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Penine Injection_

NAFDAC Reg. No. 04-6673 · Drug

Registered with NAFDAC. Registration activeAs of 27 October 2026 · synced automatically from official sources.
Product
Penine Injection_
NAFDAC number
04-6673
Active ingredient
Quinine Dihydrochloride
Strength
600 mg/2 mL
Form
Intravenous infusion
Pack size
2 mL x 10's (in ampoules)
Manufacturer
Not listed
Applicant (holder)
Pemason Pharmaceuticals Ltd
Approved
30 Jan 2025
Status
Active View on NAFDAC ↗
Registration valid to
29 Jan 2030
WHO alerts
None found
Community reports
None
Times checked
0

What we found

  • Penine Injection_ is on the NAFDAC register with an active registration (04-6673). A valid number alone does not prove a pack is genuine — counterfeiters copy real numbers, so also check the expiry date, seal and print quality.

Generated automatically from the NAFDAC register, WHO alerts and community data as of today. This is not medical advice. Always follow your doctor or pharmacist.

What Penine Injection_ is used for

From the official U.S. FDA label for quinine dihydrochloride, the active ingredient registered with NAFDAC.

Boxed warning: HEMATOLOGIC REACTIONS Quinine sulfate use for the treatment or prevention of nocturnal leg cramps may result in serious and life-threatening hematologic reactions, including thrombocytopenia and hemolytic uremic syndrome/thrombotic thrombocytopenic purpura (HUS/TTP). Chronic renal impairment associated with the development of TTP has been reported. …
What it is used for

Quinine sulfate is an antimalarial drug indicated only for treatment of uncomplicated Plasmodium falciparum malaria. Quinine sulfate has been shown to be effective in geographical regions where resistance to chloroquine has been documented [see Clinical Studies (14) ] . Limitations of Use: Quinine sulfate capsules are not approved for: Treatment of severe or complicated P. falciparum malaria. Prevention of malaria. Treatment or prevention of nocturnal leg cramps [see Warnings and Precautions (5.1) ] . Quinine sulfate is an antimalarial indicated for treatment of uncomplicated Plasmodium falciparum malaria. …

Possible side effects

Most common adverse reactions are a cluster of symptoms called “cinchonism”, which occurs to some degree in almost all patients taking quinine: headache, vasodilation and sweating, nausea, tinnitus, hearing impairment, vertigo or dizziness, blurred vision, disturbance in color perception, vomiting, diarrhea, abdominal pain, deafness, blindness, and disturbances in cardiac rhythm or conduction. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Overall Quinine can adversely affect almost every body system. …

Do not use if

Quinine sulfate capsules are contraindicated in patients with the following: Prolonged QT interval. One case of a fatal ventricular arrhythmia was reported in an elderly patient with a prolonged QT interval at baseline, who received quinine sulfate intravenously for P. falciparum malaria [see Warnings and Precautions (5.4) ] . Known hypersensitivity reactions to quinine. …

Warnings

Thrombocytopenia, including ITP and HUS/TTP, has been reported. Discontinue drug. (5.2) Hemolytic Anemia: Monitor hemoglobin and hematocrit. Discontinue drug if hemolytic anemia occurs. (5.3) QT Prolongation and Ventricular Arrhythmias: Avoid concomitant use with drugs known to prolong QT interval. (5.4) Avoid concomitant use with rifampin. Quinine sulfate treatment failures have been reported. (5.5) Avoid concomitant use with neuromuscular blocking agents. Quinine sulfate may potentiate neuromuscular blockade and cause respiratory depression. (5.6) Serious and Life-Threatening Hypersensitivity Reactions: Discontinue drug. …

Pregnancy & breastfeeding

IN SPECIFIC POPULATIONS Renal Impairment: Reduce dose and dosing frequency for patients with severe chronic renal impairment. (2.2 , 8.6 , 12.3) Hepatic Impairment: Closely monitor for adverse reactions. Quinine should not be administered in patients with severe (Child-Pugh C) hepatic impairment. …

General information only, not dosing advice. Always follow the leaflet in your pack and your doctor or pharmacist.

Check your pack of Penine Injection_

Add the expiry date on your pack for a full Trust Score.

3 free checks left today Official sources: NAFDAC Green Book & recalls · WHO · U.S. FDA · NLM RxNorm

About Penine Injection_

What is in Penine Injection_?

Penine Injection_ contains Quinine Dihydrochloride (600 mg/2 mL), as intravenous infusion, according to its NAFDAC registration record.

Is Penine Injection_ registered with NAFDAC?

Yes. Penine Injection_ is listed on the NAFDAC register under registration number 04-6673, and its registration is active as of 27 October 2026.

Has Penine Injection_ been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Penine Injection_ in our automatically synced alert list.

How can I check that my pack of Penine Injection_ is genuine?

Run a free authenticity scan with the NAFDAC number 04-6673, your pack's expiry date and batch number to get a Trust Score, compare the pack with the NAFDAC record (ingredient, strength, form, manufacturer), and buy only from licensed pharmacies.

What is Penine Injection_ used for?

Quinine sulfate is an antimalarial drug indicated only for treatment of uncomplicated Plasmodium falciparum malaria. Quinine sulfate has been shown to be effective in geographical regions where resistance to chloroquine has been documented [see Clinical Studies (14) ] . Limitations of Use: Quinine sulfate capsules are not approved for: Treatment of severe or complicated P. falciparum malaria. Prev (Summarised from the official U.S. FDA label for quinine dihydrochloride. Always follow your doctor or pharmacist.)

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