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SPC, UK: Rocephin 250mg, 1g and 2g vials (2012)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Roche Products Limited
Διεύθυνση :
Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, Hertfordshire, AL7 1TW
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Name of the medicinal product

Rocephin 250mg vials. Rocephin 1g vials. Rocephin 2g vials.

Qualitative and quantitative composition

Each 250mg vial contains 250mg ceftriaxone as 298.3mg hydrated disodium ceftriaxone. Each 1g vial contains 1g ceftriaxone as 1.19g hydrated disodium ceftriaxone. Each 2g vial contains 2g ceftriaxone as ...

Pharmaceutical form

Powder for solution for injection. Powder for solution for injection. Powder for solution for infusion.

Therapeutic indications

Ceftriaxone is indicated for the treatment of the following infections when known or likely to be due to one or more susceptible micro-organisms (see section 5.1) and when parenteral therapy is required: ...

Posology and method of administration

Rocephin may be administered by deep intramuscular injection, slow intravenous injection, or as a slow intravenous infusion, after reconstitution of the solution according to the directions given below. ...

Contraindications

Rocephin is contraindicated in patients with known hypersensitivity to beta-lactam antibiotics. In patients hypersensitive to penicillin, the possibility of allergic cross-reactions should be borne in ...

Special warnings and precautions for use

As with other cephalosporins, anaphylactic reactions with fatal outcome were also reported, even if a patient is not known to be allergic or previously exposed. Before therapy with ceftriaxone is instituted, ...

Interaction with other medicinal products and other forms of interaction

No impairment of renal function has so far been observed after concurrent administration of large doses of Rocephin and potent diuretics (e.g. furosemide). No interference with the action or increase in ...

Pregnancy and lactation

Pregnancy For ceftriaxone, limited clinical data on exposed pregnancies are available. Ceftriaxone crosses the placental barrier. Reproductive studies in animals have shown no evidence of embryotoxicity, ...

Effects on ability to drive and use machines

Since Rocephin sometimes induces dizziness the ability to drive and use machines can be impaired.

Undesirable effects

The most frequently reported adverse events for ceftriaxone are diarrhoea, nausea and vomiting. Other reported adverse events include hypersensitivity reactions such as allergic skin reactions and anaphylactic ...

Overdose

In the case of overdose nausea, vomiting, diarrhoea, can occur. Ceftriaxone concentration can not be reduced by haemodialysis or peritoneal dialysis. There is no specific antidote. Treatment is symptomatic. ...

Pharmacodynamic properties

ATC classification Pharmacotherapeutic group: cephalosporins and related substances ATC code: J01DA13 Mode of action Ceftriaxone has bactericidal activity resulting from the inhibition of bacterial cell ...

Pharmacokinetic properties

The pharmacokinetics of Rocephin are largely determined by its concentration-dependent binding to serum albumin. The plasma free (unbound) fraction of the drug in man is approximately 5% over most of the ...

Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

List of excipients

None.

Incompatibilities

Solutions containing ceftriaxone should not be mixed with or added to solutions containing other agents. In particular, diluents containing calcium, (e.g. Ringers solution, Hartmanns solution) should not ...

Shelf life

3 years. For shelf life of diluted product see section 6.6.

Special precautions for storage

Do not store above 25°C. Keep vial in the outer carton. For shelf life of diluted product see section 6.6.

Nature and contents of container

Rocephin 250mg and 1g: Type 1 Ph. Eur 15ml glass vial with teflonised rubber stopper and aluminium cap, containing a sterile, white to yellowish-orange crystalline powder. Packs of 1 vial. Rocephin 2g: ...

Special precautions for disposal and other handling

Instructions for use, handling and disposal Preparation of solutions for injection and infusion The use of freshly prepared solutions is recommended. These maintain potency for at least 6 hours at or below ...

Marketing authorization holder

Roche Products Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom

Marketing authorization number(s)

Vials 250mg: PL 00031/0169 Vials 1g: PL 00031/0171 Vials 2g: PL 00031/0172

Date of first authorization / renewal of the authorization

23 October 2003

Date of revision of the text

7 July 2010
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