Ospamox - instructions for use, dose, side effects, contraindications

core: active ingredient: amoxicillin trihydrate - 547.0 mg (in terms of amoxicillin - 500.0 mg); Excipients: perfume peach-apricot - 1.4 mg, flavoring orange - 2.0 mg, magnesium stearate 2.2 mg, aspartame 2.4 mg, croscarmellose sodium 10.0 mg, mannitol 12.0 mg, talcum powder - 15.0 mg, silicon dioxide colloidal anhydrous - 30.0 mg, microcrystalline cellulose - 51.0 mg;

shell: aspartame 0.23 mg, mannitol 2.45 mg, maltodextrin 2.45 mg, starch 2.45 mg, titanium dioxide 2.57 mg, talc 3.85 mg.

1 tablet dispersible 750 mg contains:

core: active ingredient: amoxicillin trihydrate 861.0 mg (in terms of amoxicillin 750.0 mg); Excipients: flavored with peach-apricot 2.1 mg, orange flavor 3.0 mg, magnesium stearate 3.3 mg, aspartame 3.6 mg, croscarmellose sodium 15.0 mg, mannitol 18.0 mg, talcum powder, 22.5 mg, silicon dioxide colloidal anhydrous - 45.0 mg, microcrystalline cellulose - 76.5 mg;

sheath: aspartame 0.30 mg, mannitol 3.50 mg, maltodextrin 3.50 mg, starch 3.50 mg, titanium dioxide 3.70 mg, talc 5.50 mg.

1 tablet dispersible 1000 mg contains:

core: active substance: amoxicillin trihydrate - 1148.0 mg (in terms of amoxicillin - 1000.0 mg); Excipients: peach-apricot flavoring 2.8 mg, orange flavor 4.0 mg, magnesium stearate 4.4 mg, aspartame 4.8 mg, croscarmellose sodium 20.0 mg, mannitol 24.0 mg, talcum powder, 30.0 mg, silicon dioxide colloidal anhydrous - 60.0 mg, microcrystalline cellulose - 102.0 mg;

shell: aspartame 0.40 mg, mannitol 4.20 mg, maltodextrin 4.20 mg, starch 4.20 mg, titanium dioxide 4.40 mg, talc 6.60 mg.

Description:

Dosage 500 mg: oblong, biconvex tablets from white to yellow-white, with a risk on both sides, with a width of about 8 mm and a length of about 18 mm. On the cross-section the tablet is white to yellow-white.

Dosage of 750 mg: oblong, biconvex tablets from white to yellow-white, with a risk on both sides, with a width of about 9 mm and a length of about 20 mm. On the cross-section the tablet is white to yellow-white.

Dosage of 1000 mg: oblong, biconvex tablets from white to yellow-white, with a risk on both sides, with a width of approximately 10 mm and a length of approximately 22 mm. On the cross-section the tablet is white to yellow-white.

Pharmacotherapeutic group:Antibiotic-penicillin semisynthetic

ATX: & nbsp

J.01.C.A.04 Amoxicillin

Pharmacodynamics:

Amoxicillin is an aminobenzyl penicillin, a semisynthetic broad-spectrum antibiotic that has a bactericidal effect by inhibiting bacterial cell wall synthesis.

The threshold values of the minimum inhibitory concentration (MIC) for various sensitive organisms vary.

Boundaries of resistance

The boundary values of the MIC for amoxicillin, according to the European Committee for the Study of Antimicrobial Susceptibility (EUCAST), version 5.0.

Pathogen	The boundary values of the MIC (mg / L)
Pathogen	Sensitive ≤	Stable>
Enterobacteriaceae	8¹	8
Staphylococcus spp.	see note²	see note²
Enterococcus spp.³	4	8
Streptococcus groups A, B, C and G	see note⁴	see note⁴
Streptococcus pneumoniae	see note⁵	see note⁵
Streptococcus groups viridans	0,5	2
Haemophilus influenzae	2⁶	2⁶
Moraxella catarrhalis	see note⁷	see note ⁷
Neisseria meningitidis	0,125	1
Gram-positive anaerobes, except Clostridium difficile⁸	4	8
Gram-negative anaerobes⁸	0,5	2
Helicobacter pylori	0,125⁹	0,125⁹
Pasteurella multocida	1	1
Boundary values without a specific type of bacteria¹⁰	2	8

¹The wild type of enterobacteria is classified as susceptible to aminopenicillin. In some countries, preference is given to a separate classification of wild types of strains E. coli and P.mirabilis as intermediate products. In this case, use the IPC boundary value S ≤0.5 mg / l.

²Most staphylococci are resistant to amoxicillin, thanks to the ability to synthesize penicillinase. Methicillin-resistant strains, with some exceptions, are resistant to beta-lactam antibiotics.

³ Susceptibility to amoxicillin can be determined by ampicillin.

⁴Susceptibility to penicillin streptococci group A, AT, FROM and G can be determined by benzylpenicillin.

⁵Boundary values refer only to non-meningitis strains. If strains are classified as an intermediate product of ampicillin, oral amoxicillin treatment should be avoided. Susceptibility is determined by the value of the MIC for ampicillin.

⁶Boundary values refer to intravenous use. Strains synthesizing beta-lactams should be considered as resistant.

⁷Strains synthesizing beta-lactamases should be considered as resistant strains.

⁸Susceptibility to amoxicillin can be determined by benzylpenicillin.

⁹Boundary values refer to epidemiological clipping points that distinguish wild types of strains and strains with reduced susceptibility.

¹⁰ Boundary values without a certain type of bacteria, refer to a dosage of at least 0.5 g 3-4 times a day (from 1.5 to 2 g / day).

The sensitivity of microorganisms to amoxicillin in the laboratory

Usually sensitive pathogens

Aerobic Gram-positive microorganisms:

Enterococcus faecalis

Beta-hemolytic streptococci (groups A, B, C and G)

Listeria monocytogenes

Types of bacteria in which acquired resistance is possible

Aerobic Gram-negative microorganisms:

Escherichia coli

Haemophilus influenzae

Helicobacter pylori

Proteus mirabilis

Salmonella typhi

Salmonella paratyphi

Shigella spp.

Pasteurella multocida

Aerobic Gram-positive microorganisms:

Coagulase-negative staphylococci

Staphylococcus aureus¹

Streptococcus pneumoniae

Streptococcus groups viridans

Anaerobic Gram-positive microorganisms:

Clostridium spp.

Anaerobic Gram-negative microorganisms:

Fusobacterium spp.

Other microorganisms:

Borrelia burgdorferi

Naturally resistant organisms²

Aerobic Gram-positive microorganisms:

Enterococcus faecium¹

Aerobic Gram-negative microorganisms:

Acinetobacter spp.

Enterobacter spp.

Klebsiella spp.

Pseudomonas spp.

Anaerobic Gram-negative microorganisms:

Bacteroides spp. (some strains Bacteroides fragilis resistant)

Other microorganisms:

Chlamydia spp.

Mycoplasma spp.

Legionella spp.

¹Natural average sensitivity in the absence of acquired mechanisms of resistance.

²Almost all strains S. aureus are resistant to amoxicillin, since they produce penicillinase.

Bacteria can have resistance to amoxicillin (and hence ampicillin) by production of beta-lactamase, hydrolyzing aminopenicillins (which may be inhibited by clavulanic acid), changes in penicillin-binding proteins, disturbances in permeability to the drug or due to operation of a special pump action pumps efflux drug from the cell. In one microorganism can simultaneously present multiple resistance mechanisms that explain the existence of the variable and unpredictable cross-resistance to other beta-lactam antibiotics and antibacterial agents from other groups.

The prevalence of resistant strains varies geographically and at different times, so it is advisable to focus on local information on resistance, especially when treating severe infections.

Pharmacokinetics:

After oral administration amoxicillin fast absorbed from the gastrointestinal tract (GIT), the absolute bioavailability with oral administration is 75-90%.Food intake does not affect the absorption of amoxicillin, so the drug can be taken while eating. Absorption of amoxicillin is linear in the dose range from 250 mg to 1000 mg. The maximum concentrations (C_mOh) in the blood plasma are achieved 1-2 hours after ingestion. After a single dose of amoxicillin inside at a dose of 500 mg C_mOh in the blood plasma was in the range of 6-11 mcg / ml, after oral administration at a dose of 3000 mg - 27 mcg / ml.

Binding to plasma proteins - 17%. Has a large volume allocation of: in high concentrations is found in blood plasma, sputum, bronchial secretion (in the purulent bronchial secretion the distribution is weak), the fluid of the middle ear (with its inflammation), the mucous membrane of the paranasal sinuses, the fluid contained in the blisters, the tissue of the tonsils, urine, gall bladder (with normal liver function), poorly penetrates the blood-brain barrier, with inflammation of the meninges, the concentration in the cerebrospinal fluid is about 20% of the concentration in the blood plasma. Amoxicillin penetrates the placental barrier and is found in small amounts in breast milk.

Partially is metabolized with the formation of inactive metabolites. 50-70% is displayed in an unchanged form by the kidneys (via tubular secretion - 80% and glomerular filtration - 20%) after 6 hours, 10-20% - the liver. About 7-25% the initial dose of amoxicillin is excreted as an inactive metabolite, penicillic acid. The half-life (T_1/2) amoxicillin in patients with normal renal function is 1-1.5 h. Amoxicillin is removed during hemodialysis.

Special patient groups

Age

T_1/2 amoxicillin in children aged 3 months to 2 years is similar to T_1/2in older children and adults.

Since elderly patients have an increased likelihood of reducing renal function, dose selection is performed with caution, and monitoring of renal function is also necessary.

Floor

When administered orally to healthy men and women, the sex of patients does not significantly affect the pharmacokinetics of amoxicillin.

Renal insufficiency

The total serum clearance of amoxicillin increases in proportion to the decrease in renal function. If the kidney function is impaired (creatinine clearance (CC) ≤ 15 ml / min) T_1/2 increases and can reach an anuria of 8.5 hours.

Liver failure

In patients with impaired liver function, dose selection is performed with caution, and regular monitoring of liver function is necessary.

Indications:

Infectious-inflammatory diseases caused by microorganisms sensitive to amoxicillin:

- infections of the upper respiratory tract, including infections of the ear, nose and throat: acute otitis media, acute sinusitis and tonsillitis;

- infections of the lower respiratory tract: exacerbation of chronic bronchitis, community-acquired pneumonia;

- infections of the gastrointestinal tract: bacterial enteritis;

- eradication Helicobacter pylori in combination therapy;

- infections of the genitourinary system: cystitis;

- infections of the skin and soft tissues;

- endocarditis: prophylaxis of endocarditis in patients at risk for endocarditis (for example, during dental procedures);

- Lyme disease (early stage).

Contraindications:

- Hypersensitivity to amoxicillin, other beta-lactam antibiotics (other penicillins, cephalosporins, carbapenems, monobactams) or any components of the drug;

- phenylketonuria;

- children under 1 year (for this dosage form).

Carefully:

- Acute lymphoblastic leukemia;

- Infectious mononucleosis;

- a violation of the function of the kidneys of severe severity (see section "Method of administration and dose");

- pregnancy and the period of breastfeeding.

Pregnancy and lactation:

During pregnancy and during breastfeeding, Ospamox^®apply only if the intended benefit to the mother exceeds the potential risk to the fetus and the baby.

Studies in animals have not revealed data on the dangers of taking Ospamox^® during pregnancy and its effect on embryonic development of the fetus.

Amoxicillin penetrates into breast milk in small amounts. Infants who are breastfed may develop sensitization, diarrhea, candidiasis of the oral mucosa. In such cases, breastfeeding should be discontinued.

Dosing and Administration:

Inside, regardless of food intake. In order to reduce the risk of developing adverse events from the gastrointestinal tract, it is recommended to take the drug while eating.

The tablet can be swallowed whole, divided by risk into two equal parts or chewed with a glass of water, and can be dissolved in water to form a syrup (at least 10 ml of water for every 250 mg of amoxicillin, that is 20 ml of water per tablet with a dosage of 500 mg) or suspension (in 100 ml).The dosage regimen is set individually depending on the age, body weight, function of the patient's kidneys and the severity of the infection.

The course of treatment is 5-12 days. Typically, therapy is recommended to continue for 2-3 days after the disappearance of symptoms.

In the case of infection of mild to moderate severity, the duration of taking the drug is 5-7 days. In infections caused by beta-hemolytic streptococcus, complete eradication of the pathogen requires a therapy for at least 10 days.

Adults and children 12 years of age or older or with a body weight of 40 kg or more

The standard dose is from 750 mg to 3000 mg of amoxicillin per day, divided into 2-3 doses.

For infectious and inflammatory diseases of mild and moderate severity, it is recommended to use the drug 500-750 mg 2 times a day or 500 mg 3 times a day.

In the treatment of severe infections, as well as infections with hard-to-reach foci of infections (eg, acute otitis media), a three-time administration of the drug is recommended.

In chronic diseases, recurrent infections, infections of severe course, the dose of the drug can be increased to 750-1000 mg 3 times a day.

Special recommendations for dosing

Indications for use *	Dosage*
Acute Sinusitis	From 250 mg to 500 mg every 8 hours or from 750 mg to 1 g every 12 hours
Acute otitis media	500 mg every 8 hours or from 750 mg to 1 g every 12 hours. In severe cases, from 750 mg to 1 g every 8 hours for 10 days
Acute tonsillitis and pharyngitis
Exacerbation of chronic bronchitis
Community-acquired pneumonia	From 500 mg to 1 g every 8 hours
Eradication Helicobacter pylori in combination therapy	From 750 mg to 1 g 2 times a day in combination with one of the proton pump inhibitors (for example, omeprazole, lansoprazole) and other antibiotics (for example, clarithromycin, metronidazole) for 7 days
Acute cystitis, acute pyelonephritis	In severe cases, 750 mg to 1 g every 8 hours. In acute cystitis can be given in a dose of 3 g 2 times for 1 day
Prophylaxis of endocarditis	2 g, once for 30-60 minutes before the operation
Lyme disease (early stage)	From 500 mg to 1 g every 8 hours (4 g per day maximum) for 14 days (10-21 days)
* Treatment in each case should be prescribed in accordance with the official guidelines for the therapy of this disease.

Children from 1 year to 12 years of age or with a body weight of less than 40 kg

The daily dose of amoxicillin for children is 25-50 mg / kg / day, divided into 3 doses (maximum 60 mg / kg / day), depending on the indications and severity of the disease.

Children up to 1 year are recommended to use Ospamox® powder to prepare a suspension for ingestion, 125 mg / 5 ml, 250 mg / 5 ml, 500 mg / 5 ml (see Instructions for use of the drug).

Method of preparation preparation

To take the drug in a dissolved form, 1/2 tablet (dosage depending on the calculated daily dose per kg of body weight) should be dissolved in water, taking into account the ratio: not less than 10 ml of water for every 250 mg of amoxicillin.

Special recommendations for dosing

Prophylaxis of endocarditis: 50 mg / kg once for 1 hour before the operation.

Patients with impaired renal function

In patients with CK> 30 ml / min there is no need for dose adjustment.

At CC <30 ml / min, it is recommended to increase the interval between doses or reduce the subsequent doses.

kk	Dosage regimen of Ospamox^® in adults and children 10 years and older or with a body weight of 40 kg or more	Dosage regimen of Ospamox^®in children under 10 years of age or with a body weight of less than 40 kg
10-30 ml / min	500 mg twice a day	The standard dose is 2 times a day (corresponding to a 2/3 dose intake)
<10 ml / min	500 mg per day	The standard dose is 1 time per day (which corresponds to the reception of 1/3 of the dose)

When hemodialysis: 500 mg at the end of the procedure.

Have patients with impaired liver function correction of the dose is not required.

Side effects:

According to the World Health Organization (WHO), unwanted effects are classified according to their frequency of development as follows: very often (≥1/10), often (from ≥1 / 100 to <1/10), infrequently (from ≥1 / 1000 to <1/100), rarely (from ≥1 / 10000 to <1/1000), very rarely (<1/10000); frequency is unknown - according to available data, it was not possible to establish the frequency of occurrence.

Infectious and parasitic diseases

rarely: Candidiasis of the skin and mucous membranes.

Violations of the blood and lymphatic system

rarely: reversible leukopenia (including severe neutropenia and agranulocytosis), reversible thrombocytopenia or hemolytic anemia, increased coagulation time, increased prothrombin time (see section "Specific guidance").

Immune system disorders

rarely: severe allergic reactions, including angioedema, serum sickness,allergic vasculitis and anaphylaxis;

frequency is unknown: the Yarisch-Gerxheimer reaction (see Fig. section "Special instructions").

Disturbances from the nervous system

rarely: hyperkinesia (increased muscular excitability), dizziness and convulsions (seizures may occur in patients with impaired renal function, epilepsy, meningitis or receiving high doses of the drug).

Disorders from the gastrointestinal tract

often: discomfort in the stomach, nausea, loss of appetite, vomiting, flatulence, loose stools, diarrhea, enanthema (in part, around the mouth), dryness of the oral mucosa, taste disorders (as a rule, these undesirable symptoms are mild and disappear during treatment or soon after its completion, the frequency of their occurrence can be reduced by taking amoxicillin while eating);

rarely: change in the color of the surface layer of tooth enamel * (observed in children, especially when using a suspension, is usually easily eliminated by brushing teeth), black (hairy) tongue *, antibiotic-associated colitis (including pseudomembranous colitis and hemorrhagic colitis ).

Disturbances from the liver and bile ducts

rarely: hepatitis, cholestatic jaundice, moderate and transient increase in the activity of "hepatic" enzymes.

Disturbances from the skin and subcutaneous tissues

often: skin rash;

infrequently: itching, urticaria (the immediate appearance of urticaria indicates an allergic reaction to amoxicillin and requires discontinuation of therapy);

rarely: multiforme exudative erythema *, acute generalized (exanthematous) pustules *, Stevens-Johnson syndrome *, toxic epidermal necrolysis * (Lyell's syndrome), bullous and exfoliative dermatitis *.

Disorders from the kidneys and urinary tract

rarely: acute interstitial nephritis, crystalluria.

* unwanted reactions recorded in postmarketing period.

Overdose:

Symptoms: gastrointestinal disorders (abdominal pain, diarrhea, nausea, vomiting), kidney or nervous system (seizures in patients with impaired renal function or taking high doses of the drug), manifestations of water-electrolyte balance disorders. Crystalluria in the presence of amoxicillin in some cases can lead to the development of renal failure.

Treatment: symptomatic, there is no specific antidote.Recommended intake of adsorbents (Activated carbon), as a rule, there are no indications for gastric lavage; correction of disturbance of water electrolyte balance. Hemodialysis is effective.

Interaction:

Joint application with allopurinol can lead to the development of allergic skin reactions. It is not recommended simultaneous use of amoxicillin and allopurinol.

Possible increase in absorption digoxin on the background of amoxicillin therapy. Digoxin dose adjustment may be required.

Amoxicillin improves efficacy indirect anticoagulants (suppressing the intestinal microflora, reduces the synthesis of vitamin K and prothrombin index).

In some cases, the drug may increase prothrombin time (PI) and the international normalized ratio (INR), and therefore caution should be exercised while using anticoagulants and the Ospamox preparation^® and carefully monitor the PV and MNO. It may be necessary to adjust the dose of anticoagulants or to cancel amoxicillin.

Amoxicillin should not be used concomitantly in combination from bacteriostatic antibiotics, such as erythromycin, tetracyclines, chloramphenicol, sulfonamides, because of a possible decrease in activity (antagonistic action).

With simultaneous application methotrexate and amoxicillin may increase the toxicity of the former, probably because of competitive inhibition of tubular renal secretion of methotrexate amoxicillin. It is recommended to regularly monitor the concentration of methotrexate in the blood serum.

The use of amoxicillin and probenecid not recommended, t. probenecid reduces the renal tubular secretion of amoxicillin, thereby increasing its plasma concentration and prolonging its time in the serum.

Simultaneous reception of amoxicillin with estrogen-containing oral contraceptives can lead to a decrease in their effectiveness and an increased risk of bleeding ("breakthrough").

Special instructions:

Before starting treatment, it is necessary to interview the patient to identify in a history of hypersensitivity reactions to penicillins, cephalosporins or other beta-lactam antibiotics. In patients who have increased sensitivity to penicillins, there may be cross-allergic reactions with cephalosporins.

When penicillins were used, anaphylactic reactions were detected, including fatalities. In rare cases, it is possible to develop anaphylactic shock or other severe allergic reactions.

Similar reactions are possible in patients with increased sensitivity to beta-lactam antibiotics in the anamnesis or atopy. In the case of severe allergic reactions, amoxicillin cancellation and alternative treatment are required.

In patients with severe impairment of renal function, excretion of amoxicillin may be delayed and, depending on the severity of renal failure, a dose reduction of the drug may be required. See section "Dosing and Administration"). The forced diuresis accelerates the elimination of amoxicillin and reduces its plasma concentration.

Crystalluria can be observed in patients with decreased urinary excretion, mainly with parenteral administration of amoxicillin. Because the amoxicillin is deposited in urinary catheters, it is necessary to regularly check the patency of catheters, monitor the adequacy of intake and elimination of fluid in order to minimize the risk of amoxicillin-associated crystalluria.

Do not use amoxicillin for the treatment of infections, the pathogens of which are not sensitive to amoxicillin (cf. section "Pharmacological properties"), it is especially important to take this into account in the treatment of infections of the genitourinary system and severe infections of the ear, nose and throat. Perhaps the development of superinfection due to the growth of microflora insensitive to amoxicillin, which requires a corresponding change in antibacterial therapy.

It is not recommended to use the drug in patients with infectious mononucleosis, t. amoxicillin can provoke the appearance of a measles-like rash.

With the intake of almost all antibiotics, the development of antibiotic-associated colitis is possible up to a life-threatening state. This should be considered when there is diarrhea during or after antibiotic therapy. If the antibiotic-associated colitis develops, the drug should be discontinued immediately and consult a doctor for appropriate treatment. The use of drugs that inhibit intestinal peristalsis is contraindicated.

When using the drug for a long time and / or in high doses, you should regularly monitor the general blood test, liver and kidney function.

Therapy with high doses of beta-lactam antibiotics in patients with a history of renal insufficiency or convulsions, epilepsy, which is being treated, and damage to the meninges can rarely lead to convulsions.

The appearance of generalized erythema at the beginning of treatment, accompanied by pustules, may be a symptom of acute generalized exanthematous pustules. This requires discontinuation of treatment, further use of the drug is contraindicated.

The Yarisch-Gerxheimer reaction can be observed with the use of amoxicillin for the treatment of Lyme disease and is directly related to the bactericidal action of amoxicillin on the causative agent of spirochete Borrelia burgdorferi. Clinical manifestations: fever, chills, headache, myalgia, skin reactions in the region of the erythema foci. Patients should understand that the development of the Yarisch-Gerxheimer reaction is a common consequence of treating Lyme disease.

Lab tests: high concentrations of amoxicillin give a false positive reaction to urine glucose when using a Benedict reagent or Felling solution. It is recommended to use enzymatic glucose oxidase tests. Amoxicillin can reduce the amount of estriol in the urine of pregnant women.

Effect on the ability to drive transp. cf. and fur:

Studies on the effect of amoxicillin on the ability to drive vehicles and mechanisms have not been carried out. Patients should be warned about the possibility of developing dizziness and the appearance of seizures. When these undesirable phenomena appear, one should refrain from performing these activities.

Form release / dosage:

Tablets are dispersible, 500 mg, 750 mg and 1000 mg.

Packaging:

For 6, 7, 8, 10 dispersible tablets are placed in a blister of the combined material: polyvinyl chloride / polyvinylidene chloride / aluminum.

Dosage 500 mg: 1, 2, 3 or 10 blisters of 10 tablets dispersible in a pack of cardboard along with instructions for use.

For 2 blisters of 6 tablets dispersible in a pack of cardboard along with instructions for use.

For 2 blisters of 7 tablets dispersible in a pack of cardboard along with instructions for use.

For 2 blisters of 8 tablets dispersible in a pack of cardboard along with instructions for use.

Dosage of 750 mg: 2 blisters for 7 tablets dispersible in a pack of cardboard along with the instructions forapplication.

For 2 blisters of 8 tablets dispersible in a pack of cardboard along with instructions for use.

For 2 or 3 blisters of 10 tablets dispersible in a pack of cardboard along with instructions for use.

Dosage of 1000 mg: 2 blisters for 6 tablets dispersible in a pack of cardboard together with instructions for use.

For 2 blisters of 7 tablets dispersible in a pack of cardboard along with instructions for use.

For 2 blisters of 8 tablets dispersible in a pack of cardboard along with instructions for use.

For 2 or 3 blisters of 10 tablets dispersible in a pack of cardboard along with instructions for use.

Storage conditions:

In the original packaging, at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use the drug after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-004073

Date of registration:11.01.2017

Expiration Date:11.01.2022

The owner of the registration certificate:Sandoz d.Sandoz d. Slovenia

Manufacturer: & nbsp

SANDOZ, GmbH Austria

Representation: & nbspSANDOZ SANDOZ Switzerland

Information update date: & nbsp29.01.2017

Illustrated instructions

Instructions

Ospamox® (Ospamox®)