ABPI COMPENDIUM OF DATA SHEETS
`
`IHUD
`
`SUMMARIES 0F PRODUCT CHARACTERISTICS
`
`1 999-2000
`
`With The Code of Practice for the
`
`Pharmaceutical Industry
`
`Datapharm Publications Limited
`12 WhitehaM, London swm 20v
`
`AstraZeneca Exhibit 2091 p. 1
`InnoPharma Licensing LLC V. AstraZeneca AB IPR2017-00905
`
`

`

`1'
`Responsibility for Data Sheets and Summaries of Product Characteristics
`The data sheets and summaries of product characteristics in this Compendium are prepared independently by each
`participating company and each proof is checked and the text confirmed as correct by the participant concerned.
`Neither Datapharm Publications Limited nor The Association of the British Pharmaceutical Industry lABPll gives arr,
`guarantee whatsoever as to the accuracy of the information contained in the data sheets or summaries of D’Oduc‘;
`characteristics and accepts no liability whatsoever in respect of any loss, damage or expense arising from any. such
`information or for any error or omission in the data sheets or summaries of product characteristics and in panicula.
`(but without prejudice to the generality of the foregoing) shall not be liable for any consequential damages 0:
`expenses or any loss of profit or any liability to third parties incurred by anyone reiying on the information containec
`in the data sheets and summaries of product characteristics appearing in this Compendium.
`
`Published by Datapharm Publications Limited
`
`Copyright ', 1999‘
`Copyright in the material included in this Compendium
`is reserved by the individual companies and
`organisations which have contributed it,
`
`lSBN 0 907102 18 2
`ISSN 1364-5005
`
`Typeset. printed and bound in Great Britain
`by William Clowes Limited Beccles and Landon
`ii
`
`AstraZeneca Exhibit 2091 p. 2
`
`

`

`DRGANON LABORATORIES LIMlTED
`
`1095
`
`Children: It should be noted that smaller and less
`frequent doses may achiovo the same response.
`Administrarl'onrDeep intramuscular injection
`Contraindications: Known or suspected prostutic or
`mammary carcinoma. Pregnancy. Breast—feeding. Hy»
`persensrtlvity to one of thc excipients.
`Special warnings and special precautions for use:
`Patients. especially the elderly. with the following
`conditions should be monitored:
`ischaemic heart
`disease. since androgons may produce hypercholes-
`terolaemia; latent or overt cardiac failure. renal dys~
`function. hypertension. epilepsy or migraine (or a
`history of these conditions}. since androgens may
`occasionally induce fluid and sodium retention: skel-
`etal metastases, since androgens may induce hyper-
`calcacmiu or hypercalciuria in these patients.
`The use of steroids may influence the results of
`certain laboratory tests.
`Androgens should be used cautiously in prepubenal
`boys to avoid premature epiphyseal closure or pre-
`cocious sexual development.
`ll androgensassociated adverse reactions occur,
`Su‘stanon 100 treatment should be interrupted and.
`after disappearance of the symptoms. be resumed at
`a lower dosage.
`lnleraclion with other modicaments and other forms
`of interaction: Enzyme-inducing agents may exert
`increasing or decreasing eflects on testosterone
`levels. Therefore adjustment of
`the dose, and/or
`intervals between injections may be required.
`Pregnancy and lactation: On the basis of its pharma~
`cological effect. Sustanon 100 is suspected to cause
`birth defects andlor other irreversible adverse effects
`on pregnancy outcome. Therefore. Sustanon 100 is
`contraindicated during pregnancy and lactation.
`Effects on ability to drive and use of machines: As far
`as is known Sustanon 100 has no influenc: on
`alertness and concentration
`Undesirable effects: The following adverse reactions
`hava been associated with androgen therapy in
`general: In prepubertal boys. precocious sexual dc-
`veloprnent. an increased frequency of erections.
`phallic enlargement and premature epiphyseal clo~
`Sure; unapism and other signs of excessive sexual
`stimulation; water and sodium retention; oligosper-
`mic and a decreased ejaculatory volume.
`Treatment chauld be interrupted until these symp-
`toms have disappeared, after which it should be
`continued at a lower dosage.
`Hoarseness of the voice may be the first symptom
`a! vocal change which may lead to irreversible
`lowering of the voice. ll signs of virilisation, partlcu~
`larly'lowpring of the voice. develop. treatment should
`be discontinued.
`
`Pharmacological properties Therapeutic classifica-
`tion: (303 CA 03. Destrogen preparation for hormone
`replacement therapy.
`Pharmacodynami‘c properties: The pharmacodynam-
`ics of Sandrena are similar to the se of oral oestrogen}.
`but the maior dillerence to oral administration has in
`the pharmacokinetic profile.
`The clinical elficacy of Sandrena in the treatment of
`menopausal symptoms is comparable to that of
`peroral oestrogen Combined with medroxyproges-
`tcrone acetate. percutaneous oestradiol lowers total
`cholesterol without reducing the HDL cholesterol
`level.
`Phil!”IECUklncflCDfapflfllES§Sfl ndre ha is an alcohol
`based oestradlol gel. When applied to the skin the
`alcohol evaporates rapidly and oestradiol is absorbed
`through the skin into the circulation. To some extent.
`however. the oestradiol is stored in the subcutaneous
`tissue from where it is released gradually into CircuA
`lotion. Pcrcutancous administration circumvents the
`hepatic first-pass metabolism. For these reasons. the
`fluctuations in the plasma oestrogen concentrations
`with Sandrena are less pronounced than peroral
`oestrogen.
`_
`A 1.5 mg pcrcutancous dose of oestradidl (1.59
`Sandrenal results in a plasma concentration of about
`340 pmolrl. which corresponds to the level of eetlv
`follicular stage in prontenopausal women. During
`Sandreria treatment the oestradial/ciostronc ratio re-
`mains at 0.7. while during pcroral oestru geritreatment
`it usually drops to lessthan 0.2..
`The mean oestradiol exposure at steady state of
`Sanorcna is 32 per cent compared with an equivalent
`oral dose of oestradiol valerate. Otherwise the metals
`olism and excretion of transdermal ocstradiol follow
`the fate of natural ocstrogcns.
`Preclinicalsafery data:0estrudiol is a natural female
`hormone with an established clinical use. therefore
`no toxicological studios have been performed With
`Sandrena. The necessary studies on the irrita nt effects
`of the gel have been studied in rabbits and skin
`sensitisation in guinea pig. Based on the results from
`these studies it can be concluded that Sundrena could
`very infrequently cause milcl skin Irritation. The
`frequency of the occurrence of dermal irritation can
`be reduced by daily change ofthe application site.
`Pharmaceutical particulars
`List of excipr’ents: Carbomcr 934 HP: Sodium hydrox:
`ide; Propylene glycol PhEur; Spir. fort—Ethanol 96%
`BP. Aq. punt-Purified water PhEur.
`incompatibilities: Nu incompatibilities have been
`found.
`Shelf life: 3 veers.
`Special prcca utions for storage: At room temperature
`lbclow 251:).
`Nature and contents ofcontainer: Single dosualu mln~
`iurn foil sachets supplied in packages containing 28
`of either dose Or 91 sachets of 1 mg dose.
`instructions for use/handling: None
`Marketing authorisation holder
`Orion Corporation. Orioninite 1. PD. Box 65. FIN-
`02101.E5POO,FINLAND
`_
`Distributed by Drgenon Laboratories Limited. Cam-
`0 L.
`bytlge Science Park. Milton Road, Cambridge. C84
`Marketing authorisation number
`1 391 “0004.00le
`Date of Epartlall revision of the text October 1996
`Legal Category POM
`
`Special warnings and special precautions for use:
`Before therapy is initiated. a thorough medical history
`should be taken. A complete gynaecological exami-
`nation should be performed and repeated at least
`once a your during therapy.
`Prolonged use without addition of a progestogen
`may cause endometrial hyperplasia. Therefore.
`in
`women with an intact uterus. Sandrena treatment
`should be combined with cyclic progestogcn admin-
`istration. Withdrawal bleeding resembling normal
`menstruation will usually occur after each course of
`progestogen. The cause of unexpected or prolonged
`uterine bleeding during therapy should be clarified.
`Atypical adunomatous hyperplasia of the endomo-
`triurn must be treated before commencing oestrogen
`therapy.
`Consider discontinuation prior to surgery or pro-
`longed immobilisation. Development of do new
`frequent severe headaches or migraine should be
`investigated and possible prodromal symptoms of
`vascular occlusion should be clarified.
`The risks and benulits of treatment should b
`evaluated and close monitoring performed for pa-
`tients with:
`v endometriosis
`- uterineleiomyoma
`- endomutrial hyperplasia tsimple glandular hyper-
`plasia or hyperplasia giandularis cyclical
`- diseases of the cardiovascular system including
`cerebrovascular disorders.
`- a history oithromboemhulic disease.
`- severe hypertension.
`- history of for close family history all breast cancer.
`— severe disturbances of lipid metabolism,
`- renal dysfunction
`systemic lupus erythemotosus
`- porphyfiu
`At present there is suggestive evidence of a slight
`increase in the relative risk of carcinoma of the breast
`with longAtcrm hormone replacement therapy. how
`ever, the results are contradictory. Regular breast
`examinations and mammography, Where appropri-
`ate. should be carried out in women on hormone
`replacement therapy.
`Some conditions may be aggravated during oestro-
`gcn therapy or pregnancy. Women on Sundrena
`treatment with one of the following conditions tar
`with a history thereof during previous pregnancy or
`hormone usel should therefore be closely monitored.
`These conditions include:
`v mild hypertension,
`- migrainoorsevere headache.
`v cemgn breastdiscasc.
`-
`liver function disturbances.
`- cholestasis.
`‘ choleflthiasis.
`- diabetes mellitus.
`Overdosageflfle acute intramuscular toxicity of Sus~
`- asthma.
`f
`tartan 150 is very low. Thereioro toxic s m toI'll
`- otosclnrosis,
`not expected to occur.
`V
`p
`s a e
`- multiple sclerosis.
`Pharmacological properties
`- galactorrhea, elevated prolactin levels.
`Pharmacbdynamlt‘ properties: Testosterone is the
`- history of herpes gestationis,
`principal endogenous hormone essential for normal
`- epilepsy.
`growth and development of the male sex organs and
`interaction with other modi'camcnls and other forms
`male secondary sex characteristics. During adult lile
`or interaction: No interactions between Sandreno and
`testosterone is essential for the functioning of the
`other medicines have been reported. There are some
`testes and accessory structures, and for the mainte-
`indications that oestroguns may reduce the effects of
`nance of libido. sense of well-being. erectile potency
`antihypertensive.
`anticoagulant
`and
`onlidiabatic
`prostate and seminal vesicle function.
`‘
`drugs. Concomitant treatment with potent inducers of
`Treatment of hypogonadal males with Sustanon
`liver enzymes 18.9. barbiturates, carbamazepine. gri-
`100 results in a clinically significant rise of plasms
`scofuivin and rifampicinl may reduce the plasma
`concentrations of testosterone. dihydtotcstos’erona
`levels of oestradiol. The significance of these interac-
`and androstenedione. as well as a decrease of'SHBG.
`tions in transdermal application has not been eluci-
`{sex hormone binding globulinl. In the males with
`dated.
`SUSTANDN‘ 100‘
`primary.lhypergonadotropicl hypogonadism treat-
`Pregnancyand lactation: Sandrana is not indicated in
`rnent with Sustanon results in a normalisation of
`pitultaryfunction.
`Qualitative and quantitative compasmufi
`women o‘lchiId-bean’ng capacity, n has no cal-“mean.
`Testosterone propionate PhEur 20 mg
`rive efficacy. Sandrena should not be used during
`100 contains a
`Phormacokr’netic properties: Susta non
`Testosterone phenylpriopinnaie 5P ‘m "‘9'
`pregnancy or lactation.
`number at esters of testosterone with
`different dura~
`Testosterone lsocaproate BP «l mu
`olysed into the
`Elicich on ability to drive and use machines: Destro-
`lions of action. The esters are hydr
`Equivalent to a total of 7‘ mg of toslflfilchNEl
`natural humane testosterone. as so
`on as they enter
`gcns such 33 Sandrcna do not affect the ability to
`the general circulation.
`Pharmaceutical lorrn Sustanon 100_ is a clear, sterile.
`drive or use machines.
`0W solution for deep intramuscular injection.
`A single dose of Sustanon 100 leads to an increase
`Undesr'rable effects: Adverse drug reactions are usu-
`Clinical particulars
`of total plasma testosterone,with peak level reached
`ally mild and only seldom lead to discontinuation of
`Therapeutic indications: Testosterone replacement
`approximately 24-4Ehr5 lt.....l after administration.
`treatment. ll they do occur. it will usually booming
`therapy in male hypogonadol disorders, for example:
`the first months of treatment.
`the normal ran e in
`-
`Plasma testosterone levels return to the lower limit of
`alter castration: eunuchoidism: hypopltuitarism: en»
`Occasionally for oestrogens in general: Breast
`docrine impotence: male climacteric 5Ymploms like
`days.
`g
`males alter approxrmatalv 21
`tenderness. headache. oedema, weight increase. un-
`Testosterone is metaboli
`decreased libido: certain types of infertility our: to
`sud via the normal
`3‘?!-
`_
`.
`s:heduled vaginal bleeding or spotting.
`disorders of sperrnalogcnesis.
`Rarely for oestrogens in general: Migraine, changes
`ways. Excretion mainly takes place via the urirEc ‘as
`Testosterone therapy may also be indicated lor the
`cunyugatcs oi etiocholanulone and androsterone
`"I libido and mood. gastrointestinal discomfort leg.
`prevention andtreatment of osteoporosis in hypo gon-
`adal males
`nausea. vomiting, stomach crampsl. hypertension.
`Praclinicalsafety data: Not applicable.
`alterations in liver function and biliary flow.
`Pharmaceutical particulars
`Posology and method of administratio n:
`In clinical trials dermal irritation has been very
`List of excipierrts:
`Dusagczln general. dosage should be adjusted to the
`infrequentwith Sandrena.
`Benzyl Alcohol PhEur 0.1 ml
`individual response of the patient.
`Aracliis Oil PhEurto 1.0 ml
`Oucrdosage: Generally, oestrogcns are well tolerated
`Adults: Usually. one injection of 1 ml per two weeks
`is adequate.
`even in massive doses. Possible symptoms of over-
`fr'COmp-flllbrlll’lES: NO l’EleVfilll
`dose include those listed under undesirable effects.
`Elderly: it should be noted that smaller and less
`Treatment is symptomatic.
`frequent doses may achieve the same response.
`Shelfvl‘iio.‘ 5 years.
`
`
`Il'lCCll'l'I
`
`95
`
`llblliles Hit!
`
`AstraZeneca Exhibit 2091 p. 3
`
`

`

`
`
`1096
`
`ORGANON LABfiRATOi'lIES LlMITED
`
`when 250 is very low. Therelore toxic symptoms are
`not expected to occur.
`Pharmacological properties
`Pharmacoo‘ynamic properties: Testosterone is the
`principal endogenous hormone essential for normal
`growth and development of the male sex organs and
`male secondary sex characterislics. During adult life
`testosterone is essential for the lunctioning of tho
`lestes and accessory structures, and for the mainte
`nance of libido. sense of well-being. erectile potency.
`prostate and seminal vesicle lunction.
`Treatment ol hypogonadal males with Sustanon
`250 results in a clinically significant rise of plaSma
`concentrations of testosterone. dihydrotestoslerone
`and androstenodione. as well as ll decrease of SHSG
`(sex hormone binding globulin}.
`In the males wrth
`primary lhypergonadotropicl hypogonadism treat-
`ment with Sustanon results in a normalisation of
`pituitary lunction.
`Pharmacoitinctl‘c properties: Sustonon 250 contains a
`number of esters of testosterone with different dura—
`tions of action. The esters are hydrolysed into the
`natural hormone testosterone as soon as lhey enter
`the general circulation.
`A single dose of Sustanon 250 leads to an increase
`at
`total plasma testosterone with peak-levels at
`approximately 70 Merritt
`lC....l. which are reached
`approximately 24—l8h Hm...) alter administration.
`Plasma testosterone levels return to the lower limit of
`the normal range in males in approximately 21 days.
`Testosterone is metabolised via the normal path-
`ways. Excretion mainly takes place via the urine as
`coniunates ol' etiocholanolona and androsterone.
`Preclinicalsafety data: No! applies blc.
`Pharmacc utlcal panicutars
`List of oxelpienrs:
`Benzyl Alcohol PhEur 0.1 ml
`Arachis Gil PhEur to 1.0 ml
`lncomparibiirties: No relevant incompatibilities are
`known.
`Shelf~lifer5 years
`Special precautions for storage: Store bctween 15-
`25'6, protect irorn light
`Nature and contents of containers: 1 ml ampoulcs in
`boxes of 3
`lnslruciions Iot- usemandling: not applicable.
`Marketing authorisation number 0065/5086
`Data at first authorisation 28 February 1973
`Data of preparation oi the last March lQSS
`Legal category POM
`
`Special precautions for storage: Store between 15-
`251:. protect from light.
`Nature and contents of containers: l ml ampaul‘cs in
`boxes of 3.
`Instructions for use/handlingrnot applicable.
`Marketing authorisation number 0055:5019
`Date of lirst authorisation 28 February 1973
`Date of preparation of the text March 1995
`Legal category POM
`
`SUSTANON’ 25‘0
`Qualitative and quantitativacomposition
`Testosterone propionate PhEur 30 mg
`Testosterone phenylpriopionale EP 60 mg
`Testosterone isocoproate BP so mg
`Testosterone decanoate BP 100 mg
`[equivalentto a total of 1T6 mg oi Testosteroncl
`Pharmaceutical form _ Sustonon 250 is a clear. sterile.
`oily solution tor deep intramuscular injection.
`Clinical particulars
`Therapeutic indications.- Testosterone replacement
`therapy in male hypogonadaldisorders. (or example:
`after castration; eunuchoidism; hypopituilarism: en»
`docrina impotence: male climacteric symptoms like
`decreased libido: certain types of infertility due to
`disprders of SpermatogenEsis.
`Testosterone therapy may also be indicated for the
`provenllon and treatment of osteoporosis in hypogon-
`adsi males
`Posoiagy and method of administration:
`Dosage: In general. dosage should be adjusted to the
`individual response of the patient.
`Adults: Usually. one Injection of ‘lml per three
`weeks is adequate.
`Elderly: it should be noted that smaller and less
`frequent closes may achieve the same response.
`Children: It should be noted that smaller and less
`frequent doses may achieve the same response.
`Administration: Deep intramuscular lnieclion
`Contra-indications: Known or suspected prostatic or
`mammary carcinoma. Pregnancy. Breast-feeding. Hy-
`persensitivity to one of the excipients.
`Special warnings and special precautions for use:
`Patients. especially the elderly. with the following
`conditions should be monitored:
`ischaemic heart
`disease. since androgens may produce hypercholcs-
`terolaemia. Latent or oven cardiac failure, renal
`dysluncfion. hypertension. epilepsy or migraine (or a
`history of these conditions]. since androgcns mall
`occasionally induce fluid and sodium retention. Sincl-
`etal melaslases. since androgens may induce hyper-
`calcaemia or hypercailciuria in these patients.
`The use of steroids may influence the results of
`certain laboratory tests.
`Androgensshould be used cautiouslyin prepubenal
`boys to avoid premature epiphyseal closure or pre-
`cocious sexual development.
`if androgen-associated adverse reactions occur.
`Sustanon 2-50 treatment should be interrupted and.
`alter disappearance of the symptoms. be resumed at
`a lower dosage.
`interaction with other medical-items and other forms
`of intEractl‘on: Enzymevinducing agents may exert
`increasing or decreasing effects on testosterone
`levels. Therefore adjustment of
`the dosu. and/or
`intervals between injections may be required.
`Pregnancy and lactation: 0n the basis of its pharma-
`cological ollect. Suslanon 250 is suspectod to cause
`birth defects andlcr other irreversible adverse ellecls
`on pregnancy outcome. Therefore. Suslonon 250 is
`contraindicated during pregnancy and lactation.
`Effects on ability to drive and use of machines: As far
`as is known Sustanon 250 has no influence on
`alertness and concentration.
`Undesirabie effects: The lollowing adverse reactions
`have been associated Mth androgen therapy in
`general:
`In prepubertal boys. precocious sexual develop-
`ment. an increased frequency of erections. Dhallic
`enlargement and premature epiphyseal closure: pria-
`pism and other signs of excessive sexual stimulation;
`water and sodium retention: oligospermia and a
`decreased eiaculatory volume.
`Treatment should be interrupted until these symp-
`toms have disappeared. after which it should be
`continued at a lower dosage.
`Hoarseness of the voice may be the first symptom
`ol vocal change which may lead Io irreversible
`lowering ofthe voice. If signs ofvirilisation,pat1icu-
`larly lowering of the voice. develop. treatment should
`bra-discontinued.
`
`Overdosa‘gic: The acute mlra muscular toxicilyo‘l Sus»
`
`carcinoma or breast carcinoma in the male. Prog-
`nancy. Breast-feeding.
`Use in nrcgnancyand lactatioanestosteroncimplants
`are contra-indicated during pregnancy and lactation.
`Warnings and mesa utions:
`— Androgens should be used with caution in women
`to avoid unacceptable and irreversible virilization.
`Female patients should therefore be counselled to
`report any deepening or hoorsening oi the voice
`without delay.
`>
`_
`‘
`- Androgens should be used Wrth caution in preoub-
`ortal boys to avoid premature epiphyseal closure or
`precocious sexual development. Skeletal matura-
`tion should be monitored regularly.
`- Due to the long-lasting action and the difficulty oi
`removal. Testosterone implants should be used
`with extra caution. Therefore. it may be advisable to
`establish the beneficial client and tolerance for
`androgen therapy by prior treatment with a shorter-
`acting testosterone preparation. This applies in
`particular to lpreloubenal boys. women and elderly
`men.
`- Patients with latent or overt cardiac failure. renal or
`hepatic dysfunction. hypertension. epilepsy or mi-
`amine lor a history of these conditions} should be
`kept under close medical supervision. since aggra-
`vation of recurrence may occasionally be induced.
`ll androgen-associated adverse reactions occur the.
`-
`implant should be removed it possible.
`- The use of steroids may influence the results of
`certain laboratory lests.
`Effects an ability to drive- and to use machines:As far
`as is known Testosterone implants have no ollects on
`alertness and concentration.
`interactions: Enzyme-inducing drugs may influence
`plasma testosterone levels.
`Other undesirable effects (frequency and serious
`miss}: The following adverse reactions have been
`associated with androgen therapy:
`-
`in general: water and sodium retention. hypercel-
`caemia;
`-
`in women: symptoms of virilizntion, such as voice
`changes ldeepening. hoarspningl and hirsutism;
`in prepuberl‘al boys: precocious sexual develop-
`ment.
`increased frequency of erections. phallic
`enlargement and premature cpiphysepl closure;
`in mempriapism and othersigns ofexccssive sexual
`stimulation, Dligoqurmia and decreased ejacula
`tory volume
`Dverdosnpoflhe acute toxicity of testosterone is lo~.~.‘.
`Priapism in men and undesired deepening of m:-
`voiceinwomenaresymptomsolchronicoveidosogo.
`In this case the implanttsl should be removed.
`Pharmaceutical precaution: Store below EST: and
`protect from light
`incompatibilities: Non 9,
`Legal category POM.
`Package quantities Each sterile implant is supplier:
`singly. in a sealed glass tube.
`Further information Testosterone is a naturally-
`gccurrlng hormone formed in the interstitial cells of
`'thc testes under the control olthe nnlerloriobe of the
`pituitary gland which controls the development and.
`maintenance of
`the male sex organs and male
`secondary sex characteristics. Testosterone also pro-
`duces systemic effects. such as increasing the retenr
`tion of nitrogen. calcium. sodium, potassium. chloride
`and phosphate leading to an increase in skeleta-
`weight, water retention and an increase in the growth
`of bone.
`'
`Testosterone implants, when inserted subcutanp
`ously release testosterone into the bloodstream at .1
`relatively even rate supplying near physiological
`plasma testosterone levels.
`Surlace area of the implantsis the most imporla n:
`factor influencing the rate at absorption. In general
`the absorption rate estimated by removal of implants:
`at intervals and weighing appears to be npprecinblr
`more rapid than when the rate is assessed upon the
`clinical requirement. in addition to clinical evidence
`individual variction in the rate of absorption or
`implants must be taken into account.
`The average daily absorption oi testosterone has
`been estimated at 0.5 mg for a we mg impia m with
`an approximate duration of 3d weeks.
`Product lies not; numbers
`50 mg
`GOESISUBZR
`10o n10
`0065.5083R
`zoo mg
`ODESISOBm
`
`.
`
`-
`
`ZISPIN V
`Qualitative and quantitative composition
`let contains 30 mg of miners-pine.
`Pharmacouticaltorm Tablet
`
`Each tab-
`
`AstraZeneca Exhibit 2091 p. 4
`
`TESTOSTERONE IMPLANT
`Presentation Testosterone implants are pellets con-
`taining 50, 100 or 200 mg testosterone in glass
`ampoules.
`Uses
`in the male: testosterone replacememlherapv
`in primary or secondary thOQOI‘ada' dlsmders‘ for
`example:
`- ahercastration.
`. eunuchoidism,
`- hypopitultarism,
`- endocrineimpmence.
`.
`lnlonility due to spermatogenic film'de's-
`- male climacteric syn-rpm ms such as decreased libido
`and decreased mental and Dh‘lSlcal “Cl'V'W'
`Moreover, restostgmne therapy may be indicated
`in osteoporosis in the male due to androgen deli-
`money.
`In the female as an adiunct to oestrogen replace-
`ment therapy in postmenopausalwomon to allevrale
`Svmptoms. such as decreased libido andi'or loss at
`Energy.
`‘
`I
`_
`Dance and administration
`in males. 100-500 mg depending on indlwdualrequrre-
`merits. A dosage oi 600 mg is x lDO'm‘gl usually
`maintains plasma testosterone levels within the nor-
`mal Ph‘rsiplogical range for 4-5 months.
`in females: 59-190 mg as an adjunct to oestradiol
`implants.
`‘
`Method oi
`implantation: Testosterone implants
`should be inserted subcutaneously into an areawhere
`there is relatively littlu movemen'l or blend supply.
`such as the lower abdominal wall or the buttock.
`Insertion is made under local anaesthesia USII'IQI a
`"033! and a cannula, The wound is closed eitherwth
`an adhesive dressing or a fine suture. The Implants
`must be placed subcutaneously to facilitate removal
`if necessary. Full aseptic ’no touch' technique should
`be adopted.
`.
`Contra-indications.warnings. etc.
`Contra-indications: Knoiivn or suspected prostatnc
`
`