USA - engelsk - NLM (National Library of Medicine)

piramal critical care, inc. - levothyroxine sodium anhydrous (unii: 054i36cpmn) (levothyroxine - unii:q51bo43mg4) - levothyroxine sodium for injection is indicated for the treatment of myxedema coma. important limitations of use: the relative bioavailability between levothyroxine sodium for injection and oral levothyroxine products has not been established. caution should be used when switching patients from oral levothyroxine products to levothyroxine sodium for injection as accurate dosing conversion has not been studied. none. 8.1 pregnancy pregnancy category a – there are no reported cases of levothyroxine sodium for injection used to treat myxedema coma in patients who were pregnant or lactating. studies in pregnant women treated with oral levothyroxine to maintain a euthyroid state have not shown an increased risk of fetal abnormalities. therefore, pregnant patients who develop myxedema should be treated with levothyroxine sodium for injection as the risk of nontreatment is associated with a high probability of significant morbidity or mortality to the maternal patient and the fetus. 8.2 labor and delivery patients in labor who develop myxedema have not been reported in the literature. however, patients should be treated with levothyroxine sodium for injection as the risk of nontreatment is associated with a high probability of significant morbidity or mortality to the maternal patient and the fetus. 8.3 nursing mothers adequate replacement doses of thyroid hormones are required to maintain normal lactation. there are no reported cases of levothyroxine sodium for injection used to treat myxedema coma in patients who are lactating. however, such patients should be treated with levothyroxine sodium for injection as the risk of nontreatment is associated with a high probability of significant morbidity or mortality to the nursing patient. 8.4 pediatric use myxedema coma is a disease of the elderly. an approved, oral dosage form of levothyroxine should be used in the pediatric patient population for maintaining a euthyroid state in non-complicated hypothyroidism. 8.5 geriatric use and patients with underlying cardiovascular disease see section 2, dosage and administration, for full prescribing information in the geriatric patient population. because of the increased prevalence of cardiovascular disease in the elderly, cautious use of levothyroxine sodium for injection in the elderly and in patients with known cardiac risk factors is advised. atrial fibrillation is a common side effect associated with levothyroxine treatment in the elderly [ see dosage and administration ( 2) and warnings and precautions ( 5) ].

USA - engelsk - NLM (National Library of Medicine)

piramal critical care inc - doxycycline hyclate (unii: 19xts3t51u) (doxycycline anhydrous - unii:334895s862) - to reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline for injection, usp and other antibacterial drugs, doxycycline for injection, usp should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. doxycycline for injection, usp is indicated in infections caused by the following microorganisms: • rickettsiae (rocky mountain spotted fever, typhus fever, and the typhus group, q fever, rickettsial pox and tick fevers) • mycoplasma pneumoniae (pplo, eaton agent). • agents of psittacosis and ornithosis. • agents of lymphogranuloma venereum and granuloma inguinale. • the spirochetal agent of relapsing fever (borrelia recurrentis) . the following g

Storbritannien - engelsk - MHRA (Medicines & Healthcare Products Regulatory Agency)

piramal critical care ltd - alfentanil hydrochloride - solution for injection - 5mg/1ml

Den Europæiske Union - engelsk - EMA (European Medicines Agency)

piramal critical care b.v. - miglustat - gaucher disease - other alimentary tract and metabolism products, - yargesa is indicated for the oral treatment of adult patients with mild to moderate type 1 gaucher disease.yargesa may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable.yargesa is indicated for the treatment of progressive neurological manifestations in adult patients and paediatric patients with niemann-pick type c disease.

Belgien - engelsk - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

piramal critical care b.v. - fentanyl citrate 0,0785 mg/ml - eq. fentanyl 0,05 mg/ml - solution for injection - 0,05 mg/ml - fentanyl citrate 0.0785 mg/ml - fentanyl

Belgien - engelsk - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

piramal critical care b.v. - fentanyl citrate 0,0785 mg/ml - eq. fentanyl 0,05 mg/ml - solution for injection - 0,05 mg/ml - fentanyl citrate 0.0785 mg/ml - fentanyl

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

device technologies australia pty ltd - sevoflurane, quantity: 1 ml/ml - inhalation - excipient ingredients: - piramal sevoflurane may be used for induction and maintenance of general anaesthesia in adult and paediatric patients undergoing surgery.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

piramal critical care pty ltd - fentanyl citrate, quantity: 78.5 microgram/ml (equivalent: fentanyl, qty 50 microgram/ml) - injection, solution - excipient ingredients: water for injections; sodium chloride - sublimaze is indicated for analgesic action of short duration during anaesthetic periods, premedication, induction and maintenance, and in the immediate post-operative period (recovery room) as the need arises; use as a narcotic analgesic supplement in general and regional anaesthesia; administration with a neuroleptic such as droperidol injection as an anaesthetic premedication, for the induction of anaesthesia, and as an adjunct in the maintenance of general and regional anaesthesia.

Irland - engelsk - HPRA (Health Products Regulatory Authority)

piramal critical care b.v. - sevoflurane - inhalation vapour, liquid - 100 percent volume/volume - halogenated hydrocarbons; sevoflurane

Irland - engelsk - HPRA (Health Products Regulatory Authority)

piramal critical care b.v. - alfentanil hydrochloride - solution for injection/infusion - 500 microgram(s)/millilitre - opioid anesthetics; alfentanil