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SPC, New Zealand: DBL SODIUM NITROPRUSSIDE Solution for injection (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

DBL Sodium Nitroprusside 50 mg/2 mL Concentrated Injection Vial.

Qualitative and quantitative composition

DBL Sodium Nitroprusside concentrated injection is a sterile solution containing the equivalent of 50 milligram of sodium nitroprusside dihydrate [sodium nitrosylpentacyanoferrate (III)] per 2 mL, in sterile ...

Pharmaceutical form

Solution for injection. DBL Sodium Nitroprusside concentrated injection is a clear solution, sodium nitroprusside is a reddish-brown powder which is soluble in water. In aqueous solution, it is photosensitive ...

Therapeutic indications

DBL Sodium Nitroprusside concentrated injection is indicated for: Immediate reduction of blood pressure in patients with hypertensive crises. Concomitant oral antihypertensive medication should be started ...

Posology and method of administration

Dose SODIUM NITROPRUSSIDE IS ONLY TO BE USED AS AN INFUSION WITH STERILE 5% GLUCOSE IN WATER. IT SHOULD NOT BE ADMINISTERED BY DIRECT INJECTION. Product is for single use in one patient only. Discard any ...

Contraindications

Sodium nitroprusside should not be used in the treatment of compensatory hypertension, e.g. arteriovenous shunt or coarctation of the aorta. It is also contraindicated in physically poor risk patients ...

Special warnings and precautions for use

SODIUM NITROPRUSSIDE IS ONLY TO BE USED AS AN INFUSION WITH STERILE 5% GLUCOSE IN WATER. IT SHOULD NOT BE ADMINISTERED BY DIRECT INJECTION. The principal hazards of sodium nitroprusside administration ...

Interaction with other medicinal products and other forms of interaction

Ganglion blocking agents and other antihypertensive agents, volatile liquid anaesthetics, inhaled anaesthetics, negative inotropes and most other circulatory depressants potentiate the hypotensive action ...

Fertility, pregnancy and lactation

Fertility No data available. Pregnancy Category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing harmful effects on the human foetus or neonate without ...

Effects on ability to drive and use machines

No data available.

Undesirable effects

The most important adverse reactions to sodium nitroprusside are the avoidable ones of excessive hypotension and cyanide toxicity, described above under Section 4.4. The adverse effects described in this ...

Overdose

Overdosage of nitroprusside can be manifested as excessive hypotension or cyanide toxicity (see section 4.4) or as thiocyanate toxicity (see section 4.8). The acute intravenous mean lethal doses (LD50) ...

Pharmacodynamic properties

The principal pharmacological action of sodium nitroprusside is relaxation of vascular smooth muscle and consequent dilation of peripheral arteries and veins. Other smooth muscle (e.g. uterus, duodenum) ...

Pharmacokinetic properties

Infused sodium nitroprusside is rapidly distributed to a volume that is approximately coextensive with the extracellular space. The drug is cleared from this volume by intraerythrocytic reaction with haemoglobin ...

Preclinical safety data

Genotoxicity The mutagenic potential of sodium nitroprusside has not been assessed. Carcinogenicity Sodium nitroprusside has not undergone adequate carcinogenicity testing in animals. Reproductive and ...

List of excipients

Water for injection

Incompatibilities

No data available.

Shelf life

Shelf life: 18 months. 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light.

Special precautions for storage

Store below 25°C. Protect from light. Retain in carton until time of use.

Nature and contents of container

DBL Sodium Nitroprusside concentrated injection is a clear solution available in amber glass vials containing the equivalent of 50 mg sodium nitroprusside dihydrate in 2 mL solution.. Strength Volume ...

Special precautions for disposal and other handling

Any unused medicine or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Pfizer New Zealand Limited, P O Box 3998, Auckland, New Zealand, 1140, Toll Free Number: 0800 736 363

Date of first authorization / renewal of the authorization

Date of first approval: 01 Nov 2012

Date of revision of the text

30 January 2019

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