Philippines - English - FDA (Food And Drug Administration)

pan-ject pharmaceuticals corporation; distributor: pan-ject pharmaceuticals corporation - tramadol hydrochloride - solution for injection (i.m/i.v.) - 50mg/ml (100mg/2ml)

Philippines - English - FDA (Food And Drug Administration)

pan-ject pharmaceuticals corporation; distributor: pan-ject pharmaceuticals corporation - dexamethasone (as sodium phosphate) - solution for injection - 4mg/ ml

Philippines - English - FDA (Food And Drug Administration)

pan-ject pharmaceuticals corporation; distributor: pan-ject pharmaceuticals corporation - phenytoin (as sodium) - solution for injection - 50mg/ml (250mg/5ml)

Philippines - English - FDA (Food And Drug Administration)

pan-ject pharmaceuticals corporation - calcium folinate - lyophilized powder for injection (im/iv) - 50mg

Philippines - English - FDA (Food And Drug Administration)

pan-ject pharmaceuticals corporation - diclofenac sodium - solution for injection (im/iv infusion) - 25mg / ml (75mg / 3ml)

United States - English - NLM (National Library of Medicine)

medi-physics inc. dba ge healthcare. - ioflupane i-123 (unii: 3mm99t8r5q) (ioflupane i-123 - unii:3mm99t8r5q) - ioflupane i-123 2 mci in 1 ml - datscan is indicated as an adjunct to other diagnostic evaluations for striatal dopamine transporter visualization using single photon emission computed tomography (spect) brain imaging in adult patients with: - suspected parkinsonian syndromes (ps) or - suspected dementia with lewy bodies (dlb). datscan is contraindicated in patients with known serious hypersensitivity to ioflupane i 123 [see warnings and precautions (5.1)] . risk summary radioactive iodine products cross the placenta and can permanently impair fetal thyroid function. administration of an appropriate thyroid blocking agent is recommended before use of datscan in a pregnant woman to protect the woman and fetus from accumulation of iodine-123 [see dosage and administration (2.2)] . there are no available data on datscan use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. animal reproduction studies have not been conducted with ioflupane i 123. all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. administration of datscan at a dose of 185 mbq (5 mci) results in an absorbed radiation dose to the uterus of 0.3 rad (3.0 mgy). radiation doses greater than 15 rad (150 mgy) have been associated with congenital anomalies but doses under 5 rad (50 mgy) generally have not. advise pregnant women of the potential risks of fetal exposure to radiation doses with administration of datscan. the estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. risk summary iodine-123, the radionuclide in datscan, is present in human milk. there is no information on the effects on the breastfed infant or on milk production. advise a lactating woman to interrupt breastfeeding and pump and discard breastmilk for at least 6 days (>10 physical half-lives) after datscan administration in order to minimize radiation exposure to a breastfed infant. the safety and efficacy of datscan have not been established in pediatric patients. in the two principal clinical studies of datscan for suspected parkinsonian syndromes, 45% of the subjects were aged 65 and over, while 10% were 75 and over [see clinical studies (14.1)] . no overall differences in safety or effectiveness were observed between these subjects and younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. datscan is excreted by the kidney and patients with severe renal impairment may have increased radiation exposure and altered datscan images.

European Union - English - EMA (European Medicines Agency)

novartis vaccines and diagnostics s.r.l. - influenza virus surface antigens (haemagglutinin and neuraminidase) of strain a/viet nam/1194/2004 (h5n1) - influenza, human, immunization, disease outbreaks - vaccines, - active immunisation against h5n1 subtype of influenza a virus., this indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of the vaccine containing a/vietnam/1194/2004 (h5n1)-like strain., prepandemic influenza vaccine (h5n1) novartis vaccines and diagnostic should be used in accordance with official recommendations.,

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

curium pharma uk ltd - ioflupane [i-123] - solution for injection - 74mbq/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

curium pharma uk ltd - ioflupane [i-123] - solution for injection - 74mbq/1ml

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

juno pharmaceuticals pty ltd - phenytoin sodium, quantity: 100 mg - injection, solution - excipient ingredients: propylene glycol; sodium hydroxide; ethanol; water for injections - control of status epilepticus, tonic-clonic (grand mal), psychomotor seizures and the prevention of seizures occuring during or following neurosurgery. phenytoin will prevent or effectively decrease the incidence and severity of convulvsive seizures in a high percentage of cases, with patients exhibiting little tendency to become resistant to its action. besides its effectiveness in controlling seizures, phenytoin frequently improves the mental condition and outlook of epileptic patients. it has also been used in the treatment of certain cardiac arrhythmias, particularly in those patients who do not respond to convential antiarrhythmic agents or to cardioversion. phenytoin serum level determinations may be necessary for optimal dosage adjustments (see dosage and administation).