Information för alternativet: Cefadroxil Mylan 100 Mg/Ml Pulver Till Oral Suspension, visar 2 alternativ

Välj alternativ:

1. Cefadroxil Mylan 100 Mg/Ml Pulver Till Oral Suspension
2. Cefadroxil Mylan 1 G Filmdragerad Tablett
3. Cefadroxil Mylan 500 Mg Kapsel, Hård

Document: Cefadroxil Mylan powder for oral suspension ENG SmPC change

• Cefadroxil Mylan powder for oral suspension SmPC
• Cefadroxil Mylan powder for oral suspension ENG SmPC

---

Weight (kg)	Age (years)	Dosage Suspension 100 mg/ml	Package
<10	<1	3 ml x 1	60ml
10-20	1-5	6 ml x 1	100 ml
20-30	5-10	9 ml x 1	100 ml
30-40	10-12	10 ml x 1	100 ml

Uncomplicated urinarytract infections:

_{12.5 mg/kgbodyweighttwicedaily.}

Weight (kg)	Age (years)	Dosage Suspension 100 mg/ml	Package
<10	<1	1.25 ml x 2	60 ml
10-20	1-5	2.5 ml x 2	60 ml
20-30	5-10	4 ml x 2	100 ml
30-40	10-12	5 ml x 2	100 ml

Seriousinfections e.g. urinarytract and respiratory tract infections:

_{25 mg/kgbodyweight twicedaily.}

Weight (kg)	Age (years)	Dosage Suspension 100 mg/ml	Package
<10	<1	2.5 ml x 2	60 ml
10-20	1-5	5 ml x 2	100 ml
20-30	5-10	8 ml x 2	60+100 ml
30-40	10-12	10 ml x 2	2x100 ml

Treatment should be applied 2 to 3 furtherdaysafter clinical symptoms fadeaway.In the case ofstreptococcal infections aminimum of 10 days is recommended.

Patients with impaired kidneyfunction

Thehalf-lifein plasmais prolonged with impaired kidneyfunction. Therecommended dose is 500 mg, but theintervalbetween doses should beincreased. With a creatinineclearanceof 25-50 ml/min a dosemaybegiven every12 hours,with 10-25 ml/min every24 hoursand withcreatinineclearanceof less than 10 ml/min one every36 hours.

Method of administration

For oral use.

Cefadroxilshould betaken with food.

Thesuspension should beshaken wellbeforeuse.

For instructions on reconstitution of the medicinal product before administration, see section 6.6.

4.3 Contraindications

Hypersensitivity, or suspected hypersensitivity,to the active substance, other cephalosporins or to anyof theexcipients listed in section 6.1.

4.4 Specialwarnings andprecautionsforuse

Special caution is calledforwhen known penicillin allergyis present,as cross-allergymay occur.

Asaconsequenceoftreatment with cephalosporins, in exceptional cases a false positiveCoombs test hasbeen reported.

Duringtreatment with cefadroxil, afalse positive reaction forglucosein theurinemayoccurwhenBenedict´s orFehling´s solutions, copper sulfate orClinitest tablets areusedin thetest, butnot in the enzymetest with Clinistix.

Patients with rarehereditaryproblems offructoseintolerance,glucose-galactose malabsorption or sucrase-isomaltaseinsufficiencyshould not takethis medicine. 1 ml of Cefadroxil Mylanoral suspension contains approximately 0.621 g of sucrose. This should be taken into account when doses of 8 ml or above are given to patients with diabetes mellitus.

4.5 Interaction with othermedicinal products andotherforms ofinteraction

- Theoccurrenceof diarrhoeamayimpair theabsorption ofothermedicaments and thereforelead toan impairment oftheirefficacy.

- Forced diuresisleads to adecreaseofcefadroxilblood levels.

- Cefadroxilshould not be combined with bacteriostaticantibiotics (e.gtetracycline, erythromycin, sulfonamides, andchloramphenicol) sincean antagonistic effect is possible.

- Treatment with cefadroxil in combination with aminoglycoside antibiotics,polymyxin B, vancomycin,colistin or high-doseloop diuretics should beavoided sincesuch combinations can potentiatenephrotoxic effects.

- Theconcomitant administration of probenecid canproducehigher and sustained concentrations of cefadroxilin theserum and in the bile.

- As with othercephalosporins (in high doses)frequent checks oncoagulation parameters arenecessaryduringconcomitant long-term use ofanticoagulants or thrombocyteaggregationinhibitors to avoid haemorrhagiccomplications.

4.6 Fertility, pregnancy andlactation

Pregnancy

Studies in animals did not reveal anyteratogeniceffect.In theabsenceof teratogeniceffects in animals, amalformativeeffect is not expectedin humans.

To present time, substances causingmalformation in humans havebeen shown to be teratogenic in animals duringwell-conducted studies in two species.

Inclinical practice, analysisof alargenumber ofexposedpregnancies did not appear to revealanymalformativeorfoetotoxic effect specificallyrelated tocefadroxil. However, absenceof risk could beconfirmed byepidemiological studies.

Consequently, cefadroxilcan beprescribed during pregnancy, if necessary.

Breast-feeding

Low levels of cefadroxilareexcreted in breast milk and the ingested quantities arelower than therapeuticdoses. Consequently, breast-feedingispossible when takingthis antibiotic. However, breast-feeding (ortreatment) should bediscontinued if theinfantdevelops diarrhoea, candidosis oraskin eruption.

4.7 Effects on ability to driveandusemachines

No effects havebeen observed.

4.8 Undesirable effects

Theadverseeffects arepresentedaccordingto thefrequencyof thecases,

Verycommon (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); veryrare(<1/10,000);not known (cannot beestimated from the available data).

About 6%of patients takingthe preparation sufferfrom undesirableeffects.

- Infections and infestations:

Uncommon: Clinical pictures dueto agrowth ofopportunistic organisms (fungi) such as vaginal mycoses or thrush.

Rare: Eosinophilia, thrombocytopenia, leucopenia, neutropenia, agranulocytosis occurduringprolonged usebut subsideupon discontinuation oftherapy.

Not known: haemolyticanaemia.

- Nervous system disorders:

Veryrare: Headache, dizziness, nervousness, sleeplessness, fatigue.

- Gastrointestinal disorders:

Common: Nausea, vomiting, diarrhoea, dyspepsia,abdominal pain, glossitis.

Not known: pseudomembranous colitis has been reported.

- Hepatobiliary disorders:

Rare: Minor elevation ofserum transaminases (ASAT, ALAT) and alkaline phosphatases.

- Skin and subcutaneous tissue disorders:

Common: Pruritus, rash,allergic exanthema, urticaria.

Rare: Angioneuroticoedema, drugfever, serum sickness-likereactions,

Veryrare:Immediate allergicreaction (anaphylacticshock).

Not known: Stevens Johnson syndromeand erythema multiforme havebeen reported.

- Musculoskeletal and connective tissue disorders:

Rare: arthralgia

- Renal and urinary disorders:

Rare: interstitial nephritis.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via [To be completed nationally].

4.9 Overdose

Toxicity:Acute toxicityvaries fordifferent substances butgenerallyspeakingappears low.

Incases of impaired kidneyfunction, parenteral administration ofhigh doses has givenriseto neurological symptoms.

Symptoms:Inexceptional cases, anaphylacticshock mayoccur within 20-40 minutes; a fallin blood pressurewith tachycardiaor bradycardia, breathingdifficulties, nausea, vomiting, exanthema, oedema. Toxic reactions: nausea, vomiting, diarrhoea, electrolyticdisorders, reducedconsciousness,muscular fasciculations, myoclonia,cramps, coma. Haemolytic reactions: kidneyinsufficiency, acidosis. Possiblycoagulopathyand impairment ofalready impaired kidneyfunction.

Treatment: When justified; ventricle emptying,charcoal. Symptomatic treatment. Possibly dialysisin toxic reactions and impaired kidneyfunction.

5. PHARMACOLOGICALPROPERTIES

5.1 Pharmacodynamicproperties

Pharmacotherapeuticgroup: Antibacterials forsystemic use,otherbeta-lactam antibacterials, first generation cephlasporins, ATC code: J01DB05.

Mechanism of action

Cefadroxilis a semisynthetic cephalosporin derivativefororal administration which inhibits bacterial wallsynthesisof activelydividing cells bybindingto one ormorepenicillin-binding proteins. Theresultis formation of adefectivecellwallthat is osmoticallyunstable. Cefadroxilexhibits time-dependent bactericidal activity.

Breakpoints

ThefollowingMIC breakpoints aresuggested: Susceptible: <1 mg/l

Resistant: >16 mg/l

Susceptibility

Susceptible Betahaemolyticstreptocci groupA, C, Gand B Staphylococcus aureus¹

Other staphylococci includingS. saprophyticus¹

Streptococcus pneumoniaeandanaerobicstreptococci

Intermediately susceptible	E. coli2 Klebsiella spp. 2 Proteus mirabilis2 Moxarella catarrhalis3
Resistant	Citrobacter spp, Enterobacter spp, Proteus ssp (indol positive) Serratia spp Morganella morganii Campylobacter Haemophilus influenzae Pseudomonas spp including Ps. aeruginosa, Clostridium difficile, Listeria monocytogenes, Legionella, Chlamydia and Mycoplasma spp Enterococci Anaerobic gramnegative rods

¹_{S. aureus and otherstaphylococci includingbetalactamaseproducingstrains}

²E. Coli and Klebsiellaspp., P. mirabilis:Considered susceptible in lowerurinarytract infection

³M. catarrhalis: Betalactamaseproducingstrains, which arein majority,areresistant

All betahaemolyticstreptocci aresusceptible to beta lactam antibiotics andno resistancehas yet been observed. Cefadroxilcannot be used against gram positive rods with plasmid mediated betalactamaseproduction (TEM, SHV)as the substancewillbehydrolysedand inactivated. Thus, resistant isolates of E. coli, Klebsiellaspp, and P. mirabilis maybe encountered.

There can becross-resistancewithin the betalactam antibiotics group(penicillins and cefalosporins).

Penicillin resistant pneumococci and meticillin resistant Staphylococcusaureus areresistant to cefadroxil.

Resistancecan develop during treatment in the followingspecies: Enterobacter, Citrobacter, Pseudomonas (predominatelyaeruginosa), Morganellaand Serratia.

5.2 Pharmacokineticproperties

Absorption

Cefadroxilis stablein an acid environment, and isabsorbed justas wellinconjunction with foodas without. Maximal serum concentration (approx. 16 microg/ml afterasingle doseof

500 mgcefadroxil) is attained about 1.5 hours after ingestion.

Distribution

About 20%of cefadroxilisbound to serum proteins.

Elimination

Cefadroxilis excreted via glomerular filtration andtubular secretion. After24 hours, approx. 90%of theactive substancewillhavebeenexcreted in the urine. In people with normally functioningkidneys, thehalf-lifeofcefadroxilin serum is about 1 hour 20minutes.

After asingle doseof 1gofcefadroxil, sufficient concentrationsofcefadroxilarepresentin theurineafter 24 hours to combat the most commonlyoccurringurinal tract pathogens.

5.3 Preclinical safety data

Thereis no preclinical data ofrelevanceforthe safety-judgement beyondwhat has already been considered in theSummaryof Product Characteristics.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Silica, colloidal anhydrous, magnesium stearate, guar galactomannan, saccharin, titanium

dioxide (E171), talc, sucrose, peach-apricot flavour.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

After reconstitutions (ready prepared oral suspension) 14 days at 2-8°C or 7 days at 25°C

6.4 Special precautions for storage

For storage conditions after reconstitution of the medicinal product, see section 6.3. Keep the container in the outer carton in order to protect from light.

6.5 Nature and contents of container

Powder for oral suspension 100 mg/ml: 60 ml and 100 ml in amber glass bottles with cap to cap closures made of polypropylene.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

Ready to use suspension – white to slightly yellowish suspension

60ml of ready – for – use suspension is obtained by adding 30ml of water to 45g of powder.

100ml of ready – for – use suspension is obtained by adding 50ml of water to 75g of powder.

7. MARKETING AUTHORISATION HOLDER

[To be completed nationally]

8. MARKETING AUTHORISATION NUMBER(S)

[To be completed nationally]

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

[To be completed nationally]

10. DATE OF REVISION OF THE TEXT

2016-05-19