Australia - Kiingereza - Department of Health (Therapeutic Goods Administration)

elekta pty ltd - 40887 - radiation therapy treatment planning system, application program software - monaco is a standalone software as a medical device (samd). it is a radiation treatment planning (rtp) system. it is used to make treatment plans for patients with prescriptions for external beam radiation therapy. the system calculates dose for photon, electron, proton and carbon treatment plans and displays, on-screen and in hard-copy, two-or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups. the monaco product line is intended for use in radiation treatment planning.

Australia - Kiingereza - Department of Health (Therapeutic Goods Administration)

elekta pty ltd - 45446 - patient positioning system, ultrasound - the clarity system is a 3d ultrasound based medical device for soft tissue visualization and target structure localization. it is used in the treatment planning and treatment delivery phases of cancer radiation therapy. the system is used by radiation treatment specialists such as radiation oncologists, medical physicists, radiation therapists, radiation therapy technologists and dosimetrists. the system produces ultrasound images that must be interpreted by a trained medical professional. the system does not provide a medical diagnosis of the patient being examined. the system is not fully automated and requires user interaction.

Singapoo - Kiingereza - HSA (Health Sciences Authority)

b. braun singapore pte ltd - general & plastic surgery - caiman seal & cut is a bipolar rf sealing system, which consists of the lektrafuse rf generator and caiman instruments. this system can be used for grasping, preparation, sealing and cutting of tissue during open and minimally invasive surgical procedures. caiman seal & cut can be used on vessels and vessel bundles with diameters up to and including 7 mm as well as soft tissue in general surgery and also surgical specialties such as gynecology, urology and bariatric, colorectal and thoracic surgery.

Umoja wa Ulaya - Kiingereza - EMA (European Medicines Agency)

pharmathen s.a. - memantine hydrochloride - alzheimer disease - psychoanaleptics, , other anti-dementia drugs - treatment of patients with moderate to severe alzheimer’s disease.

Marekani - Kiingereza - NLM (National Library of Medicine)

lek pharmaceuticals - bromocriptine mesylate (unii: ffp983j3od) (bromocriptine - unii:3a64e3g5zo) - tablet - 2.5 mg - bromocriptine mesylate tablets are indicated for the treatment of dysfunctions associated with hyperprolactinemia including amenorrhea with or without galactorrhea, infertility or hypogonadism. bromocriptine mesylate treatment is indicated in patients with prolactin-secreting adenomas, which may be the basic underlying endocrinopathy contributing to the above clinical presentations. reduction in tumor size has been demonstrated in both male and female patients with macroadenomas. in cases where adenectomy is elected, a course of bromocriptine mesylate therapy may be used to reduce the tumor mass prior to surgery. acromegaly bromocriptine mesylate tablets are indicated in the treatment of acromegaly. bromocriptine mesylate therapy, alone or as adjunctive therapy with pituitary irradiation or surgery, reduces serum growth hormone by 50% or more in approximately one-half of patients treated, although not usually to normal levels. since the effects of external pituitary radiation may not become maximal for

Marekani - Kiingereza - NLM (National Library of Medicine)

lek pharmaceuticals - lisinopril (unii: e7199s1ywr) (lisinopril - unii:e7199s1ywr) - tablet - 2.5 mg -  lisinopril tablets are indicated for the treatment of hypertension. they may be used alone as initial therapy or concomitantly with other classes of antihypertensive agents. lisinopril tablets are indicated as adjunctive therapy in the management of heart failure in patients who are not responding adequately to diuretics and digitalis.  lisinopril tablets are indicated for the treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction, to improve survival. patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin, and beta-blockers. in using lisinopril tablets, consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril tablets do not have a similar risk. (see warnings.) in considering the use of lisinopril tablet