Medica RCP |Docetaxel Accord 20mg | Indications | Side Effects | Composition | Route | all.price

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Products » Items » Docetaxel Accord 20mg

Contraindicated
Embryotoxic and foetotoxic in rabbits and rats

Contraindicated

Docetaxel Accord 20mg :
Type	Medicine Authorised
Originator	Taxotere 20mg
Agent	Mediterranean Pharmaceutical Company
Distributor	Mediterranean Pharmaceutical Company
Laboratory	Accord HealthCare
Responsible Party	Accord Healthcare Limited
Origin	UK
Manufacturer	Accord healthcare Limited
Manufacturing Type	G
Origin	UK
ATC	L01CD02

Docetaxel Accord 20mg :

Injectable

Intravenous

Docetaxel Accord 20mg :

L Antineoplastic and immunomodulating agents

L01 Antineoplastic agents

L01C Plant alkaloids and other natural products

L01CD Taxanes

L01CD02 Docetaxel

Docetaxel Accord 20mg :

Docetaxel : 20mg

Docetaxel Accord 20mg :

Adults : Breast cancer 75mg/m² every 3 weeks for 6 cycles

Adults : Gastric adenocarcinoma 75mg/m² every 3 weeks

Adults : Head and neck carcinoma 75mg/m² every 3 weeks for 4 cycles

Adults : Non-small cell lung cancer 75mg/m²

Adults : Prostate cancer 75mg/m²

Docetaxel Accord 20mg :

Citric acid (E330)

Ethanol (Ethyl alcohol)* Contraindicated in pregnant women, children under 12 years old, people with liver disease. Skin irritation (topical application)

Polysorbate 80 (E433) Emulsifying Agents

* Excipient with known effect

Hazard Level
◼ Major
◼ Moderate
◼ Minor
◼ Safe

Docetaxel Accord 20mg :

Revision Date : 13/04/2015

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
Abdominal pain	Very Common
Abdominal pain upper	Common
Acute leukaemia	Not known
Acute myeloid leukaemia	Not known
Acute respiratory distress syndrome	Not known
Alopecia	Very Common
ALT increased	Common
Amenorrhoea (amenorrhea)	Very Common
Anaemia	Very Common
Anaphylactic shock	Not known
Arrhythmia	Common
Arthralgia (Pain joint) (Joint ache)	Very Common
Ascites	Not known
AST increased	Common
Asthenia	Very Common
Back pain	Very Common
Blood alkaline phosphatase increased	Common
Blood bilirubin increased	Common
Bone marrow failure	Not known
Bone pain	Very Common
Bronchospasm	Not known
Burning sensation	Not known
Cancer pain	Common
Cardiac failure	Common
Chest discomfort	Not known
Chest pain	Very Common
Chills	Very Common
Colitis	Not known
Colitis ischaemic	Not known
Congestive cardiomyopathy	Not known
Congestive heart failure	Common
Conjunctivitis	Very Common
Constipation	Very Common
Cough	Very Common
Cutaneous lupus erythematosus	Not known
Cystoid macular oedema	Not known
Dacryostenosis acquired	Not known
Deafness	Not known
Decreased appetite	Very Common
Dehydration	Common
Dermatitis	Common
Dermatitis bullous	Not known
Diarrhoea (Diarrhea)	Very Common
Disseminated intravascular coagulation	Not known
Dizziness	Common
Dry mouth (Xerostomia)	Common
Dry skin	Common
Dysaesthesia	Not known
Dysguesia (taste perversion) (Taste abnormality) (Taste disturbance)	Very Common
Dyspepsia	Very Common
Dysphagia	Very Common
Dyspnoea (dyspnea)	Very Common
Embolism venous	Not known
Epistaxis (Nasal bleeding)	Very Common
Erythema	Very Common
Erythema multiforme	Not known
Exfoliative rash	Common
Fatigue	Very Common
Febrile neutropenia (Neutropenic fever)	Very Common
Fluid retention	Very Common
Flushing	Not known
Gastroduodenal haemorrhage	Common
Gastrointestinal pain	Common
Gastrointestinal perforation	Not known
Haemorrhage	Common
Hand and foot syndrome (Palmar-plantar erythrodysaesthesia syndrome)	Very Common
Headache	Very Common
Hepatitis	Not known
Hot flush	Very Common
Hypersensitivity	Very Common
Hypertension	Common
Hypoacusis	Very Common
Hypoesthesia	Very Common
Hyponatraemia (Hyponatremia)	Not known
Hypotension	Common
Ileus	Not known
Infection	Very Common
Influenza-like illness	Very Common
Infusion site discolouration	Not known
Infusion site erythema	Not known
Infusion site extravasation	Not known
Infusion site inflammation	Not known
Infusion site phlebitis	Not known
Infusion site reactions	Common
Infusion site swelling	Not known
Injection site dryness	Not known
Insomnia	Very Common
Interstitial pneumonitis	Not known
Intestinal obstruction	Not known
Lacrimation increased (Epiphora)	Very Common
Laryngeal pain	Very Common
Left ventricular dysfunction	Common
Lethargy	Very Common
Loss of consciousness	Not known
Lyell Syndrome (Toxic epidermal necrolysis)	Not known
Lymphoedema	Very Common
Mucosal inflammation	Very Common
Myalgia	Very Common
Myelodysplastic syndrome	Not known
Myocardial infarction	Not known
Myocardial ischaemia	Common
Nail discolouration	Common
Nail disorders	Very Common
Nasopharyngitis	Very Common
Nausea	Very Common
Neuropathy peripheral	Common
Neurotoxicity	Uncommon
Neutropenia	Very Common
Neutropenic colitis	Not known
Neutropenic infection	Very Common
Neutropenic sepsis	Very Common
Non-cardiac chest pain	Common
Odynophagia	Very Common
Oedema	Very Common
Oedema peripheral	Very Common
Oesophagitis	Very Common
Onychalgia	Not known
Onycholysis	Common
Oral candidiasis	Common
Ototoxicity	Not known
Pain	Very Common
Pain in extremity (Pain in limb)	Very Common
Paraesthesia (paresthesia)	Very Common
Parosmia	Very Common
Pericardial effusion	Not known
Peripheral motor neuropathy	Very Common
Peripheral sensory neuropathy	Very Common
Pharyngitis	Very Common
Phlebitis	Common
Photopsia	Not known
Pleural effusion	Not known
Pneumonia	Very Common
Pneumonitis	Not known
Pulmonary fibrosis	Not known
Pulmonary oedema	Not known
Pyrexia	Very Common
Radiation pneumonitis	Not known
Rash erythematous	Common
Rash generalised	Not known
Rash pruritic	Very Common
Recall phenomenon	Not known
Renal failure	Not known
Respiratory failure	Not known
Rhinorrhoea	Very Common
Scleroderma-like reaction	Not known
Seizures	Not known
Sepsis (Systemic infection) (Sepsis state)	Very Common
Skin disorders	Very Common
Skin exfoliation (Flaking skin)	Common
Skin rash	Very Common
Skin reaction	Very Common
Skin toxicity	Very Common
Somnolence	Uncommon
Stevens-Johnson syndrome	Not known
Stomatitis	Very Common
Syncope	Uncommon
Thrombocytopenia (Thrombopenia)	Very Common
Vein disorder	Common
Visual disturbance	Not known
Visual field defect	Not known
Vomiting	Very Common
Weight decreased (Weight loss)	Very Common
Weight increased (weight gain)	Very Common

Docetaxel Accord 20mg :

Belgium

Cyprus

Czech Republic

Denmark

Finland

France

Germany

Greece

Italy

Jordan

KSA

Lebanon

Norway

Portugal

Spain

Switzerland

The Netherlands

Form	Concentrate for solution for infusion
Packaging	Bottle
Package Size	1x1ml
Strength	20mg
Storage Condition	<25°C protect from light
Public Price	4563508,95 L.L.
Stratum	B
NSSF	✔
Quarantine	✘
Reg. Number	56816/1
Submission date	01/01/2016
Registration Year	2016

P.P. =	Public Price
P/U =	Price Per Unit

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