Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

apotex pty ltd - remifentanil hydrochloride, quantity: 5.485 mg - injection, powder for - excipient ingredients: hydrochloric acid; glycine - remifentanil is indicated:,- as an opioid adjunct for use during induction and/or maintenance of general anaesthesia during surgical procedures, including cardiac surgery, in adults;,- as an opioid adjunct for use during induction and/or maintenance of general anaesthesia during surgical, but not cardiac procedures, in children aged 1?12 years;,- for continuation as an analgesic into the immediate post-operative period under the close supervision of medically-qualified persons trained in the use of anaesthetic agents, during transition to longer-acting analgesia following adult cardiac surgery ? when endotracheal intubation and controlled ventilation are anticipated;,- for provision of analgesia and sedation in mechanically-ventilated intensive care patients.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - remifentanil hydrochloride, quantity: 5.485 mg (equivalent: remifentanil, qty 5 mg) - injection, powder for - excipient ingredients: glycine; hydrochloric acid - remifentanil viatris for injection is indicated * as an opioid adjunct for use during induction and/or maintenance of general anaesthesia during surgical procedures including cardiac surgery in adults.. * as an opioid adjunct for use during induction and/or maintenance of general anaesthesia during surgical but not cardiac procedures in children aged 1 to 12 years.. * for continuation as an analgesic into the immediate post-operative period under the close supervision of medically qualified persons trained in the use of anaesthetic drugs, during transition to longer acting analgesia following adult cardiac surgery - when endotracheal intubation and controlled ventilation are anticipated.. * for provision of analgesia and sedation in mechanically ventilated intensive care patients.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - remifentanil hydrochloride, quantity: 2.194 mg (equivalent: remifentanil, qty 2 mg) - injection, powder for - excipient ingredients: glycine; hydrochloric acid - remifentanil viatris for injection is indicated * as an opioid adjunct for use during induction and/or maintenance of general anaesthesia during surgical procedures including cardiac surgery in adults.. * as an opioid adjunct for use during induction and/or maintenance of general anaesthesia during surgical but not cardiac procedures in children aged 1 to 12 years.. * for continuation as an analgesic into the immediate post-operative period under the close supervision of medically qualified persons trained in the use of anaesthetic drugs, during transition to longer acting analgesia following adult cardiac surgery - when endotracheal intubation and controlled ventilation are anticipated.. * for provision of analgesia and sedation in mechanically ventilated intensive care patients.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - remifentanil hydrochloride, quantity: 1.097 mg (equivalent: remifentanil, qty 1 mg) - injection, powder for - excipient ingredients: hydrochloric acid; glycine - remifentanil viatris for injection is indicated * as an opioid adjunct for use during induction and/or maintenance of general anaesthesia during surgical procedures including cardiac surgery in adults.. * as an opioid adjunct for use during induction and/or maintenance of general anaesthesia during surgical but not cardiac procedures in children aged 1 to 12 years.. * for continuation as an analgesic into the immediate post-operative period under the close supervision of medically qualified persons trained in the use of anaesthetic drugs, during transition to longer acting analgesia following adult cardiac surgery - when endotracheal intubation and controlled ventilation are anticipated.. * for provision of analgesia and sedation in mechanically ventilated intensive care patients.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - water for injections, quantity: 40 ml - injection, solution - excipient ingredients: - treatment and perioperative prophylaxis of bleedings in acquired deficiency of the prothrombin complex coagulation factors, such as deficiency caused by treatment with vitamin k antagonists, or in case of overdose of vitamin k antagonists, when rapid correction of the deficiency is required.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

takeda pharmaceuticals australia pty ltd - factor viii inhibitor bypassing fraction, quantity: 1000 mg - injection, powder for - excipient ingredients: sodium citrate dihydrate; sodium chloride - feiba-nf is indicated for routine prophylaxis, control of spontaneous bleeding episodes and use in surgery in haemophilia a or b patients with inhibitors.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - water for injections, quantity: 20 ml - injection, solution - excipient ingredients: - treatment and perioperative prophylaxis of bleedings in acquired deficiency of the prothrombin complex coagulation factors, such as deficiency caused by treatment with vitamin k antagonists, or in case of overdose of vitamin k antagonists, when rapid correction of the deficiency is required.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

takeda pharmaceuticals australia pty ltd - factor viii inhibitor bypassing fraction, quantity: 1000 u - injection, powder for - excipient ingredients: sodium citrate dihydrate; sodium chloride - feiba-nf is indicated for routine prophylaxis, control of spontaneous bleeding episodes and use in surgery in haemophilia a or b patients with inhibitors.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

takeda pharmaceuticals australia pty ltd - factor viii inhibitor bypassing fraction, quantity: 500 u - injection, powder for - excipient ingredients: sodium citrate dihydrate; sodium chloride - feiba-nf is indicated for routine prophylaxis, control of spontaneous bleeding episodes and use in surgery in haemophilia a or b patients with inhibitors.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - omalizumab, quantity: 150 mg - injection, solution - excipient ingredients: water for injections - 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.