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Products » Items » Bortezomib SPC


Contraindicated

Contraindicated
Bortezomib SPC :
Type Medicine Authorised
Originator Velcade 3.5mg
Agent Advanced Health Care Services
Distributor Advanced Health Care Services
Laboratory Sudair
Manufacturer Pharmaline SAL*
Manufacturing Type Licensed by Sudair Pharma Company, KSA
Origin Lebanon
ATC L01XX32

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Bortezomib SPC :

Revision Date : 30/01/2015


Effect Frequency
Abdominal discomfort Uncommon
Abdominal distension Common
Abdominal pain Common
Abnormal ECG Rare
Abnormal faeces Rare
Acidosis Rare
Acne Uncommon
Acute febrile neutrophilic dermatosis (Sweet's syndrome) Uncommon
Acute kidney injury Uncommon
Acute pulmonary oedema Uncommon
Acute respiratory distress syndrome Rare
Adjustment disorder Rare
Alcohol intolerance Rare
Amnesia Uncommon
Amyloidosis Rare
Anaemia Very Common
Anal fissure Rare
Anal sphincter atony Rare
Anaphylactic reactions Uncommon
Anaphylactic shock Rare
Angina pectoris Uncommon
Angina unstable Rare
Angioedema (Angioneurotic oedema) (Quincke oedema) Uncommon
Anxiety disorder Common
Aplasia Rare
Apnoea (Apnea) Rare
Arrhythmia Uncommon
Arthritis Uncommon
Ascites Rare
Asthenia Very Common
Atelectasis Rare
Atrial fibrillation Uncommon
Atrial flutter Rare
Atrioventricular block (AVB) Rare
Autonomic nervous system imbalance (Autonomic instability) Rare
Autonomic neuropathy Rare
Azotaemia Uncommon
Bacteraemia Uncommon
Bacterial infection Uncommon
Benign neoplasm Rare
Bladder irritation Rare
Blindness Not known
Blister Uncommon
Blood disorder Rare
Blood gases abnormal Rare
Blood glucose abnormal Common
Blood test abnormal Uncommon
Blood uric acid abnormal Uncommon
Bone disorder Rare
Bradycardia Uncommon
Brain stem syndrome Rare
Breast disorder female Rare
Bronchial disorder Rare
Bronchospasm Uncommon
Budd-Chiari syndrome Rare
C-reactive protein increased Uncommon
Cardiac failure Uncommon
Cardiac fibrillation Uncommon
Cardiac tamponade Uncommon
Cardiac valve disorders Rare
Cardio-respiratory arrest Uncommon
Cardiogenic shock Rare
Cardiomyopathy Uncommon
Cardiovascular disorders Rare
Catheter site pain Rare
Cellulitis Uncommon
Cerebral haemorrhage Rare
Cerebral oedema (Brain oedema) Rare
Cerebrovascular accident Uncommon
Cerebrovascular disorders Rare
Change of bowel habit Rare
Cheilitis Rare
Chest discomfort Uncommon
Chest pain Uncommon
Chills Common
Cholelithiasis (Calculus biliary) (Gallstones) Rare
Cholestasis Uncommon
Chronic obstructive pulmonary disease Uncommon
Chronic renal insufficiency (Renal failure chronic) Uncommon
Circulatory collapse Uncommon
Clostridium difficile colitis Uncommon
Coagulopathy Uncommon
Cognitive disorder Rare
Cold sweat Rare
Colitis Uncommon
Colitis ischaemic Uncommon
Coma Rare
Complication associated with device Uncommon
Confusional state Uncommon
Conjunctivitis Common
Constipation Very Common
Contusion Uncommon
Corneal lesion Rare
Coronary artery insufficiency Rare
Cough Common
Cranial nerve paralysis Rare
Cushing's syndrome Uncommon
Cytomegalovirus hepatitis Rare
Dacryoadenitis acquired Rare
Deafness Not known
Death Rare
Decreased appetite Very Common
Decubitus ulcer Uncommon
Deep vein thrombosis Uncommon
Dehydration Common
Delirium Rare
Dermatitis Uncommon
Device related infection Uncommon
Diabetes mellitus Uncommon
Diarrhoea (Diarrhea) Very Common
Diplopia Uncommon
Discomfort Uncommon
Disseminated intravascular coagulation Rare
Disturbance in attention Uncommon
Dizziness Common
Drooling Rare
Dry eye Uncommon
Dry skin Common
Dry throat Rare
Dysacusis Uncommon
Dysaesthesia Very Common
Dysguesia (taste perversion) (Taste abnormality) (Taste disturbance) Common
Dyskinesia Uncommon
Dyspepsia Common
Dysphagia Uncommon
Dysphonia Uncommon
Dyspnoea (dyspnea) Common
Ear discomfort Uncommon
Ear disorder Rare
Ear haemorrhage Rare
Ear infection Uncommon
Ecchymosis Uncommon
ECG QT prolonged Rare
Encephalopathy Uncommon
Enteritis Uncommon
Enzyme abnormality Common
Epididymal tenderness Rare
Epididymitis Rare
Epistaxis (Nasal bleeding) Common
Epstein-Barr virus infection Rare
Erectile dysfunction Uncommon
Erythema Common
Erythema multiforme Uncommon
Erythromelalgia Rare
Erythrosis Rare
Exophthalmos (Bulging eyes) Rare
Extravasation Uncommon
Eye discharge Uncommon
Eye disorder Rare
Eye haemorrhage Uncommon
Eye inflammation (Ocular inflammation) Uncommon
Eye irritation Uncommon
Eye pain Uncommon
Eye swelling Common
Eyelid disorder Rare
Eyelid infection Uncommon
Face injury Rare
Face oedema Uncommon
Faecal incontinence Rare
Failure to thrive Uncommon
Fall Uncommon
Fatigue Very Common
Febrile neutropenia (Neutropenic fever) Uncommon
Fecaloma Rare
Feeling cold Uncommon
Feeling of body temperature change Uncommon
Fistula Rare
Flatulence Common
Fluid overload Rare
Fluid retention Uncommon
Flushing Uncommon
Fracture Rare
Fungal infection Common
Gait disturbance Uncommon
Gastric pH decreased Rare
Gastritis Uncommon
Gastroduodenal haemorrhage Common
Gastrointestinal disorders Uncommon
Gastrointestinal inflammation Uncommon
Gastrointestinal motility disorder Uncommon
Gastrointestinal obstruction Uncommon
Gastrointestinal pain Common
Gastrointestinal ulceration and perforation Rare
Gastrooesophageal reflux disease Uncommon
General physical health deterioration Uncommon
Genital herpes Rare
Genital pain Uncommon
Gingival bleeding (Gingival hemorrhage) Uncommon
Gingival hyperplasia Rare
Gout Rare
Haematemesis Uncommon
Haematoma Uncommon
Haematuria (Hematuria) Uncommon
Haemolytic anemia Uncommon
Haemoptysis Rare
Haemorrhage Uncommon
Haemorrhage intracranial Rare
Haemorrhage subcutaneous Rare
Haemorrhagic diathesis Rare
Hair disorder Uncommon
Hallucination Uncommon
Hand and foot syndrome (Palmar-plantar erythrodysaesthesia syndrome) Rare
Headache Very Common
Hepatic enzyme abnormal Common
Hepatic failure (Hepatic insufficiency) (Liver failure) Rare
Hepatic haemorrhage Rare
Hepatitis Uncommon
Hepatitis B Uncommon
Hepatomegaly Rare
Hepatotoxicity (liver toxicity) Uncommon
Hernia Rare
Herpes simplex Common
Herpes virus infection Uncommon
Herpes zoster Common
Herpes zoster disseminated Common
Hiatus hernia Rare
Hiccups Uncommon
Hordeolum Uncommon
Hyperaemia Uncommon
Hyperbilirubinaemia Uncommon
Hypercalcaemia Uncommon
Hyperchloraemia Rare
Hyperhidrosis Uncommon
Hyperkalaemia Uncommon
Hypermagnesaemia Rare
Hypernatraemia Uncommon
Hyperphosphataemia Rare
Hypersensitivity Uncommon
Hypertension Common
Hyperthyroidism Uncommon
Hyperventilation Rare
Hyperviscosity syndrome Rare
Hypoacusis Uncommon
Hypocalcaemia Common
Hypocapnia Rare
Hypochloraemia Rare
Hypokalaemia Common
Hypomagnesaemia Uncommon
Hyponatraemia (Hyponatremia) Common
Hypophosphataemia Uncommon
Hypotension Common
Hypothyroidism Rare
Hypotonia (Muscle tone decreased) Rare
Hypovolaemia (Volume depletion) (Hypovolemia) Rare
Hypovolaemic shock Uncommon
Hypoxia Uncommon
Ichthyosis Rare
Ileus Uncommon
Impaired healing Rare
Inappropriate antidiuretic hormone secretion (SIADH) Uncommon
Increased appetite Rare
Increased upper airway secretion Rare
Infection Uncommon
Influenza Uncommon
Injection site haemorrhage Rare
Injection site pain Uncommon
Injection site phlebitis Rare
Injection site reaction Uncommon
INR abnormal Rare
Interstitial pneumonitis Rare
Irritability Rare
Irritable bowel syndrome Uncommon
Jaw pain Rare
Jessner's lymphocytic infiltration Rare
Joint effusion Rare
Joint injury Rare
Joint stiffness Uncommon
Joint swelling Uncommon
Laceration Rare
Lacrimation increased (Epiphora) Uncommon
Left ventricular failure Uncommon
Lethargy Common
Leucopenia (Leukopenia) Common
Leukocytosis Uncommon
Libido decreased Rare
Lip pain Rare
Lip swelling Uncommon
Livedo reticularis Rare
Liver disorder Uncommon
Loss of consciousness Common
Lower respiratory tract infection Common
Lung infiltration (pulmonary infiltration) Rare
Lyell Syndrome (Toxic epidermal necrolysis) Uncommon
Lymphadenopathy Uncommon
Lymphocytic infiltration Rare
Lymphoedema Rare
Lymphopenia Common
Macrophage activation Rare
Malaise Common
Mass Rare
Mastoiditis Rare
Megacolon Rare
Meningitis Rare
Meningitis bacterial Rare
Meningoencephalitis herpetic Uncommon
Mental disorder Uncommon
Metabolic disorder Rare
Micturition disorder Uncommon
Migraine Uncommon
Mood disorders and disturbances Common
Motor dysfunction Rare
Mouth ulceration Uncommon
Mucous membrane disorder Uncommon
Multi-organ failure Rare
Muscle spasms Common
Muscle twitching (Muscle twitch) Uncommon
Muscle weakness Common
Musculoskeletal and connective tissue infections and inflammations Rare
Musculoskeletal pain Very Common
Myalgia Not known
Mycosis fungoides Rare
Myocardial infarction Rare
Myocardial ischaemia Common
Myopathy Uncommon
Nail disorders Rare
Nausea Very Common
Nausea and vomiting symptoms Very Common
Neoplasm malignant Rare
Nervous system disorder Rare
Neuralgia Very Common
Neuropathy peripheral Very Common
Neurotoxicity Uncommon
Neutropenia Very Common
Night sweats Uncommon
Non-cardiac chest pain Rare
Ocular hyperaemia Uncommon
Oedema Common
Oedema peripheral Common
Oesophagitis Rare
Oliguria Uncommon
Ophthalmic herpes zoster Common
Optic neuropathy Rare
Oral disorder Common
Oropharyngeal blistering Rare
Oropharyngeal pain Common
Orthopnoea Rare
Orthostatic hypotension Common
Pain Common
Pain in extremity (Pain in limb) Common
Pallor Rare
Palpitations Uncommon
Pancreatitis Uncommon
Pancreatitis acute Rare
Pancreatitis chronic Uncommon
Pancytopenia Uncommon
Papule Rare
Paraesthesia (paresthesia) Not known
Paralysis Rare
Paresis Rare
Parosmia Uncommon
Pelvic pain Rare
Pericardial effusion Uncommon
Pericarditis Uncommon
Periodontitis Rare
Peripheral embolism Rare
Peripheral motor neuropathy Common
Peripheral sensorimotor neuropathy Uncommon
Peripheral sensory neuropathy Very Common
Peripheral venous disease Rare
Perirenal haematoma Uncommon
Peritonitis Rare
Petechiae Uncommon
Phlebitis Uncommon
Photophobia Rare
Photopsia Rare
Photosensitivity reaction Rare
Pigmentation disorder Uncommon
Plasma cell leukaemia Rare
Platelet aggregation increased Rare
Platelet disorder Rare
Pleural effusion Uncommon
Pleurisy (Pleuritis ) Uncommon
Pneumonia Common
Pneumonitis Rare
Pneumothorax Rare
Pollakiuria (Urinary frequency) Uncommon
Polyneuropathy Not known
Poor peripheral circulation Uncommon
Post herpetic neuralgia Uncommon
Post viral fatigue syndrome Rare
Posterior reversible leukoencephalopathy syndrome (PRES) Uncommon
Presyncope Rare
Procedural pain Rare
Proctalgia Rare
Prostatitis Rare
Protein total abnormal Uncommon
Proteinuria Uncommon
Pruritus Common
Psoriasis Uncommon
Psychomotor hyperactivity (Psychomotor restlessness) Rare
Psychotic disorders Uncommon
Pulmonary alveolar haemorrhage Uncommon
Pulmonary embolism Uncommon
Pulmonary fibrosis Rare
Pulmonary hypertension Rare
Pulmonary oedema Uncommon
Purpura Uncommon
Pyrexia Very Common
Radiation injury Rare
Radiculopathy Rare
Rectal discharge Rare
Reflexes abnormal Uncommon
Renal cell carcinoma Rare
Renal impairment Common
Respiratory alkalosis Rare
Respiratory failure Rare
Respiratory tract congestion Uncommon
Restless legs syndrome Uncommon
Restlessness Uncommon
Retinitis Rare
Rhabdomyolysis Rare
Rhinorrhoea Uncommon
Right ventricular failure Uncommon
Salivary gland disorder Uncommon
Sciatica Uncommon
Seborrhoea Rare
Seizures Uncommon
Sensation of foreign body Rare
Sepsis (Systemic infection) (Sepsis state) Uncommon
Septic shock Uncommon
Sinus arrest (Sinus pause) Rare
Skin disorders Rare
Skin induration Rare
Skin infection Uncommon
Skin lesion Uncommon
Skin mass Uncommon
Skin rash Very Common
Skin reaction Rare
Skin ulcer Rare
Sleep disorders and disturbances Common
Speech disorder Uncommon
Spinal cord compression Rare
Staphylococcal bacteraemia Uncommon
Staphylococcal infection Uncommon
Stevens-Johnson syndrome Uncommon
Stomatitis Common
Subarachnoid haemorrhage Rare
Sudden death Uncommon
Suicidal ideation Rare
Syncope Common
Synovial cyst Rare
Tachycardia Uncommon
Tachypnoea Rare
Temporomandibular joint syndrome Rare
Tenderness Rare
Testicular disorder Rare
Thermal burn Rare
Thirst Uncommon
Throat irritation Rare
Throat tightness Rare
Thrombocytopenia (Thrombopenia) Very Common
Thrombocytopenic purpura Rare
Thrombocytosis Rare
Thrombophlebitis Uncommon
Thrombophlebitis superficial Uncommon
Tinnitus Uncommon
Tongue coated Uncommon
Tongue oedema Rare
Tonsillitis Rare
Tooth infection Uncommon
Torsade de pointes Rare
Toxic skin eruption Uncommon
Transfusion reaction Rare
Transient ischaemic attack Rare
Tremor Uncommon
Troponin I increased Rare
Tumour lysis syndrome Uncommon
Type III immune complex mediated reaction Rare
Ulcer Rare
Upper respiratory tract infection Common
Upper-airway cough syndrome Rare
Urinary retention Uncommon
Urinary tract infection Uncommon
Urinary tract signs and symptoms Uncommon
Urine analysis abnormal Rare
Urticaria Uncommon
Vaginal haemorrhage Uncommon
Vasculitis Uncommon
Vasodilation Rare
Vein discolouration Rare
Ventricular dysfunction Uncommon
Vertigo Common
Vestibular neuronitis Rare
Viral infection Uncommon
Virus identification and serology Rare
Visual disturbance Common
Visual field defect Rare
Vitamin B complex deficiency Rare
Vitamin B12 deficiency Rare
Vomiting Very Common
Vulval ulceration Rare
Weight decreased (Weight loss) Common
Weight increased (weight gain) Uncommon
Wheezing Uncommon

Different Units By MoH Code

Bortezomib SPC  MoH 11269 :
Form Powder for solution for injection
Packaging Bottle
Package Size Box of 1
Strength 3.5mg
Public Price 15743400,84 L.L.
Stratum D
NSSF ✔
Quarantine ✘
Reg. Number 177320/1
Submission date 12/11/2020
Registration Year 08/11/2022
Pending Year 20/05/2021
Pending Reason Incomplete study


Price Comparison

● Country: Lebanon
● Form: Powder for solution for injection
● Package Size: Box of 1
● Public Price: 15743400.84 LBP ( 15,743,400.84 LBP )
● Pack size unit used: 1
● Cost/Unit: 15743400,84 LBP ( 15,743,400.00 LBP )
● Pricing Date: 10/11/2025

● Country: KSA
● Package Size: 10x10ml
● Public Price: 3029.45 SAR ( 71,616,198.00 LBP )
● Pack size unit used: 10
● Cost/Unit: 302,945 SAR ( 7,139,280.00 LBP )
● Reference: sfda
● Pricing Date: 16/01/2021
● Type: Medicine Authorised

    ◼ Lebanon
    ◼ Country of Origin
    ◼ Reference Countries
    ◼ Other Countries
Prices are provided in Dollar ($)
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