SCHEDULE No. 1: Oral solid dosage forms: Fluoroquinolones
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1 ANNEX B/ SECTION 8: TECHNICAL SPECIFICATIONS NOTE: The estimated Global need for required below products is provided in Annex H of this ITB. Actual quantity to be ordered in 2015 can vary due to countries demand fluctuations. IDA/GDF make no guarantees in this regard. SCHEDULE No. 1: Oral solid dosage forms: Fluoroquinolones Item No. 1:Levofloxacin 250 mg tablet (blister) General Description: Levofloxacin 250mg film-coated tablets. Technical Specifications: Each tablet should contain Levofloxacin 250mg and should be biconvex film coated tablets and should be scored with central break-line on one side Packaging Al/PVC/PVDC film blister pack of 5 x 4 tablets x 5 blisters in a carton box or 10 tablets x 10 blisters in a carton box. Shelf life and storing conditions: minimum accepted 36 months shelf life. Store below 30 Item No. 2: Levofloxacin 500 mg tablet (blister) General Description: Levofloxacin 500mg film-coated tablets. Technical Specifications: Each tablet contains Levofloxacin 500mg and should be biconvex film coated tablets and should be scored with central break-line on one side Packaging: Al/PVC/PVDC film blister pack of 5 x 4 tablets x 5 blisters in a carton box or 10 tablets x10 blisters in a carton box. Shelf life and storing conditions: minimum accepted 36 months shelf life. Store below 25 Item No. 3: Levofloxacin 750 mg tablet (blister) General Description: Levofloxacin 750mg film-coated tablets. Technical Specifications: Each tablet should contain Levofloxacin 750 mg and should be biconvex film coated tablets and should be scored with central break-line on one side Packaging: Al/PVC/PVDC film blister pack of 5 x 4 tablets x 5 blisters in a carton box or 10 tablets x10 blisters in a carton box.
2 Shelf life and storing conditions: minimum accepted 36 months shelf life. Store below 25 Item No. 4: Moxifloxacin 400 mg tablet (blister) General Description: Moxifloxacin 400mg film-coated tablets. Technical Specifications: Each tablet should contain Moxifloxacin 400mg and/or scored tablets. Packaging: Al/PVC/PVDC film blister of 10 tablets x 10 blister in a carton box. Shelf life and storing conditions: minimum accepted 36 months shelf life. Store below 25 SCHEDULE No. 2: Oral solid dosage forms: Bacteriostatic Second Line Drugs Item No. 1: Ethionamide 250 mg tablet (blister/strip) General Description: Ethionamide 250mg film-coated tablets. Technical Specifications: Each tablet should contain Ethionamide 250mg and should be biconvex film coated tablets and should be scored with central break-line on one side Packaging: Al/PVC/PVDC film blister or Alu/Alu strip of 10 tablets x 10 blisters in a carton box. Shelf life and storing conditions: minimum accepted 24 months shelf life. Store below 25 Item No. 2: Prothionamide 250 mg tablet (blister) General Description: Prothionamide 250mg film-coated tablets. Technical Specifications: Each tablet should contain Prothionamide 250mg and should be biconvex film coated tablets and should be scored with central break-line on one side Packaging: Al/PVC/PVDC film blister of 10 tablets x 10 blisters in a carton box. Shelf life and storing conditions: minimum accepted 24 months shelf life. Store below 25
3 Item No. 3: Cycloserine 250 mg capsules (blister/strip) General Description: Cycloserine 250mg hard capsules. Technical Specifications: Each hard capsule should contain Cycloserine 250mg. Packaging: Al/PVC/PVDC film blister or Alu/Alu strip of 10 capsules x 10 blisters in a carton box. Item No. 4: PAS Acid granules (sachet) General Description: P-aminosalicylic acid (PAS) 4 g enteric coated delayed-release granules in sachets. Technical Specifications: Each sachet should contain aminosalicylic acid 4 g. Packaging: 30 Alu/PET/LLDPE sachets of 4 gr / 1 carton box. Shelf life and storing conditions: minimum accepted shelf life 24 months. Store in a dry place below 25 C, protect from light and moisture. Item No. 5: PAS Sodium powder for oral solution (sachet) General Description: P-aminosalicylate sodium salt powder for oral solution 5.52 g sachet. Technical Specifications: Each laminated sachet should contain power P- aminosalicylate sodium salt Packaging: Alu/PET/Alu/LLDPE laminated sachets in a carton box. The following quantities are preferable: 25 sachets in one carton box or; 300 sachets in one carton box Shelf life and storing conditions: minimum accepted shelf life 36 months. Store below 25 Item No. 6: PAS Sodium enteric coated granules (container) General Description: P-aminosalicylate sodium enteric coated delayed-release granules 60% w/w, 100 g HDPE container. Technical Specifications: Each granule contains P-aminosalicylate sodium salt.
4 Packaging: 100gr in LPDE bag placed in a triple laminated Alu/PET/Alu sachet further packed in HDPE container, includes dosing spoon and an insert. Shelf life and storing conditions: minimum accepted shelf life 36 months. Store below 25 C degrees, in a dry place, protected from light Item No. 7: PAS Sodium enteric coated granules (sachet) General Description: P-aminosalicylate sodium enteric coated delayed-release granules 60% w/w, 9.2 g sachets. Technical Specifications: Each granule should contain P-aminosalicylate sodium salt Packaging: 30 PET/Alu/LLDPE sachets of 9.2 g/ 1 carton box. Item No. 8: Terizidone 250 mg capsule (blister) General Description: Terizidone 250 mg capsules Technical Specifications: Each hard capsule should contain Terizidone 250 mg. Packaging: Al/PVC/PVDC blister pack of 10 hard capsules x 10 blister in a carton box. Shelf life and storing conditions: Minimum required 24 months. Store below 25 C degrees, in a dry place, protected from light.
5 SCHEDULE No.3: Parenteral Injectables Item No. 1: Capreomycin 1 g injectable- powder (vial/ampoule) General Description: Capreomycin 1 g powder for injection. Technical Specifications: Each vial/amp should contain Capreomycin 1 g. Packaging: 1 vial/ampoule in a carton box. Shelf life and storing conditions: Minimum required 24 months. Store below 25 C degrees, in a dry place, protected from light. Item No. 2: Kanamycin 1 g injectable solution (vial/ampoule) General Description: Kanamycin 1 g solution for injection. Technical Specifications: Each vial/amp should contain kanamycin 1 gram as sulphate. Packaging: 10, 50, 100 vials/ampoules in a carton box. Shelf life and storing conditions: Minimum required 36 months. Store below 25 C degrees, in a dry place, protected from light. Item No. 3: Kanamycin 1 g powder for injection (vial/ampoule) General Description: Kanamycin 1 g powder for solution Technical Specifications: Each vial/amp should contain kanamycin 1 gram powder as sulphate. Packaging: 10, 50, 100 vials/ampoules in a carton box. Shelf life and storing conditions: Minimum required 36 months. Store below 25 C degrees, in a dry place, protected from light. Item No.4: Amikacin 500 mg injectable solution (vial/ampoule) General Description: Amikacin 500mg solution for injection (2 ml) Technical Specifications: Each vial/amp should contain Amikacin 500mg. Packaging: 10 or 20 or 50 or 100 vials/ampoules in a carton box
6 SCHEDULE No.4: Oral solid dosage forms: Third line anti-tb Item No. 1: Amoxicillin Clavunalate mg tablet (blister) General Description: Amoxicillin Clavunalate mg film coated tablets Technical Specifications: Each tablet should contain 1004 mg Amoxicillin Trihydrate equivalent to Amoxicillin base 875 mg mg Clavunalate potassium equivalent to clavulanic acid mg. Packaging: Al/PVC/PVDC film blister pack of 7 tablets per blister x 2 blisters or 10 tablets per blister x 10 blisters /1 carton box C degrees, in a dry place, protected from light, Item No. 2: Amoxicillin Clavunalate mg tablet (blister) General Description: Amoxicillin Clavunalate mg film coated tablets Technical Specifications: Each tablet should contain 574 mg Amoxicillin Trihydrate equivalent to Amoxicillin base 500 mg and mg Clavunalate potassium equivalent to clavulanic acid 125 mg. Packaging: Al/PVC/PVDC film blister pack of 10 tablets x 2 blisters or 10 tablets per blister x 10 blisters / 1 carton box. C degrees, in a dry place, protected from light, Item No. 3: Amoxicillin Clavunalate mg tablet (blister) General Description: Amoxicillin Clavunalate mg film coated tablets Technical Specifications: Each tablet should contain 287 mg Amoxicillin Trihydrate equivalent to Amoxicillin base 250 mg and mg Potassium Clavulanatec equivalent to clavulanic acid 125 mg. Packaging: Al/PVC/PVDC blister pack of 7tablets per blister x 2 blisters or 5 tablets per blister x 3 blisters. Shelf life and storing conditions: minimum accepted shelf life 24 months. Do not store above 25º C degrees, keep in a dry place and protect from light.
7 Item No. 4: Amoxicillin Clavunalate mg powder for oral suspension Technical Specifications: 250 mg/62.5 per 5 ml powder for oral suspension. White to off-white powder for reconstitution with water. Each 5 ml of reconstituted suspension contains 287 mg Amoxicillin Trihydrate equivalent to 250 mg of amoxicillin base and mg potassium clavunalate equivalent to 62.5 mg of clavulanic acid. Packaging: Glass bottles with aluminium screw caps or a ROPP, internally lacquered closure, containing a Polymer (PVC) liner, containing powder for reconstitution to 100ml. Shelf life and storing conditions: minimum accepted shelf life 24 months. Do not store above 25º C degrees; store in original container to protect from moisture. Item No. 5: Amoxicillin Clavunalate mg powder for oral suspension Technical Specifications: 125 mg/31.25 per 5 ml powder for oral suspension. White to off-white powder for reconstitution with water. Each 5 ml of reconstituted suspension contains Amoxicillin Trihydrate equivalent to 125 mg of amoxicillin base and mg potassium clavunalate equivalent to mg of clavulanic acid. Packaging: Glass bottles with aluminium screw caps or a ROPP, internally lacquered closure, containing a Polymer (PVC) liner, containing powder for reconstitution to 100ml. Shelf life and storing conditions: minimum accepted shelf life 24 months. Do not store above 25º C degrees; store in original container to protect from moisture. Reconstituted suspension to store between 2º and 8ºC for 7 days. Do not freeze. Item No. 6: Clarithromycin 250 mg tablet (blister) General Description: Clarithromycin 250 mg film-coated tablets Technical Specifications: Each tablet should contained clarithromycin 500 mg Packaging: Al/PVC/PVDC film blister pack of 7 tablets per blister x 2 blisters or 10 tablets per blister x 2 blisters /1 carton box Item No. 7: Clarithromycin 500 mg tablet (blister) General Description: Clarithromycin 500 film-coated tablets Technical Specifications: Each tablet should contained clarithromycin 500 mg
8 Packaging: Al/PVC/PVDC film blister pack of 7 tablets per blister x 2 blisters or 10 tablets per blister x 10 blisters /1 carton box Item No. 8: Imipenem / Cilastatin 500 mg mg injectable powder for solution for IV (vial/ampoule) General Description: Imipenem / Cilastatin 500 mg mg powder for solution for IV infusion Technical Specifications: Each vial/amp should contain 500 mg of Imipenem monohydrate and 500 mg of Cilastatin sodium. Packing: 10, 20, 50, 100 vials in a carton box Item No. 9: Linezolid 600 mg tablet (blister) General Description: Linezolid 600 mg film-coated tablets Technical Specifications: Each film coated tablet contains linezolid 600 mg, white oval shaped bevel edged, biconvex film coated tablets Packaging: Al/PVC/PVDC film blister pack of 10 tablets per blister x 2 blisters /1 carton box; Shelf life and storing conditions: minimum accepted shelf life 36 months. Do not store above 30º C degrees, keep it in a dry place, protected from light.
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