ZINFORO Powder for concentrate for solution (2018)
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Περιεχόμενα
Name of the medicinal product
Zinforo 600 mg powder for concentrate for solution for infusion.
Qualitative and quantitative composition
Each vial contains ceftaroline fosamil acetic acid solvate monohydrate equivalent to 600 mg ceftaroline fosamil. After reconstitution, 1 ml of the solution contains 30 mg of ceftaroline fosamil. For the ...
Pharmaceutical form
Powder for concentrate for solution for infusion (powder for concentrate). A pale yellowish-white to light yellow powder.
Therapeutic indications
Zinforo is indicated for the treatment of the following infections in adults and children from the age of 2 months (see sections 4.4 and 5.1): Complicated skin and soft tissue infections (cSSTI) Community-acquired ...
Posology and method of administration
Posology Adults and adolescents (aged from 12 to < 18 years with bodyweight ≥33 kg) with creatinine clearance (CrCL) > 50 mL/min: see Table 1. Table 1. Dosage in adults and adolescents (aged from 12 to ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hypersensitivity to the cephalosporin class of antibacterials. Immediate and severe hypersensitivity (e.g. anaphylactic ...
Special warnings and precautions for use
Hypersensitivity reactions Serious and occasionally fatal hypersensitivity reactions are possible (see sections 4.3 and 4.8). Patients who have a history of hypersensitivity to cephalosporins, penicillins ...
Interaction with other medicinal products and other forms of interaction
No clinical drug-drug interaction studies have been conducted with ceftaroline fosamil. The interaction potential of ceftaroline or ceftaroline fosamil on medicinal products metabolised by CYP450 enzymes ...
Fertility, pregnancy and lactation
Pregnancy There are no or limited amount of data from the use of ceftaroline fosamil in pregnant women. Animal studies conducted in rat and rabbit do not indicate harmful effects with respect to reproductive ...
Effects on ability to drive and use machines
Undesirable effects e.g. dizziness may occur and this may have an effect on the ability to drive and use of machines (see section 4.8).
Undesirable effects
Summary of the safety profile The most common adverse reactions occurring in ≥3% of approximately 3242 patients treated with Zinforo in clinical studies were diarrhoea, headache, nausea, and pruritus, ...
Overdose
Limited data in patients receiving higher than recommended Zinforo dosages show similar adverse reactions as observed in the patients receiving recommended dosages. Relative overdosing could occur in patients ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antibacterials for systemic use, other cephalosporins and penems ATC code: J01DI02 The active moiety after Zinforo administration is ceftaroline. Mechanism of action In vitro ...
Pharmacokinetic properties
The C<sub>max</sub> and AUC of ceftaroline increase approximately in proportion to dose within the single dose range of 50 to 1000 mg. No appreciable accumulation of ceftaroline is observed following multiple ...
Preclinical safety data
The kidney was the primary target organ of toxicity in both the monkey and rat. Histopathologic findings included pigment deposition and inflammation of the tubular epithelium. Renal changes were not reversible ...
List of excipients
Arginine
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
Shelf life <u>Dry powder:</u> 3 years. <u>After reconstitution:</u> The reconstituted vial should be diluted immediately. <u>After dilution:</u> Once the intravenous solution is prepared with diluents ...
Special precautions for storage
Store below 30°C. Store in the original package in order to protect from light. For storage conditions after reconstitution of the medicinal product, see section 6.3.
Nature and contents of container
20 ml glass vial (Type 1) closed with a rubber (halobutyl) stopper and aluminium seal with flip-off cap. The medicinal product is supplied in packs of 10 vials.
Special precautions for disposal and other handling
The powder must be reconstituted with water for injections and the resulting concentrate must then be immediately diluted prior to use. The reconstituted solution is a pale yellow solution that is free ...
Marketing authorization holder
Pfizer Ireland Pharmaceuticals, Operations Support Group, Ringaskiddy, County Cork, Ireland
Marketing authorization number(s)
EU/1/12/785/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 23 August 2012 Date of the latest renewal: 24 April 2017
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