Ziihera 300 mg Powder for concentrate for solution for infusion

Jazz Pharmaceuticals Research UK Limited🇬🇧 Electronic Medicines Compendium

Approval Date: N/A
Approval ID: c6381a82ccd4cb21
Company: Jazz Pharmaceuticals Research UK Limited
Type: Standard

Approval Details

Approval Id: c6381a82ccd4cb21
Drug Approval Emc Name: Ziihera 300 mg Powder for concentrate for solution for infusion
Drug Name: Ziihera 300 mg Powder for concentrate for solution for infusion
Company Name: Jazz Pharmaceuticals Research UK Limited
Company Address: Building 730, Kent Science Park, Sittingbourne, Kent, ME9 8AG, UK
Company Telephone: +44 (0)1865 405 000
Company Medical Info Direct Line: +44 (0) 8081 890 387
Company Medical Info Email: [email protected]
Company Customer Care Direct Line: +44 (0)1865 405 019
Atc Code: L01FD07
Legal Category: Prescription only medicine
Authorisation Holder: 7. Marketing authorisation holder Jazz Pharmaceuticals Research UK Limited Building 730, Kent Science Park, Sittingbourne, Kent ME9 8AG, United Kingdom Email: [email protected]
Authorisation Number: 8. Marketing authorisation number(s) PL 36772/0002
Authorisation Date: 9. Date of first authorisation/renewal of the authorisation 19/02/2026
Instruction Authorisation Holder: 7. Marketing authorisation holder Jazz Pharmaceuticals Research UK Limited Building 730, Kent Science Park, Sittingbourne, Kent ME9 8AG, United Kingdom Email: [email protected]
Instruction Authorisation Number: 8. Marketing authorisation number(s) PL 36772/0002
Instruction Authorisation Date: 9. Date of first authorisation/renewal of the authorisation 19/02/2026
Instruction Composition: 2. Qualitative and quantitative composition One vial of powder contains 300 mg of zanidatamab. After reconstitution, one vial contains 50 mg/mL of zanidatamab. Zanidatamab is a humanised (IgG1) bispecific antibody produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. For the full list of excipients, see section 6.1.
Instruction Dosage Form: 3. Pharmaceutical form Powder for concentrate for solution for infusion (powder for concentrate). White lyophilised cake.
Instruction Clinical Particulars: 4. Clinical particulars 4.1 Therapeutic indications Ziihera as monotherapy is indicated for the treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC3+) biliary tract cancer (BTC) previously treated with at least one prior line of systemic therapy (for biomarker-based patient selection, see section 4.2). 4.2 Posology and method of administration Ziihera must be initiated by a physician experienced in the diagnosis and treatment of patients with biliary tract cancer. It must be administered by a qualified healthcare professional, with appropriate resuscitation equipment available. Patient selection Patients treated with Ziihera for BTC should have documented HER2-positive tumour status, defined as a score of 3 + by immunohistochemistry (IHC) assessed by a CE-marked in vitro diagnostic (IVD) medical device with the corresponding intended purpose. If a CE-marked IVD is not available, an alternate validated test should be used. Posology The recommended dose of Ziihera is 20 mg/kg, administered as an intravenous infusion every 2 weeks (every 14 days) until disease progression or unacceptable toxicity. For duration of infusion, see Table 4. Premedications Premedication should be administered 30 to 60 minutes prior to each infusion to prevent potential infusion related reactions. Premedication is recommended to include a corticosteroid, antihistamine, and antipyretic (see section 4.4). Dose modifications for left ventricular dysfunction Left ventricular function must be assessed at baseline and at regular intervals during treatment. The recommendations on dose modifications in the event of left ventricular ejection fraction (LVEF) decrease are indicated in Table 1. Table 1. Dose modifications for left ventricular dysfunction Left ventricular dysfunction (see section 4.4) Severity Treatment modification Absolute decrease of ≥ 16% points in LVEF from pre-treatment baseline • Withhold treatment for at least 4 weeks. • Repeat LVEF assessment within 4 weeks. • Resume treatment within 4 to 8 weeks, if LVEF returns to normal limits and the absolute decrease is ≤ 15% points from baseline. • If LVEF has not recovered to within 15% points from baseline, permanently discontinue. LVEF value below 50% and absolute decrease of ≥ 10% points below pre-treatment baseline Dose modifications for infusion related reactions Management of infusion related reactions (IRRs) may require reduced infusion rate, dose interruption, or treatment discontinuation as described in Table 2. Table 2. Dose and infusion duration modifications for infusion-related reactions Infusion related reactions (see sections 4.4 and 4.8) Severity Treatment modification Mild (Grade 1) • Reduce infusion rate by 50%. • Subsequent infusions should start at this reduced rate. • Infusion rate for subsequent infusions may be increased gradually to the rate prior to symptoms, as tolerated. Moderate (Grade 2) • Hold infusion immediately. • Treat with appropriate therapy. • Resume infusion at 50% of previous infusion rate once symptoms resolve. • Infusion rate for subsequent infusions may be increased gradually to the rate prior to symptoms, as tolerated. Severe (Grade 3) • Hold infusion immediately. • Promptly treat with appropriate therapy. • Resume infusion at the next scheduled dose at 50% of previous infusion rate once symptoms resolve. • Permanently discontinue for recurrent Grade 3 symptoms. Life threatening (Grade 4) • Hold infusion immediately. • Promptly treat with appropriate therapy. • Permanently discontinue. Dose modifications for pneumonitis Management of pneumonitis may require treatment discontinuation as described in Table 3. Table 3. Dose modifications for pneumonitis Pneumonitis (see section 4.4) Severity Treatment modification Confirmed Grade ≥ 2 • Permanently discontinue. Missed dose If a patient misses a dose of Ziihera, the scheduled dose should be administered as soon as possible. The administration schedule should be adjusted to maintain a 2-week interval between doses. Special populations Renal impairment Dose adjustments are not required for patients with mild or moderate renal impairment (eGFR 30 to 89 mL/min estimated using the CKD-EPI). Zanidatamab has not been evaluated in patients with severe renal impairment and patients with end-stage renal disease with or without dialysis. However, due to minor involvement of renal processes in the clearance of zanidatamab, no dose adjustment is recommended for patients with renal impairment as no difference in exposure is expected (see section
Instruction Pharmacology: 5. Pharmacological properties 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Antineoplastic agents, HER2 (Human Epidermal Growth Factor Receptor 2) inhibitors, ATC code: L01FD07. Mechanism of action Zanidatamab is a dual HER2-targeted bispecific antibody that simultaneously binds extracellular domains 2 and 4 on separate HER2 monomers (binding in trans). Binding of zanidatamab with HER2 results in internalization leading to a reduction of the receptor on the cell surface. Zanidatamab induces complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). These mechanisms result in tumour growth inhibition and tumour cell death. Immunogenicity The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies (ADA) in the studies described below with incidence of ADA in other studies. ADA were rarely detected. Zanidatamab is categorised as a low-risk molecule to elicit an immune response on the basis of assessment of the immunogenicity risk factors and the low incidence of ADAs observed to date across the clinical studies (1.6% [3 of 183 evaluable participants] and 1.2% [1 of 85 evaluable participants] in Study 101 and Study 203, respectively). No evidence of ADA impact on pharmacokinetics, efficacy or safety was observed, however, data are still limited. Cardiac electrophysiology The relationship between time-matched zanidatamab serum concentrations and ΔQTcF measurements was evaluated based on data obtained during treatment with zanidatamab from participants in Study 101. The C-QT analysis dataset included measurements of QTcF from 179 out of the 192 participants enrolled in Study 101. Zanidatamab has no effect on QTc interval and there was no relationship between zanidatamab exposure and change in QTc interval. Clinical efficacy and safety The efficacy of Ziihera was evaluated in Cohort 1 (N=62) of ZWI-ZW25-203 (Study 203), a multicentre open-label single arm trial of patients with locally advanced unresectable or metastatic biliary tract cancer who received at least one prior gemcitabine-containing systemic chemotherapy regimen for advanced disease, and experienced disease progression after or developed intolerance to the most recent prior therapy, and whose tumour tested HER2-positive (IHC3+). Patients received Ziihera every 2 weeks at a dose of 20 mg/kg intravenously. It was administered until disease progression or unacceptable toxicity. The major efficacy outcome measures were confirmed objective response rate (cORR) and duration of response (DoR) as determined by an independent central review (ICR) according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1. The median age was 64 years (range: 38 to 79 years), 47% of patients were age 65 or older; 55% were female; 61% were Asian, 31% were White. All patients had a baseline Eastern Cooperative Oncology Group (ECOG) performance status of 0 (32%) or 1 (68%). Fifty-three percent of patients had gallbladder cancer, 27% had intrahepatic cholangiocarcinoma, and 19% had extrahepatic cholangiocarcinoma. Forty percent of patients had received more than one prior line of therapy for metastatic or locally advanced disease. The most commonly received prior treatments, other than gemcitabine, included: cisplatin (76%), oxaliplatin (16%), 5-fluoruracil (39%), and PD-1 or PD-L1 inhibitor (26%). The median overall survival (OS) in the IHC3+ population was 18.1 months (95% CI: 12.2, 22.9). The median duration of study follow-up in the IHC3+ population was 34.0 months. Efficacy results are summarised in Table
Instruction Pharmaceutical Particulars: 6. Pharmaceutical particulars 6.1 List of excipients Polysorbate 20 (E432) Disodium succinate Succinic acid (E363) Sucrose Water for injections 6.2 Incompatibilities This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. 6.3 Shelf life Unopened vial 2 years. Reconstituted solution Chemical and physical in-use stability of reconstituted solution has been demonstrated for up to 6 hours at room temperature (18 °C to 24 °C) and up to 24 hours at 2 °C to 8 °C. From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the reconstituted solution should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and should not exceed 4 hours at room temperature (18 ℃ to 24 ℃) or in the refrigerator (2 °C to 8 °C). Diluted solution Chemical and physical in-use stability of the diluted solution has been demonstrated for up to 24 hours at room temperature (18 °C to 24 °C) and at 2 °C to 8 °C. From a microbial point of view, the product should be used immediately. If not used immediately, in-use storage time and conditions are the responsibility of the user and should not exceed 12 hours at room temperature (18 °C to 24 °C) or 24 hours in the refrigerator at 2 °C to 8 °C. These storage times start from the time of reconstitution. 6.4 Special precautions for storage Store in a refrigerator (2 °C – 8 °C). Do not freeze. For storage conditions after reconstitution and dilution of the product, see section 6.3. 6.5 Nature and contents of container 20 mL Type I glass vial with a chlorobutyl stopper and flip-off cap. Each pack contains either 1 vial or 2 vials. Not all pack sizes may be marketed. 6.6 Special precautions for disposal and other handling Ziihera must be reconstituted with sterile water for injections and subsequently diluted with sodium chloride 9 mg/mL (0.9%) solution for injection or 5% glucose for infusion. Aseptic technique must be used for reconstitution and dilution of Ziihera. Reconstitution • Calculate the recommended dose of Ziihera based on the patient's weight to determine the number of vials needed. • Remove the vial(s) from the refrigerator and allow them to reach room temperature. • Reconstitute each vial with 5.7 mL of sterile water for injections to obtain a concentration of 50 mg/mL in an extractable volume of 6 mL. • Gently swirl the vial until complete dissolution. Do not shake. Reconstitution should take no more than 10 minutes. • Allow the reconstituted vial to settle to allow bubbles to dissipate. • Visually inspect the reconstituted solution for particulate matter and discoloration. The reconstituted product should be a colourless to light yellow, clear to slightly opalescent solution that is essentially free of particles. Discard the reconstituted vial if any discoloration or particulate matter is observed. Dilution • Withdraw the necessary volume for the calculated dose from each vial. • Slowly add the necessary dose volume to an appropriate size infusion bag containing sodium chloride 9 mg/mL (0.9%) solution for injection or 5% glucose for infusion. The final concentration of the diluted solution should be between 0.4 mg/mL and 6 mg/mL. • Mix the diluted solution by gentle inversion. Do not shake. • The solution for infusion must be a clear, colourless solution with no visible particles. If particulate matter or discoloration is identified, the solution must be discarded. • Compatibility with intravenous administration materials and the diluted Ziihera solution has been demonstrated in the following materials: o Intravenous bag: polyvinyl chloride (PVC), polyolefin (PO), ethyl vinyl acetate (EVA), polypropylene (PP) and ethylene-propylene copolymer. o Infusion sets: polyvinyl chloride/ bis (2-ethylhexyl) phthalate (PVC/DEHP), polyurethane (PUR), polyethylene-lined (PE-lined) acrylonitrile-butadiene-styrene (ABS). o Inline filters: polyethersulfone solution filter (PES), polyvinylidene fluoride air filter (PVDF). o Closed system transfer devices: acrylonitrile-butadiene-styrene (ABS), acrylic copolymer, polycarbonate (PC), polyisoprene (PI), polyester polypropylene (PP), polytetrafluoroethylene (PTFE), silicone and stainless steel (SS). Administration • Administer Ziihera as an intravenous infusion with a 0.2 or 0.22 micron filter. • Do not co-administer Ziihera and other intravenous medicinal products concurrently through the same intravenous line. Disposal Ziihera vials are for single dose use only. Discard any portion of the reconstituted solution that remains unused. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Instruction Content: ## Composition 2. Qualitative and quantitative composition One vial of powder contains 300 mg of zanidatamab. After reconstitution, one vial contains 50 mg/mL of zanidatamab. Zanidatamab is a humanised (IgG1) bispecific antibody produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. For the full list of excipients, see section 6.1. ## Pharmaceutical Form 3. Pharmaceutical form Powder for concentrate for solution for infusion (powder for concentrate). White lyophilised cake. ## Clinical Particulars 4. Clinical particulars 4.1 Therapeutic indications Ziihera as monotherapy is indicated for the treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC3+) biliary tract cancer (BTC) previously treated with at least one prior line of systemic therapy (for biomarker-based patient selection, see section 4.2). 4.2 Posology and method of administration Ziihera must be initiated by a physician experienced in the diagnosis and treatment of patients with biliary tract cancer. It must be administered by a qualified healthcare professional, with appropriate resuscitation equipment available. Patient selection Patients treated with Ziihera for BTC should have documented HER2-positive tumour status, defined as a score of 3 + by immunohistochemistry (IHC) assessed by a CE-marked in vitro diagnostic (IVD) medical device with the corresponding intended purpose. If a CE-marked IVD is not available, an alternate validated test should be used. Posology The recommended dose of Ziihera is 20 mg/kg, administered as an intravenous infusion every 2 weeks (every 14 days) until disease progression or unacceptable toxicity. For duration of infusion, see Table 4. Premedications Premedication should be administered 30 to 60 minutes prior to each infusion to prevent potential infusion related reactions. Premedication is recommended to include a corticosteroid, antihistamine, and antipyretic (see section 4.4). Dose modifications for left ventricular dysfunction Left ventricular function must be assessed at baseline and at regular intervals during treatment. The recommendations on dose modifications in the event of left ventricular ejection fraction (LVEF) decrease are indicated in Table 1. Table 1. Dose modifications for left ventricular dysfunction Left ventricular dysfunction (see section 4.4) Severity Treatment modification Absolute decrease of ≥ 16% points in LVEF from pre-treatment baseline • Withhold treatment for at least 4 weeks. • Repeat LVEF assessment within 4 weeks. • Resume treatment within 4 to 8 weeks, if LVEF returns to normal limits and the absolute decrease is ≤ 15% points from baseline. • If LVEF has not recovered to within 15% points from baseline, permanently discontinue. LVEF value below 50% and absolute decrease of ≥ 10% points below pre-treatment baseline Dose modifications for infusion related reactions Management of infusion related reactions (IRRs) may require reduced infusion rate, dose interruption, or treatment discontinuation as described in Table 2. Table 2. Dose and infusion duration modifications for infusion-related reactions Infusion related reactions (see sections 4.4 and 4.8) Severity Treatment modification Mild (Grade 1) • Reduce infusion rate by 50%. • Subsequent infusions should start at this reduced rate. • Infusion rate for subsequent infusions may be increased gradually to the rate prior to symptoms, as tolerated. Moderate (Grade 2) • Hold infusion immediately. • Treat with appropriate therapy. • Resume infusion at 50% of previous infusion rate once symptoms resolve. • Infusion rate for subsequent infusions may be increased gradually to the rate prior to symptoms, as tolerated. Severe (Grade 3) • Hold infusion immediately. • Promptly treat with appropriate therapy. • Resume infusion at the next scheduled dose at 50% of previous infusion rate once symptoms resolve. • Permanently discontinue for recurrent Grade 3 symptoms. Life threatening (Grade 4) • Hold infusion immediately. • Promptly treat with appropriate therapy. • Permanently discontinue. Dose modifications for pneumonitis Management of pneumonitis may require treatment discontinuation as described in Table 3. Table 3. Dose modifications for pneumonitis Pneumonitis (see section 4.4) Severity Treatment modification Confirmed Grade ≥ 2 • Permanently discontinue. Missed dose If a patient misses a dose of Ziihera, the scheduled dose should be administered as soon as possible. The administration schedule should be adjusted to maintain a 2-week interval between doses. Special populations Renal impairment Dose adjustments are not required for patients with mild or moderate renal impairment (eGFR 30 to 89 mL/min estimated using the CKD-EPI). Zanidatamab has not been evaluated in patients with severe renal impairment and patients with end-stage renal disease with or without dialysis. However, due to minor involvement of renal processes in the clearance of zanidatamab, no dose adjustment is recommended for patients with renal impairment as no difference in exposure is expected (see section ## Pharmacological Properties 5. Pharmacological properties 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Antineoplastic agents, HER2 (Human Epidermal Growth Factor Receptor 2) inhibitors, ATC code: L01FD07. Mechanism of action Zanidatamab is a dual HER2-targeted bispecific antibody that simultaneously binds extracellular domains 2 and 4 on separate HER2 monomers (binding in trans). Binding of zanidatamab with HER2 results in internalization leading to a reduction of the receptor on the cell surface. Zanidatamab induces complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). These mechanisms result in tumour growth inhibition and tumour cell death. Immunogenicity The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies (ADA) in the studies described below with incidence of ADA in other studies. ADA were rarely detected. Zanidatamab is categorised as a low-risk molecule to elicit an immune response on the basis of assessment of the immunogenicity risk factors and the low incidence of ADAs observed to date across the clinical studies (1.6% [3 of 183 evaluable participants] and 1.2% [1 of 85 evaluable participants] in Study 101 and Study 203, respectively). No evidence of ADA impact on pharmacokinetics, efficacy or safety was observed, however, data are still limited. Cardiac electrophysiology The relationship between time-matched zanidatamab serum concentrations and ΔQTcF measurements was evaluated based on data obtained during treatment with zanidatamab from participants in Study 101. The C-QT analysis dataset included measurements of QTcF from 179 out of the 192 participants enrolled in Study 101. Zanidatamab has no effect on QTc interval and there was no relationship between zanidatamab exposure and change in QTc interval. Clinical efficacy and safety The efficacy of Ziihera was evaluated in Cohort 1 (N=62) of ZWI-ZW25-203 (Study 203), a multicentre open-label single arm trial of patients with locally advanced unresectable or metastatic biliary tract cancer who received at least one prior gemcitabine-containing systemic chemotherapy regimen for advanced disease, and experienced disease progression after or developed intolerance to the most recent prior therapy, and whose tumour tested HER2-positive (IHC3+). Patients received Ziihera every 2 weeks at a dose of 20 mg/kg intravenously. It was administered until disease progression or unacceptable toxicity. The major efficacy outcome measures were confirmed objective response rate (cORR) and duration of response (DoR) as determined by an independent central review (ICR) according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1. The median age was 64 years (range: 38 to 79 years), 47% of patients were age 65 or older; 55% were female; 61% were Asian, 31% were White. All patients had a baseline Eastern Cooperative Oncology Group (ECOG) performance status of 0 (32%) or 1 (68%). Fifty-three percent of patients had gallbladder cancer, 27% had intrahepatic cholangiocarcinoma, and 19% had extrahepatic cholangiocarcinoma. Forty percent of patients had received more than one prior line of therapy for metastatic or locally advanced disease. The most commonly received prior treatments, other than gemcitabine, included: cisplatin (76%), oxaliplatin (16%), 5-fluoruracil (39%), and PD-1 or PD-L1 inhibitor (26%). The median overall survival (OS) in the IHC3+ population was 18.1 months (95% CI: 12.2, 22.9). The median duration of study follow-up in the IHC3+ population was 34.0 months. Efficacy results are summarised in Table ## Pharmaceutical Particulars 6. Pharmaceutical particulars 6.1 List of excipients Polysorbate 20 (E432) Disodium succinate Succinic acid (E363) Sucrose Water for injections 6.2 Incompatibilities This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. 6.3 Shelf life Unopened vial 2 years. Reconstituted solution Chemical and physical in-use stability of reconstituted solution has been demonstrated for up to 6 hours at room temperature (18 °C to 24 °C) and up to 24 hours at 2 °C to 8 °C. From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the reconstituted solution should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and should not exceed 4 hours at room temperature (18 ℃ to 24 ℃) or in the refrigerator (2 °C to 8 °C). Diluted solution Chemical and physical in-use stability of the diluted solution has been demonstrated for up to 24 hours at room temperature (18 °C to 24 °C) and at 2 °C to 8 °C. From a microbial point of view, the product should be used immediately. If not used immediately, in-use storage time and conditions are the responsibility of the user and should not exceed 12 hours at room temperature (18 °C to 24 °C) or 24 hours in the refrigerator at 2 °C to 8 °C. These storage times start from the time of reconstitution. 6.4 Special precautions for storage Store in a refrigerator (2 °C – 8 °C). Do not freeze. For storage conditions after reconstitution and dilution of the product, see section 6.3. 6.5 Nature and contents of container 20 mL Type I glass vial with a chlorobutyl stopper and flip-off cap. Each pack contains either 1 vial or 2 vials. Not all pack sizes may be marketed. 6.6 Special precautions for disposal and other handling Ziihera must be reconstituted with sterile water for injections and subsequently diluted with sodium chloride 9 mg/mL (0.9%) solution for injection or 5% glucose for infusion. Aseptic technique must be used for reconstitution and dilution of Ziihera. Reconstitution • Calculate the recommended dose of Ziihera based on the patient's weight to determine the number of vials needed. • Remove the vial(s) from the refrigerator and allow them to reach room temperature. • Reconstitute each vial with 5.7 mL of sterile water for injections to obtain a concentration of 50 mg/mL in an extractable volume of 6 mL. • Gently swirl the vial until complete dissolution. Do not shake. Reconstitution should take no more than 10 minutes. • Allow the reconstituted vial to settle to allow bubbles to dissipate. • Visually inspect the reconstituted solution for particulate matter and discoloration. The reconstituted product should be a colourless to light yellow, clear to slightly opalescent solution that is essentially free of particles. Discard the reconstituted vial if any discoloration or particulate matter is observed. Dilution • Withdraw the necessary volume for the calculated dose from each vial. • Slowly add the necessary dose volume to an appropriate size infusion bag containing sodium chloride 9 mg/mL (0.9%) solution for injection or 5% glucose for infusion. The final concentration of the diluted solution should be between 0.4 mg/mL and 6 mg/mL. • Mix the diluted solution by gentle inversion. Do not shake. • The solution for infusion must be a clear, colourless solution with no visible particles. If particulate matter or discoloration is identified, the solution must be discarded. • Compatibility with intravenous administration materials and the diluted Ziihera solution has been demonstrated in the following materials: o Intravenous bag: polyvinyl chloride (PVC), polyolefin (PO), ethyl vinyl acetate (EVA), polypropylene (PP) and ethylene-propylene copolymer. o Infusion sets: polyvinyl chloride/ bis (2-ethylhexyl) phthalate (PVC/DEHP), polyurethane (PUR), polyethylene-lined (PE-lined) acrylonitrile-butadiene-styrene (ABS). o Inline filters: polyethersulfone solution filter (PES), polyvinylidene fluoride air filter (PVDF). o Closed system transfer devices: acrylonitrile-butadiene-styrene (ABS), acrylic copolymer, polycarbonate (PC), polyisoprene (PI), polyester polypropylene (PP), polytetrafluoroethylene (PTFE), silicone and stainless steel (SS). Administration • Administer Ziihera as an intravenous infusion with a 0.2 or 0.22 micron filter. • Do not co-administer Ziihera and other intravenous medicinal products concurrently through the same intravenous line. Disposal Ziihera vials are for single dose use only. Discard any portion of the reconstituted solution that remains unused. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Company Detail Path: /organization/jazz-pharmaceuticals-research-uk-limited

Active Ingredients

Approved

Quick Info

Agency

UK EMC

Country

🇬🇧

Approval ID

c6381a82ccd4cb21

Type

Standard

Back to UK EMC Approvals