Australija - anglų - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - omalizumab, quantity: 75 mg - injection, solution - excipient ingredients: arginine hydrochloride; water for injections; histidine; histidine hydrochloride monohydrate; polysorbate 20 - allergic asthma,children 6 to < 12 years of age - in children aged 6 to <12 years, xolair is indicated as add-on therapy to improve asthma control in patients with severe allergic asthma who have documented exacerbations despite daily high dose inhaled corticosteroids, and who have immunoglobulin e levels corresponding to the recommended dose range (see table 1 in section 4.2 dose and method of administration).,adults and adolescents 12 years of age and above -xolair is indicated for the management of adult and adolescent patients with moderate to severe allergic asthma, who are already being treated with inhaled steroids, and who have serum immunoglobulin e levels corresponding to the recommended dose range (see table 1 in section 4.2 dose and method of administration).,chronic rhinosinusitis with nasal polyps (crswnp),xolair is indicated as add-on treatment in adult patients (18 years of age and above) for the treatment of severe crswnp with inadequate response to intranasal corticosteroids. recommended dosing is determined by serum immunoglobulin e levels and body weight corresponding to the recommended dose range in the product information (see section 4.2 dose and method of administration).,chronic spontaneous urticaria (csu),xolair is indicated for adults and adolescents (12 years of age and above) with chronic spontaneous urticaria who remain symptomatic despite h1 antihistamine treatment.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - tramadol hydrochloride, quantity: 50 mg/ml - injection, solution - excipient ingredients: sodium acetate; water for injections - tramadol sandoz injections are indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

seqirus pty ltd - tramadol hydrochloride, quantity: 50 mg/ml - injection, solution - excipient ingredients: water for injections; sodium acetate - tramal solution for injection is indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

seqirus pty ltd - tramadol hydrochloride, quantity: 50 mg/ml - injection, solution - excipient ingredients: sodium acetate; water for injections - tramal solution for injection is indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.

Naujoji Zelandija - anglų - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - furosemide 10 mg/ml - solution for infusion - 10 mg/ml - active: furosemide 10 mg/ml excipient: mannitol sodium hydroxide water for injection - oedema lasix is indicated in adults, infants and children for the treatment of oedema associated with congestive heart failure, cirrhosis of the liver and renal disease including the nephrotic syndrome. lasix is particularly useful when an agent with greater diuretic potential than that of those commonly employed is desired. parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations. lasix injection is also indicated as adjunctive therapy in acute pulmonary oedema and cerebral oedema where intense and rapid onset of diuresis is desired. if gastrointestinal absorption is impaired or oral medication is not practical for any reason, lasix is indicated by the intravenous route. parenteral use should be replaced with oral lasix as soon as practical.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

medsurge pharma pty ltd - baclofen, quantity: 10 mg - injection, solution - excipient ingredients: sodium chloride; water for injections - baclofen solution for intrathecal injection is indicated in patients with severe chronic spasticity of spinal origin (associated with injury, multiple sclerosis, or other spinal cord diseases) or of cerebral origin who are unresponsive to orally administered antispastics (including oral baclofen) and/or who experience unacceptable side effects at effective oral doses.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

medsurge pharma pty ltd - baclofen, quantity: 10 mg - injection, solution - excipient ingredients: water for injections; sodium chloride - baclofen solution for intrathecal injection is indicated in patients with severe chronic spasticity of spinal origin (associated with injury, multiple sclerosis, or other spinal cord diseases) or of cerebral origin who are unresponsive to orally administered antispastics (including oral baclofen) and/or who experience unacceptable side effects at effective oral doses.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

medsurge pharma pty ltd - baclofen, quantity: 0.05 mg - injection, solution - excipient ingredients: sodium chloride; water for injections - baclofen solution for intrathecal injection is indicated in patients with severe chronic spasticity of spinal origin (associated with injury, multiple sclerosis, or other spinal cord diseases) or of cerebral origin who are unresponsive to orally administered antispastics (including oral baclofen) and/or who experience unacceptable side effects at effective oral doses.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - tramadol hydrochloride, quantity: 100 mg - injection, solution - excipient ingredients: sodium acetate trihydrate; water for injections - tramadol an solution for injection is indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - ropivacaine hydrochloride, quantity: 2 mg/ml - injection, solution - excipient ingredients: water for injections; sodium hydroxide; hydrochloric acid; sodium chloride - surgical anaesthesia (adults and children over 12 years of age). - epidural block for surgery including caesarean section. - intrathecal anaesthesia. - field block (minor nerve block and infiltration). - major nerve block. analgesia (adults and children over 12 years of age). - continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain. - field block (minor nerve block and infiltration). - continuous peripheral nerve block infusion or intermittent injections for post operative pain management. analgesia (children aged 0 - 12 years). - caudal epidural block in neonates (> 37 weeks gestation and over 2500 g weight), infants and children up to and including 12 years . - continuous epidural infusion in infants (> 30 days and over 2500 g weight) and children up to and including 12 years. - peripheral nerve block in children aged 1 up to and including 12 years. for peri- and postoperative pain management. there are no safety or efficacy data to support the use of ropivacaine for analgesia for longer than 72 hours. (data for peripheral nerve block administered as a continuous peripheral infusion or intermittent injections support the use for up to 48 hours only).