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SPC, UK: VANCOMYCIN Powder for solution for intravenous infusion / oral use (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Vancomycin 1g Powder for Solution for Infusion.

Qualitative and quantitative composition

Each vial contains 1000 mg vancomycin hydrochloride equivalent to 1,000,000 IU vancomycin. For the full list of excipients, see section 6.1.

Pharmaceutical form

Powder for solution for intravenous infusion. Powder for solution for oral use. A white to cream coloured porous cake.

Therapeutic indications

Intravenous administration Vancomycin is indicated in all age groups for the treatment of the following infections (see sections 4.2, 4.4 and 5.1): Complicated skin and soft tissue infections (cSSTI). ...

Posology and method of administration

Posology Where appropriate, vancomycin should be administered in combination with other antibacterial agents. Intravenous administration The initial dose should be based on total body weight. Subsequent ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see section 4.4). Vancomycin should not be administered intramuscularly due to the risk of necrosis at the site ...

Special warnings and precautions for use

Hypersensitivity reactions Serious and occasionally fatal hypersensitivity reactions are possible (see sections 4.3 and 4.8). In case of hypersensitivity reactions, treatment with vancomycin must be discontinued ...

Interaction with other medicinal products and other forms of interaction

Concomitant administration of vancomycin and anaesthetic agents has been associated with erythema, histamine-like flushing and anaphylactoid reactions. There have been reports that the frequency of infusion-related ...

Pregnancy and lactation

Pregnancy Teratology studies have been performed at five times the human dose in rats and three times the human dose in rabbits, and have revealed no evidence of harm to the foetus due to vancomycin. In ...

Effects on ability to drive and use machines

Vancomycin has no or negligible influence on the ability to drive or use machines.

Undesirable effects

Summary of the Safety profile The most common adverse reactions are phlebitis, pseudo-allergic reactions and flushing of the upper body (red-neck syndrome) in connection with too rapid intravenous infusion ...

Overdose

Supportive care is advised, with maintenance of glomerular filtration. Vancomycin is poorly removed from the blood by haemodialysis or peritoneal dialysis. Haemoperfusion with Amberlite resin XAD-4 has ...

Pharmacodynamic properties

ATC Code: J01XA01 for intravenous use and A07AA09 for oral use. Mechanism of action Vancomycin is a tricyclic glycopeptide antibiotic that inhibits the synthesis of the cell wall in sensitive bacteria ...

Pharmacokinetic properties

Absorption Vancomycin is administered intravenously for the treatment of systemic infections. In the case of patients with normal renal function, intravenous infusion of multiple doses of 1g vancomycin ...

Preclinical safety data

Although no long-term studies in animals have been performed to evaluate carcinogenic potential, no mutagenic potential of vancomycin was found in standard laboratory tests. No definitive fertility studies ...

List of excipients

None.

Incompatibilities

Vancomycin solution has a low pH that may cause chemical or physical instability when it is mixed with other compounds. This medicinal product must not be mixed with other medicinal products except those ...

Shelf life

Shelf life Unopened: 36 months. Reconstituted solution intended for parenteral administration Physical and chemical stability have been demonstrated for a period of 24 hours when stored at 2° to 8°C. ...

Special precautions for storage

Unopened: Do not store above 25°C After reconstitution: Store at 2-8°C (see 6.3 Shelf Life).

Nature and contents of container

Packs* of one, two, five or ten Type II colourless glass 20ml vials stoppered with Type I rubber stopper, capped with a flip-off cap. * Not all pack sizes may be marketed

Special precautions for disposal and other handling

Preparation of solution: At the time of use, add 20ml of water for injections to the 1g vial. Vials reconstituted in this manner will give a solution of 50mg/ml. The reconstituted solution is clear and ...

Marketing authorization holder

Wockhardt UK Limited, Ash Road North, Wrexham LL13 9UF, United Kingdom

Marketing authorization number(s)

PL 29831/0322

Date of first authorization / renewal of the authorization

Date of first authorisation: 4 April 2008

Date of revision of the text

15/02/2019

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