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PHARMACEUTICAL FORMS

THERAPEUTIC AREAS

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

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