Medica RCP |Iclusig 45mg | Indications | Side Effects | Composition | Route | all.price

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Products » Items » Iclusig 45mg

Contraindicated
Reproductive toxicity in animals

Contraindicated

Iclusig 45mg :
Type	Medicine Authorised
Originator	B
Agent	Droguerie de l'Union
Distributor	Droguerie de l'Union
Laboratory	Ariad Pharmaceuticals
Responsible Party	Ariad Pharmaceutical, Inc.
Origin	U.S.A.
Manufacturer	Patheon Inc
Origin	Canada
ATC	L01XE24

Iclusig 45mg :

Oral

Iclusig 45mg :

L Antineoplastic and immunomodulating agents

L01 Antineoplastic agents

L01X Other antineoplastic agents

L01XE Protein kinase inhibitors

L01XE24 Ponatinib

Iclusig 45mg :

Ponatinib : 45mg

Iclusig 45mg :

Adults : Chronic myeloid leukaemia 45mg/day

Adults : Philadelphia chromosome positive acute lymphoblastic leukaemia((Ph+ALL)) 45mg/day

Iclusig 45mg :

Colloidal silica anhydrous (colloidal silicon dioxide) (Aerosil 200) (E551) Anti-caking

◼

Lactose *

Magnesium stearate (E470b)

Microcrystalline cellulose (E460(i)) (Avicel PH-102)

Sodium carboxymethyl starch

* Excipient with known effect

Hazard Level
◼ Major
◼ Moderate
◼ Minor
◼ Safe

Iclusig 45mg :

PEG-4000 (Polyethylene glycol 4000)

Polyvinyl alcohol (E1203)

Talc (E553b)

Titanium dioxide (E171) (CI 77891)

Iclusig 45mg :

Revision Date : 03/08/2018

Frequency	Percentage
Very Common	≥ 1/10
Common	≥ 1/100 - < 1/10
Uncommon	≥ 1/1,000 - < 1/100
Rare	≥ 1/10,000 - < 1/1,000
Very Rare	< 1/10,000
Unknown	Cannot be Estimated

Effect	Frequency
5'nucleotidase increased	Uncommon
Abdominal bloating (Meteorism)	Common
Abdominal discomfort	Common
Abdominal pain	Very Common
Acute coronary syndrome	Common
Alopecia	Common
ALT increased	Very Common
Amylase increased	Common
Anaemia	Very Common
Angina pectoris	Common
Arteriospasm coronary	Uncommon
Artery dissection	Common
Arthralgia (Pain joint) (Joint ache)	Very Common
AST increased	Very Common
Asthenia	Very Common
Atrial fibrillation	Common
Atrial flutter	Common
Back pain	Very Common
Blood bilirubin increased	Common
Bone pain	Very Common
Cardiac discomfort	Uncommon
Cardiac failure	Common
Cellulitis	Common
Cephalea	Very Common
Cerebral artery stenosis	Uncommon
Cerebral haemorrhage	Uncommon
Cerebral infarction	Common
Cerebrovascular accident	Common
Chills	Common
Congestive heart failure	Common
Conjunctivitis	Common
Constipation	Very Common
Coronary artery disorder	Common
Cough	Very Common
Decreased appetite	Very Common
Deep vein thrombosis	Common
Dehydration	Common
Dermatitis exfoliative	Common
Diarrhoea (Diarrhea)	Very Common
Dry eye	Common
Dry mouth (Xerostomia)	Common
Dry skin	Very Common
Dyspepsia	Common
Dysphonia	Common
Dyspnoea (dyspnea)	Very Common
Ecchymosis	Common
Ejection fraction decreased	Common
Embolism venous	Uncommon
Epistaxis (Nasal bleeding)	Common
Erectile dysfunction	Common
Erythema	Common
Exfoliative rash	Common
Eyelid oedema	Common
Face oedema	Common
Fatigue	Very Common
Febrile neutropenia (Neutropenic fever)	Common
Flu-like syndrome	Common
Fluid retention	Common
Flushing	Common
Folliculitis	Common
Gamma-GT increased	Common
Gastric haemorrhage	Common
Gastrooesophageal reflux disease	Common
Haemorrhage intracranial	Uncommon
Hepatic failure (Hepatic insufficiency) (Liver failure)	Uncommon
Hepatotoxicity (liver toxicity)	Uncommon
Hot flush	Common
Hyperaesthesia	Common
Hyperglycaemia	Common
Hyperhidrosis	Common
Hyperkeratosis	Common
Hypertension	Very Common
Hypertensive crisis	Uncommon
Hypertriglyceridaemia	Common
Hyperuricaemia	Common
Hypocalcaemia	Common
Hypoesthesia	Common
Hypokalaemia	Common
Hyponatraemia (Hyponatremia)	Common
Hypophosphataemia	Common
Hypothyroidism	Very Common
Insomnia	Very Common
Intermittent claudication	Common
Ischaemic cardiomyopathy	Uncommon
Jaundice	Uncommon
Left ventricular dysfunction	Uncommon
Lethargy	Common
Leucopenia (Leukopenia)	Common
Lightheadedness	Very Common
Lipase increased	Very Common
Lymphocyte count decreased	Common
Mass	Common
Migraine	Common
Muscle spasms	Very Common
Musculoskeletal chest pain	Common
Musculoskeletal pain	Common
Myalgia	Very Common
Myocardial infarction	Common
Myocardial ischaemia	Uncommon
Nausea	Very Common
Neck pain	Common
Neuropathy peripheral	Common
Neutropenia	Very Common
Night sweats	Common
Non-cardiac chest pain	Common
Oedema peripheral	Very Common
Pain	Very Common
Pain in extremity (Pain in limb)	Very Common
Pain of skin	Common
Pancreatitis	Common
Pancytopenia	Common
Paraesthesia (paresthesia)	Common
Pericardial effusion	Common
Periorbital oedema	Common
Peripheral arterial occlusive disease	Common
Peripheral artery stenosis	Common
Peripheral ischaemia	Common
Petechiae	Common
Phosphatase alkaline increased	Common
Pleural effusion	Common
Pneumonia	Common
Poor peripheral circulation	Uncommon
Pruritus	Common
Pulmonary embolism	Common
Pulmonary hypertension	Common
Pyrexia	Very Common
Rash pruritic	Common
Renal artery stenosis	Uncommon
Retinal artery occlusion	Uncommon
Retinal vein occlusion	Uncommon
Retinal vein thrombosis	Uncommon
Right ventricular dysfunction	Uncommon
Septicemia	Common
Skin exfoliation (Flaking skin)	Common
Skin hyperpigmentation	Common
Skin rash	Very Common
Splenic infarction	Uncommon
Stomatitis	Common
Thrombocytopenia (Thrombopenia)	Very Common
Transient ischaemic attack	Common
Tumour lysis syndrome	Uncommon
Upper respiratory tract infection	Very Common
Venous thrombosis	Uncommon
Vision blurred	Common
Visual impairment	Uncommon
Vomiting	Very Common
Weight decreased (Weight loss)	Common

Iclusig 45mg :

Abu Dhabi

Bahrain

Belgium

Cyprus

Denmark

Finland

France

Greece

Ireland

Italy

Lebanon

Norway

Oman

Spain

Sweden

The Netherlands

Form	Tablet, Film-Coated
Packaging	Plastic Bottle
Package Size	Box of 30
Strength	45mg
Public Price	7408556 L.L.
Stratum	E2
NSSF	✘
Quarantine	✘
Reg. Number	70618/1
Submission date	15/05/2018
Registration Year	29/08/2018

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