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Therapeutic indications:
Treatment of: - Exacerbations of inflammatory and degenerative forms of rheumatism: rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, spondylarthritis, non-articular rheumatism.- Treatment of painful conditions due to inflammation of non rheumatic origin.- Renal colic and biliary colic - Post-traumatic and post-operative pain, inflammation and swelling
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" עעבקנהזןולעטמרופ " רשואוקדבנונכותותואירבהדרשמי ." רשואמןולע : רבמצד 2009

“This leaflet format has been determined by the Ministryof Healthand thecontent thereof has been

checked and approved.” Date of approval: December 2009

Physician’s Package Insert אפורלןולע





ךותהקרזהל דבלבתירירש INJECTION

Name of the medicinal product


ampoules 75 mg/3 ml solution for injection.

Qualitative and quantitative composition

Each ampoule of 3 ml contains:

Active Ingredient

Diclofenac sodium 75 mg

Other Ingredients

Propyleneglycol, benzyl alcohol, mannitol, sodium metabisulfite, sodium hydroxide,

water for injection.

Pharmaceutical form

Solution for injection.

Clinical particulars

Therapeutic indications

Exacerbations of inflammatory and degenerative forms of rheumatism: rheumatoid

arthritis, ankylosing spondylitis, osteoarthritis,spondylarthritis,non-articular


Treatment of painful conditions due to inflammation of non rheumatic origin.

Renal colic and biliary colic.

Post-traumatic and post-operative pain, inflammation and swelling.

Posologyand method of administration

As a general recommendation, the dose should be individually adjusted andthe

lowest effective dose given for the shortest possible duration.


Abitren solution for injection should not be given formorethan2days;ifnecessary,

treatment can be continued with the tablets or suppositories.

Intramuscular Injection

The following directions for intramuscular injection must be followedinordertoavoid

damage to a nerve or other tissue at the injection site.

The dose is generally one 75 mg ampoule daily, given by deep intraglutealinjection

into the upper outer quadrant. In severe cases(e.g.colic),thedailydosecan

exceptionally be increased to two injections of 75 mg, separated by an interval of a

fewhours(one into each buttock). Alternatively, one ampoule of 75 mg can be

combinedwithother pharmaceutical forms of Abitren (e.g. tablets, suppositories) up

to a total maximum daily dose of 150 mg.

In migraine attacks, clinical experience is limited to initial use of one ampoule of

75mg administered as soon as possible, followed by suppositories upto100mgon

the same day if required. The total dose should not exceed 175 mg on the first day.


Children and adolescents

Because of their dosage strength, the Abitren solution for injection is not suitable for

children and adolescents.


Known hypersensitivity to the active substance, sodium metabisulfiteoranyofthe

other excipients.

Active gastric or intestinal ulcer, bleeding or perforation.

Last trimester of pregnancy (see Pregnancy and lactation).

Severe hepatic renal and cardiac failure (see Special warnings and special

precautions for use).

Like other non-steroidal anti-inflammatory drugs (NSAIDs), Abitrenisalso

contraindicatedinpatientsinwhomattacks of asthma, urticaria, or acute rhinitis are

precipitated by acetylsalicylic acid or other NSAIDs

Special warnings and special precautions for use


Gastrointestinal bleeding ulceration or perforation, whichcanbefatal,havebeen

reported with all NSAIDs and may occur at any time duringtreatment,withorwithout

warningsymptoms or a previous history of serious gastrointestinal events. They

generally have more serious consequences in the elderly. If gastrointestinalbleeding

or ulceration occurs in patients receiving Abitren, the medicinalproductshouldbe


Seriousskinreactions,some of them fatal, including exfoliative dermatitis, Stevens-

Johnsonsyndromeand toxic epidermal necrolysis, have been reported very rarely in

associationwith the use of NSAIDs, including diclofenac (see Undesirable effects).

Patients appear to be at highest risk of thesereactionsearlyinthecourseoftherapy,

the onset of the reaction occurring in the majority ofcaseswithinthefirstmonthof

treatment. Abitren should be discontinued at the firstappearanceofskinrash,

mucosal lesions or any other sign of hypersensitivity.

As with other NSAIDs, allergic reactions,includinganaphylactic/anaphylactoid

reactions,canalso occur in rare cases without earlier exposure to diclofenac. The

sodium metabisulphite in the solution for injection can also lead to isolated severe

hypersensitivity reactions and bronchospasm.

Like other NSAIDs, diclofenac may mask the signs and symptoms of infection due to

its pharmacodynamic properties.



The concomitant use of diclofenacwithsystemicNSAIDsincluding

cyclooxygenase-2selective inhibitors, should be avoided due to the absence of any

evidence demonstrating synergistic benefits and the potentialforadditiveundesirable


Caution is indicated in the elderly on basic medical grounds. In particular it is

recommendedthatthelowesteffectivedose be used in frail elderly patients or those

with a low body weight.


Pre-existing asthma

In patients with asthma, seasonal allergic rhinitis, swelling ofthenasalmucosa(i.e.

nasalpolyps),chronicobstructivepulmonary diseases or chronic infections of the

respiratorytract(especiallyif linked to allergic rhinitis-like symptoms), reactions on

NSAIDs like asthma exacerbations (so-called intolerance toanalgesics/analgesic-

asthma), Quincke’s edema or urticaria are more frequent than inotherpatients.

Therefore special precaution is recommended insuchpatients(readinessfor

emergency). This is applicable as well for patients who are allergic toother

substances, e.g. with skin reactions, pruritus or urticaria.

Special caution is recommended when Abitren injection is used parenterally in

patients with bronchial asthma because symptoms may be exacerbated.

Gastrointestinal effects

AswithallNSAIDs,close medical surveillance is imperative and particular caution

should be exercised when prescribing Abitren in patients with symptoms indicative of

gastrointestinal (GI) disorders or with a history suggestive of gastricorintestinal

ulceration, bleeding or perforation, (see Undesirable effects). The risk ofGIbleeding

is higher with increasing NSAID doses and inpatientswithahistoryofulcer,

particularly if complicated with hemorrhage or perforation and in the elderly.

To reduce the risk of GI toxicity in patients with a historyofulcer,particularlyif

complicatedwithhaemorrhageorperforation, and in the elderly, the treatment should

be initiated and maintained at the lowest effective dose.

Combination therapy with protective agents (e.g. proton pumpinhibitorsor

misoprostol) should be considered for these patients, and also for patientsrequiring

concomitant use of medicinal products containing low-dose acetylsalicylic acid

(ASA)/aspirin, or other medicinal products likely to increase gastrointestinal risk .

Patients with a history of GI toxicity, particularly the elderly, should report anyunusual

abdominal symptoms (especially GI bleeding). Cautionisrecommendedinpatients

receiving concomitant medications which could increase theriskofulcerationor

bleeding, such as systemic corticosteroids,anticoagulants,anti-plateletagentsor

selectiveserotonin-reuptake inhibitors (see Interaction with other medicinal products

and other forms of interaction).

Closemedical surveillance and caution should also be exercised in patients with

ulcerativecolitis or Crohn’s disease, as their condition may by exacerbated (see

Undesirable effects)

Hepatic Effects

Elevations of one or more liver tests may occur during therapy withdiclofenacsodium.

Theselaboratory abnormalities may progress, may remain unchanged, or may be

transient with continued therapy. Borderline elevations (i.e. less than3timestheULN

[ULN = the upper limit of normal range]) or greaterelevationsoftransaminases

occurredinabout15%ofdiclofenac-treated patients. Of the markers of hepatic

function, ALT (SGPT) is recommended for the monitoring of liver injury.

Inclinicaltrials,meaningfulelevations (i.e., more than 3 times the ULN) of AST (GOT)

(ALT was not measured in all studies) occurred in about 2% of approximately 5,700

patients at some time during diclofenac treatment. In a large,open-label,controlled

trialof3,700 patients treated for 2-6 months, patients were monitored first at 8 weeks

and1,200patientsweremonitored again at 24 weeks. Meaningful elevations of ALT

and/or AST occurred in about 4% of patients andincludedmarkedelevations(i.e.,

more than 8 times the ULN) in about 1% of the 3,700 patients.


Inthatopen-labelstudy,ahigherincidence of borderline (less than 3 times the ULN),

moderate(3-8timestheULN),andmarked(> 8 times the ULN) elevations of ALT or

ASTwasobserved in patients receiving diclofenac when compared to other NSAIDs.

Elevationsin transaminases were seen more frequently in patients with osteoarthritis

than in those with rheumatoid arthritis.

Almost all meaningful elevations in transaminases were detected beforepatients

becamesymptomatic. Abnormal tests occurred during the first 2 months of therapy

withdiclofenac in 42 of the 51 patients in all trials who developed marked

transaminase elevations.

In postmarketing reports, cases of drug-induced hepatotoxicity have been reported in

thefirstmonth, and in some cases, the first 2 months of therapy, but can occur at any

timeduring treatment with diclofenac. Postmarketing surveillance has reported cases

of severe hepatic reactions, including liver necrosis,jaundice,fulfillmenthepatitiswith

and without jaundice, and liver failure. Some of these reported cases resultedin

fatalities or liver transplantation.

Physiciansshould measure transaminases periodically in patients receiving long-term

therapy with diclofenac, because severe hepatotoxicity may develop without a

prodromeofdistinguishingsymptoms.Theoptimum times for making the first and

subsequenttransaminase measurements are not known. Based on clinical trial data

andpostmarketing experiences, transaminases should be monitored within 4 to

8weeksafterinitiating treatment with diclofenac. However, severe hepatic reactions

can occur at any time during treatment with diclofenac.

If abnormal liver tests persist or worsen, if clinical signs and/or symptomsconsistent

with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia,

rash, abdominal pain, diarrhea, dark urine, etc.), diclofenac sodium should be

discontinuedimmediately.Tominimize the possibility that hepatic injury will become

severe between transaminase measurements,physicians should inform patients of

the warning signs and symptoms of hepatotoxicity (e.g.,nausea,fatigue,lethargy,

diarrhea,pruritus,jaundice,right upper quadrant tenderness, and “flu-like”

symptoms), and the appropriate action patients should takeifthesesignsand

symptoms appear.

To minimize the potential risk for an adverse liver relatedeventinpatientstreatedwith

diclofenac sodium, the lowest effective dose should be usedfortheshortestduration

possible. Caution should be exercised in prescribing diclofenacsodiumwith

concomitant drugs that are known to be potentially hepatotoxic (e.g.,antibiotics,anti-


Renal effects

As fluid retention and edema have been reported in association with NSAID therapy,

particular caution is called for in patients withimpairedcardiacorrenalfunction,

history of hypertension, the elderly, patientsreceivingconcomitanttreatmentwith

diureticsormedicinal products that can significantly impact renal function, and in

those patients with substantial extracellular volume depletion of anycause,e.g.

beforeorafter major surgery (see Contraindications). Monitoring of renal function is

recommendedasa precautionary measure when using Abitren in such cases.

Discontinuation of therapy is normally followedby recovery to the pre-treatment state.


Hematological effects

During prolonged treatment with diclofenac, as with otherNSAIDs,monitoringofthe

blood count is recommended.

Likeother NSAIDs, diclofenac may temporarily inhibit platelet aggregation. Patients

with defects of hemostasis, should be carefully monitored.

Interaction with other medicinal products and other forms of interaction

Thefollowinginteractionsincludethose observed with Abitren for injection and/or

other pharmaceutical forms of diclofenac.


If used concomitantly, diclofenac may raise plasma concentrations oflithium.

Monitoring of the serum lithium level is recommended.


Ifusedconcomitantly, diclofenac may raise plasma concentrations of digoxin.

Monitoring of the serum digoxin level is recommended.

Diuretics and antihypertensive agents:

LikeotherNSAIDs,concomitant use of diclofenac with diuretics or antihypertensive

agents(e.g. beta-blockers, angiotensin converting enzyme (ACE) inhibitors) may

cause a decrease in their antihypertensive effect. Therefore, the combination should

beadministeredwithcautionandpatients, especially the elderly, should have their

bloodpressureperiodically monitored. Patients should be adequately hydrated and

considerationshouldbe given to monitoring of renal function after initiation of

concomitanttherapyand periodically thereafter, particularly for diuretics and ACE

inhibitors due to the increased risk of nephrotoxicity. Concomitanttreatmentwith

potassium-sparing drugs may be associated with increased serum potassium levels,

whichshouldthereforebemonitored frequently (see Special warnings and special

precaution for use).

Other NSAIDs and corticosteroids:

Concomitant administration of diclofenac and other systemic NSAIDsor

corticosteroids may increase the frequency of gastrointestinal undesirableeffects(see

Special warnings and special precautions for use).

Anticoagulants and anti-platelet agents:

Caution is recommended since concomitant administration could increase the risk of

bleeding(see Special warnings and special precautions for use) . Although clinical

investigations do not appear to indicate that diclofenac affectstheactionof

anticoagulants,there are isolated reports of an increased risk of haemorrhage in

patientsreceiving diclofenac and anticoagulants concomitantly. Close monitoring of

such patients is therefore recommended.

Selective serotonin reuptake inhibitors (SSRIs):

Concomitant administration of systemicNSAIDs and SSRIs may increase the riskof

gastrointestinal bleeding (see Special warnings and special precautions for use).


Clinical studies have shown that diclofenac can be given togetherwithoral

antidiabetic agents without influencing their clinical effect. However, there havebeen

isolated reports of both hypoglycemic and hyperglycemic effectsnecessitating

changes in the dosage of the antidiabetic agents during treatment with diclofenac. For

thisreason, monitoring of the blood glucose level is recommended as a precautionary

measure during concomitant therapy.


Caution is recommended when NSAIDs are administered less than 24 hours before or

after treatment with methotrexate, since blood concentrations of methotrexate may

rise and the toxicity of this substance be increased.



Diclofenac, like other NSAIDs may increase the nephrotoxicity of ciclosporin due to

the effect on renal prostaglandins. Therefore, it should be given at doses lower than

those that would be used in patients not receiving ciclosporin.

Quinolone antibacterials:

There have been isolated reports of convulsions which may have been due to

concomitant use of quinolones and NSAIDs.

Pregnancyand lactation


Theuseofdiclofenac in pregnant women has not been studied. Therefore, Abitren

shouldnotbeusedduringthefirst two trimesters of pregnancy unless the potential

benefit to the mother outweighs the risk to the fetus.AswithotherNSAIDs,useduring

the third trimester of pregnancy is contraindicated owing tothepossibilityofuterine

inertia and/or premature closure of the ductus arteriosus (see Contraindications).

Animal studies have not shown any directlyor indirectly harmful effects on pregnancy,

embryonal/fetaldevelopment, parturition orpostnatal development (see Preclinical

safety data).


Like other NSAIDs, diclofenac passes into the breastmilkinsmallamounts.

Therefore, Abitren should not be administered during breast feeding in order to avoid

undesirable effect in the infant.


Aswithother NSAIDs, the use of Abitren may impair female fertility and is not

recommendedinwomen attempting to conceive. In women who have difficulties

conceiving or who are undergoing investigation of infertility,withdrawalofAbitren

should be considered.

Effects on abilityto drive and use machines

Patients experiencing visual disturbances,dizziness, vertigo, somnolence, or other

central nervous systemdisturbances while taking diclofenac should refrain from

driving or using machines.

Undesirable effects

Adverse reactions are ranked under heading offrequency, the most frequent first,

using the following convention: common (≥1/100, < 1/10); uncommon (≥1/1,000, <

1/100); rare (≥1/10,000, < 1/1,000); very rare (< 1/10,000), including isolated reports.

The following undesirable effects include those reported with Abitren solution for

injection and/or other pharmaceutical forms ofdiclofenac, with either short-termor


Infections and infestations

Very rare: Injection site abscess.

Blood and lymphatic system disorders

Very rare: Thrombocytopenia, leukopenia, anemia (including hemolytic and aplastic

anemia), agranulocytosis.

Immune system disorders

Rare: Hypersensitivity, anaphylactic and anaphylactoid reactions (including

hypotension and shock).


Very rare: Angioneurotic edema (including face edema).

Psychiatric disorders

Very rare: Disorientation, depression, insomnia, nightmare, irritability, psychotic

disorder .

Nervous system disorders

Common: Headache, dizziness.

Rare: Somnolence.

Very rare: Paresthesia, memory impairment, convulsion, anxiety, tremor, aseptic

meningitis, taste disturbances, cerebrovascular accident.

Eye disorders

Very rare: Visual disturbances, vision blurred, diplopia.

Ear and labyrinth disorders

Common: Vertigo.

Very rare: Tinnitus, hearing impaired.

Cardiac disorders

Very rare: Palpitations, chest pain, cardiac failure, myocardial infarction.

Vascular disorders

Very rare: Hypertension, vasculitis.

Respiratory, thoracic and mediastinal disorders

Rare:Asthma (including dyspnea).

Very rare: Pneumonitis.

Gastrointestinal disorders

Common:Nausea, vomiting, diarrhea, dyspepsia, abdominalpain,flatulence,


Rare:Gastritis, gastrointestinal haemorrhage,hematemesis,diarrheahemorrhagic,

melena, gastrointestinal ulcer (with or without bleeding or perforation).

Very rare: Colitis (including hemorrhagic colitis and exacerbation of ulcerative colitis

orCrohn'sdisease), constipation, stomatitis, glossitis, esophageal disorder,

diaphragm-like intestinal strictures, pancreatitis.


Common:Transaminases increased.

Rare:Hepatitis, jaundice, liver disorder.

Very rare: Fulminant hepatitis.

Skin and subcutaneous tissue disorders

Common: Rash.

Rare: Urticaria.

Very rare: Bullous eruptions, eczema, erythema, erythema multiforme, Stevens-

Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), dermatitis

exfoliative, loss of hair, photosensitivity reaction, purpura, allergic purpura, pruritus.

Renal and urinarydisorders

Very rare: Acute renal failure, haematuria, proteinuria, nephrotic syndrome, interstitial

nephritis, renal papillary necrosis.


General disorders and administration site conditions

Common: Injection site reaction, injection site pain, injection site induration

Rare:Edema, injection site necrosis.



There is no typical clinical picture resulting from diclofenac overdosage. Overdosage

can cause symptoms such as vomiting, gastrointestinalhaemorrhage,diarrhea,

dizziness, tinnitus or convulsions. In the event of significant poisoning,acuterenal

failure and liver damage are possible.

Therapeutic measures

Managementofacutepoisoningwith NSAIDs essentially consists of supportive

measures and symptomatic treatment. Supportive measures andsymptomatic

treatment should be given for complications such as hypotension, renalfailure,

convulsions, gastrointestinal disorder, and respiratory depression.

Specialmeasuressuchasforced diuresis, dialysis or haemoperfusion are probably of

nohelp in eliminating NSAIDs due to the high protein binding and extensive


Pharmacological properties

Pharmacodynamic properties

Pharmacotherapeutic group: Anti-inflammatory andantirheumaticproducts,non

steroids, acetic acid derivatives and related substances (ATC code: M01A B05).

Mechanism of action

Diclofenac is a non-steroidal compoundwithpronouncedantirheumatic,anti-

inflammatory, analgesic, and antipyretic properties.Inhibitionofprostaglandin

biosynthesis, which has been demonstrated in experiments, is consideredtobe

fundamentaltoitsmechanismof action. Prostaglandins play an important role in

causing inflammation, pain and fever.

Diclofenacin vitrodoes not suppress proteoglycan biosynthesis incartilageat

concentrations equivalent to the concentrations reached in humans.

Pharmacodynamic effects

Inrheumatic diseases, the anti-inflammatory and analgesic properties of diclofenac

elicit a clinical response characterized by marked relief from signsandsymptoms

such as pain at rest, pain on movement, morning stiffness, andswellingofthejoints,

as well as by an improvement in function.

Diclofenac has also been found to exert a pronounced analgesic effect inmoderate

andseverepainof non-rheumatic origin, an effect which sets in within 15 to 30


Diclofenac has also been shown to have a beneficial effect in migraine attacks.

In post-traumatic and post-operative inflammatory conditions, diclofenac rapidly

relieves both spontaneous pain and pain on movement andreducesinflammatory

swelling and wound edema.

When used concomitantly with opioids for themanagementofpost-operativepain,

diclofenac significantly reduces the need for opioids.

Abitreninjection is particularly suitable for initial treatment of inflammatory and

degenerativerheumaticdiseases,andof painful conditions due to inflammation of

non-rheumatic origin.


Pharmacokinetic properties


After administration of 75 mg diclofenac by intramuscular injection, absorption sets in

immediately, and mean peak plasma concentrations of about 2.5 micrograms/mL

(8 micromol/L) are reached after about 20 minutes. The amount absorbed is in linear

proportion to the size of the dose.

When 75 mg diclofenac is administered as anintravenousinfusionover2hours,

meanpeakplasmaconcentrationsare about 1.9 micrograms/mL (5.9 micromol/L).

Shorter infusions result in higher peak plasma concentrations, whilelongerinfusions

giveplateauconcentrationsproportionalto the infusion rate after 3 to 4 hours. In

contrast, plasma concentrations decline rapidly once peak levels have beenreached

following intramuscular injection or administration of tablets or suppositories.

The area under the concentration curve (AUC) after intramuscular orintravenous

administration is about twice as large as itisfollowingoralorrectaladministration,

becauseabout half the active substance is metabolised during its first passage

through the liver ("first pass" effect) when administered via the oral or rectal routes.

Pharmacokineticbehavior does not change after repeated administration. No

accumulation occurs provided the recommended dosage intervals are observed.


99.7% of diclofenac binds to serum proteins, mainlytoalbumin(99.4%).Theapparent

volume of distribution calculated is 0.12 to 0.17 L/kg.

Diclofenac enters the synovial fluid, where maximum concentrations are measured

2to4hoursafterpeak plasma values have been reached. The apparent half-life for

elimination from the synovial fluidis3 to 6 hours. Two hours after reaching peak

plasmalevels,concentrations of the active substance are already higher in the

synovial fluid than in the plasma, and they remain higher for up to 12 hours.


Biotransformation of diclofenac takes place partlybyglucuronidationoftheintact

molecule,butmainlyby single and multiple hydroxylation and methoxylation, resulting

in several phenolic metabolites (3'-hydroxy-,4'-hydroxy-,5-hydroxy-,4',5-dihydroxy-,

and 3'- methoxy-diclofenac), most of which are converted toglucuronideconjugates.

Twoofthesephenolic metabolites are biologically active, but to a much lesser extent

than diclofenac.


Total systemic clearance of diclofenac from plasma is 263 ± 56 mL/min(meanvalue±

SD). The terminal half-life in plasma is 1 to 2hours.Fourofthemetabolites,including

the two active ones, also have short plasma half-lives of 1to3hours.Onemetabolite,

3'-hydroxy- 4'-methoxy-diclofenac, has a muchlonger plasma half-life. However, this

metabolite is virtually inactive.

About60%ofthe administered dose is excreted in the urine as the glucuronide

conjugate of the intact molecule and as metabolites, most of which are alsoconverted

to glucuronide conjugates. Less than 1% is excreted asunchangedsubstance.The

rest of the dose is eliminated as metabolites through the bile in the feces.

Characteristics in patients

Norelevant age-dependent differences in the drug’s absorption, metabolism, or

excretionhavebeenobserved.However, in a few elderly patients a 15-minute

intravenous infusion resulted in 50% higher plasma concentrationsthanexpected

from the data on young healthy subjects.


In patients suffering from renal impairment, no accumulation of the unchanged active

substancecan be inferred from the single-dose kinetics when applying the usual

dosageschedule.Atacreatinine clearance of less than 10 mL/min, the calculated

steady-state plasma levels of the hydroxy metabolites are about 4 times higherthanin

normal subjects. However, the metabolites are ultimately cleared through the bile.

Inpatients with chronic hepatitis or non-decompensated cirrhosis, the kinetics and

metabolism of diclofenac are the same as in patients without liver disease.

Preclinical safetydata

Preclinical data from acute and repeated dose toxicity studies, aswellasfrom

genotoxicity, mutagenicity, and carcinogenicity studieswithdiclofenacrevealedno

specifichazard for humans at the intended therapeutic doses. There was no evidence

that diclofenac had a teratogenic potential in mice, rats or rabbits.

Diclofenachad no influence on the fertility of parent animals in rats. The prenatal,

perinatal and postnatal development of the offspring was not affected.


As a rule, Abitren solution for injection should not be mixed with otherinjection



Protect from light.

Drug Registration Number:

015 57 24238 00

Manufactured by

Teva Pharmaceutical Works Private Limited Company,


License Holder

Abic Ltd.,

P.O.Box 8077, Netanya.

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