- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Fertility, pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
PosologyFOR ADULTS ONLY The recommended dose for oxaliplatin in adjuvant setting is 85 mg/m² intravenously repeated every 2 weeks for 12 cycles (6 months).The recommended dose for oxaliplatin in treatment of metastatic colorectal cancer is 85 mg/m² intravenously repeated every 2 weeks until disease progression or unacceptable toxicity.Dosage given should be adjusted according to tolerability (see section 4.4).
Oxaliplatin should always be administered before fluoropyrimidines i.e. 5 fluorouracil (5 FU).Oxaliplatin is administered as a 2- to 6-hour intravenous infusion in 250 to 500 ml of glucose 5% solution (50 mg/ml) to give a concentration between 0.2 mg/ml and 0.70 mg/ml; 0.70 mg/ml is the highest concentration in clinical practice for an oxaliplatin dose of 85 mg/m2.Oxaliplatin was mainly used in combination with continuous infusion 5-fluorouracil based regimens. For the two-weekly treatment schedule 5-fluorouracil regimens combining bolus and continuous infusion were used.Special Populations - Renal impairment:Oxaliplatin must not be administered in patients with severe renal impairment (See sections 4.3 and 5.2).In patients with mild to moderate renal impairment, the recommended dose of oxaliplatin is 85 mg/m2 (see sections 4.4 and 5.2).- Hepatic impairment:In a phase I study including patients with several levels of hepatic impairment, frequency and severity of hepatobiliary disorders appeared to be related to progressive disease and impaired liver function tests at baseline. No specific dose adjustment for patients with abnormal liver function tests was performed during clinical development.- Elderly patients:No increase in severe toxicities was observed when oxaliplatin was used as a single agent or in combination with 5-fluorouracil in patients over the age of 65. In consequence no specific dose adaptation is required for elderly patients.- Paediatric population:There is no relevant indication for use of oxaliplatin in children. The effectiveness of oxaliplatin single agent in the paediatric populations with solid tumours has not been established (see section 5.1).
Method of administrationOxaliplatin is administered by intravenous infusion.The administration of oxaliplatin does not require hyperhydration.Oxaliplatin diluted in 250 to 500 ml of glucose 5% solution (50 mg/ml) to give a concentration not less than 0.2 mg/ml must be infused either via a peripheral vein or central venous line over 2 to 6 hours. Oxaliplatin infusion must always precede the administration of 5-fluorouracil.In the event of extravasation, administration must be discontinued immediately.Instructions for use:Oxaliplatin must be reconstituted and further diluted before use. Only glucose 5% (50 mg/ml) diluent is to be used to reconstitute and then dilute the freeze-dried medicinal product. (See section 6.6).
Renal impairmentPatients with mild to moderate renal impairment should be closely monitored for adverse reactions and the dose adjusted according to toxicity (see section 5.2).
Hypersensitivity reactionsSpecial surveillance should be ensured for patients with a history of allergic manifestations to other products containing platinum. In case of anaphylactic manifestations the infusion should be interrupted immediately and an appropriate symptomatic treatment started. Re-administration of oxaliplatin to such patients is contra-indicated. Cross reactions, sometimes fatal, have been reported with all platinum compounds.In case of oxaliplatin extravasation, the infusion must be stopped immediately and usual local symptomatic treatment initiated.
Neurological symptomsNeurological toxicity of oxaliplatin should be carefully monitored, especially if co-administered with other medicinal products with specific neurological toxicity. A neurological examination should be performed before each administration and periodically thereafter.For patients who develop acute laryngopharyngeal dysaesthesia (see section 4.8), during or within the hours following the 2-hour infusion, the next oxaliplatin infusion should be administered over 6 hours.
Peripheral neuropathyIf neurological symptoms (paraesthesia, dysaesthesia) occur, the following recommended oxaliplatin dosage adjustment should be based on the duration and severity of these symptoms:- If symptoms last longer than seven days and are troublesome, the subsequent oxaliplatin dose should be reduced from 85 to 65 mg/m2 (metastatic setting) or 75 mg/m2 (adjuvant setting).- If paraesthesia without functional impairment persists until the next cycle, the subsequent oxaliplatin dose should be reduced from 85 to 65 mg/m2 (metastatic setting) or 75 mg/m2 (adjuvant setting).- If paraesthesia with functional impairment persists until the next cycle, oxaliplatin should be discontinued.- If these symptoms improve following discontinuation of oxaliplatin therapy, resumption of therapy may be considered.Patients should be informed of the possibilities of persistent symptoms of peripheral sensory neuropathy after the end of the treatment. Localised moderate parasthesias or parasthesias that may interfere with functional activities can persist after up to 3 years following treatment cessation in the adjuvant setting.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS)Cases of Reversible Posterior Leukoencephalopathy Syndrome (RPLS also known as PRES, Posterior Reversible Encephalopathy Syndrome) have been reported in patients receiving oxaliplatin in combination chemotherapy. RPLS is a rare, reversible, rapidly evolving neurological condition, which can include seizure, hypertension, headache, confusion, blindness, and other visual and neurological disturbances (see section 4.8). Diagnosis of RPLS is based upon confirmation by brain imaging, preferably MRI (Magnetic Resonance Imaging)
Nausea, vomiting, diarrhoea, dehydration and haematological changesGastrointestinal toxicity, which manifests as nausea and vomiting, warrants prophylactic and/or therapeutic anti-emetic therapy (see section 4.8).Dehydration, paralytic ileus, intestinal obstruction, hypokalemia, metabolic acidosis and renal impairment may be caused by severe diarrhoea/emesis particularly when combining oxaliplatin with 5-fluorouracil.If haematological toxicity occurs (neutrophils < 1.5x109/l or platelets < 50x109/l), administration of the next course of therapy should be postponed until haematological values return to acceptable levels. A full blood count with white cell differential should be performed prior to start of therapy and before each subsequent course.Patients must be adequately informed of the risk of diarrhoea/emesis, mucositis/stomatitis and neutropenia after oxaliplatin and 5-fluorouracil administration so that they can urgently contact their treating physician for appropriate management.If mucositis/stomatitis occurs with or without neutropenia, the next treatment should be delayed until recovery from mucositis/stomatitis to grade 1 or less and/or until the neutrophil count is ≥ 1.5 x 109/l.For oxaliplatin combined with 5-fluorouracil (with or without folinic acid), the usual dose adjustments for 5-fluorouracil associated toxicities should apply.If grade 4 diarrhoea, grade 3-4 neutropenia (neutrophils < 1.0x109/l), grade 3-4 thrombocytopenia (platelets < 50x109/l) occur, the dose of oxaliplatin should be reduced from 85 to 65 mg/m² (metastatic setting) or 75 mg/m² (adjuvant setting), in addition to any 5-fluorouracil dose reductions required.
PulmonaryIn the case of unexplained respiratory symptoms such as non-productive cough, dyspnoea, crackles or radiological pulmonary infiltrates, oxaliplatin should be discontinued until further pulmonary investigations exclude an interstitial lung disease (see section 4.8).
HepaticIn cases of abnormal test results of liver function or portal hypertension, which does not obviously depend on liver metastases, very rare cases of drug induced hepatic vascular disorder should be considered.
PregnancyFor use in pregnant women see section 4.6.
FertilityGenotoxic effects were observed with oxaliplatin in the preclinical studies. Therefore male patients treated with oxaliplatin are advised not to father a child during and up to 6 months after treatment and to seek advice on conservation of sperm prior to treatment, because oxaliplatin may have an anti-fertility effect which could be irreversible.Women should not become pregnant during treatment with oxaliplatin and should use an effective method of contraception (see section 4.6).
PregnancyTo date there is no available information on safety of use in pregnant women. In animal studies, reproductive toxicity was observed. Consequently, oxaliplatin is not recommended during pregnancy and in women of childbearing potential not using contraceptive measures. The use of oxaliplatin should only be considered after suitably appraising the patient of the risk to the foetus and with the patient's consent.Appropriate contraceptive measures must be taken during and after cessation of therapy during 4 months for women and 6 months for men.
BreastfeedingExcretion in breast milk has not been studied. Breast-feeding is contra-indicated during oxaliplatin therapy.
FertilityOxaliplatin may have an anti-fertility effect (see section 4.4).
|MedDRA Organ System Class||Very common||Common||Uncommon||Rare|
|Infections and infestations*||- Infection||- Rhinitis - Upper respiratory tract infection - Neutropenic sepsis|
|Blood and lymphatic system disorders*||- Anaemia - Neutropenia - Thrombocytopenia - Leukopenia - Lymphopenia||-Febrile neutropenia||- Autoimmune thrombocytopenia - Haemolytic anaemia|
|Immune system disorders*||- Allergy/allergic reaction+|
|Metabolism and nutrition disorders||- Anorexia - Hyperglycaemia - Hypokalaemia - Hypernatremia||- Dehydration||- Metabolic acidosis|
|Psychiatric disorders||- Depression - Insomnia||- Nervousness|
|Nervous system disorders*||- Peripheral sensory neuropathy - Sensory disturbance - Dysgeusia - Headache||- Dizziness - Motor neuritis - Meningism||- Dysarthria - Reversible Posterior Leukoencephalopathy syndrome (RPLS, or PRES)** (see section 4.4)|
|Eye disorders||- Conjunctivitis - Visual disturbance||- Visual acuity reduced transiently - Visual field disturbance - Optic neuritis - Transient vision loss, reversible following therapy discontinuation|
|Ear and labyrinth disorders||- Ototoxicity||- Deafness|
|Vascular disorders||- Haemorrhage - Flushing - Deep vein thrombosis - Hypertension|
|Respiratory, thoracic and mediastinal disorders||- Dyspnoea - Cough - Epistaxis||- Pulmonary embolism - Hiccups||- Interstitial lung disease, sometimes fatal - Pulmonary fibrosis**|
|Gastointestinal disorders*||- Nausea - Diarrhoea - Vomiting - Stomatitis/ mucositis - Abdominal pain - Constipation||- Rectal haemorrhage - Dyspepsia - Gastroesophageal reflux - Gastrointestinal haemorrhage||- Ileus - Intestinal obstruction||- Colitis including Clostridium difficile diarrhoea - Pancreatitis|
|Skin and subcutaneous tissue disorders||- Skin disorder - Alopecia||- Skin exfoliation (i.e Hand and Foot syndrome) - Rash erythematous - Rash - Hyperhidrosis - Nail disorder|
|Musculoskeletal, connective tissue disorders||- Back pain||- Arthralgia - Bone pain|
|Renal and urinary disorders||- Dysuria - Micturition frequency abnormal - Haematuria|
|General disorders and administration site conditions||- Fatigue - Fever++ - Asthenia - Pain - Injection site reaction+++|
|Investigations||- Hepatic enzyme increase - Blood alkaline phosphatase increase - Blood bilirubin increase - Blood lactate dehydrogenase increase - Weight increase(adjuvant setting)||- Blood creatinine increase - Weight decrease(metastatic setting)|
Blood and lymphatic system disorders
|Incidence by patient (%), by grade|
|Oxaliplatin and 5 FU/FA 85 mg/m² every 2 weeks||Metastatic setting||Adjuvant setting|
|All grades||gr 3||gr 4||All grades||gr 3||gr4|
Post-marketing experience with frequency unknownHaemolytic uraemic syndrome
Immune system disorders
|Incidence by patient (%), by grade|
|Oxaliplatin / 5 FU/FA85 mg/m² every 2 weeks||Metastatic Setting||Adjuvant Setting|
|All grades||gr 3||gr 4||All grades||gr 3||gr 4|
|Allergic reactions/ Allergy||9.1||1||<1||10.3||2.3||0.6|
Nervous system disordersThe dose limiting toxicity of oxaliplatin is neurological. It involves a sensory peripheral neuropathy characterised by dysaesthesia and/or paraesthesia of the extremities with or without cramps, often triggered by the cold. These symptoms occur in up to 95% of patients treated. The duration of these symptoms, which usually regress between courses of treatment, increases with the number of treatment cycles.The onset of pain and/or a functional disorder are indications, depending on the duration of the symptoms, for dose adjustment, or even treatment discontinuation (see section 4.4).This functional disorder includes difficulties in executing delicate movements and is a possible consequence of sensory impairment. The risk of occurrence of persistent symptoms for a cumulative dose of 850 mg/m² (10 cycles) is approximately 10% and 20% for a cumulative dose of 1020 mg/m² (12 cycles). In the majority of cases, the neurological signs and symptoms improve or totally recover when treatment is discontinued. In the adjuvant setting of colon cancer, 6 months after treatment cessation, 87% of patients had no or mild symptoms. After up to 3 years of follow up, about 3% of patients presented either with persisting localized paresthesias of moderate intensity (2.3%) or with paresthesias that may interfere with functional activities (0.5%).Acute neurosensory manifestations (see section 5.3) have been reported. They start within hours of administration and often occur on exposure to cold. They usually present as transient paresthesia, dysesthesia and hypoesthesia. An acute syndrome of pharyngolaryngeal dysesthesia occurs in between 1% - 2%, and is characterised by subjective sensations of dysphagia or dyspnoea/feeling of suffocation, without any objective evidence of respiratory distress (no cyanosis or hypoxia) or of laryngospasm or bronchospasm (no stridor or wheezing); Although antihistamines and bronchodilators have been administered in such cases, the symptoms are rapidly reversible even in the absence of treatment. Prolongation of the infusion helps to reduce the incidence of this syndrome (see section 4.4). Occasionally other symptoms that have been observed include jaw spasm/muscle spasms/muscle contractions involuntary/muscle twitching/myoclonus, coordination abnormal/gait abnormal/ ataxia/ balance disorders, throat or chest tightness/ pressure/ discomfort/pain. In addition, cranial nerve dysfunctions may be associated with above mentioned events, or also occur as an isolated event such as ptosis, diplopia, aphonia/dysphonia, hoarseness, sometimes described as vocal cord paralysis, abnormal tongue sensation or dysarthria, sometimes described as aphasia, trigeminal neuralgia/facial pain/eye pain, decrease in visual acuity, visual field disorders.Other neurological symptoms such as dysarthria, loss of deep tendon reflex and Lhermitte's sign were reported during treatment with oxaliplatin. Isolated cases of optic neuritis have been reported.
Post marketing experience with frequency unknownConvulsion
|Incidence by patient (%), by grade|
|Oxaliplatin/ 5 FU/FA85 mg/m² every 2 weeks||Metastatic setting||Adjuvant setting|
|All grades||gr 3||gr 4||All grades||gr 3||gr 4|
Very rare (< 1/10,000):Liver sinusoidal obstruction syndrome, also known as veno-occlusive disease of liver, or pathological manifestations related to such liver disorder, including peliosis hepatitis, nodular regenerative hyperplasia, perisinusoidal fibrosis. Clinical manifestations may be portal hypertension and/or increased transaminases.
Renal and urinary disorders
Very rare (< 1/10,000):Acute tubular necrosis, acute interstitial nephritis and acute renal failure.
Response rate under FOLFOX4 versus LV5FU2
|Response rate % (95% CI)Independent radiological review ITT analysis||LV5FU2||FOLFOX4||OxaliplatinSingle agent|
|Front-line treatmentEFC2962 Response assessment every 8 weeks||22 (16-27)||49 (42-46)||NA*|
|P value = 0.0001|
|Pretreated patientsEFC4584 (refractory to CPT-11 + 5FU/FA) Response assessment every 6 weeks||0.7 (0.0-2.7)||11.1 (7.6-15.5)||1.1 (0.2-3.2)|
|P value = 0.0001|
|Pretreated patientsEFC2964 (refractory to 5-FU/FA) Response assessment every 12 weeks||NA*||23 (13-36)||NA*|
NA: Not Applicable
Median Progression Free Survival (PFS) / Median Time to Progression (TTP) FOLFOX4 versus LV5FU2
|Median PFS/TTP, Months (95% CI)Independent radiological review ITT analysis||LV5FU2||FOLFOX4||OxaliplatinSingle agent|
|Front-line treatmentEFC2962 (PFS)||6.0 (5.5-6.5)||8.2 (7.2-8.8)||NA*|
|Log-rank P value = 0.0003|
|Pretreated patientsEFC4584 (TTP) (refractory to CPT-11 + 5FU/FA)||2.6 (1.8-2.9)||5.3 (4.7-6.1)||2.1 (1.6-2.7)|
|Log-rank P value < 0.0001|
|Pretreated patientsEFC2964 (refractory to 5-FU/FA)||NA*||5.1 (3.1-5.7)||NA*|
NA: Not Applicable
Median Overall Survival (OS) under FOLFOX4 versus LV5FU2
|Median OS, Months (95% CI)ITT analysis||LV5FU2||FOLFOX4||OxaliplatinSingle agent|
|Front-line treatmentEFC2962||14.7 (13.0-18.2)||16.2 (14.7-18.2)||NA*|
|Log-rank P value = 0.12|
|Pretreated patientsEFC4584 (refractory to CPT-11 + 5FU/FA)||8.8 (7.3-9.3)||9.9 (9.1-10.5)||8.1 (7.2-8.7)|
|Log-rank P value < 0.09|
|Pretreated patientsEFC2964 (refractory to 5-FU/FA)||NA*||10.8 (9.3-12.8)||NA*|
NA : Not ApplicableIn pretreated patients (EFC4584), who were symptomatic at baseline, a higher proportion of those treated with oxaliplatin and 5-FU/FA experienced a significant improvement of their disease-related symptoms compared to those treated with 5-FU/FA alone (27.7% vs 14.6% p= 0.0033). In non pretreated patients (EFC2962), no statistical difference between the two treatment groups was found for any of the quality of life dimensions. However, the quality of life scores were generally better in the control arm for measurement of global health status and pain and worse in the oxaliplatin arm for nausea and vomiting.In the adjuvant setting, the comparative MOSAIC phase III study (EFC3313) randomised 2246 patients (899 stage II/ Duke's B2 and 1347 stage III/ Duke's C) further to complete resection of the primary tumour of colon cancer either to 5-FU/FA alone (LV5FU2, N=1123 (B2/C) = 448/675) or to combination of oxaliplatin and 5-FU/FA (FOLFOX4, N =1123, (B2/C) = 451/672).
EFC 3313 3-year disease free survival (ITT analysis)* for the overall population.
|Percent 3-year disease free survival (95 % CI)||73.3 (70.6-75.9)||78.7 (76.2-81.1)|
|Hazard ratio (95 % CI)||0.76 (0.64-0.89)|
|Stratified log rank test||P=0.0008|
EFC 3313 3-year disease free survival (ITT analysis)* according to disease stage
|Patient stage||Stage II(Duke's B2)||Stage III(Duke's C)|
|Percent 3-year disease free survival(95 % CI)||84.3 (80.9-87.7)||87.4 (84.3-90.5)||65.8 (62.2-69.5)||72.8 (69.4-76.2)|
|Hazard ratio (95 % CI)||0.79 (0.57-1.09)||0.75 (0.62-0.90)|
Overall Survival (ITT analysis)At time of the analysis of the 3-year disease free survival, which was the primary endpoint of the MOSAIC trial, 85.1 % of the patients were still alive in the FOLFOX4 arm versus 83.8 % in the LV5FU2 arm. This translated into an overall reduction in mortality risk of 10 % in favour of FOLFOX4 not reaching statistical significance (hazard ratio = 0.90).The figures were 92.2 % versus 92.4 % in the Stage II (Duke's B2) sub-population (hazard ratio = 1.01) and 80.4 % versus 78.1 % in the Stage III (Duke's C) sub-population (hazard ratio = 0.87), for FOLFOX4 and LV5FU2, respectively.Oxaliplatin single agent has been evaluated in paediatric population in 2 Phase I (69 patients) and 2 Phase II (166 patients) studies. A total of 235 paediatric patients (7 months-22 years of age) with solid tumours have been treated. The effectiveness of oxaliplatin single agent in the paediatric populations treated has not been established. Accrual in both Phase II studies was stopped for lack of tumour response.
Instructions for HandlingThe handling of this cytotoxic agent by healthcare personnel requires every precaution to guarantee the protection of the handler and his surroundings.The preparation of injectable solutions of cytotoxic agents must be carried out by trained specialist personnel with knowledge of the medicines used, in conditions that guarantee the integrity of the medicinal product, the protection of the environment and in particular the protection of the personnel handling the medicines, in accordance with the hospital policy. It requires a preparation area reserved for this purpose. It is forbidden to smoke, eat or drink in this area.Personnel must be provided with appropriate handling materials, notably long sleeved gowns, protection masks, caps, protective goggles, sterile single-use gloves, protective covers for the work area, containers and collection bags for waste.Excreta and vomit must be handled with care.Pregnant women must be warned to avoid handling cytotoxic agents.Any broken container must be treated with the same precautions and considered as contaminated waste. Contaminated waste should be incinerated in suitably labelled rigid containers. See below chapter Disposal.If Oxaliplatin powder, reconstituted solution or solution for infusion, should come into contact with skin, wash immediately and thoroughly with water.If Oxaliplatin powder, reconstituted solution or solution for infusion, should come into contact with mucous membranes, wash immediately and thoroughly with water.
Special precautions for administration- DO NOT use injection equipment containing aluminium.- DO NOT administer undiluted.- Only glucose 5 % (50 mg/ml) infusion solution is to be used as a diluent. DO NOT reconstitute or dilute for infusion with sodium chloride or chloride containing solutions.- DO NOT mix with any other medicinal products in the same infusion bag or administer simultaneously by the same infusion line - DO NOT mix with alkaline medicinal products or solutions, in particular 5 fluorouracil, folinic acid preparations containing trometamol as an excipient and trometamol salts of others active substances. Alkaline medicinal products or solutions will adversely affect the stability of oxaliplatin
Instruction for use with folinic acid (FA) (as calcium folinate or disodium folinate)Oxaliplatin 85 mg/m² intravenous infusion in 250 to 500 ml of glucose 5 % (50 mg/ml) solution is given at the same time as folinic acid (FA) intravenous infusion in glucose 5 % (50 mg/ml) solution, over 2 to 6 hours, using a Y-line placed immediately before the site of infusion. These two medicinal products should not be combined in the same infusion bag. Folinic acid (FA) must not contain trometamol as an excipient and must only be diluted using isotonic glucose 5 % (50 mg/ml) solution, never in alkaline solutions or sodium chloride or chloride containing solutions.
Instruction for use with 5 fluorouracil (5 FU)Oxaliplatin should always be administered before fluoropyrimidines i.e. 5 fluorouracil (5 FU).After oxaliplatin administration, flush the line and then administer 5 fluorouracil (5 FU).For additional information on medicinal products combined with oxaliplatin, see the corresponding manufacturer's summary of product characteristics.- USE ONLY the recommended solvents (see below).- Any reconstituted solution that shows evidence of precipitation should not be used and should be destroyed with due regard to legal requirements for disposal of hazardous waste (see below).
Reconstitution of the solutionWater for injections or 5% glucose solution should be used to reconstitute the solution.- For a vial of 50 mg: add 10 ml of solvent to obtain a concentration of 5 mg oxaliplatin/ml.- For a vial of 100 mg: add 20 ml of solvent to obtain a concentration of 5 mg oxaliplatin/ml.Inspect visually prior to use. Only clear solutions without particles should be used.The medicinal product is for single use only. Any unused infusion solution should be discarded.
Dilution for intravenous infusionWithdraw the required amount of reconstituted solution from the vial(s) and then dilute with 250 ml to 500 ml of a 5% glucose solution to give an oxaliplatin concentration between not less than 0.2 mg/ml and 0.7 mg/ml. The concentration range over which the physico-chemical stability of oxaliplatin has been demonstrated is 0.2 mg/ml to 1.3 mg/ml. Administer by intravenous infusion (see section 4.2).Inspect visually prior to use. Only clear solutions without particles should be used.The medicinal product is for single use only. Any unused infusion solution should be discarded.
DisposalRemnants of the medicinal product as well as all materials that have been used for reconstitution, for dilution and administration must be destroyed according to hospital standard procedures applicable to cytotoxic agents in accordance with local requirements related to the disposal of hazardous waste.
Hospira UK Ltd
Queensway, Royal Leamington Spa, Warwickshire, CV31 3RW
+44 (0) 1926 834446
+44 (0)1926 820 820
+44 (0) 1926 834400
+44 (0)1926 821 022