.
Prior to administration of the first course of topotecan, patients must have a baseline neutrophil count
of ?1.5 x 10 9/l, a platelet count of ? 100 x 10 9/l and a haemoglobin level of ? 9g/dl (after transfusion if necessary). Neutropenia and thrombocytopenia should be managed. For further details, refer to the SPC.
Dosage: Small Cell Lung Carcinoma
Initial dose: 1.5 mg/ m 2
body surface area/day, administered by intravenous infusion over 30 minutes for 5 consecutive days, with a 3 week interval between the start of each course.
Subsequent doses: Topotecan should not be re-administered unless the neutrophil count is ? 1 x 109/l, the platelet count is ? 100 x 10 9/l, and the haemoglobin level is ? 9 g/dl (after transfusion if necessary).
Dosage: Cervical Carcinoma
Initial dose: 0.75 mg/m 2
/day administered as 30 minute intravenous infusion daily, on days 1, 2 and 3. Cisplatin is administered as an intravenous infusion on day 1 at a dose of 50 mg/m 2
/day and following the topotecan dose. This treatment schedule is repeated every 21 days for 6 courses or until progressive disease.
Subsequent doses: Topotecan should not be re-administered unless the neutrophil count is more than or equal to 1.5 x 10 9/l, the platelet count is more than or equal to 100 x 10 9/l, and the haemoglobin level is more than or equal to 9g/dl (after transfusion if necessary).
Dosage: Renally impaired patients
Limited data indicate that the dose should be reduced in patients with moderate renal impairment. Please refer to the SPC for further details.
Dosage: Paediatric population
Limited data available. Use not recommended.
Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C under normal light conditions and at 2-8°C when protected from light. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Handling and disposal
The normal procedures for proper handling and disposal of anti-tumour medicinal products should be adopted:
- Staff should be adequately trained in the preparation, administration and disposal of cytotoxics
- Pregnant staff should be excluded from working with this medicinal product.
- Staff handling this medicinal product should wear adequate protective clothing including mask,goggles and gloves.
- All items for used in the preparation, administration, and cleaning of the medicinal product, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration. Liquid waste may be flushed with large amounts of water.
- Accidental contact with the skin or eyes should be treated immediately with copious amounts of water. If there is lasting irritation, a doctor should be consulted.
- Any unused product or waste material should be disposed of in accordance with local requirements.