WHO Pharmaceuticals Newsletter 1998, No. 09&10
(1998; 23 pages)
Table des matières
Ouvrir ce répertoire et afficher son contenuRegulatory decisions
Ouvrir ce répertoire et afficher son contenuDrug surveillance
Fermer ce répertoireNew developments
Afficher le documentFomepizole - approved as an antidote in ethylene glycol poisoning: USA
Afficher le documentInfliximab - approved for Crohn’s disease: USA
Afficher le documentLeflunomide - oral treatment approved for active rheumatoid arthritis: USA
Afficher le documentLepirudin - approved for heparin-associated thrombocytopenia: UK
Afficher le documentOral contraceptives - approved for emergency use: USA
Afficher le documentRotavirus vaccine - approved to help prevent rotaviral disease: USA
Afficher le documentThalidomide - approved for use in leprosy: USA
Afficher le documentNew indications
Afficher le documentNew formulations
Afficher le documentNewly approved products
Ouvrir ce répertoire et afficher son contenuMedical devices
Ouvrir ce répertoire et afficher son contenuGeneral information
Ouvrir ce répertoire et afficher son contenuMedication errors
Ouvrir ce répertoire et afficher son contenuVeterinary medicine
 

Newly approved products

abciximab

ReoPro, Eli Lilly: Malaysia

solution for injection 2 mg/ml

(vials 5 ml and 20 ml)

platelet aggregation inhibitor

Indications: Coronary angioplasty.

*basiliximab

Simulect, Novartis: Switzerland

solution for injection 20 mg/5ml vial

platelet aggregation inhibitor

Indications: Kidney transplant rejection.

*dexketoprofen

Sympal; Enantyum: Menarini: Germany

coated tablets 12.5, 25 mg

nonsteroidal anti-inflammatory agent

Indications: Symptomatic treatment of moderate to severe pain.

donepezil

Aricept, Pfizer: Iceland

coated tablets 5 mg, 10 mg

cholinesterase inhibitor

Indications: Symptomatic treatment of mild to moderate Alzheimer’s disease.

ferumoxides

Feridex, Ferumoxides: Eiken: Japan

intravenous injection 56 mg Fe/ampoule

diagnostic aid; contrast medium

Indications: Diagnosis of location of hepatic tumors in magnetic resonance imagining computed tomography.

fexofenadine

Telfast, Hoechst Merrell Dow: Spain

tablet 180 mg

histamine H1-antagonist (metabolite of terfenadine)

Indication: Relief of symptoms associated with seasonal allergic rhinitis in adults.

*incadronate disodium

Bisphonal, Yamanouchi: Japan

solution for intravenous infusion 10 mg/ampoule

biphosphonate

Indications: Hypercalcaemia due to malignant tumours.

Contraindications: Patients with a history of hypersensitivity to this product or other biphosphonates. Safety in pregnant women, infants and children has not been established.

Precautions: The usefulness of this product in the treatment of hypercalcaemia due to reasons other than malignant tumours (such as parathyroidal hyperactivity) has not been established. To be used with caution in patients with serious renal disorders, patients with cardiac disease, debilitated patients, and the elderly. Renal function tests should be performed after administration.

Adverse reactions: Fever, hypotension, disturbed consciousness; renal effects (raised levels of urinary protein, sugar, bilirubin, increased sediment); hepatic effects (raised serum transaminases and LDH); haematological effects (leukocytosis, neutrophilia, eosinopenia, lymphopenia).

irinotecan

Campto, Rhone-Poulenc Rorer: Switzerland

infusion concentrate 40 mg/2 ml vial;

100 mg/5 ml vial

antineoplastic agent

Indications: [Not stated].

lacidipine

Lacidipine BI Pharma, Boehringer-Ingelheim: Germany

tablet 2, 4 mg

calcium channel blocker

Indications: Essential hypertension.

metergoline

Liserdol, Kohl Pharma: Germany

coated tablet 4 mg

prolactin antagonist

Indications: Suppression of lactation; galactorrhoea, prolactin-dependent amenorrhoea; prolactin-dependent infertility in women; disturbances of fertility, diminished libido and impotence in men.

modafinil

Modiodal, Lab. L. Lafon: Germany

tablets 100 mg

psychostimulant

Indications: Narcolepsy with or without cataplexy.

nelfinavir

Viracept, Roche: Spain, UK

tablet 250 mg

HIV protease inhibitor; antiretroviral agent

Indications: Treatment of HIV-1 infected patients with advanced or progressive immunodeficiency, in combination with antiretroviral nucleoside analogues.

nevirapine

Viramune, Boehringer Ingelheim: EC, Spain, UK

tablet 200 mg

HIV-1 non-nucleoside reverse transcriptase inhibitor; antiretroviral agent

Indications: Patients with advanced or progressive HIV infection as part of combination therapy with nucleoside analogues.

*pentazocine + naloxone

Pentagin: Sankyo: Japan

tablet 25 mg + 250 micrograms

narcotic analgesic + morphine antagonist

Indications: Relief of pain in various types of cancer.

Contraindications: Patients who are hypersensitive to pentazocine or naloxone, patients with head injuries or intracranial hypertension, severe respiratory depression or severely impaired health. Precautions: Patients with a history of drug dependence, biliary tract disease, myocardial infarction, hepatic dysfunction and elderly patients. Patients shouldnot operate machinery or drive during treatment.

Adverse reactions: Shock, respiratory depression.

prasterone

Mylis, Kanebo: Japan

vaginal suppository 600 mg

hormone

Indications: Promotion of cervical ripening insufficiency in the third trimester of pregnancy.

quetiapine

Seroquel, Zeneca: Bahrain, Iceland

tablets 25 mg, 100 mg, 200 mg

neuroleptic benzodiazepine derivative with antipsychotic effect

Indications: Treatment of schizophrenia.

ritonavir

Norvir: Abbott: Japan

capsule 100 mg

antiretroviral agent

Indications: In combination with nucleoside analogue reverse transcriptase inhibitors for the treatment of AIDS and symptomatic and asymptomatic HIV infection with pre-treatment CD4 lymphocyte count of 500/mm3 or less.

*sildenafil

Viagra, Pfizer: EC, Switzerland

tablets 25 mg, 50 mg, 100 mg

cGMP-specific phosphodiesterase type 5

Indication: Erectile dysfunction.

Contraindications: Known history of hypersensitivity to any component of the product. Concurrent administration to patients using organic nitrates in any form.

Precautions: Patients should undergo a thorough cardiovascular examination before starting treatment. Adverse reactions: Headache, flushing, abnormal vision.

Note: First approved in the USA - see Pharmaceuticals Newsletter Nos. 5&6, May & June 1998.

*stavudine

Zerit, Bristol-Myers Squibb: Japan

capsules 15 mg, 20 mg

antiretroviral agent

Indications: AIDS; symptomatic or asymptomatic treatment of HIV infection with CD4 count of 500/mm3 or less before treatment. Note: Not to be used as monotherapy as a first-line therapy.

tetracycline and metronidazole and bismuth subcitrate

Panmycin, Trichozole, De-Nol: Pharmacia & Upjohn: New Zealand

tetracycline: capsule 250 mg

metronidazole: tablet 400 mg

bismuth subcitrate: 120 mg

(triple therapy pack)

antibiotic + antiprotozoal agent + bismuth salt

Indications: Triple therapy for the eradication of Helicobacter pylori (tetracycline four times a day, metronidazole three times a day and bismuth subcitrate four times a day, for 14 days).

tropisetron

Navoban, Novartis: Japan

capsule 5 mg

serotonin receptor antagonist; antiemetic

Indications: Cancer-chemotherapy induced gastrointestinal symptoms including nausea and vomiting (e.g. cisplatin).

 

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Dernière mise à jour: le 3 mai 2013