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PHARMACEUTICAL FORMS

THERAPEUTIC AREAS

Oral
CYPROTERONE ACETATE

Dosage: 50 mg, 100 mg

Therapeutic Class: Antiandrogens

ATC code: G03HA01

Prostatic cancer

Tablet

PVC-Aluminium blister strip
with 10/28 tablets (CPA50)
and 10/12 tablets (CPA100)

Pack sizes: 10, 20, 56, 84 and 168 tablets

Shelf life:

• Climatic Zone II: 36 mths
• Climatic Zone IV: 36 mths

DIOSMINE

Dosage: 600 mg

Therapeutic Class:

Cardiovascular system – capillary stabilizing agent

ATC code: C05CA03

Improvement of symptoms of venous insufficiency of the lower limbs, e.g. heavy legs and pain, complaints resulting from bedsores.
Symptomatic treatment of haemorrhoidal crisis.

Tablet
PVC-Aluminium blister strip
with 15 tablets

Pack sizes: 15 and 30 tablets

Shelf life:

• Climatic Zone II: 36 mths
• Climatic Zone IV: no data

NOMEGESTROL ACETATE

Dosage: 5 mg

Therapeutic Class:  Progestogens

ATC code: G03DB04

Treatment of menstrual cycle disorders due to absence or low secretion of progesterone in premenopausal women.
In postmenopausal women as hormone replacement therapy (HRT) for estrogen deficiency symptoms in combination with estrogens.

Breakable tablet

PVC-Aluminium blister strip
with 10 or 14 tablets

Pack sizes: 10, 30, 42, 60, 84 and 90 tablets

Shelf life / Storage conditions:

• Climatic Zone II: 36 mths
• Climatic Zone IV: 36 mths in Aluminium pouch

GESTODENE / ETHINYLESTRADIOL

Dosage: 75 µg/20 µg, 75 µg/30 µg

Therapeutic Class:
Hormonal contraceptives
for systemic use

ATC code: G03AA10

Oral contraception

Coated tablet
PVC-Aluminium blister strip with 21 tablets

Pack sizes:
1x 21, 3x 21, 6x 21 tablets

Shelf life / Storage conditions:

• Climatic Zone II: 36 mths
• Climatic Zone IV: 36 mths in Aluminium pouch

GESTODENE / ETHINYLESTRADIOL

Dosage: 60 µg/15 µg

Therapeutic Class:

Hormonal contraceptives
for systemic use

ATC code: G03AA10

Oral contraception

Film-coated tablet
PVC-Aluminium blister strip
with 24 + 4 tablets

Pack sizes:

1x 28, 3x 28, 6x 28 tablets

Shelf life:

• Climatic Zone II: 36 mths
• Climatic Zone IV: 36 mths

DROSPIRENONE / ETHINYLESTRADIOL

Dosage:  3 mg/0.03 mg

Therapeutic Class:

Hormonal contraceptives
for systemic use

ATC code: G03AA12

Oral contraception

Film-coated tablet

PVC-Aluminium blister strips with 21 tablets

Pack sizes:
1x 21, 3x 21, 6x 21 film-coated tablets

Shelf life:

• Climatic Zone II: 36 mths
• Climatic Zone IV: 36 mths

DIENOGEST

Dosage: 2 mg

Therapeutic Class:

Progestogens

ATC code: G03DB08

Treatment of endometriosis

Film-coated tablet
PVC-Aluminium blister strips with 14 tablets

Pack sizes: 2x 14,  6x 14 tablets

Shelf life:

• Climatic Zone II: 36 mths
• Climatic Zone IV: 36 mths

DESOGESTREL / ETHINYLESTRADIOL

Dosage: 150 µg/20 µg, 150 µg/30 µg

Therapeutic Class:

Hormonal contraceptives
for systemic use

ATC code: G03AA09

Oral contraception

Tablet

PVC-Aluminium blister strip
with 21 tablets in Aluminium pouch

Pack sizes: 1x 21, 3x 21 and 6x 21 tablets

Shelf life:

• Climatic Zone II:
30 mths (150 µg/20 µg)
36 mths (150 µg/30 µg)
• Climatic Zone IV:
36 mths

DESOGESTREL

Dosage: 75 µg

Therapeutic Class:

Hormonal contraceptives
for systemic use

ATC code: G03AC09

Oral contraception

Film-coated tablet
PVC/PVDC-Aluminium blister strip with 28 film-coated tablets

Pack sizes: 1x 28, 3x 28, 6x 28 film-coated tablets

Shelf life:

• Climatic Zone II: 36 mths
• Climatic Zone IV: no data

CYPROTERONE ACETATE / ETHINYLESTRADIOL

Dosage: 2 mg/0.035 mg

Therapeutic Class:

Anti-androgens and oestrogens

ATC code: G03HB01

Severe acne

Coated tablet

PVC-Aluminium blister strip with 21 tablets

Pack sizes:
1x 21, 3x 21, 6x 21 coated tablets

Shelf life / Storage conditions:

• Climatic Zone II: 36 mths
• Climatic Zone IV: 36 mths in Aluminium pouch

CYPROTERONE ACETATE

Dosage: 50 mg

Therapeutic Class:

Antiandrogens

ATC code: G03HA01

Control of libido in severe hypersexuality and/or sexual deviation in the adult male.
Treatment of prostate cancer.

Tablet
PVC-Aluminium blister strip
with 10/28 tablets

Pack sizes:
10, 20, 56, 84 and 168 tablets

Shelf life:

• Climatic Zone II: 36 mths
• Climatic Zone IV: 36 mths

URAPIDIL

Dosage: 30 mg, 60 mg, 90 mg

Therapeutic Class:
Antiadrenergic agent – peripherally acting

ATC code: C02CA06

Hypertension

Prolonged-release capsule,
hard Polypropylene bottle
with polyethylene desiccant cap

Pack sizes:
30, 50, 60, 90 and 100 capsules

Shelf life:

• Climatic Zone II: 24 mths
• Climatic Zone IV: no data

Parenteral
AMIODARONE

Dosage:  50 mg/ml

Therapeutic Class:
Antiarrythmics (Class III)

ATC code: C01BD01

Treatment of severe rhythm disorders not responding to other therapies or when other treatments cannot be used.

Concentrate for solution for injection / infusion
3 ml in glass ampoule

Pack sizes: 5 and 10 ampoules

Shelf life:

• Climatic Zone II: 24 mths
• Climatic Zone IV: no data

LEVETIRACETAM

Dosage: 5 mg/ml, 10 mg/ml, 15 mg/ml

Therapeutic Class: Antiepileptics

ATC code: N03AX14

Monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy.

Ready-to-use solution for infusion
100 ml Nexcel® dual port bag

Pack size: 10 bags

Shelf life:

• Climatic Zone II: 36 mths
• Climatic Zone IV: no data

TRANEXAMIC ACID

Dosage: 100 mg/ml

Therapeutic Class: Antifibrinolytics

ATC code: B02AA02

Prevention and treatment of haemorrhages due to general and local fibrinolysis in adults and children.

Solution for injection
5 ml and 10 ml glass ampoules

Pack size: 5 ampoules

Shelf life:

• Climatic Zone II: 36 mths
• Climatic Zone IV: no data

OXALIPLATINE

Dosage: 50 mg, 100 mg

Therapeutic Class: Antineoplastic agent

ATC code: L01XA03

Treatment of metastatic colorectal and stage III (Duke’s C) colon cancer in combination with 5-fluorouracil and folinic acid.

Powder for solution for infusion
Glass vial

Pack size: 1 vial

Shelf life:

• Climatic Zone II: 36 mths
• Climatic Zone IV: no data

PIPERACILLIN / TAZOBACTAM

Dosage: 2 g/250 mg, 3 g/375 mg, 4 g/500 mg, 12 g/1.5 g, 36 g/4.5 g

Therapeutic Class:

Beta-lactam antibacterials, penicillins

ATC code: J01CR05

Treatment of severe pneumonia, complicated infections of urinary tract, intra-abdominal, skin and soft tissue infections (including diabetic foot infections), in patients with bacteraemia, neutropenic patients with fever suspected to be due to a bacterial infection.

Powder for solution for infusion

Pack sizes: 1, 5, 10 and 12 vials

Shelf life / Storage conditions:

• Climatic Zone II: 24 mths, do not store above 25°C
• Climatic Zone IV: 24 mths, do not store above 25°C.

FLUCLOXACILLINE

Dosage: 1 g, 2 g, 4g

Therapeutic Class:

Beta-lactam antibacterials;
betalactamase resistant penicillins

ATC code: J01CF05

Treatment of acute and chronic infections caused by  flucloxacillin-sensitive penicillinase producing staphylococci (with the exception of methicillin-resistant staphylococci (MRSA/MRSE)) in the respiratory tract, of the skin, mucosa and soft tissues as well as of the bones and bone marrow.

Powder for solution for injection / infusion
Glass vial

Pack sizes: 1, 5, 10, 25, 50 and 100 vials

Shelf life:

• Climatic Zone II: 36 mths
• Climatic Zone IV: 30 mths

PACLITAXEL

Dosage: 6 mg/ml

Therapeutic Class:

Antineoplastic agents (taxanes)

ATC code: L01CD01

Treatment of advanced ovarian cancer, node positive and locally advanced or metastatic breast cancer, advanced non-small cell lung carcinoma (NSCLC) and advanced AIDS-related Kaposi’s sarcoma (KS).

Concentrate for solution for infusion
5 ml (30 mg), 16.7 ml (100 mg) and 50 ml (300 mg) in glass vial

Pack sizes: 1 and 10 vials

Shelf life / Storage conditions:

• Climatic Zone II: 24 mths, do not store above 25°C
• Climatic Zone IV: 24 mths

ERYTHROMYCINE

Dosage:  1 g

Therapeutic Class:

Macrolides, lincosamides and streptogramins

ATC code: J01FA01

Treatment of nosocomial pneumonia; skin and soft-tissue infections in patients who are hypersensitive to penicillin or where penicillin is unsuitable for other reasons.

Powder for solution for infusion
Glass vial

Pack sizes: 1 and 10 vials

Shelf life:

• Climatic Zone II: 36 mths
• Climatic Zone IV: no data

CLOXACILLINE

Dosage: 500 mg, 1 g, 2 g, 10 g

Therapeutic Class:

Beta-lactam antibacterials;
betalactamase resistant penicillins

ATC code: J01CF02

Treatment of infections caused by penicillinase producing staphylococci as skin and soft-tissue infections, endocarditis, osteomyelitis and sepsis.

Powder for solution
for injection / infusion
Glass vial

Pack sizes: 1 and 10 vials

Shelf life:

• Climatic Zone II:  36 mths
• Climatic Zone IV: 36 mths

CEFUROXIME

Dosage:  250 mg, 750 mg, 1.5 g

Therapeutic Class:

Other beta-lactam antibacterials,
2nd generation cephalosporines

ATC code: J01DC02

Treatment for community acquired pneumonia; acute exacerbations of chronic bronchitis; urinary tract infections including pyelonephritis; soft-tissue infections, intra-abdominal infections; prophylaxis against infection in surgery.

Powder for solution for
injection / infusion
Glass vial

Pack size: 10 vials

Shelf life:

• Climatic Zone II: 24 mths
• Climatic Zone IV: 36 mths

CEFTRIAXONE

Dosage: 250 mg, 500 mg, 1 g, 2 g, 10 g

Therapeutic Class:
Other beta-lactam antibacterials,
3rd generation cephalosporines

ATC code: J01DD04

Treatment for bacterial meningitis; pneumonia; acute otitis media, intra-abdominal infections; urinary tract infections including pyelonephritis; infections of bones and joints, the skin and soft tissues; gonorrhoea; syphilis; bacterial endocarditis.

Powder for solution for injection / infusion
Glass vial

Pack sizes: 1 or 10 vials

Shelf life:

• Climatic Zone II: 36 mths
• Climatic Zone IV: 24 mths

CEFTAZIDIME

Dosage:  250 mg, 500 mg, 1 g, 2 g, 3 g, 6 g

Therapeutic Class:

Other beta-lactam antibacterials,
3rd generation cephalosporines

ATC code: J01DD02

Treatment for nosocomial pneumonia; broncho-pulmonary infections in cystic fibrosis; bacterial meningitis; chronic suppurative otitis media and malignant otitis externa; infections of the urinary tract, the skin and soft tissues, the bone and joint; intra-abdominal infections; peritonitis associated with dialysis in patients on CAPD; bacteraemia; neutropenic patients with fever that is suspected to be due to a bacterial infection.

Powder for solution for injection / infusion
Glass vial

Pack sizes: 1 and 10 vials

Shelf life / Storage conditions:

• Climatic Zone II: 36 mths
• Climatic Zone IV: 36 mths,do not store above 25°C.

CEFOTAXIME

Dosage:  0.5 g, 1 g, 2 g

Therapeutic Class:

Other beta-lactam antibacterials,
3rd generation cephalosporins

ATC code: J01DD01

Treatment of severe infections caused by bacteria sensitive to cefotaxime, such as bacterial pneumonia, infections of the kidneys and upper urinary tract, the skin and soft tissues; intra-abdominal infections (including peritonitis); acute bacterial meningitis (especially caused by H. Influenzae, N. meningitis, E. coli, Klebsiella strains); Sepsis.

Powder for solution for injection / infusion
Glass vial

Pack size: 10 vials

Shelf life / Storage conditions:

• Climatic Zone II: 36 mths
• Climatic Zone IV: 36 mths, do not store above 25°C.

CEFEPIME

Dosage:  1 g, 2 g

Therapeutic Class:

Other beta-lactam antibacterials,
4th generation cephalosporins

ATC code: J01DE01

Treatment of infections caused by cefepime-susceptible pathogens, such as pneumonia, urinary tract infections, infections of the abdomen including peritonitis, the gall bladder and bile ducts; in patients with bacteraemia and for the empirical treatment of febrile episodes in patients with neutropenia.

Powder for solution for injection / infusion
Glass vial

Pack sizes: 1 and 10 vials

Shelf life:

• Climatic Zone II: 36 mths
• Climatic Zone IV: no data

URAPIDIL

Dosage: 5 mg/ml

Therapeutic Class:
Antiadrenergic agent – peripherally acting

ATC code: C02CA06

Hypertensive emergencies, severe and very severe forms of hypertensive disease, hypertension resistant to treatment.
Controlled lowering of blood pressure in hypertensive patients during and/or after surgery.
Possible to overlap acute parenteral therapy with changing to continuous treatment with oral agents that lower blood pressure; e.g. Urapidil Stragen prolonged-release capsules, hard 30 mg, 60 mg or 90 mg.

Solution for injection /
Concentrate for solution for infusion
5 ml, 10 ml and 20 ml in
glass ampoule

Pack size: 5 ampoules

Shelf life / Storage conditions:

• Climatic Zone II: 36 mths
• Climatic Zone IV: 18 mths

MILRINONE

Dosage: 1 mg/ml

Therapeutic Class:
Cardiac stimulants excl. cardiac glycosides

ATC code: C01CE02

Short-term treatment of severe congestive and acute heart failure.

Concentrate for solution for infusion
10 ml and 20 ml glass ampoule

Pack sizes: 1, 3, 5 and 10 ampoules

Shelf life:

• Climatic Zone II: 36 mths
• Climatic Zone IV: 36 mths

ATOSIBAN

Dosage: 7.5 mg/ml

Therapeutic Class:

Genito urinary system and sex hormones – other gynecologicals

ATC code: G02CX01

Indicated to delay imminent pre-term birth in pregnant adult women.

Solution for injection /
Concentrate for solution for infusion
0.9 ml (6.75 mg) and 5 ml (37.5 mg) in vial

Pack size: 1 vial

Shelf life / Storage conditions:

• Climatic Zone II: 30 mths, store in a refrigerator (2°C to 8°C)
• Climatic Zone IV: no data

Topical
DICLOFENAC

Dosage: 1%

Therapeutic Class:
Musculo-skeletal system – anti-inflammatory preparations, non-steroids for topical use

ATC code: M02AA15

Tendonitis of the upper and lower limbs; post-operative and post-traumatic oedema; symptomatic treatment of painful osteoarthritis of the fingers and knees.

Gel
Aluminium tube with 50 g and 100 g gel

Pack size: 1 tube

Shelf life:

• Climatic Zone II: 36 mths
• Climatic Zone IV: no data

ADAPALENE

Dosage:  1 mg/g

Therapeutic Class:
Topical Retinoids for topical use
in acne

ATC code: D10AD03

Cutaneous treatment of acne vulgaris in which comedones, papules and pustules predominate.

Cream: Aluminium tube with 30 g, 45 g and 60 g cream
Gel: LDPE tube with with 30 g, 45 g and 60 g gel

Pack size: 1 tube

Shelf life:

• Climatic Zone II: 30 mths
• Climatic Zone IV: no data

Oral
CYPROTERONE ACETATE
Dosage: 50 mg, 100 mg Therapeutic Class: Antiandrogens ATC code: G03HA01 Prostatic cancer Tablet PVC-Aluminium blister strip with 10/28 tablets... Read More
DIOSMINE
Dosage: 600 mg Therapeutic Class: Cardiovascular system – capillary stabilizing agent ATC code: C05CA03 Improvement of symptoms of venous insufficiency of ... Read More
NOMEGESTROL ACETATE
Dosage: 5 mg Therapeutic Class:  Progestogens ATC code: G03DB04 Treatment of menstrual cycle disorders due to absence or low secretion of progesterone in premenopa... Read More
GESTODENE / ETHINYLESTRADIOL
Dosage: 75 µg/20 µg, 75 µg/30 µg Therapeutic Class: Hormonal contraceptives for systemic use ATC code: G03AA10 Oral contraception Coated tabl... Read More
GESTODENE / ETHINYLESTRADIOL
Dosage: 60 µg/15 µg Therapeutic Class: Hormonal contraceptives for systemic use ATC code: G03AA10 Oral contraception Film-coated tablet ... Read More
DROSPIRENONE / ETHINYLESTRADIOL
Dosage:  3 mg/0.03 mg Therapeutic Class: Hormonal contraceptives for systemic use ATC code: G03AA12 Oral contraception Film-coated tablet ... Read More
DIENOGEST
Dosage: 2 mg Therapeutic Class: Progestogens ATC code: G03DB08 Treatment of endometriosis Film-coated tablet PVC-Aluminium blister strips with 1... Read More
DESOGESTREL / ETHINYLESTRADIOL
Dosage: 150 µg/20 µg, 150 µg/30 µg Therapeutic Class: ... Read More
DESOGESTREL
Dosage: 75 µg Therapeutic Class: Hormonal contraceptives for systemic use ATC code: G03AC09 Oral contraception Film-coated tablet PVC/PVD... Read More
CYPROTERONE ACETATE / ETHINYLESTRADIOL
Dosage: 2 mg/0.035 mg Therapeutic Class: Anti-androgens and oestrogens ATC code: G03HB01 Severe acne Coated tablet PVC-Aluminium blister strip ... Read More
CYPROTERONE ACETATE
Dosage: 50 mg Therapeutic Class: Antiandrogens ATC code: G03HA01 Control of libido in severe hypersexuality and/or sexual deviation in the adult male. ... Read More
URAPIDIL
Dosage: 30 mg, 60 mg, 90 mg Therapeutic Class: Antiadrenergic agent – peripherally acting ATC code: C02CA06 Hypertension Prolonged-release capsule,... Read More
Parenteral
AMIODARONE
Dosage:  50 mg/ml Therapeutic Class: Antiarrythmics (Class III) ATC code: C01BD01 Treatment of severe rhythm disorders not responding to other therapies or wh... Read More
LEVETIRACETAM
Dosage: 5 mg/ml, 10 mg/ml, 15 mg/ml Therapeutic Class: Antiepileptics ATC code: N03AX14 Monotherapy in the treatment of partial onset seizures with or without secon... Read More
TRANEXAMIC ACID
Dosage: 100 mg/ml Therapeutic Class: Antifibrinolytics ATC code: B02AA02 Prevention and treatment of haemorrhages due to general and local fibrinolysis in adults a... Read More
OXALIPLATINE
Dosage: 50 mg, 100 mg Therapeutic Class: Antineoplastic agent ATC code: L01XA03 Treatment of metastatic colorectal and stage III (Duke’s C) colon cancer in combi... Read More
PIPERACILLIN / TAZOBACTAM
Dosage: 2 g/250 mg, 3 g/375 mg, 4 g/500 mg, 12 g/1.5 g, 36 g/4.5 g Therapeutic Class: Beta-lactam antibacterials, penicillins ATC code: J01CR05 Treatment of ... Read More
FLUCLOXACILLINE
Dosage: 1 g, 2 g, 4g Therapeutic Class: Beta-lactam antibacterials; betalactamase resistant penicillins ATC code: J01CF05 Treatment of acute and chronic... Read More
PACLITAXEL
Dosage: 6 mg/ml Therapeutic Class: Antineoplastic agents (taxanes) ATC code: L01CD01 Treatment of advanced ovarian cancer, node positive and locally advanced ... Read More
ERYTHROMYCINE
Dosage:  1 g Therapeutic Class: Macrolides, lincosamides and streptogramins ATC code: J01FA01 Treatment of nosocomial pneumonia; skin and soft-tissue infecti... Read More
CLOXACILLINE
Dosage: 500 mg, 1 g, 2 g, 10 g Therapeutic Class: Beta-lactam antibacterials; betalactamase resistant penicillins ATC code: J01CF02 Treatment of infect... Read More
CEFUROXIME
Dosage:  250 mg, 750 mg, 1.5 g Therapeutic Class: Other beta-lactam antibacterials, 2nd generation cephalosporines ATC code: J01DC02 Treatm... Read More
CEFTRIAXONE
Dosage: 250 mg, 500 mg, 1 g, 2 g, 10 g Therapeutic Class: Other beta-lactam antibacterials, 3rd generation cephalosporines ATC code: J01DD04 ... Read More
CEFTAZIDIME
Dosage:  250 mg, 500 mg, 1 g, 2 g, 3 g, 6 g Therapeutic Class: Other beta-lactam antibacterials, 3rd generation cephalosporines ATC code: J01DD02... Read More
CEFOTAXIME
Dosage:  0.5 g, 1 g, 2 g Therapeutic Class: Other beta-lactam antibacterials, 3rd generation cephalosporins ATC code: J01DD01 Treatment of ... Read More
CEFEPIME
Dosage:  1 g, 2 g Therapeutic Class: Other beta-lactam antibacterials, 4th generation cephalosporins ATC code: J01DE01 Treatment of infecti... Read More
URAPIDIL
Dosage: 5 mg/ml Therapeutic Class: Antiadrenergic agent – peripherally acting ATC code: C02CA06 Hypertensive emergencies, severe and very severe forms of hyp... Read More
MILRINONE
Dosage: 1 mg/ml Therapeutic Class: Cardiac stimulants excl. cardiac glycosides ATC code: C01CE02 Short-term treatment of severe congestive and acute heart fail... Read More
ATOSIBAN
Dosage: 7.5 mg/ml Therapeutic Class: Genito urinary system and sex hormones – other gynecologicals ATC code: G02CX01 Indicated to delay imminent pre-term b... Read More
Topical
DICLOFENAC
Dosage: 1% Therapeutic Class: Musculo-skeletal system – anti-inflammatory preparations, non-steroids for topical use ATC code: M02AA15 Tendonitis of the upper and lower limbs... Read More
ADAPALENE
Dosage:  1 mg/g Therapeutic Class: Topical Retinoids for topical use in acne ATC code: D10AD03 Cutaneous treatment of acne vulgaris in which comedones, ... Read More