Sumamed forte - instructions for use, dose, side effects, contraindications

Supplementary substances: sucrose * 898,206 mg / 902,706 mg / 904,206 mg, sodium phosphate 20,000 mg / 20,000 mg / 20,000 mg, giprolose 1,600 mg / 1,600 mg / 1,600 mg, xanthan gum 1,600 mg / 1,600 mg / 1,600 mg, banana flavor 12,000 mg / 0/0, flavoring vanilla 4,500 mg / 0/0, strawberry flavoring 0 / 12,000 mg / 0, raspberry flavor 0/0 / 10,500 mg, titanium dioxide 5,000 mg / 5,000 mg / 5,000 mg, silicon dioxide colloid 7,000 mg / 7,000 mg / 7,000 mg.

* values from the calculation of the theoretical activity of the substance 95.4%; The amount of sucrose can vary depending on the actual activity of azithromycin.

Description:

Powder from white to yellowish white with a characteristic aroma of banana (15 ml), strawberries (30 ml), raspberries (37.5 ml). After dissolution in water, a homogeneous suspension from white toyellowish white with a characteristic aroma of banana (15 ml), strawberries (30 ml), raspberries (37.5 ml).

Pharmacotherapeutic group:Antibiotic - azalide

ATX: & nbsp

J.01.F.A.10 Azithromycin

Pharmacodynamics:

Azithromycin is a bacteriostatic broad-spectrum antibiotic from the group of macrolides-azalides. It has a wide spectrum of antimicrobial action. The mechanism of action of azithromycin is associated with the suppression of protein synthesis of a microbial cell. Communicating with 50Sthe subunit of the ribosome, depresses peptidranslokazu at the stage of translation and suppresses protein synthesis, slowing the growth and multiplication of bacteria. In high concentrations has a bactericidal effect.

It has activity against a number of gram-positive, gram-negative, anaerobes, intracellular and other microorganisms.

Sensitive microorganisms:

aerobic gram-positive microorganisms - Staphylococcus aureus (methicillin-sensitive strains), Streptococcus pneumoniae (penicillin-sensitive strains), Streptococcus pyogenes,

aerobic gbacterial microorganisms - Haemophilus influenzae, Haemophilus parainfluenzae, Legionella pneumophila, Moraxella catarrhalis, Pasteurella multocida, Neisseria gonorrhoeae,

anaerobic microorganisms - Clostridium perfringens, Fusobacterium spp., Prevotella spp., Porphyriomonas spp.,

other microorganisms - Chlamydia trachomatis, Chlamydia pneumoniae, Chlamydia psittaci, Mycoplasma pneumoniae, Mycoplasma hominis, Borrelia burgdorferi.

Microorganisms with acquired resistance to azithromycin:

Aerobic Gram-positive microorganisms - Streptococcus pneumoniae (penicillin-resistant strains and strains with an average sensitivity to penicillin).

Microorganisms with natural resistance:

aerobic gram-positive microorganisms - Enterococcus faecalis, Staphylococcus aureus (methicillin-resistant strains), Staphylococcus epidermidis (methicillin-resistant strains);

anaerobic microorganisms - Bacteroides fragilis.

Cases of cross-resistance between Streptococcus pneumoniae, Streptococcus pyogenes (beta-hemolytic group streptococcus A), Enterococcus faecalis and Staphylococcus aureus, including Staphylococcus aureus (methicillin-resistant strains) to erythromycin, azithromycin, other macrolides and lincosamides.

The sensitivity scale of microorganisms to azithromycin (Minimum inhibitory concentration (MIC), mg / L)

Microorganisms	MIC, mg / L *
Microorganisms	Sensitive	Sustainable
Staphylococcus	not more than 1	more than 2
Streptococcus A, B, C, G	not more than 0,25	more than 0.5
Streptococcus pneumoniae	not more than 0,25	more than 0.5
Haemophilus influenzae	not more than 0,12	more than 4
Moraxella catarrhalis	no more than 0.5	more than 0.5
Neisseria gonorrhoeae	not more than 0,25	more than 0.5

* Azithromycin was used to treat infectious diseases caused by Salmonella typhi (MIC not more than 16 mg / l) and Shigella spp..

Pharmacokinetics:

After oral administration, the bioavailability is 37%, the maximum concentration in the blood plasma (C_m_Oh) is created after 2-3 hours, the volume of distribution is 31.1 l / kg. Binding to plasma proteins is inversely proportional to the concentration in the blood and is 12 to 52%. Penetrates through cell membranes (effective for infections caused by intracellular pathogens). It is transported by phagocytes, polymorphonuclear leukocytes and macrophages to the site of infection, where it is released in the presence of bacteria. Easily passes through the histohematological barriers and enters the tissues. The concentration in tissues and cells is 50 times higher than in plasma, and in the focus of infection - 24-34% more than in healthy tissues.

Slowly removed from the tissues and has a long half-life of 2-4 days. The therapeutic concentration of azithromycin is maintained up to 5-7 days after the last dose. Azithromycin is output, basically, in the unchanged form - 50% of the intestine, 12% of the kidneys. In the liver, demethylated, losing activity.

In patients with severe renal failure (creatinine clearance less than 10 ml / min), the half-life of azithromycin increases by 33%.

Indications:

Infectious and inflammatory diseases caused by microorganisms sensitive to the preparation, including:

- upper respiratory tract, including pharyngitis / tonsillitis, sinusitis, otitis media;

- lower respiratory tract, including acute bronchitis, exacerbation of chronic bronchitis and community-acquired pneumonia;

- skin and soft tissues, including erysipelas, impetigo, secondary infected dermatoses;

- Lyme disease (initial stage of borreliosis) - migrating erythema (erythema migrans).

Contraindications:

Hypersensitivity to azithromycin, erythromycin, other macrolides or ketolides, or other components of the drug; impaired hepatic function; deficiency of sugar / isomaltase, intolerance to fructose, glucose-galactose malabsorption; children's age up to 6 months; simultaneous reception of ergotamine and dihydroergotamine.

Carefully:

Myasthenia gravis; impaired liver function of mild and moderate severity; terminal renal failure with GFR (glomerular filtration rate) less than 10 ml / min; in patients with the presence of pro-arrhythmic factors (especially in elderly patients): with congenital or acquired interval lengthening QT, in patients receiving antiarrhythmic drug therapy classes IA (quinidine, procainamide), III (dofetilide, amiodarone and sotalol), cisapride, terfenadine, antipsychotic drugs (pimozide), antidepressants (citalopram), fluoroquinolones (moxifloxacin and levofloxacin), with disturbances of water-electrolyte balance, especially in the case of hypokalemia or hypomagnesemia, clinically significant bradycardia, cardiac arrhythmia, or severe heart failure; simultaneous use of digoxin, warfarin, cyclosporine; diabetes.

Pregnancy and lactation:

In pregnancy and during breastfeeding apply only if the intended benefit to the mother exceeds the potential risk to the fetus and the baby. If it is necessary to use the drug during breastfeeding, it is recommended to suspend breastfeeding.

Dosing and Administration:

Inside, 1 time per day, 1 hour before or 2 hours after meals. After taking the drug Sumamed® forte, the child must definitely offer drink a few sips of water so that he can swallow the remains of the suspension.

Before each intake of the drug, the contents of the vial are shaken carefully until a homogeneous suspension is obtained. If the required volume of the suspension has not been removed from the vial within 20 minutes after shaking, the suspension should be shaken again, take the necessary volume and give the baby.

The required dose is measured using a syringe for dosing with a 1 ml dividing rate and a nominal suspension capacity of 5 ml (200 mg azithromycin) or a measuring spoon with a nominal slurry capacity of 2.5 ml (100 mg azithromycin) or 5 ml (200 mg azithromycin), nested in a cardboard box together with a bottle.

After use a syringe (after having disassembled it) and the measuring spoon is washed with running water, dried and stored in a dry place until the next dose of Sumamed ® forte.

When infectious-inflammatory diseases of upper and lower lower respiratory tract, skin and soft tissues

At the rate of 10 mg / kg body weight 1 time per day for 3 days (course dose 30 mg / kg).

To accurately dispense Sumamed® forte according to the body weight of the child, the table below should be used.

Body mass	The volume of suspension (ml) at 1 reception
10-14 kg	2.5 ml of suspension (100 mg of azithromycin)
15-24 kg	5.0 ml of suspension (200 mg of azithromycin)
25-34 kg	7.5 ml of suspension (300 mg of azithromycin)
35-44 kg	10.0 ml of suspension (400 mg of azithromycin)
not less than 45 kg	12.5 ml of suspension (500 mg of azithromycin) (corresponding to the dose for adult patients)

With pharyngitis / tonsillitis caused by Streptococcus pyogenes, the drug Sumamed® forte is used at a dose of 20 mg / kg / day for 3 days (exchange dose of 60 mg / kg). The maximum daily dose is 500 mg.

Children with a body weight of up to 10 kg should take the drug Sumamed ® in the form of powder to prepare a suspension for oral intake with a concentration of 100 mg / 5 ml.

With Lyme disease (the initial stage of borreliosis) - migratory erythema (erythema misrans)

On the 1st day at a dose of 20 mg / kg / day, then from the 2nd to the 5th day at a dose of 10 mg / kg / day (exchange dose of 60 mg / kg).

In case of impaired renal function: the patients with GFR - 10 - 80 ml / min dose adjustment is not required.

When a violation of liver function: when application in patients with impaired liver function of mild and moderate severity, dose adjustment is not required.

Elderly patients: correction of the dose is not required. In elderly patients with the use of the drug Sumamed® forte it is recommended that special care be taken in connection with the possible presence of pro-arrhythmic factors that may increase the risk of developing cardiac arrhythmia and arrhythmia of the type "pirouette".

Method of preparation and storage of the suspension

To the contents of the vial, intended for the preparation of 15 ml of suspension (nominal volume), from Using a syringe for dosing, 9.5 ml of water is added. Shake until a homogeneous suspension is obtained. The volume of the resulting suspension is about 20 ml, which exceeds the nominal volume by approximately 5 ml. it To compensate for the inevitable loss of dosing of the drug. The prepared suspension can be stored at temperature not higher than 25 ° С no more than 5 days.

TO content bottle, intended for the preparation of 30 ml of suspension (nominal volume), 16,5 ml of water is added by means of a syringe for dosing. Shake until a homogeneous suspension is obtained. The volume of the resulting suspension is about 35 ml, which exceeds the nominal volume by approximately 5 ml. it To compensate for the inevitable loss of dosing of the drug. The prepared suspension can be store at temperature not higher than 25 ° C not more than 10 days.

TO content bottle, intended for the preparation of 37.5 ml suspension (nominal volume), 20 ml of water is added using a syringe for dosing. Shake until a homogeneous suspension is obtained. The volume of the resulting suspension is about 42.5 ml, which exceeds the nominal volume by approximately 5 ml. This is provided to compensate for the inevitable loss of the suspension when the drug is dosed. The prepared suspension can be stored at a temperature of no higher than 25 ° C for not more than 10 days.

Side effects:

Frequency of side effects classified according to the recommendations of the World Health Organization: very often - not less than 10%; often - not less than 1%, but less than 10%; infrequently - not less than 0,1%, but less than 1%; rarely - not less than 0.01%, but less than 0.1%; very rarely - less than 0.01%; The unknown frequency can not be estimated from the available data.

Infectious diseases: infrequently - candidiasis, including oral and genital mucosa, pneumonia, pharyngitis, gastroenteritis, respiratory diseases, rhinitis; an unknown frequency is pseudomembranous colitis.

From the side of the blood and lymphatic system: infrequently - leukopenia, neutropenia, eosinophilia; very rarely - thrombocytopenia, hemolytic anemia.

From the side of metabolism and nutrition: infrequently - anorexia.

Allergic reactions: infrequently angioedema, hypersensitivity reaction; unknown frequency - anaphylactic reaction.

From the nervous system: often - headache; infrequently - dizziness, a violation of taste, paresthesia, drowsiness, insomnia, nervousness; rarely - agitation; unknown frequency - hypesthesia, anxiety, aggression, fainting, seizures, psychomotor hyperactivity, loss of smell, perverted sense of smell, loss of taste sensations, myasthenia gravis, delirium, hallucinations.

From the side of the organ of vision: infrequently - impaired vision.

From the side of the hearing organ and labyrinthine disorders: infrequently - hearing disorder, vertigo; unknown frequency - hearing impairment, including deafness and / or tinnitus.

From the cardiovascular system: infrequently - sensation palpitation, "tides" of blood to the face; unknown frequency - decrease arterial pressure, increase interval QT on the electrocardiogram, arrhythmia of the type "pirouette", ventricular tachycardia.

From the respiratory system: infrequently - shortness of breath, nosebleed.

From the gastrointestinal tract: very often - diarrhea; often - nausea, vomiting,abdominal pain; infrequent - meteorism, dyspepsia, constipation, gastritis, dysphagia, bloating, dryness of the oral mucosa, belching, ulcers of the oral mucosa, increased secretion of the salivary glands; very rarely - a change in the color of the tongue, pancreatitis.

From the liver and bile ducts: infrequently - hepatitis; rarely - abnormal liver function, cholestatic jaundice; unknown frequency - hepatic insufficiency (in rare cases with a lethal outcome in mainly on the background of a violation of the function liver of severe degree); necrosis of the liver, fulminant hepatitis.

From the skin and subcutaneous tissues: infrequently - skin rash, itching, hives, dermatitis, dry skin, sweating; rarely - the reaction of photosensitization; unknown frequency - Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme.

From the musculoskeletal system: infrequently - osteoarthritis, myalgia, back pain, neck pain; unknown frequency - arthralgia.

From the side of the kidneys and urinary tract: infrequently - dysuria, pain in the kidney; unknown frequency interstitial nephritis, acute renal failure.

From the genitals and the breast: infrequently - metrorrhagia, dysfunction of testicles.

Other: infrequently - asthenia, malaise, fatigue, face swelling, chest pain, fever, peripheral edema.

Laboratory data: often - a decrease in the number of lymphocytes, an increase in the number of eosinophils, an increase in the number of basophils, an increase in the number of monocytes, an increase in the number of neutrophils, a decrease concentration of bicarbonates in the blood plasma; infrequently, increased activity of aspartate aminotransferase, alanine aminotransferase, increased bilirubin concentration in the blood plasma, increased urea concentration in the blood plasma, increased plasma creatinine concentration, a change in potassium in the blood plasma, increased activity of alkaline phosphatase in the blood plasma, an increase in the level of chlorine in the blood plasma , an increase in the concentration of glucose in the blood, an increase in the number platelets, increase of hematocrit, increase of bicarbonate concentration in blood plasma, change of sodium content in blood plasma.

Overdose:

Undesirable reactions that occur when an overdose of Sumamed ® forte are similar to those that occur when taking the recommended doses.Typical symptoms of overdose are severe nausea, temporary hearing loss, vomiting, diarrhea. Treatment: reception of activated charcoal, general symptomatic treatment, control of vital functions.

Interaction:

Antacid preparations

Antacid preparations do not affect the bioavailability of azithromycin, but reduce the maximum concentration in the blood by 30%, so the drug should be taken at least one hour before or two hours after taking these drugs and food.

Cetirizine

Simultaneous use of azithromycin with cetirizine (20 mg) for 5 days in healthy volunteers did not lead to a pharmacokinetic interaction and a significant change in the interval QT.

Didanosine (dideoxyinosine)

Simultaneous use of azithromycin (1200 mg / day) and didanosine (400 mg / day) in 6 HIV-infected patients showed no change in the pharmacokinetic indications of didanosine compared with the placebo group.

Digoxin (substrates of P-glycoprotein)

Simultaneous use of macrolide antibiotics, including azithromycin, with P-glycoprotein substrates, such as digoxin, leads to an increase in the concentration of the P-glycoprotein substrate in the blood serum. Thus, with the simultaneous use of azithromycin and digoxin, it is necessary to take into account the possibility of increasing the concentration of digoxin in the blood serum.

Zidovudine

The simultaneous use of azithromycin (a single dose of 1000 mg and repeated administration of 1200 mg or 600 mg) has little effect on the pharmacokinetics, including the excretion of zidovudine or its glucuronide metabolite by the kidneys. However, the use of azithromycin caused an increase in the concentration phosphorylated zidovudine, a clinically active metabolite in peripheral blood mononuclear cells. The clinical significance of this fact is unclear. Azithromycin weakly interacts with isoenzymes of the cytochrome P450 system. It was not revealed that azithromycin participates in pharmacokinetic interactions similar to erythromycin and other macrolides. Azithromycin It is not an inhibitor and inducer of cytochrome P450 isoenzymes.

Alkaloids of ergot

Given the theoretical possibility of the emergence of ergotism, the simultaneous use of azithromycin with derivatives of alkaloids ergot is not recommended. Pharmacokinetic studies of concurrent use azithromycin and drugs, metabolism which occurs with participation isoenzymes of the cytochrome P450 system.

Atorvastatin

Simultaneous use of atorvastatin (10 mg daily) and azithromycin (500 mg daily) did not cause a change in the concentrations of atorvastatin in blood plasma (based on the inhibition of HMG-CoA reductase). However, in the post-marketing period, separate reports were received on cases of rhabdomyolysis in patients receiving concomitantly azithromycin and statins.

Carbamazepine

In pharmacokinetic studies involving healthy volunteers, there was no significant effect on the concentration of carbamazepine and its active metabolite in blood plasma in patients receiving concomitantly azithromycin.

Cimetidine

In pharmacokinetic studies of the effect of a single dose of cimetidine on the pharmacokinetics of azithromycin, no changes in the pharmacokinetics of azithromycin have been observed, provided cimetidine is administered 2 hours before azithromycin.

Anticoagulants of indirect action (coumarin derivatives)

In pharmacokinetic studies azithromycin ns influenced the anticoagulant effect of a single dose of 15 mg of warfarin taken healthy volunteers. It was reported on the potentiation of anticoagulant effect after simultaneous use of azithromycin and anticoagulants of indirect action (coumarin derivatives). Despite the fact that a causal relationship has not been established, the need frequent monitoring of prothrombin time the use of azithromycin in patients who receive oral anticoagulants of indirect action (coumarin derivatives).

Cyclosporin

In a pharmacokinetic study involving healthy volunteers who within 3 days were ingested azithromycin (500 mg / day once), and then ciclosporin (10 mg / kg / day once), there was a significant increase in the maximum concentration in the blood plasma (Cmax) and the area under the "concentration-time" curve (AUC0-5) cyclosporine. It should be observed caution with the simultaneous use of these drugs. When the need for simultaneous use of these drugs, it is necessary to monitor the concentration of cyclosporine in the blood plasma and, accordingly, adjust the dose.

Efavirenz

Simultaneous application azithromycin (600 mg / day once) and efavirenz (400 mg / day) daily for 7 days did not cause any clinically significant pharmacokinetic interaction.

Fluconazole

Simultaneous use of azithromycin (1200 mg once) did not change the pharmacokinetics of fluconazole (800 mg once). The total exposure and half-life of azithromycin ns changed with simultaneous application of fluconazole, but a decrease in Cmah azithromycin (by 18%), that ns had clinical significance.

Indinavir

Simultaneous use of azithromycin (1200 mg once) did not cause a statistically significant effect on the pharmacokinetics of indinavir (800 mg three times daily for 5 days).

Methylprednisolone

Azithromycin does not significantly affect the pharmacokinetics methylprednisolone.

Nelfinavir

Simultaneous use of azithromycin (1200 mg) and nelfinavir (750 mg 3 times a day) causes an increase in the equilibrium concentrations of azithromycin in the blood serum. Clinically significant side effects were not observed and dosage adjustment of azithromycin in its simultaneous application with nelfinavir is not required.

Rifabutin

Simultaneous use of azithromycin and rifabutin does not affect the concentration of each of the drugs in the blood serum. With the simultaneous use of azithromycin and rifabutin, neutropenia was sometimes observed. Despite the fact that neutropenia was associated with the use of rifabutin, a causal relationship between the use of a combination of azithromycin and rifabutin and neutropenia has not been established.

Sildenafil

When used in healthy volunteers, evidence of the effect of azithromycin (500 mg / day daily for 3 days) on AUC and Cmah sildenafil or its main circulating metabolite.

Terfenadine

In pharmacokinetic studies, no evidence was obtained interactions between azithromycin and terfenadine. Individual cases were reported where the possibility of such interaction could not be ruled out completely, but there was not one concrete proof that such an interaction took place. It was found that the simultaneous use of terfenadine and macrolides may cause arrhythmia and lengthening of the interval QT.

Theophylline

No interaction between azithromycin and theophylline.

Triazolem /midazolam

Significant changes in pharmacokinetic parameters with the simultaneous use of azithromycin with triazolam or midazolam in therapeutic doses are not revealed.

Trimethoprim / sulfamethoxazole

Simultaneous application trimethoprim / sulfamethoxazole with azithromycin did not reveal significant impact on Cmah, total exposure or kidney excretion of trimethoprim or sulfamethoxazole. The concentrations of azithromycin in the serum corresponded to those detected in other studies.

Special instructions:

When using Sumamed ® forte in patients with diabetes mellitus, as well as with a low-calorie diet, it is necessary to take into account that sucrose (0.32 XE / 5 ml) is included in the suspension. If you miss one dose of Sumamed® Fort, the missed dose should be taken as soon as possible, and the subsequent dose should be taken at intervals of 24 hours.

Sumamed® Forte should be taken at least one hour before or two hours after taking antacid preparations.

Sumamed® Forte preparation follows take with caution in patients with impaired liver function of mild and moderate severity due to the possibility of developing fulminant hepatitis and hepaticinsufficiency of a serious degree.

In the presence of symptoms of impairment liver function, such as rapidly accruing asthenia, jaundice, darkening of urine, tendency to bleeding, hepatic encephalopathy drug therapy Sumamed® forte should be discontinued and conduct a study of the functional state of the liver.

For violations of kidney function: patients with GFR 10 - 80 ml / min correction of the dose is not required, therapy with Sumamed® forte should be performed with caution under the control of the state of kidney function.

As with the use of other antibacterial drugs, with the treatment with Sumamed® Forte, patients should be regularly examined for the presence of unresponsive microorganisms and signs of development of superinfections, including fungal ones. Sumamed® forte preparation should not be used for longer courses than indicated in the instructions, since the pharmacokinetic properties azithromycin allow us to recommend a short and simple dosing regimen.

There is no data on the possible interaction between azithromycin and derivatives of ergotamine and dihydroergotamine, but because of the development of ergotism with the simultaneous use of macrolides with derivatives of ergotamine and dihydroergotamine, this combination is not recommended.

With long-term use of the drug Sumamed® forte, the development of pseudomembranous colitis caused by Clostridium difficile, both in the form of mild diarrhea, and severe colitis. With the development of antibiotic-associated diarrhea against the background of taking the drug Sumamed® Forte, and also 2 months after the end of therapy, clostridial pseudomembranous colitis. Do not use drugs that inhibit the intestinal peristalsis.

When treating macrolides, including azithromycin, prolonged cardiac repolarization and interval QT, increasing the risk of developing cardiac arrhythmias, including arrhythmias such as "pirouettes", which can lead to cardiac arrest.

Caution should be used when using Sumamed® forte in patients with proarrhythmogenic factors (especially in elderly patients), including congenital or acquired lengthening of the interval QT; in patients taking antiarrhythmic drugs classes IA (quinidine, procainamide), III (dofetilide, amiodarone and sotalol), cisapride, terfenadine. antipsychotic

drugs (pimozide), antidepressants (citalopram), fluoroquinolones (moxifloxacin and levofloxacin), with disturbances of water-electrolyte balance, especially in case of hypokalemia or hypomagnesemia, clinically significant bradycardia, cardiac arrhythmia or severe heart failure.

The use of the drug Sumamed ® forte can provoke the development of myasthenic syndrome or cause an exacerbation of myasthenia gravis.

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

With the development of undesirable effects from the nervous system and the organ of vision, care should be taken when performing actions requiring increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Powder for the preparation of a suspension for oral administration of 200 mg / 5 ml.

Packaging:

16.740 g (15 ml, banana flavor), 29.295 g (30 ml, strawberry flavor) or 35.573 g (37.5 ml, raspberry flavor) of the powder are placed in an opaque white bottle of 50 ml high density polyethylene (15 ml) or 100 ml (30 ml, 37.5 ml) with a polypropylene resistant cover.

1 bottle with instructions a measuring spoon and / or a syringe for dosing are placed in a cardboard box.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N011923 / 01

Date of registration:19.08.2011 / 30.01.2015

Expiration Date:Unlimited

The owner of the registration certificate:Pliva of Hrvatska dooPliva of Hrvatska doo Croatia

Manufacturer: & nbsp

PLIVA HRVATSKA, d.o.o. Croatia

Representation: & nbspTeva Teva Israel

Information update date: & nbsp09.12.2016

Illustrated instructions

Instructions

Sumamed® forte (Sumamed® forte)