Medica RCP |Kaletra Tablets 200/50mg | Indications | Side Effects | Composition | Route | all.price

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Products » Items » Kaletra Tablets 200/50mg

May be acceptable
If it is considered to be clearly essential

Contraindicated

Kaletra Tablets 200/50mg :
Type	Medicine Non Marketed
Originator	B
Agent	Interpharma
Distributor	Interpharma
Laboratory	AbbVie
Responsible Party	Abbvie Ltd
Origin	UK
Manufacturer	Abbvie Deutschland GmbH & Co KG
Origin	Germany
ATC	J05AR10
Revision Date	01/12/2013

Kaletra Tablets 200/50mg :

Oral

Kaletra Tablets 200/50mg :

J Anti-Infectives for systemic use

J05 Antivirals for systemic use

J05A Direct acting antiviral drugs

J05AR Antivirals for treatment of HIV infections, combinations

J05AR10 lopinavir and ritonavir

Kaletra Tablets 200/50mg :

Lopinavir : 200mg

Ritonavir : 50mg

Kaletra Tablets 200/50mg :

Adults : Treatment of HIV 1 tablet BID

Kaletra Tablets 200/50mg :

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

◼

Copovidone

Hyprolose (hydroxypropylcellulose) (E463)

Hypromellose (Hydroxypropylmethyl cellulose) (HPMC) (E464)

Iron oxide (E172) (CI 7749)

PEG-3350 (Polyethylene glycol 3350) (Macrogol 3350) (E1521)

PEG-4000 (Polyethylene glycol 4000)

Polysorbate 80 (E433) Emulsifying Agents

Sodium stearyl fumarate

Sorbitan Laurate

Talc (E553b)

Titanium dioxide (E171) (CI 77891)

* Excipient with known effect

Hazard Level
◼ Major
◼ Moderate
◼ Minor
◼ Safe

Kaletra Tablets 200/50mg :

Revision Date : 18/12/2013

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 distension	Common
Abdominal pain	Common
Abdominal pain lower	Common
Abdominal pain upper	Common
Abnormal dreams	Uncommon
Ageusia (Taste loss)	Uncommon
Alopecia	Uncommon
ALT increased	Common
Amenorrhoea (amenorrhea)	Common
Anaemia	Common
Angioedema (Angioneurotic oedema) (Quincke oedema)	Common
Anxiety	Common
Arteriosclerosis	Uncommon
Arthralgia (Pain joint) (Joint ache)	Common
AST increased	Common
Asthenia	Common
Atrioventricular block (AVB)	Uncommon
Autoimmune disorder	Not known
Back pain	Common
Basedow's disease	Not known
Blood creatine phosphokinase increased	Not known
Blood glucose abnormal	Common
Body fat disorder	Not known
Breast enlargement	Not known
Capillaritis	Uncommon
Cellulitis	Common
Cerebrovascular accident	Uncommon
Cholangitis	Uncommon
Colitis	Common
Constipation	Uncommon
Creatinine renal clearance decreased	Uncommon
Cushing's syndrome	Not known
Decreased appetite	Common
Deep vein thrombosis	Uncommon
Dermatitis	Common
Diabetes mellitus	Common
Diarrhoea (Diarrhea)	Very Common
Dizziness	Common
Dry mouth (Xerostomia)	Uncommon
Duodenitis	Uncommon
Dysguesia (taste perversion) (Taste abnormality) (Taste disturbance)	Uncommon
Dyspepsia	Common
Eczema	Common
Erectile dysfunction	Common
Erythema multiforme	Not known
Facial wasting	Common
Faecal incontinence	Uncommon
Fatigue	Common
Flatulence	Common
Folliculitis	Common
Furuncle	Common
Gamma-GT increased	Common
Gastritis	Uncommon
Gastroduodenal haemorrhage	Uncommon
Gastroenteritis	Common
Gastrointestinal ulcer	Uncommon
Gastrooesophageal reflux disease	Common
Haematuria (Hematuria)	Uncommon
Haemorrhoids	Common
Headache	Common
Hepatic steatosis	Uncommon
Hepatitis	Common
Hepatomegaly	Uncommon
Hyperbilirubinaemia	Uncommon
Hypercholesterolaemia	Common
Hyperglycaemia	Not known
Hyperlactacidaemia	Not known
Hypersensitivity	Common
Hypertension	Common
Hypertriglyceridaemia	Common
Hypogonadism	Uncommon
Immune reconstitution inflammatory syndrome	Uncommon
Increased appetite	Uncommon
Insomnia	Common
Insulin resistance	Not known
Jaundice	Not known
Leucopenia (Leukopenia)	Common
Libido decreased	Uncommon
Lipodystrophy acquired	Common
Lipohypertrophy	Not known
Lower respiratory tract infection	Common
Lymphadenopathy	Common
Maculopapular rash	Common
Menorrhagia	Common
Menstrual disorder	Common
Metabolic disorder	Not known
Migraine	Common
Mouth ulceration	Uncommon
Muscle disorder	Common
Muscle spasms	Common
Muscle weakness	Common
Musculoskeletal pain	Common
Myalgia	Common
Myocardial infarction	Uncommon
Myositis	Not known
Nausea	Very Common
Nephritis	Uncommon
Neuropathy peripheral	Common
Neutropenia	Common
Night sweats	Common
Osteonecrosis	Uncommon
Pancreatitis	Common
Pruritus	Common
Rectal haemorrhage	Uncommon
Rhabdomyolysis	Uncommon
Seborrhoeic dermatitis	Common
Seizures	Uncommon
Skin infection	Common
Skin rash	Common
Stevens-Johnson syndrome	Not known
Stomatitis	Uncommon
Tinnitus	Uncommon
Tremor	Uncommon
Tricuspid valve incompetence	Uncommon
Upper respiratory tract infection	Very Common
Urticaria	Common
Vasculitis	Uncommon
Vertigo	Uncommon
Visual disturbance	Uncommon
Vomiting	Common
Weight decreased (Weight loss)	Common
Weight increased (weight gain)	Uncommon

Kaletra Tablets 200/50mg :

Abu Dhabi

Bahrain

Belgium

Cyprus

Czech Republic

Denmark

Finland

France

Germany

Greece

Italy

Kuweit

New Zealand

Norway

Oman

Portugal

Qatar

Spain

Sweden

Switzerland

The Netherlands

Turkey

UAE

Form	Tablet, Film-Coated
Packaging	Bottle
Package Size	Box of 120
Strength	200/50mg
NSSF	✘
Quarantine	✘
Reg. Number	218103/09
Submission date	01/01/2009
Registration Year	2011
Archived Date	02/03/2021

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