CARBOPLATIN INJECTION 150MG/15ML

CARBOPLATIN INJECTION 150MG/15ML

CARBOPLATIN  is a chemotherapy drug. It targets fast-dividing cells, like cancer cells, and causes these cells to die. This medicine is used to treat ovarian cancer and many other cancers.

Carboplatin  Injection is an anticancer medicine that is used in the treatment of ovarian cancer (cancer of the ovary, part of the female reproductive organs that produces eggs) and lung cancer. This medicine works by preventing the growth of cancer cells by damaging the genetic material (DNA and RNA) which is required for their growth and development.

Carboplatin  Injection causes side effects like nausea, vomiting, temporary hair loss, pain, and weakness. This medicine may decrease the number of blood cells (red and white blood cells) in your body, making you more susceptible to infections or bleeding. Inform your doctor if you experience a fever, sore throat, chills, unusual bleeding or bruises, or dark urine.

Carboplatin  Injection is given by a qualified medical practitioner, therefore do not self-administer. Your doctor will determine the appropriate dose and duration of the therapy. This can vary depending on the severity of your condition. It may take many weeks or months for you to notice or feel the effects, but do not stop taking it until your doctor advises you to do so. Carboplatin  Injection can affect your heart, liver, and kidney adversely. Inform your doctor if you have any heart, liver, or kidney problems before starting this medicine. You should also inform your doctor if you are pregnant, planning a pregnancy, or breastfeeding.

Side effects

Major & minor side effects of Carboplatin  Injection

  • Low blood cell count
  • Abnormal Liver function
  • Pain at the injection site
  • Temporary Hair Loss
  • Muscle pain or weakness
  • Blood in urine and stools
  • Tingling or numbness of the hands and feet
  • Blurred vision
  • Ringing or buzzing in the ears
  • Black or Tarry stools
  • Cough or hoarseness

Uses of Carboplatin  Injection

What is it prescribed for?

  • Ovarian Cancer
    Ovarian Cancer is a condition in which there is an uncontrolled growth of cells in the ovary. The ovary is a part of the female reproductive system which produces eggs and female hormones (chemical messengers in the body). Ovarian cancer has symptoms like pain in the lower part of the stomach and pelvis region, abnormal vaginal bleeding, etc. Carboplatin  Injection is used along with other medicines in the treatment of ovarian cancer. It works by entering and attaching itself to the genetic material (DNA and RNA) of the cancer cells, thus preventing them from dividing and growing.
  • Small Cell Lung Cancer
    Small cell lung cancer is fast-growing cancer in the tissue of the lungs and is commonly caused by smoking. It begins with small tumours (abnormal growth of body tissue) in the lungs but eventually spreads to other body parts too. Its symptoms are breathlessness, chest pain, coughing, etc. Carboplatin  Injection is used in the treatment of lung cancer. It stops the growth of cancer cells and thus prevents them from spreading to other body parts.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

  • blood disorders
  • hearing problems
  • kidney disease
  • recent or ongoing radiation therapy
  • an unusual or allergic reaction to carboplatin, cisplatin, other chemotherapy, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

This drug is usually given as an infusion into a vein. It is administered in a hospital or clinic by a specially trained health care professional.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • signs of infection – fever or chills, cough, sore throat, pain or difficulty passing urine
  • signs of decreased platelets or bleeding – bruising, pinpoint red spots on the skin, black, tarry stools, nosebleeds
  • signs of decreased red blood cells – unusually weak or tired, fainting spells, lightheadedness
  • breathing problems
  • changes in hearing
  • changes in vision
  • chest pain
  • high blood pressure
  • low blood counts – This drug may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding.
  • nausea and vomiting
  • pain, swelling, redness or irritation at the injection site
  • pain, tingling, numbness in the hands or feet
  • problems with balance, talking, walking
  • trouble passing urine or change in the amount of urine

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • hair loss
  • loss of appetite
  • metallic taste in the mouth or changes in taste

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.

CARBOPLATIN INJECTION

PRODUCT PROFILE

Product: CARBOPLATIN INJECTION

Generic Name: CARBOPLATIN BP

Strength :150MG/15ML

Lot size: 1500 units

Claimed Volume: 15ml

Solution To be Filled:  15.2ml

Label Claim:  Each ml contains:

  • Carboplatin BP equivalent to Carboplatin – 150mg
  • WFI   (IP)  –  Q.s.

Shelf Life:   2 Years

Storage:   Store Between 15¡ to 20¡.Protect from light. Do not freeze.

Dosage Form:   As directed by the physician.

Dosage Form:

Liquid for Injection  ( For IV Use ).

Operating Parameters:Room Temperature :   25 + 2°C and  Relative Humidity  :   60 + 5 % .

MANUFACTURING FORMULA 

S.NoIngredientStandard QuantityOveragesRequired Quantity
01Carboplatin BP225 gm*Approx 5 %236.25*
02WFIQSQS

Calculations

(Lot size) X  (Strength per ml) X (Volume per unit) X 100 x 100 X Overages / 1000 X Assay (on an anhydrous basis)  X (100 – % of Water/LOD).

PACKING MATERIALS

ItemSpecificationQuantity
 Vials20 ml Vial White type I1537
Seal20mm F/O – Violet ( Code-K )1575
PlugsRubber Plugs 20mm -Silicone1537

BEFORE MANUFACTURING PROCESS INSTRUCTIONS:           

Clean thoroughly all the glassware with purified water and finally rinse with WFI. Cleaning of the compounding vessel, filling vessels, filtration equipment, and stirrer used earlier for products other than Active ingredients should be counter-checked and documented.  Rinse water samples should be checked by Q.C. for the absence of active ingredients of the previous product handled.

PRECAUTIONS:    

a) All parts in contact with the product must be of inert material.

b) Wear proper dress and accessories while handling raw materials.

c) Check that the manufacturing vessel is thoroughly cleaned.

d) Keep the sample solution collected at each stage separately till the batch manufacturing is Completed.

e) Check integrity of sterile membrane filter using bubble test before & after the filtration.

f) Check autoclave load indicators (chemical) of sterile loads before using every individual.

 MANUFACTURING PROCESS

Stage – 01: After the Q.C approval for chemical and BET testing, collect freshly prepared WFI into a manufacturing vessel.

Stage – 02:      Add the Carboplatin to the Manufacturing vessel with WFI.

Stage – 03:      Agitate for 15mins to ensure complete dissolution.

Stage – 04:      Flush Nitrogen gas throughout the manufacturing process.

Stage -05;       Check and Adjust the pH.

Stage – 06:       Inform to QC department to collect the sample for bulk analysis.

Stage – 07:       Start the filtration after getting results from QC.

STERILIZATION OF EQUIPMENT

1. Sterilize the membrane holder with 0.22µ member filter and 2micron filter,50ltr SS filling vessels filtration assembly, and filling assembly in steam sterilizer at 121°C and 15 PSI for 30 minutes before filtration.

2. Sterilize the filtration vessel in a steam sterilizer at 121°C and 15 PSI for 30 minutes before filtration.

FILTERATION PROCESS:

Previously Filter the solution through a 2.0-micron pre-filter with the help of filter housing aseptically in filtration zone and finally filter through  0.22 membrane filter ( MDI ) and take the pre integrity. Filter the solution in the aseptic area aseptically using 1.0 – 1.5 kg/cm2 pressure of filtered (0.2µ) Nitrogen.

Collect the filtrate in a sterilized and nitrogen-purged glass bottle. After filtration performs the post integrity test .

VIAL  WASHING AND STERILIZATION

Wash the glass vial on the vial washing machine as per the standard washing cycle using highly purified water.

Pass into sterilization tunnel above 300°C having conveyor speed 120 mm/min & then vials are Depyrogenated.

FILLING AND SEALING

After sterilization, the vials pass from the cooling stabilization zone and fill the approved solution in sterilized and Depyrogenated vials under LAF and seal with a rubber plug and F/O aluminum seal. Carry out filling with an automatic filling machine with the help of SS316 filling pump as per SOP After filling place the rubber plug on the filled vial. Seal the vial with the help of an Automatic sealing machine as per SOP. Transfer the filled vials for Visual inspection.

VISUAL INSPECTION:

Inspect each of the vials by manually with the help of visual inspection board containing white and black backgrounds with illumination for particulate matter, less volumes and sealing quality by trained inspector (workman).Check the filled vials for presence of any foreign particles. Keep good vials separate with a label containing product name, Lot.No,Mfg .Dt & Exp.Dt. Keep the rejected vials in separate box with their type of rejection. Transfer the good vials to the quarantine area. QC  chemist does the random sampling of products for final analysis.

LABELLING AND PACKING 

Label and pack the visually inspected and passed vials using the labeling and packing machine as per approved technical direction. Take the dispensed packaging materials i.e, label, carton, literature, inner C-Box Outer C box, etc. Take the passed vials from the quarantine area for labeling. Paste the pre-printed labels on the vials with the help of a labeling machine. Check the initial coding on labels for batch no., Mfg.Dt, Exp.Dt and MRP. The packing supervisor and QA chemist shall randomly inspect the quality of labeling and coding. Pack the final product in corrugated boxes. After the QC approval transfer the finished product to the store for dispatch.

Storage:    Finished goods are to be stored at room temperature below 250 C. Protect from light and Keep out of reach of children.

STANDARDS AND INPROCESS CHECK

S.NoParametersStandardsFrequencyPerson Responsible
1ClarityClear colorless   solutionAt the time of  adjusting pH before make-up and after the makeup of the volumeMfg. Chemist

IPQA Incharge

2Bubble Test for Membrane

Filters Pre and post filtration

Should passBefore filtration and after filtrationMfg. Chemist

IPQA Incharge

3Fill Volume Check15.2 ml30 minutesMfg. Chemist

IPQA Incharge

4Clarity of Filled VialsClear30 minutesMfg. Chemist

IPQA Incharge

5Spot CheckAll the vials should pass30 minutesMfg. Chemist

IPQA Incharge

6Overprinting  on Labels  and

other Packing material.

At the time of labeling & packing30 minutesMfg. Chemist

IPQA Incharge

7pH5.0 – 7.0Before filtration and after fillingQC incharge
8Sterility TestIs NegativeBefore filtration and after fillingQC incharge
Assay90-110%Before filtration and after fillingQC incharge

YIELDS   

S.NoProcessTheoreticalPermissible
1Bulk99.50%98 – 99.5%
2Filling99.0%97 – 99.0%
3After visual inspection and packing97%96 – 97%

EQUIPMENT, MACHINERY AND ACCESSORIES

S.No.EquipmentMakePurpose
150 L Manufacturing VesselS.S 316Manufacturing
2100 L Filling VesselS.S 316Holding of filtered solution
3pH MeterMaxThroughout mfg.
42.0 micron Pre- filterMDIPre -filtration of Bulk solution
50.22 micron membrane filterMDIFiltration of Bulk solution
6Vial Washing MachineLaxmi pharmaWashing of Vials
7Sterilising TunnelFabtecdepyrogenation of Washed Vials
8AutoclaveNANA
9Filling   MachineN.K.ENGFilling of solution into Vials
10Sealing MachineN.K.ENGSealing of Vials
11Visual Inspection TablePragathiVisual inspection
12Labelling MachineMaharishiVials Labelling

ANALYSIS:

Bulk solution analyzed and released by Q.C for filling.

Filled Vials are drawn online for analysis by QC.

CONTROL SAMPLES 

03 labeled and duly packed Vials are collected online by IPQA Incharge during packing and sent to QC for storage in the control sample room.

WASTAGE / REJECTION DISPOSAL

Control samples are destroyed 3 months after the expiry of the batch as per the standard operating procedure. Destruction records are to be maintained. Filled rejected Vials are first inactivated by using suitable chemicals and then destroyed by crushing as per the standard operating procedure. Printed packing material is destroyed by shredding it into small pieces.

DOCUMENTATION CHECK 

Checked and duly signed by authorized production and Q.A. personnel.  Batch records are to be preserved for 5 years after manufacturing in the record room.

 TRANSFER

Packed finished goods are transferred to FGS  after proper entry in ERP. Dispatched after complete analysis and release by QA.  Distribution records are maintained at finished goods stores.

TECHNICAL DIRECTION   

Generic name:  CARBOPLATIN BP                           

Claim      : 150MG/15ML

Description of Product: Carboplatin for Injection

S. No.ComponentBrief DescriptionQty./ MasterPackaging Instructions
1.Glass Vial 20 ml20ml white type I   Vial.40 No.Fill sterile dry powder as per required weight aseptically.
2.Rubber plug20 mm bromo butyl -Silicone40 No.Plug the vial using a sterile rubber plug aseptically.
3.Flip – off seal

( Violet –  Code -k )

20mm standard virgin Flip-off aluminium seal with RANI color plastic flip.40 No.Seal the vial properly using flip-off aluminium seal.
4. Label

 

Sticker Label for vial printed as per the party art work given.Size : 95 X2  mm ± 1 mm40 No.Paste one label on each vial duly coded with batch No. Exp. date & Mfg. Date.
5.  Unit carton

 

Unit carton made up of 300 GSM ± 10% laminated art card, printed as per approved text, color and design.Size :  50X50X85  mm ± 1 mm40 No.Put 1 tray containing one vial +  1 , 10 ml WFI amp.  in  each unit carton duly coded with all batch details.
6.LiteratureAs per party artwork40 No.Put 1 in each unit carton .
7.Water for injection.NANANA
8.Plastic TrayNANANA
9.Shrink packShrink pack made from  9 inch polythene roll.16 Nos10 unit carton in each shrink pack
10.Shipper Corrugated boxMaster carton made up of  5 ply and 100 GSM, printed as per approved text, color and design.

Size :As Per std

08 No.Put 4 Shrink in each master carton.
11.Gum/Tape/Patti

 

48 mm  ±1 mm wide self adhesive unprinted BOPP , PlainAs per RequirementClose the corrugated boxs flaps and seal them using BOPP tape.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

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