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Zemaira (Alpha 1-Antitrypsin) - Infusion Related Reaction - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Infusion Related Reaction (12)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Zemaira (Alpha 1-Antitrypsin) where reactions include infusion related reaction. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Zemaira side effects in 40 year old female

Reported by a pharmacist from United States on 2012-07-06

Patient: 40 year old female, weighing 59.0 kg (129.7 pounds)

Reactions: Product Colour Issue, Discomfort, Infusion Related Reaction

Drug(s) suspected as cause:
Zemaira



Possible Zemaira side effects in male

Reported by a physician from United States on 2012-04-23

Patient: male, weighing 97.5 kg (214.6 pounds)

Reactions: Vomiting, Nausea, Peritoneal Dialysis, Headache, Infusion Related Reaction

Drug(s) suspected as cause:
Zemaira
    Indication: Alpha-1 Anti-Trypsin Deficiency

Zemaira
    Dosage: 80 mg/kg 1x/week, 990 mg vial intravenous (not otherwise specified)
    Indication: Alpha-1 Anti-Trypsin Deficiency

Zemaira
    Indication: Alpha-1 Anti-Trypsin Deficiency

Zemaira
    Dosage: 80 mg/kg 1x/week, 80 mg/kg weekly 15 minute total infusion time intravenous (not otherwise specifie
    Indication: Alpha-1 Anti-Trypsin Deficiency
    Start date: 2009-05-20

Other drugs received by patient: Cellcept; Folic Acid; Protonix; Amitriptyline HCL (Amitriptyline); Oxycodone HCL and Acetaminophen; Lantis (Insulin Glargine); BL Ferrous SU (Ferrous Sulfate); Prograff (Tacrolimus); Prochlorperazine; Prednisone; Calcium 600 D (Calcium with Vitamin D); Actos; Humalog; Lisinopril; Sodium Bicarbonate; Glipizide; Simvastatin



Possible Zemaira side effects in 61 year old female

Reported by a physician from United States on 2012-01-23

Patient: 61 year old female, weighing 91.2 kg (200.6 pounds)

Reactions: Contusion, Angioedema, Pain in Extremity, Condition Aggravated, Nasal Congestion, Musculoskeletal Chest Pain, Headache, Oral Pruritus, Fall, Oral Discomfort, Pruritus Generalised, Fatigue, Limb Injury, Dizziness, Infusion Related Reaction

Drug(s) suspected as cause:
Zemaira

Zemaira

Zemaira
    Dosage: (60 mg/kg 1x/week, 1012 mg vials; 60 mg/kg infused over 30 minutes intravenous (not otherwise specif
    Indication: Alpha-1 Anti-Trypsin Deficiency
    Start date: 2011-01-26

Zemaira
    Dosage: (60 mg/kg 1x/week, 1012 mg vials; 60 mg/kg infused over 30 minutes intravenous (not otherwise specif
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2011-01-26

Zemaira
    Dosage: (60 mg/kg 1x/week, 1012 mg vials; 60 mg/kg infused over 30 minutes intravenous (not otherwise specif
    Indication: Alpha-1 Anti-Trypsin Deficiency
    Start date: 2011-03-31

Zemaira
    Dosage: (60 mg/kg 1x/week, 1012 mg vials; 60 mg/kg infused over 30 minutes intravenous (not otherwise specif
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2011-03-31

Zemaira
    Dosage: (60 mg/kg 1x/week, 1012 mg vials; 60 mg/kg infused over 30 minutes intravenous (not otherwise specif
    Indication: Alpha-1 Anti-Trypsin Deficiency
    Start date: 2011-02-20

Zemaira
    Dosage: (60 mg/kg 1x/week, 1012 mg vials; 60 mg/kg infused over 30 minutes intravenous (not otherwise specif
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2011-02-20

Zemaira
    Dosage: (60 mg/kg 1x/week, 1012 mg vials; 60 mg/kg infused over 30 minutes intravenous (not otherwise specif
    Indication: Alpha-1 Anti-Trypsin Deficiency
    Start date: 2011-05-05

Zemaira
    Dosage: (60 mg/kg 1x/week, 1012 mg vials; 60 mg/kg infused over 30 minutes intravenous (not otherwise specif
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2011-05-05

Zemaira
    Dosage: (60 mg/kg 1x/week, 1012 mg vials; 60 mg/kg infused over 30 minutes intravenous (not otherwise specif
    Indication: Alpha-1 Anti-Trypsin Deficiency
    Start date: 2011-01-28

Zemaira
    Dosage: (60 mg/kg 1x/week, 1012 mg vials; 60 mg/kg infused over 30 minutes intravenous (not otherwise specif
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2011-01-28

Zemaira
    Dosage: (60 mg/kg 1x/week, 1012 mg vials; 60 mg/kg infused over 30 minutes intravenous (not otherwise specif
    Indication: Alpha-1 Anti-Trypsin Deficiency
    Start date: 2011-01-26

Zemaira
    Dosage: (60 mg/kg 1x/week, 1012 mg vials; 60 mg/kg infused over 30 minutes intravenous (not otherwise specif
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2011-01-26

Zemaira
    Dosage: (60 mg/kg 1x/week, 1012 mg vials; 60 mg/kg infused over 30 minutes intravenous (not otherwise specif
    Indication: Alpha-1 Anti-Trypsin Deficiency
    Start date: 2010-11-01

Zemaira
    Dosage: (60 mg/kg 1x/week, 1012 mg vials; 60 mg/kg infused over 30 minutes intravenous (not otherwise specif
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2010-11-01

Zemaira

Zemaira

Zemaira

Other drugs received by patient: Novolog; Protonix; Sodium Chloride 0.9%; Ibuprofen; Xanax; Levothyroxine Sodium; Vitamin B12; Novolog; Celexa; Lantus; Atenolol; Albuterol; Multivitamin (Accomin Multivitamin); Vitamin D; Gabapentin; Cardizem



Possible Zemaira side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-20

Patient: male, weighing 110.0 kg (242.0 pounds)

Reactions: Chest Discomfort, Pharyngeal Disorder, Dizziness, Headache, Infusion Related Reaction

Drug(s) suspected as cause:
Zemaira

Other drugs received by patient: Ascorbic Acid; Losartan Potassium; Symbicort; Combivent; PRE MED Benadril; Amlodipine



Possible Zemaira side effects in 68 year old female

Reported by a pharmacist from United States on 2012-01-18

Patient: 68 year old female, weighing 66.2 kg (145.7 pounds)

Reactions: Vomiting, Nausea, Lower Respiratory Tract Infection, Infusion Related Reaction

Drug(s) suspected as cause:
Zemaira
    Dosage: see image
    Indication: Alpha-1 Anti-Trypsin Deficiency
    Start date: 2010-11-22

Zemaira
    Dosage: see image
    Indication: Emphysema
    Start date: 2010-11-22

Zemaira
    Start date: 2010-11-22

Zemaira
    Start date: 2010-11-22

Other drugs received by patient: Calan; Benzonatate; Xanax; Advair HFA; Orphenadrine Citrate; Zyrtec; Pravastatin; Lyrica; Avapro; Maxzide; Oxygen; Multivitamin Accomin Multivitamin); Sodium Chloride; Albuterol



Possible Zemaira side effects in 56 year old male

Reported by a physician from United States on 2012-01-06

Patient: 56 year old male, weighing 70.3 kg (154.7 pounds)

Reactions: Myalgia, Syncope, Bone Pain, Dizziness, Feeling Abnormal, Chest X-RAY Abnormal, Loss of Consciousness, Infusion Related Reaction

Drug(s) suspected as cause:
Zemaira

Zemaira
    Dosage: (intravenous (not otherwise specified)), (60 mg/kg 1x/week, approx. 30-60 minutes; 0.08 ml/kg/min (5
    Indication: Obstructive Airways Disorder
    Start date: 2011-03-25

Zemaira
    Dosage: (intravenous (not otherwise specified)), (60 mg/kg 1x/week, approx. 30-60 minutes; 0.08 ml/kg/min (5
    Indication: Obstructive Airways Disorder
    Start date: 2011-11-04
    End date: 2011-11-04

Zemaira
    Dosage: (intravenous (not otherwise specified)), (60 mg/kg 1x/week, approx. 30-60 minutes; 0.08 ml/kg/min (5
    Indication: Obstructive Airways Disorder
    Start date: 2011-01-01

Zemaira

Other drugs received by patient: Symbicort; Daliresp; Spiriva; Proventil; Mucinex



Possible Zemaira side effects in 56 year old female

Reported by a pharmacist from United States on 2011-11-29

Patient: 56 year old female, weighing 83.5 kg (183.6 pounds)

Reactions: LIP Swelling, Hypoaesthesia, Paraesthesia, Infusion Related Reaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zemaira

Zemaira
    Dosage: see image
    Indication: Alpha-1 Anti-Trypsin Deficiency
    Start date: 2011-01-05

Zemaira
    Dosage: see image
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2011-01-05

Zemaira
    Dosage: see image
    Indication: Alpha-1 Anti-Trypsin Deficiency
    Start date: 2010-11-17

Zemaira
    Dosage: see image
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2010-11-17

Zemaira
    Dosage: see image
    Indication: Alpha-1 Anti-Trypsin Deficiency
    Start date: 2010-11-01

Zemaira
    Dosage: see image
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2010-11-01

Other drugs received by patient: Sodium Chloride 0.9%; Singulair; Pravastatin; Lorazepam; Metformin HCL; Ibuprofen; Advair Diskus 100 / 50; Spiriva; Carvedilol; Effexor; Folic Acid; Klor-CON; Benzonatate; Furosemide; Zyrtec; Albuterol



Possible Zemaira side effects in 56 year old male

Reported by a physician from United States on 2011-11-25

Patient: 56 year old male, weighing 155.0 kg (341.0 pounds)

Reactions: Myalgia, Bone Pain, Dizziness, Chest X-RAY Abnormal, Loss of Consciousness, Infusion Related Reaction

Drug(s) suspected as cause:
Zemaira
    Dosage: see image
    Indication: Obstructive Airways Disorder
    Start date: 2011-11-04
    End date: 2011-11-04

Zemaira
    Dosage: see image
    Indication: Obstructive Airways Disorder
    Start date: 2011-03-25

Other drugs received by patient: Proventil; Mucinex; Daliresp; Spiriva; Symbicort



Possible Zemaira side effects in 52 year old female

Reported by a physician from United States on 2011-10-27

Patient: 52 year old female, weighing 84.4 kg (185.6 pounds)

Reactions: Malaise, Fatigue, Upper Respiratory Tract Infection, Infusion Related Reaction

Drug(s) suspected as cause:
Zemaira
    Dosage: see image
    Indication: Alpha-1 Anti-Trypsin Deficiency
    Start date: 2007-02-01

Zemaira

Zemaira

Zemaira

Other drugs received by patient: Proair HFA (Procaterol Hydrochloride); Diphenhydramine HCL; Heparin (Heparin); Lorcet-HD; Guaifenesin; Advair (Seretide / 01420901 / ); Valium; EPI-PEN (Epinephrine); Spiriva (Tiotropium Bromide); Multivitamin (Accomin Multivitamin); Acetaminophen



Possible Zemaira side effects in 69 year old female

Reported by a pharmacist from United States on 2011-10-21

Patient: 69 year old female, weighing 69.4 kg (152.7 pounds)

Reactions: Dyspnoea, Gastrointestinal Haemorrhage, Bacteraemia, Device Related Infection, Infusion Related Reaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zemaira

Other drugs received by patient: Levothyroxine Sodium; Advair Diskus 100 / 50; Spiriva; Heparin; Fosamax; Crestor; Albuterol



Possible Zemaira side effects in 52 year old female

Reported by a pharmacist from United States on 2011-10-20

Patient: 52 year old female, weighing 84.4 kg (185.6 pounds)

Reactions: Fatigue, Malaise, Staphylococcal Infection, Upper Respiratory Tract Infection, Infusion Related Reaction

Drug(s) suspected as cause:
Zemaira
    Dosage: see image
    Indication: Alpha-1 Anti-Trypsin Deficiency
    Start date: 2007-02-01

Zemaira

Zemaira

Other drugs received by patient: Diphenhydramine HCL; Proair HFA (Procaterol Hydrochloride); Valium; Multivitamin (Accomin Multivitamin); Epipen; Heparin; Lorcet-HD; Guaifenesin; Acetaminophen; Advair Diskus 100 / 50; Spiriva



Possible Zemaira side effects in male

Reported by a physician from United States on 2011-10-20

Patient: male, weighing 104.3 kg (229.5 pounds)

Reactions: Dyspnoea, Rash, Nasal Congestion, Feeling Abnormal, Infusion Related Reaction

Drug(s) suspected as cause:
Zemaira
    Dosage: 60 mg/kg 1x/week, at max rate of 8.3 ml per min intravenous (not otherwise specified)
    Indication: Emphysema
    Start date: 2011-09-12

Zemaira
    Dosage: 60 mg/kg 1x/week, at max rate of 8.3 ml per min intravenous (not otherwise specified)
    Indication: Alpha-1 Anti-Trypsin Deficiency
    Start date: 2011-09-12

Other drugs received by patient: Multivitamin (Daily Multivitamin); Proventil HFA (Salbutamol); Combivent; Losartan Potassium; Metoprolol Succinate

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